Abstract: Biological navigation devices and methods are disclosed. The devices can be used as or to support colonoscopies or endoscopes. The devices can have longitudinally extensible cells that can be selectively inflated. The devices can have articulable links. The devices can be removably attached to elongated elements, such as colonoscopes or other endoscopes.

Abstract: An injectate delivery device for expanding tissue is provided. The injectate delivery device comprises: at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween; at least one fluid delivery element in fluid communication with the at least one fluid delivery tube lumen; a radially expanding element comprising the at least one fluid delivery element; a supply of vacuum constructed and arranged to cause tissue to tend toward the at least one fluid delivery element; and at least one control constructed and arranged to perform a function. The at least one control can be constructed and arranged to expand the radially expandable element and activate the supply of vacuum. Systems and method of injectate delivery are also provided.

Abstract: A rectal injection device and a method of operating a rectal injection device. In one embodiment, the device includes: (1) a handle having a trigger associated therewith, (2) an extension tube extending from the handle and terminating in a head, (3) at least two needles coupled to the head and configured to move relative thereto between a retracted position and a deployed position and (4) a pullrod coupling the trigger and the needles and configured to cause the needles to move.

Abstract: A medical assembly and method are provided to effectively treat abnormal tissue, such as, a tumor. The target tissue is thermally ablate using a suitable source, such as RF or laser energy. A cooling shield is placed in contact with non-target tissue adjacent the target tissue, and actively cooled to conduct thermal energy away from the non-target tissue. In one method, the cooling shield can be placed between two organs, in which case, one of the two organs can comprise the target tissue, and the other of the two organs can comprise the non-target tissue. In this case, the cooling shield may comprise an actively cooled inflatable balloon, which can be disposed between the two organs when deflated, and then inflated. The inflated balloon can be actively cooled by pumping a cooling medium through it. In another method, the cooling shield can be embedded within the non-target tissue. In this case, the cooling shield can comprise one or more needles.

Abstract: A system for delivering a lead comprises an imaging device comprising a proximal end and an expandable distal end having an inner balloon and an outer balloon. The outer balloon is concentric with the inner balloon. The expandable distal end includes a channel defined between the inner balloon and the outer balloon. The imaging device further comprises a lumen extending between the proximal and distal ends and an imaging assembly for imaging through the expandable distal end. The system further comprises an elongate rail comprising a proximal end and a distal end positionable through the lumen of the imaging device and the channel. The elongate rail comprises a fixation element on the distal end. The system also comprises a lead comprising a proximal end, a distal end introduced through the lumen of the imaging device guided by the elongated rail, and one or more electrodes on the distal end.

Abstract: A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The catheter includes an inflatable balloon mounted on a distal end region of the catheter shaft of the catheter. The catheter shaft includes a guidewire lumen having a distal opening and a lateral opening in a distal region of the catheter shaft proximal of the distal opening, and an inflation lumen in fluid communication with the balloon. The balloon is configured to be inflated in the subintimal space to a first inflation state at inflation pressures below a threshold inflation pressure to orient the lateral opening toward the lumen of the blood vessel, and inflated to a second inflation state at inflation pressures above the threshold inflation pressure. The catheter includes means for retaining the balloon in the first inflation state at pressures below the threshold inflation pressure.

Abstract: Embodiments of the invention are directed to a laser ablation system. In one embodiment, the laser ablation system comprises a shaft, a balloon, a laser fiber and a viewing fiber. The shaft has a proximal end and a distal end. The balloon is attached to the distal end of the shaft, a portion of which is within the balloon. The laser fiber has a distal end comprising a light dispenser that is configured to deliver laser light through the balloon. The viewing fiber is configured to image an interior balloon. In accordance with another embodiment, the laser ablation system comprises a shaft, a balloon and a laser fiber. The shaft has a proximal end and a distal end. The balloon is attached to the distal end of the shaft, which is within the balloon. The balloon includes an inflated state, in which the balloon is shaped to conform to a cavity of a patient. The laser fiber has a distal end comprising light dispenser that is configured to deliver laser light through the balloon.

Abstract: The present invention relates to a device for protecting rectal anastomosis. The device of the present invention is a double type leakage prevention system composed of micro-villi of a head filter and a triple lumen catheter, and thus minimizes contamination of the anastomotic area from intestinal contents, thereby enabling successful healing of the rectal anastomotic area. The device of the present invention has a main tube with side holes, and thus the intestinal contents, even when passing through the head filter, are sucked into the main tube through the side holes, so that the intestinal contents can be effectively drained while being diverted from the anastomotic area. The device of the present invention is inserted through the anus after surgery and thus involves less risk of additional complications due to the installation of the device, and has advantages of low manufacturing costs due to the simplification of the structure and convenient use and handling.

Abstract: An interdental laterally expansive wedge includes a prismatic wedge member having a furled bottom side expansible from a first position to an expanded position when fluid is forcibly directed into the wedge member through a proximal interconnect. Lateral expansion of the wedge member is thereby effected when each of a pair of basal ridges is forced apart to impress consistent and even pressure in contact with interproximal structure, such as approximal teeth and a matrix band inserted to gird a cavosurface for approximal filling preparation and finishing. Importantly, the present interdental laterally expansive wedge is laterally expansive without effecting deformation or ballooning between and around the teeth, and prevents invasion into the cavity proper.

Abstract: A catheter comprising an inner sleeve and an outer sleeve surrounding the inner sleeve, the inner and the outer sleeves being longitudinally displaceable relative to one another to enable the catheter to move from an open state to a closed state, each sleeve having a distal portion and a proximal portion, the catheter further comprising a retainer which is open in the open state, and closed in the closed state, the catheter further comprising a lock mechanism comprising lock formed in a lock portion of the catheter for locking the catheter in the open state, and a releaser for releasing the lock, the releaser being adapted to remove at least a part of the lock portion from the catheter.

Abstract: A medical assembly and method are provided to effectively treat abnormal tissue, such as, a tumor. The target tissue is thermally ablated using a suitable source, such as RF or laser energy. A cooling shield is placed in contact with non-target tissue adjacent the target tissue, and actively cooled to conduct thermal energy away from the non-target tissue. In one method, the cooling shield can be placed between two organs, in which case, one of the two organs can comprise the target tissue, and the other of the two organs can comprise the non-target tissue. In this case, the cooling shield may comprise an actively cooled inflatable balloon, which can be disposed between the two organs when deflated, and then inflated. The inflatable balloon can be actively cooled by pumping a cooling medium through it. In another method, the cooling shield can be embedded within the non-target tissue. In this case, the cooling shield can comprise one or more needles.

Abstract: A pleural drainage system having an inflatable membrane and a method of using the system are disclosed. The pleural drainage system includes a pleural drainage catheter system. The pleural drainage catheter system includes an inflatable membrane and a drainage catheter integrally coupled to the inflation membrane, the drainage catheter defining a drainage lumen through which fluid is drawn from the pleural cavity, and an inflation lumen coupled for flow of inflation fluid to and from an interior of the inflatable membrane. The pleural drainage system further includes a suction system coupled to the drainage catheter and a fluid collector coupled to receive fluid from the drainage catheter. The pleural drainage system further includes an inflation system connected to deliver inflation fluid to the interior of the inflatable membrane. The pleural drainage system may be used to monitor an associated airleak in the pleural cavity of a patient.

Abstract: A medical instrument for an endoscope according to the invention is the medical instrument to be used in the endoscope by being inserted therein, and the medical instrument includes: a flexible elongated sheath having a first lumen and a second lumen; a conductive wire which is inserted into the first lumen and of which a portion of a distal side is exposed to the outside of the sheath as an instrument unit; and a balloon which is attached to the sheath and is expandable with the supply of fluid from the second lumen. The balloon is configured such that an axial dimension thereof is larger than a radial dimension upon expansion and a distal end of the balloon upon expansion is located closer to a proximal side than the treatment unit exposed from the sheath.

Abstract: A catheter balloon is configured to improve its fold-in or collapsing behavior. The catheter balloon has a balloon body portion, a first tapered end portion and a second tapered end portion. The balloon body portion has a substantially cylindrical shape in an expanded state. The first tapered end portion is formed at a first end of the balloon body portion. The first tapered end portion includes a first predetermined embossment. The second tapered end portion is formed at a second end of the balloon body portion. The second tapered end portion includes a second predetermined embossment. The balloon body portion is formed free of a predetermined embossment. In other words, the balloon body portion is formed without folds so that there is only predetermined folding on the conical end portions for inducing the folding of the balloon body portion in a predetermined direction upon collapsing.

Abstract: Methods for cardiac ventricular restoration include delivering an implantable expandable device into the ventricle via a catheter. The expandable device is anchored either to the wall of the left ventricle or to the inter-ventricular septum and then expanded. When expanded, the device assumes a size and shape which fills the lower portion of the ventricular cavity restoring the normal volume and ellipsoid shape of the remaining portion of the cavity and favorably altering myocardial oxygen demand and wall stress.

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: 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: Methods for cardiac ventricular restoration include delivering an implantable expandable device into the ventricle via a catheter. The expandable device is anchored either to the wall of the left ventricle or to the inter-ventricular septum and then expanded. When expanded, the device assumes a size and shape which fills the lower portion of the ventricular cavity restoring the normal volume and ellipsoid shape of the remaining portion of the cavity and favorably altering myocardial oxygen demand and wall stress.

Abstract: A balloon catheter for interatrial septum dehiscence including an expandable and contractible balloon, and a shaft to which the balloon can be attached at the distal end thereof, wherein fixing members are provided at balloon mounting portions to be attached to the shaft. The fixing members are a pair of members in opposed relationship to each other at the ends of the balloon. The pair of members generally has an identical shape.

Abstract: Balloon catheters such as guide catheters can be configured to provide distal occlusion, while still providing sufficient interior lumen space for device delivery. Such catheters can provide a desired level of balloon expansion, yet prevent vessel damage caused by balloon over-expansion. A catheter can include an elongate shaft having a distal region, a proximal region and a lumen extending therebetween. A balloon is inflated to a desired expansion configuration with a desired diameter. Over-inflation of the balloon causes longitudinal expansion instead of increased radial expansion, thus maintaining the diameter of the balloon.

Abstract: An apparatus and method for phototherapy are described in which laser light or other radiation is projected from within a catheter, through a balloon member, and toward the surface of tissue. The light reflected from body fluids or the tissue surface is captured by a collecting device located within the catheter, e.g., within the balloon member, and the intensity of the reflected light is ascertained. The apparatus and method provides for accurately positioning the apparatus against the tissue treatment site.

Abstract: Apparatus and methods are provided for ablating body tissue using radio frequency (RF) energy. A catheter having a lumen for delivering fluid can be inserted into a patient's body. A porous member, which may be expandable, is attached to the distal portion of the catheter. The porous member defines an interior region in communication with the lumen, such that the interior region is capable of receiving electrolyte fluid delivered from the proximal portion of the catheter. An RF electrode is disposed in the interior region and is configured for coupling to a source of RF energy, whereby RF energy may be transferred from the electrode to selected tissue areas in a patient's body via electrolyte fluid delivered through the lumen and into the interior region of the porous member.

Abstract: The present invention relates to a catheter or cannula system that facilitates cardiopulmonary bypass surgeries and enables prolonged circulatory support of the heart. More specifically, the present invention provides an aortic catheter system including a porous aortic root balloon capable of occluding the aorta, delivering cardioplegia and providing tactile feedback and helping to maintain the competency of regurgitant aortic valves.

Abstract: A dilatation balloon configured and formed to have a first inflation profile at a first pressure and a second inflation profile at a second higher pressure and methods of making and using the same.

Abstract: Instruments for thermally-mediated treatment of a patient's lower esophageal sphincter (LES) to induce an injury healing response to thereby populate the extracellular compartment of walls of the LES with collagen matrices to altere the biomechanics of the LES to provide an increased intra-esophageal pressure for preventing acid reflux. A preferred embodiment is a bougie-type device for trans-esophageal introduction that carries conductive electrodes for delivering Rf energy to walls of the LES (i) to induce the injury healing response or (ii) to “model” collagenous tissues of the LES by shrinking collagen fibers therein. Typically, an Rf source is connected to at least one conductive electrode that may be operated in a mono-polar or bi-polar fashion. A sensor array of individual sensors is provided in the working end.

Abstract: Apparatus and methods are provided for thermally or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner, thereby improving or restoring tissue function. The apparatus comprises a catheter in communication with an end effector. The end effector induces a temperature rise in an annulus of tissue surrounding the leaflets of a valve sufficient to cause shrinkage of the tissue, thereby reducing a diameter of the annulus and causing the valves to close more tightly. Alternatively, the end effector selectively induces a temperature rise in the chordae tendineae sufficient to cause a controlled degree of shortening of the chordae tendineae, thereby enabling the valve leaflets to be properly aligned. In another alternative, the end effector is configured to mechanically shorten the effective length of the chordae tendineae by forcing the tendineae through a tortuous path, again properly aligning the valve leaflets.

Abstract: An inflatable member suitable for angioplasty or other medical procedures comprising asymmetric conic shoulder portions that optimize the wrapped profile. The asymmetry distributes the inflatable member material of the shoulder portions over a larger area to reduce the inflatable member profile and improve flexibility. Optionally, the asymmetrical shoulder portions preformed creases to facilitate folding. In an alternate embodiment, each shoulder portion has at least three radially spaced preformed creases to optimize folding in the shoulder portion. The invention also comprises methods of forming such inflatable members, the methods generally comprising using molds having the requisite characteristics. Specifically, the mold may have ridges within the areas corresponding the shoulder portions to form the preformed creases when the inflatable member is blow molded.

Abstract: An active cannula which does more than merely maintain a passage is usable to create and/or enlarge a passage, to position a scope or instrument, to move or locate tissue, etc. The cannula can vary in size or shape as needed, intraoperatively. Because a cannula of the present invention is expandable, the surgeon can make a relatively small incision, stretch the tissue with the expandable cannula, contract the cannula and remove it, allowing the skin to come back to its unstretched condition. Thus, a smaller incision can be made to fit the same size instrument. The cannulas can assume such a non-circular shape, to fit into a natural skin opening and cause less trauma. The devices can be used to seal off a space, expand an existing space or a potential space for working or visualization, move tissue (for example, to stretch an incision), or protect tissue.

Abstract: Balloon catheters according to the present invention have surface contours with protrusions and grooves to make non-continuous lesions. There is a heating element inside the balloon. The balloon will be filled with a fluid before ablation to expand the balloon for tissue contact, and to transfer heating energy from the heating element to the tissue in contact with the balloon. Since the balloon surface has contours with grooves and protrusions, the tissue contact will not be continuous along the balloon surfaces, and therefore the ablation on the tissue will not be continuous. The energy transmitter can be ultrasound transducer, electrical resistant heater, and microwave antenna.

Abstract: A balloon catheter with a balloon having at least a section which has an uninflated configuration with at least two lobes and an inflated configuration with a cylindrical surface. In a presently preferred embodiment, the balloon has a lobed inner surface and a lobed outer surface. In one embodiment, the balloon has a uniform wall thickness around a circumference of the lobed balloon section. However, in alternative embodiments the balloon wall thickness may nonuniform around the balloon circumference. Each lobe forms a deflated balloon wing when the balloon is deflated.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli.

Abstract: A balloon catheter having an elongated tubular portion having a proximal end portion and a distal end portion. The balloon is attached to the catheter near the distal end portion. At least one reservoir is attached to the balloon. An expandable copolymer gel fills the reservoir and an electrode is operably attached to the expandable copolymer gel. This permits the balloon to change shape in response to a voltage applied to the electrode.

Abstract: Improved stent securement in a balloon catheter including balloon modification.

Abstract: A balloon catheter and stent delivery system for medical treatment of a patient includes a balloon inflatable to an inflated shape having a cylindrical working portion, and a deflated shape that is temporarily reformed to enhance longitudinal retention of the stent while the catheter system is advanced or withdrawn, with various additional features.

Abstract: The invention is directed to an inflatable member for intralumenal catheter which has been formed by vapor and/or gas cover deposition and a balloon formed by the method. Multi-furcated inflatable members can be made with essentially no pin holes and other defects.

Abstract: Disclosed is a balloon on a distal portion of a balloon angioplasty catheter. The section of the balloon onto which a stent can be mounted has a central segment that is substantially cylindrical in shape that is centered between two segments each having the shape of a sector of a prolate spheroid. This shape for a balloon for a stent delivery catheter provides a more cylindrical shape for the stent after it is implanted in an artery that has a typical distribution of plaque in an arterial stenosis, which distribution of plaque is greatest for some limited length at a central region of the stenosis and then decreases somewhat uniformly as one approaches the edges of the stenosis. Another embodiment of the invention utilizes two segments that are frustums of a cone instead of sectors of a prolate spheroid, which conical segments surround the central cylindrical segment. Also disclosed is a balloon whose compliance decreases continuously as a function of the distance away from either end of the central segment.

Abstract: An expandable multifunctional instrument for creating a space at an obstructed site in anatomical tissue in the body including an elongate member having a distal end for being positioned at the obstructed site, a proximal end for being disposed externally of the body and an expandable member at the distal end of the elongate member. The expandable member includes a balloon movable fluidically from a non-expanded position to an expanded position at the obstructed site. The balloon assumes a preformed, predetermined configuration in the expanded position at the obstructed site to separate the anatomical tissue to create a space at the obstructed site.

Abstract: Dilating an obstructed region in a narrow, highly torturous lumen with a dilatation catheter having near its distal end an inflatable balloon with a dilatation section, a proximal taper section, and distal taper section. The dilatation section is generally cylindrical in shape when the balloon is inflated. The distal taper section has a relatively abrupt slope, and the proximal taper section has a relatively gradual slope.

Abstract: The systems and methods described herein include drug delivery catheters that have dimpled porous balloons mounted onto the distal end of the catheter. In one embodiment, the balloons are adapted for delivering therapeutic agents to the tissue wall of a body lumen, and to this end include a plurality of dimples formed in the exterior surface of the balloon, with each dimple having at least one aperture through which a fluid delivered into the interior of the balloon can extravasate. It is understood that the balloons described herein provide, inter alia, increased coverage of the tissue wall to which the agent is being delivered and less traumatic contact between the agent being delivered and the tissue wall.

Abstract: The invention features a catheter particularly for the delivery of a therapeutically active substance comprising a catheter body and an inflatable structure comprising three inflatable elements and a diaphragm fixed to these elements and defining with them, a passage duct for the body fluid and a sealed cavity to contain a therapeutically active substance. The said first (3), second (4) and third (7) inflatable elements are made of one preformed piece consisting of a helically coiled tube, said third element (7) being constituted by one or more turns of the coil, the diameter of the said tube at the portion constituting the third element being less than the diameter of the said tube at the tube portions constituting the said first and second elements respectively and intended to rest against the internal wall of said body duct; the said catheter body is disposed inside the coil of the said tube, in the aforementioned duct. This invention is useful in the preventive treatment of restenosis.

Abstract: The invention is directed to an inflatable member for intralumenal catheter which has been formed by vapor and/or gas cover deposition and a balloon formed by the method. Multi-furcated inflatable members can be made with essentially no pin holes and other defects.

Abstract: A balloon catheter having a balloon disposed upon an elongate shaft near a relatively rigid distal insertion tip, a fluid lumen for fluid communication with a body cavity and an inflation lumen for fluid communication with the balloon. The balloon holds the catheter tip within a body cavity such as the stomach for long-term enteral feeding. The balloon is configured such that upon inflation, the balloon distends distally to cover the distal tip thus insulating it from sensitive anatomy.