Abstract: A laser catheter with a pressure sensor is provided according to embodiments of the invention. The pressure sensor may be coupled with the distal end of the laser catheter and may comprise any of various piezoelectric materials, for example Polyvinylidene Difluoride (PVDF). In various embodiments of the invention the pressure sensor is configured to detect pressure longitudinally and coaxially. The pressure sensor may provide an electric potential that is proportional to the vessel pressure and may be used to monitor and/or adjust laser parameters. In other embodiments the results from the pressure sensor may be used to determine the vessel size and/or the type of material being ablated.

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: 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.

Abstract: A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which comprises poly(HEMA) complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Abstract: Embodiments of a balloon biasing laser catheter are provided. In some embodiments, the laser catheter may include a distal tip that extends from the distal end of the catheter from a point near the light guide aperture. The distal tip may be disposed at the periphery of the catheter. In some embodiments, a balloon may be disposed between the light guide aperture and the distal tip, such that the a light guide extending from the aperture may be disposed proximate with the distal tip having the balloon in between. A retaining wire may be coupled with the distal tip and slidably coupled with the light guide. The retaining wire may keep the light guide biased relatively parallel with the distal tip and/or the catheter body when the balloon is inflated. The light guide may include a guidewire lumen the extends to the distal end of the distal tip.

Abstract: A device for extending a lead according to an embodiment of the present disclosure includes a body, wherein the body is elongated and includes at least two apertures; a first filament loop comprising a filament, the filament extending along the inner surface of the body and through at least one of the at least two apertures, the first filament loop extending outside the outer surface of the body; a second filament loop extending outside the outer surface of the body; the first and second filament loops arranged so as to receive therethrough a lead, the first and second filament loops being tightenable about the lead in a manner that grips the lead between the first and second filament loops and an outer surface of the lead; and a tether coupled to the lead via one or more of the body, the first filament loop, and the second filament loop.

Abstract: A system includes a microprocessor executable verification module in a base unit and a microprocessor readable identifier of an endovasoular device in a memory of the endovascular device. The microprocessor executable verification module, based on the identifier, at least one of configures the endovascular device for use and determines whether the endovascular device can be enabled for use.

Abstract: A catheter tip is provided according to various embodiments of the disclosure. The catheter tip may comprise a distal end, a proximal end, and tubular walls. The distal end includes a distal aperture with a distal inside diameter, and the proximal end includes a proximal aperture with a proximal inside diameter. The proximal inside diameter may be greater than the distal inside diameter. The proximal end comprises attachment means configured to couple the proximal end with a distal end of a laser catheter. The tubular walls may include at least an inside taper from the proximal end to the distal end such that the inner tubular walls generally taper from the proximal inside diameter to the distal inside diameter. Moreover, the tubular walls may be configured to direct at least a liquid medium, for example, a biocompatible solution, toward the distal aperture.

Abstract: A method and device for local delivery of water-soluble or water-insoluble therapeutic agents to the surface of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with an amphiphilic polymer coating comprising a therapeutic agent and an amphiphilic polymer or co-polymer. The medical disposable device is inserted into a body lumen, and expanded to contact the amphiphilic polymer coating against the body lumen. The total solubility of the polymer or co-polymer in vivo prevents any embolic hazard associated with the amphiphilic polymer coating.

Abstract: Lead tip removal is accomplished by first stabilizing an area around the lead tip attachment site in the heart wall. A balloon located at the tip of the lead when inflated expands substantially perpendicular to the lead, stabilizing the area around the lead tip. Upon further inflation, the balloon expands substantially parallel with the lead, causing the lead tip to pull away from the heart wall. In another embodiment, a sheath is inserted over the lead and advanced to the heart wall. A passive or active stabilization device is attached to the sheath tip to stabilize the area around the lead tip. In another embodiment, a balloon is located at the tip of the sheath that, when inflated, expands substantially perpendicular to the lead, stabilizing the area around the lead tip. The lead tip is removed with less force due to the stabilization provided to the lead tip area.

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: 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: 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.