Abstract: The present disclosure relates to a delivery system, a catheter system and a method for the minimally invasive application of prostheses to an individual in need thereof and a method for loading a prosthesis onto a catheter system and/or a delivery system.

Abstract: An aspiration thrombectomy system including an aspiration catheter having a proximal end and a distal end, the aspiration catheter having a lumen to accommodate fluid, a vacuum source including a controllable vacuum valve, a tubing connected to the aspiration catheter, and a controller configured to detect a change in a catheter diameter corresponding to a change in the connection between the aspiration catheter and the tubing. The controller is configured to change a pulsation protocol associated with the aspiration catheter responsive to the change in the catheter diameter, and the pulsation protocol specifies pressure variations and pressure patterns to modulate the vacuum valve to change a level of vacuum at the distal end of the aspiration catheter.

Abstract: A device set designed for PCNL surgery includes a puncture needle, a guidewire, a dilator, a balloon catheter, a sheath, and a drainage catheter which are all placed in a single package. A tip length of the dilator is substantially the same as a tip length of the balloon catheter. The device set may include a puncture needle, a guidewire, a plurality of dilators having different sizes, a sheath, and a drainage catheter, which are all placed in a single package, wherein all the dilators have substantially the same tip length.

Abstract: An integrated catheter assembly for rapid vascular insertion including a catheter configured for receipt of a needle and a guidewire; a catheter assembly comprising an integrated assembly comprising a catheter, needle, and guidewire; and a method of rapidly inserting a catheter to obtain vascular access. The catheter includes a central lumen for receiving the needle and guidewire. The lumen includes a distal port and a transverse side port adjacent an intermediate portion thereof which provide open vascular communication from two ports between the central lumen and the vasculature. The needle and guidewire, when integrated with the catheter, extend through the transverse side port wherein a proximal end of the needle extends contiguous to and exterior of a proximal portion of the catheter.

Abstract: An aspiration thrombectomy system including an aspiration catheter having a proximal end and a distal end, the aspiration catheter having a lumen to accommodate fluid, a vacuum source including a controllable vacuum valve, a tubing connected to the aspiration catheter, and a controller configured to detect a change in a catheter diameter corresponding to a change in the connection between the aspiration catheter and the tubing. The controller is configured to change a pulsation protocol associated with the aspiration catheter responsive to the change in the catheter diameter, and the pulsation protocol specifies pressure variations and pressure patterns to modulate the vacuum valve to change a level of vacuum at the distal end of the aspiration catheter.

Abstract: An aspiration thrombectomy system including an aspiration catheter having a proximal end and a distal end, the aspiration catheter having a lumen to accommodate fluid, a vacuum source including a controllable vacuum valve, a tubing connected to the aspiration catheter, and a controller configured to detect a change in a catheter diameter corresponding to a change in the connection between the aspiration catheter and the tubing. The controller is configured to change a pulsation protocol associated with the aspiration catheter responsive to the change in the catheter diameter, and the pulsation protocol specifies pressure variations and pressure patterns to modulate the vacuum valve to change a level of vacuum at the distal end of the aspiration catheter.

Abstract: A surgical cannula includes a seal structure including a one-way check valve and a cannula body. The cannula body includes an insertion portion having a distal opening that is configured to be inserted into tissue, and a receiving portion that includes a proximal opening and is configured to reversibly receive the seal structure. In addition, the seal structure is configured to removably associate with the proximal opening of the cannula body, retain a positive pressure within the cannula body when engaged with the cannula body, and retain a positive pressure within the cannula body when an object is inserted through the cannula and the seal structure. Also, the cannula further includes one or more suture attachment structures extending outward laterally from the cannula body; and one or more internal recesses in an inner wall of the cannula located directly adjacent to the one or more suture attachment structures.

Abstract: A device and method are disclosed for intravenous cannulation. The device employs a spring to precisely and accurately control the force and velocity imparted to a piercing needle, with mechanical constraints built into the device to precisely and accurately control the distance through which the piercing needle travels. A sheathed-needle configuration is used with an outer, echogenic needle that can be seen via ultrasound; and an inner needle used to pierce the vein. The operator releases the piercing needle with a controlled velocity, controlled force, and controlled travel distance. The device reduces the human error and complications that have previously been associated with manually piercing a vein for cannulation.

Abstract: The present disclosure discusses a devices, systems and methods for transvascular, transvenous and/or transdural access, to the brain parenchyma, subarachnoid or subdural spaces. In some embodiments, the disclosed systems and methods may be used for local drug delivery, tissue biopsy, nanofluidic or microelectronic device/component delivery/insertion/implantation, in situ imaging, ablation of abnormal brain tissue and the like. Embodiments of the present disclosure include an access catheter system for extravascular procedures in the brain having an elongate, flexible tubular body, with at least one lumen extending axially there through between a proximal end, and a distal end. The access catheter system may include a side exit port and a distal end port. Further, the access catheter system may include a selective deflector positioned within the lumen configured to deflect a procedure catheter and permit a guide catheter.

Abstract: A medical device is disclosed that can effectively destroy an object in a biological lumen, a method for controlling rotation of the medical device, and a rotation controller. The medical device to be inserted into a biological lumen to destroy a thrombus in the biological lumen includes a long shaft portion that is rotationally driven, a drive unit that rotates the shaft portion, a breaking member that is provided at a distal portion of the shaft portion and is rotatable, and a control unit that controls the rotation of the drive unit, in which the control unit controls the drive unit to repeat the rotation while interposing a stop of the rotation between rotations of the drive unit.

Abstract: Removable vascular access devices include integrated safety features configured to prevent unintended migration of guidewires into a patient's body. The guidewires include safety guidewires that provide a tactile and/or visual indicator of insertion length. Introducer sets include the removable vascular access devices, catheters and the guidewires.

Abstract: The present disclosure describes systems and methods configured to determine shear wave velocity and tissue stiffness levels of thin tissue of finite size, also referred to as bounded tissue, via shear wave elastography. Systems can include an ultrasound transducer configured to acquire echoes responsive to pulses transmitted toward a tissue. Systems can also transmit a push pulse into the tissue for generating shear waves, and tracking pulses intersecting the shear waves. The system can also apply a directional filter to received echo data and generate directionally filtered shear wave data based on a dimension and angular orientation of the bounded target relative to the ultrasound transducer. The system can estimate velocities of the shear waves at different shear wave frequencies based on the filtered shear wave data and angular orientation relative to the transducer, and determine a tissue stiffness value independent of the shape or form of the tissue.

Abstract: Devices used to provide transseptal access are disclosed. The devices may comprise at least one cannula, a needle, and a handle. The cannula and the needle may be configured to be inserted through a dilator while not damaging a lumen wall of the dilator. The handle may be configured to lock the needle in a retracted position. The devices may be configured to telescopically advance the needle through an atrial septum.

Abstract: Systems and methods for providing assistance to a surgeon during an implant surgery are disclosed. A method includes defining areas of interest in diagnostic data of a patient and defining a screw bone type based on the surgeon's input. Post defining the areas of interest, salient points are determined for the areas of interest. Successively, an XZ angle, an XY angle, and a position entry point for a screw are determined based on the salient points of the areas of interest. Successively, a maximum screw diameter and a length of the screw are determined based on the salient points. Thereafter, the screw is identified and suggested to the surgeon for usage during the implant surgery.

Abstract: A catheter adapter may include a distal end, a proximal end, a lumen extending between the distal end and the proximal end, and a side port. A central axis of a fluid path extending through the side port may be disposed at an angle with respect to a longitudinal axis of the catheter adapter. The angle may be less than 45°. Additionally or alternatively to the angle being less than 45°, the catheter adapter may include a wedge and/or an insert configured to facilitate instrument delivery to the catheter assembly via the side port.

Abstract: An atherectomy system that utilizes an anchoring balloon with a rotary debulker and a crossing balloon to remove or debulk lesions formed on the interior wall surface of a body vessel. The system may include a first balloon coupled to a first tubular member, a rotary debulker coupled to a second tubular member, a second balloon coupled to both the third tubular member and the axially moveable fourth tubular member such that the second balloon is disposed inside the third tubular member. Methods for operating this device are also provided.

Abstract: The present disclosure relates to interventional devices such as catheters and guidewire devices having micro-fabricated features for providing flexibility while maintaining good torquability. An interventional device includes an elongated member (500) having an arrangement of fenestrations which define a plurality of axially extending beams coupling a plurality of circumferentially extending rings. The fenestrations are arranged so that the resulting beams form a distributed, non-helical and non-linear pattern along the length of the elongated member. The pattern of fenestrations thereby minimizes or eliminates preferred bending axes.

Abstract: Embodiments of the present disclosure include a method of transcatheterly delivering a band to encircle multiple papillary muscles in a heart. The method may comprise transcutaneously inserting a catheter into a heart and delivering a first end of a first guidewire to a ventricle in the heart via the catheter. The method may further comprise looping a first end of a first guidewire around a first papillary muscle and a second end of a second guidewire around a second papillary muscle. The first end of the first guidewire and the second end of the second guidewire may be brought out of the body while the first and second guidewires remain looped around the first and second papillary muscles, respectively. The first and second guidewires may be interconnected, and at least one end of the first and second guidewires may be pulled to establish a single loop around the papillary muscles.

Abstract: High torque guidewires and methods for making and using them are provided. A guidewire may include an inner core wire movable relative to an outer jacket. The outer jacket includes proximal and distal ends, a lumen extending there between, thereby defining a longitudinal axis, and one or more helical slots adjacent the distal end. The core wire includes a proximal portion, a distal portion slidably received in the outer jacket lumen and terminating in a curved distal tip that extends from the outer jacket distal end, and one or more pins on the distal portion, each pin slidably received in a respective helical slot in the outer jacket such that axial movement of the core wire relative to the outer jacket causes the pin to slide within the helical slot and rotate the distal tip relative to the outer jacket distal end.

Abstract: A catheter assembly is disclosed, which includes a catheter, a catheter hub, a guide wire, and a guide wire hub. The guide wire has a guide wire rigidity changing portion that gradually decreases in rigidity from a proximal side toward a distal side, and the catheter has a catheter rigidity changing portion that gradually decreases in rigidity from a proximal side toward a distal side. In the catheter assembly, the catheter hub and the guide wire hub are connected to each other in a state where the distal side of the guide wire is exposed from a distal end of a lumen of a shaft portion and a guide wire rigidity changing point and a catheter rigidity changing point are aligned with each other in an axial direction.

Abstract: An introducer needle assembly including a compressible section between the rigid needle and the hub. Once the vessel is entered as determined by blood entering the syringe, the compressible section of the introducer needed is occluded by compressing the section with the thumb and a finger. Neither blood for air can pass. Since the compressible section is in a flattened area it is easier to hold the needle while the syringe is unscrewed. The operator then can begin threading a guidewire down the divide which is now easier to enter because blood is not coming out of the hub thus obscuring the lumen.

Abstract: An insertion device for delivering media inside a patient includes an outer guide tube having a side port. An inner guide tube is nested within the outer guide tube and movable axially within the outer guide tube. The inner guide tube includes a deflector at an end within the outer guide tube. The device also includes a catheter nested within the inner guide tube and movable axially within the inner guide tube. The deflector of the inner guide tube is positionable such that it deflects the dispensing end of the catheter outward through the opening in the outer guide tube when the catheter is advanced axially within the inner guide tube. A therapeutic delivery cannula may be nested within the catheter, such that the deflected end of the catheter determines the direction of travel of the therapeutic delivery cannula into patient tissue when the cannula emerges from the catheter.

Abstract: An accessory device may be used in combination with a thrombectomy catheter. The accessory device may be configured to deflect a distal portion of the thrombectomy catheter and/or disrupt a lesion in a vessel.

Abstract: Methods and systems are disclosed herein for improved safer planning support during interventional procedures for inserting stents into a hollow organ of a patient by a guide device. One method includes: providing or recording a three-dimensional image data set of the hollow organ in a first position; segmentation or providing a segmentation of the three-dimensional image data set; providing or recording a two-dimensional image of the guide device introduced into the hollow organ; overlaying the three-dimensional image data set with the two-dimensional image; determining at least one corrected position of one or more section(s) of the hollow organ respectively using the overlaying of the three-dimensional image data set with the two-dimensional image; and determining the respective deformation energy of the hollow organ in the section(s) for the case of removal of the guide device using the previously determined corrected position compared to the first position.

Abstract: The invention being disclosed describes a medical device for removal of a thrombus or clot in a vascular setting by using a rotational, expandable basket structure in combination with drug infusion, blood/particle aspiration and clot isolation by distal and proximal occlusion.

Abstract: Systems and methods that facilitate visualization and identification of lumens of a multi-lumen brachytherapy device are disclosed. In one embodiment, visualization and identification can be attained by modifying a feature of at least one of the lumens relative to the other lumens. The feature may include a marking on the lumen, a diameter of the lumen or a composition of the lumen. In an additional embodiment, for brachytherapy devices in which multiple lumens are coupled to a distal end point such as a rigid connection member, visualization and identification of the lumens can be attained by modifying a feature of the rigid connection member. It will be readily appreciated that visualization and identification can be further enhanced through a combination of two or more of the techniques described herein.

Abstract: Distal access aspiration guide catheter system and methods for delivering implantable devices, catheters, or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens are described. A distal access aspiration guide catheter having a proximal, medial, and distal possessing high flexibility, high resistance to kinking and a large lumen to wall thickness ratio.

Abstract: An article that includes a guidewire and a removable angled guidewire storage device. The guidewire comprises an angled portion that is at an angle relative to a reminder of the guidewire. A distal end of the removable angled guidewire storage device has a conical shape having a wall that is configured to maintain the angled portion of the guidewire at the angle relative to the reminder of the guidewire. A proximal end of the removable angled guidewire storage device has an opening that is adapted to fit over at least a portion of an introducer. The angled guidewire storage device includes an internal channel having walls extending between the conical shape at the distal end of the removable angled guidewire storage device and the opening at the proximal end of the angled guidewire storage device for receiving and holding the guidewire.

Abstract: A steerable catheter includes a body portion, a flexible catheter body with a proximal end and a distal tip and a continuous steering wire passing through the flexible body from the proximal end to the distal tip and turning back through the flexible body from the distal tip to the proximal end.

Abstract: A guide wire has a wire body; and a distal side coating layer that covers a distal portion of the wire body. The guide wire has a cylindrical member that has an outer diameter substantially the same as an outer diameter of a proximal portion of the distal side coating layer, that encircles a portion of the wire body and that has a distal portion positioned proximate the proximal portion of the distal side coating layer; and a joint member that is disposed at a proximal side of the cylindrical member and joins the cylindrical member and the wire body. The joint member has a gradually decreasing outer diameter portion whose outer diameter gradually decreases toward a proximal side of the wire body, and an outer peripheral surface of the cylindrical member has a surface continuous with the gradually decreasing outer diameter portion.

Abstract: A wireguide set is provided for changing access between two access sites. The wireguide set includes a wireguide and a catheter. The wireguide passes through one access site while the catheter passes through another access site. The wireguide and catheter are connectable to each other inside the patient's body. Once connected, the catheter can pull the wireguide through the access site of the catheter. The wireguide set may be used to treat peripheral arterial disease occlusions in the lower leg where it is difficult or impossible to gain access through the occlusion from a femoral site.

Abstract: A stent graft delivery device (10) has an indwelling catheter (26) extending from a handle (12) through a pusher lumen and a stent graft lumen outside the guide wire catheter (32) of the delivery device towards the nose cone dilator (16). The indwelling catheter comprises a material able to transmit rotational and longitudinal movement (advancement and withdrawal) from the distal end to the proximal end thereof and a more flexible tip (24). The indwelling catheter facilitates catheterization of a branch artery.

Abstract: A distal end portion 2B of the core has a structure of a combined truncated cone 26 formed by connecting truncated cones satisfying a predetermined relational expression. An outer diameter ratio between the maximum outer diameter and the minimum outer diameter of the combined truncated cone 26 is greater than the outer diameter ratio between a large diameter proximal portion and a small diameter distal portion of an inner coil 4, and is greater than the outer diameter ratio between a large diameter proximal portion and a small diameter distal portion of the outer coil. Because of this, the rotation angle of the proximal side is reduced when rotation operation is performed and the torsional moment toward the distal end side is increased. Thus, the perforation performance at the completely occluded lesion can be improved.

Abstract: A rotational device for removing a stenotic lesion from within a vessel of a patient is disclosed. The device comprises a flexible hollow drive shaft having a distal end insertable into the vessel and an abrasive element located on the drive shaft proximal to the distal end of the drive shaft to abrade a stenotic lesion when the drive shaft rotates. The hollow drive shaft defines a lumen for fluid supplied into the drive shaft to flow in an antegrade direction along the lumen and into the vessel from the drive shaft distal to the abrasive element so that the fluid entering the vessel flows in a retrograde direction over the abrasive element and the drive shaft to entrain debris abraded by the abrasive element for removal of said debris from the patient.

Abstract: A catheter shaft and methods for making and using the same. The catheter shaft may include a core portion, a cap portion, and one or more lumens. The cap portion may be disposed on or over a section of the core portion and define a region with a different exterior or interior surface characteristic. For example, the cap portion may define a lubricious region along the catheter shaft. Manufacturing the catheter shaft may include a modified co-extrusion process that incorporates a flow valve on at least one of the material supply lines so that the supply line can be regulated by a user.

Abstract: Devices detect and assist in the avoidance of blood vessels during a surgical procedure, to avoid rupturing these blood vessels. Devices may be any penetration sensor device, such as a dilator sensor device, a hollow needle sensor device, or a trocar sensor device, which penetrates the skin and subcutaneous layers to reach a target location inside the body. The penetration sensor device includes a sensor probe which can make optical measurements to determine various parameters of the tissue at the tip of the sensor probe. These parameters may include an optical signal level returned from tissue contacting the tip of the sensor probe, an oxygen saturation level of the tissue, a total hemoglobin concentration, a blood flow, and a pulse. Based on these parameters, the presence or absence of a blood vessel at the tip of the penetration sensor device can be determined while the device travels towards the target location for surgery.

Abstract: Systems for delivering medical devices, as well as related methods are described.

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 endoluminal stent transit device. The endoluminal stent transit device includes a wire having a distal end and a proximal end, and a guide element attached to the wire at the distal end, which is movable between a first position and a second position. The guide element in the first position is in a contracted configuration while located within a lumen of a catheter and has a first diameter smaller than the catheter, and in the second position is in an expanded configuration while located outside of the lumen of the catheter and has a second diameter larger than the catheter.

Abstract: Disclosed herein is a removable cap for connection to an input port of a catheter, comprising a proximal end having a lumen configured to house a guidewire therethrough; a distal end configured to reversibly mate with a luer lock of the input port of a catheter, the distal end having a lumen configured to house the guidewire therethrough; and a tubular body between the proximal end and the distal end, wherein the tubular body comprises an anti-migration feature transformable between a first configuration to allow slidable movement of the guidewire within the cap in a first direction toward the patient, and a second configuration to prevent slidable movement of the guidewire within the cap in the first direction toward the patient. Systems and methods are also disclosed.

Abstract: Methods of providing sympathetic nerve blocks comprise inserting a portion of a catheter into a subject. A distal end of the catheter is positioned on a lateral side of at least one vertebra of a vertebral column of the subject proximate to a portion of a sympathetic nervous system of the subject. A medication is supplied through the catheter to effect a sympathetic nerve block in the subject. Methods of alleviating pain in lower extremities of subjects comprise inserting a portion of a catheter into a subject and supplying a medication through the catheter. Catheters and catheter assemblies may be used in administering such sympathetic nerve blocks. Catheters and catheter assemblies may be used in administering medication to one or more of a peripheral nervous system of a subject and a spinal cord of a subject.

Abstract: A forwardly directed fluid jet crossing catheter having a distally directed cylindrical flow fluid jet stream to cross a chronic total occlusion is set forth. The distal end of the device includes a formable catheter tip region having flexible internal components. Low and high pressure cavities are formed substantially by joined proximal and distal catheter tubes having an adhesive plug seal in common therebetween which partially defines one end of each of the low pressure and high pressure cavities. A guidewire tube and a high pressure tube are aligned along and within the low pressure and high pressure cavities and through the adhesive plug seal. The high pressure tube openly terminates in the high pressure cavity, whereby pressurized fluid transfers from the high pressure cavity in the guidewire tube entry hole to subsequently pass along the guidewire lumen and co-located guidewire to exit as a cylindrical fluid jet stream.

Abstract: A coaxial guidewire for use in accessing smaller vessels within a patient's body, consists of an inner core wire and an outer hollow wire. The distal end of the inner core wire tapers and supports a spring coil. The core wire, including the spring coil, fits within a 25-gauge needle that is used to locate an artery of the patient. When the needle is removed over the inner core wire, the outer hollow wire, having a distal end that tapers to the outer diameter of the spring coil, fits over the inner wire and is advanced until the distal end of the outer wire meets the spring coil of the core wire. A dilator and introducer sheath combination may then be fed over the assembled coaxial guidewire. When the distal end of the sheath is in the desired position, the dilator and the coaxial guidewire are removed.

Abstract: Systems and methods for accessing body tissue are disclosed. The systems and methods can include an introducer assembly for percutaneous access to a body lumen. The assembly can include a needle and an over-the-needle guidewire. The needle and the guidewire can be inserted into body tissue and the guidewire advanced into the body tissue relative to the needle. The needle can be removed after advancing the guidewire.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator disposed on and slideable along the elongated body of the needle and a medical article. The medical article is disposed on and slideable along the dilator. A track extends in a proximal direction from the dilator. The needle hub slides along at least a portion of the track between a first position and a second position. The device further includes a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position.

Abstract: A catheter guidewire for facilitating introduction of a flexible catheter into the human body (e.g., into the bladder) has a proximal end having a first stiffness which is sufficient to facilitate guidance of a stiff plastic expansion sheath through the tissue. A distal end of the guide wire has a second stiffness, substantially less than the first stiffness, to avoid damage to internal walls of the bladder. Preferably, the guide wire incorporates an intermediate portion having a stiffness between the first stiffness value and the second stiffness value.

Abstract: Devices and methods for locating sinus ostia and positioning a guide wire within the sinus ostia. The subject devices include a shaft having a distal end, a proximal end, a curved region located between the distal and proximal ends, and an interior channel, an extensible and retractable guide wire movably mounted within the interior channel and a probe tip joined to the guide wire.

Abstract: An aspiration catheter includes an aspiration tube and an aspiration lumen extending between and opening to the distal and proximal ends of the aspiration tube, and a guidewire tube bonded to the outer surface of the aspiration tube on a distal end portion of the aspiration tube, with at least a portion of the guidewire tube being parallel to the aspiration tube. A guidewire lumen extends through the guidewire tube and opens at a proximal opening located at a proximal end of the guidewire tube. The outer surface of the aspiration tube has a flat portion where the outer surface is parallel to an axial direction of the aspiration lumen, and the proximal opening of the guidewire lumen is located at the flat portion of the outer surface of the aspiration tube.

Abstract: A surgical guide wire or K-wire and method of use are provided. The K-wire or guide wire has opposite end portions and a shank portion in between. One end portion has a deformable end portion that, once outside of a confining guide passage, can be deformed to present a projected forward facing area that is larger than the transverse cross section of the K-wire or guide wire while in the passage. The increased area will provide increased resistance to additional forward axial movement into the surgical site.

Abstract: A surgical guide wire or K-wire and method of use are provided. The K-wire or guide wire has opposite end portions and a shank portion in between. One end portion has a deformable end portion that, once outside of a confining guide passage, can be deformed to present a projected forward facing area that is larger than the transverse cross section of the K-wire or guide wire while in the passage. The increased area will provide increased resistance to additional forward axial movement into the surgical site.