Abstract: A breast cavity spacer device, such as for use with a percutaneous lumpectomy, is provided. The device includes a body having a projection on one end. The body has a bore extending there through. A catheter is disposed at least partially within the bore. A balloon member is fluidly coupled on one end of the catheter, the balloon member having an elliptical shape.

Abstract: Apparatus and method for repairing an abnormality in the wall of a body lumen, the method comprising isolating the abnormality in the wall of the body lumen from flow in the body lumen; positioning flowable forming material adjacent to the abnormality in the wall of the body lumen; and transforming the flowable forming material into a substantially stationary state so as to repair the abnormality in the wall of the body lumen, and the apparatus comprising a supply of flowable forming material; zone isolation apparatus for isolating the abnormality in the wall of the body lumen from flow in the body lumen; and positioning apparatus for positioning the flowable forming material adjacent to the abnormality in the wall of the body lumen so as to repair the abnormality in the wall of the body lumen.

Abstract: Provided is a puncture device assembly excellent in operability. Provided is a puncture device assembly which includes an inner needle that can puncture skin, a sheath tube that has a lumen through which the inner needle can be inserted, and a support portion which is provided at a proximal portion of the sheath tube and prevents kink of the sheath tube. The support portion has a cylindrical body which is bendable and can maintain a curved shape in a state where the sheath tube is inserted.

Abstract: A cannula assembly includes a cannula adapted for insertion within tissue and having a longitudinal passage extending along a longitudinal axis of the cannula for passage of a surgical instrument. An expandable member is mounted to the cannula and longitudinally spaced from a distal end of the cannula. The expandable member is adapted to expand, upon introduction of fluids therein, in a radially outward direction relative to the longitudinal axis whereby the expandable member engages the tissue to facilitate anchoring of the cannula relative to the tissue, and also to expand in a radially inward direction relative to the longitudinal axis and within the longitudinal passage to engage the surgical instrument positioned within the longitudinal passage to facilitate formation of a seal about the surgical instrument.

Abstract: Methods and devices incorporating a guidewire entry port subassembly for use in rapid exchange catheters. The use of a subassembly allows for stronger quality control and simpler fabrication of a rapid exchange device. In several embodiments, methods of making a molded guidewire entry port using a mold, often in conjunction with one or more mandrels, are disclosed. Several device embodiments include a separate molded guidewire port as well as molded guidewire ports which are attached, during a molding step, to segments of a catheter.

Abstract: A catheter and method for draining a bladder and injecting a two part biologic adhesive is provided. The catheter has a tubular body extending between proximal and distal ends. A balloon is located adjacent the distal end with a first port extending between the proximal end and the balloon providing for inflation an deflation of the balloon. A second port extends substantially between the proximal end and the distal end for drainage. A pair of ports separate from one another and from the first and second ports extend between the proximal end and the balloon. The pair of ports are each arranged in fluid communication with separate openings located between the balloon and the proximal end to provide separate fluid flow paths for the separate components of the two part biologic adhesive between the proximal end and the openings.

Abstract: In one general aspect, a medical device can include an implant having a medial portion and a distal portion. The medical device can include a delivery member including a dilator having a distal portion, and a tube coupled to the dilator. The tube can define a lumen in fluid communication with an opening in the tube. The opening can be disposed between the distal portion of the implant and the distal portion of the dilator of the delivery member. The medical device can include a sleeve having a lumen. The distal portion of the implant and at least a portion of the delivery member can be disposed within the lumen portion of the sleeve.

Abstract: Catheter and methods for designing, making, and using catheters are disclosed. An example catheter is a balloon catheter. The balloon catheter may include a proximal shaft. The proximal shaft may be a bare metal hypotube having a skew value of ?1.0 to ?2.5. A midshaft may be attached to the proximal shaft. A distal shaft may be attached to the midshaft. A balloon may be coupled to the distal shaft. An inflation lumen may be defined that extends from the proximal shaft, through the midshaft, and into the distal shaft. The inflation lumen may be in fluid communication with the balloon.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: System and methods are provided for treating a patient that include a delivery device sized for introduction into a target site within a patient's body, a source of one or more therapeutic and/or diagnostic agents coupled to the delivery device, and a tubular member sized for introduction into the patient's vasculature to isolate the thoracic duct. Once the thoracic duct is isolated, fluid may be removed from the thoracic duct, e.g., to prevent the agents that transit from the target site into the thoracic duct from entering the patient's vasculature, and/or to modulate flow through the thoracic duct to modulate concentration and/or resident time of the agents at the target site. The one or more agents may include particles sized for preferential transit into the lymphatic system.

Abstract: A tamponade trocar includes an elongate balloon having a closed distal end and is adapted to expand from a small diameter to a large diameter. A cannula is positioned at a proximal portion within the balloon lumen. A rigid stylet is removably positioned within the balloon and cannula lumens. A distal end of the stylet supported balloon is inserted into a perforation in a body wall and advanced into a body cavity while the balloon is unexpanded. The balloon is expanded and the cannula is advanced to a distal portion of the balloon lumen and across the body wall. At this stage, the perforation is dilated and in compressive tamponade. The proximal portion of the balloon may be removed and a seal housing may be coupled to the proximal end of the cannula. The distal end of the balloon may be punctured and opened, making the trocar ready for use.

Abstract: Disclosed herein are therapeutic compositions for treating and preventing diseases such as neointimal hyperplasia (NIH), where the compositions comprise a therapeutic particle that has a localized association with a blood vessel and a therapeutic agent, such as an anti-NIH agent. Methods of use of the therapeutic compositions are also disclosed.

Abstract: A balloon catheter having a soft distal tip member having a non-tacky inner (liner) layer material and a soft flexible outer layer material, with both materials being readily thermally bondable to the catheter balloon.

Abstract: Catheter having a hypotube with a skive defined by a first angled cut, an axial cut, and a second angled cut. A midshaft member includes a guidewire lumen and an inflation lumen in fluid communication with an inflation lumen of the hypotube, the inflation lumen of the midshaft member configured to receive at least a portion of the hypotube. A distal tabular shaft member extends distally from the midshaft member. The distal tubular shaft member has a guidewire lumen and an inflation lumen defined therein, the guidewire lumen of the distal tubular shaft member in fluid communication with the guidewire lumen of the midshaft member. The inflation lumen of the distal tubular shaft member is in fluid communication with the inflation lumen of the midshaft member and a balloon is coupled to the distal tubular shaft member and in fluid communication with the inflation lumen.

Abstract: A hemostasis component for an invasive medical device has an inflatable cylinder affixed to the medical device at a location aligned with an ingress point of a patient. An inflation source is in fluid communication with the inflatable cylinder and a flow control valve that is effective to regulate the flow of fluid from the inflation source to the inflatable cylinder is provided. The flexible cylinder is located on the proximal end of a tunneling catheter, where it exits the skin. A thin tube is provided to inflate the flexible cylinder. In the event of bleeding, the flexible cylinder is inflated for as long as is needed to achieve hemostasis, without having to place sutures. Inflation is a simple procedure that can be done by the patient, as opposed to having to place a suture, which must be performed by a physician or a physician's delegate, under sterile conditions.

Abstract: The invention is directed to a device for sealing a natural or artificial opening of the large intestine, or the rectum, of a patient, and for occluding same, and/or for removing stool therefrom, particularly for continuous, and/or intermittent irrigation, preferably into an external, bag-like collection container, comprising an inflatable balloon with an approximately annular structure formed from a flat, everted tube section, wherein the outer layer of the everted tube section is provided with a radially enlarged region for insertion into the rectum, and has a region that is tapered relative thereto, and that remains at least regionally outside the rectum during use, the intrarectal balloon section having no functional or spatial connection to the transanal balloon section.

Abstract: Devices and methods for delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects. An implantable delivery device comprising a reservoir is initially attached to a deliver catheter or delivery tool and is introduced into the body and positioned at a desired site. A therapeutic or diagnostic substance is then introduced into the reservoir and the delivery catheter or deliver tool is then removed, leaving the implantable delivery device implanted within the body. The substance is then delivered from the reservoir at a rate that causes the desire diagnostic or therapeutic effect. Also provided are substance eluting stents that elute substance from a selected surface of the stent (e.g., the outer surface) but not from another surface of the stent (e.g., the inner surface).

Abstract: Embodiments of aortic occlusion devices are described herein that include radially expandable and collapsible proximal and distal end portions, such as annular self-expanding stents or frames, that are configured to radially expand within an aorta to secure the device within the aorta. The devices can also include a catheter extending axially between the distal end portion and the proximal end portion and a porous covering, or filter, positioned around the catheter and between the proximal end portion and the distal end portion and configured to filter emboli from blood flowing into upper-body arteries. The device can further include a one-way valve positioned at or adjacent to the distal end portion of the device and configured to restrict retrograde blood flow through the device toward the heart.

Abstract: The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Abstract: Devices, systems and methods wherein a dilator, such as a balloon or other expandable member, is positionable within the frontal sinus ostium and adjacent frontal recess and useable to dilate the frontal sinus ostium and substantially all of the frontal sinus recess without requiring repositioning and repeated re-expansion of the dilator. One balloon catheter device of the invention comprises a catheter body that is less than about 50 cm in length (and in some embodiments less than 25 cm in length and a semi-compliant or non-compliant balloon on the catheter body. The balloon may have a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm. Such balloon may be constructed to withstand inflation pressures of about 12 atmospheres. In some embodiments, the dilator is advanced through or over a guide (e.g., guidewire or guide catheter) that has a preformed shape.

Abstract: A catheter having an elongated shaft which has a multilayered distal tip with a first layer formed of a polyimide first material and a second layer formed of a polymeric second material. In one embodiment the multilayered distal tip is a separate member, distal to the distal end of a proximal portion of the shaft. In another embodiment, the shaft has an outer tubular member, and a multilayered inner tubular member with a distal end which forms the multilayered distal tip of the shaft. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. In one embodiment, the polymeric second material is a polyamide material.

Abstract: A system for examining a colon includes a catheter, such as a rectal catheter, having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end of the catheter, and a flexible tube coupled with the catheter. The system includes a first balloon located adjacent a distal end of the flexible tube, and a second balloon extending around the catheter and being located between the distal and proximal ends of the catheter, whereby the distance between the first and second balloons is adjustable by sliding the flexible tube through the central lumen of the catheter. The first and second balloons are inflatable for isolating a section of a colon, and a gas or contrast agent may be introduced into the isolated colon section for conducting the examination.

Abstract: A tubular parison for forming a medical device balloon. The parison is formed of a polymeric material, for instance a thermoplastic elastomer. The parison has an elongation at break which is not more than 80% of the elongation of the bulk polymeric material. The elongation of the parison is controlled by altering extrusion conditions. Balloons prepared from the parisons provide higher wall strength and/or higher inflation durability than balloons prepared from conventional parisons of the same material.

Abstract: An ablation device comprises a balloon having an open proximal end and a closed distal end. A cylindrical tube extends into the balloon through the proximal end. An end support member is positioned at the distal end of the balloon. The end support member comprises a cylindrical portion facing the proximal end of the balloon. The cylindrical portion is received within a bore at the distal end of the tube. A seal is formed between the proximal end of the balloon and the cylindrical tube.

Abstract: Medical device system comprising a catheter including an elongate tubular member having an inner wall surface defining a lumen extending longitudinally through at least a portion of the tubular member. The medical device also includes an inner stop extending inwardly from the inner wall surface of the tubular member at a distal end section of the catheter and a pusher device insertable into the lumen. The pusher device has a contact surface to abut the inner stop of the tubular member.

Abstract: The present disclosure describes a gastric jejunal tube having a gastric lumen and a jejunal lumen that run the length of the tube. The cross-sectional sizes of the lumens change from above to below the most distal gastric port. A method of making the gastric jejunal tube is also described.

Abstract: A kit of parts comprises a system and instructions for use for controlling patient temperature which uses a central venous line catheter having a heat exchange element. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the heat exchange element. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Abstract: A medical device for providing direct port-like endoscopic access to the urinary bladder of a patient and a method of utilizing and inserting the medical device. The medical device can include a hollow tube with a main channel and a separate channel, a cap with an inflation port and a hollow flexible stem fluidly connecting the inflation port and the separate channel. A method can include inserting a needle above the pubic symphysis of a mammal, threading a guide wire through the needle, removing the needle and inserting the medical device. The method can optionally include determining measuring the depth between the skin surface of the patient's suprapubic region and urinary bladder.

Abstract: A drug introduction sleeve is disclosed that includes a selectively expandable body portion. The body portion is defined by a first open end and a second open end. A hollow interior is formed within the body portion. The body portion is selectively expandable from a first unexpanded configuration to a second expanded configuration whereby the volume of the hollow interior is increased when the body portion is expanded to the second expanded configuration, sufficient to temporarily retain a drug bolus.

Abstract: An apparatus is provided that operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The -apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.

Abstract: Described are needleless injection systems and methods that involve features including one or more of a tissue tensioner and a fitting for attaching to a distal end of a shaft, exemplary embodiments including: an elastic sleeve sized to fit under tension about the distal end of a flexible scope, such as an endoscope; a non-metal, polymeric tube-like device being optionally attached to the elastic sleeve for delivering a therapeutic fluid to a treatment site within a patient wherein the elastic sleeve may include an integral balloon (tissue tensioner) feature that can be used to position the injection orifice of the tube-like device proximate a treatment area.

Abstract: Medical balloons are energetically treated to form regions that facilitate deflation to a desirable configuration.

Abstract: An anti-clog suction tip apparatus includes a suction tip having a suction opening and an interior defining a suction channel. An ejection wire channel extends to a wire exit opening into the suction channel that is located proximate the suction opening. An ejection wire including a ball tip at an end thereof occupies the ejection wire channel and is transitionable between a retracted configuration and an advanced configuration such that, in the retracted configuration, the ejection wire including the ball tip is retained within the ejection wire channel and does not obstruct suctioning of debris through the suction channel; and in the advanced configuration, the ball tip of the ejection wire does not extend more than three millimeters beyond the suction opening.

Abstract: A medical system for the treatment of morbid obesity comprising an inflatable balloon implanted in a gastric cavity, a percutaneous fillant delivery tube and a control module connected to the tube for regulating the inflation and deflation of the balloon. The balloon may be individually contoured and inflated to occupy a large volume of the gastric cavity to provide a feeling of satiety. The balloon may also be deflated to give the gastric cavity lining a rest during less critical time.

Abstract: An implantable intragastric volume occupying device system is provided which generally includes a volume occupying device and an active agent, for example, a metabolic agent or satiety inducing agent. The volume occupying device may be structured to contain the agent and permit controlled release of the agent to the patient while the volume occupying device is positioned within the patient's stomach. Methods for treating obesity are also provided which include positioning a volume occupying device in the stomach of a patient and administering a satiety inducing agent to the patient while the volume occupying device is positioned in the stomach. In one embodiment, the active agent may be contained in a reservoir and dispensed to a portion of the patient's body.

Abstract: In laparoscopic surgery, small (5-12 mm diameter) incisions are made in the abdominal wall through which instruments dissect and remove specimens that may be several centimeters in diameter. Removal of the sample typically requires either enlarging these incisions or morcellating the sample to pass through the sub-centimeter ports. The laparoscopic device permits extraction of the sample to be removed in a female using the vagina, which has sufficient elasticity to accommodate removal of large specimens. The posterior portion of the vagina communicates to the abdomen through a few tissue layers, and is distant from vital anatomic structures. Utilizing the vagina is optimal due to its ease of access to the abdomen and repair, minimal scarring and post-operative pain, and faster recovery following surgery. A deployable collection bag is housed in a sheath, which is deployed into the vagina or abdominal cavity to extract a large (multiple-centimeter) specimen(s) through the vagina.

Abstract: A device and method for minimizing exposure of soft mucosa tissues to radiation, the device including a low-volume intracavity balloon catheter having multiple expansion portions, including an isometrically expanding portion and a substantially planar anterior portion.

Abstract: Devices, systems, and methods for delivery of therapeutics, in particular thrombolytic agents, in particular plasmin, are provided. The devices, systems, and methods also provide for occlusion of a vessel or graft distal and/or proximal to a treatment zone. Also provided are devices, systems, and methods that trap emboli.

Abstract: An in vitro testing process for simulating conditions of a stomach, comprising, in combination: providing an intragastric device to an acetone bath; inducing swelling of the intragastric device; exacerbating weak spots in the intragastric device; observing the results; and estimating the results of an in vivo study. Improvements to an intragastric space filler to reduce failure at a balloon to shaft area including an adhesive fillet, washers, a balloon cuff and collar, a molded in balloon fillet, and a one-piece molded balloon assembly.

Abstract: Systems and methods related to polymer foams for the treatment of blood vessel dissections are generally described. Some embodiments relate to compositions and methods for the preparation of polymer foams, and methods for using the polymer foams. The polymer foams can be applied to or within a dissection caused by an intimal tear in a blood vessel, sealing the dissection and preventing further perfusion thereof. In some embodiments, the polymer foam can be formed within a body cavity (i.e., in-situ foam formation). The foam may be used to fill the dissection as a thrombosing agent. In addition, the foam may be used in conjunction with medical devices such as stents, stent-grafts, balloons, and catheters.

Abstract: Method for fabricating a catheter including providing an inner tubular member formed from a first polymeric material, the inner tubular member having a distal section, a distal end, and a lumen defined therein by a first inner diameter; necking down at least a portion of the distal section of the inner tubular member to form a necked tip having a second inner diameter; and removing a portion of polymeric material from an inner surface along the necked tip to define a third inner diameter for the necked tip. The method can include positioning the distal section of the inner tubular member in a balloon having a working length, a distal neck, and a distal leg, with the distal end of the inner tubular member extending distally beyond a distal end of the distal leg, and coupling the distal leg of the balloon to at least a portion of the distal section of the inner tubular member.

Abstract: A catheter device is useful in a procedure in which an injectable material or device is injected into a tissue of a patient. In one implementation, for example, the catheter device is useful in injecting a compound into a tissue of the heart, such as the myocardium. The distal tip of the catheter may include an extensible and retractable needle in combination with a camera, a balloon, a vacuum port, or any combination thereof.

Abstract: A perfusion catheter system comprises a main line, a first branch line having a tip at a distal end thereof, and a second branch line having a tip at a distal end thereof. The tip of the first branch line is heavier than the tip of the second branch line. The tip of the first branch line may be weighted. There may be a self-inflating balloon at the tip of the first branch line. There may be a self-inflating balloon at the tip of the second branch line. There may be a clamp disposed along the second branch line. The clamp may include a base, a clamping arm hingedly connected to the base, and an aperture extending through the base. The second branch line may extend through the aperture in the base.

Abstract: An apparatus for creating an accessory maxillary ostium for purposes of ventilation, irrigation, or procedural work within the maxillary antrum. An introducer having a ventilation tube and grommet is provided to create and then provide access through the accessory maxillary ostium. An irrigation catheter may be advanced through the ventilation tube in order to irrigate or express the contents of the sinus cavities. A secondary irrigation catheter or a balloon catheter may be advanced through an outer irrigation catheter, deeply into the sinus cavity, in order to irrigate or express the contents of the sinus cavities. Moreover, the balloon catheter may alternatively or additionally be employed to for dilation of the natural ostium. Still further, a device for delivering drugs, fluids or the like, may be coupled to the ventilation tube for delivery of same.

Abstract: Elongate, flexible catheter includes an elongated shaft having a proximal end, a distal end, and a lumen defined therein. The shaft includes a tubular member having an outer layer and an inner layer. The outer layer includes a first polymer selected from the group consisting of nylon 12, polyether block amide, and combinations thereof. The inner layer includes a second polymer having a heat deflection temperature greater than about 53° C. selected from the group consisting of nylon 11, nylon 6, nylon 6,6, nylon 6,12, polyamide-imide, polyetherimide, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polyethereetherketone, and combinations thereof. Method of making an elongate, flexible catheter is also provided.

Abstract: Methods and systems for treatment of hypoxic tumors are provided, including the steps of positioning a delivery device in a bodily cavity adjacent to tumor tissue, delivering an oxygenating agent to the tumor tissue via the delivery device and radiating the tumor tissue with radiation. Methods and systems of treatment of tumors are also provided, including the steps of positioning a delivery device in a bodily cavity adjacent to tumor tissue, delivering a photosensitizing agent to the tumor tissue via the delivery device, and radiating the tumor tissue with light.

Abstract: This invention relates to a method that comprises the introduction of a catheter via left subclavian vein, advancing into the right atrium and then positioning it in the inferior vena cava, just at the cava-diaphragm junction, where it is anchored at its extreme; and thereafter an external inflation of a balloon positioned in said catheter takes place through a physiological solution to reach a diameter corresponding to half the diameter of the inferior vena cava, resulting in hemi-occlusion in the expiration phase (breath-out) and total occlusion for a short period during the inspiration phase (breath-in), regulating (normalizing) the venous return and decreasing the cardiac volume overload, as a treatment for heart failure. The invention also comprises hydromechanics devices to normalize the venous return in the circulatory system. Said venous return is increased in 90% of patients with heart failure.

Abstract: An apparatus may include a medical device including an elongate shaft disposed about a guidewire, and a distal tip including a plurality of rounded protrusions, wherein adjacent protrusions are fixed directly to each other by a relatively flexible connector. The plurality of protrusions may decrease in size from a proximalmost protrusion distally to distalmost protrusion.

Abstract: A catheter is configured to prevent kinking of a catheter during handling or mounting of a pressure device. The catheter has a proximal end of its catheter shaft that is provided with a bending section having a flexibility greater than that of the section of the catheter shaft joining the proximal end.

Abstract: The end of the elongated tubular element of the appliance that is designed to be inserted into a body cavity is formed entirely of soft, compliant material. That end carries an inflatable balloon made of non-expandable material, formed in the fully inflated shape, to prevent overexpansion. The balloon is inflated to a predetermined low pressure level to prevent pressure necrosis in the adjacent tissue. A method and apparatus for introducing the soft end of the appliance into the body cavity are also provided. The introducer apparatus includes rigid core surrounded by a soft, compliant sleeve. The sleeve extends beyond the rigid core to form an invertable section. The soft end of the appliance is situated adjacent the apparatus, the balloon is wrapped around the apparatus, and the sleeve section is inverted over the appliance, compressing the balloon and forming a soft, rounded insertion tip. The unit is then introduced into the body cavity.