Abstract: Implantable devices formed of materials which are not readily imageable, and which may shift from a delivery configuration to a deployment configuration upon deployment, are delivered and deployed with a deployment/delivery device having sensors generating a signal indicating contact of the delivery/deployment device with tissue to guarantee purchase of the implantable device with tissue upon deployment. The implantable device may be a tissue anchor with talons which shift from a delivery configuration to a deployed configuration. The sensors may be positioned along a distal end of the delivery/deployment device to indicate purchase of the device with tissue, to ensure purchase of the talons with tissue upon deployment. The sensors may include at least three sensors, which may be spaced apart from one another, to indicate full contact of the distal end of the delivery/deployment device with tissue. The sensors may optionally be aligned with the talons.

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: A medical device for cutting a suture during a minimally invasive procedure may include an elongate shaft having a proximal end, a distal end, and a central longitudinal axis, a handle disposed at the proximal end of the elongate shaft, the handle including an actuation mechanism, and a cutting blade disposed proximate the distal end of the elongate shaft. The cutting blade is axially translatable within the elongate shaft in response to operation of the actuation mechanism. The elongate shaft includes a distal port to receive a suture. The elongate shaft includes a transverse slot extending inward from an outer surface of the elongate shaft generally perpendicular to the central longitudinal axis. The elongate shaft includes a suture lumen extending from the distal port axially within the elongate shaft to the transverse slot. The cutting blade intersects the transverse slot adjacent the suture lumen.

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: Implantable devices and systems include one or more leads adapted to be emplaced in the internal thoracic vein (ITV) of a patient. The lead may include features to adapt the lead for such placement. An associated device for use with the lead may include operational circuitry adapted for use with a lead having an electrode for sensing and/or therapy purposes coupled thereto. Methods for implantation and use of such devices and systems are disclosed as well.

Abstract: The present disclosure relates generally to the field of medical devices. In particular, the present disclosure relates to medical devices, systems and methods to treat a regurgitating cardiac valve, including, for example a tricuspid or mitral valve.

Abstract: A vascular introducer hub has a body that includes a proximal end, a distal end, and a lumen defined therethrough. The hub includes first and second seals disposed within the body. The first seal includes a first polymeric material and the second seal includes a second polymeric material. The hub is characterized by the first and second polymeric materials having different durometers.

Abstract: A heart valve anchor has a body that includes a distal portion, a distal end, a proximal portion, and a proximal end. The distal end and the proximal end define a longitudinal axis. The body has an expandable portion that includes a first radially expandable portion at the distal portion of the body, a second radially expandable portion at the proximal portion of the body, and a root portion disposed between the first and second radially expandable portions. The body has a first configuration adapted to be housed at least partially within a tissue penetrating device, and a second configuration in which the first and second radially expandable portions are partially or fully expanded such that the anchor engages tissue in a region between the first and second radially expandable portions.

Abstract: Implantable leads of a cardiac stimulus system are disclosed, as well as methods for implanting leads of a cardiac stimulus system. The lead may be comprised of a proximal portion having a coupler for coupling to an implantable pulse generator, an intermediate portion comprising a plurality of electrodes disposed thereon, and a distal portion. The intermediate portion may have a first diameter and the distal portion may have a second diameter. The distal portion may also have an attachment feature for attaching to a lead pulling tool for delivery to an ITV and an intercostal vein. Methods may include pulling a lead from a first position to a second position within the vasculature, exiting the vasculature at the second location, and attaching a portion of the lead that exits the vasculature to an electrode or implantable device for use with the lead.

Abstract: Implantation of a cardiac stimulus system using the ITV. Superior, intercostal, and inferior access methods are discussed and disclosed. Superior access may be performed using the brachiocephalic vein to access the ITV, with access to the brachiocephalic vein achieved using subclavian vein, using standard visualization techniques. A positioning mechanism may be advanced to the ITV, a location of the positioning mechanism may then be obtained, and an external access may then be established. Inferior external access may be accomplished inferior to the lower rib margin via the superior epigastric or musculophrenic vein. Intercostal external access may be accomplished via an intercostal vein between two ribs. A lead may then be attached to the positioning mechanism and drawn into the ITV.

Abstract: Anchor delivery systems and methods for repairing a valve inside a body, such as a heart valve, may include a delivery catheter having a distal end comprised of two or more rotatably coupled knuckles. An anchor delivery mechanism is disposed distally of the two or more knuckles, and includes a first pincer arm having a distal end and a proximal end rotatably coupled to a distal end of the anchor delivery mechanism at a first connection point, and a second pincer arm having a distal end and a proximal end rotatably coupled to the distal end of the anchor delivery mechanism at a second connection point opposite the first connection point. In a closed position, the distal ends of the first and second pincer arms are positioned together. In an open position, the distal ends of the first and second pincer arms are rotated apart from each other.

Abstract: Implantation of a cardiac stimulus system using an illuminating catheter system, and devices for such implantation. Multiple catheter systems for allowing for selective visualization of the internal thoracic vasculature are discussed and disclosed. A multiple lumen catheter may be used to selectively direct a contrast agent to a desired portion of the thoracic vasculature which may include the internal thoracic vein(s) and/or one or more intercostal veins.

Abstract: Implantation of a cardiac stimulus system using the intercostal veins. Superior, intercostal, and inferior access methods are discussed and disclosed. Superior access may be performed by entering the brachiocephalic vein from a jugular, subclavian, or other vein, and then accessing the internal thoracic vein, traversing a portion of the internal thoracic vein and then accessing an intercostal vein therefrom. Inferior access may be accomplished inferior to the lower rib margin via the superior epigastric vein, advancing superiorly into the internal thoracic vein and then accessing an intercostal vein therefrom. Intercostal access may include creating an opening in an intercostal space between two ribs and advancing a needle using ultrasound guidance to enter the intercostal vein directly.

Abstract: Anchor delivery systems and methods for repairing a valve inside a body, such as an atrioventricular valve, may include an anchor delivery device including a sheath for at least partially retaining an anchor in a collapsed form. The anchor delivery device may be configured to deliver the anchor to the atrioventricular valve. The anchor and an adjacent anchor may be connectable to each other in an expanded form, to link a series of anchors implanted at least partially around the atrioventricular valve. In some embodiments, the anchors may be connectable by a connecting member, such as a pledget, or a material disposable on a bulb of the anchor. In other embodiments, a bulb of the anchor and a bulb of the adjacent anchor may be configured to be directly interlocked.

Abstract: A minimally invasive endoluminal annuloplasty system and method of use includes a guide catheter configured to direct a working catheter to a treatment site within a cardiac cavity. The guide catheter may be translatably disposed within the working catheter which may be translatably disposed within an introducer sheath that extends into the cardiac cavity. The guide catheter may be sized to reduce noise, and/or may be formed from a material that assists with visualization. In one embodiment the guide catheter comprises a distal guidewire anchor. Visualization may be used to embed the distal guidewire anchor into tissue at the target site.

Abstract: Anchor delivery systems and methods for repairing a valve inside a body, such as an atrioventricular valve, may include an anchor delivery device including a sheath for at least partially retaining an anchor in a collapsed form. The anchor delivery device may be configured to deliver the anchor to the atrioventricular valve. The anchor and an adjacent anchor may be connectable to each other in an expanded form, to link a series of anchors implanted at least partially around the atrioventricular valve. In some embodiments, the anchors may be connectable by a connecting member, such as a pledget, or a material disposable on a bulb of the anchor. In other embodiments, a bulb of the anchor and a bulb of the adjacent anchor may be configured to be directly interlocked.

Abstract: Apparatuses, systems, and methods for crossing a tissue region 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: A catheter configured to dynamically compensate for the impact of internal and external forces that act upon the catheter during use is disclosed. The catheter may include sensors configured to measure received forces on control cables that extend within the catheter. A controller, coupled to the sensors, may record received force measurements associated with a working position of a distal end of the catheter. The controller may monitor subsequently received forces to identify force variances that may deflect the distal end of the catheter from its working position and may apply a driving force to one or more of the control cables to minimize the force variances. Monitoring received forces during use and applying compensating drive forces may reduce deflection of the distal end of the catheter, increasing the accuracy and precision of an annuloplasty procedure while minimizing potential damage to cardiac tissue.

Abstract: Implantation of a cardiac stimulus system using the ITV. Access to the ITV may be performed using the intercostal vein as an access point, and entering the ITV through an ostium therebetween. The intercostal vein may be located on a costal groove on an inferior portion of a rib. Advancement from the intercostal vein to the ITV may then be performed in a superior direction, an inferior direction, or both.

Abstract: The present disclosure relates generally to medical devices and methods for medical devices to be placed within a lumen of a patient, wherein the devices comprise one or more radiopaque filaments arranged with the devices and viewable to assist in placement and orientation of the devices with respect to the lumen.