Abstract: Provided is a flexible stent in which a free end strut does not tend to project outside when the stent is bent and shortening can be suppressed at the time of expansion of the stent. The flexible stent includes annular bodies having a wavy line pattern and connection elements that connect the annular bodies. The wavy line pattern is formed by V-shaped elements, in which two leg parts are joined by an apex part, being connected in a state where the apex parts alternately face opposite directions in an axial direction. A bending direction of one end part of the connection element and a bending direction of another end part thereof are opposite to one another. The end part of the connection element is connected to a portion other than the apex part of the V-shaped element of the adjacent annular body with the end part of the connection element being extended in a direction different from the direction in which the leg part extends.

Abstract: An inflatable bone tamp is provided that includes a shaft defining a lumen. A balloon is coupled to the shaft such that a material can flow through the lumen and into the balloon to inflate the balloon. A connector is coupled to the shaft. The connector includes a first port and a second port. The ports are in communication with the lumen. A flow control device is coupled to the first port. The flow control device controls flow of the material through the first port and into the lumen. A damper is coupled to the second port. The damper controls pressure within the inflatable bone tamp when pressure within the inflatable bone tamp reaches a threshold. Kits, systems and methods are disclosed.

Abstract: A slit maker is configured to make a slit in skin to receive a hair follicle. The slit maker has a shaft, having a shaft central axis. A helix is mechanically coupled to the shaft. A tip is at an end of the helix. An edge is beveled onto the tip being collinear to an edge line. An edge angle is measured from the edge line to the shaft central axis. The edge angle is at least 10 degrees but no more than 60 degrees or least 130 degrees but no more than 170 degrees.

Abstract: A positioning device is configured to selectively position or otherwise manipulate one or more organs within the body of a subject. The positioning device includes a shaped expandable element that is configured to be selectively transitioned between an unexpanded, or collapsed, state and an expanded state. While in the expanded state, the expandable element repositions or otherwise manipulates an organ. Systems that include positioning devices are also disclosed, as are methods for positioning or otherwise manipulating organs.

Abstract: A surgical retrieval apparatus includes a handle including an elongated sleeve extending therefrom that, together cooperate to define a lumen therethrough. A shaft having an end effector assembly disposed at a distal end thereof and a plunger disposed at a proximal end thereof is selectively translatable between a first position and a second position, wherein the end effector assembly extends from the sleeve. An articulation mechanism is configured to articulate the end effector assembly relative to the shaft. A specimen retrieval bag is coupled to the end effector assembly and is deployable to an extended position upon movement of the end effector assembly to the second position.

Abstract: A method and apparatus are disclosed for a system that maps the proximal and distal ablation subzones and their respective margins using the tools that are used to access the ablation target wherein the tools have markings to indicate which probe and balloon kyphoplasty (BKP) system or vertebroplasty (VP) system to use. Examples of access tools comprise introducers, stylets, and bone drills. In some embodiments of the system, the probe has a marking indicating which BKP or VP system to use.

Abstract: A surgical system is provided that includes a body extending along a longitudinal axis. A first member is rotatably positioned within the body and includes a first threaded surface. A second member is positioned within the body and includes a second threaded surface that engages the first threaded surface. The second member is non-rotatable relative to the body. A third member is positioned within the first member. An inflatable bone tamp includes an outer shaft coupled to the body, a balloon coupled to the outer shaft and an inner shaft coupled to the third member and the balloon. The first member is rotatable relative to the body to translate the third member along the longitudinal axis to move the balloon from a first length to a second length. Kits and methods are disclosed.

Abstract: Disclosed herein are improved methods and apparatuses for providing hemostasis within a cavity defined by an internal surface of a bleeding tissue space. A catheter comprising a proximal end and a distal end may be advanced into the cavity through a proximal opening of the tissue space into the cavity. A distal balloon coupled to the catheter may be positioned adjacent a distal opening of the tissue space, and expanded to seal the distal opening. A hemostatic agent may be applied from the catheter to the internal surface of the tissue space to inhibit bleeding of the tissue space. The hemostatic agent may be applied without occluding the proximal opening, the distal opening, and a path extending therebetween with the hemostatic agent.

Abstract: A medical device-includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes one or more balloon pressurization steps. The balloon pressurization steps are selected to enhance scaffold retention to the balloon while retaining, at least partially, the original balloon folds as the balloon is pressurized and de-pressurized within a crimper head. By at least partially retaining the original balloon folds, a uniformity of scaffold expansion by the balloon is improved.

Abstract: A medical device includes an expandable conduit, a prosthetic heart valve and a delivery device, including a balloon catheter. The expandable conduit may include one or more inner or outer sleeves supported by a frame or stent. The sleeve(s) may be a bioprosthetic tissue wrapped, molded or sewn about the frame or stent. Coupled to an end of the expandable conduit is the prosthetic heart valve. The conduit and heart valve may be crimped on the balloon catheter for percutaneous deployment. The frame may be constructed of a balloon-expandable material for the conduit portion and a self-expandable material for the prosthetic heart valve portion. The prosthetic heart valve is anchored at the native heart valve and then the conduit to be expanded into place to protect the aorta. The self-expanding prosthetic heart valve avoids the need for balloon mounting. This provides for a smaller diameter and easier delivery.

Abstract: The present invention relates to a method for coating catheter balloons with the pharmacological agent paclitaxel and the biological and biodegradable polymer composition shellac and optionally further components. Moreover the present invention relates to paclitaxel and shellac coated catheter balloons obtained according to the coating methods disclosed herein as well as the use of such coated catheter balloons for the short time release of the pharmaceutically active agent paclitaxel for prophylaxis and treatment of restenosis especially restenosis caused by angioplasty. The coated catheter balloons can be used alone or in combination with a coated or uncoated stent crimped on the catheter balloon before or after the coating with shellac and paclitaxel.

Abstract: Methods and apparatuses for mechanically removing objects from a body. In particular, described herein are thrombectomy methods and mechanical thrombectomy apparatuses for removal of blood clots from within a lumen of a blood vessel.

Abstract: This disclosure describes various examples of multi-purpose tools and associated methods for safely gaining access to extravascular spaces. The multi-purpose tools described herein are particularly suited for safely gaining access to the sub-sternal space underneath the sternum/ribcage as well as tunneling subcutaneously above the ribcage for the purpose of positioning of a medical electrical lead. This eliminates the need for separate tools for tunneling in different extravascular spaces by providing a single tool capable of the multiple uses.

Abstract: A medical system for use in a lithotripsy procedure may include a processor configured to receive input from a first imaging device, wherein the first imaging device may be configured to send image data representative of an image captured in a lumen of a kidney, bladder, or ureter to the processor. The processor may be configured to display the image on a display device coupled to the processor, and analyze the image to sense the presence of an object within the image. If an object was sensed within the image, the processor may analyze the image to estimate a size of the object, and display the estimate on the display device.

Abstract: A system and method for percutaneous loop kyphoplasty is described. An apparatus for the treatment of a targeted vertebral bone fracture includes a first trocar having a first lumen, a proximal end and a distal end, wherein the distal end of the first trocar is configured for surgical insertion into a vertebral body at a first location, a second trocar having a second lumen, a proximal and a distal end, wherein the distal end of the second trocar is configured for surgical insertion into the vertebral body at a second location, a wire tool that is slidable within the first trocar, a grasper tool that is slidable within the second trocar and is configured to temporarily couple to the wire tool within the vertebral body, and a non-deployable balloon that is advanced through the first or second trocar into the vertebral body to facilitate expansion within the vertebral body.

Abstract: A dilation system includes a handle, guide member, balloon dilation member, balloon, dilation member movement actuator, and endoscope. The handle is configured to provide single-handed use to a user. The handle includes a first and second body member pivotably coupled together such that the first body member and the second body member are configured to pivot toward and away from one another. The handle includes a rotation mechanism configured to impart rotation upon the guide member. The handle further includes a locking feature configured to lock endoscope in position relative to the handle. The handle may further include a rotation limiting feature configured to limit rotation of the guide member and or the body members. The dilation member movement actuator is configured to translate to thereby cause translation of the balloon dilation member. One or more components of the dilation system may include a plurality of measure markings.

Abstract: Systems and methods for restructure and stabilization of bones that provide an anti-microbial effect are disclosed herein. A device includes a delivery catheter having an inner void for passing at least one light sensitive liquid, and an inner lumen; an expandable member releasably engaging the distal end of the delivery catheter; at least one channel positioned in the expandable member; and a light conducting fiber sized to pass through the inner lumen of the delivery catheter and into the expandable member, wherein, when the light conducting fiber is in the at least one channel, the light conducting fiber is able to disperse light energy to provide an anti-microbial effect. When the light conducting fiber is in the expandable member, the light conducting fiber is able to disperse the light energy to initiate hardening of the light sensitive liquid within the expandable member to form a photodynamic implant.

Abstract: Tissue dissecting device, including an inflatable bladder configured to be inserted into a body via an introducer tube in a compact deflated state, and to be inflated to a substantially planar form in a manner which dissects tissue. Method for dissecting tissue, including inserting an inflatable bladder, in a deflated state, via an introducer tube, into a space in a body, and inflating the bladder to substantially planer form, thereby dissecting tissue. Method for dissecting tissue, including inserting an introducer tube via an incision into a body, inserting an inflatable bladder, in a defined state, via the introducer tube, into a space in the body, pulling the introducer tube back at least a length of the deflated bladder, inflating the bladder, via a filling tube, to substantially planar form, thereby dissecting tissue, disconnecting the filling tube from the bladder, retracting the filling tube and the introducer tube from the body.

Abstract: Extra-urethral implants and methods of use are disclosed. Implants can treat disorders or diseases of the prostate by, for example, enlarging the lumen of the prostatic urethra.

Abstract: A system for bypassing an anastomosis site in a hollow organ is provided. The system includes a sleeve configured for spanning the anastomosis site at an internal surface of the hollow organ and a band configured for attachment to an external surface of the hollow organ and limiting migration of the sleeve beyond the anastomosis site.

Abstract: A system is configured to create or enlarge a cavity in a tissue body and generally includes a cannula, a friction reduction covering, and a cavity creation member. The cavity creation member includes an end portion that is configured to transition between a first shape and a second shape that is different from the first shape. In operation, retracting the friction reduction covering relative to end portion causes the end portion to change shape from the first shape to the second shape such that the cavity creation member is configured to create or enlarge a cavity in the tissue body as the second end portion exits the friction reduction member.

Abstract: This invention relates to an implant having the capability of being adjusted to fit symmetrical and asymmetrical shaped voids formed in the bone or outside the bone of a patient. The implant can be individualized so as to accommodate various distortion in the void and can be disposed as a series of similar shaped implants that have different dimensions and/or characteristics to allow the surgeon to select an appropriate implant from said series.

Abstract: A textile-reinforced medical dilation balloon is provided, including a woven tubular textile sleeve with substantially longitudinal thermoplastic warp threads and at least one weft thread woven substantially perpendicular relative to the warp threads, where the sleeve defines a sleeve lumen. A medical dilation balloon is disposed within the sleeve lumen, and an adhesive coating substantially covers the inner and outer surfaces of the sleeve, attaching it to the balloon.

Abstract: An inflation device useful for inflating a balloon provided with a surgical instrument, such as a balloon sinus dilation instrument. The inflation device includes a syringe, a connector, and mechanical pressure indicator. The syringe includes a plunger slidably disposed within a barrel. The connector is configured to fluidly connect an outlet of the syringe with a surgical instrument balloon in establishing a closed inflation system between the syringe and an interior of the balloon. The pressure indicator is associated with the syringe and is configured to transition from a non-alert state to an alert state when a pressure of the inflation system has reached a predetermined level. In some embodiments, the inflation device is characterized by the absence of a pressure gauge.

Abstract: A balloon catheter has a balloon and an outer shaft fixed to a proximal end of the balloon. Each of the proximal end of the balloon and a distal end of the outer shaft has an inner projection extending in an axial direction of the balloon catheter, an outer projection extending in the axial direction, and a gap formed between the inner projection and the outer projection. At a fixing part, the inner projection of the balloon or the outer projection of the balloon is disposed in the gap of the outer shaft, and the inner projection of the outer shaft or the outer projection of the outer shaft is disposed in the gap of the balloon. The balloon catheter has improved fixing strength between the balloon and the outer shaft without increasing an outer diameter of the fixing part between the balloon and the outer shaft.

Abstract: A medical balloon for a balloon catheter is described. The balloon has at least a first layer made from a first material and a second layer made from a second material, said first and second layers being in overlying relationship with one another and being integral with one another; wherein the first layer has a softening or melting temperature which is higher than a softening or melting temperature of the second layer. A method of forming the medical balloon is also described, including locating a raw tubing in a mold; preheating and inflating the raw tubing so as to cause it to stretch; heating the raw tubing to soften or melt the second layer; setting the inflated raw tubing to form the medical balloon; and cooling the set balloon.

Abstract: Medical devices, medical device systems, and methods for using the same are disclosed. An example medical device system may include a guide catheter having a proximal end, a distal end, and a lumen extending therebetween. The guide catheter may be designed to guide a therapeutic catheter to a target site. A guidewire may be disposed within the lumen of the guide catheter. The system may also include a trap balloon catheter including a catheter shaft and a balloon coupled to the catheter shaft. The trap balloon catheter may be designed to extend through the lumen of the guide catheter to a position adjacent to the distal end of the guide catheter. A trap balloon retainer may be coupled to the catheter shaft. The trap balloon retainer may be designed to prevent a distal end of the trap balloon catheter from extending distally beyond the distal end of the guide catheter.

Abstract: According to some embodiments, a method of treating a subject having diabetes or symptoms associated with diabetes is provided. The method includes delivering a neuromodulation catheter within a vessel (e.g., hepatic artery) having surrounding nerves that innervate the liver (e.g., sympathetic nerves of the hepatic plexus). The method may also include modulating (e.g., disrupting, ablating, stimulating) the nerves by mechanical compression, energy delivery, or fluid delivery.

Abstract: A dilation catheter includes a shaft and an expandable element. The shaft includes a proximal portion and a distal portion. The distal portion includes a tip and a bend. The tip is sized and configured to pass through an isthmus of a Eustachian tube (ET). The bend is proximal to the tip. The bend is formed at an angle configured to provide insertion of the tip into the isthmus of the ET via an ear canal associated with the ET. The expandable element is disposed at the distal portion of the shaft. The expandable element is configured to transition between a non-expanded state and an expanded state. The expandable element in the non-expanded state is configured for insertion into the ET via the isthmus. The expandable element in the expanded state is configured to dilate the ET.

Abstract: Embodiments of the invention include bioactive agent eluting devices. In an embodiment the invention includes a bioactive agent delivery device including a substrate, a hydrophilic polymer disposed on the substrate, and a substantially amorphous bioactive agent disposed on the surface of the hydrophilic polymer. In an embodiment, the invention includes a method of making a bioactive agent delivery device including depositing a hydrophilic polymer on a substrate forming a hydrophilic surface and depositing a substantially amorphous bioactive agent on the hydrophilic surface. In an embodiment, the invention includes a bioactive agent-eluting catheter including a catheter shaft and an expandable balloon disposed on the catheter shaft. Other embodiments are included herein.

Abstract: An apparatus for treating obesity and reflux disease of an obese patient has a volume filling device to be invaginated by a stomach wall portion with the outer surface of the volume filling device resting against the stomach wall, such that the volume of the food cavity is reduced in size by a volume substantially exceeding the volume of the volume filling device. An implantable movement restriction device to be invaginated by the stomach fundus wall has an outer surface to be rested against the stomach wall in a position between the patient's diaphragm and the lower part of the invaginated stomach fundus wall, such that movement of the cardiac notch of the patient's stomach towards the patient's diaphragm is restricted, to thereby prevent the cardia from sliding through the patient's diaphragm opening into the patient's thorax.

Abstract: An adjustable balloon that includes a handle having an inflation port, an access cannula, a rotary handle, an inner sleeve and sharp tip. The inner sleeve extends within the access cannula to support compliant, inflatable structure. The access cannula may be retracted into the handle by operation of the rotary handle to expose the inflatable structure, such that the inflatable structure may have an adjustable length. The access cannula may include length indicators to show a length of the inflatable structure as a result of the access cannula being withdrawn into the handle.

Abstract: A tissue insertion prosthesis system includes an expansible, multi-chambered implant for use in a tissue prosthesis receiving cavity, such that the implant includes an expansible envelope having a plurality of chambers. The system also includes a method of determining a size of a cavity at a site to be filled by a tissue prosthesis. Finally, the system includes a method to facilitate a removal of a biomaterial delivery device from an inflatable member that has been inserted into a cavity formed by the removal of a portion of a nuclear material from an intervertebral disc and to be filled by a tissue prosthesis.

Abstract: Apparatus and methods are provided for flaring a stent deployed within a branch vessel including an ostium communicating with a main vessel, a first end of the stent extending at least partially from the branch. A catheter is provided that includes a first balloon carried on its distal end, and a second balloon that includes a distal section overlying at least a portion of the first balloon and a proximal section. The catheter distal end is introduced into the main vessel and positioned through the ostium and stent into the branch until the first balloon is disposed within the stent. The first balloon is expanded to anchor the stent, and the second balloon is expanded to flare the first end of the stent. Optionally, the first balloon is expanded further, e.g., to expand the stent within the branch body lumen and/or dilate the lesion.

Abstract: According to some embodiments, a method of treating a subject having diabetes or symptoms associated with diabetes is provided. The method includes delivering a neuromodulation catheter within a vessel (e.g., hepatic artery) having surrounding nerves that innervate the liver (e.g., sympathetic nerves of the hepatic plexus). The method may also include modulating (e.g., disrupting, ablating, stimulating) the nerves by mechanical compression, energy delivery, or fluid delivery.

Abstract: Devices for the occlusion of body cavities, such as the embolization of vascular aneurysms and the like, and methods for making and using such devices. The devices may include novel expansile materials, novel infrastructure design, or both. The devices provided are very flexible and enable deployment with reduced or no damage to bodily tissues, conduits, cavities, or similar structures.

Abstract: A deflation catheter device, comprising: a catheter tube having a proximal end and a distal end; a stylet disposed within the catheter tube; a stylet handle attached to the stylet; and a y-connector disposed near a proximal end of the catheter tube, configured to provide fluid communication from the distal end of the catheter tube and a suction port, and configured to provide access for the stylet from the proximal end of the catheter tube to the distal end of the catheter tube.

Abstract: An apparatus for use in a stomach of a subject includes a balloon adapted for placement in the stomach and having an opening to an interior of the balloon, an internal tube in the interior of the balloon with a proximal end coupled to the opening of the balloon, and an inflation tube. The inflation tube has a distal end in the interior of the balloon and a proximal end that can receive a fluid on an exterior of the balloon. The inflation tube can stretch from the stomach to a mouth of the subject to facilitate inflation of the balloon and has a resting position that is substantially within the interior of the balloon. The internal tube is disposed around at least a portion of the inflation tube that is in the interior of the balloon.

Abstract: In intervertebral operative spinal procedures, using separate or pre-attached spreader blocks to control the directional growth of a distracting balloon.

Abstract: A nerve repair conduit configured to be secured on first and second portions of a selected nerve. The nerve repair conduit includes a polymeric body having a proximal end, a distal end, an exterior surface and an interior surface defining an interior lumen. In addition, the nerve conduit includes at least one drug reservoir to hold agent(s) that may, for example, facilitate nerve regeneration. The drugs diffuse from the drug reservoir(s) into the nerve repair conduit through an outlet (e.g., a semipermeable membrane) in proximity to the first and second portions of a selected nerve. The nerve repair conduit may be configured to deliver the agent(s) at a rate having substantially zero-order kinetics and/or at a constant rate over a selected period of time (e.g., at least 1 week).

Abstract: Methods, devices and systems facilitate gastric retention of a variety of therapeutic devices. devices generally include a support portion for preventing the device from passing through the pyloric valve or esophagus wherein a retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.

Abstract: A catheter can efficiently transmit an operator's pushing force to a distal end of the catheter with a reduced risk of getting caught at a curved region of a lumen (e.g., a blood vessel, bile duct, pancreatic duct or the like). The catheter includes a first core wire and a second core wire disposed between an inner tube and an outer tube. The second core wire can move to an optimal position depending on external forces exerted at a curved region of the lumen when the catheter is inserted into the curved region. Therefore, there is a reduced risk that the first core wire and the second core wire will interfere with each other, which would prevent the catheter from bending along the lumen and potentially break one or both of the first core wire and the second core wire.

Abstract: A system for implanting a prosthesis includes a prosthesis delivery device having a handle, an inner lumen, a nose cone, an intermediate lumen, a prosthesis sheath at the distal end of the intermediate lumen for holding therein a prosthesis to be implanted, and an outer lumen fixedly connected to the handle. The system can include a lumen control assembly operable to move the intermediate lumen with the prosthesis sheath between a retracted position and an extended position.

Abstract: Apparatus and methods for an endovascular catheter that can be inserted within tortuous body anatomies and then selectively stiffened and fixed in place. In a particular embodiment, this stiffness is reversible. The stiffness or a comparable mechanical characteristic of the catheter assembly may be adjusted to a relatively low value during insertion (so that it easily navigates a guide wire or the like), and then subsequently adjusted to a relatively high value in situ to keep the catheter assembly substantially fixed in place (i.e., during delivery of an interventional device).

Abstract: Articles are provided having no orientation or a multi-directional orientation. Such articles may be in the form of films, ribbons, sheets, and/or tapes and may be utilized as buttresses with a surgical stapling apparatus or as reinforcing means for suture lines. The articles may be produced with etchings on at least a part of a surface of the article.

Abstract: A steerable laser probe may include a handle, an actuation lever, an optic fiber, and a housing tube. The housing tube may have a first housing tube portion having a first stiffness and a second housing tube portion having a second stiffness. The second stiffness may be greater than the first stiffness. The optic fiber may be disposed within the housing tube and within an inner bore of the handle. An actuation of the actuation lever about a pivot pin of the handle may gradually curve the optic fiber. An actuation of the actuation lever about the pivot pin of the handle may gradually straighten the optic fiber.

Abstract: A device having multiple chambers may be configured to expand to contact a substantial section of an interior wall of a body structure or lumen in order to simultaneously exclude blood or other liquid from a target structure while providing for delivery of a therapeutic agent directly to the interior wall. The expandable device may be manufactured from a plurality of flat sheets of material heat sealed to one another to form an inflation chamber and one, two or more delivery chambers. The sheets may also be bonded to an elongate catheter body having inflation and delivery lumens. The excluding of blood flow and delivery of therapeutic agents are completed by the same device.

Abstract: A device for repairing a heart valve comprises a medical device (10). The medical device (10) comprises an element in order to downsize the annulus upon insertion and allow the leaflets to open and close properly. The medical device (10) provides a temporary or permanent downsizing of the heart valve. An annuloplasty implant and/or heart valve prosthesis is in embodiments releasably attached to the medical device for insertion to the annulus and permanent fixation of the latter in a desired shape.

Abstract: Systems and methods are provided for reversibly controlling a size and/or restricting the movement of a body orifice, such as a pyloric opening, using an implantable device configured to allow a distance between opposed ends thereof to be adjusted. A device is provided having attachment members and a connector portion extending therebetween and configured such that a size of the pyloric opening is decreased upon the implantation of the device. The connector can be adjustable to allow a size of the pyloric opening to be adjusted after it has been restricted. The connector can include two or more bridge portions having different lengths such that cutting a first bridge portion can increase the distance between the attachment members so as to increase the size of the pyloric opening. To revert to a natural size of the body orifice, the entire connector can be cut or otherwise broken and/or removed.

Abstract: The disclosure pertains to valvuloplasty devices which include a first outer shaft, a second inner shaft, a plurality of elongate members disposed therebetween and adapted to be expanded radially by relative motion between the first outer shaft and second inner shaft and a circumferential member disposed about the central portions of the plurality of elongate members, wherein the circumferential member is urged by radial expansion of the plurality of elongate members to contact the valve to be treated thereby effecting a valvuloplasty and methods of use therefor.