Abstract: A device for occluding a perforation in a blood vessel includes an expandable member. The expandable member includes a central expandable balloon disposed between a proximal and a distal balloon, wherein the proximal and distal balloons each contain first and second compositions, respectively. The proximal, central and distal balloons have respective stiffnesses, and the central balloon has a third stiffness that is less than the first and second stiffnesses. Upon expansion, the central balloon causes the proximal balloon and the distal balloon to substantially simultaneously release the first and second compositions, thereby allowing the first composition and the second composition to combine in-situ and form, therein, a biocompatible foam to occlude a perforation within the vasculature.

Abstract: Devices, methods and systems for removing unwanted tissue from within a patient's vasculature system are provided. Specifically, a laser ablation catheter having a tip with an open, arched-shaped cross section is described. The cross section of the tip enhances the catheter's ability to ablate, separate, and/or dilate the various layers within a patient's vasculature, thereby facilitating the removal undesirable lesions and fibrous tissue within a patient's vasculature.

Abstract: A system for ablation and removal of occlusions from blood vessels is provided. Laser cutting systems and mechanical cutting systems are provided in catheter devices, the cutting systems operable to ablate, cut, dislodge, and otherwise remove occlusions within a blood vessel that may limit or prevent proper circulation. Aspiration systems are further provided, the aspiration systems operable to remove ablated, cut, or dislodged material through a primary orifice at the distal end of the catheter and/or through an auxiliary orifice, which may be on the side of the catheter.

Abstract: A device for extending a lead according to some embodiments includes a body, a coil element coupled to the body, the body configured to cover the coil element during use, the coil element comprising an inner lumen sized to receive an outer surface of a lead, the coil element is movable between a first configuration in which the coil element slides over the lead, and a second configuration in which at least some coils grip the outer surface of the lead; an actuation mechanism operatively coupled to the coil element, the actuation mechanism configured to move the coil element between the first and second configurations; and a tether coupled to the lead via the body, the coil element, and/or actuation mechanism, the tether configured to extend further proximally than a proximal-most end of the lead and configured to transfer tension force applied to the tether to the lead.

Abstract: Catheters for ablation and removal of occlusions from blood vessels are provided. Laser cutting systems and mechanical cutting systems are provided in catheter devices, the cutting systems operable to ablate, cut, dislodge, and otherwise remove occlusions within a blood vessel that may limit or prevent proper circulation. A helical or partially-helical inner surface structure is provided in the catheter, the structure operable to remove or translate dislodged material(s).

Abstract: Methods and systems for separating an object, such as a lead, from formed tissue are provided. Specifically, a tissue slitting device is configured to engage patient formed tissue at a slitting engagement point. While the object is subjected to a first traction force, the tissue slitting device is caused to move further into the engaged tissue and slit the tissue past the point of engagement. The slitting device causes the tissue to separate along an axial direction of the length of the formed tissue and releases at least some of the force containing the object. The methods and systems are well suited for use in cardiac pacing or defibrillator lead explant procedures.

Abstract: A method for treating a stenosis includes providing a laser ablation system including a laser catheter, the laser catheter including a distal end having a plurality of laser emitters; positioning the distal end of the laser catheter within the subject proximate the target vascular portion; delivering laser energy to the laser catheter and emitting the laser energy from the plurality of laser emitters to ablate the stenosis; withdrawing the laser catheter from the subject; providing a balloon system including a drug-coated balloon, the balloon carrying at least one therapeutic agent, the therapeutic agent being a restenosis inhibitor; positioning the balloon within the subject proximate the target vascular portion; expanding the balloon to engage the target vascular portion; delivering the therapeutic agent from the balloon to the target vascular portion; delivering the therapeutic agent from the balloon to the target vascular portion; and withdrawing the balloon from the subject.

Abstract: A method of forming a coated medical device is described in which a coating including a therapeutic agent dispersed in a polymer or oligomer matrix is applied to an outer surface of the medical device. The coating is then post-processed to selectively remove a substantial portion of the polymer or oligomer matrix from the coating. The post-processed coating is then sterilized.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the surgical device includes a handle, an elongate sheath and a circular cutting blade that extends from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the surgical device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device's elongate shaft. The surgical device has a barrel cam cylinder in the handle assembly that imparts rotation of the blade and a separate cam mechanism in the tip of outer sheath assembly that imparts and controls the extension and retraction of the blade.

Abstract: Device and method for puncturing blood vessels while using fluoroscopy. The disclosed device enables improved needle orientation control and avoids direct exposure of the clinician's hand to X-ray during the puncturing procedure.

Abstract: In some embodiments, without limitation, the invention comprises an apparatus for cutting an endocardial lead within a patient. The apparatus comprises a generally flexible tubular member having a proximal end and distal end. At least one blade or cutting surface is affixed to the distal end of the tubular member. The apparatus optionally includes an adjustment mechanism adapted to adjust the blade or cutting surface between an extended position and a retracted position. The blade or cutting surface engages the endocardial lead to cut the lead. Various embodiments include a v-shaped groove defining the cutting surfaces. Other embodiments may comprise a rotatable blade of an inner shaft rotating within the tubular member and cutting the lead received within the v-shaped groove, and blades or cutting surfaces functioning like guillotines or scissors retracting into a distal end of the tubular member.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the tissue separating device includes a handle, an elongate sheath and a circular cutting blade that may extend from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device's elongate shaft. The tissue separating device includes a cam mechanism at the distal portion of the sheath that allows the user of the device to more accurately control the extension and rotation of the cutting blade upon being actuated by the handle.

Abstract: An endovascular device monitoring system is provided that determines, based on movement of the endovascular device past a selected reference location, at least one of a movement rate of a endovascular device and position of a distal end of a endovascular device in a body of a patient.

Abstract: The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using laser-induced pressure waves to disrupt vascular blockages. The present disclosure not only provides devices and methods for using laser-induced pressure waves to disrupt vascular blockages, but the present disclosure also provides devices and method for assisting the guidewire in penetrating an occlusion, devices and method for using a sealable valve in the tip of the balloon catheter to reduce the overall size and diameter of the balloon catheter, thereby allowing the balloon catheter to penetrate smaller size blood vessels and devices and method that use stationary light absorbing material in lieu of and/or in combination of using liquid medium that flows into a balloon for a balloon catheter.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the surgical device includes a handle, an elongate inner sheath and a circular cutting blade that extends from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the surgical device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device's elongate shaft. The surgical device has a barrel cam cylinder in the handle assembly that imparts rotation of the blade and a separate cam mechanism in the tip of outer sheath assembly that imparts and controls the extension and retraction of the blade.

Abstract: The invention generally relates to method and apparatus for crossing an obstruction in a tubular member, and more particularly to a medical device method for crossing of a chronic occlusion in a subintimal or interstitial space of an artery.

Abstract: The present disclosure relates to a system and method for providing laser energy through a catheter towards a second end portion of the catheter. Based on a characteristic of the laser energy multiple types of ablation therapy may be implemented. A first ablation therapy is directed at the target site when the laser energy at the second end portion of the laser energy delivery system has a first characteristic. A second ablation therapy is directed at the target site when the laser energy at the second end portion of the laser energy delivery system has a second characteristic. The first ablation therapy may be an optical ablation therapy wherein the laser energy is directed at the target site as optical energy and the second ablation therapy may be a pressure wave ablation therapy wherein pressure waves are directed at the target site as pressure wave energy.

Abstract: Devices for removing implanted objects from body vessels are provided. A device includes a sheath assembly having a cutting tip. The cutting tip includes a cutting surface that is adapted to cut tissue coupled to an implanted object as the cutting tip rotates. The sheath assembly further includes an outer shield carried outside of the cutting tip. The outer shield includes a distal opening, and the outer shield is translatable relative to the cutting tip from a first position to a second position and vice versa. In the first position the cutting surface of the cutting tip is disposed within the outer shield, and in the second position the cutting tip extends through the distal opening and the cutting surface is at least partially disposed outside of the outer shield.

Abstract: An angioplasty catheter comprises a catheter body having a balloon or other radially expandable shell at its distal end. An external structure is carried over the shell and scores a stenosed region in a blood vessel when the balloon is inflated therein. The catheter has an attachment structure disposed between the catheter body and the balloon to accommodate foreshortening and rotation of the external structure as the balloon is expanded. The external structure may be part of a helical cage structure which floats over the balloon. Stabilizing struts are provided between at least some of the helical struts.