Abstract: A combination flush catheter and selective catheter as one convertible catheter and methods of using the same. The selective catheter may be a reverse curve or guide catheter. The additional steps of removal of the flush catheter and re-insertion of the selective catheter may be eliminated, reducing the possibility of errors and making the procedure smoother and shorter.

Abstract: Inflatable medical balloons are disclosed herein. The inflatable medical balloons include balloon walls that are reinforced with graphene. The balloon walls can include any number of layers and one or more of the layers may include graphene. Catheters including the medical balloons are also disclosed in addition to methods for manufacturing the inflatable medical balloons.

Abstract: Today's suppositories are typically packaged individually for digital administration into the anal canal of a patient. A suppository applicator described herein, which works with individually packaged suppositories, can alternatively be shipped in a prepackaged operational arrangement with a suppository to enable the patient to administer the suppository through use of the applicator in a single operation after opening a hygienic wrapper containing the applicator-suppository combination. A method for manufacturing a suppository includes manufacturing the suppository in the presence of and in contact with an element configured to be used to insert the suppository into a body cavity. The method may include using the element to define a shape of the suppository during the manufacturing.

Abstract: The present disclosure relates to a basket for a catheter designed to be deployed in complex vasculature to optimally treat vascular and arterial disease conditions such as blood clots, blood emboli, and deep vein thrombosis. The basket may comprise a shaft with a plurality of cuts along a portion of its length to form a plurality of tines that provide support for a plurality of porous tubes to form the limbs of the basket. The limbs of the basket expand radially away from the longitudinal axis of the basket when the longitudinal length of the basket is reduced. The limbs may also be connected to a drug delivery system, and in this manner, baskets of the present disclosure allow for the use of both mechanical and pharmaceutical means of thrombolysis.

Abstract: A collapsible, transluminally deliverable embolic protection device (200) for temporarily positioning in the aortic arch is disclosed. The device is connectable to a transluminal delivery unit (130) extending proximally from a connection point (131). The device has a frame with a periphery, and a blood permeable unit within said periphery for preventing embolic particles from passing therethrough into side vessels of said aortic arch to the brain of a patient. Further, the device has at least one tissue apposition sustaining unit, not being a delivery shaft of said device, for application of a force offset to said connection point at said device, such as at said periphery, towards an inner wall of said aortic arch when said device is positioned in said aortic arch, such that tissue apposition of said periphery to an inner wall of said aortic arch is supported by said force. In addition related methods are disclosed.

Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on said substrate, wherein said 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 said coating and on said substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of said medical device in the body of said subject a portion of said pharmaceutical agent and/or active biological agent is delivered at said intervention site along with at least a portion of said polymer and/or a at least a portion of said pharmaceutical carrying agents.

Abstract: A tack device for holding plaque against blood vessel walls in treating atherosclerotic occlusive disease can be formed as a thin, annular band of durable, flexible material. The tack device may also have a plurality of barbs or anchoring points on its outer annular periphery. The annular band can have a length in the axial direction of the blood vessel walls that is about equal to or less than its diameter as installed in the blood vessel. A preferred method is to perform angioplasty with a drug eluting balloon as a first step, and if there is any dissection to the blood vessel caused by the balloon angioplasty, one or more tack devices may be installed to tack down the dissected area of the blood vessel surface, in order to avoid the need to install a stent and thereby maintain a ‘stent-free’ environment.

Abstract: An intravascular sensor assembly including a flexible elongate member having a longitudinal axis (LA) is provided. The sensor assembly includes a first engagement feature proximal to a distal end of the flexible elongate member; a core member disposed inside a lumen of the flexible elongate member, the core member configured to translate within the flexible elongate member along the LA proximal to the first engagement feature; and a component holding a sensor circuit, the component fixedly secured to a distal end of the core member such that the mounting structure translates along the LA of the flexible elongate member with the core member. A system and a method for performing measurements using a sensor as above are also provided.

Abstract: An adaptable inflation device for up to two balloon catheters for angioplasty includes a plurality of three port valves controlling flow to two fluid channels each coupled at an outlet to a balloon catheter for angioplasty. A single in line pressure gauge, which may be removable, monitors pressure of each channel. Each balloon catheter may be inflated and deflated, sequentially inflated, simultaneously inflated, sequentially deflated, simultaneously deflated, inflated to the same pressures, inflated to different pressures, partially deflated, and fully deflated.

Abstract: Surgery is performed on a patient with a novel device by: excising tissue from tissue mass within a patient to create a cavity within the tissue mass; inserting a novel device of this invention into the cavity; shaping a flexible expandable component of the device to adjust dimensions on the flexible expandable component; providing a liquid into the component through the liquid input port; and controlling pressure or flow rate of the liquid in the component to move the liquid through the multiple openings and into the cavity. The device has a liquid inlet port, an exterior surface having length, width and depth, and multiple openings in the surface distributed throughout the length, width and depth to act as liquid delivery ports; the exterior surface of the liquid delivery device being shapeable by internal pneumatic pressure or hydraulic pressure to better fit inside dimensions of a surgical cavity; the multiple openings deliver the liquid through the multiple openings.

Abstract: Methods of using a medical device having catheter with one or more expandable constricting/occluding members for preventing distal embolization during extracranial or intracranial carotid procedures or vertebral artery procedures by augmenting collateral cerebral circulation by coarctation of the aorta to enhance reversal of blood flow in an internal carotid artery, an external carotid artery, and/or a common carotid artery are disclosed. An interventional catheter can also be advanced into a right cerebral artery and a procedure performed on a lesion in the right cerebral artery.

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: Methods and devices quickly and accurately locate the sphenopalatine ganglion (SPG) while performing a sphenopalatine ganglion block procedure that introduces a medication to the SPG. The methods and devices also prevent the medication applied to the SPG from flowing down a patient's throat during the procedure.

Abstract: Extracellular matrix (ECM) constructs having a biodegradable support scaffold and an anchoring mechanism, which includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein. In a preferred embodiment, the support scaffold and anchoring mechanism comprise an ECM material. In some embodiments, the microneedles are also capable of administering a biologically active agent and/or a pharmacological composition to the engaged tissue.

Abstract: Methods, apparatus and compositions are provided for treatment of cancer of a selected organ by intraluminal delivery of oncolytic agents through a blood vessel or duct leading to the cancer tissue. During the time the oncolytic agents are being applied to the targeted tissue downstream, the designated vessel or duct can be selectively occluded to increase concentration and pressure of the applied agents at the target site. Oncolytic compositions including oncolytic viruses formulated with delivery visualization markers are provided.

Abstract: Described herein are methods and devices for selectively applying fluids (particularly anesthetics) to a target tissue from within a blood vessel while minimizing the amount of fluid applied to non-target tissue. The injection catheters described herein may include an elongate body, a directional injector, and one or more holdfasts for securing the catheter before extending the injector. The methods of selectively applying anesthetic to a target structure generally include the steps of inserting an injection catheter into a body vessel, positioning the injection catheter within the body vessel near the target structure, anchoring the injection catheter before extending a directional injector from the injection catheter, and applying anesthetic from the injection catheter to the target structure.

Abstract: Extracellular matrix (ECM) constructs having a biodegradable support scaffold and an anchoring mechanism, which includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein. In a preferred embodiment, the support scaffold and anchoring mechanism comprise an ECM material. In some embodiments, the microneedles are also capable of administering a biologically active agent and/or a pharmacological composition to the engaged tissue.

Abstract: A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and an arterial lateral opening that is in fluid communication with the second lumen.

Abstract: Extracellular matrix (ECM) constructs having a biodegradable support scaffold and an anchoring mechanism, which includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein. In a preferred embodiment, the support scaffold and anchoring mechanism comprise an ECM material. In some embodiments, the microneedles are also capable of administering a biologically active agent and/or a pharmacological composition to the engaged tissue.

Abstract: A medical device for the treatment and irrigation of a sinus opening is described. The device allows for single-handed operation to access, dilate and irrigate a sinus opening. The device includes a sinus guide catheter, a guiding element, a balloon dilation catheter, a balloon catheter movement mechanism and a guiding element movement mechanism. A method for treating a sinus opening and irrigating a sinus is also described.

Abstract: The present invention is directed to a catheter balloon of a balloon catheter comprising a coating consisting of or containing at least one fatty acid, oil or fat and sirolimus as well as to the use of these systems and compositions. Optionally a stent is crimped on such a coated catheter balloon. Further, methods for coating the inventive catheter balloons are described.

Abstract: Provided is a medical robot system which includes a medical manipulator capable of handling organs such as a uterine of different shapes and sizes. The medical robot system includes a robot arm, a medical manipulator which is detachably provided in the robot arm and supports an organ to a predetermined position, and a controller unit operable by an operator to control the robot arm and the medical manipulator. The medical manipulator also includes a first arm portion in a base side thereof, a second arm portion in a front side thereof for supporting the organ, and a connection portion connecting the first arm portion with the second arm portion. The control unit adjusts a relative direction of the second arm portion and the first arm portion and a length of the second arm portion in a telescopic manner thereby being suitable for organs of various shapes and sizes.

Abstract: A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

Abstract: An occluding catheter for preventing stroke by occluding blood flow through right and left carotid arteries is provided. The occluding catheter includes a shaft that has a proximal end and a distal end, and a proximal occluding balloon carried by the shaft. The proximal occluding balloon is inflated to occlude blood flow through one of the right carotid artery and the left carotid artery. A distal occluding balloon is carried by the shaft and is inflated to occlude blood flow through one of the right carotid artery and the left carotid artery that is not occluded by the proximal occluding balloon. The shaft has a segment that is located between the proximal occluding balloon and the distal occluding balloon. Also provided is an alternative arrangement with a single occluding balloon, and an associated method of diverting emboli from cerebral circulation.

Abstract: A system for retrieving an implantable medical device includes a delivery sheath that houses an inflatable balloon catheter and a retrieval device. The retrieval device includes a first support rod and a second support rod and a helix extending between distal ends of the first support rod and the second support rod. The inflatable balloon catheter is translatable into a position between the implantable medical device and a wall of a patient blood vessel. The balloon is inflated to force the device away from the wall. The helical member of the retrieval device is expanded radially be translating the second support rod distally. The helical member is moved over the balloon catheter and the medical device, where rotation of the first support rod will cause the helical member to radially compress to trap the balloon catheter and medical device therein for subsequent retrieval from the body.

Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on said substrate, wherein said 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 said coating and on said substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of said medical device in the body of said subject a portion of said pharmaceutical agent and/or active biological agent is delivered at said intervention site along with at least a portion of said polymer and/or a at least a portion of said pharmaceutical carrying agents.

Abstract: Some embodiments of an infusion pump system may be configured to provide a desired level of resistance to liquid ingress to the pump casing while contemporaneously providing air transmissibility for equalization of air pressure differentials between the interior and exterior of the pump casing. Further, some embodiments can detect when moisture inside a casing of the infusion pump system is greater than or equal to a threshold level and can initiate one or more patient safety countermeasures.

Abstract: An intravascular device can comprise a carrier and an expansion apparatus. The device can be used for intravascular treatment of atherosclerotic plaque. The carrier can be reversibly expandable and collapsible within a vessel and can have ribbon strips extending between opposite ends in a longitudinal direction of the carrier. The ribbon strips can each be formed with a plurality of elongated protrusions thereon. The expansion apparatus can be used to actuate the ribbon strips each with the plurality elongated protrusions to pierce a luminal surface of the plaque with lines or patterns of microperforations which act as serrations for forming cleavage lines or planes in the plaque.

Abstract: Materials and methods for delivering materials for filling aneurysms in which the materials comprise a glycosaminoglycan and optionally, contrast media and physiological buffers and in which delivery methods include percutaneous delivery with a balloon catheter or a needle catheter.

Abstract: A profile altering tip is provided for a delivery system. The tip defines a first profile with a generally conical shape and a second profile with a generally round shape. During use of the delivery system, a tip profile control assembly can alter the tip from the first profile to the second profile.

Abstract: A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

Abstract: Methods and devices are disclosed that, in various embodiments and permutations and combinations of inventions, diagnose and treat Deep Vein Thrombosis or associated symptoms. In one series of embodiments, the invention consists of methods and devices for identifying patients whose Deep Vein Thrombosis or associated symptoms are caused or exacerbated, at least in part, by blockages of one or more of the patient's internal peripheral veins. In some instances, stenoses or other flow limiting structures or lesions in the patient's affected veins are identified. Further, in some instances the nature of such lesions and whether there is a significant disruption of blood pressure, or both, is ascertained. In some embodiments, methods and devices for applying one or more therapies to the blockages in the patient's peripheral veins are provided.

Abstract: A method for controlling narrowing of at least one airway and associated apparatus are provided. The method includes positioning a needle-less injection assembly in an airway of a patient, and introducing a medication from at least one port of the needle-less injection assembly across an epithelium of a wall of the airway and into collagenous and smooth muscle layers of the airway wall such that the medication controls at least one mechanism of airway narrowing.

Abstract: In an embodiment, an apparatus comprises a needle (e.g., hypodermic needle or trocar) and sensor (e.g., fiber Braggs grating sensor) coupled to a system to determine (e.g., in real time) stress and/or vibrations encountered by the needle. Consequently, various embodiments may (a) help identify nearby vessels, (b) determine whether the needle penetrated a hollow body structure, and (c) accurately guide needles towards a target structure (e.g., vessel). Other embodiments are described herein.

Abstract: Methods and devices are provided for switching fluid flow through a body part, such as all or portions of an organ or extremity. In general, fluid inflow and fluid outflow vessels to at least a portion of a body part can be switched such that all fluid in at least a portion of the inflow and outflow vessels flows in an opposite direction. In other words, the fluid inflow vessel (or at least a portion thereof) becomes the fluid outflow vessel that receives fluid from a body part, and the fluid outflow vessel (or at least a portion thereof) becomes the fluid inflow vessel that delivers fluid to a body part.

Abstract: A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

Abstract: Various embodiments of a pelvic treatment system and method are provided. The present invention can include one or more drug eluting darts or barbs that are lodged into the wall and will elute the drug over a desired time period (weeks, months for example) to treat OAB, BPH, tissue weaknesses, or other disorders or diseases.

Abstract: An object of the present invention is to provide a device used in an operation using a catheter assembly and the catheter assembly having the device, which allows a hole formed in a body surface to have a minimum size and a catheter to be smoothly inserted into the body. An auxiliary dilator includes a body part having a tapered portion tapering toward a front end of the auxiliary dilator. The body part surrounds an extension part of a main dilator with a front end entry portion of the extension part protruding from the tapered portion, and a separation part attached to the body part enabling the body part to be removed from the main dilator.

Abstract: Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.

Abstract: Systems, devices, and methods for imaging a sinus in a patient involving a through sinus are presented. In one instance, a system includes a radiopaque wound filler for disposing into the through sinus. The system further includes a radiopaque solution for deploying into the sinus, and a radiopaque solution unit having a radiopaque solution reservoir and a positive pressure source. Other systems, devices, and methods are presented.

Abstract: A system and method for implanting and stabilizing spinal cord stimulators in an epidural space of the spinal column of a patient to prevent or limit axial movement of the stimulators once implanted in the epidural space. The system includes a drill assembly, a guide wire assembly, and a guide wire receiver. The drill assembly includes a cannula, a drill for creating access points in the patient's spinal column for implanting the stimulators, and an incremental drill adjuster for drilling into the patient's lamina a pre-set, discrete distance. The guide wire assembly includes a hollowed guide wire sleeve, a guide wire housed within the sleeve, and a magnet disposed on a proximal end of the guide wire assembly. The guide wire receiver includes a scoop for receiving and catching the magnet to assist in feeding the stimulators through the epidural space.

Abstract: The disclosure describes devices and methods for asymmetrical irradiation at a body cavity or site, such as after removal of tissue, e.g. biopsy or cancer. One device includes a lumen which is off-set or off-settable from a longitudinal axis to increase the intensity of radiation received from a radiation source by a first tissue portion surrounding the body cavity and to reduce or minimize radiation received by a second tissue portion (e.g. healthy tissue) surrounding the body cavity.

Abstract: The present invention is directed to an inflated interspinous spacer. The interspinous spacer is inserted into the interspinous space between adjacent spinous process in a deflated or unexpanded state, and is inflated or expanded with an injectable filler material. Upon inflation, the spacer preferably distracts the spinous processes and assumes a shape that retains the spacer in position and preferably mechanically locks with the spinous processes. The spacer includes two separate balloons configured to have different compressive modulus so that one balloon is softer and more deformable than the other balloon.

Abstract: The present invention is directed towards instruments and methods for discharging an anesthetic drug on a continuous basis for use as a nerve block. In accordance with the present invention, a catheter assembly is provided that comprises an electrically conductive wire, a protective sheath and an inflatable balloon. The inflatable balloon is at the distal end of the catheter capable of being inflated and deflated. A balloon channel terminates within the inflatable balloon at the distal end of the catheter and extends proximally along the length of the catheter to the proximal end of the catheter. The balloon channel has a balloon channel opening at a distal end of the balloon channel within the inflatable balloon, capable of releasing an injected substance into the inflatable balloon. The balloon channel further has a balloon channel injection opening at a proximal end of the balloon channel, capable of receiving an injected substance.

Abstract: Extracellular matrix (ECM) constructs having a biodegradable support scaffold and an anchoring mechanism, which includes a plurality of biodegradable microneedles that are capable of piercing tissue and anchoring therein. In a preferred embodiment, the support scaffold and anchoring mechanism comprise an ECM material. In some embodiments, the microneedles are also capable of administering a biologically active agent and/or a pharmacological composition to the engaged tissue.

Abstract: Devices for delivering drugs or other treatment agents locally to the vasculature of a mammal are disclosed. These devices have several related structures and are designed to deliver the drugs to facilitate rapid mixing with the blood flowing past the devices.

Abstract: A needleless fluid injection system (100) including an injection console (102), an injection chamber in operative communication with the console, an injectate shaft (104) in operative communication with the console, which has an injection lumen extending from a proximal end to a distal end of the shaft, and at least one injection orifice extending through a wall of the injection lumen proximate the distal end of the shaft. The injection lumen can include a sealing cap (40) at its distal end.

Abstract: A medical device, and a system and packaged kit containing the medical device for the treatment of a sinus opening is described. The medical device comprises a proximal end, a distal end, and a shaft system having an inflation lumen and an irrigation lumen the proximal and. The shaft system has a proximal shaft section and a distal shaft section. An inflatable balloon is attached to the distal shaft section in a position that is proximal to said distal end. The irrigation tip is distal to the balloon on the distal shaft section and has a tip opening and one or more radially facing openings. A method for treating a sinus opening includes inserting a system that includes the medical device, a sinus guide catheter and a sinus guide element into a patient's anatomy, dilating the sinus opening and irrigating a target in the nasal anatomy.

Abstract: A medical device and a system and for dilating a stenotic airway of a patient are described. The medical device comprises a proximal end, a distal end, and a shaft system having an inflation lumen and a ventilation lumen the proximal end. The shaft system has a proximal shaft section and a distal shaft section. An inflatable balloon is attached to the distal shaft section in a position that is proximal to the distal end. The ventilating tip is distal to the balloon on the distal shaft section and has one or more radially facing openings. A method for treating a stenotic airway includes inserting the medical device into a patient's airway, and dilating and ventilating the airway.

Abstract: Embodiments herein include devices and methods directed toward creating reverse flow within a vessel and thereby providing protection against embolic debris. Embodiments comprise a catheter and a plurality of occluders that are expandable and adjustable within a lumen to create low-pressure areas that reroute blood flow and embolic debris therein.