Abstract: Devices used to deflate an inflatable hemostasis device are disclosed. The devices may be configured to deflate the inflatable hemostasis device in staged increments over a period of time. The devices may include a barrel member and a plunger member comprising an insert configured to couple with a retention ring of the barrel to restrict a retraction distance of the plunger member.

Abstract: An inflatable bone tamp for performing a minimally invasive surgical procedure includes an outer shaft defining an internal lumen, an inflatable structure coupled to the outer shaft, and an inner shaft movably disposed within the internal lumen and coupled to a distal end region of the inflatable structure. The internal lumen is sized to receive the inflatable structure, such that by moving the inner shaft relative to the outer shaft, the inflatable structure can be retracted into the internal lumen (and likewise can be extended from within the internal lumen for deployment in bone). This retraction capability can beneficially protect the inflatable structure during positioning/removal, and can also enhance recovery from radial tears of the inflatable structure.

Abstract: In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

Abstract: A device for insertion of material into a urethra comprising: a nozzle with a rounded nozzle tip, sized for at least partial insertion into the urethra; and a source of compressed material coupled to the nozzle where a pressure of the compressed material is less than 200 cm H2O; a control, for control of flow of material from the source through the nozzle; wherein a maximum extent of the device is less than 30 cm.

Abstract: A steerable member is disclosed generally having a steerable member for a medical apparatus, including a continuous, elongated body having a proximal section, a distal section, and a middle section between the proximal and distal sections, where the proximal section of the elongated body is less flexible than the distal section. At least one pull wire sheath extends through the proximal section and the middle section, but not through the distal section, and has a channel therethrough. A pull wire is disposed in the channel of the sheath and extends through the proximal section, middle section and distal section of the elongated body, the pull wire having a distal end affixed to a distal end of the elongated body, so that the distal section of the elongated body bends in response to a force applied to the proximal end of the pull wire.

Abstract: A capture tube mechanism for delivering and releasing a self-expanding stent includes a core wire on which a proximal portion of the stent is removably retained by a distal portion of a tubular capture sleeve. In one embodiment, one or more elongated members extending through corresponding apertures through the capture sleeve and out the distal end of the capture sleeve can be pulled to split the tubular capture sleeve to release the stent. In another embodiment, the capture sleeve can be pulled proximally over one or more stop members provided on the core wire to release the stent.

Abstract: A device for removing an obstruction from a lumen in a human or animal subject may include an inflatable balloon. The inflatable balloon may include a proximal tapered portion having a proximal taper angle, a central portion, and a distal tapered portion having a distal taper angle that is greater than the proximal taper angle. The balloon may also include at least one eversion feature on the proximal tapered portion and/or the distal tapered portion. The eversion feature may facilitate preferential eversion of the distal tapered portion into an inside of the balloon without the proximal tapered portion collapsing. Preferential eversion of the distal tapered portion may be provided by the differences in the distal and proximal taper angles and by one or more of a number of different types of eversion features.

Abstract: Devices and processes for maintaining a narrow body lumen are described. One embodiment of the inventive device includes: (i) a hydraulic propulsion mechanism for propelling an imaging portion or a therapeutic portion through the narrow body lumen; and (ii) a retrieval mechanism for retrieving the imaging portion or the therapeutic portion from the narrow body lumen.

Abstract: A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

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: A method of retrieving calculus in a living body and relocating the calculus to a different location in the living body involves positioning an elongated member in the living body in which the calculus is located, drawing the calculus in the living body toward the elongated member while the elongated member is positioned in the living body so that the calculus is retained by the elongated member; moving the elongated member so that the elongated member is located at a position in the living body that is different from the position of the elongated member in the living body during the drawing of the calculus toward the elongated member; and releasing the calculus from the elongated member so that the calculus is at a position in the living body different from a location of the calculus in the living body while the calculus is being drawn toward the elongated member.

Abstract: A device for removing a urinary tract stone from a ureter may include an outer shaft, an inner shaft extending coaxially within the outer shaft, a self-expanding wire basket attached to a basket shaft extending coaxially within the inner shaft, an inflatable balloon and a handle. The balloon main include a rounded distal tip. The handle may include an inversion slider coupled to the inner shaft and configured to actuate the inner shaft, thereby inverting the distal tip of the inflatable balloon to form a pocket adapted to receive a urinary tract stone. The handle may also include a basket slider coupled to the basket shaft and configured to actuate the basket shaft to move the wire basket in and out of the inner shaft.

Abstract: A discharge device and method are disclosed that can discharge a discharge substance with a desired discharge amount at a desired flow rate. A storage unit provided in a discharge device includes a storage space which can store a discharge substance, and a discharge section which can discharge the discharge substance stored in the storage space toward the proximal side of a main body in an axial direction, and is configured to be capable of expanding deformation and contracting deformation in response to introduction and discharge of the discharge substance.

Abstract: Apparatus for use with a guidewire is provided, the apparatus including (1) a first housing, shaped to define a first channel through which the guidewire is slidable; (2) a second housing, shaped to define a second channel through which the guidewire is slidable in at least a first direction toward the first housing; (3) a guidewire-engaging element, disposed within the second housing, and configured to inhibit the guidewire from sliding through the second channel in a second direction away from the first housing; and (4) a tubular member, (a) shaped to define a lumen therethrough, through which the guidewire is slidable, and (b) coupled to the second housing and slidably coupled to the first housing. Other embodiments are also described.

Abstract: Systems for providing access across a site of obstruction and methods for manufacturing and using such systems. Such systems may include a sleeve having an inflation lumen; a bushing disposed in a distal section of the sleeve; and an everting member coupled to the sleeve with the bushing, the everting member being movable from an inverted position inside the sleeve to an everted position outside the sleeve in response to an increase in pressure in the inflation lumen.

Abstract: A rapid exchange (RX) catheter may provide a proximal seal against a guide catheter inner lumen so that aspiration may be applied through a guide catheter. The catheter may include an exit port that defines a transfer port for aspiration and may enable minimal frictional engagement with the guide catheter proximal of the exit port. Aspiration can be applied to the lumen of the guide catheter and may be directed to and effective at the tip of the RX aspiration catheter. A tip of the RX catheter may facilitate aspiration and retrieval of the clot by expanding under load and can also partially or fully occlude the vessel.

Abstract: A system for removing a kidney stone from a ureter may include: an elongate, flexible, outer shaft having a distal end configured to be advanced into the ureter and a proximal end; an elongate, flexible, inner shaft extending through at least part of the outer shaft; an expandable stone retention member extending through at least part of the inner shaft and moveable along the longitudinal axis relative to the inner shaft; an elongate, flexible camera positioned coaxially within the retention member shaft, such that a distal end of the camera is located at or near a distal end of the inner shaft; and a handle coupled with the proximal end of the outer shaft, a proximal end of the inner shaft, and a proximal end of the retention member shaft.

Abstract: Disclosed systems, methods, and devices may include a system for removing a kidney stone from a ureter. The system may have an inner shaft extending coaxially within an outer shaft, a stone retention member shaft having a stone retention member and extending coaxially within the inner shaft, a wall protection member coupled to the outer shaft and the inner shaft, and a handle coupled with proximal ends of the outer shaft, the inner shaft, and the stone retention member shaft. The handle may include an eversion mechanism coupled to the inner shaft and configured to actuate the inner shaft, thereby everting the wall protection member to form a pocket adapted to receive a kidney stone. The system may also include a retention member mechanism coupled to the stone retention member shaft and configured to actuate the stone retention member shaft.

Abstract: Disclosed systems, methods, and devices may include a system for removing a kidney stone from a ureter. The system may have an inner shaft extending coaxially within an outer shaft, a stone retention member shaft having a stone retention member and extending coaxially within the inner shaft, a wall protection member coupled to the outer shaft and the inner shaft, and a handle coupled with proximal ends of the outer shaft, the inner shaft, and the stone retention member shaft. The handle may include an eversion mechanism coupled to the inner shaft and configured to actuate the inner shaft, thereby everting the wall protection member to form a pocket adapted to receive a kidney stone. The system may also include a retention member mechanism coupled to the stone retention member shaft and configured to actuate the stone retention member shaft.

Abstract: A device for removing an obstruction from a lumen in a human or animal subject may include an inflatable balloon. The inflatable balloon may include a proximal tapered portion having a proximal taper angle, a central portion, and a distal tapered portion having a distal taper angle that is greater than the proximal taper angle. The balloon may also include at least one eversion feature on the proximal tapered portion and/or the distal tapered portion. The eversion feature may facilitate preferential eversion of the distal tapered portion into an inside of the balloon without the proximal tapered portion collapsing. Preferential eversion of the distal tapered portion may be provided by the differences in the distal and proximal taper angles and by one or more of a number of different types of eversion features.

Abstract: A system for providing access across a site of obstruction is provided. The system may include a sleeve, having a distal portion that can move from an inverted position to an everted position. A balloon situated within the sleeve can be extended so as to evert sleeve. A pathway can extend across a juncture between the distal portion and the remaining portion of the sleeve so as to provide access across the site of obstruction. A method for providing access across the site of obstruction is also provided.

Abstract: Mechanical thrombectomy apparatuses (devices, systems, etc.) and methods for positioning them within a vessel and using them to remove a thrombus, e.g., clot, from within a vessel. In particular, described herein are methods of advancing an inverting tractor thrombectomy apparatus having a tractor comprising a flexible tube of material that inverts over itself as it rolls over a distal end opening of an elongate inversion support by extending the tractor region and/or a puller coupled to the tractor distally beyond the end of the catheter. Also described herein are power-driven mechanical thrombectomy apparatuses.

Abstract: A surgical system including an expandable device is provided, including an inflatable body, an inner shaft and an outer shaft. The inflatable body has at least one folded segment, which are housed in a distal portion of the outer shaft. The inflatable body is tethered to a portion of the outer shaft. The inner shaft is affixed to a portion of the inflatable body, and is configured to control an axial and/or a radial inflation pattern of the folded inflatable body.

Abstract: The invention provides a catheter (1) which is movable between an un-expanded and an expanded configuration by use of an advancing mechanism (20). The advancing mechanism facilitates safe and non-contaminated use of the catheter.

Abstract: The invention is an integrated device and improved method for percutaneous placement of a tracheostomy tube into a patient which includes a film sheath everted from a pusher moved through a guide that is positioned over an incision site in a patient's neck. The pusher moves through an incision, which may be preexisting or created by the device, into the patient's trachea, laying down the film sheath as it advances. The film and pusher may effect blunt dissection of the patient's tissue, and the device may optionally include a blade(s), needle or other cutting tool and/or the tracheostomy tube itself so that the tracheostomy can be completed with fewer procedural steps and surgical instruments.

Abstract: An obstruction removal device is described having a retrieval component used to engage an obstruction within the vasculature and a sheath component that is capable of inverting to fold over the obstruction and the retrieval component. The sheath component helps contain the obstruction and minimizes trauma to the blood vessel during the removal process.

Abstract: A device for removing a urinary tract stone from a ureter may include an outer shaft, an inner shaft extending coaxially within the outer shaft, a self-expanding wire basket attached to a basket shaft extending coaxially within the inner shaft, an inflatable balloon and a handle. The balloon main include a rounded distal tip. The handle may include an inversion slider coupled to the inner shaft and configured to actuate the inner shaft, thereby inverting the distal tip of the inflatable balloon to form a pocket adapted to receive a urinary tract stone. The handle may also include a basket slider coupled to the basket shaft and configured to actuate the basket shaft to move the wire basket in and out of the inner shaft.

Abstract: A surgical system is disclosed, and includes a surgical fastening apparatus and an access device. The access device defines an internal lumen configured to receive the surgical fastening apparatus. The access device also includes a proximal portion and a distal portion being more flexible than the proximal portion. The access device is reconfigurable between a first condition and a different, second condition in which the distal portion of the access device is configured to fold radially inwardly and proximally upon movement of the surgical fastening apparatus therewith.

Abstract: Apparatus and methods for extending a tube, the apparatus including a foldable tube having a folded portion inside an unfolded portion of the tube, and a source of fluid coupled to the unfolded portion for providing fluid into the unfolded portion to unfold and extend the folded portion out of the unfolded portion to become an extension of the unfolded portion. The apparatus and methods are useful, inter alia, for cleansing the colon in the normal direction, that is, from the cecum to the anus, using an apparatus that is introduced via the anus. A washing liquid is supplied deep into the colon via the soft feed tube that is inserted via the anus and is extended into the colon by inflation. The washing liquid is then drained out via the anus through a drainage channel.

Abstract: Methods and devices for delivering a stent in a proximal to distal fashion are disclosed. The delivery device includes a sheath catheter, an outer catheter and an inner catheter over a guide wire. A crimped stent is positioned over the distal end of the outer catheter and is held in place by a lubricous elastic membrane attached to a retractable ring. The retractable ring is connected to pull wires and slidably deployed between the inner and outer catheters. The proximal end of the stent is aligned at the treatment location, and the lubricous elastic membrane is pulled back into the space between inner catheter and outer catheter, releasing and deploying the stent from its proximal to its distal end.

Abstract: A temporary neurostimulation lead may be secured relative to patient using a fixation device. The fixation device may include an attachment portion that is configured to be releasably fixated to the patient and a lead fixation portion that is configured to secure the temporary neurostimulation lead. The fixation device can be adhesively fixated to the patient via the attachment portion and the temporary neurostimulation lead can be fixated to the lead fixation portion of the fixation device.

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: A medical device for collecting objects from a body lumen comprises a catheter, a basket having a closed first end and an open second end, and an actuator connected to the closed first end of the basket, the catheter and basket moveable relative to one another between a first configuration and a second configuration to draw objects from a body lumen into the basket. In the first configuration the closed first end of the basket is inside the catheter and the open second end is everted over at least a part of the closed first end. The apparatus may be actuated to pull the closed first end of the basket further into the catheter and invert the second end of the basket, the second end scraping the sides of the lumen as it inverts, surrounding an object in the lumen, and drawing the object into the basket.

Abstract: A filter device for trapping embolic debris comprises a bag which is deployed by everting it from an end of a delivery catheter. After release from the catheter, with the assistance of a pusher member, the open end of the bag self-expands against the walls of a body lumen. In one method of removal after use, the device is withdrawn into catheter by pulling on a wire attached to the closed end of the bag.

Abstract: This invention relates to a gripping device (10), e.g. a surgical retrieval device. The device includes an inversible tubular member (28), which is composed of interengaged stitches of resiliently flexible filamentary material and which is progressively transformable between an everted condition and an inverted condition. The device includes also actuation means (12,20) carrying the inversible tubular member and operable for effecting progressive inversion and eversion of the inversible tubular member. Through progressive inversion of the inversible tubular member, an object can be gripped thereby.

Abstract: Techniques are disclosed for prevention or treatment of physiological shock by administering a specific therapeutic agent, which is able to use smaller volumes of reagent to achieve complete inhibition, than other previously described techniques.

Abstract: A self propelled, endoscopic apparatus formed of a flexible, fluid-filled toroid and a motorized or powerable frame The apparatus may be used to advance a variety of accessory devices into generally tubular spaces and environments for medical and non-medical applications. The apparatus when inserted into a tubular space or environment, such as the colon of a patient undergoing a colonoscopy, is advanced by the motion of the toroid. The toroid's surface circulates around itself in a continuous motion from inside its central cavity along its central axis to the outside where its surface travels in the opposite direction until it again rotates into its central cavity. As the device advances within the varying sizes, shapes and contours of body lumens, the toroid compresses and expands to accommodate and navigate the environment. The motion of the toroid can be powered or unpowered and the direction and speed may be controlled.

Abstract: The present invention relates to balloon catheters for treating a luminal system of a patient. Specifically, the invention relates to catheters having a flexible membrane positioned at a distal portion of the catheter, the flexible membrane retained in a substantially unexposed conformation prior to deployment. Preferably the flexible membrane is capable of delivering a therapeutic agent to a localized environment when deployed to an exposed conformation.

Abstract: There is provided a suction catheter having a tubular body with a lumen formed therethrough. The catheter has a plurality of spaced elongated apertures positioned near its distal tip. The catheter may have a fourth round opening positioned proximally to the three openings. The catheter has reduced impact force compared to similar suction catheters without the plurality of apertures near the distal tip.

Abstract: A lubricant supplying device of an endoscope everting tube drive comprises a drive tube everted at least once to thus form an outer and an inner tube portion. Inside the inner tube portion an endoscope shaft is mounted in an axially displaceable manner. In addition a drive device is provided which encompasses the drive tube everted at least once or the inner tube portion thereof so as to apply a driving force for an advancing movement of the endoscope shaft onto the inner tube portion, the drive means being in fluid connection with a lubricant supplying line and a lubricant discharge line for introducing a lubricant via the drive device into the drive tube everted at least once and/or for discharging it. The lubricant supply line and the lubricant discharge are connected to the drive device in two locations thereof diametrically opposite with respect to the endoscope shaft.

Abstract: A system for minimizing leakage of fluid distending media by the sides of the endoscopic instrument in endoscopic procedures such as arthroscopy, hysteroscopy or laparoscopy. A double-wall flexible tubular sheath having walls containing pressurized fluid is mounted over an endoscopic instrument. The double-wall flexible tubular sheath moves in and out of a natural opening of a tissue cavity or through an incision made in the cavity wall.

Abstract: A system for providing access across a site of obstruction is provided. The system may include a sleeve, having a distal portion that can move from an inverted position to an everted position. A balloon situated within the sleeve can be extended so as to evert sleeve. A pathway can extend across a juncture between the distal portion and the remaining portion of the sleeve so as to provide access across the site of obstruction. A method for providing access across the site of obstruction is also provided.

Abstract: A catheter including a continuous envelope forming an open-bore shaft. The envelope is characterized by a main longitudinal axis and a sagittal cross section. At least a portion of the sagittal cross section may be characterized by at least one asymmetric property that extends along the main longitudinal axis in a predetermined pattern.

Abstract: Methods and apparatus are described for a bidirectional introducer. An apparatus includes a bidirectional introducer, comprising a catheter including: a sheath; and a dilator located within and substantially coaxially with the sheath, the dilator having a distal end portion that includes at first section having a proximal first section end and a distal first section end and a second section having a proximal second section end and a distal second section end, wherein a) the distal first section end is coupled to the proximal second section end and b) at least a portion of the first section is characterized by a first rigidity and at least a portion of the second section is characterized by a second rigidity that is higher than the second rigidity.

Abstract: Disclosed is an introducer apparatus comprising an sleeve fixation mechanism or introducer member, such as a catheter, introducer, or ring-like structure, which is attached to a protective sleeve comprising a thin flexible material such a polymeric film. The sleeve is inverted into the passageway of a second member, such as a catheter, feeding tube, introducer, etc., that is advanced through the passageway of the introducer member and is introduced into a bodily passage of a patient, such as the bile duct, nasal passages, colon, etc. The sleeve everts from the passageway of the second member during its advancement to lay down a friction-reducing surface. The sleeve prevents frictional contact between the second member and delicate or sensitive tissues.

Abstract: A catheter assembly for use in the extracorporeal treatment of bodily fluids. The assembly comprises a catheter body having a withdrawal port, an infusion port, and a plurality of lumens therein. One of the lumens comprises a withdrawal lumen for transport of fluids withdrawn from a body vessel through the withdrawal port to an extracorporeal treatment unit, such as a dialyzer. Another lumen comprises an infusion lumen for return of treated fluids from the extracorporeal treatment unit into the body vessel through the infusion port. A wire extends from yet another lumen to an attachment point on the catheter assembly. The wire is capable of bowing radially outwardly from the catheter body, in order to space the infusion and withdrawal ports from the vessel wall.

Abstract: The present invention provides devices and methods for attachment of an endolumenal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve or other therapeutic or diagnostic device, within a patient's digestive tract. In one application of the invention, an endolumenal bypass sleeve is removeably attached in the vicinity of the gastroesophageal junction to treat obesity and/or its comorbidities, such as diabetes. The bypass sleeve may be at least partially deployed by eversion.

Abstract: A method for inserting a multi-lumen catheter into a patient is disclosed. The catheter includes an elongated, central, multi-lumen tube portion having a proximal end and a distal end. A distal branch portion includes a plurality of single-lumen distal extension tubes. The proximal first end of each distal extension tube is connected to the distal end of the central tube portion such that the single lumen of each distal extension tube is in fluid communication with one of the plurality of lumens of the central tube portion. A proximal branch portion includes a plurality of single-lumen proximal extension tubes. The distal first end of each proximal extension tube is connected to the proximal end of the central tube portion such that the single lumen of each distal extension tube is in fluid communication with one of the plurality of lumens of the central tube portion.

Abstract: Universal laparoscopic uterine manipulators/dilators with variable intra-uterine length to match the length of the uterus in order to avoid any risk of perforation and to provide excellent pelvic exposure irrespective of uterine size, shape and position. Moreover, semirigid/semi-flexible dilators are less likely to form false passages in the cervix and the body of the uterus as they follow the natural track of the cervical canal.

Abstract: Disclosed herein are elongate flexible medical devices which are capable of axial elongation through the mechanism of eversion or toposcopic expansion. In general, this may be accomplished by providing a flexible tubular device having a proximal end and a distal end. Retraction of the distal end in a proximal direction through the tubular body inverts the tube upon itself, causing an axial shortening of the overall length of the device. The original length of the device can be restored by coupling a pressurized media to the proximal end of the sleeve. If the distal end of the sleeve is temporarily restricted or closed, the pressurized media causes the distal end of the sleeve to travel distally until the full length of the sleeve has been restored.