Abstract: An obturator assembly for use in dissection of tissue includes an obturator housing, an obturator member mounted to the obturator housing and an obturator sleeve coaxially mounted about the obturator member and adapted for reciprocal longitudinal movement between a retracted position and an extended position. The obturator member includes an obturator rod and a penetrating end. The penetrating end defines a substantially planar dissecting segment and a central rod segment extending from the planar dissecting element. The planar segment of the penetrating end defines atraumatic outer edges which may be arcuate in character. In one embodiment, the distal entry surface of the central rod segment and the atraumatic edges of the planar dissecting segment are at least partially exposed from the nose shield when in the extended position of the obturator sleeve. The obturator sleeve may include a generally tapered nose shield for at least partially accommodating the penetrating end.

Abstract: An electromagnetic radiation therapy system comprising an apparatus that emits electromagnetic radiation centred at or around 1072 nm and configured so as to be placed around a large proportion or the whole of a human or animal body. The invention also includes methods of treating diseases associated with a lack of compliance and or elasticity of vessels such as airway and/or blood vessels.

Abstract: Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways.

Abstract: A bone fixation device (1) comprising: A) a first bone implant (2) with at least one through hole (11) having an upper opening (3) with the area A and a lower opening (4) in the case of a bone plate (10) as the first bone implant (2); or an outer opening with the area A and an inner opening in the case of a hollow intramedullary nail as the first bone implant (2); B) at least one second bone implant (5) with a head (6) and a shaft for insertion into one or more of said through holes (11); and C) at least one closing cover (7) for closing said upper opening (3) or outer opening of said through hole (11) for preventing bone and soft tissue ingrowth and/or bacterial invasion into said through hole (11) and into said second bone implant (5) wherein said closing cover (7) is D) removably attachable to said first bone implant (2); and E) dimensioned and shaped in such a way that upon attachment to said first bone implant (2) it is apt to cover at least the entire area A of said upper opening (3) or outer opening an

Abstract: A medical device for removing a material from a hollow anatomical structure is provided. The device may include a shaft member. The device may include an expandable centering element near the distal end of the device. The device may include a macerator element either attached to the shaft or independent and freely moveable from the shaft. Alternatively, the device may include a rotating wire attached to the macerator element. The device may include an aspiration lumen in for removal of material. The device may include a drive shaft attached to a motor and used to rotate the macerator element. The device may be used in combination with a distal occlusion element, which may be either a radially expandable filter or balloon member.

Abstract: A balloon catheter includes an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. A balloon having an inflation compartment is formed a balloon wall including a working surface, and further includes at least one chamber adjacent to the working surface adapted for receiving an identifier for identifying the location of the working surface. Related aspects are also disclosed.

Abstract: A catheter securement device includes a body having a generally curved channel configured to receive a central venous catheter and reposition it in a different direction than the direction of the catheter as it exits the skin of the patient. The securement device includes a cover that slidably connects to the securement device body to prevent the catheter from being pulled out of the curved channel.

Abstract: A method of reducing the risk of clinical sequelae to catheter induced vascular injuries may include introducing a guide wire into a vascular sheath residing in a blood vessel, proximally retracting the vascular sheath while leaving the wire in place, and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may further involve proximally retracting the guide wire to position the inflatable balloon adjacent the injury and inflating the balloon to reduce blood flow past the injury, while leaving the guide wire in place to provide subsequent access to the injury. The inflatable balloon can be inflated and deflated through a valve positioned at the proximal end of the guide wire.

Abstract: A method of delivering a prosthetic heart valve to a native aortic valve is disclosed. The prosthetic heart valve comprises a radially compressible and expandable metallic stent and a flexible valvular structure. A delivery system comprises a selectively steerable section and a pusher member extending through a central lumen of the steerable section. The prosthetic heart valve is compressed and inserted into a distal end portion of the delivery system. The delivery system and prosthetic heart valve are advanced through a femoral artery and around an aortic arch. A pull wire is actuated for selectively controlling a curvature of the steerable section during advancement around the aortic arch. The pusher member is advanced for ejecting the prosthetic heart valve from the delivery system into the native aortic valve, wherein the prosthetic valve self-expands after ejection.

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: A weeping balloon catheter includes a catheter having an elongate tubular body defining an inflation lumen and a combination lumen that terminates at an open distal end of the elongate tubular body. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the inflation lumen. A drug delivery balloon is disposed at least partially over the dilation balloon and includes at least one drug release opening through an outer wall of the drug delivery balloon. The drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body.

Abstract: A fixator assembly comprising a fixator for fixing inside a blood vessel, a guide tube attached to the fixator and a pump for supplying a liquid to the blood vessel or from the blood vessel via the guide tube. Blood flow past the fixator is possible during pumping so that critical situations are avoided. A method of providing a liquid to a blood vessel using the assembly is also claimed. Sampling or liquid dosing thus may be performed during extended periods of time while performing this at a well-defined position in the blood vessel and potentially close to or at the desired position in the person.

Abstract: A rapid exchange balloon catheter including: an outer conduit having a lumen and a wall surrounding the lumen, the wall including a lateral opening formed therein; an inner conduit having a proximal end and a distal end; a sealing sleeve for sealing the lateral opening of the outer conduit; a balloon whose proximal margin is attached to the outer surface of the distal end of the outer conduit, and whose distal margin is attached to the outer surface of the portion of the inner conduit that extends beyond the distal end of the outer conduit; a pushing-pulling mechanism disposed in the outer conduit; and a fluid port for the introduction of an expansion fluid and for the removal of the expansion fluid.

Abstract: Embodiments include an infusion-occlusion system having a delivery catheter, a guide catheter adapted to receive the delivery catheter, and a guidewire with an occlusion device adapted to be received within the guide catheter. The guide catheter of the catheter kit may be provided with an occlusion device at the distal end of the guide catheter. The delivery catheter may have an accessory lumen, coaxial or co-linear lumen, a supporting mandrel, or an occlusion device at its distal end. Moreover, according to some embodiments, occlusion devices may be a single material or a composite balloon having an inner liner and an outer layer of different materials, a high compliance low pressure balloon, or a filter device that restricts particles from passing through but does not restrict fluid, such as blood. An inflation device with a large volume and low volume syringe can be used to inflate the balloon.

Abstract: Catheters for occluding, visualizing, irrigating, evacuating, and delivering agents to a treatment area are disclosed. The catheters comprise a catheter body comprising five lumens, first and second occlusion balloons coupled to the catheter body, an optional space-occupying balloon coupled to the catheter body and disposed between the first and second occlusion balloons, and an optional visualization means that enables visualization between the first and second occlusion balloons. Methods for using these catheters are also disclosed. A method comprises inflating the first and second occlusion balloons, inflating the space-occupying balloon, allowing fluid to exit via an evacuation lumen, optionally irrigating or aspirating to facilitate fluid exit via said lumen, and delivering an agent to a treatment area via the agent lumen.

Abstract: A balloon catheter is provided with three lumens. The first lumen may be used as a guide wire lumen. The second lumen may be used as an inflation lumen. The third lumen may be used to provide various treatments to a vessel. Methods of using the balloon catheter to treat a patient are also provided.

Abstract: A method and apparatus for suture-less placement of an occluding patch in which release of the device can be accelerated. In one embodiment, an inactive form of an adhesive is applied on the area of the patch that will come into contact with cardiac tissue; this allows for the introduction and necessary manipulation of the catheter system until activation of the adhesive occurs. In accordance with one aspect of the invention, the adhesive properties of certain polymeric materials are relied upon rather than their ability to cure or harden into a specific shape. In another embodiment, the patch is immediately released utilizing a detaching mechanism on the balloon or the balloon catheter which supports the patch; the patch along with the inflated balloon remain on the cardiac structure occluding the opening.

Abstract: A balloon catheter having a shaft, a balloon, and an external delivery tube, as well as methods of use thereof. In one example, the balloon catheter is an agent delivery catheter including a catheter body extending between catheter proximal and distal portions. An inflatable balloon assembly is coupled with the catheter body. An agent delivery assembly, which is coupled with the catheter body and the inflatable balloon assembly, includes a delivery lumen extending through the catheter body and an agent delivery tube extending along an exterior balloon surface. The agent delivery tube includes at least one delivery orifice directed outside of the exterior balloon surface. The agent delivery assembly is isolated from fluid communication with the inflatable balloon assembly.

Abstract: A method of dilating an infundibular space within the human head includes directing at least a distal portion of an elongate member of a medical device into a nasal cavity of the human head, the distal portion including a piercing tip and an expandable portion. The piercing tip is directed through tissue of an uncinate process or tissue near an uncinate process and into an ethmoid infundibulum and the expandable portion of the distal end is expanded within the ethmoid infundibulum.

Abstract: A balloon catheter for use in connection with a guidewire comprises an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end, an inflatable balloon supported, along the distal end of the shaft, the balloon when inflated including first and second spaced ends and a working surface between the ends, and at least one wire including at least a radiopaque portion for identifying the location of working surface of the balloon.

Abstract: A vena cava filter catheter includes a catheter having a lumen disposed therethrough and at least one strand of biocompatible wire. The at least one strand has a first state in which the at least one strand has an elongate geometry suitable for traversing the lumen of the catheter and a second state in which the at least one strand assumes a pre-set geometry in which the at least one strand assumes a tortuous configuration adapted to occupy a space approximating a luminal diameter of an inferior vena cava.

Abstract: A device and method for treating a hollow anatomical structure using matter in a plasma state. Device includes a tubular delivery device comprising a tubular body, a hub, and a distal end, wherein the tubular body device having a longitudinal fluid delivery channel and an exit port near the distal end. Device also contains a container having pre-plasma matter being operatively coupled to the hub, at least one energy-emitting element operatively coupled near the distal end of the tubular delivery device. The energy-emitting element is operatively connected to energy source.

Abstract: A needleless injector including a body at a proximal end, a shaft extending distally from the body, at least one injection orifice at a distal end of the shaft in fluid communication with a fluid chamber at the proximal end, a pressure source in communication with the fluid chamber, and a tissue tensioner located at the distal end of the shaft proximal to the injection orifice, wherein the distal end including the tissue tensioner and injection orifice is positionable within a urethral lumen so that when the tissue tensioner is deployed, tissue of the urethra is tensioned at a location for injection of fluid from the injection orifice into the tissue of the urethra.

Abstract: Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, aspirate clot and fluid, and allow passage of a guidewire. Optionally, the catheter may also include a mechanical agitator for further disrupt clot in the presence of the thrombolytic agent. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.

Abstract: A method for transferring a macromolecular complex to muscle cells by exsanguinating a region of the subject's microvasculature and delivering the complex to this region under high hydrostatic pressure. A balloon catheter having a balloon that extends substantially the full length of the cannula that is inserted into the subject is provided for use in the systemic delivery of macromolecular complex.

Abstract: A method of treating a prostate condition, including the steps of providing a needleless injector that includes a body at a proximal end, an injection shaft extending from the body to a distal end of the injection shaft, an injection orifice at the distal end of the injection shaft and positioned for fluid ejection in a lateral direction relative to a longitudinal axis of the injection shaft, a pressure source in communication with the fluid chamber, and an extendable tissue tensioner located at the distal end of the injection shaft proximal to the injection orifice; inserting the injection shaft into a urethra so the injection orifice is located within the prostatic urethra; actuating the tissue tensioner to contact urethral tissue, and injecting fluid from the injection orifice into the prostate.

Abstract: Methods and devices for performing percutaneous and surgical interventions. The devices comprising a tubular portion and retractable mechanism at the distal end of the tubular portion. The retractable mechanism prevents the device from pulling out of an anatomical structure during complex interventions, for example, when switching from an antegrade to a retrograde approach within a blood vessel, enables the use of a single sheath when declotting AV hemodialysis fistulas and can provide occlusion of blood flow during interventions and means of removal of debris or clot from the blood vessel.

Abstract: The present invention provides systems and methods for the targeted delivery of a therapeutic agent using expandable devices that are temporarily or permanently placed within the body. Such therapeutic agents may be delivered as a coating on the outer surface of the expandable device. Once positioned at a desired location within the body, the device is expanded such that its drug-coated outer surface establishes direct contact with a target tissue. The expanded device remains in contact with the target tissue for a pre-determined amount of time prior to being withdrawn from the body. Delivery of the therapeutic agent using the expandable device may be followed, or preceded, by delivery of a second expandable device to the same location within the body.

Abstract: The invention relates to a method for producing a bioactive surface on the balloon (3) of a balloon catheter (1). According to said method, the surface of the balloon (3) is at least partially wetted with a first solution of an active substance (8) and the section of the surface of the balloon (3) wetted with the first solution of an active substance (8) is then wetted with a second, saturated solution of the active substance (28). The invention further relates to a balloon (3) of a balloon catheter (1) the surface of which is at least partially coated with an active substance (11), the coating (11) being homogeneous and brittle in the entire coated region.

Abstract: A coating composition for drug eluting medical devices, which is capable of forming a drug coating layer that is not susceptible to peeling during delivery to a target tissue is provided. This coating composition contains: a water-insoluble drug; at least one selected from the group consisting of hyaluronic acid, alkanoyl hyaluronic acids obtained by substituting at least part of hydrogen atoms in the hydroxyl groups of hyaluronic acid with an alkanoyl group, and salts of hyaluronic acid and the alkanoyl hyaluronic acids; and at least one selected from the group consisting of amino-acid esters and salts thereof. A drug coating layer, a medical device and a method of treatment are also provided.

Abstract: A coating composition for drug-eluting medical devices, which enables a medical device to be delivered to a target tissue for the purpose of treating an affected blood vessel part such as restenosis, without easy separation of a drug from the medical device during the delivery process is provided. The coating composition for drug-eluting medical devices contains a water-insoluble drug and at least one selected from the group consisting of ester compounds of amino acids, which have a hydropathy index of the amino acid of zero or less than zero, and salts thereof. A drug coating layer, a drug-eluting medical device and a method of treatment are also provided.

Abstract: Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes inserting an intramural crossing device into the vascular lumen, positioning at least the distal tip of the crossing device in the vascular wall, advancing an orienting device over the crossing device such that an orienting element of the orienting device resides in the vascular wall, inserting a re-entry device, and re-entering the true vascular lumen.

Abstract: System for treating vascular disease comprising a balloon having an outer surface for temporary contact with a vessel wall when in an expanded state, a coating disposed on at least a portion of the outer surface, the coating including an initial amount of a cytostatic agent selected from the group consisting of Zotarolimus (ABT578), everolimus, pimecrolimus, and a combination thereof, the coating being capable of maintaining a therapeutically effective amount of the cytostatic agent on the outer surface for delivery to a vessel wall, and further wherein between about 4.9% to about 23% of the initial amount of the cytostatic agent on the outer surface remains disposed on the outer surface after delivery of the therapeutically effective amount of the cytostatic agent to the vessel wall, and optionally, a stent disposed on the balloon.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including proximal and distal ends, a lumen extending therebetween, and a balloon on the distal end. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The valve may be biased to be closed, e.g., by a spring element disposed within the balloon. Optionally, the apparatus also includes an actuator for expanding a helical member within the balloon interior, e.g., either before or after expanding the balloon, such that the helical member and balloon may adopt an expanded helical shape for removing material within a body lumen.

Abstract: The embodiments disclosed herein relate to balloon catheter assemblies. The balloon catheter assemblies can include a hub, an elongated member, and an inflation balloon. The balloon catheter assemblies can also include a support wire having a proximal end that is longitudinally displaceable within a sleeve that is disposed in the catheter hub. A distal end of the support wire may be coupled to the inflation balloon at one or more positions.

Abstract: A device for treating the lumen of a living body includes a shaft insertable into a blood vessel, and a balloon provided on the shaft and shiftable between a deflated state and an expanded state. In the expanded state, the balloon has a recessed portion configured to form a coating chamber which is substantially blocked between an inner surface of the blood vessels and the device for treating the lumen of a living body, a discharge port provided on the recessed portion to discharge a coating substance toward the coating chamber; and a suction port provided on the recessed portion to apply a negative pressure to the coating chamber.

Abstract: Apparatus and method for repairing an abnormality in the wall of a body lumen, the method comprising isolating the abnormality in the wall of the body lumen from flow in the body lumen; positioning flowable forming material adjacent to the abnormality in the wall of the body lumen; and transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen, and the apparatus comprising a supply of flowable forming material; zone isolation apparatus for isolating the abnormality in the wall of the body lumen from flow in the body lumen; and positioning apparatus for positioning the flowable forming material adjacent to the abnormality in the wall of the body lumen so as to repair the abnormality in the wall of the body lumen.

Abstract: Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, and a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided. In accordance with one aspect there is provided a submucosal implant device for diagnosing and treating disorders of the body. The submucosal implant device may take the form of a gastric stimulator in which signals are supplied to the muscular wall of a mammal to treat motility disorders. In accordance with yet another aspect there is provided a method for performing a submucosal medical procedure to deploy a submucosal implant device in the digestive tract of a mammal.

Abstract: Cell delivery matrices and methods for facilitating local delivery of adipose derived endothelial cells to a target tissue, body cavity, or joint are described. The cell delivery matrix may be a three-dimensional matrix scaffold comprising fibrin derived from the patient's own body. The cell delivery matrix may be biocompatible and semi-permeable. The cell delivery matrix used in the methods of the invention may be comprised of any degradable, bioabsorbable or non-degradable, biocompatible polymer. Regenerative therapies comprising implanting in the subject cell delivery matrices localizing adipose derived endothelial cells are described. The cell delivery matrices maintain the adipose derived endothelial cells at the target for a therapeutically effective amount of time. The adipose derived endothelial cells can be allogenic or syngenic to the subject. The endothelial cells may be delivered alone or in combination with other therapeutic agents.

Abstract: A weeping balloon catheter includes a catheter having an elongate tubular body defining an inflation lumen and a combination lumen that terminates at an open distal end of the elongate tubular body. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the inflation lumen. A drug delivery balloon is disposed at least partially over the dilation balloon and includes at least one drug release opening through an outer wall of the drug delivery balloon. The drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body.

Abstract: Devices for the treatment of vascular aneurysms are described. The treatment is achieved through the delivery of an effective amount of elastin stabilization agent to an isolated volume at the aneurysm. The elastin stabilization agent maybe embedded in a delivery composition. The device optionally has an aspiration means to improve the effectiveness of the treatment.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: An implant can include a support component, a cover component, and a valve component. The valve component can be operable to permit flow through the implant. The implant can be delivered on a catheter, with one of the ends of the implant being selectively expanded to permit temporary occlusion of a vessel while delivering a material through the valve component to a downstream target region. The other end of the implant can thereafter be released such that the implant occludes the vessel, or the implant can be removed from the vessel entirely.

Abstract: A medical device that releases a pharmaceutical agent to a target site is disclosed. The medical device includes a balloon, and a coating on at least a portion of the balloon. Each particle of the particles of the pharmaceutical agent is at least partially encapsulated in a polymer layer. The method includes the steps of providing a device including a balloon, and a coating on at least a portion of the balloon, the coating including particles of a pharmaceutical agent, and each particle of the pharmaceutical agent is at least partially encapsulated in a polymer layer; positioning the device to allow the balloon to reach the target site; and inflating the balloon of the device.

Abstract: System and methods are provided for treating a patient that include a delivery device sized for introduction into a target site within a patient's body, a source of one or more therapeutic and/or diagnostic agents coupled to the delivery device, and a tubular member sized for introduction into the patient's vasculature to isolate the thoracic duct. Once the thoracic duct is isolated, fluid may be removed from the thoracic duct, e.g., to prevent the agents that transit from the target site into the thoracic duct from entering the patient's vasculature, and/or to modulate flow through the thoracic duct to modulate concentration and/or resident time of the agents at the target site. The one or more agents may include particles sized for preferential transit into the lymphatic system.

Abstract: The present invention relates to articles and methods of treating vascular conditions with a thixotropic, turbid, bioactive agent-containing gel material capable of being essentially removed from an implantation site upon re-establishment of fluid flow at the implantation site.

Abstract: A catheter assembly may be provided with a catheter body and an inflatable balloon. The catheter body has a proximal end, a distal end and a balloon inflation lumen. The inflatable balloon is attachable to the distal end of the catheter body. The balloon has an inner surface that at least partially defines an interior volume. The balloon is configured such that the interior volume can be in fluid communication with the inflation lumen of the catheter body to inflate the balloon. The balloon also has a proximal surface and a distal surface. The balloon is provided with a channel that extends through the balloon. The channel is configured to provide fluid communication between the proximal surface of the balloon and the distal surface of the balloon. Other catheter assemblies and methods of use are also disclosed.

Abstract: A weeping balloon catheter includes a catheter having an elongate tubular body defining a medical device lumen and a liquid delivery lumen. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the liquid delivery lumen. The dilation balloon includes a fluid communication channel through an outer wall of the dilation balloon. A flow restriction member is positioned along the fluid communication channel and has an open position permitting fluid communication along the fluid communication channel and a closed position blocking fluid communication along the fluid communication channel. A drug delivery path of the weeping balloon catheter is defined by the liquid delivery lumen and the dilation balloon.

Abstract: A drug coating layer which is a drug coating layer having a morphological form including a plurality of elongated bodies having long axes that each crystal of a water-insoluble drug independently has on a substrate surface, in which the long axes of the elongated bodies are nearly linear in shape, and the long axes of the elongated bodies form an angle in a predetermined range with respect to a substrate plane with which the long axis of the elongated body intersects. The drug coating layer can provide low toxicity and a high intravascular stenosis inhibitory effect.