Abstract: A method of lancing the tissue of a patient provides a tissue penetration element with a tip configured to penetrate tissue and a shaft portion. The tissue penetration element is disposed in proximity to the tissue of the patient. The tissue penetration element is driven distally towards the tissue of the patient. Contact is made between the tip and the tissue of the patient. The tip is advanced into the tissue during a penetration stroke to a position of maximum inward displacement. The tissue penetration element is allowed to settle upon reaching the point of maximum inward penetration for at least about 1 millisecond with no driving force imposed on the tissue penetration element. The tissue penetration element is displaced proximally over a withdrawal stroke and the tip is removed from the tissue.

Abstract: Embolism protection devices can be formed with a biocompatible expandable polymer that can expand upon release within a patient's vessel. Upon release, the structure can be configured to filter flow through the vessel. The material of the embolism protection devices can release one or more biologically active agents, such as a thrombolitic agent, including, for example, tPA. Alternatively or additionally, the embolism protection device can be connected to a tether that elutes one or more biologically active agents.

Abstract: A method of crimping a stent onto a balloon of a stent delivery catheter is disclosed. The method includes pressurizing the balloon while the stent is being radially compressed onto the balloon with a crimping apparatus. Once the stent has reached its radially compressed configuration, the pressure within the balloon is released, while an inward crimping force exerted on the stent by the crimping apparatus is maintained. After a dwell time, the inward crimping force is discontinued, and the balloon and crimped stent are removed from the crimping apparatus. Resultant of the crimping process, balloon material extends radially outward through interstices of the stent to facilitate stent retention on the balloon while advancing the stent delivery catheter through a vessel lumen.

Abstract: These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes a drive force generator and a penetrating member operatively coupled to the force generator. The force generator moves the member along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. The drive force generator is configured to be controlled to follow a predetermined velocity trajectory into the tissue and out of the tissue. A tissue stabilizing member is associated with the device and at least partially surrounds an impact location of the penetrating member on the tissue site.

Abstract: An agent injection device is provided that is capable of injecting an agent to a known predetermined tissue depth. An injection member has an elongate injection shaft with an outlet port configured to dispense an agent at a controllable time. A controllable driver is coupled to the elongate injection shaft and is configured to drive the injection member into target tissue. A velocity control system is in communication with the controllable driver and is configured to control the velocity of the elongate injection shaft.

Abstract: A device for removing blood clots and methods of making and using the same. The clot pulling device may include a first spine, a second spine disposed parallel to the first spine, and a basket disposed between and coupled to the spines. In addition, a pushing member may be coupled to the first spine and extend proximally therefrom.

Abstract: Apparatus and methods are provided for use in filtering emboli from a vessel and/or performing thrombectomy and embolectomy, wherein a vascular device disposed on a guidewire includes a support hoop disposed from a suspension strut. Alternately, a support hoop having an articulation region may be directly connected to a region proximate the distal end of the guidewire. A blood permeable sac is affixed to the support hoop to form a mouth of the blood permeable sac. The support hoop is disposed obliquely relative to the longitudinal axis of the guidewire and is capable of being properly used in a wide range of vessel diameters. The vascular device collapses during removal to prevent material from escaping from the sac. A delivery sheath and introducer sheath for use with the vascular device of the present invention are also provided.

Abstract: An apparatus for shielding a body structure during surgical procedures which is configured for insertion into the internal passage of a support structure, and includes an elongated body portion with a distal tip portion configured to cover the body structure without substantially displacing the body structure. The apparatus also includes a mounting portion at a proximal end portion thereof for mounting the apparatus within the internal passage of the support structure, and a member connected to the mounting portion to release the mounting portion with respect to the internal passage of the wall portion.

Abstract: A device for use with a gripper is provided. A cartridge is provided that defines a plurality of cavities. A plurality of penetrating members are at least partially contained in the cavities of the cartridge. The penetrating members are slidably movable to extend outward from the cartridge to penetrate tissue. Each cavity has a longitudinal opening that provides access to an elongate portion of the penetrating member. A sterility barrier is coupled to the cartridge. The sterility barrier covers a plurality of the longitudinal openings. The sterility barrier is configured to be moved so that the elongate portion is accessed by the gripper without touching the barrier.

Abstract: A cannula (10) receives surgical instruments (120) for performing a surgical procedure on a body (130). The cannula (10) comprises a tube structure (12) defining a passage (16) through which the surgical instruments (120) are inserted into the body (130). The tube structure (12) has a proximal end (20) and a distal end (62). The tube structure (12) includes an expandable portion (40) for enabling an increase in the cross-sectional area of the passage (16) at the distal end (62). The expandable portion (40) of the tube structure (12), when expanded, has a conical configuration.

Abstract: A sampling module includes a module body portion with a lancet channel, a lancet slidably disposed within the lancet channel. A cover sheet is disposed over the lancet and a lancet channel that captures the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet.

Abstract: Vascular embolic filtering systems, as well as methods for using the same, are provided. In general, the subject invention includes a system comprised of an embolic filter assembly and a multiple lumen delivery and retrieval sheath, where the embolic filter assembly includes a guide wire with an embolic filter operatively coupled to the distal end of the guide wire for capturing emboli created during interventional procedures within a target vessel. Features of the subject invention provide for the rapid exchange and deployment of embolic filters in a patient's vasculature.

Abstract: An expandable frame for an embolic filtering device used to capture embolic debris in a body vessel includes a first half frame having a first control arm connected to a second control arm by a partial loop and a second half frame having a first control arm connected to a second control arm by a partial loop. The partial loops cooperatively form a composite loop for attachment of a filtering element which will expand in the body vessel to capture embolic debris entrained in the fluid of the vessel. The lengths and positioning of the first and second control arms of each half frame can be varied to create an expandable frame which conforms to the size and shape of the body vessel in which the filtering device is deployed. Additionally, the radius of the partial loops, along with the length of the arc of the partial loops, can be varied on each of the frames to create a composite filtering assembly that can easily adapt to the size and shape of the body vessel.

Abstract: A method of penetrating tissue is provided. The method uses a lancet driver to advance a lancet into the tissue; advancing the lancet at a first desired velocity in a first layer of tissue; advancing the lancet at a second desired velocity in a second layer of tissue; and advancing the lancet at a third desired velocity in a third layer of tissue. In one embodiment, the method may including using a processor having logic for controlling velocity of the lancet in each layer of tissue.

Abstract: A self-expanding cage for use in conjunction with an embolic filtering device includes one or more circumferential members adapted to expand from an unexpanded position to a expanded position within the patient's body vessel. At least one proximal strut and at least one distal strut are attached to the circumferential member to form the basket. The circumferential member may include a plurality of bending regions which enhance the ability of the circumferential member to move between the unexpanded and expanded positions. The proximal and distal struts can be attached to one of the bending regions. When two or more circumferential members are utilized, each member may be connected by a connecting strut which may be connected at a bending region. The connecting strut can be a straight segment or may have a non-linear shape to provide additional flexibility. The expandable cage can be mounted to a elongated member, such as a guide wire, and can be either permanently mounted or rotatably mounted thereto.

Abstract: These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator. A user interface is configured to relay at least one of, penetrating member performance or a penetrating member setting.

Abstract: A system for enabling the insertion and removal of an embolic protection device, for capturing and retaining embolic debris which may be created during the performance of a therapeutic interventional procedure in a stenosed or occluded region of a blood vessel. The system, in an embodiment thereof, enables the device to be snap-fitted so as to engage the distal end of a guide wire, to provide a reference for positioning the device at a location distal to the interventional procedure site, and to enable an end of the device to be in tension, enabling a portion of the device to be in tension and another portion to be in compression, so as to assist in bending thereof in tortuous vasculature.

Abstract: The invention is directed to an expandable stent for implanting in a body lumen, such as a coronary artery, peripheral artery, or other body lumen. The invention provides for an intravascular stent having a plurality of cylindrical rings connected by undulating links. A plurality of inverted cylindrical end rings can be coupled at least in part to a plurality of adjacent cylindrical rings in the form of mirror images such that a symmetrical configuration is present on at least one of a proximal end and a distal end of the stent. The stent has a high degree of flexibility in the longitudinal direction, yet has adequate vessel wall coverage and radial strength sufficient to hold open an artery or other body lumen. The inverted end ring configuration of the stent aims at reducing the stent-to-shoulder distance as well as delivering therapeutic drug to the peri-stent area while maintaining a pristine stent deployment.

Abstract: A delivery system for delivering an endoluminal implant to a distal deployment location inside a body lumen from a proximal access location outside the lumen. The system includes the implant, a catheter, and a slidable sheath having an advanced position in which the sheath covers the implant and a retracted position in which the implant is exposed. The catheter includes a stabilizer having a distal end adjacent the implant proximal end and/or a catheter tip attached to a central core slideably disposed relative to the implant and having a proximal end adjacent the implant distal end. The catheter tip proximal end and/or the stabilizer distal end includes a docking section adapted to releasably engage a portion of the implant. Each docking section has an engagement geometry including a flared engagement surface that extends inside a short axial length of the implant or a pocket having a bottleneck geometry.

Abstract: An angioplasty catheter comprises a catheter body having a balloon or other radially expansible shell at its distal end. A non-axial 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.