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

Abstract: A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.

Abstract: An expandable balloon for a medical device having a static state, at least one first expanded state, and at least one second expanded state, the expandable balloon having a substantially polygonal geometric shape in the static state.

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

Abstract: A 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: A balloon catheter system for the intraluminal advancement of conventional guidewires beyond partially or fully occluded or stenosed lesions in body passages, such as CTOs in the vasculature, is provided. Balloons are provided. In certain embodiments of the invention, a balloon having relatively thickened proximal tapers is provided. In certain embodiments of the invention, balloons having a tapered midsection are provided. The balloons are preferably useful with crossing balloon catheter systems. In certain embodiments of the invention, the balloons preferably reduce or minimize trauma to the vascular wall or wall of other body passage in which it is used.

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: The present subject matter describes a balloon catheter and methods of using the balloon catheter. The balloon catheter is particularly useful for pericardiocentesis and percutaneous pericardiotomy.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

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

Abstract: Tracheal ventilation device, particularly a tracheal tube, which seals the trachea in a substantially air-tight manner. The device includes a cuff that blocks the trachea below the glottis and is traversed by a ventilation cannula. The cuff is larger in its filled, freely displaceable, unrestricted state than in its filled state positioned in the trachea. The cuff is of a flexible soft film material and lies against the trachea by means of its folds. The device is adapted to the morphology of a child's larynx and is available in finely graded sizes.

Abstract: An anatomic space of the body, particularly the pericardial space, is accessed in a minimally invasive manner from a skin incision by an access instrument to facilitate visualization and introduction of devices or drugs or other materials, performance of medical and surgical procedures, and introducing and fixating a cardiac lead electrode to the heart. An elongated access instrument body preferentially bends in one direction and resists bending in a transverse direction, whereby the access instrument body distal end can be directed through a path around body structures to the anatomic site by manipulation of the access instrument body proximal end portion. A distal header formed at the access instrument body distal end extends outward of the access instrument body in the transverse direction and supports an inflatable balloon surrounding a working lumen exit port that is directed toward an anatomic surface when the balloon is inflated by inflation media introduced through an inflation lumen.

Abstract: A method for preventing contrast associated nephropathy includes the steps of providing a multi-lumen dual balloon catheter and inserting the catheter into a patient's coronary sinus. The method also includes the steps of inflating the two balloons to block blood flow from the coronary sinus into the right atrium and draining blood containing contrast solution from between the two balloons through the catheter while the blood flow is blocked. A hemo filtration unit is used to remove contrast solution from the drained blood and the filtered blood returned to the right atrium. A multi-lumen dual balloon catheter is also disclosed.

Abstract: An instrument comprising a cable or tube, at a distal end of which a propulsion device is provided for moving the cable or tube in a hollow space, the propulsion device being shaped like a donut lying in a plane at right angles to the longitudinal direction of the cable or tube, wherein the donut-shaped propulsion device is, at least in part, externally delimited by at least one wire gauze that is rotatable about a closed axis of the donut body, which axis lies in the plane of the donut.

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

Abstract: The present invention provides apparatus and methods for treating vascular conditions, and in particular, hardened or fibrous material in a stenosis. In a first embodiment, the apparatus comprises a catheter having proximal and distal regions and a plurality of balloons segments disposed on the distal region at intervals about a circumference of the catheter. A first set of opposing balloon segments are configured to be inflated at substantially the same time to apply a first pressure on the vascular condition, and then a second set of opposing balloon segments are configured to be inflated at substantially the same time to apply a second pressure on the vascular condition. The plurality of balloon segments may be formed by taking one length of balloon material and affixing the material to an outer surface of the catheter at a plurality of segment dividing locations to separate adjacent balloon segments, or alternatively, by providing multiple separate balloon materials.

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

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

Abstract: A bifurcated balloon for in vivo use, comprises: a proximal hollow tubular element, two bifurcating hollow tubular elements extending distally from a distal end of the proximal hollow tubular element, each of the two elements comprising: a first distal tubular element guidable into a first branch of a vessel bifurcation, and a second distal tubular element guidable into a second branch of the vessel bifurcation. The bifurcated balloon further comprises a longitudinal chamber extending from a distal end of the first distal tubular element, and a first substantially longitudinal guidewire channel passing through the longitudinal chamber, the first guidewire channel having two ends of which a first end passes through a proximal portion of the longitudinal chamber.

Abstract: A device for interventional surgical or medical procedures is presented. The device is generally in the form of a balloon and is used to position itself or other working elements up against or through lumen walls in the body. The balloon is comprised of at least two materials of different elastic modulus, which allows for a flexible but relatively non-distensible, unfolding component of the balloon as well as an elastomeric, inflatable component of the balloon. The elastomeric component is fixedly attached to the flexible but relatively non-distensible component and together they form a pressure vessel that can be inflated within the lumens of the body.

Abstract: A self-expanding medical occlusion device treats a heart defect in a patient and is inserted into the body in minimally invasive fashion using a catheter system, and includes a braiding of thin threads which exhibits a first preliminarily definable shape as the occlusion device is being inserted into the patient's body and a second preliminarily definable shape in the implanted state, whereby the occlusion device is in a collapsed state in the first shape of the braiding and in an expanded state in the second shape of the braiding. The threads of braiding are composed of a shape memory polymer composite such that braiding deforms from a temporary shape to a permanent shape in consequence of an external stimulus, whereby the temporary shape is given in a first profile form of the braiding and the permanent shape is given in a second profile form of the braiding.

Abstract: A post dilatation balloon catheter includes a balloon member having a proximal portion, a distal portion and a circumferential bulge portion. The circumferential bulge portion extends around a circumference of the balloon member and is positioned at a location between the proximal and distal portions of the balloon member. The circumferential bulge portion inflates to a maximum inflated dimension that is greater than a maximum dimension of the proximal and distal portions of the balloon member. The balloon member is arranged into a folded state by folding at least one of the distal and proximal portions of the balloon member in a separate step from folding the circumferential bulge portion.

Abstract: A balloon catheter including: a flexible sheath which has at least one lumen; and a cylindrical balloon which is fixed to the outer peripheral surface of the sheath and can be inflated with a fluid supplied from the lumen; wherein the sheath has a large diameter portion whose outer diameter is greater than a basic outer diameter thereof, and the balloon is set to have a maximum inner diameter greater than the basic outer diameter when deflated, and is attached to the outer peripheral surface of the large diameter portion.

Abstract: An apparatus for treatment of a bifurcation of a body lumen, the bifurcation having a main vessel and a branch vessel, the apparatus includes a bifurcated balloon with a first branch portion and a second branch portion, the second branch portion including an inflatable portion adapted to extend toward the branch vessel, the bifurcated balloon also having a proximal shaft portion and a distal shaft portion connected to the inflatable portion of the second branch portion, and wherein the first branch portion and the second branch portion each have a longitudinal axis, the axis of the first branch portion being substantially parallel to the longitudinal axis of the second branch portion.

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 medical device including a coating disposed on at least a portion of a surface of the medical device, the coating including at least one polymer material having reversible wettability.

Abstract: The present invention is directed to distal tip designs for catheter, wherein distal tip material is positioned about an inner shaft. The distal tip material may also be used as a tie layer for thermally bonding two incompatible materials together, such as a waist portion of a balloon to the inner shaft.

Abstract: The present invention provides a mechanism by which the physical properties of diseased blood vessel walls can be manipulated to achieve an effective vessel lumen diameter for a prolonged period of time. The methods and devices of the present invention selectively isolate and treat the medial or adventitial layers of these diseased blood vessels. The invention is based on the delivery of proteolytic enzymes and crosslinking agents via specialized delivery devices to a select layer of the diseased blood vessel wall. By isolating and treating these layers of the artery, collagen degrading and collagen crosslinking agents can be delivered so as to affect the diameter of the blood vessels and control blood flow therein.

Abstract: The present invention provides a method of making a zero-fold dilatation balloon. Typically, the method includes: providing a tubular parison comprising a polymeric material; providing a source of heat and pressure for forming a balloon pre-form; heating, stretching, and expanding the tubular parison to form an expanded parison without confining the size of the expanded parison by a mold wall internal surface; and subjecting the resultant parison to a heat setting process to form a zero-fold balloon having a uniform profile along its entire length in a deflated state.

Abstract: There is provided a balloon catheter system, enabling only a target site to be efficiently ablated, ensuring a balloon to be able to be brought into close contact with the target site in conformity to a shape of the target site. A balloon includes a contact portion that is to contact a target site and a noncontact portion that is not to contact the target site. A membrane thickness of the contact portion is thinner than that of the noncontact portion. Then, the target site that is in contact with the thin contact portion is selectively ablated, while making heat leak from the thick noncontact portion less likely to occur. Hence, only the target portion can be efficiently ablated.

Abstract: Embodiments of the present invention relate to inflatable balloon catheters and methods for deploying an inflatable balloon catheter. For example, one embodiment is directed to a catheter assembly that includes a catheter comprising proximal and distal ends and at least one longitudinal conduit extending between the proximal and distal ends. The catheter assembly also includes an inflatable balloon comprising proximal and distal ends and configured to be at least partially positioned within the longitudinal conduit when the balloon is uninflated. The inflatable balloon is further configured to be inflated when deployed from the conduit such that a diameter of the proximal end of the inflatable balloon remains substantially constant and a diameter of the distal end of the inflatable balloon is variable and capable of at least partially occluding a lumen.

Abstract: A guiding catheter includes an inner guide movably disposed within an outer guide. Both inner and outer guides include inner and outer balloons, respectively, located at the distal tip of the guides. The inner guide balloon is fluted, thereby allowing blood to flow past the implanted balloon when inflated. The outer balloon is substantially annular in shape and is deployable as an occlusion balloon. Various sensors can be provided at the distal end of the guiding catheter to assist in locating a destination vessel or structure of interest.

Abstract: The present invention tackles the challenging anatomic characteristics of the coronary artery disease in the bifurcation point and the origin of side-branch. The invention has a specifically designed angioplasty balloon catheter, particularly the balloon shape and profile, to be used in the diseased vessels at these difficult anatomic locations. In stent implanting into a coronary artery, a balloon catheter application is an inseparable requirement. A stent is a passive device that cannot be deployed in a diseased or stenosed artery without a pre-stent, with-stent and/or post-stent balloon dilatation. In majority (more than 95%) of available coronary stents, a stent is deployed by balloon expandable mode, meaning that the stent is delivered and expanded inside a vessel lumen by expanding a delivery balloon. This is done by crimping a stent over a folded balloon for delivery into a coronary artery.

Abstract: A non-compliant fiber-reinforced medical balloon comprises a first fiber layer and a second fiber layer embedded in a continuous matrix of thermally-weldable polymer material defining a barrel wall, cone walls and neck walls. The fibers of the first fiber layer run substantially parallel to one another and substantially parallel to the longitudinal axis. The fibers of the first fiber layer have a pattern of different lengths and are divisible into a first group and a second group based on length. Each fiber of the first group begins in the neck wall at one end of the balloon, extends continuously in the longitudinal direction and terminates in the neck wall at the opposite end of the balloon. Substantially all of the fibers of the first group have a generally uniform length. Each fiber of the second group begins in the cone wall at one end of the balloon, extends continuously in the longitudinal direction and terminates in the cone wall at the opposite end of the balloon.

Abstract: Methods are provided for partial aortic obstruction for cerebral perfusion augmentation in patients suffering from global or focal cerebral ischemia. Alternatively, the methods can be used to partially obstruct aortic blood flow to condition the spinal cord to secrete neuroprotective agents prior to abdominal aortic aneurysm repair. Partial obstruction of a vessel can be accomplished by a device comprising an elongate catheter and a distally mounted expandable member. The expandable member may comprise one or two balloons. Other medical devices, such as an angioplasty, stent, or atherectomy catheter, can be inserted distal the expandable member to provide therapeutic intervention.

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

Abstract: Apparatus for treatment of a vascular bifurcation, where a first blood vessel (24) meets a second blood vessel (26). The apparatus includes a balloon (40, 90) for deployment at the vascular bifurcation. The balloon includes a first part (42, 94), which has a first inflation characteristic and is adapted to be deployed in the first blood vessel, and a second part (44, 92), which has a second inflation characteristic, different from the first inflation characteristic, and is adapted to be deployed in the second blood vessel.

Abstract: Device and method for treating a vessel including for example the insertion of a catheter toward a target destination using a guidewire. The catheter may include for example a proximal balloon, being shaped to enable the formation of for example a funnel shape when infated, and a distal balloon. The target destination, for example, a thrombosis, chronic total occlusion or myocardial infarction area may be substantially enclosed by the proximal balloon and the distal balloon.

Abstract: An elastically distensible folding member is disclosed. The folding member can be formed with a wall that is substantially shaped as a tube when the folding member is in a relaxed (i.e. unstressed) state. The tubular shaped folding member defines a tube axis and can have an axially aligned slit that extends through the wall. The folding member can be used to cover an incising element that is attached to the balloon and positioned in the lumen of the tubular folding member. During balloon inflation, the folding member can be deformed to expose the tip of the incising element to allow for a tissue incision.

Abstract: The present invention provides apparatus and methods for treating vascular conditions, and in particular, hardened or fibrous material in a stenosis. In a first embodiment, the apparatus comprises a catheter having proximal and distal regions and a plurality of balloons segments disposed on the distal region at intervals about a circumference of the catheter. A first set of opposing balloon segments are configured to be inflated at substantially the same time to apply a first pressure on the vascular condition, and then a second set of opposing balloon segments are configured to be inflated at substantially the same time to apply a second pressure on the vascular condition. The plurality of balloon segments may be formed by taking one length of balloon material and affixing the material to an outer surface of the catheter at a plurality of segment dividing locations to separate adjacent balloon segments, or alternatively, by providing multiple separate balloon materials.

Abstract: Medical balloons are described that have modified regions that enhance folding of the balloon.

Abstract: The present invention provides a balloon which achieves diameters greater than 6 mm for securement to a catheter. The balloon includes an elastomeric generally hollow pressure expandable body which exhibits essentially radial symmetry and constant length when expanded under an internally applied minimum working pressure from an uninflated state.

Abstract: Apparatus and method are provided for treatment of a bifurcation of a body lumen. The apparatus includes an elongated catheter body having a proximal end and a distal end. A balloon is associated with the distal end of the balloon catheter. The balloon includes a main vessel balloon for treating a main vessel of the bifurcation, and a branch vessel balloon for treating a branch vessel of the bifurcation. The branch vessel balloon includes an accordion configuration capable of being expanded from an unexpanded collapsed accordion configuration to an expanded accordion configuration extending into the branch vessel.

Abstract: A balloon device useful for dissecting tissue or retracting tissue for the purpose of providing access for laparoscopic surgery, the device including a balloon which inflates to a shape specially suitable for the surgical procedure and the anatomical region of deployment. The present device, when configured with a tapered dissection balloon, is particularly useful for subfascial endoscopic perforator surgical procedures.

Abstract: An anatomic space of the body, particularly the pericardial space, is accessed in a minimally invasive manner from a skin incision by an access instrument to facilitate visualization and introduction of devices or drugs or other materials, performance of medical and surgical procedures, and introducing and fixating a cardiac lead electrode to the heart. An elongated access instrument body preferentially bends in one direction and resists bending in a transverse direction, whereby the access instrument body distal end can be directed through a path around body structures to the anatomic site by manipulation of the access instrument body proximal end portion. A distal header formed at the access instrument body distal end extends outward of the access instrument body in the transverse direction and supports an inflatable balloon surrounding a working lumen exit port that is directed toward an anatomic surface when the balloon is inflated by inflation media introduced through an inflation lumen.

Abstract: A catheter for delivering a therapeutic or diagnostic agent to a branch blood vessel of a major blood vessel, generally comprising an elongated shaft having at least one lumen in fluid communication with an agent delivery port in a distal section of the shaft, an expandable tubular member on the distal section of the shaft, and a radially expandable member on the tubular member. The tubular member is configured to extend within the blood vessel up-stream and down-stream of a branch vessel, and has an interior passageway which is radially expandable within the blood vessel to separate blood flow through the blood vessel into an outer blood flow stream exterior to the tubular member and an inner blood flow stream within the interior passageway of the tubular member. The radially expandable member is located down-stream of the shaft agent delivery port, and has an expanded configuration with an outer diameter larger than an outer diameter of the tubular member.

Abstract: The present invention is directed to an apparatus and method for delivering a drug to a selected site in the vascular system of a patient. More specifically, the apparatus is a balloon catheter comprising an expandable balloon with a pouch around at least a portion of the balloon. When the balloon is not expanded, an agent can be located in the area between the pouch and the balloon. The agent is released through the pouch when the balloon is expanded.

Abstract: An endoluminal graft repair device includes a multi-lumen catheter with a balloon coupled to a distal end portion of the catheter. A portion of the outer surface of the balloon is designed and configured to define a repair cavity. A repair cavity lumen of the catheter is coupled to and in fluid communication with the repair cavity. The catheter and balloon are inserted into an artery system, advanced and positioned interluminally through percutaneous procedures so that the repair cavity is positioned to substantially align with the location of an endoluminal leak in an endoluminal graft used to treat aortic aneurysmal disease. The balloon is inflated by injecting an inflation fluid through an inflation lumen of the catheter into the balloon to fix the position of the repair cavity substantially adjacent the location of the endoluminal leak. A repair agent is conveyed to the repair cavity through the repair cavity lumen.

Abstract: A stent delivery system comprises an inner member and an expandable balloon mounted in a collapsed state on the inner member, the expandable balloon having a first and a second end. A compressible stent having a first diameter is mounted in a compressed state around the expandable balloon between the first and second ends of the balloon. At least a first retainer pillow is formed in the expandable balloon at its first end and has an outer diameter which is at least substantially equal to the diameter of the compressed stent. A first pillow support member is mounted on the inner member and supports the first retainer pillow to maintain the pillow's outer diameter.

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).