Abstract: Body access device variations are described herein which may comprise a cannula configured for insertion into a body, an electrode at or near a distal end of the cannula, where the electrode is positioned to contact tissue adjacent to the distal end of the cannula during advancement into the body.

Abstract: An automated therapy system having an infusion catheter; a sensor adapted to sense a patient parameter; and a controller communicating with the sensor and programmed to control flow output from the infusion catheter into a patient based on the patient parameter without removing fluid from the patient. The invention also includes a method of controlling infusion of a fluid to a patient. The method includes the following steps: monitoring a patient parameter with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient.

Abstract: Devices that employ external compression stocking-type garments in the treatment of edema, chronic wounds, deep venous thrombosis prevention or claudication all share a number of significant limitations. These include the frequent need for custom fitting to assure an appropriate fit, vigilant maintenance to assure a continued “good fit,” limited compliance with proper use by patients and difficulty of application. There is a large body of evidence demonstrating that patients often decline to wear the compressive stockings as prescribed or in the form that would be most beneficial because they find these devices to be difficult to put on and take off. Building on the limitations of existing therapies, and distilled lessons learned from the field of prosthetics and wound healing, the present invention employs vacuum-assisted negative pressure to provide compression and help pump fluid from the tissues of affected limbs.

Abstract: Current treatment options for Overactive Bladder and Urinary Incontinence include exercise and behavioral modifications, pharmacological therapies, surgical intervention, and neuromodulation. Although each of these treatments is used in the treatment of individuals with these conditions, each has severe limitations. Building on the limitations of existing therapies, and with the distillation of lessons learned from the field of pulsed electric stimulation, the present invention employs Low Frequency Induction Therapy for the delivery of an effective, cost efficient, noninvasive alternative to available treatment options. The device of the present application allows for consistent, user-friendly modulation of the pudendal nerve and the sacral plexus, via pulsed electromagnetic stimulation of the posterior tibial nerve, on an outpatient basis.

Abstract: Methods, devices and systems facilitate gastric retention of a variety of therapeutic devices. devices generally include a support portion for preventing the device from passing through the pyloric valve or esophagus wherein a retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or trough a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.

Abstract: The present invention relates to a system and a method for sensing for the rupture of an implant (such as a breast implant) that has been implanted in body tissues or in an organ of a patient. In one embodiment, a system according to the present invention includes, among other possible things, a sensor coupled to an outer surface of the implant and configured to measure a property at the outer surface of the implant, for example, electrical conduction, chemical composition, or an optical property that is indicative of whether an implant rupture has occurred. The sensor is also configured to transmit a wireless signal to a device external to the body, which alerts the patient or a healthcare provider whether the measured property indicates that the implant rupture may have occurred.

Abstract: Devices and methods for applying gastrointestinal stimulation include implanting a stimulation device including a body with at least one expandable portion and a bridging portion and at least one stimulation member in the gastrointestinal tract. The at least one stimulation member includes one or more energy delivery members, one or more sensors, or a combination of both. The body maintains the device within the gastrointestinal space, and preferentially within the pyloric portion of the patient's stomach, and prevents passage of the device from the gastrointestinal space, but is not rigidly anchored or affixed to the gastrointestinal wall tissue.

Abstract: A device and a method for treating a medical condition include a reversible member disposed in a patient's gastro-intestinal tract, and a dispensing member coupled to the reversible member that delivers a drug and/or a noxious when a predetermined substance is detected. In a different embodiment, the device and method of the present invention include a polymer infused with a drug and disposed into a preformed shell inside the gastric space, where it expands and hardens, releasing the drug over time. Both the casing and the polymer may be biocompatible. The present invention enables the slow-release of anti-addictive agents without patient tampering and with the appropriate dosage. Ancillary systems such as sensors, actuators, refill and recharge ports, and communication and data processing units may also be included.

Abstract: The device of the present invention may create and maintain a pressure differential in the vicinity of the user's nasopharynx. Using a portable filter and pressurized air source, the region of the user's nasopharynx can be subjected to positive or negative pressured air. Positive pressure will prevent exposure surrounding air while negative air pressure will isolate those around the user from potential toxins or pathogens exhaled from the user. In the positive pressure embodiments, the surrounding air may be displaced by the positive pressure environment preventing exposure to ambient air in all instances other than a direct blast of high flow air directed at the users nasopharynx (such as an uncovered and maliciously directed sneeze). If adequate pressure is used, though, even this scenario would not allow for transmission of airborne illness with repulsion of any infective droplets being repelled by the positive pressure created.

Abstract: Devices that employ external compression stocking-type garments in the treatment of edema, chronic wounds, deep venous thrombosis prevention or claudication all share a number of significant limitations. These include the frequent need for custom fitting to assure an appropriate fit, vigilant maintenance to assure a continued “good fit,” limited compliance with proper use by patients and difficulty of application. There is a large body of evidence demonstrating that patients often decline to wear the compressive stockings as prescribed or in the form that would be most beneficial because they find these devices to be difficult to put on and take off. Building on the limitations of existing therapies, and distilled lessons learned from the field of prosthetics and wound healing, the present invention employs vacuum-assisted negative pressure to provide compression and help pump fluid from the tissues of affected limbs.

Abstract: Current treatment options for Overactive Bladder and Urinary Incontinence include exercise and behavioral modifications, pharmacological therapies, surgical intervention, and neuromodulation. Although each of these treatments is used in the treatment of individuals with these conditions, each has severe limitations. Building on the limitations of existing therapies, and with the distillation of lessons learned from the field of pulsed electric stimulation, the present invention employs Low Frequency Induction Therapy for the delivery of an effective, cost efficient, noninvasive alternative to available treatment options. The device of the present application allows for consistent, user-friendly modulation of the pudendal nerve and the sacral plexus, via pulsed electromagnetic stimulation of the posterior tibial nerve, on an outpatient basis.

Abstract: Pyloric valve corking devices are disclosed herein that generally include an occluding member, expanding from a first configuration to a larger second configuration, and a bridging member extending from the occluding member. The bridging member has a length that is adapted to pass at least partially through the gastric opening, so to enable the occluding member to obstruct the gastric opening, and that is also adapted to permit the occluding member to intermittently move relative to the gastric opening. A second occluding member may be attached to the distal end of the bridging member. The reduction in flow of gastric contents into the duodenum can be actively regulated using a pump or valve, or can be passively regulated with movements of the occluding device.

Abstract: Embodiments of the invention provide apparatus, systems and methods for introducing fluids into a body cavity for hypothermic, resuscitative, or other treatment. One embodiment provides an apparatus for introducing fluids into a peritoneal cavity comprising an access device for insertion into subcutaneous tissue, an infusion member and an advancement member. The access device includes a lumen, a proximal end, a tissue penetrating distal end and a stop for controlling the depth of the distal end into tissue. The infusion member includes an infusion lumen, a removal lumen and at least one sensor and is advanceable from a lumen of the access device into the peritoneal cavity. The advancement member is removably positionable in an infusion member lumen and has sufficient column strength to advance the infusion member tip through abdominal wall tissue into the peritoneal cavity. When the advancement member is removed, the infusion member tip is substantially atraumatic.

Abstract: The present invention provides a rapid, economical test for the detection of a right to left shunt applicable to the population at large due to its safety and noninvasiveness. The intended procedure involves gaining access to the circulatory system, injecting a measurable substance, ideally during prolonged and/or repeated Valsalva maneuvers, and then rapidly and repeatedly, ideally continuously, assaying for the substance. Through the determination of the appearance of a small amount of the substance prior to the subsequent high concentrations generated by the remainder of the bolus, one may safely diagnose a meaningful communication between the right and left heart, or other right to left shunt bypassing the lungs.

Abstract: A method for determining the quantity of an analyte in a fluid is described along with various components of an apparatus designed to carry out the method. The method involves habituating a patient's eye to one or more colors, measuring the recovery time, and correlating the recovery time to the quantity of the analyte. A reproducible, objective, non-attentiveness-dependant test for assessing analyte levels is further disclosed. To this end, a device that measures saccadic eye movements may be used to assess the return of vision to the prehabituated state. The method and apparatus are particularly suited for noninvasively measuring blood glucose levels.

Abstract: Apparatus for delivering a medical device to a location in a patient's body includes an elongate catheter body having a proximal end and a distal end, a pod coupled with the distal end of the catheter body and adapted to house the medical device during delivery to the location and to open to release the medical device, and at least one distal actuator coupled with at least one of the pod and the medical device. The distal actuator is adapted to promote opening of the pod. A method involves advancing a pod at the distal end of an elongate catheter to the location within the body and activating an actuator coupled with the pod and/or the medical device to cause the pod to open. Opening the pod releases the medical device.

Abstract: Methods, devices and systems facilitate retention of a variety of therapeutic devices. Devices generally include an anchoring element, which has been designed to promote fibrotic ingrowth, and an anchored device, which has been designed to firmly engage the complementary region of the anchoring element. The anchoring element may be placed in a minimally invasive procedure temporally separated from the deployment of the anchored device. Once enough time has passed to ensure appropriate fixation of the anchoring element by tissue and cellular ingrowth at the site of placement, the anchored device may then be deployed during which it firmly engages the complementary region of the anchoring element. In this manner, a firm attachment to the implantation site may be made with a minimum of required hardware. Some embodiments are delivered through a delivery tube or catheter and while some embodiments may require laparoscopy or open surgery for one or more of the placement procedures.

Abstract: A device and methods for treating renal failure are disclosed. One embodiment of the device is an implantable peritoneal dialysis device. When in use, the device can have a semi-permeable reservoir implanted in the peritoneal cavity. The reservoir can receive blood waste and drain through one or more conduits, via a pump, to the biological bladder. Solids and/or a solution benefiting dialysis can be pumped to the reservoir and/or implanted in the peritoneal cavity.

Abstract: An implantable fluid management device, designed to drain excess fluid from a variety of locations in a living host into a second location within the host, such as the bladder of that host. The device may be used to treat ascites, chronic pericardial effusions, normopressure hydrocephalus, hydrocephalus, pulmonary edema, or any fluid collection within the body of a human, or a non-human mammal.

Abstract: Methods, devices and systems facilitate gastric retention of a variety of therapeutic devices. devices generally include a support portion for preventing the device from passing through the pyloric valve or esophagus wherein a retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.