Abstract: Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion with a lumen extending therein; inserting the device into the vascular lumen; positioning the distal portion in the vascular wall; and directing the distal portion within the vascular wall.

Abstract: Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion with a lumen extending therein; inserting the device into the vascular lumen; positioning the distal portion in the vascular wall; and directing the distal portion within the vascular wall.

Abstract: A leaflet clip has an elongated member including a proximal end portion and a distal end portion, and first and second clipping arms movable between an open position and a closed position. The clipping arms include respective proximal end portions coupled to the proximal end portion of the elongated member, and respective distal end portions extending distally and radially outward relative to the elongated member. The leaflet clip further includes a tubular member coaxially disposed about the elongated member. Axial motion of the tubular member with respect to the elongated member or axial motion of the elongated member with respect to the tubular member causes corresponding movement of the clipping arms between the open and closed positions.

Abstract: A tissue puncture locator device that includes an expandable member, a deformable membrane, and an actuator. The expandable member is movable between an unexpanded position and an expanded position. The deformable membrane extends around at least a portion of the expandable member. The membrane has a stress relief portion. The actuator is operable to move the expandable member between the unexpanded and expanded positions.

Abstract: A balloon catheter device includes a multifilar tube shaft having a shaft lumen. A shaft lumen coating is provided on a surface of the multifilar tube shaft and extends from a proximal end of the multifilar tube shaft and terminates before a distal end of the multifilar tube shaft. An inflation balloon is disposed at the distal end of the multifilar tube shaft such that the shaft lumen coating and the inflation balloon form a continuously sealed length of the shaft lumen. The shaft lumen defines an inflation lumen that is in fluid communication with an interior space of the inflation balloon.

Abstract: A non-compliant medical balloon, where the non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon, is made with a first fiber layer, a second fiber layer over said first fiber layer such that the fibers of the first fiber layer and the fibers of the second fiber layer form an angle and a binding layer coating the first fiber layer and said second fiber layer. The interior surface area of the non-compliant medical balloon remains unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A medical device having enhanced steerability for navigation through a patient's vasculature and for positioning the device for performing a medical procedure, such as pulmonary vein isolation. The device generally includes an elongate body, a balloon defining a proximal neck that is affixed to the distal end of the elongate body such that the neck and elongate body are coterminous, a shaft disposed at least partially within the elongate body and at least partially within the balloon, and a pull wire affixed to a distal portion of the shaft, such that pulling the pull wire will cause deflection of the balloon at a point that is immediately distal of the proximal neck of the balloon. Further, the shape of the balloon when deflected and when in a neutral configuration may be substantially the same.

Abstract: A non-compliant medical balloon, where the non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon, is made with a first fiber layer, a second fiber layer over said first fiber layer such that the fibers of the first fiber layer and the fibers of the second fiber layer form an angle and a binding layer coating the first fiber layer and said second fiber layer. The interior surface area of the non-compliant medical balloon remains unchanged when the balloon changes from a deflated state to an inflated state.

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.

Abstract: A system for moving particles suspended in a first fluid, and for infusing them into the stream of a second fluid, includes a catheter with a multi-lumen distal tip. The tip is formed with a plurality of parallel lumens, wherein each lumen has a predetermined diameter. Importantly, the diameter of each lumen is dimensioned to sequentially receive particles therethrough, to prevent the particles from flocculating before they enter the stream of the second fluid. A valve, affixed to the outside of the catheter, can be provided to regulate flow of the second fluid and thereby facilitate entry of the particles into the stream of the second fluid.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of randomly oriented fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a woven fabric layer composed of at least two woven fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A method and apparatus for reattaching the opposed ends of a member, such as a tendon, ligament or bone, during preparing and healing of the member using a surgical repair device that can be securely attached to the member and then safely guided through tortuous anatomy for reattachment and repair. The repair device further includes structural means so as to secure opposed ends of the member against separation during healing. Devices for aiding in the positioning of the surgical repair device are provided.

Abstract: A non-compliant medical balloon is formed with a first fiber layer including a first fiber and a second fiber layer over said first fiber layer. The first fiber is substantially parallel to a longitudinal axis of the non-compliant medical balloon.

Abstract: A multi-layer inflatable balloon cuff may be adapted to seal a patient's trachea when associated with an endotracheal tube. The outer layer and the inner layer of the balloon cuff may have different material properties that may enhance a cuff's mechanical pressure seal by reducing wrinkles or folds that may form against a patient's tracheal walls.

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 non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a matted fabric layer composed of at least two matted fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A non-compliant medical balloon, where the non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon, is made with a first fiber layer, a second fiber layer over said first fiber layer such that the fibers of the first fiber layer and the fibers of the second fiber layer form an angle and a binding layer coating the first fiber layer and said second fiber layer.

Abstract: A laparoscopic apparatus for tunneling dissection including a hollow tunneling member and an inflatable balloon disposed at the distal end of the tunneling member to form together a blunt tipped obturator. The tunneling member has a bore sized allow the insertion of a conventional laparoscope therein to provide observation during surgical procedures. The laparoscope provides direct observation of dissection through the open distal end of the tunneling member. Observation is provided both when the device is used to tunnel between tissue layer to a region of interest within the body of a patient, and during subsequent balloon inflation when the tissue layers are dissected to cause separation of the tissue layers and the creature of an anatomical working space. After the anatomic space has been created, the device and laparoscope are withdrawn through the incision.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a matted fabric layer composed of at least two matted fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: Balloon catheter comprises a shaft having a proximal end, a distal end, and an inflation lumen extending therein, and a balloon on the shaft which has an interior in fluid communication with the inflation lumen. The balloon is formed of a blend of polymeric materials comprising a transparent amorphous nylon having a Shore D duromcter hardness of not less than 77D and being not more than about 40% by weight of the blend, and a polyamide or a polyether block amide having a Shore D duromcter hardness of no more than 73D. An increase in radial diameter of the balloon above nominal pressure for one atmosphere of pressure is no greater than 0.025 mm/atm. A guidewire catheter is also provided.

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: A method and apparatus for reattaching the opposed ends of a member, such as a tendon, ligament or bone, during preparing and healing of the member using a surgical repair device that can be securely attached to the member and then safely guided through tortuous anatomy for reattachment and repair. The repair device further includes structural means so as to secure opposed ends of the member against separation during healing. Devices for aiding in the positioning of the surgical repair device are provided.

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: Composite fiber reinforced balloons for medical devices are prepared by applying a web of fibers to the exterior of a preformed underlayer balloon which has been pressurized and expanded to a predetermined pressure or above ambient size, encasing the web with a matrix material to form an assembly with the fiber web bonded to the underlayer balloon. The assembly may have an outer layer formed by inserting the assembly into a preformed outer layer balloon. The overlayer balloon can be bonded to the assembly during a heat set step.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a matted fabric layer composed of at least two matted fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A perfusion guidewire is disclosed. The perfusion guidewire includes an elongate core member and a collapsible sheath tightly wrapped around at least the distal portion of the elongate core member such that the wrapped sheath is folded upon itself, forming a plurality of layers of material in a radial direction from the longitudinal axis of the elongate core member. The wrapped sheath is tightly wrapped about the elongate core member such that the wrapped sheath and elongate core member travel as a unit during navigation within the blood vessel of the body of a patient. The wrapped sheath is expandable to a larger diameter in order to allow a perfusate to pass through the lumen of the sheath.

Abstract: A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing pressure within the balloon. The non-compliant medical balloon is composed of a matted fabric layer composed of at least two matted fabric fibers forming an angle. The angle remains substantially unchanged when the balloon changes from a deflated state to an inflated state.

Abstract: A laparoscopic apparatus for tunneling dissection including a hollow tunneling member and an inflatable balloon disposed at the distal end of the tunneling member to form together a blunt tipped obturator. The tunneling member has a bore sized allow the insertion of a conventional laparoscope therein to provide observation during surgical procedures. After the anatomic space has been created, the device and laparoscope are withdrawn through the incision. The anatomic working space may be insufflated with an insufflation gas if required for the particular procedure. The apparatus is prepared for use by inserting the tunneling member into the interior of the balloon, forming the balloon into a generally cylindrical roll about the tunneling member, and preferably, through the use of an integral balloon cover, securing the balloon roll to the tunneling member to form a semi-rigid blunt tipped obturator.

Abstract: A catheter balloon formed of a polymeric material such as expanded polytetrafluoroethylene (ePTFE) bonded to a second layer formed of a low tensile set polymer and/or impregnated with a low tensile set polymer. In a presently preferred embodiment, the low tensile set polymer is a silicone-polyurethane copolymer elastomer or a diene polymer elastomer. The low tensile set polymer has high strength, low modulus, high elongation, and low tensile set. The diene or silicone-polyurethane has a low tensile set, which facilitates deflation of the balloon to a low profile deflated configuration. One aspect of the invention provides improved attachment of the diene to the ePTFE. In one embodiment, the second layer is formed of a diene mixed with a bonding promoter such as a vulcanizing agent which is covalently bonded to the diene.

Abstract: Laparoscopic apparatus and method for insertion into a space or potential space in a body comprising an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

Abstract: The present invention is directed to a non-compliant medical balloon suitable for angioplasty and other medical procedures and which integrally includes very thin inelastic fibers having high tensile strength, and methods for manufacturing the balloon. More particularly, the invention is directed to a fiber-reinforced medical balloon having a long axis, wherein the balloon comprises an inner polymeric wall capable of sustaining pressure when inflated or expanded and a fiber/polymeric matrix outer wall surrounding and reinforcing the inner polymeric wall. The fiber/polymeric matrix outer wall is formed from at least two layers of fibers and a polymer layer. The fibers of the first fiber layer are substantially equal in length to the length of the long axis of the balloon and run along the length of the long axis. The fiber of the second fiber layer runs radially around the circumference of the long axis of the balloon substantially over the entire length of the long axis.

Abstract: A laparoscopic apparatus for tunneling dissection including a hollow tunneling member and an inflatable balloon disposed at the distal end of the tunneling member to form together a blunt tipped obturator. The tunneling member has a bore sized allow the insertion of a conventional laparoscope therein to provide observation during surgical procedures. The laparoscope provides direct observation of dissection through the open distal end of the tunneling member. Observation is provided both when the device is used to tunnel between tissue layers to a region of interest within the body of a patient, and during subsequent balloon inflation when the tissue layers are dissected to cause separation of the tissue layers and the creature of an anatomical working space. After the anatomic space has been created, the device and laparoscope are withdrawn through the incision.

Abstract: An intra-aortic balloon catheter having an ultra-thin stretch blow molded balloon membrane. The balloon membrane is made from thermoplastic elastomeric and/or semicrystalline materials such as but not limited to polyurethane and polyetheramid.

Abstract: A medical device, such as a stent or balloon of a balloon catheter which includes a body portion which has an exterior surface which contacts, at least in part, a vessel wall during treatment. The body portion is expandable from a first position, wherein the body portion is sized for insertion into the vessel lumen, to a second position, wherein at least a portion of the exterior surface is in contact with the lumen wall. The medical device includes a first coating disposed over at least a portion of the exterior surface of the body portion with the first coating including a drug or therapeutic substance which is intended for controlled release from the surface. The medical device further includes a second coating overlying at least a substantial portion of the first coating. The second coating includes a material that is generally impervious to elution of the drug or therapeutic substance therethrough when the body portion is in a first position when inserted into the vessel lumen.

Abstract: The present invention relates to catheter balloons for medical devices. In particular, the present invention provides biaxially oriented semi-compliant catheter balloons comprising acrylonitrile polymers, acrylonitrile copolymers, and acrylonitrile blends, and methods of making same. The catheter balloons provided herein exhibit relatively high tensile strength, controlled compliance, reduced tendency for pinholing, ease of coating with and of bonding to other compounds, as well as resistance to moisture.

Abstract: A combination dilatation and drug delivery device includes a flexible catheter, a drug delivery sheath mounted to a distal end region of the catheter and a dilatation balloon also mounted to the catheter and contained within a compartment formed by the sheath. The sheath is radially expandable by supplying a liquid therapeutic agent to the compartment under a moderate pressure. The dilatation balloon is expandable by providing a dilatation fluid to the balloon under a much higher pressure. The sheath can be formed of a highly elastic material or can be made quite thin, and in either case is mounted independently of the dilatation balloon. Thus when radially expanded, the sheath is moved into a conforming contact with surrounding vascular tissue. The conforming contact protects tissue and the therapeutic agent from exposure to blood, and more effectively confines the therapeutic agent to the intended treatment area.

Abstract: An intra-aortic balloon catheter having an ultra-thin stretch blow molded balloon membrane. The balloon membrane is made from thermoplastic elastomeric and/or semicrystalline materials such as but not limited to polyurethane and polyetheramid.

Abstract: An intra-aortic balloon catheter having an ultra-thin stretch blow molded balloon membrane. The balloon membrane is made from thermoplastic elastomeric and/or semicrystalline materials such as but not limited to polyurethane and polyetheramid.