Abstract: A lead for navigating small vessels and a catheter system for implantation of leads into small vessels. Veins that return blood to the heart against the force of gravity often have valves in them to prevent backflow of deoxygenated blood. Leads and catheter systems in accordance with embodiments of the invention allow cannulation and lead implantation in small, tortuous, obstructed, and difficult to access veins enabling a range of stimulation and sensing applications.

Abstract: A biomedical electrode according to the present invention includes: a plate-shaped support portion; an elastic pillar portion that is provided on a first surface of the plate-shaped support portion; and a conductive resin layer that is formed to cover a distal end of the elastic pillar portion, in which when measured at 37° C. according to JIS K 6253 (1997), a type A durometer hardness of a surface of the elastic pillar portion is higher than 35 and 65 or lower.

Abstract: An intelligent anti-icing material and a preparation method and use thereof are disclosed. The intelligent anti-icing material includes a hydrophobic resin and a nickel-titanium alloy wire embedded in the hydrophobic resin. When the surrounding temperature decreases, the hydrophobic resin in the intelligent anti-icing material shrinks, and the nickel-titanium alloy wire featured by thermoelastic martensitic transformation undergoes phase transformation and expands, which changes the direction of the expansion force inside the ice layer, and thus tiny cracks occur at the interface between the ice layer and the surface of the material, thereby reducing the adhesion of the ice layer to the surface of the material, accelerating the spontaneous shedding of the ice layer, without heating, and achieving an excellent anti-icing effect.

Abstract: A bi-directional perfusion cannula is provided that includes an elongate tube for insertion into an artery. The elongate tube has a first aperture at a distal end of the tube which is forward during insertion and configured so that blood can flow into the artery in the direction of insertion, an elbow formed in the elongate tube, and a second aperture formed in or slightly rearward of the elbow and configured for supplying blood into the artery in a second direction which is generally opposite to the insertion direction.

Abstract: Systems and methods for providing a reinforced cannula for use in a blood pump assembly. The reinforced cannula comprises one or more thermoformed reinforced end portions. The thermoformed reinforced end portions may be stiffer than a medial portion of the cannula, allowing the medial portion of the cannula body to stretch and bend more readily than the cannula ends when the cannula is subject to an applied stress, reducing the stress and strain on the cannula ends.

Abstract: A medical device includes a resin base including one or more than one material selected from a group consisted by an ethylene propylene resin containing fluorine, a styrene resin containing fluorine, an olefin resin containing fluorine, a vinyl chloride resin containing fluorine, a polyester resin containing fluorine, a polyurethane resin containing fluorine, and a nylon resin containing fluorine; an underlayer formed on the resin base, the underlayer including an oxazolidone ring; and an epoxy resin layer formed on the underlayer.

Abstract: An embolization microcatheter having an elongated microcatheter body configured for passing therein a suspension of particles suspended in a suspension fluid; and a microcatheter head connected to a distal end of said microcatheter body and comprising a proximal head section and a distal head section, wherein the proximal head section includes a proximal wall forming a proximal section lumen, the proximal wall having a plurality of through-holes, wherein the distal head section includes a distal wall forming a distal section lumen, and a suspension delivery opening at a distal end of the distal end section; wherein the distal section is devoid of through-holes, and wherein each of the plurality of through-holes are shaped and/or sized to allow passage therethrough of the suspension fluid while blocking passage of the particles suspended therein.

Abstract: Nipple shields can be used by breastfeeding mothers to facilitate the feeding process. The disclosed embodiments relate to nipple shields with a port through which liquid supplement can flow from a supply tube into an interior section of the shield. The liquid supplement can be drawn through ports in a tip of the shield in order to augment a naturally expressed flow of milk. A flap of material is bonded to an interior portion of the nipple shield over an optional channel formed in the interior portion so as to form a closed, flap-covered channel leading from an input port on a lower portion of the shield to a an interior location near the tip of the shield.

Abstract: A catheter assembly includes a catheter body extending from a catheter proximal portion to a catheter distal portion. The catheter body includes an inner liner and an outer sleeve. A braid assembly is within the catheter body and between the inner liner and the outer sleeve. The braid assembly includes a first filar array including one or more first filars helically extending around the catheter body in a first direction. The braid assembly further includes a second filar array including one or more second filars helically extending around the catheter body in a second direction opposed to the first direction.

Abstract: An aspiration catheter includes a catheter body having a proximal end, a distal end, and an aspiration lumen therebetween. A distal segment comprising an expandable distal tip of the aspiration catheter comprises a membrane and an expandable supporting structure, such as a scaffold, configured to radially expand the expandable distal tip. The expandable supporting structure may include supporting elements and other features which increase resistance to collapse of the expandable membrane under vacuum or negative pressure applied to aspirate clot through the aspiration lumen in the expanded configuration.

Abstract: The present disclosure relates to devices and methods for accessing a targeted vessel, such as a coronary artery, near the aortic root. A catheter device includes a proximal section, an intermediate section, and a distal section. The intermediate section includes a more proximal section (a proximal-intermediate section) and a more distal section (a distal-intermediate section). The proximal-intermediate section is microfabricated to enable preferred bending along a single plane. The distal-intermediate section is more rigid than the proximal-intermediate section and the distal section. In use, the proximal-intermediate section abuts against the aortic wall and bends to allow the distal-intermediate section to extend across the aortic root toward a targeted vessel on the opposite side of the aorta.

Abstract: An expandable delivery sheath includes an elastic outer tubular layer and an inner tubular layer. The inner tubular layer include a thick wall portion integrally connected to a thin wall portion. The thin wall portion can include longitudinal reinforcing members/rods that facilitate unfolding during the passage of the implant, thus decreasing the push force and increasing the consistency of the push force. The inner tubular layer can have a non-expanded or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the non-expanded condition with the sheath reassuming its smaller profile.

Abstract: A sheath for guiding and controlling a length of a catheter, the sheath comprising a body defining a longitudinal axis. The body can include a proximal portion and a distal portion, a bore extending along the longitudinal axis between and through the proximal portion and the distal portion, and a looped portion located between the proximal portion and the distal portion.

Abstract: In one aspect, a medical balloon assembly includes a tip sleeve secured to the distal end portion of a balloon catheter that includes the distal neck of a balloon. The tip sleeve has at least an inner layer and an outer layer. The inner layer is formed from a bondable material that is directly bondable to the exterior of the distal neck portion of the balloon. The tip sleeve is bonded directly to the distal neck of the balloon. The outer layer is formed from a lubricious polymer. Such a medical balloon assembly is made by receiving the distal neck inside the proximal end portion of the tip sleeve and directly bonding the distal neck of the balloon to the inner layer of the tip sleeve.

Abstract: Certain embodiments herein relate to an extension catheter for positioning through a conventional guiding catheter into the vasculature of a patient, the extension catheter having a distal tubular member and a proximal elongated shaft coupled to the distal tubular member, wherein the proximal shaft has a length or section containing at least one discontinuous or segmented structure, and further wherein such structures that can be modified or varied to modify the torsional compliance characteristics of the device. Further embodiments relate to a multi-layer catheter having a protective wrap at or near the distal end of the catheter.

Abstract: A root canal irrigant needle for use with a dental syringe for use in a dental procedure such as a root canal is provided. The root canal irrigant needle has a non-circular shape and has multiple irrigant outlets located along the length of the root canal irrigant needle. The location and angular orientation of the multiple irrigant outlets allow for an efficient removal of debris from the root canal.

Abstract: The invention relates to a method for manufacturing an endoscope insertion tube (2). The insertion tube (2) has a proximal passive flexible section (20) and a distal angled section (A). The passive flexible section (20) and the angled section (A) are integrally formed. Individual cuts (201, 202) are made in the flexible section (20), provided as a tube-like element, in such a way that adjacent individual cuts (201, 202) are equidistant from one another.

Abstract: A tube element for a device for introduction into a body passage comprises a first tube element end and a second tube element end, wherein a longitudinal dimension is formed between the first and second tube element end. The tube element has a sheath comprising an outer wall and an inner wall. A cross-sectional element is arranged between the first and second tube element ends. The cross-sectional element contains a plurality of opening arrangements. Each opening arrangement comprises a first opening containing an insert element and a second opening, the internal pressure of which can be changed by a pressure changing means.

Abstract: A catheter may include an inner liner, at least one support structure over the inner liner, and an outer jacket over the at least one support structure. In some examples, the catheter includes a tip jacket positioned over a distal portion of the outer jacket and extend beyond a distal-most part of the inner liner and a distal-most part of the outer jacket to define a single-layer catheter tip. In some examples, the at least one support structure may include a braid and a coil. The catheter may include a marker band over a distal portion of one of the braid or the coil. The other of the braid or the coil ends proximally of a proximal end of the marker band, such that the catheter includes a location with lower radial and/or flexural stiffness proximal of the marker band.

Abstract: Distal tips for use with delivery catheters are disclosed that are configured to facilitate deflection of the catheters as they are advanced through the vasculature to a desired treatment site. Distal tips so configured realize one or more of the objectives of safer, more accurate steering of the catheter through the vasculature.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal member having a proximal end, a distal end, and a proximal diameter. The guide extension catheter may additionally include a collar member attached to an extension portion of the proximal member, where the extension portion may be located at the distal end of the proximal member. The extension portion may allow a delivery device to be inserted through the guide extension catheter to extend along a surface of the extension portion and align with a lumen of a distal sheath of the guide extension catheter.

Abstract: An implantable medical device deployment system is disclosed that employs both a sheath element and a constraint member to protect implantable medical devices during delivery in a body while providing simple, accurate, and reliable device deployment. The delivery system is configured so that loading and deployment forces are not directly related to device diameter, length, or design, thus allowing a more universal delivery system across various delivered device configurations and product lines. The deployment system can provide numerous benefits, include better protection for drug-coated implantable devices.

Abstract: An implant delivery system is provided for deploying an expandable implant in a patient lumen. An outer sheath has an outer sheath lumen that extends between an outer sheath proximal opening and an outer sheath open tip. At least one outer sheath side wall opening selectively places an outer sheath outer surface in fluid communication with the outer sheath lumen. At least one outer sheath open slit extends at least partially between the outer sheath open tip and a respective outer sheath side wall opening. A shaft has at least one shaft side wall opening that selectively places a shaft outer surface in fluid communication with at least one shaft lumen. When the shaft is operably joined to the outer sheath, at least a portion of the at least one shaft side wall opening is selectively aligned with a respective outer sheath side wall opening.

Abstract: The present invention relates to a shaft for a catheter which may be usable having a tubular core which may be usable with a minimally invasive procedure such as intravascular medical treatment system. It also relates to a method of fabricating such shaft.

Abstract: In some aspects, catheter devices can include: a reinforcing member having a proximal and distal ends, the reinforcing member comprising: discrete longitudinally arranged structural regions between the proximal and distal ends comprising: a first, proximal, structural region defining a first series of wall perforations that generate structural properties within the first structural region, the first series of wall perforations setting a first stiffness of the first structural region; and a second structural region, disposed distally relative to the first structural region, defining a second series of wall perforations that generate structural properties within the second structural region, the second series of wall perforations setting a second stiffness of the second structural region, which is less than the first stiffness, wherein the second series of wall perforations differs from the first series of wall perforations by at least one of: cut balance, cut frequency, or pitch.

Abstract: A multiple lumen central venous catheter with the lumens exit ports on the distal sides of the catheter; enclosed in a separate casing that has exit ports in the walls at its distal end; that allows the enclosed catheter to rotate in the casing, allowing the exit ports in the catheter to align or non-align to open and close the individual lumens at the distal end.

Abstract: The present embodiments provide strain relief members for a medical device delivery system, methods of use thereof, and methods of manufacturing. In one embodiment a strain relief member may include a support having a first end with a first outer diameter, a second end having a second outer diameter, an inner surface facing a support lumen that extends axially through the support along a longitudinal axis, and an outer surface opposite to the inner surface. An embodiment may also include an overlay coupled to a portion of the outer surface of the support, where the overlay comprises a first material and the support comprises a second material, and the first material is more flexible than the second material. A liner may be disposed in a portion of the support lumen and a first connector disposed over a portion of the support.

Abstract: A method of changing a catheter into a distal steering tool catheter includes adding to an existing catheter a tube assembly that passes through the catheter, the tube assembly including an internal tube and an external tube whose distal ends are coupled to each other and which are arranged for longitudinal axial movement relative to one another, and providing a tube manipulator coupled to the tube assembly, which is operative to cause relative axial movement of the internal and external tubes and bending of a distal portion of at least one of the internal and external tubes.

Abstract: An elastic percutaneous elastic introducer sheath is disclosed which can locally expand and reduce to accommodate a transcatheter medical device. The elastic introducer sheath includes a non-circumferentially continuous elastic frame, a liner, and a jacket.

Abstract: A method of manufacturing tubing suitable for use as a component of a medical device, such as a catheter body, and the real-time adjustment of characteristics of the tubing as it passes from one reel to another reel during manufacture. Thus, a length of tubing is manufactured that includes a plurality of segments of different flexibilities and the length of tubing is then cut into a plurality of sub-lengths of tubing that are suitable for use as a component of a medical device. In one embodiment, a method of manufacturing a length of catheter tubing comprises: extruding a base layer; overlaying a braided layer on the base layer; overlaying a sub-jacket layer over the braided layer; overlaying an outer jacket on the jacket sub-layer; and heating at least a portion the jacket sub-layer to change a characteristic of the length of catheter tubing.

Abstract: The present disclosure provides improved medical delivery devices for delivering a medical device into a subject. In one embodiment, the medical delivery device includes a non-porous composite inner layer constructed of a lubricious material having a plurality of pores and a thermoplastic elastomer reflowed into the plurality of pores. In other embodiments, the medical delivery device further includes a thermoplastic elastomer coated braided metallic member surrounding the nonporous composite inner layer to provide strength and structure to the device.

Abstract: Devices for moving blood within a patient, and methods of doing so. The devices can include a pump portion that includes an impeller and a housing around the impeller, as well as a fluid lumen. The impeller can be activated to cause rotation of the impeller and thereby move fluid within the fluid lumen.

Abstract: A microcatheter includes an inner polymeric tube defining an inner lumen. It includes a proximal section with an inner wire layer helically wound in a constricted state over the inner polymeric tube and includes an outer wire layer helically wound over the inner wire layer in a constricted state within the proximal section. It includes a distal section with a distal wire layer helically wound in a constricted state and having an outer diameter. The proximal and distal sections are joined. The outer diameter of the outer wire layer is substantially the same as the outer diameter of distal wire layer at the location where the proximal and distal sections are joined.

Abstract: A retrieval system for a biostimulator, such as a leadless cardiac pacemaker, is described. The biostimulator retrieval system includes a docking cap rotatably coupled to an outer catheter by a bearing. A torque shaft extends through the outer catheter and attaches to the docking cap to transmit torque to the docking cap to cause rotation of the docking cap relative to the outer catheter. The rotating docking cap can transmit torque to an attachment feature of a biostimulator received within the docking cap. The attachment feature can be captured by a snare that extends through the torque shaft. A cincher tube extends through the torque shaft around the snare, and advances over the snare independently from the torque shaft that is attached to the docking cap, to cinch the snare onto the attachment feature. Other embodiments are also described and claimed.

Abstract: Guidewires having conductive elements are described where in one variation, the guidewire may be formed by disposing an insulative layer upon a surface of the guidewire core, and printing one or more conductive traces directly upon a surface of the insulative layer.

Abstract: An interventional catheter for treating an artery includes an elongated body sized and shaped to be transcervically introduced into a common carotid artery at an access location in the neck. The elongated body has an overall length such that the distal most section can be positioned in an intracranial artery and at least a portion of the proximal most section is positioned in the common carotid artery during use.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. A delivery component can have a plurality of slots that provide for desired bending of the delivery component, particularly compound bending of the delivery component that can facilitate steering of the delivery component in three dimensions.

Abstract: A microcatheter is characterized as having a hardness-transition section along an entire or partial length an outer layer, hardness of the outer layer varying in the hardness-transition section so as to increase from the distal tip to the proximal tip along the lengthwise direction, due to arrangement of a second forming material in a stripe pattern extending in the lengthwise direction of the outer layer in the first forming material including a forming material formable into the outer layer so that a surface area ratio of the two forming materials in a circumferential direction of a cross section varies along the lengthwise direction for the first forming material and the second forming material.

Abstract: Catheters and methods for supporting a guidewire or delivering a radiopaque, diagnostic or therapeutic agent through a vessel stenosis or other tortuous anatomy are disclosed. A catheter can comprise an elongate shaft body and a tip member disposed at a distal end of the shaft body. The shaft body can extend from a proximal end to the distal end and can define an inner lumen. The shaft body can include a liner, a braid member surrounding the liner, a multi-layer coil surrounding the braid member, and a polymer cover surrounding the multi-layer coil. An outer surface portion of the polymer cover can include one or more helical threads, which can be enveloped in an outer wrapper. The tip member can be made from a metal or a polymer. Polymer tip members can include a hard or semi-hard distal tip.

Abstract: A device comprises a tubular member with a longitudinal axis having a proximal end and a distal end, at least one partial cut located at, along or near the distal end of the tubular member, the at least one partial cut comprising an orientation that is angled relative to both the longitudinal axis and an axis transverse to the longitudinal axis, a pusher member positioned within an interior of the tubular member and configured to selectively advance the distal end of the tubular member longitudinally, wherein the distal end of the tubular member is configured to at least partially rotate when the pusher member is advanced relative to the tubular member so at to facilitate placement of the distal end in a particular branch of a subject's intraluminal network, wherein the distal end of the tubular member is configured to longitudinally elongate along or near an area of the at least one partial cut.

Abstract: A method of manufacturing a catheter shaft includes the steps of forming an inner layer of a first polymeric material, forming a plait matrix layer including a second polymeric material about the inner layer, and forming an outer layer of a third polymeric material about the plait matrix layer. The plait matrix layer includes a braided wire mesh partially or fully embedded within the second polymeric material, which is different from at least one of the first polymeric material forming the inner layer and the third polymeric material forming the outer layer. The second polymeric material has a higher yield strain and/or a lower hardness than at least the first polymeric material, and preferably both the first and the third polymeric materials. The first polymeric material and the third polymeric material may be different or the same. The catheter shaft may be formed by stepwise extrusion, co-extrusion, and/or reflow processes.

Abstract: A catheter may include an inner liner, at least one support structure over the inner liner, and an outer jacket over the at least one support structure. In some examples, the catheter includes a tip jacket positioned over a distal portion of the outer jacket and extend beyond a distal-most part of the inner liner and a distal-most part of the outer jacket to define a single-layer catheter tip. In some examples, the at least one support structure may include a braid and a coil. The catheter may include a marker band over a distal portion of one of the braid or the coil. The other of the braid or the coil ends proximally of a proximal end of the marker band, such that the catheter includes a location with lower radial and/or flexural stiffness proximal of the marker band.

Abstract: A vascular access device is disclosed including a catheter, a catheter adapter having a distal end and a proximal end, an overall length extending from the distal end to the proximal end, an internal cavity, an upper portion, a lower portion and a tip having a distal opening having a circumference through which the catheter extends, an introducer needle extending through the catheter; and a needle hub connected to the proximal end of the introducer needle. The catheter adapter being connected to the proximal end of the catheter and at least a majority of the catheter adapter is made from a first material and at least a portion of the tip is made from a second material that is more flexible than the first material.

Abstract: A catheter comprises a heater control supplying power, a handle, a base catheter with lumen and comprising a proximal section and a distal segment, and a variable stiffness element. The element comprises a heater connected to the heater control, coiled at least at the distal segment, and comprising a shaft portion of a first metallic conductive material and a heater portion of a second metallic conductive material. A jacket is disposed about the heater portion. A variable flex sub-assembly between the catheter and jacket comprises a non-conducting braid and a binding material. Without power, the binding material is stiffened. Responsive to heating of the binding material, the binding material softens to increase flexibility of the variable flex sub-assembly at least at the distal segment. Responsive to removing power, the binding material cools and stiffens to decrease flexibility of the variable flex sub-assembly at least at the distal segment.

Abstract: In some examples, a catheter includes an elongated body including a structural support layer comprising at least two filaments of different materials wound longitudinally adjacent to each other to define a coil structure, and an outer jacket positioned over the structural support layer.

Abstract: A system of devices for treating an artery includes an arterial access sheath adapted tointroduce an interventional catheter into an artery and an elongated dilator positionable within the internal lumen of the sheath body. The system also includes a catheter formed of an elongated catheter body sized and shaped to be introduced via a carotid artery access site into a common carotid artery through the internal lumen of the arterial access sheath. The catheter has an overall length and a distal most section length such that the distal most section can be positioned in an intracranial artery and at least a portion of the proximal most section is positioned in the common carotid artery during use.

Abstract: A pre-curved steerable catheter includes a catheter body (102) having a distal end portion. The distal end portion includes a permanently curved flexible end portion (110). A pull wire (108) is disposed in a pull wire lumen within the catheter body. The pull wire extends from the distal end portion to a proximal end portion of the catheter body wherein the pull wire, when tensioned, provides a change in an angle of the curved flexible end portion of the catheter body.

Abstract: A medical device includes an elongate shaft including a multifilar coil comprising a first strand and a second strand wound in the same winding direction, the multifilar coil comprising a first section having a first end and a second end wherein the first strand and the second strand are wound with identical pitch patterns between the first end and the second end of the first section, the multifilar coil further comprising a second section having a first end and a second end, wherein the first strand and the second strand are wound with different pitch patterns from each other between the first end and second end of the second section, and a polymeric tubular member coextending with the multifilar coil.

Abstract: Methods and apparatuses for detecting tension on a tendon and/or mechanical deformation (e.g., breakage) of one or more steering tendon of a steerable and flexible articulating device. Theses apparatuses may have one or more tendons that are each electrically conductive and configured to steer the apparatus when tension is applied to the proximal end of the tendon. Tension and/or breakage (or other deformation) of one or more of these tendons may be detected by monitoring the electrical resistance of the tendons.

Abstract: A system of devices for treating an artery includes an arterial access sheath adapted to introduce an interventional catheter into an artery and an elongated dilator positionable within the internal lumen of the sheath body. The system also includes a catheter formed of an elongated catheter body sized and shaped to be introduced via a carotid artery access site into a common carotid artery through the internal lumen of the arterial access sheath. The catheter has an overall length and a distal most section length such that the distal most section can be positioned in an intracranial artery and at least a portion of the proximal most section is positioned in the common carotid artery during use.