Abstract: A biopsy device is configured wherein a first retraction of a charge handle moves a cannula slide and a sampling slide in unison to charge a sampling spring, to latch the sampling slide to retain the sampling spring in a charged state, and to charge a vacuum system. A second retraction of the charge handle occurs, and a return of the charge handle to the home position moves the cannula slide in a distal direction away from the sampling slide to charge the cannula retract spring and to latch the cannula slide to retain the cannula retract spring in a charged state. A third retraction of the charge handle moves the carriage assembly as a whole in the proximal direction to charge the prime pierce spring and to latch the carriage latch cover member to retain the prime pierce spring in a charged state.

Abstract: A biopsy device includes a housing body, and a cannula assembly having a first elongate cannula and a second elongate cannula coaxial with the first elongate cannula. The second elongate cannula has a side wall and a lumen. The side wall has a vacuum side port in fluid communication with the lumen. A vacuum source is positioned in the housing body. The vacuum source has a chamber side wall, which may define a U-shaped volume, and has a chamber vacuum port. A seal is interposed in sealing engagement between the chamber vacuum port and the second elongate cannula. A trigger slide assembly is configured to move the second elongate cannula to align the vacuum side port of the second elongate cannula with the chamber vacuum port of the vacuum source to supply vacuum from the vacuum source to the lumen of the second elongate cannula.

Abstract: A dressing for use in protectively covering and isolating a medical device placed on and/or through the skin surface of a patient is disclosed. Examples of such devices include infusion needles for accessing subcutaneously implanted access ports, catheters of various types and purposes, insulin infusion needles, etc. In one embodiment, a dressing for covering a medical device on a skin surface of a patient is disclosed and comprises a dressing portion that is configured to rest against a skin surface of a patient, with the dressing portion defining a hole, and a polymeric cover film that is at least indirectly attached to the dressing portion. The cover film includes a pliable domed portion aligned with the hole of the dressing portion. The pliable domed portion defines a cavity that is configured to receive therein the medical device when the dressing is placed on the skin of the patient.

Abstract: Various embodiments of a non-deforming surgical fastener are discussed. In one embodiment, the fastener includes two legs and a backspan extending between the two legs. The fastener also includes a backspan thickness that is adapted to reduce the pressure and/or increase the holding strength applied to underlying materials. The non-deforming fastener is constructed and arranged to retain substantially the same shape before, during and after deployment into the target implantation site.

Abstract: A guidance system for assisting with the insertion of a needle into a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system includes a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, wherein a magnetic axis of the magnetic element is configured to be coaxially or otherwise aligned with the needle cannula.

Abstract: A stent including a plurality of curved sections and a connector. The curved sections surround a longitudinal axis to define a tube portion and are distributed along the longitudinal axis to form a helix. The connector includes a bioresorbable material and is positioned between two adjacent curved sections. The stent has a spring constant that changes to a different spring constant after exposure to biological material.

Abstract: A stent device delivery system and method of making. The stent device delivery system includes a stent device and an outer sheath overlaying the stent device in a radially compact, delivery configuration of the stent device. The outer sheath may include a first layer of polymeric material and a reinforcement layer of polymeric material that are laminated together.

Abstract: A peelable protective sheath and related assemblies/systems and methods are disclosed. The protective sheath may be used on a balloon catheter to protect the balloon and any coating thereon. The protective sheath may be peelable to make removal of the protective sheath easier. The peelable protective sheath may be inserted into a hemostatic valve and introducer while still disposed over the balloon of a balloon catheter to protect the balloon and any bioactive coating thereon from damage during insertion. The peelable protective sheath may be peeled from a proximal end to initiate removal. Alternatively, the peelable protective sheath may be peeled from a distal end of the peelable protective sheath as the balloon catheter is inserted through a hemostatic valve and introducer.

Abstract: A deployment device for positioning a soft tissue repair prosthesis includes a self-expanding support body releasably attachable to the prosthesis. The support body may be removably insertable into a pocket of the prosthesis. A handle coupled to the support body facilitates positioning the patch and/or removal of the support body from the pocket. The support body may substantially occupy the pocket in an expanded configuration. The handle may be arranged to direct a pulling force to the outer peripheral edge of the support body and/or cause a portion thereof to be pulled downward and below the body during withdrawal of the deployment device from the prosthesis. The support body may include support segments pivotally coupled together and foldable to collapse the support body for insertion into and removal from the pocket. One or more resilient support members may be provided for collapsing and expanding the support body and the prosthesis.

Abstract: An implantable prosthesis includes a scaffold with a plurality of expandable segments axially spaced apart along a substrate, adjacent segments connected by one or more support members when the prosthesis is in a collapsed configuration and disconnected when the prosthesis is in an expanded configuration.

Abstract: A prosthesis for repairing a hernia defect includes a patch body, a hoisting frame releasably attachable to the patch body, and a tether attached to the hoisting frame with a free end extendable through the thickness of the patch body and accessible from the side of the patch body opposite to where the hoisting frame is releasably attached. The patch body and/or the hoisting frame includes a self-expanding support member. The hoisting frame includes a frame body with an outer frame component and a force translation component for directing pulling forces on the tether across the frame body. The outer frame component has a loop configuration to generally follow the patch periphery with overlapping end portions or a gap between free ends thereof. The force translation component is separable into multiple segments to facilitate withdrawal of the hoisting frame through an opening when released from the patch.

Abstract: Preferred embodiments of a stent with a high degree of flexibility are shown and described. The stent can include a continuous helical winding having interconnected struts joined at vertices, and having bridges connecting sections of the helical winding to each other. An annular ring can be provided at one or both ends of the helical winding, and the annular ring can have extensions extending to connect to the helical winding. One of the extensions can connect to a bridge and another extension can connect to a vertex. The struts at the ends of the helical winding can have strut lengths that differ from the strut lengths of the struts in a central portion of the winding between the ends of the winding.

Abstract: A catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient is disclosed. The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspects of the patient or physical aspect of the catheter assembly itself when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological parameters to another location, such as a patient electronic medical record, smartphone or other mobile device, nurse station, etc. Catheter assemblies configured to detect the frequency of catheter flushing, flushing quality, etc., are also disclosed.

Abstract: An insertion tool for inserting a catheter into a body of a patient is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component.

Abstract: An insertion device to assist in accessing an access port that has been subcutaneously implanted in the body of a patient is disclosed. The implanted access port is accessed by a needle of a needle assembly, such as a needle-based infusion set. In one embodiment, the insertion device comprises a body that includes a stabilizing portion and a guide portion. The stabilizing portion stabilizes a position of the implanted access port when the body is placed on the skin of the patient atop the implanted access port. The guide portion guides a needle of the needle assembly along a predetermined path such that the needle transcutaneously pierces a septum of the implanted access port.

Abstract: A surgical fastener is provided for various surgical fastening applications, including attaching an implantable prosthesis, such as a soft tissue repair fabric, to tissue and/or muscle. The surgical fastener may include a coil body and a separate head that is attached to the coil body. The head may include two or more radial wings extending in an outward radial direction from the head body. Each wing may include an external thread to engage with a corresponding internal thread of a delivery device. Each wing may be spaced from an adjacent wing by an opening therebetween to receive a drive member for driving the surgical fastener. The coil body may be attached to the center of the head. A proximal-most coil of the coil body may be spaced from a distal face of the head to form a gap therebetween.

Abstract: A procedure kit that removably retains components to be used during a medical procedure, such as the insertion of a catheter into a patient, is disclosed. The procedure kit is securable to a surface or structure such that the kit is positioned as desired by the clinician, thus minimizing chances that the kit will fall to the ground or undesirably move. In one embodiment, the procedure kit comprises a body defining a plurality of pockets that are sized to removably receive therein components for use in the medical procedure, an openable flap that covers at least a portion of the pockets; and an adhesive portion included on a portion of the body to enable the procedure kit to be secured to a structure or surface proximate to the patient, such as the sterile drape covering the patient.

Abstract: Surgical instruments and their methods of use are described. In one embodiment, a surgical instrument includes a power transmission including a trigger and a fastener driver operatively coupled to the trigger. Actuation of the trigger from a first configuration to a second configuration moves the fastener driver between at least a first position and a second position. Additionally, an actuation lockout system operatively associated with the power transmission is moveable between a locked configuration and an unlocked configuration. The actuation lockout system prevents movement of the fastener driver from the first position to the second position when the actuation lockout system is in the locked configuration. Actuation of the trigger from the first configuration towards the second configuration moves the actuation lockout system from the locked configuration to the unlocked configuration.

Abstract: Embodiments disclosed herein generally relate to an access sheath and access systems. In some embodiments, the access sheath may be non-adjustable access sheath or an adjustable access sheath. For example, a length of the adjustable access sheath may be modified or customized (e.g., before insertion thereof in a patient) to a suitable length for a particular patient. In some embodiments, the access sheath and/or dilator may have a substantially fixed or predetermined length.

Abstract: Surgical instruments and their methods of use are disclosed. In some embodiments, the surgical instrument may include a handle and an elongated shaft assembly extending distally from the handle. The surgical instrument may also include a fastener deployment system for deploying fasteners from the elongated shaft assembly including a reciprocating driveshaft disposed within the elongated shaft assembly. The driveshaft may include an internal channel and at least one guide surface shaped and arranged to maintain an orientation of at least one fastener in the channel of the driveshaft. In other embodiments, the fastener deployment system may include a follower disposed within the elongated shaft assembly for displacing one or more fasteners within the elongated shaft assembly towards a distal fastener deployment position.