Abstract: Medical devices and method for making and using medical devices are disclosed. An example method for treating a blood vessel may include disposing a medical device within the blood vessel at a position adjacent to a lesion. The medical device may include an elongate shaft having a distal end region, a balloon coupled to the distal end region, and a cavitation member disposed within the balloon. The method may also include inflating the balloon to a first pressure, activating the cavitation member, and inflating the balloon to a second pressure greater than the first pressure.

Abstract: Medical devices and method for making and using medical devices are disclosed. An example method for treating a blood vessel may include disposing a medical device within the blood vessel at a position adjacent to a lesion. The medical device may comprise an elongate shaft having a distal end region, a balloon coupled to the distal end region, and a force transmitting member at least partially disposed at least partially within the balloon. The force transmitting member may be designed to transmit energy to the lesion. The method may also include inflating the balloon to a first pressure, actuating the force transmitting member to at least partial break apart the lesion, and inflating the balloon to a second pressure greater than the first pressure.

Abstract: Medical devices and method for making and using medical devices are disclosed. An example method for treating a blood vessel may include disposing a medical device within the blood vessel at a position adjacent to a lesion. The medical device may include an elongate shaft having a distal end region, a balloon coupled to the distal end region, and an iron-containing fluid disposed within the balloon. The method may also include inflating the balloon to a first pressure, delivering a plurality of electromagnetic pulses to the iron-containing fluid, and inflating the balloon to a second pressure greater than the first pressure.

Abstract: A medical device made of a hybrid polymeric structure includes a tubular body including a first layer and a second layer. The first layer includes a fibrous matrix comprising a plurality of randomly oriented nanofibers made at least in part of a first polymeric material and pores formed between at least a portion of the nanofibers. The second layer is made at least in part of a second polymeric material. At least a portion of the second layer is disposed about and between the plurality of nanofibers such that at least a portion of the second polymeric material is embedded into at least a portion of the pores of the fibrous matrix.

Abstract: An aortic arch embolic protection device may include an anchoring structure including a first anchoring ring at an upstream end and a second anchoring ring at a downstream end. A first filter element may extend from the first anchoring ring to the second anchoring ring and define a lumen through the aortic arch embolic protection device. A second filter element may be disposed within the lumen of the first filter element, wherein the second filter element includes an access port configured to facilitate passage of an interventional catheter through the access port. The anchoring structure may include a tubular scaffold extending from the first anchoring ring to the second anchoring ring. The second filter element may extend from the second anchoring ring upstream to the access port. The second filter element may extend transversely across the lumen of the first filter element at a plurality of axial locations.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems and methods that include a porous coating on a medical device. The porous coating may be formed by forming a scaffold along an exterior surface of the medical device to support the porous coating during application thereof and electrospinning a polymer to apply the porous coating on the scaffold.

Abstract: A method for making a tubular medical device having a hybrid polymeric structure includes forming a first layer comprising a non-woven fibrous matrix made of a first polymeric material and forming a second layer comprising a second polymeric material about the first layer such that at least a portion of the second polymeric material of the second layer embeds into at least a portion of the first polymeric material of the first layer.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for crossing a tissue region. The apparatuses, systems, and methods may include a catheter and a tip section arranged therewith. The tip section may be configured to puncture the tissue region and create an opening therein, dilate the opening in the tissue region, and pass through the opening.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for applying ablation therapy to a tissue region. The apparatuses, systems, and methods may include a balloon structure and one or more electrodes arranged on or within the balloon structure and configured to deliver energy to the tissue region.

Abstract: A heart valve anchor apparatus may include a body having a proximal portion and a distal portion. The body may include a first radially expandable portion at the proximal portion of the body, a second radially expandable portion at the distal portion of the body, and a root portion extending from the first radially expandable portion to the second radially expandable portion, the root portion having an outer extent. The first radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. The second radially expandable portion may be configured to self-expand to an outer extent greater than the outer extent of the root portion when radially unconstrained. In an unstressed configuration, the body may define a longitudinal centerline that extends away from a plane tangent to the root portion.

Abstract: An implantable or insertable medical device can include a silicone substrate and a plasma-enhanced chemical vapor deposition coating on the silicone substrate. The coating may include a silicon-containing compound. A method of forming the coating is also provided.

Abstract: A direct visualization catheter adapted for transseptal crossing includes at least an outer member, and inner member, a transparent balloon member, and an imaging element. The outer member includes a tubular body extending from a proximal end to a distal end and defines a first lumen there through. The inner member is slidably disposed within the first lumen of the outer member and includes an elongate body with a distal end. The transparent balloon member is coupled between the distal end of the outer member and the distal end of the inner member such that the shape of the transparent balloon member is adjusted by sliding the inner member and the outer member relative to each other. The imaging element is disposed within the balloon member.

Abstract: According to one aspect, a visualization device may include an image sensor, a lens for focusing light onto the image sensor, a first end, a second end opposite the first end, a lateral wall surface extending between the first end and the second end, and a coating on the lateral wall surface. The coating may include at least one of an electrically-insulating layer and a light-blocking layer, and may be deposited on the lateral wall surface using, for example, physical vapor deposition (PVD).

Abstract: A needle device for obtaining a tissue sample includes a distal member extending longitudinally from a proximal end to a distal end and including a distal channel extending longitudinally therethrough, the distal member formed of a first material selected to permit flexing of the distal member, a proximal member extending longitudinally from a proximal end to a distal end and including a proximal channel extending longitudinally therethrough, the proximal member formed of a second material selected to provide axial and torsional strength therealong in combination with a coupler for connecting the distal member and the proximal member, the coupler extending longitudinally from a proximal end configured to engage the distal end of the proximal member to a distal end configured to engage the proximal end of the distal member.

Abstract: A device for collecting a tissue sample includes a needle body extending along a longitudinal axis from a proximal end to a distal end and including a channel extending longitudinally therethrough and a plurality of cut outs extending laterally into the needle body, each of the plurality of cut outs extending at an angle relative to the longitudinal axis from an outer surface of the needle body toward the distal end thereof so that the channel is open to an exterior of the needle body via the plurality of cut outs.

Abstract: Methods and materials related to ostomy devices, and particularly to valves for use with continent ostomies (e.g., ileostomies) are provided herein.

Abstract: Devices provided herein can include implantable transseptal flow control components adapted to be implanted in an opening in a septal wall. In a closed configuration, the implantable transseptal flow control components provided herein prevent blood from flowing through the opening. In an open configuration, the implantable transseptal flow control components provided herein allow blood to flow from the left atrium to the right atrium. In a closed configuration, implantable transseptal flow control components provided herein can be configured such that blood does not stagnate at a location proximate to a left atrium flow control component side when the pressure differential is below a second predetermined threshold pressure value. Implantable transseptal flow control components provided herein can remain in a closed configuration when a pressure differential between the left atrium and the right atrium is less than a first non-zero predetermined threshold pressure value.

Abstract: A balloon catheter visualization system for repairing a heart valve in a patent includes one or more elongate shafts, each shaft defining at least one lumen and comprising a distal end portion and a proximal end portion. The system also includes a transparent balloon member coupled to the one or more elongate shafts and is in fluid communication with at least one lumen of the one or more elongate shafts. The system also includes an imaging element disposed within the balloon member and coupled to a distal end portion of the one or more elongate shafts, a fastener releasably coupled to a distal end portion of the one or more elongate shafts, and a connector coupled to a distal end portion of the one or more elongate shafts. The connector is adapted to fasten the fastener to tissue.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: A medical device system may include a valve replacement implant including an anchor member reversibly actuatable between a delivery configuration and a deployed configuration, wherein the implant includes at least one locking element configured to lock the anchor member in the deployed configuration, and at least one actuator element configured to engage the at least one locking element and actuate the anchor member between the delivery configuration and the deployed configuration. The at least one actuator element may include a self-biased cam mechanism configured to extend into and engage a first locking portion of the at least one locking element.