Abstract: A medical balloon comprises a first end, a second end spaced apart from the first, and a generally cylindrical balloon wall extending therebetween to define an inflation chamber. The balloon wall is adapted for inflation from a first folded configuration having a first plurality of pleats to an expanded, unpleated configuration, and deflation therefrom to a second folded configuration having a second plurality of pleats. The balloon wall includes a first layer formed of a polymer and having a substantially constant radial thickness. A second layer is firmly attached to the first layer and has a plurality of first regions of greater radial thickness interleaved with a plurality of second regions of reduced radial thickness. During deflation from the expanded, unpleated configuration to the second folded configuration, the balloon wall folds along the regions of reduced radial thickness of the second layer to form the second plurality of pleats.

Abstract: A multi-method and multi-apparatus for treating obesity. The multi-method includes a method for estimating a volume of an intragastric balloon appropriate for an individual patient, a method for using an enterocutaneous fistula to inspect an intragastric balloon without sedation and endoscopic complications associated with an upper endoscopy, and a method for decreasing ability of the stomach of an individual patient to distend or expand after a meal increasing satiety and helping the individual patient to comply with a weight loss diet. The multi-apparatus includes an intragastric balloon for inflating without installation of a pressurized gas or liquid, an intragastric balloon for minimizing trauma of the intragastric balloon on the gastric mucosa, and an intragastric balloon for administering therapeutic medications.

Abstract: Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, and a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided. In accordance with one aspect there is provided a submucosal implant device for diagnosing and treating disorders of the body. The submucosal implant device may take the form of a gastric stimulator in which signals are supplied to the muscular wall of a mammal to treat motility disorders. In accordance with yet another aspect there is provided a method for performing a submucosal medical procedure to deploy a submucosal implant device in the digestive tract of a mammal.

Abstract: A balloon for renal nerve modulation, the balloon comprising a polymer material forming a balloon wall having an interior surface and an exterior surface and flexible circuits adhesively bonded to the exterior surface of the balloon wall, wherein the exterior surface comprises laser induced microstructures on at least a portion of said exterior surface.

Abstract: Implantable device (10) for the treatment of hydrocephalus syndrome in a patient, comprising movement means (11), implantable in the patient, designed to move the cerebrospinal fluid (CSF) in the patient's skull in order to control the intracranial pressure (ICP); a pressure sensor (17) designed to detect the instant pressure (ICP, Pmis) of the cerebrospinal fluid (CSF) in the skull; and electronic monitoring and control means (20, 21, 22) designed to govern the operation of device (10); wherein movement means (11) comprise an assembly consisting of a rotary volumetric micropump (12); a catheter (13) connected at one extremity to micropump (12); and a bag (14), made of yielding material, fitted at the other extremity of the catheter and designed to contract and expand, wherein said assembly is filled with a given volume of a service fluid (F) which remains constant over time, and wherein electronic monitoring and control means (20, 21, 22) are designed to process the values (Pmis), as detected by sensor (17),

Abstract: A balloon catheter, in particular a balloon catheter for angioplasty, the balloon having an inner or outer surface modified by means of a photoactivation reaction.

Abstract: A suprapyloric anchor assembly includes an antral cap having at least three stabilizing members configured to reside in an antrum and engage tissue circumscribing a pyloric valve. A duodenal member is configured to reside at least partially in a duodenal bulb, and one or more tethers connect the antral cap to the duodenal member. The tether(s) is/are configured to allow passage of stomach contents through the pyloric valve. Optionally, one or more gastric balloon(s) may attached to the suprapyloric anchor and be inflated with the gastric cavity.

Abstract: Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.

Abstract: One aspect of the present invention relates to bronchoscopic lung volume reduction using solutions of biopolymers that can be polymerized in situ with a crosslinker and a polymeric additive which accelerates the cross-linking reaction. In certain embodiments, the biopolymer solutions can be in the form of a foam or gel. The biopolymer compositions disclosed herein may also be used for indications other than lung volume reduction, such as sealing fistulas or performing emergency tamponade of vessels.

Abstract: A pressure relief apparatus for a balloon dilation catheter having a shaft with a dilation balloon attached to the distal end of the shaft and an inflation/deflation lumen for inflating and deflating the balloon includes a pressure relief port formed through the wall of the inflation/deflation lumen with a pressure relief member secured across the pressure relief port to form a fluid tight seal such that the fluid tight seal formed by the pressure relief member fails at a predetermined pressure to release pressure from the inflation/deflation lumen through the pressure relief port.

Abstract: An implant configured for ingestion by a patient. After the implant has been swallowed by the patient and is disposed within the target location, e.g. the patient's stomach, an inflation subcomponent causes the implant to expand from a compact delivery state to an expanded, volume-occupying, deployed state. In the deployed state the implant creates a sensation of satiety in the patient stomach and thereby aids in limiting food intake and obesity. After a predetermined time a deflation subcomponent is actuated and the implant reduces in size so as to allow it to pass through the remainder of the patient's digestive track. The device may further incorporate tracking and visualization subcomponents, as well as pharmaceutical delivery subcomponents.

Abstract: Instruments, systems and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, a mucosal resection device. Systems include a combination of one or more of such instruments with or without injectable agents. Embodiments of various methods for performing the procedures are also provided.

Abstract: Method for fabricating a balloon catheter including providing an inner tubular member having a distal section and a distal end with a lumen extending therein and forming a balloon having a distal leg with a first segment having a first diameter and a first wall thickness and a second segment having a second wall thickness. The second diameter is greater than the first diameter and the first wall thickness is greater than the second wall thickness. The distal end section of the inner tubular member can be positioned in the balloon and bonded to the first segment while reducing the diameter of the second segment. Method also provided for fabricating a multilayer balloon catheter including removing at least a portion of an outer layer from the distal leg of the balloon.

Abstract: A system and method for occluding a pulmonary vein. The device includes a treatment device comprising an inner balloon, an outer balloon, and a space therebetween. Delivery of fluid to the inner balloon inflates the treatment element to a first diameter. If a greater treatment element diameter is required to completely occlude a pulmonary vein, fluid is delivered to the space between the first and second balloons, which expands the second balloon and causes the treatment element to have a second diameter that is greater than the first diameter. The fluid delivered to the inner balloon and fluid delivered to the space between the balloons may be from different sources and may be delivered and exhausted independently. Once the treatment element is caused to have a diameter sufficient to completely occlude the pulmonary vein, the treatment element is activated to cool or heat ostial tissue.

Abstract: A deflation device for use in deflating an inflatable or implantable balloon device, comprising, in combination: an endoscope tube, having a distal end, a proximal end, and a lumen; a cap disposed at the distal end of the endoscope tube and having walls defining a balloon interface chamber; a coring device disposed within the lumen and configured to travel within the lumen such that a distal end of the coring device is extendable beyond the distal end of the cap; wherein the cap is configured to provide a normal surface of a balloon relative to the orientation of the coring device as the coring device is disposed near the distal end of the cap.

Abstract: The present disclosure describes an orally administrable implement comprising expandable material designed specifically to swell in a targeted gastrointestinal (Gl) organ of a mammal, including human to form a pseudobezoar, so that upon swelling it touches the walls of the targeted organ. In one design, the swollen pseudobezoar provides sponge-like cleansing of the targeted Gl organ to prepare the said organ for further examination. In another design the expandable material scrapes the walls of the targeted Gl organ by creating a sufficient friction tension between its permeable wails and the mucosa of the Gl organ walls to collect enough adequate tissue samples, occult blood, or both, for the purpose of tissue sample analysis, DNA analysis, occult blood analysis, or a combination thereof. Safety mechanisms for the controlled disintegration of the pseudobezoars in cases of possible obstruction are also described.

Abstract: A pessary having a main stem and an inflatable bladder disposed about the proximal larger diameter section of the main stem. The main stem further provides a distal smaller diameter portion having a cap at its distal tip and a check valve disposed there under. The check valve communicates with a central fluid passage that may extend into the proximal larger diameter section of the main stem. Secondary fluid passages connect the central fluid passage to the inflatable bladder volume disposed about the outer circumference of the proximal larger diameter section of the main stem. The main stem provides support to the pelvic structures and the inflatable bladder acts to hold the device in position. At least one void through the proximal larger diameter portion of the main stem allows bodily material to pass from the vagina through the pessary device thereby decreasing the amount of vaginal discharge.

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: The present invention provides a human tissue radiation protector with auxiliary method of radiotherapy, wherein said human tissue radiation protector comprises an interconnected expander, a syringe and a marker set onto the expander; said marker is made of radiopaque materials, which could assist the expander in positioning; as well as multiple radiation dosage detector capable of measurement the radiation dosage at different positions of the expander; said method allows to place the expander of the human tissue radiation protector between the tumor and nearby human tissues or organs so as to separate them, and assist the expander in positioning via the marker and measurement the radiation dosage via the radiation dosage detector.

Abstract: A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

Abstract: The teachings are directed to an intragastric device comprising a flexible and expandable bladder having a predetermined shape upon expansion for contacting the antrum of the stomach of a subject. The device is designed to avoid passage of any part of the device beyond the pylorus and lower esophageal sphincter while the bladder is expanded during use. In these embodiments, the bladder can contain a high specific gravity material when expanded; wherein, the high specific gravity material contributes to an in vivo specific gravity of the device that ranges from about 1.2 g/ml to about 2.1 g/ml and functions to direct the device to the pyloric antrum of the subject during use of the device. Moreover, these embodiments can include a filling material comprising a biocompatible fluid component and a hydrogel component to make the device substantially leakproof and contribute to the in vivo specific gravity of the device.

Abstract: The invention relates to an intraluminar method of treating a reflux disease in a patient by implanting a device comprising an movement restriction device that, when implanted in a patient, fills a volume in the patient's abdomen that is close to and at least partially above the patient's cardia when the patient is in a standing position. The invention further relates to a method of restoring the location of the cardia in a patient suffering from a reflux disease and to an instrument suitable to use with intraluminar method and/or restoration method. Also disclosed are instruments treating a patient suffering hiatal hernia and providing a movement restriction device to be invaginated in the stomach fundus wall.

Abstract: A delivery device for percutaneously deploying a prosthetic valve includes a sheath, an inner shaft, and a release assembly. The release assembly is disposed between the sheath and the inner shaft, and includes a retraction member, a release member, and a retention member. The retraction member can self-retract in length from an extended condition to a retracted condition. The release member can self-expand from a compressed condition to an expanded condition. The retention member is distal the release member. In a delivery state, the sheath end is distal the retention member, the release member is in the compressed condition and the retraction member in the extended condition to retain the prosthesis. In a deployment state, the sheath end is positioned to permit the release member to self-transition to the expanded condition, allowing the retraction member to self-transition to the retracted condition and release the prosthesis.

Abstract: A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

Abstract: Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Abstract: Methods, devices and systems for delivering a device assembly into a gastric or other space within the body, allowing the device to expand to occupy volume within the gastric space and, after an effective period of time, delivering a substance or stimulus to begin breakdown of the expanded device so that it may release from the body.

Abstract: A transorally implanted intragastric balloon or treating obesity and for weight control including a variable size balloon with one or interconnected regions acting to exert a pressure on the stomach, to provide a stomach volume occupying effect, and/or to anchor the balloon within the stomach.

Abstract: Embodiments of the invention include a sleeve for use in a body lumen defined by body tissue. The sleeve includes a collapsible wall defining a lumen and including an inflatable member configured to increase a volume of the lumen when the inflatable member is in an inflated state, a conduit configured to inflate the inflatable member, and a port defined by the collapsible wall and in flow communication with the lumen.

Abstract: Implantation device for implanting a prosthesis (110) in a vessel (1), including a balloon (128) and a dilation catheter (120) for supplying fluid to the balloon (128), the dilation catheter (120) having a proximal end, a distal end (124) and a distal part designed to be introduced into the vessel (1), characterized in that the distal part includes a bend (123) and also an upstream portion (121) and a downstream portion (122) that are contiguous to the bend and that are arranged between the bend and, respectively, the proximal end and the distal end (124).

Abstract: Described herein are bioerodible, biodegradable, or digestible self-deploying intragastric implants that may be swallowed. Once swallowed, the implants undergo self-expansion in the stomach and apply a suitable pressure against the stomach wall to provide a feeling of satiety to the individual. The implants then dissolve or are disassembled perhaps using gastric liquids and pass out of the stomach. Methods of using the devices, perhaps for an individual participating in a dietary control regimen, are described.

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

Abstract: The present invention is directed to a novel device and method for providing a disposable endotracheal intubation device for use with an auxiliary passageway serving as a guide for the placement of an orogastric or other enterally directed device in a patient. The present invention pertains to a medical catheter device, removably attachable to an endotracheal tube, for guiding the path of an enteral tube into the esophagus of a patient. The catheter device preferably employs an adjustable clamp to fix the position of the catheter relative to the endotracheal tube. The present invention also pertains to a combination medical intubation device comprising an endotracheal tube and a catheter proximate the endotracheal tube to guide the path of an enteral tube. The present invention also pertains to a method of intubating a patient using this combination medical intubation device.

Abstract: An assembly including an obstruction device including a proximal obstruction balloon and a distal obstruction balloon mounted on a shaft, the balloons being inflatable via an inflation lumen, and a delivery system that includes an insertion tool and an injection site assembly assembled with one of the balloons, the insertion tool including a connector which is connectable to the injection site assembly and which permits passing tools and injection fluid therethrough.

Abstract: A balloon resection method is disclosed generally including inserting a catheter with at least one balloon having an outer wall with a resecting, non-slip surface for resecting unwanted biological material, such as tissues or tumors, and supplying fluid thereto in pulsed fashion to repeatedly deflate and inflate the balloon. In certain embodiments, a pump controls the pulsed supply of fluid based on an established frequency or change in volume. In some embodiments, the a keyed connector is used to identify the balloon type, and in some cases, intra-lumen diameters and densities are calculated. In some embodiments, the balloon portion of the catheter includes multiple balloon segments, which in some cases, are inflatable separately from one another.

Abstract: A device for characterizing a luminal dimension, such as the aortic annulus, has also been developed. These include a balloon or basket with sensing and transmitting elements for assessing two or three dimensional shape of lumens using a guide wire and catheter. Sheath introducer devices were developed for percutaneous delivery of bioprosthetic valves during various percutaneous procedures, such as TAVI. A marker needle dispenser for pre-marking anatomical features that are either desirable to target or desirable to avoid has been developed. The needle contains a central passage or lumen for loading marker and spacer material. These are characterized by specific spacing, color, shape or diagnostic imaging criteria to facilitate passage through and placement within the vasculature. Hemostatic stents or balloons are used to prevent bleeding and facilitate closure at sites for entry of catheters or introducer sheaths into luminal structures, especially for procedures such as TAVI through the subclavian artery.

Abstract: Methods, devices and systems for delivering a device assembly into a gastric or other space within the body, allowing the device to expand to occupy volume within the gastric space and, after an effective period of time, delivering a substance or stimulus to begin breakdown of the expanded device so that it may release from the body.

Abstract: An implant configured for ingestion by a patient. After the implant has been swallowed by the patient and is disposed within the target location, e.g. the patient's stomach, an inflation subcomponent causes the implant to expand from a compact delivery state to an expanded, volume-occupying, deployed state. In the deployed state the implant creates a sensation of satiety in the patient stomach and thereby aids in limiting food intake and obesity. After a predetermined time a deflation subcomponent is actuated and the implant reduces in size so as to allow it to pass through the remainder of the patient's digestive track. The device may further incorporate tracking and visualization subcomponents, as well as pharmaceutical delivery subcomponents.

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: Described herein are bioerodible, biodegradable, or digestible self-deploying intragastric implants that may be swallowed. Once swallowed, the implants undergo self-expansion in the stomach and apply a suitable pressure against the stomach wall to provide a feeling of satiety to the individual. The implants then dissolve or are disassembled perhaps using gastric liquids and pass out of the stomach. Methods of using the devices, perhaps for an individual participating in a dietary control regimen, are described.

Abstract: The present invention is a catheter device that includes a disruptable guidewire channel. The guidewire channel is configured to provide necessary trackability of the catheter along the guidewire during introduction of the catheter to a treatment site. Once treatment is completed, the guidewire channel can then be disrupted so as to free the guidewire from the catheter in situ. The apparatus of the present invention provides distinct advantages over existing over-the-wire and rapid exchange catheter introduction methods, including the ability to achieve much faster treatment implement exchanges, the ability to rapidly deliver multiple treatment implements in series, and the ability to maintain multiple treatment implements simultaneously at a treatment site using a single guidewire.

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 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: 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: The present invention relates generally to a device and method for the treatment of, ocular hypertension, glaucoma, and increasing the amplitude of accommodation. In an illustrative embodiment, the device includes a self-expanding wire. Once the device is within the posterior chamber between the iris and anterior lens capsule, the wire expands to compress the ciliary muscle. When the device is in place the scleral spur is moved posteriorly resulting in traction on the trabecular meshwork, which causes a reduction in intraocular pressure for the treatment of patients with ocular hypertension and glaucoma. In addition, the compression of the ciliary muscle increases the force of contraction of the ciliary muscle, which increases the amplitude of accommodation in patients with deficient accommodative amplitude and presbyopia.

Abstract: A plurality of tubes is combined to form a tube assembly, which may be used as an airway dilation shaft. The tubes define lumens that extend along parallel axes that are laterally offset from each other. The tubes may be contained within an outer tube or within a shrink wrap. Different functions may be achieved by the different lumens, such as inflating an airway dilation balloon, carrying oxygen or suction, delivering drugs or other substances, and carrying a guide wire. The hardness, inner diameter, outer diameter, and/or wall thickness of each tube may vary along its length. The tubes may distally terminate at different longitudinal positions. A first tube may be disposed within a second tube, with a third tube being external to yet parallel with the first and second tubes. The tubes may be tested for integrity before or after they are combined to form a tube assembly.

Abstract: A medical balloon that may be inflated and deflated includes a barrel wall having a large diameter proximal end and a small diameter distal end, the barrel wall being disposed between proximal and distal tapered cone walls, each having proximal and distal ends, and proximal and distal cylindrical neck walls extending therefrom along a longitudinal axis and wherein the barrel wall is continuously tapered inwardly toward a longitudinal axis of the balloon from the large diameter proximal end of the barrel wall to the small diameter distal end of the barrel wall.

Abstract: Briefly, in accordance with one embodiment, a tool for use with an endoscopic procedure comprises a thermoplastic polyurethane expandable vessel.

Abstract: Briefly, in accordance with one embodiment, a multi-lumen shaft may be used to with an endoscopic instrument.

Abstract: The present disclosure is directed toward devices, systems and methods that reduce stress being exerted directly onto balloon seals.

Abstract: Medical devices and methods of treatment are described herein. More particularly, medical devices and methods for providing access to a bodily passage during dilation are described herein. An exemplary medical device comprises an elongate member and a balloon. The elongate member is moveable between a first, non-expanded configuration and a second, expanded configuration.