Abstract: The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Abstract: Self-supporting uniaxially expanded polytetrafluoroethylene (ePTFE) membranes that have high intrinsic strength, a high matrix modulus, and a high crystallinity index are provided. In some embodiments, the ePTFE membrane is stretched in the machine direction. Uniaxially oriented ePTFE membranes have a matrix tensile strength at least about 1000 MPa in the machine direction, a matrix modulus at least about 100 GPa ambient temperature (i. e., about 20° C.), and a crystallinity index of at least about 94%. In some embodiments, the ePTFE membrane has a tenacity greater than or equal to about 5 gf/d and a denier less than or equal to about 750 g/9000 m. In addition, the uniaxially oriented ePTFE membranes have a <P2> orientation of at least about 0.98. Also, the fibrils in the ePTFE membranes have a nearly perfect parallel alignment. The ePTFE membrane may be used to form composites, laminates, fibers, tapes, sheets, tubes, or other three-dimensional objects.

Abstract: The present disclosure relates to a medical delivery device that includes a barrel having an inner surface, a plunger rod having a distal end inserted within the barrel, and a stopper attached to the distal end of the plunger rod and contacting at least a portion of the inner surface of the barrel. In at least one embodiment, the inner surface is hydrophilic. The stopper may include an elastomeric body, one or more fluoropolymer layers, and two or more ribs laminated with the one or more fluoropolymer layers. In some embodiments, the contact width between at least one rib having a sealing surface and the portion of the inner surface of the barrel measured at a compressibility of greater than about 7.9% of the stopper is less than about 1.0 mm.

Abstract: Thin, self-supporting biaxially expanded polytetrafluoroethylene (ePTFE) membranes that have a high crystallinity index, high intrinsic strength, low areal density (i.e., lightweight), and high optical transparency are provided. In particular, the ePTFE membrane may have a crystallinity index of at least about 94% and a matrix tensile strength at least about 600 MPa in both longitudinal nd transverse directions. In addition, the ePTFE membrane is transparent or invisible to the naked eye through a complete conversion of the PTFE primary particles into fibrils. The ePTFE membrane may have a thickness per layer of less than 100 nm and a porosity reater than 50%. Further, the ePTFE membrane is stackable, which, in turn, may be used to control permeability, pore size, and/or bulk mechanical properties. The ePTFE membrane may be used to form composites, laminates, fibers, tapes, sheets, tubes, or three-dimensional objects. Additionally, the ePTFE membrane may be used in filtration applications.

Abstract: The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise a steering line or lines which facilitate bending and steering of the expandable implant through the vasculature of a patient.

Abstract: A treatment system includes an insert that is resiliently deflectable. The tip portion of the insert can be configured to be coupled to the trailing portion of an implant. A guide tube having an internal lumen is configured to permit passage of the tip portion and the body portion of the insert through a guide tube. The guide tube can have a length that is less than that of the insert. Treatment systems include a plurality of inserts, each insert differing from in at least one of length, diameter, and curvature. Treating a patient can include sizing a fistula using an insert.

Abstract: In one aspect, the present invention provides a device for occluding an aperture in a body, for example, a patent foramen ovale (PFO), including a first side adapted to be disposed on one side of the septum and a second side adapted to be disposed on the opposite side of the septum. The device has an elongated, low-profile delivery configuration and a shortened, radially expanded deployment configuration. The first and second sides are adapted to occlude the aperture upon deployment of the device at its intended delivery location. The device also includes a radially expandable center portion. In some embodiments, the center portion includes a plurality of ribs provided by slits in device. The ribs expand radially when the device is deployed. The expandable center portion facilitates the positioning of the device in the aperture. The device can be secured in the deployed configuration using a catch system.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems (200), and methods for deploying a medical device (202). In certain instances, the medical device (202) may be a shunt device. In addition, the apparatuses, systems (200), and methods may include one or more constraining lines (212) arranged through a portion of the implantable medical device (202) and one or more release lines (216) configured to engage the one or more constraining lines (212).

Abstract: The present disclosure relates to medical delivery devices that include a barrel having an inner surface, and in at least one embodiment, the inner surface is hydrophilic. The medical delivery device may further include a stopper may having an elastomeric body, one or more fluoropolymer layers, and two or more ribs laminated to the one or more fluoropolymer layers. In some embodiments, the contact angle of the inner surface of the barrel is less than about 58°. Additionally, the stopper includes a sliding surface that is less than about 2.0 mm. The barrel provides inner surface that in combination with the fluoropolymer laminate or fluoropolymer film achieve high levels of air and liquid impermeability while also maintaining an acceptably low break loose force, low average glide force, and low glide force variation. In some embodiments, the compressibility stopper against the barrel is greater than about 7.9%.

Abstract: High temperature insulative composites as well as articles formed from the high temperature insulative composites are described herein. The high temperature insulative composites are not only conformable, low dusting, and provide a thermal conductivity of 25 wM/m K at atmospheric conditions, but can also act as a heat propagation barrier when exposed to temperatures sufficient to partially or completely volatilize the fibrillated polymeric matrix within the high temperature insulative composite.

Abstract: A novel modified treated porous polyethylene membrane is imbibed with a hydrophilic polymer and heat treated to form a film having improved hand and noise. The films are useful to produce articles, especially textile laminates that can form waterproof breathable apparel.

Abstract: Vascular filtering devices and methods for their use are disclosed. In some embodiments, the vascular filtering devices include an elongate member having an unsupported membrane bag portion attached thereto. The membrane may be porous in some examples. Multiple elongate extensions may also extend from the membrane, and may extend along the elongate member, such as to a proximal region of the elongate member. The unsupported membrane bag portion may be configured to inflate or otherwise radially expand away from the elongate member as a result of blood flowing through the vessel within which the vascular filtering device is positioned.

Abstract: A nickel-titanium alloy with an average grain size of between 0.2 and 10 microns and a recoverable strain of greater than 9% is disclosed herein, in which the alloy is formed using a method which involves applying a shape set heat treatment to the nickel-titanium alloy. The heat treatment includes applying heat at a temperature between 225° C. and 350° C. for a period of time between 20 and 240 minutes.

Abstract: An additive manufacturing process is provided to produce integral 3-dimensional (3D) articles by laminating together a plurality of expanded polytetrafluoroethylene (ePTFE) membranes. The process includes repetitive cycles of ePTFE membrane lamination paired with laser cutting/bonding to produce a desired geometry based on a predefined pattern. The process may be practiced manually or may be configured to work with commercially available LOM machines/systems developed for use with other roll-to-roll processible materials, such as paper.

Abstract: A structured fluoropolymer film including a plurality of structures having a height at least two times a thickness of a corresponding unstructured fluoropolymer film and at least a 20% increase in displacement induction period when compared to the corresponding unstructured fluoropolymer film when measured in a biaxial tensile curve at a temperature of about 125° C. In addition, the structured fluoropolymer film has a methane permeability of less than 500 ?g*?m/cm2/min. The structured fluoropolymer film exhibits a higher resistance to strain and retain barrier properties during manufacture and/or use.

Abstract: Disclosed is a sealing element and a method of manufacture. The sealing element has a sealing surface for providing a seal against a contact surface. A sintered PTFE film is coupled to the elastomeric body, and defines the sealing surface, which is of particular suitability for a dynamic seal. The sealing film comprises a lubricious particulate material.

Abstract: Implantable medical devices for connecting tissue layers, such as for connecting a gallbladder and a portion of a gastrointestinal tract to create an anastomosis, include a tubular structure having a plurality of apposition portions, a central region, and a covering material. The devices are endoscopically deployable and may include flange members having hinge members or variable properties such as length, angle, shape, material stiffness, and wire diameter.

Abstract: A non-shortening catheter balloon having a longitudinal axis and an inflatable balloon able to be affixed to a catheter shaft is provided. The balloon has an uninflated length which remains relatively unchanged upon inflation and is formed of least two helically oriented wrapped passes of balloon materials at a balanced force angle. Methods of making this balloon are also provided.

Abstract: A multi lumen catheter assembly. The assembly provides an expandable, low profile, fixed length sheath and catheter, with fixed infusion ports. The assembly has an expandable outer sheath that expands upon pressure activation with a fluid and the sheath allows the fluid to exit from at least one predetermined fixed location from a distal end of the catheter assembly. The catheter assembly can be used in various medical device procedures, such as a TIPS (Transjugular Intrahepatic Portosystemic Shunt) procedure, or anywhere a low profile, multi lumen, infusion catheter system is desired.

Abstract: An endoluminal access device including an outer sheath defining a lumen and a guide assembly. The guide assembly includes an expandable portion configured to be transitioned between a collapsed configuration having a first diameter and an expanded configuration having a second diameter that is greater than the first diameter. The expandable portion includes a first arm defining a first lumen and an aperture in communication with the first lumen. The expandable portion is configured to expand outwardly from a central longitudinal axis when the expandable portion transitions to the expanded configuration and to deflect inwardly toward the central longitudinal axis when the expandable portion is transitioned to the collapsed configuration. The endoluminal access device further includes an endoluminal tool deliverable from the first lumen of the first arm and outwardly from the aperture of the first arm.