Abstract: A combination artificial airway device and esophageal obturator (10) includes a esophageal cuff (16) and supraglottic cuff (14) that are inflated in a sequence to provide quick isolation of the esophagus relative to the tracheal air passage. The supraglottic cuff is asymmetrical in shape with a wedge like or cone like shape that is ergonomically shaped for providing less trauma to the pharyngeal tissues. A pressure indicator (25) surrounds a pilot balloon (28) for continuous monitoring of the internal pressure within the cuffs (14 & 16).

Abstract: A system for pumping a fluid into an object for insertion into the human body comprising a housing having a pump chamber with means for pumping said fluid therein. A source of fluid is connected to the pumping means and a value is connected to the pumping mechanism and the object. The housing includes means connected to the pumping means for entering an amount of the fluid to be pumped thereby. Upon entering a desired amount of fluid in the entering means, the pumping means causes an amount of the fluid equal to the entered amount to be pumped through the pump chamber and further through the valve to fill the object with the desired amount of fluid.

Abstract: Devices and methods for securing a catheter within a heart. In at least one embodiment of an apparatus for securing a catheter within a heart, the apparatus comprises a catheter having a proximal end and a distal end and at least one lumen defined therethrough, the catheter defining at least one aperture positioned therethrough at or near the distal end of the catheter, at least one balloon coupled to the catheter and positioned externally to the catheter, and a conduit having a proximal end and a distal end, the distal end of the conduit coupled to the at least one balloon, wherein when the catheter is positioned within an aperture in an atrial wall and when the at least one balloon is positioned at or near the aperture in the atrial wall, inflation of the at least one balloon causes the catheter to be held in place at the atrial wall.

Abstract: A balloon dilation catheter includes a dilation balloon and a shaft having a coaxial portion including an outer tubular member having a bore, a proximate end and a distal end and a transition neck formed at the distal end of the coaxial portion, the transition neck having a proximate end at the distal end of the outer tubular member and a distal end, an access fitting adjacent the proximate end of the catheter shaft for directing a guidewire into the catheter shaft, an inflation port for directing an incompressible inflation medium into the catheter shaft, a guidewire tubular member disposed coaxially in the outer tubular member and extending continuously through the outer tubular member to the distal end of the outer tubular member and through the transition neck, the outer tubular member and guidewire tubular member defining a first, annular inflation/deflation lumen therebetween in fluid communication with the inflation port, at least one second inflation/deflation lumen formed through the transition neck,

Abstract: A targeted drug delivery device is provided. The device comprises an elongated member with proximal and distal ends, a plurality of infusion ports associated with the distal end of the elongated member, and a selector mechanism for selectively placing an introducer port into fluid communication with at least one infusion port. A method for treating tissue is also provided. The method comprises introducing a medical device into the tissue, selecting an region of the tissue to treat, positioning the medical device in proximity to the region, and introducing a medicament through the device to treat only that region.

Abstract: Apparatus and methods are described for performing angioplasty and stenting with embolic protection. A catheter system includes an angioplasty balloon catheter, a balloon-expandable stent, an embolic protection device and a linking device. The catheter system has an undeployed configuration in which the balloon-expandable stent is mounted on the inflatable angioplasty balloon in an uninflated condition, the embolic protection member is positioned distally to the balloon-expandable stent and the angioplasty balloon, and the linking device is mounted on the catheter shaft of the angioplasty balloon catheter and the device shaft of the embolic protection device. The linking device prevents any relative longitudinal motion of the angioplasty balloon catheter and the embolic protection device, which might lead to accidental dislodgement of the balloon-expandable stent.

Abstract: A system for treating a body lumen comprises a catheter including a flexible conduit that is elongated along a longitudinal axis and suitable for insertion into a body lumen, the conduit having a proximal end and a distal end, one or more waveguides integrated with the flexible conduit, the one or more waveguides constructed and arranged to deliver and collect radiation concentrated along a predetermined radial axis of the conduit, the predetermined radial axis of the conduit substantially aligned with respect to at least one therapy delivery component of the catheter, at least one radiation source connected to a transmission input of the one or more waveguides integrated with the flexible conduit, and at least one optical detector connected to a transmission output of the one or more waveguides integrated with the flexible conduit.

Abstract: This present disclosure relates to a medical device and method capable of locally administering therapeutic agents efficiently. The medical device preferably includes one balloon catheter with conduits external to the balloon and with ports in the conduits where the conduits provide adequate sealing and sufficient penetration of the body vessel wall. Moreover, the placement of the conduits and location of the ports help ensure the optimal and sufficient administration of the therapeutic agent evenly to the entire treatment site. Other embodiments of the present disclosure relate to providing means to isolate the inflation medium and the therapeutic agent during administration to the treatment site and to introduce more than one therapeutic agent simultaneously to the treatment site.

Abstract: A method for dilating a stenotic region in an airway of a patient may include advancing a balloon catheter through the airway of the patient to position an inflatable balloon of the catheter within at least a portion of the stenotic region, maintaining a position of the catheter relative to the patient, and inflating the balloon of the catheter to dilate the stenotic region of the airway. A system for dilating a stenotic region in an airway of a patient may include a catheter shaft having an overall length of less than 70 cm, an inflatable balloon disposed along a distal portion of the catheter shaft, and a stylet.

Abstract: A system and method for infusing a drug under continuous positive pressure (such as convection enhanced deliver) to a target tissue to be treated is particularly useful for post-resection anticancer drug therapy. The system comprises a drug infusion catheter having an expandable device which is expanded within the target tissue such that the target tissue conforms to an outer surface of the expandable device, thereby creating a form of seal around the target volume in order to maintain an effective drug pressure gradient within the target tissue. The system further comprises a sensor to measure a parameter which can be correlated to the degree of conformance between the target tissue and the outer surface of the expandable device. The sensor is coupled to a feedback control system to determine whether there is a loss of conformance, and to adjust the expansion of the expandable device in order to maintain good conformance.

Abstract: A catheter assembly comprises a catheter shaft, a balloon and a pair of collars. The collars may be fixed or rotatable about a catheter shaft prior to exposure to an electric current. Where the collars are fixed to the shaft, the balloon is rotatable about the collars. When exposed to the electric current the collars expand to engage the waists of the balloon thereby sealing the balloon. Where the collars are rotatable about the shaft, the each waist of the balloon is engaged to a respective collars. When the rotatable collars are exposed to the electric current the collars expand to engage the shaft of the catheter thereby sealing the balloon.

Abstract: An apparatus for tissue dissection and instrument anchoring and methods for using such apparatus are disclosed. The apparatus includes a cannula, a dissection balloon releasably attached to the cannula at the distal end, an anchoring balloon disposed on the cannula, and a means for inflating both balloons.

Abstract: Renal function may be modulated by an implantable device having one or more leads or catheters disposed near the kidney via the lymphatic system. In one embodiment, lymphatic drainage from the kidney is modulated to increase or decrease tubular reabsorption of salt and water. The renal function modulation therapy may be delivered in an open-loop or closed-loop fashion, with the latter dependent upon a physiological variable such as blood pressure or cardiac output.

Abstract: A tubular transition member having an annular wall with at least one cut extending through the annular wall is disclosed for controlling a transition in stiffness of a catheter from a stiffer more pushable proximal section to a more flexible and trackable distal section and increasing kink resistance. The transition member may extend across the junction formed between the stiffer proximal section and the more flexible distal section. The transition member may be used in conjunction with any type of catheter including single-operator-exchange type catheters, over-the wire type catheters, and/or fixed-wire type catheters.

Abstract: Medical device components and processes are disclosed. For example, tube-shaped catheter components and processes of making tube-shaped catheter components are disclosed. Devices and systems, including medical devices and systems, such as catheters, containing tube-shaped catheter components are also disclosed.

Abstract: A catheter for treating arrhythmia comprises a catheter shaft of a double-cylinder structure where an inner shaft is slidably inserted in an outer shaft, a balloon installed so as to straddle between the tip portion of the inner shaft and the tip portion of the outer shaft, a pair of high frequency current-carrying electrodes of which at least one electrode is provided inside the balloon, and a temperature sensor for monitoring the temperature in the balloon. The front edge portion of the balloon at least in a deflated state protrude from the tip portion of the inner shaft. Alternatively, a tube that is more flexible than the inner shaft is provided on the tip portion of the inner shaft.

Abstract: Medical device components, such as tube-shaped catheter components, are disclosed. In some embodiments, a medical device component includes a region that includes a polyamide having a hoop stress ratio of at least about 1.25.

Abstract: A medical device has a cuff adapted to be positioned in the trachea of a subject with a patient tube, and a first tube having a distal end coupled to the cuff and a proximal end communicable with the surroundings. More effective and simpler sample taking and/or dosing of medicament is achieved by a second tube that is coupled with a distal end to the cuff and communicable with the surroundings via a proximal end, together with a pumping device that is connected to the proximal end of the first tube and to the proximal end of the second tube in order to circulate a fluid through the cuff. The cuff has a membrane that is permeable to a specific substance, the membrane being disposed to allow transfer of the specific substance between the interior and the exterior of the cuff.

Abstract: Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a removable tubular restraint or by structural elements built into the wall of the expandable portion of the sheath. In one application, the sheath is utilized to introduce a formed in place orthopedic fixation rod such as for use in spinal fixation procedures, preparation of a spinal segment, or placement of a vertebral body spacer. The sheath can further comprise structural elements to permit re-collapse of the sheath under fluid pressure following completion of the procedure and prior to removal from the patient.

Abstract: Alloy compositions, including devices and instruments that include the compositions, are disclosed. The compositions have high hardness, strength, corrosion resistance, and biocompatibility. The compositions can be used to manufacture, for example, medical devices and products.

Abstract: The invention relates to a method for loading structured surfaces that are preferably made of a polymer material with the pharmacological agent paclitaxel as well as the coated medical products obtained by means of said method.

Abstract: A system for performing a medical procedure includes an introducer and a guide pin that include features that coordinate to indicate the distance the guide pin is extended beyond the tip of the introducer when both are deployed at a target location. By incorporating measurement features into the guide pin/introducer combination, accurate measurement capabilities are provided without requiring dedicated measurement tools.

Abstract: A medical device, at least a portion of which is formed from a polymer composition including at least one liquid crystal block copolymer having at least one A block and at least one B block wherein the A block is formed of mesogenic repeat units and the B block is a soft block.

Abstract: Systems and methods for treating a tissue region employ an expandable structure projecting beyond the distal end of a catheter tube. A distal tail projects beyond the far end of the basket assembly. The distal tail includes a guidewire lumen that accommodates passage of a guidewire without threading the guidewire through the catheter tube.

Abstract: A catheter system comprising a guidewire, an endovascular catheter, and an aspiration catheter. The guidewire has an expandable occluder mounted on a distal end. The guidewire and the endovascular catheter are insertable into a lumen of the aspiration catheter. The aspiration catheter also includes infusion and aspiration lumen(s) and port(s). Methods of using the catheter system for treating a vascular lesion and removing embolic material during the procedure are also disclosed.

Abstract: Devices and methods that can be used to protect the esophagus during procedures such as atrial ablation. The devices can include an elongate tubular member that defines one or more lumens extending therethrough. The devices also can have a balloon attached at or near an end of the elongate tubular member. The balloon can partially or completely surround the outer surface of a segment of the elongate tubular member, and can be in fluid communication with a lumen of the elongate tubular member.

Abstract: The present invention provides a balloon catheter system comprising one or more conduits to which are attached an inner compliant balloon having a non-helical shape in its deflated state, said balloon being enclosed by an outer non-compliant or semi-compliant balloon, wherein the inner balloon is constructed such that upon inflation, said inner balloon is capable of adopting a spiral or helical conformation. The present invention also provides methods for using said balloon catheter system.

Abstract: A patient's pharyngeal wall is treated by inserting an expander member into the airway and positioning an active portion of the expander member in opposition to portions of the pharyngeal wall to be treated. The expander member is activated to urge the wall portions outwardly to an outwardly displaced position. The expander member is then deactivated while leaving the wall portions in the outwardly placed position and the expander member is removed from said airway. A further aspect of the treatment includes stabilization of at least a portion of the pharyngeal wall after compression of portions of the wall.

Abstract: Medical device polymeric tubing segments suitable for forming catheter shafts or as balloon parisons are formed with discrete regions having different orientation relative to each other. Wall thickness may also be varied of the length of the segment.

Abstract: A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof.

Abstract: A tissue penetrating catheter that is usable to advance a tissue penetrator from within a blood vessel, through the wall of the blood vessel to a target location. The catheter includes at least one stabilizing device thereon for stabilizing catheter prior to advancing the tissue penetrator. The tissue penetrator may extend through a lumen in the body of the catheter and project transversely through an exit port. The stabilizing device may be located closely adjacent to the exit port, or may surround the exit port. The stabilizing device may be one or more balloons, or other mechanical structure that is expandable into contact with the inner luminal wall of the blood vessel. Desirably, the exit port is forced into contact with the blood vessel wall to shorten the distance that the tissue penetrator projects from the catheter body to the target location. The catheter is particular useful for forming blood flow tracts between blood vessels, in particular in coronary revascularization procedures.

Abstract: Sinusitis, enlarged nasal turbinates, tumors, infections, hearing disorders, allergic conditions, facial fractures and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies, endoscopic studies and transillumination studies. Access and occluder devices may be used to establish fluid tight seals in the anterior or posterior nasal cavities/nasopharynx and to facilitate insertion of working devices (e.g., scopes, guidewires, catheters, tissue cutting or remodeling devices, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting devices, substance delivery implants, etc.

Abstract: Disclosed herein are methods and stent graft configurations related to the treatment of aneurysms through the local administration of zinc chelator(s). The zinc chelator(s) can be locally administered by placing one or more of them directly onto a stent graft, incorporating them into a coating found on a stent graft, including them in a delivery device that is associated with a stent graft, and/or injecting them through delivery and/or injection catheters at or near the time of stent graft deployment.

Abstract: A balloon catheter having a multilayer catheter shaft is formed to have an inner layer and an outer layer, where the inner layer and outer layer are selected from materials that enhance the pushability of the catheter while preserving the flexibility. Using a combination of a high Shore D duromater value material and a lower Shore D duromater value material, various combinations of multilayer catheter shafts are disclosed utilizing different glass transition temperatures and block copolyamides to obtain the desired characteristics.

Abstract: combination of at least two polyamides. The catheter component can be made from a blend of the two polyamides, or a co-extrusion of the two polyamides with an inner layer and an outer layer. The first polyamide has a Shore D durometer hardness of more than seventy seven (77), and can be selected from various transparent amorphous nylons having an amorphous segment such as an aliphatic segment, an aromatic segment, or a cycloaliphatic segment. The second polyamide has a lower durometer hardness than the first polyamide, and preferably less than 73, and can be a block copolymer of nylon and polytetramethylene glycol. Both polyamides have the same amide block or segment, e.g. nylon 12. Adding small amounts of the high hardness polyamide can reinforce the low polyamide at the amorphous segments, thereby increasing the overall strength of the material.

Abstract: A novel approach to diagnostic and therapeutic interventions in the peritoneal cavity is described. More specifically, a technique for accessing the peritoneal cavity via the wall of the digestive tract is provided so that examination of and/or a surgical procedure in the peritoneal cavity can be conducted via the wall of the digestive tract with the use of a flexible endoscope. As presently proposed, the technique is particularly adapted to transgastric peritoneoscopy. However, access in addition or in the alternative through the intestinal wall is contemplated and described as well. Transgastric and/or transintestinal peritoneoscopy will have an excellent cosmetic result as there are no incisions in the abdominal wall and no potential for visible post-surgical scars or hernias.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Abstract: The stent with cathodic protection and stent delivery system includes a stent delivery system including a catheter; a balloon operably attached to the catheter; and a stent disposed on the balloon. The stent includes a stent body having a first stent layer of an anodic stent material disposed about a second stent layer of a cathodic stent material; and a battery having a first battery layer of an anodic battery material and a second battery layer of a cathodic battery material. The first stent layer is electrically coupled to the first battery layer and the second stent layer is electrically coupled to the second battery layer.

Abstract: This document provides methods and materials that can be used to reduce or prevent contrast agent-induced toxicity. For example, devices for capturing contrast agents from blood are provided.

Abstract: A dilatation balloon for use in combination with a catheter device, the balloon having a waist, cone and body portion and having a first layer formed from a first polymeric composition, the balloon having a second layer disposed on at least a portion of the first layer, the second layer formed from a second polymeric composition which is crosslinked on at least a portion of the dilatation balloon, and methods of making and using the same.

Abstract: The present disclosure relates to devices methods for the reverse transport of lipids such as cholesterols for the treatment diseases and conditions caused by vulnerable plaques. The devices can reduce or eliminate vulnerable plaques by transporting the plaques away from their location.

Abstract: Systems and methods for removing obstructions from, delivering implantable devices or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens. A catheter having a proximal portion of a first diameter and a distal portion of a second diameter (smaller than the first diameter) is advanced into a body lumen. The distal portion of the catheter is caused to expand to a diameter that is larger than the second diameter but no larger than the first diameter. A working device is then advanced out of the distal end of the catheter and used to remove obstructive matter, deliver an implantable device or substance and/or restore flow. The distal portion can be reduced in diameter prior to removal from the body.

Abstract: The invention provides hybrid basket-type intravascular catheter probes designed to optimize blood vessel wall contact or close proximity while traversing tortuous curves. Related diagnostic systems and methods are also provided.

Abstract: The invention relates to a device and method for approximating two vessels. The device includes a first catheter and a second catheter. The second catheter is slidably disposed in the first catheter. A first expansible member is disposed on the first catheter, and a second expansible member is disposed on the second catheter. The medical device also includes a locking mechanism for interlocking the first catheter and second catheter to prevent relative movement between the first and second catheters.

Abstract: Systems and methods for selective cooling or heating of a target site in the human body include a catheter having a supply elongated element and a delivery elongated element, with inlet and exit ports. Blood is withdrawn from the supply elongated element and cooled or heated in a control unit. The treated blood is sent to the targeted area via delivery elongated element. The supply elongated element can act as an insulator for the treated blood in the delivery elongated element.

Abstract: An apparatus for the introduction of a drainage tube into a patient's chest cavity, comprising a housing having a distal end, a proximal end, and a longitudinal axis; a scalpel operable in a protruding position between a closed position in which the cutting portions are adjacent one another and adapted to make an incision in the dermis of the patient, and an open position in which the cutting portions are spaced from one another forming a scalpel passage along the longitudinal axis between the cutting portions. The apparatus further comprising a trocar comprising first and second trocar portions, each extending along the length of the trocar; the trocar being operable between an closed position wherein the first and second trocar portions are substantially adjacent one another, and a closed position in which the first and second trocar portions are spaced from one another and adapted for the introduction of the drainage tube therethrough.

Abstract: A system for treatment of a vessel bifurcation and its method of use comprises a catheter having a catheter shaft, a portion of which is characterized as an axle about which a rotatable assembly is disposed and rotatable thereabout. The system employs a series of lumens, openings and/or ports to provide a balloon mounted on the rotatable assembly with fluid communication to the catheter shaft.

Abstract: A valvuloplasty catheter has a dog-bone shaped balloon with semi-compliant smaller diameter waist and non-compliant larger diameter bulbous end regions. The balloon centers across the valve with the waist adjacent to the annulus. One bulbous region serves to hyperextend the valve leaflets and the other assists in stabilizing the balloon position to reduce migration. The semi-compliant waist increases in diameter as fluid enters the balloon until it comes into contact with the valve annulus. The pressure within the balloon per unit of volume delivery has a greater slope after contact with the annulus than before resulting in a change in slope for the pressure versus volume curve. The diameter of the balloon and annulus are determined at this inflection point when the balloon contacts the annulus.

Abstract: The present invention provides for an apparatus to locate a blood vessel puncture having a bleed back entrance port near a first end, a bleed back exit port near a second end; and a lumen extending between the bleed back entrance port and the bleed back exit port, wherein said bleed back entrance port has a diameter substantially equal to or greater than the lumen diameter. The present invention further provides for a method for locating a blood vessel puncture by inserting a locator into a blood vessel lumen, the locator having a bleed back entrance port at a first end, a bleed back exit port at a second end, and a finger adjacent the bleed back entrance port, observing a blood flow out of the bleed back exit port, and withdrawing the locator out of the blood vessel lumen until the finger contacts the blood vessel wall.

Abstract: The invention relates to a laryngeal mask (1) comprising at least one airway tube (2) and a mask portion (3), which mask portion (3) comprises a top face (4) and a bottom face (5), said bottom face (5) comprising a lumen (6) that communicates with the tube (2) interior (7), and said top face (4) comprising a closed transition face (8), and said mask portion (3) being at least on the bottom face in the periphery delimited by an inflatable cuff (9), and said mask portion (3) comprising a joint throughout the entire internal circumference of the cuff (9), facing towards the lumen (6) and for providing a closed cuff. Hereby a product is provided which is formed integrally with regard to mask portion and airway tube portion thereby eliminating the risk that the two parts are separated in use.