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.

Abstract: A hernia repair device is provided which may include a soft tissue repair prosthesis and an expandable device configured to be removably connected with the soft tissue repair prosthesis. Attachment components may be used to removably connect the soft tissue repair prosthesis with the expandable device. The hernia repair device may be manipulated into a reduced configuration for insertion into the body. When expanded, the expandable device may be configured to position the soft tissue repair prosthesis adjacent a hernia defect. The expandable device and/or the attachment components may be shaped and/or configured to minimize the maximum dimension of the hernia repair device in its reduced configuration.

Abstract: The present disclosure is directed to an over-the-needle (OTN) catheter assembly having an expandable catheter. More specifically, the OTN catheter assembly includes a catheter having an expandable body with a proximal end and a distal end coaxially mounted onto a needle. The body defines a lumen extending from the proximal end to the distal end. Further, the body is expandable between a compressed length and an expanded length. The needle is configured within the lumen of the catheter and has a first length. The first length is longer than the compressed length of the catheter and shorter than the expanded length of the catheter. In addition, the body of the catheter is configured to expand from the compressed length to the expanded length when heat is applied to the catheter such that the distal end of the catheter extends past a distal end of the needle.

Abstract: A method for preparing a laminate coronary stent comprising: providing a stent framework; and depositing a plurality of layers on said stent framework to form said laminate coronary stent; wherein at least one of said layers comprises a bioabsorbable polymer.

Abstract: A collapsible, coiled mandrel, for use in co-curing of a hollow carbon-epoxy structure such as a stringer in aircraft construction, is made of a fiber stiffened with doping material that maintains an outer coil shape resistant to external compression forces when used as a mandrel during lay-up and curing, and is collapsible when an end of the fiber is pulled along its longitudinal axis so that it can be easily removed after curing and discarded. A method of fabricating a collapsible, coiled mandrel employs a mold with a shaped recess for forming a coil with a fiber wetted with a doping material fed in by an applicator, and rotating the applicator while backing it out to form the coil in the mold. In an alternative embodiment, a collapsible, coiled mandrel may be formed of a metal coil having a mandrel-shaped cross section and sleeved in a protective liner.

Abstract: The foregoing application describes a system and method of performing a minimally invasive surgical operation. More specifically, the invention involves the use of disposable cannula and slender dilators of variable lengths, which incorporate a source of illumination to carry light to a surgical site and video capabilities for capturing and displaying images from a CMOS or CCD camera device. According to one embodiment, fiber optics run semi-circumferentially or along walls of the cannula/dilator and terminate at about a centimeter from the distal end of the cannula/dilator, thereby preventing illumination from “bottoming out” at the floor of the incision. According to one alternate embodiment, the light fibers may be fashioned in an annulus around one or more camera chips to provide illumination and video of the surgical site.

Abstract: Improved methods and devices for performing an endoscopic surgery are provided. Systems are taught for operatively treating gastrointestinal disorders endoscopically in a stable, yet dynamic operative environment, and in a minimally-invasive manner. Such systems include, for example, an endoscopic surgical suite. The surgical suite can have a reversibly-expandable retractor that expands to provide a stable, operative environment within a subject. The expansion can be asymmetric around a stabilizer subsystem to maximize space for a tool and an endoscope to each be maneuvered independently to visualize a target tissue and treat the target tissue from outside the patient in a minimally invasive manner.

Abstract: Shapeable guide catheters and methods for manufacturing and using such shapeable guide catheters. In one embodiment, the shapeable guide catheter comprises a tubular member having a shapeable region, a malleable shaping member attached to the shapeable region such that, when the shape of the shapeable region is changed from a first shape to a second shape, the shaping member will plastically deform to thereafter substantially hold the shapeable region in the second shape, a tubular outer jacket disposed about the outer surface of the tubular member and a tubular inner jacket disposed within the lumen of the tubular member. The shapeable region of the guide catheter may be manually formed into a desired shape before insertion of the guide catheter into the body. In some embodiments, the guide catheter is sized to be inserted through a nostril of a human patient and used to guide the transnasal insertion of another device (e.g., a guidewire, catheter, etc.

Abstract: Inflation devices for inflating intragastric devices and associated systems and methods are disclosed herein. In several embodiments, an inflation device can include a tube, an inner detent, and an outer detent. The tube can extend from a proximal portion of the inflation device to a distal portion of the inflation device, and can include a handle at the proximal portion and a barb at the distal portion. The barb can have a cross-sectional dimension greater than a cross-sectional dimension of a corresponding inflation port of an intragastric device. The inner detent can be positioned over the barb and can include a mating interface. The outer detent can be positioned over the inner detent, and can be configured to attach over a proximal cap of the intragastric device. The tube can be longitudinally advanceable relative to at least one of the inner and outer detents.

Abstract: A sealing device attached to an intragastric balloon device having a at least one flexible membrane aligned with and configured to seal an aspiration port of a lumen when the membrane is in a closed state and further configured to provide access to the lumen when the membrane is in a open state.

Abstract: A surgical access system for accessing a surgical target site within a spine includes a retractor and an elongated element. The refractor has a closed configuration defining a lumen with an internal circumference, and an open configuration in which the internal circumference, at least at the distal end of the retractor, is enlarged relative to said closed configuration. The open configuration creates and maintains an operative corridor to said target site. The elongated element is releasably coupled to an interior wall of the retractor and has an extension extending distal of the distal end of the retractor into the surgical target site. When coupled to the retractor, the elongated element covers a body structure at the target site without blocking access to the operative corridor.

Abstract: A bone filling device includes a catheter that defines a longitudinal axis and extends between a proximal end and a distal end. A first lumen extends along the longitudinal axis of the catheter and defines a first passageway. A second lumen extends along the longitudinal axis of the catheter and defines a second passageway. An inflatable body includes a wall that defines a fillable cavity. The fillable cavity is in fluid communication with the first passageway. A bone filler delivery port continuous with the second passageway and configured to dispense bone filling material.

Abstract: A stent deployment device comprises an elongate catheter shaft (2), and an inflatable balloon (3). The inflatable balloon (3) is movable between a collapsed configuration and an expanded configuration. In the expanded configuration part of the longitudinal axis of the balloon (3) is curved in three-dimensional space, and part of the balloon (3) is helically shaped. A stent (6) is movable from a collapsed delivery configuration to a partially expanded intermediate configuration, and subsequently from the intermediate configuration to a fully expanded deployed configuration. In the delivery configuration the longitudinal axis of the stent (6) is straight. The longitudinal axis of the stent (6) may be straight or curved in three-dimensional space in the intermediate configuration. In the deployed configuration the longitudinal axis of the stent (6) is curved in three-dimensional space. The balloon (3) in the expanded configuration exerts force on the stent (6).

Abstract: Methods and devices described herein facilitate diaphragm entry for posterior access of body organs.

Abstract: Systems and methods for treating an afflicted vessel and/or vessel associated with an afflicted tissue of a mammalian patient are presented herein. In particular, devices for the control of flow rate and/or pressure within a vessel of a mammalian patient, and methods of treating an afflicted vessel and/or a vessel associated with an afflicted tissue using the devices are presented herein.

Abstract: A retinal treatment apparatus for treatment of a detached retina of an eye is provided. The treatment apparatus includes a removable elastomeric patch formed of a biocompatible material containing ferromagnetic particles encapsulated within the elastomeric patch and a permanent rare-earth magnet secured adjacent an exterior surface of the eye. The removable elastomeric patch is inserted into the eye and positioned adjacent the detached retina, and wherein the permanent rare-earth magnet is secured to the exterior surface of the eye substantially adjacent to the removable elastomeric patch to maintain the elastomeric patch against the retina, thereby maintaining the retina against an underlying support tissue of the retina.

Abstract: The invention comprises a system to alleviate conditions such as prostate cancer, benign prostatic hyperplasia (BPH), and the like. The system includes a probe for mechanically cutting tissue and a device for simultaneously tamponading, inducing hemostasis, and dilating a plurality of lumens while minimizing inflammation. The tamponading device has a plurality of balloons configured for inflation with a coolant fluid. Other components of the system include a luminally protective sheath, a microscopic end cauterizing probe, a surgical console, an identification-sensitive self-sealed cassette, and a plurality of flexible tubing lines with pinch valves thereon.

Abstract: Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

Abstract: Methods and apparatus for treating bones, including, in one or more embodiments, methods and apparatus for treatment of vertebral fractures that include an inflation device for cavity creation and an inflation and containment device for maintaining vertebral height and cement containment. Methods for treating a bone comprising: creating a cavity in the bone; inflating a containment jacket in the cavity; inflating a balloon within the containment jacket so that the balloon occupies a first portion of the containment jacket; introducing a first filler material into a second portion of the containment jacket, wherein the second portion of the containment jacket is not occupied by the balloon; removing the balloon from the containment jacket; and introducing a second filler material into the first portion of the containment jacket.

Abstract: A coating for an expandable portion of a catheter comprising a hydrophobic matrix and a dispersed phase is disclosed. The dispersed phase comprises a plurality of micro-reservoirs dispersed in the hydrophobic matrix, wherein the plurality of micro-reservoirs comprises a first active agent and a first biodegradable or bioerodable polymer. A coating formulation and a method for forming the coating are also disclosed. A catheter comprising the coating on the expandable portion and a method for treating a condition are also provided.

Abstract: Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.

Abstract: A sinus dilation instrument useful with a navigation system and including a handle, a rigid probe, a balloon, and an identifier device. The probe extends from the handle, forms a curved segment, and carries the balloon. The identifier device is programmed to generate a signal indicative of an instrument identification assigned to the instrument, and is a frontal, maxillary or sphenoid sinus instrument. The signal is formatted to be recognized by an IGS. Once connected, the IGS recognizes the instrument and can retrieve information indicative of a spatial location of the balloon, for example via an instrument tracking device. A surgeon can “plug and play” the sinus dilation instrument with the IGS to perform a procedure.

Abstract: A set of sinus balloon catheters are provided for treating a patient's paranasal sinus system, including dilating prepared openings, and natural ostia and ducts and excising sinus cavities. These include a balloon catheter with a bend placing a distal segment at 90° to a proximal segment and a balloon catheter which is substantially straight. The catheters have sufficient stiffness and column strength that the balloon carrying distal segment of the catheter can be pushed into the prepared opening, natural ostium or duct, or sinus to be excised. The catheters have appropriate inflated working diameters and appropriate outer diameters with the balloon deflated that will enable the catheter to be pushed into the respective prepared opening, natural ostium or duct, or sinus cavity to be excised. The methods use the balloon catheters to dilate prepared openings to selected parts of the sinus system, to dilate natural ostia and ducts of the sinus system, and/or to dilate sinus cavities to remove them.

Abstract: A catheter that can efficiently transmit a pressing force applied to the distal end of the catheter without breaking at a midpoint of the catheter. The catheter includes a metal tube having a first wall and a second wall disposed in an outer tube, and a reinforcing member that is joined at its proximal end to an outer peripheral surface of the first wall. A distal end of the first wall extends distally beyond a distal end of the second wall and is bent toward the second wall. Thus, the second wall is not provided at a connected portion between the first wall and the proximal end of the reinforcing member, and the reinforcing member having a diameter increased at least by an amount corresponding to a thickness of the second wall can be disposed in the catheter without increasing the diameter of the outer tube.

Abstract: Methods and apparatus for the treatment of a body cavity or lumen are described where a heated fluid and/or gas may be introduced through a catheter and into treatment area within the body contained between one or more inflatable/expandable members. The catheter may also have optional pressure sensing elements which may allow for control of the pressure within the treatment zone and also prevent the pressure from exceeding a pressure of the inflatable/expandable members to thereby contain the treatment area between these inflatable/expandable members. Optionally, a chilled or room temperature fluid such as water may then be used to rapidly terminate the treatment session.

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

Abstract: A tissue expansion system includes driver assembly having a syringe pump and a controller held in a common enclosure. The driver assembly is connected to both an inflatable bladder and an inflation medium source. Fluid is delivered from the driver assembly to the inflatable bladder through a pressure sensor. The pump is actuated to deliver predetermined incremental volumes of the inflation medium to the inflatable bladder at spaced apart time intervals. Pressure is monitored and the pumping is interrupted if the pressure exceeds a predetermined high threshold value. Pumping is recommenced when the pressure falls below a lower threshold value until the total incremental delivery volume has been reached.

Abstract: A device (10) for stretching the foreskin of a subject is disclosed. The device has a body (10) having a passage (14) that extends through the body (10) to a distal end (18). The distal end (18) is adapted to receive a balloon (B). Fluid may be introduced through the passage (14) to cause the balloon (B) to expand. A flow regulating member (20) is positioned across the passage (14) to selectively close the passage (14) to fluid flow.

Abstract: Systems, apparatus and methods are disclosed for medical treatment comprising bone access and dilatation and/or cavity creation or enlargement using a narrow gauge, preferably 11-gauge or smaller, cannula wherein a catheter/expandable element assembly meeting medical protocols is designed, adapted and fabricated to fit through the interior of the associated 11-gauge or smaller cannula.

Abstract: A delivery system for an implantable medical device having at least one retention member at an end thereof includes a shaft extending in a longitudinal direction. An elongated sheath surrounds the shaft. The sheath is slidable relative to the shaft in the longitudinal direction. A space is defined inside of the sheath and is adapted to receive the medical device in an assembled or collapsed condition. A retainer is positioned at a first end of the space. At least one recess is provided in the retainer and is adapted to receive the retention member of the medical device in the assembled condition. A selectively activable member is disposed in the compartment between the longitudinal shaft and the medical device. When in an activated state, the member expands radially relative to the shaft, thereby urging the retention member to disengage from the recess.

Abstract: A stent with at least one cross-section having either a vertex or having first and second contour points where the radius of curvature of the first point is at least 2.5 times the radius of curvature of the second point.

Abstract: Embodiments of a cannula seal are disclosed. In some embodiments, a cannula seal can include a base portion that engages with a cannula; and a seal portion integrally formed with the base portion that slidebly engages with an instrument shaft such that an insertion frictional force between the seal portion and the instrument shaft for insertion of the instrument shaft is symmetrical and substantially equal with a retraction frictional force.

Abstract: Apparatuses and methods for implanting objects, such as a marker, in the lungs of patients. In one embodiment, a bronchoscopic catheter assembly for implanting an object in the lung of a patient includes a handle, a delivery catheter projecting outwardly from the handle, and a push wire contained within the catheter In one aspect of this embodiment, the catheter can be configured to releasably hold a plurality of markers at a distal end. In another aspect of this embodiment, the push wire can be operably connected to the handle and axially moveable within the delivery catheter to eject the marker out of the catheter within the bronchi of the patient. In a further aspect of this embodiment, the marker can further include an anti-migration device associated with the marker for holding the marker in place once the marker is deployed in the bronchi. The anti-migration device can be integral with the marker or positioned proximate to the marker to prevent migration of the marker.

Abstract: Disclosed herein are methods and devices for treating diverticular disease. The method can include injecting a sterile fluid between a mucosal layer of the diverticulum and a serosal layer of the diverticulum to form an expanded cavity in the diverticulum comprising the sterile fluid; injecting a filler material in the expanded cavity; and removing at least a portion of the sterile fluid from the expanded cavity. The device can include a flexible overtube having a lumen; a flexible shaft at least partially disposed within the lumen of the flexible overtube; a cutting tip at a distal end of the flexible shaft; an input port fluidly coupled to the lumen of the flexible shaft; and an output port fluidly coupled to a proximal end of the lumen of the overtube. Also disclosed herein are systems and kits for treating diverticular disease.

Abstract: A medical device includes a balloon member, a port that couples a compartment interior of the balloon member to a region exterior of the balloon member, and a tubular member that defines a lumen. A distal end of the tubular member is attached to an internal surface of the balloon member within the compartment so that a portion of the internal surface of the balloon member provides a seal at a distal end of the lumen. The tubular member passes through the port, and the proximal end of the tubular member is configured to remain exterior of the compartment. A delivery of a sufficient amount of a filling material into the lumen of the tubular member causes a length of the tubular member to pass through the port and into the balloon compartment.

Abstract: An intravascular filter configured for upstream or downstream retrieval and a method for retrieving an intravascular filter from a patient's vena cava through the patient's femoral vein. The filter includes a downstream hub, an upstream hub, a plurality of primary struts extending from the downstream hub to the upstream hub, a plurality of secondary struts extending upstream from fixed ends housed in the downstream hub to free ends, secondary strut eyelets disposed at the free ends of the secondary struts, a loop member disposed through the secondary strut eyelets, an upstream coupling element disposed with the upstream hub, and a tether extending from the loop member to the upstream coupling element.

Abstract: Tissue expansion system includes a pump, a controller, and inflatable bladder, and a pressure sensor. The pump is adapted for substantially continuous operation in response to a pressure within a subcutaneously implanted inflatable bladder. The pump is thus able to deliver inflation medium to the bladder when the pressure within the bladder is below a predetermined lower threshold while stopping delivery of the fluid when the pressure rises above a higher threshold or reaches a predetermined maximum volume.

Abstract: A probe for ablating tissue comprises an electrosurgical working end configured to provide a first plasma about a first surface location and a second plasma about a second surface location, the first plasma having first ablation parameters and the second plasma having second ablation parameters. The probe has a working end with a thickness below 3 mm and produces a low temperature plasma.

Abstract: The present invention relates to technical field of cardiac medical instruments, and more particularly to a balloon dilatation catheter provided with soft coating tip. In the balloon dilatation catheter provided with soft coating tip of the present invention, the balloon dilatation catheter comprises a balloon, and inner catheter. A distal end of the balloon at a terminal end of the inner catheter extends outward to form a catheter tip with taper inner cavity. A tip coating layer made of a material which is softer than a material of the balloon is coated on the catheter tip. The material of the balloon generally selects a relatively hard material. The distal end of the balloon extends outward to form a catheter tip.

Abstract: Inventive embodiments disclosed herein include a catheter for dilating a sinus cavity lumen. The catheter includes a guide tube, having a proximal end and a distal end, that terminates in a distal tip; a sleeve member annularly positioned over the guide tube, wherein the sleeve member is movable relative to the guide tube and is capable of being advanced over the guide tube; and a balloon coupled to the sleeve member, wherein the balloon can be extendable and inflated at or beyond the end of the guide tube.

Abstract: Several gastrointestinal surgery procedures are effective as treatments for metabolic disorders such as obesity and diabetes. Minimally invasive procedures including intra-luminal gastrointestinal implants have been proposed to mimic the anatomical, physiological and metabolic changes achieved by these procedures. Many of these designs include long sleeve like elements that prevent contact of food with the walls of the small intestine. It is desirable to have simple delivery systems that can place these implants under endoscopic guidance. However, in order to anchor these sleeve elements safely and reliably, the inventors have previously disclosed anchoring means that anchor the sleeves at the junctions of the stomach and the intestine or the stomach and esophagus.

Abstract: An access port for performing surgery transvaginally is provided. The access port includes an elongated flexible member having proximal and distal ends and a central portion therebetween, and a retention mechanism formed on the distal end of the elongated member. The retention mechanism includes a first configuration for inserting the distal end of the elongated member within an opening and a second configuration for selectively securing the elongated member within an opening. Also provided is a method of performing a transvaginal surgery. The method includes providing an access port including a retention mechanism configured to selectively retain the access port within the vagina of a patient, forming an incision in the wall of the vagina into the abdomen of the patient, inserting a distal end of the access port into the vagina and through the incision, and activating the retention mechanism to secure the distal end of the access port within the abdominal cavity of the patient.

Abstract: A system for tissue dissection and retraction is disclosed herein. A tissue dissection assembly generally comprises an elongate body shaft, an actuation member movable relative to the elongate body shaft, and at least one dissector arm member having at least a first end attached to the elongate body shaft, wherein the at least one dissector arm member is adapted to reconfigure within a plane from a low profile to an expanded profile when urged via the actuation member, and wherein the at least one dissector arm is further adapted to dissect tissue within the plane. In use, the assembly dissects tissue within the plane typically by advancing the elongate body shaft into the tissue region where the dissector arm member or members are then reconfigured within the plane from its low profile to its expanded profile to thereby dissect the tissue region along the plane.

Abstract: A suture passer guide that includes an elongate member having a longitudinal axis and defining a first proximal opening and a first distal opening. The first proximal and distal openings are substantially aligned with one another such that a suture passer can be extended through the first proximal and distal openings at an acute angle relative to the longitudinal axis of the elongate member. The suture passer guide can be configured to be passed through a central lumen of an endoscopic port.

Abstract: The invention relates to an insufflator with a supply connection (22) and a delivery connection (14) and a pressure and flow measuring device arranged between said connections (14, 22) for determining measured quantities characterizing a gas pressure at a delivery connection and a gas volume flow at the delivery connection. The pressure and flow measuring device comprises a multilayer board (20) which comprises on its interior at least one flow channel (26) that is connected at its input to the supply connection (22) and at its output (8) to the delivery connection (14). Arranged on the board (20) are pressure measurement sensors (32, 34) and electronic components (4, 6) for the wiring of the pressure measurement sensors.

Abstract: Suprapatellar systems, system components, and methods of operating on a tibial fracture of a patient are disclosed. A method can include making an incision proximal to a patella of a knee joint, forming an operation space, and inserting a portion of a retractor in the operation space to define an entry canal. The retractor can be inserted in a low profile configuration and, once positioned as desired by a surgeon, expanded to a high profile configuration. Expansion of the retractor can expand the operation space in at least one of an anterior-posterior direction or a medial-lateral direction and can increase a diameter of the entry canal. The method can further include inserting a trocar, having at least one guide hole, in the entry canal and guiding a guide pin through the at least one guide hole and into a tibia.

Abstract: A shaped medical balloon is provided that has a conforming shape, yet is inexpensive to manufacture, wherein a central portion of the balloon is folded inside and welded together at the fold and is further welded to said lumen, thus creating a conforming depression in the surface of said balloon at the central portion.

Abstract: One embodiment of the apparatus comprises a housing with a sheath portion projecting distally therefrom. The sheath portion has a sheath with a lumen, and a bearing surface in the sheath lumen or aligned with the sheath lumen, and located at or near a distal end of the sheath. The implant is at least partially positioned in the apparatus, and comprises an implant body and a tether connected to the implant body. The tether extends from the implant body distally within the sheath portion and around the bearing surface, where the tether changes direction, and extends back proximally from the bearing surface along and within the sheath portion. The apparatus is configured to move the first tether portion proximally and thereby draw the implant body distally along and within the sheath lumen.