Abstract: A fluid displacement and pressurizing device which includes a housing, a first piston in the housing, a plunger which extends from the housing and has a second piston thereon, and an actuator that works to selectively lock the piston to either the housing or the plunger depending on the position of the second piston in the housing. Effectively, the actuator includes a first locking mechanism that locks and unlocks the first piston relative to the housing and a second locking mechanism that locks and unlocks the plunger relative to the piston. As such, the first locking mechanism is not only a locking mechanism but is also an actuating mechanism with regard to actuating the second locking mechanism.

Abstract: Methods and devices described for improved catheters including those having a deflectable section to allow for expansion while maintaining flow through a vessel.

Abstract: Devices, systems for localized delivery of a chemotherapy, hormonal therapy or targeted drug/biologic therapy to a target tissue area of an internal body organ of a patient. A catheter 10 forms a sealed treatment chamber in a natural lumen extending through the target tissue area. Air is purged from the chamber, which is then filled with a liquid drug solution for an adequate treatment session time, solution volume and drug concentration to saturate the target tissue area, thereby providing the treatment. The liquid drug solution may be circulated or recirculated through the chamber or maintained stationary therewithin. The drug may saturate the target tissue area and pass therethrough into the lymphatic system or interstitial space, which may serve as a reservoir of the drug for continued therapeutic treatment after withdrawal of the catheter. The chamber is evacuated at the end of the treatment session.

Abstract: Methods of using a soft tissue cutting device are disclosed. The methods include providing the soft tissue cutting device, positioning the soft tissue cutting device in a priming slot of a tray configured for receiving and holding the soft tissue cutting device, attaching a priming syringe to the soft tissue cutting device, priming a balloon disposed on a distal end of the soft tissue cutting device by equalizing a first pressure inside the balloon to a second pressure inside the priming syringe, removing the soft tissue cutting device from the priming slot, and positioning the distal end of the soft tissue cutting device on a safety slot included in the tray to determine whether the tissue cutting device has been properly primed.

Abstract: An endoscope can include a substantially rigid elongate body. A visualization channel can extend through the elongate body. An elongate viewing instrument that can advance distally and retract proximally through a visualization channel of the elongate body. The elongate viewing instrument can include a distal portion that is pre-biased to assume a curved shape when the distal portion is unconfined. The distal portion can curve when the distal portion is advanced distally to exit the visualization channel and can straighten when the distal portion is retracted proximally to enter the visualization channel. A distal end of the elongate viewing instrument can further include a light port that is configured to illuminate a target and provide an image of the illuminated target.

Abstract: A balloon guide catheter including a catheter shaft having a main lumen defined therein extending axially therethrough to receive a guidewire therein and an inflation lumen defined axially therein arranged semi-encircling the main lumen. The inflation lumen having an inlet port radially outward from the catheter shaft and an exhaust vent(s) disposed proximate the distal end of the catheter shaft. The exhaust vent(s) being disposed longitudinally through a distal terminating end of the inflation lumen or radially inward in fluid communication with the main lumen. A porous membrane is disposed at the exhaust vent(s) to permit only gas to pass therethrough. Secured about the outer surface proximate the distal end of the catheter shaft and coinciding with the inlet port is a balloon.

Abstract: Methods for purging a balloon catheter of air. An inflation fluid is inserted into a balloon and an inflation lumen of a balloon catheter. The inflation lumen is in fluid communication with the balloon. The balloon catheter is positioned in an inverted orientation with a distal end thereof disposed below a proximal end thereof. The distal end of the balloon catheter includes a balloon. A vibration source is positioned in direct contact with an outer surface of the balloon catheter. The balloon catheter is vibrated via the vibration source. A vacuum is applied or pulled on the inflation lumen of the balloon catheter. The steps of vibrating the balloon catheter and applying the vacuum are performed simultaneously.

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: Inflation devices and methods for using them are provided for selectively inflating and deflating multiple balloons on a catheter. For example, the inflation device may include a first valve including a plurality of first valve ports and a first valve member movable between multiple positions for opening and closing fluid paths between the first valve ports, a second valve including a plurality of second valve ports and a second valve member movable between multiple positions for opening and closing fluid paths between the second valve ports, and an actuator coupled to the first and second valve members for directing the first and second valve members between multiple positions, e.g., to selectively pull vacuum and sequentially inflate the balloons.

Abstract: A volume indicator for a syringe can include an indicator body configured to removably clip onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include inflation indicia corresponding to a range of expanded diameters for a prosthetic heart valve. The volume indicator can include one or more first engagement elements that correspond to one or more second engagement elements on a syringe.

Abstract: A method of treating a gynecological malignancy includes introducing an implant within a uterus of a patient and positioning the implant adjacent to an endometrium of the uterus to enable a bioactive agent supported on the implant to treat the gynecological malignancy. The implant may be one or more deployable implants including a balloon, an IUD, a stent, or combinations thereof. Such implants may be introduced by one or more surgical instruments.

Abstract: A needle-free connector for accessing a patient's intravenous line includes a hollow body having a first end with a first opening, a second end with a second opening, and an inner wall defining a chamber. A hollow piston disposed in the chamber is axially collapsible to allow fluid to flow between the inner wall of the hollow body and the outer surface of the hollow piston. An inner surface of the hollow piston includes a fluted section having a radial array of axial slots. The fluted section has a first radial thickness configured to buckle in response to axial force applied to the hollow piston. The hollow piston further includes a retrograde-reducing stiffener. The retrograde-reducing stiffener has a second radial thickness that is greater than the first radial thickness.

Abstract: A balloon catheter (100), suitable for delivery of a balloon to the stomach via application by the nose, the balloon catheter comprising a catheter (2) and one or more inflatable balloons (1) fixedly attached to the catheter. The balloons have an outer diameter from 4 to 7 cm, are made of a relatively hard material (e.g. durometer 70 to 100 shore A), and have an effective length of 7 to 18 cm or a total inner volume of 90 to 330 ml, when inflated by 0.2 psi. A system comprising the balloon catheter, and a pressure sensor for measuring a pressure of a fluid inside the balloon, and optionally a fluid pump for inflating and/or deflating the balloon, and a control unit for reading the pressure sensor and optionally for controlling the fluid pump.

Abstract: Catheter system, devices and methods for diagnosing and treating lateral stenosis causing back pain and or leg pain. The devices comprise a tubular part for insertion into a working cannula to self-position itself safely within the foramen, and minimize the risk of displacement medially or laterally, to prevent nerve or dura injury. An expandable membrane is configured to maintain the catheter device within the foramen. Expansion of this membrane would decompress the nerve within the foramen by opening the foraminal canal as the membrane expands.

Abstract: A catheter comprising an elongated member having a distal end and a proximal end. The proximal end defines a drainage inlet extending from an external wall of the elongated member into the elongated member. The elongated member defines a first lumen that connects the drainage inlet with a drainage outlet defined by the distal end. The catheter also includes an inflatable retention balloon defined by the external wall of the elongated member and located between the drainage inlet and the drainage outlet. The catheter further includes a fluid inlet valve that protrudes from the elongated member and defines a second lumen that extends from the fluid inlet valve through the elongated member and to the inflatable retention balloon. The catheter additionally includes a secondary balloon that protrudes from the elongated member, the elongated member defining a third lumen that extends from the inflatable retention balloon to the secondary balloon.

Abstract: A fluid pressure gun device for a balloon catheter includes a tubular cavity, a fluid tube, a pressure monitoring device, a plunger, a screw structure, a cover and a detent structure, wherein inside the body of the cavity forms a chamber. The plunger is disposed in the chamber, and the inside of the casing forms a chamber. The screwing structure includes two screwing blocks, and each screwing block is oppositely arranged in the chamber according to the plunger as the center. Each of the screw blocks is screwed with the plunger, and a plurality of springs respectively lean against the screw block and the cover. The detent structure is used to depart the screw blocks from the plunger. The plunger is supported by each screw block at least on two opposite sides, and making it a highly reliable combination of the plunger and each screw block.

Abstract: There is provided an apparatus for extraction of at least one object from a cavity. The apparatus includes a sleeve including an inflatable section configured to surround the at least one object during inflation; a handle configured to enable a user to hold the sleeve, the handle defining a holding edge of an opening at a first portion of the sleeve; and a handle-mount mounted to a peripheral area around the opening, the handle-mount being for attachment of a pump used for inflating the inflatable section. There is also provided a pressure limitation apparatus configured to operate with a birth assistance device when attached via a conduit.

Abstract: A nozzle, such as a nozzle for use as a part of a beverage preparation package. The nozzle may include a nozzle body with a conduit, the conduit having an inlet end and an outlet end. The nozzle may also include a plug that is connected to the nozzle body in a detachable manner. The plug and the conduit may be configured such that, when the plug is detached from the nozzle body, the plug is adapted to travel along the conduit and be retained within the conduit at the outlet end such that fluid can flow through the conduit from the inlet end towards the outlet end.

Abstract: A catheter assembly configured for use with a male luer is provided herein. The catheter assembly can comprise a catheter hub having an interior chamber and a valve located in the interior chamber. The valve can comprise a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior. The valve can include a barrier layer having a concave shape that extends in the valve interior from the sidewall at the distal portion. The barrier layer can have at least one slit extending therethrough that is in a normally closed configuration to prevent a fluid from passing through the barrier layer. The catheter assembly can further comprise a sealing ring located circumferentially at a distal end of the valve distally to the barrier layer. The sealing ring can form a seal between the valve and the interior chamber at the distal end.

Abstract: A catheter directionally conducts a pulsating body fluid and has a line segment defining an inner volume. A pump chamber section is arranged proximally as an extension of the line segment and defines a pump chamber having a frame therein accommodating a balloon. A first opening connects the inner volume to an external volume and a second opening is arranged proximally from the first opening to connect the inner volume to the external volume. A check valve is assigned to the second opening and the check valve includes a valve foil having an aperture formed therein offset from the second opening. A third opening communicates with the pump chamber. The frame is of a shape memory material which provides rigidity for a pulsatile operation of the balloon. During operation, the pulsating body fluid is conveyed in the inner volume directionally between the first and second opening by operating the balloon.

Abstract: Methods and devices related to fluid delivery catheters and more particularly relates to catheters used to deliver fluid to medical devices and/or position medical devices.

Abstract: A catheter delivery system (10) includes: (i) an introducer sheath (12); (ii) a catheter (14) disposed at least partially within the introducer sheath and movable axial along the introducer sheath; (iii) an invaginating tube (16) sealably secured at or near a first axial end (16a) of the invaginating tube to the introducer sheath at or near a first axial end (12 a) of the introducer sheath; (iv) a runner (28) slidably connected to the catheter; (v) the invaginating tube being sealably secured at or near a second axial end (16b) of the invaginating tube to the runner, such that the runner with inavaginating tube secured thereto is sealably connected to the catheter and movable axially along at least a portion of the catheter; and (vi) means for pressurising the annular space defined between the introducer sheath, the catheter and the invaginating tube.

Abstract: The anti-back-flow devices and methods prevent fluid from leaking proximally from a catheter, but allow ready access to the catheter using any male luer device. The devices include proximal surfaces that urge open a valve in response to force from a male luer tip. The valves are associated a female luer hub and adapted to function with standard and typical non-standard male luer fittings.

Abstract: Methods and devices described for improved catheters including those having a deflectable section to allow for expansion while maintaining flow through a vessel.

Abstract: A gastrostomy device (100) comprises a gastrostomy tube (200) having a retainer lumen (235) extending between a proximal part and a distal part of the tube (200); and an inflatable retaining element (300) coupled to the tube (200) at the distal part. An interior space of the retaining element (300) is in fluid communication with the retainer lumen (300). The gastrostomy device (100) also comprises an indicator (410) being in fluid communication with the retainer lumen (235) at the proximal part of the tube (200). The indicator (410) is configured for indicating a pressure in the retaining element (300) continuously within a range from a pressure corresponding to an empty retaining element (300) to an optimal pressure for the inflated retaining element (300).

Abstract: Devices used to pressurize, depressurize, or otherwise displace fluid are disclosed. The devices may be configured to displace fluid in order to inflate or deflate a medical device, such as a balloon. The devices further include a crank member for providing a mechanical advantage when pressurizing or otherwise displacing fluid.

Abstract: Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed include pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

Abstract: A cuff pressure stabilizer includes a substantially rigid protective housing and a balloon disposed therein. The balloon has a base low pressure of 10 cm H2O when it contains a base low-pressure volume of air. When the balloon contains a first medium-pressure volume of air, the balloon has a first medium pressure of 25 cm H2O, and less than 10% of an outer surface of the balloon touches an inner surface of the housing. When the balloon contains a second medium-pressure volume of air, the balloon has a second medium pressure of 40 cm H2O, and at least 20% of the outer surface of the balloon touches a portion of the inner surface of the housing. The second medium-pressure volume of air equals the base low-pressure volume of air plus a second incremental quantity of air that is between 10 cc and 60 cc. Other embodiments are also described.

Abstract: A cleaning catheter (200) includes fluid-delivery and suction lumens (520, 530). A flow regulator (700) defines suction and fluid ports (830, 827). A mechanical user control element (320) is configured to mechanically and non-electrically set activation states of the flow regulator (700), and transition between first and third configurations via a second configuration. When the control element (320) is in the first configuration, the flow regulator (700) blocks fluid communication (a) between the suction port (830) and the suction lumen (530) and (b) between the fluid port (827) and the fluid-delivery lumen (520). When the control element (320) is in the second configuration, the flow regulator effects fluid communication between the suction port (830) and the suction lumen (530), and blocks fluid communication between the fluid port (827) and the fluid-delivery lumen (520).

Abstract: An inflation device including a handle mechanism configured to selectively engage and disengage threads within the device. In some instances the threads are configured to couple a plunger to a syringe body. The handle mechanism may be configured to (1) provide a mechanical advantage and (2) change the location and direction of the input force, thereby making the device easier to use.

Abstract: A method and apparatus for treating a stricture in a body lumen. The method comprises (a) sensing pressure being exerted by a treatment device on the stricture, (b) determining if enough force is being exerted on the stricture, (c) if enough force is being exerted on the stricture, timing the application of enough force, (d) determining if too much force is being exerted by the treatment device on the stricture, (e) if too much force is being applied to the stricture, decrementing the force being applied to the stricture, (f) determining if not enough force is being applied to the stricture, (g) if not enough force is being applied to the stricture incrementing the force being applied to the stricture, and (h) repeating (a)-(g) until (i) a desired pressure has been maintained on the tissue for a desired time.

Abstract: A device for reducing pressure within a lumen includes a reservoir structured for holding a fluid therein, an injection port in fluid communication with the reservoir, a compliant body structured to expand and contract upon changes in pressure, and a conduit extending between and fluidly coupling the reservoir and the compliant body. The fluid may be a compressible or a noncompressible fluid.

Abstract: A cleaning catheter (200) includes fluid-delivery and suction lumens (520, 530). A flow regulator (700) defines suction and fluid ports (830, 827). A mechanical user control element (320) is configured to mechanically and non-electrically set activation states of the flow regulator (700), and transition between first and third configurations via a second configuration. When the control element (320) is in the first configuration, the flow regulator (700) blocks fluid communication (a) between the suction port (830) and the suction lumen (530) and (b) between the fluid port (827) and the fluid-delivery lumen (520). When the control element (320) is in the second configuration, the flow regulator effects fluid communication between the suction port (830) and the suction lumen (530), and blocks fluid communication between the fluid port (827) and the fluid-delivery lumen (520).

Abstract: A fluid delivery device is provided for delivering fluid to a target site such as an intervertebral disc during discography. The fluid delivery device includes pressure and volume sensors to determine the pressure and the volume of the fluid delivered to the intervertebral disc. The fluid delivery device is hand-held during use and includes a syringe assembly having a plunger with threads that enables controlled discharge of the fluid from the fluid delivery device by rotating the plunger in a housing of the fluid delivery device. The fluid delivery device includes a communication module to wirelessly transfer data to an external device outside of a sterile field, while the fluid delivery device is in the sterile field. The fluid delivery device may also include a physiological sensor to monitor involuntary pain responses based on changing physiological parameters such as increases in body temperature or blood pressure.

Abstract: A safety catheter includes a flexible, multi-lumen shaft having an outer diameter, a distal tip, a proximal catheter end with a drain end and a proximal inflation end. The multi-lumen shaft defines a drain lumen, a distal hollow balloon portion, at least one inflation lumen, and a drainage port. A hollow stretch valve is coaxially disposed in the inflation or drainage lumen, or both, has a fixed portion within the inflation or drainage lumen, or both, and prevents fluid from passing through the drainage port in a steady state and has a sliding portion slidably disposed within the inflation or drainage lumen, or both, such that, in a stretched state when the proximal catheter end is stretched, the sliding portion slides within the inflation or drainage lumen, or both to permit fluid to pass through the balloon drainage port and/or wall of the catheter.

Abstract: A collateral ventilation bypass trap system directly linked with a patient's lung or lungs may be utilized to increase the expiratory flow from the diseased lung or lungs, thereby treating one aspect of chronic obstructive pulmonary disease. The system includes a trap, a filter/one-way valve and an air carrying conduit. The system also includes a retention device for securing system elements in position.

Abstract: A fluid delivery device is provided for delivering fluid to a target site such as an intervertebral disc during discography. The fluid delivery device includes pressure and volume sensors to determine the pressure and the volume of the fluid delivered to the intervertebral disc. The fluid delivery device is hand-held during use and includes a syringe assembly having a plunger with threads that enables controlled discharge of the fluid from the fluid delivery device by rotating the plunger in a housing of the fluid delivery device. The fluid delivery device may also include a communication module to wirelessly transfer data to an external device outside of a sterile field, while the fluid delivery device is in the sterile field. The fluid delivery device may also include a physiological sensor to monitor involuntary pain responses based on changing physiological parameters such as increases in body temperature or blood pressure.

Abstract: A relief valve incorporated within a Luer connector regulates the amount of air pressure applied by a syringe to a balloon at the end of a catheter to prevent bursting of the balloon.

Abstract: A multilayer film including a layer of sealing film, having main top and bottom surfaces, and a layer of thermoplastic polymer film, laminated to the layer of sealing film, on at least one of the main top and bottom surfaces. The sealing film has a composition and thickness imparting gas barrier character to the multilayer film, of which the layer(s) of thermoplastic polymer film by themselves lack such gas barrier character. Such multilayer film is usefully employed to form biologically compatible therapeutic articles such as medical balloons that are constructed to be inflated in vivo.

Abstract: A system and method for inflating and deflating a catheter balloon using osmosis. An elongate catheter shaft has a proximally disposed osmotic membrane in fluid communication with a distally mounted balloon through a fluid-filled catheter lumen. The balloon is inflated by exposing the exterior of the membrane to a solution that is hypotonic relative to the solution within the catheter lumen. The balloon is deflated by exposing the exterior of the membrane to a solution that is hypertonic in relation to the solution within the catheter lumen.

Abstract: Composite fiber reinforced balloons for medical devices prepared by applying a web of fibers to the exterior of a preformed underlying balloon and encasing the web with a matrix material to form a composite balloon. The fiber web is applied to at least the cone portion of the underlying balloon form. Either the cone portion of the underlying balloon form, or the web fibers applied to said cone portion, or both, have a friction-enhancing material coated thereon.

Abstract: Several embodiments of an endourethral prosthesis, assembly, and attendant methods are provided for patients presenting with lower urinary tract symptoms (LUTS) or urinary retention. The endourethral prosthesis includes a reversibly expandable element disposed circumferentially about, and longitudinally along a tubular member adapted to receive urine. The tubular member is positionable within a lower urinary tract such that the reversibly expandable element operatively engages a structure of the lower urinary tract so as to prevent migration of the prosthesis so positioned. The reversibly expandible element is in non-reversible fluid communication with the tubular element for selective expansion thereof, the reversibly expandible element is further operatively engagable so as to discharge fluid non-reversibly received from the tubular member exterior to same.

Abstract: A low profile inflation valve located inside a balloon catheter that enables a user to inflate the balloon and exchange other medical apparatus over the catheter while the balloon remains inflated. The low profile inflation valve of the present invention includes a first tube having a lumen and at least one region of decreased inner diameter, and a structure movably located inside the lumen of said first tube, wherein said region of decreased inner diameter of said first tube forms a seal with a portion of said structure.

Abstract: A low profile catheter valve comprises a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Abstract: Methods and systems for controlling and monitoring pressurization data. The methods and systems advance beyond the prior art in their ability to convey pressurization data unambiguously. The methods and systems include a novel combination of visual cues and control features to insure that pressurization data may be analyzed accurately. For example, the visual cues and control features include changing the background color of the display area and providing a pressurization arrow to indicate pressurization or depressurization; a time showing the elapsed time of pressurization or depressurization; a pressurization number indicating the number of pressurization cycles that have occurred; software keys for making configuration choices; and text and graphic display modes. A touch interface may be provide for user interaction. To insure accurate pressure measurements, at least one pressure reference standard may also be utilized.

Abstract: A catheter device for non-surgical entry into a uterus, includes a tubular body having a lumen extending from a first end thereof to a second end thereof, the lumen having an external opening adjacent to or at the first end for dispensing a diagnostic fluid into the uterus. An elongated balloon is disposed distally on the tubular body for insertion into the cervical canal of the uterus, the balloon having opposing portions which occlude opposing openings of the canal.

Abstract: An apparatus for regulating flow of an inflation fluid to a stent delivery balloon. A valve, which is situated in the flow path of the inflation lumen, regulates the flow of liquid used to inflate and deflate the balloon. The valve performs to restrict flow and to respond to pressure applied to assure a desired inflation rate when fluid is flowing toward the delivery balloon. On deflation, when fluid is flowing away from the delivery balloon, the valve is designed to offer little or no resistance, allowing the balloon to be deflated quickly.

Abstract: A balloon catheter has a tubular basic body with distal and proximal ends, defining a lumen extending between the ends, and a balloon near the distal end connected with the lumen, wherein the catheter has a maximum radial profile size corresponding to that of a guidewire. A controllable closing device or valve is arranged inside the inflation lumen which can selectively close off the lumen.

Abstract: A low profile inflation valve includes a first tube having a lumen and at least one region of decreased inner diameter, and a structure, which may be a tube, movably located inside the lumen. The region of decreased inner diameter of the first tube forms a seal with a portion of the structure. A method of making a low profile inflation valve using a first tube and second tube comprises the steps of creating an aperture in at least one side of the second tube; placing the second tube inside the first tube, the first tube being made of thermoplastic material; applying heat to a localized area of the first tube; and compressing the first tube to form a region of reduced internal diameter, the reduced diameter forming a seal with the outside diameter of the second tube.

Abstract: A hand-actuated retention catheter 5 is disclosed. The retention catheter includes a tube 12, an overcoat layer 14 encircling the tube 12 and a cavity 16 interposed between the tube 12 and the overcoat layer 14. The cavity 16 encircles the tube and includes a bulbous balloon portion 24 and an enlarged fluid reservoir portion 22 interconnected and separated by a catheter sleeve portion 26 which has a narrowed outside diameter. The expandable balloon portion 24 can be expanded by compressing the fluid reservoir portion 22. Methods of making the hand-actuated retention catheter and methods of using the same are also disclosed.