Abstract: Methods and apparatus for off-axis visualization are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

Abstract: A highly articulated robotic probe comprises an outer sleeve and an inner core. The outer sleeve and inner core include a plurality of links. The links of the outer sleeve and inner core are configured to pivot relative to one another. Various characteristics of the links determine the overall pivot angle of the articulated probe. Each of the plurality of links may have one or more channels. The channels form a semi-continuous passage from link to link and are configured to receive an elongated member such as an inner core, tool or cable. One or more cables may be used to control the outer links of the outer sleeve and the inner links of the inner core. Various characteristics of the cables determine the overall performance of the articulated probe.

Abstract: Devices and systems are provided for controlling movement of a working end of a surgical device by means of a robotic system. In one embodiment, systems and devices are provided for moving an end effector on a distal end of a surgical fastening device. Movement can include rotational movement of the end effector about an axis of the shaft, articulation of the end effector relative to the shaft, and actuation of an end effector, e.g., closing, firing, and/or cutting.

Abstract: An endoscope with a wide angle lens that comprises an optical axis that is angularly offset from a longitudinal axis of the endoscope such that the optical axis resides at an angle greater than zero degrees to the longitudinal axis. The wide angle lens system simultaneously gathers an endoscopic image field, the endoscopic image field at least spanning the longitudinal axis and an angle greater than ninety degrees to the longitudinal axis. The endoscope includes a transmission system with a lens system having f-sin(theta) distortion or substantially f-sin(theta) distortion that distributes the angle of incidence of the light rays gathered from the endoscopic field of view on to the image surface area in order to even out the information density across the surface area of the imager.

Abstract: An endo-surgical device, system and method are provided. The endo-surgical device includes a flared prow that limits the displacement and rotation of the cannula to keep the knife away from tissues that are not intended to be cut. The endo-surgical tool can be utilized as part of a system for performing an endo-surgical procedure.

Abstract: A surgical retractor system having a frame and a plurality of arms connected thereto is disclosed. At least one arm is moveable relative to the frame and the relative movement is constrained to a direction along the longitudinal axis of the arm. At least one retractor blade is removably connected to each of the plurality of arms. The blade is fixably rotatable about an axis normal to the longitudinal axis of the arm to which it is connected.

Abstract: Feedback of position is provided for high intensity focused ultrasound. The location of a beam from a HIFU transducer is determined using ultrasound imaging. The ultrasound imaging detects tissue displacement caused by a beam transmitted from the HIFU transducer. The displacement or information derived from the displacement may be used to determine a center line or point location (e.g., foci) of the tissues response to HIFU. The location of the line or point may be displayed in an image, such as an overlay or by color coding.

Abstract: A system for deploying needles in tissue includes a controller and a visual display. A treatment probe has both a needle and tines deployable from the needle which may be advanced into the tissue. The treatment probe also has adjustable stops which control the deployed positions of both the needle and the tines. The adjustable stops are coupled to the controller so that the virtual treatment and safety boundaries resulting from the treatment can be presented on the visual display prior to actual deployment of the system.

Abstract: Operation of a patient's heart or lungs may be analyzed by transmitting ultrasound energy into the patient's lung, and detecting Doppler shifts of reflected ultrasound induced by moving borders between blood vessels/soft tissue in the lung and air filled alveoli that surround the blood vessels. Movement of the border is caused by pressure waves in the blood vessels that result in changes in diameter of those blood vessels. The detected Doppler shifts are processed with a noise reduction algorithm, and periodic features in the resulting data are then analyzed to determine the rate of the patient's heartbeat, the rate of the patient's breathing, and/or the appearance of anomalies in the patient's heartbeat.

Abstract: An ultrasonic diagnostic apparatus has an IQ signal acquiring unit, a signal generating unit, a first Doppler signal extracting unit and a second Doppler signal extracting unit. The IQ signal acquiring unit acquires a plurality of groups including an ultrasonic reception IQ signal, under respective interference conditions that differ from one another. The signal generating unit generates an added signal by adding the groups, and to generate an added amplitude signal by adding the amplitudes of the groups. The first Doppler signal extracting unit extracts a first Doppler signal that corresponds to motion from the added signal. The second Doppler signal extracting unit configured to extract a second Doppler signal having a property that differ from the property of the first Doppler signal. At this point, the Doppler signal extracting units are configured so as to extract the Doppler signals respectively while reducing an artifact due to tissue motion.

Abstract: There is provided herein a breath sampling device comprising a controller adapted to initiate a signal to trigger a valve functionally associated with a breath sampling tube upon said controller receiving a signal indicating a blockage in the breath sampling tube. The valve is adapted to facilitate an increase of pressure within the breath sampling tube between the blockage and a pump functionally associated with the breath sampling tube. There is further provided herein an airway adapter comprising a restrictor located in proximity to a connection point between the airway adapter and a breath sampling tube, wherein the restrictor may be adapted to reduce the flow rate of liquids entering the breath sampling tube.

Abstract: A method, apparatus and computer program product are disclosed for non-invasively determining blood pressure related parameters of a subject. A cuff attached to a subject is inflated to a target pressure which is such that normal blood pressure oscillation of the subject appears in an output signal of a pressure sensor monitoring the pressure of the cuff. The output signal of the pressure sensor is acquired for at most a predetermined time period, while the cuff is maintained substantially at the target pressure, thereby to obtain blood pressure waveform data for the subject, and the blood pressure related parameters are derived from the blood pressure waveform data.

Abstract: The presence of a cardiac pulse in a patient is determined by evaluating physiological signals in the patient. In one embodiment, a medical device evaluates optical characteristics of light transmitted into a patient to ascertain physiological signals, such as pulsatile changes in general blood volume proximate a light detector module. Using these features, the medical device determines whether a cardiac pulse is present in the patient. The medical device may also be configured to report whether the patient is in a VF, VT, asystole, or PEA condition, in addition to being in a pulseless condition, and prompt different therapies, such as chest compressions, rescue breathing, defibrillation, and PEA-specific electrotherapy, depending on the analysis of the physiological signals. Auto-capture of a cardiac pulse using pacing stimuli is further provided.

Abstract: Clothing with an integrated heart rate monitoring device for monitoring the vital signs of a user is disclosed herein. The monitoring device preferably comprises an optical sensor, an accelerometer and processor. The optical sensor preferably comprises a photodetector and a plurality of light emitting diodes. A sensor signal from the optical sensor is processed to generate a real-time vital sign for a user.

Abstract: Apparatus and methods are described, including a method for treating a clinical episode. The method comprises sensing at least one parameter of a subject without contacting or viewing the subject or clothes the subject is wearing, analyzing the parameter, detecting the clinical episode at least in part responsively to the analysis, and responsively to detecting the clinical episode, treating the clinical episode using a device implanted in the subject. Other applications are also described.

Abstract: A method and system for electronically classifying a pre-processed heart sound signal of a patient as functional (normal) or pathological is provided. The pre-processed patient heart sound signal is segmentised and features are extracted therefrom (104) to build up a feature vector which is representative of the heart sound signal. The feature vector is then fed to a diagnostic decision support network (105) comprising a plurality of artificial neural networks, each relating to a known heart pathology, which is in turn used to conduct the classification.

Abstract: Systems and methods provide for detecting respiration disturbances and changes in respiration disturbances, preferably by detecting variability in one or more respiration parameters. Respiration rate variability is determined for a variety of diagnostic and therapeutic purposes, including disease/disorder detection, diagnosis, treatment, and therapy titration. Systems and methods provide for generating a footprint, such as a two- or three-dimensional histogram, representative of a patient's respiration parameter variability, and generating one or more indices representative of quantitative measurements of the footprint.

Abstract: Systems and methods for monitoring a sound pressure level dose at an ear are provided. A system includes an audio transducer which outputs a sound signal is placed within an ear to receive sound at the ear. A sound level threshold detector determines whether a sound pressure level of the sound signal is at a minimum level and outputs a sound pressure level signal corresponding to the sound pressure level when the sound pressure level is not at the minimum level. A time period is calculated during which the sound pressure level is not at the minimum threshold level. A listening fatigue calculator determines whether a cumulative effect of exposure to the sound signal at the ear over the time period will cause harm to the ear. At least a portion of the system is disposed in situ at the ear.

Abstract: A device for collection of exfoliated cells from the rectal mucosa comprises a hollow, cylindrical body having an inflatable and invertible flexible membrane attached to one end thereof. Applying positive pressure to inflate the membrane after the device is inserted, preferably through a rectal access tube, into the rectum causes exfoliated cells to be collected on the surface of the membrane. Before removal of the device, negative pressure is applied and the membrane, along with the collected sample of exfoliated cells, is deflated, inverted and withdrawn into the body of the device, thereby avoiding contact of the collected sample with body surfaces or the rectal access tube as the device is removed from the rectum.

Abstract: A medical device is provided having reduced penetration force. The device includes a body having a central hollow channel and a piezoelectric transducer received within and secured to the body. The piezoelectric transducer has a hollow portion concentric with the central hollow channel. A tubular member is associated with and in communication with the piezoelectric transducer. The tubular member has at least one open end formed concentric with the central hollow channel and the hollow portion of the piezoelectric transducer, wherein the transducer is adapted for vibrating at a frequency to produce an oscillating displacement of the tubular member.

Abstract: A biopsy device includes a handle unit, a hollow needle comprised in a disposable unit, which is releasably attached to the handle unit, and a sample-receiving device, which is movable in the hollow needle between two positions. Tissue is severed when the sample-receiving device is in a first one of the positions, and the severed tissue sample is ejected from the sample-receiving device in a second one of the two positions. A control system is provided for controlling movement of the sample-receiving device and for arresting the sample-receiving device in the second position. The distance between the two positions and/or a length of the hollow needle may be detectable in a calibration cycle, which is automatically initiated upon attachment of the disposable unit to the handle unit. The disposable unit may include electronic memory device for communicating with the control system.

Abstract: An excisional biopsy and delivery device may comprise one or more rotating, penetrating and cutting rod elements. The rod elements may be configured to advance from a stored and confined first position and rotate about an axis, while being simultaneously revolved about a central axis. The rod elements may then assume a second released and expanded configuration that is operative to cut around and surround target tissue. In this manner, the rod elements are operative to move through the surrounding tissue to create a volume of revolution and to sever and capture the target tissue contained within the volume of revolution from the surrounding tissue. The severed and captured volume of revolution containing the target issue may then be removed.

Abstract: The invention relates to a device for taking a liquid bone marrow sample (aspiration) and a solid bone sample (biopsy) in the same procedure, which can thus replace specialized needles for taking bone marrow and needles exclusively used for taking bone biopsies. The device for taking liquid bone marrow samples and a solid bone sample has a simple mechanism that uses two grooved clamps, it is easy to disassemble for sterilization and its handle is designed to perform the puncture easily. The needle of the device is hollow, and within it a guide is placed with two sections of different diameters. The guide makes it possible to open up the empty needle channel to allow the bone marrow liquid to flow and be extracted, and also to close the channel to be able to penetrate the tissue. The purpose of this invention is to combine the procedures of bone marrow aspiration and bone biopsy, thus reducing the patient's discomfort and the time needed for the procedure.

Abstract: A fluid handling module that is removably engageable with a bodily fluid analyzer is provided. The module may comprise a fluid handling element, and a fluid component separator that is accessible via the fluid handling element and configured to separate at least one component of a bodily fluid transported to the fluid component separator. The fluid handling element may have at least one control element interface.

Abstract: Devices, systems, and methods for determining isometric and isotonic activity of luminal organs. In an exemplary method for detecting a luminal organ response to mechanical stimulation of the present disclosure, the method comprises the steps of maintaining a luminal organ at a first internal pressure, increasing the first internal pressure of the luminal organ, and measuring a first organ parameter change in response to the increase in internal pressure.

Abstract: An apparatus and method determine change in volume of a body part or body organ on a real-time basis. In a breastfeeding application, an inflatable cuff is positioned on a nursing breast and allows direct access to the nipple by the breastfeeding infant. The inflatable cuff includes an outer shell portion and an inner inflatable cuff or bladder. The pressure in the inflatable cuff is monitored regularly by a pressure sensor, during a breastfeeding session. When the pressure drops below a preselected pressure, a controller directs a pump to pump air into the inflatable cuff to maintain the preselected pressure. The volume of added air is monitored during the breastfeeding session. Various calibrations are used to correlate the amount of added air, to the volume of breast milk withdrawn from the breast. The volume of breast milk withdrawn during breastfeeding is calculated and displayed throughout the breastfeeding session.

Abstract: Dual-axis swallowing accelerometry is an emerging tool for the assessment of dysphagia (swallowing difficulties). These signals however can be very noisy as a result of physiological and motion artifacts. A novel scheme for denoising those signals is proposed, i.e., a computationally efficient search for the optimal denoising threshold within a reduced wavelet subspace. To determine a viable subspace, the algorithm relies on the minimum value of the estimated upper bound for the reconstruction error. A numerical analysis of the proposed scheme using synthetic test signals demonstrated that the proposed scheme is computationally more efficient than minimum noiseless description length (MNDL) based de-noising. It also yields smaller reconstruction errors (i.e., higher signal-to-noise (SNR) ratio) than MNDL, SURE and Donoho denoising methods. When applied to dual-axis swallowing accelerometry signals, the proposed scheme improves the SNR values for dry, wet and wet chin tuck swallows.

Abstract: A system for applying focused ultrasound energy to a nerve surrounding an artery of a patient includes a piezoelectric array comprising a plurality of piezoelectric elements, a controller configured to control at least a subset of the piezoelectric elements so that at least one of the piezoelectric elements in the subset is in a signal transmitting mode, in a signal sensing mode, or both, a first platform on which the piezoelectric elements are coupled and a second platform, wherein the second platform is configured to support at least a part of the patient, a programmable generator configured to generate output power for one or more of the piezoelectric elements, and a programmable processor configured to process a signal sensed by at least one of the piezoelectric elements.

Abstract: A method of forming a compression sleeve for being wrapped around a leg of a wearer includes securing two layers of flexible material together to at least partially define first and second adjacent flexible sections. The securing of the two layers of flexible material includes securing two bladder layers together to define a first inflatable bladder and a second inflatable bladder disposed more proximally than the first inflatable bladder when the sleeve is wrapped around the leg. The first bladder forms at least a part of the first flexible sleeve section and the second bladder forms at least a part of the second flexible sleeve section. The method further includes securing a structural component to the sleeve such that the structural component extends generally between the first and second adjacent flexible sections to maintain a spacing between the sleeve sections lengthwise of the leg when the sleeve is wrapped around the leg.

Abstract: A portable hydro massage device for submersion in a body of water containing a female user, i.e. a bathtub, provides a local massage to the labium region and a focused stimulant to the female user's clitoris thereby resulting in a superior sensation to the entire body promoting an overall euphoric state and calming effect. The apparatus employs a saddle shaped housing, where the buttocks are placed, and a saddle horn for controlling the stimulus. Disposed within the midsection of the saddle horn is a hydro jet with a driven flow from a circulating water pump that draws suction from the main body of water. The hydro jet is adjustable in pressure and a method is provided for aeration of the water discharged to allow for a rhythmic pulsation effect. The saddle horn may be held and the lower body positioned as needed to focus the discharged stream from the hydro jet to the desired point of the pelvic region.

Abstract: A shoulder orthosis is provided having an arm support and an optional arm spacer connected to the arm support. The arm support includes an arm retainer and a supportive strapping system. One optional arm spacer includes a pair of individual pillows which are attachably combinable with one another at a first face of the first individual pillow and a face of the second individual pillow to form one combined pillow having a first shape. The individual pillows are alternately attachably combinable with one another at a second face of the first individual pillow and the face of the second individual pillow to form another combined pillow having a second shape different from the first shape.

Abstract: Upper assembly including slot, hole array. Lower assembly conforming to hips. Lower assembly anchoring holes shaped/spaced as array. Lower assembly fastener hole for each slot; fastener hole having same position relative to anchoring holes as slot to array; having horizontal dimension equal to horizontal dimension of corresponding slot. Adjuster plate including anchoring points spaced as array holes. Each anchoring point dimensioned less than corresponding hole so as to fit snugly therein, and projecting a distance equal to thickness of corresponding upper and lower assembly anchoring hole. Forming an adjuster plate fastener hole for each lower assembly fastener hole. Each adjuster plate fastener hole having same position relative to anchoring points as slot to array. Releasable fastener for each lower assembly fastener hole.

Abstract: The present invention relates generally to the field of hemodialysis, including methods and kits that can be employed to improve hemodialysis therapy. The present invention encompasses methods and kits useful for reducing vascular access complications associated with hemodialysis therapy and prolonging the period of time for which a vascular access site can be used in a patient.

Abstract: Splitable-tip catheters are disclosed with bioresorbable adhesive to provide spatial separation of distal tip elements during use. The invention can be particularly useful in hemodialysis applications where it is desirable to separate blood extraction and return lumens. The adhesive facilitates insertion of the distal end of the catheter as an assembly, e.g., into a blood vessel using a single guidewire, while the bioresorbable nature of the adhesive allows the tip elements to separate in vivo.

Abstract: A self expanding cannula with improved drainage properties based upon its greater length is provided, along with methods of using the cannula in cardiopulmonary bypass.

Abstract: A device and system for removing cerebrospinal fluid (CSF) from a CSF space within a patient's body includes a housing adapted for implantation into a subcutaneous body space remote from the CSF space. A fluid pump is mounted inside the device housing. The pump has a pump actuator, a fluid inlet extending through the housing wall and a fluid outlet extending through the housing wall. A battery-powered electric motor is mounted inside the housing and is operatively coupled to the pump actuator. Device control circuitry controls operation of the electric motor. The device control circuitry includes a processor responsive to CSF space pressure signals, outflow pressure signals, and CSF flow rate signals to calculate CSF space pressures, CSF outflow pressures, and CSF removal volumes. A telemetry unit includes a transmitter to wirelessly transmit pump data and a receiver to receive external operational commands.

Abstract: A device for inducing weight loss in a patient includes a tubular prosthesis positionable at the gastro-esophageal junction region, preferably below the z-line. In a method for inducing weight loss, the prosthesis is placed such that an opening at its proximal end receives masticated food from the esophagus, and such that the masticated food passes through the pouch and into the stomach via an opening in its distal end.

Abstract: Systems and methods are disclosed herein that generally involve CED devices with various features for reducing or preventing backflow. In some embodiments, CED devices include a tissue-receiving space disposed proximal to a distal fluid outlet. Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space. In some embodiments, CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.

Abstract: Apparatus and methods for phacoemulsification combine a phacoemulsification needle having an offset feature with a handpiece capable of producing longitudinal motion to create a hybrid phacoemulsification effect that is more efficient than conventional longitudinal handpiece-needle combinations and has been demonstrated under certain conditions to be more efficient than needles used with handpieces providing torsional motion. The phacoemulsification needle is of the type having a hollow passageway that terminates in a straight needle tip formed off-axis from the passageway, allowing the needle tip to move eccentrically when the needle is subjected to torsional or longitudinal vibratory motion. The tip may be flared or may be coextensive with the needle body. The tip may also be angled with respect to the needle body. The aspiration passageway formed through the needle body may be positioned or shaped to be off-axis from the needle body axis.

Abstract: To treat body surfaces, such as the sinuses, which are coated with biofilms, the surface is irrigated and suctioned with a fluid which may contain a biocide or other chemical agent for disrupting the biofilm while ultrasonic energy is applied to either the fluid barrier formed over the biofilm or a body surface proximal to the biofilm. Action of the fluid enhanced by the ultrasonic energy tends to remove sections of biofilm which are suctioned out of the site. An electrical field may also be applied to the biofilm to enhance the disruptive action. Apparatus for practicing this method to treat chronic rhinosinusitis comprises an elongated tube adapted to be inserted into sinus cavities through the nose or mouth. The tube includes a first lumen which feeds an irrigating fluid containing biocides and/or biofilm-disruptive chemicals to the treatment site and a second lumen which suctions fluid from the site.

Abstract: The invention relates to an apparatus for peritoneal dialysis having a device for the regular dispensing and reuptake of dialysate. The device has a pressure measuring device for the measurement of intraperitoneal pressure.

Abstract: Systems and methods for providing multiple pass continuous flow dialysis therapy are provided. The present invention includes a fluid circuit connected to a patient via a catheter thereby defining a fluid loop along which a therapy fluid including a dialysate can be continuously circulated into, through and out of a peritoneal cavity of a patient to remove a therapeutically effective amount of excess water and solutes including uremic toxins. The feed rate and discharge rate of therapy fluid into the fluid loop can be controllably regulated in proportion to the circulation rate of fluid in the fluid loop such that the therapy fluid can pass a multiple number of times along the fluid loop prior to discharge.

Abstract: A system and method for balancing flows of renal replacement fluid is disclosed. The method uses pressure controls and pressure sensing devices to more precisely meter and balance the flow of fresh dialysate and spent dialysate. The balancing system may use one or two balancing devices, such as a balance tube, a tortuous path, or a balance chamber.

Abstract: An apparatus and system diabetes management.

Abstract: A needleless injector including a body at a proximal end, a shaft extending distally from the body, at least one injection orifice at a distal end of the shaft in fluid communication with a fluid chamber at the proximal end, a pressure source in communication with the fluid chamber, and a tissue tensioner located at the distal end of the shaft proximal to the injection orifice, wherein the distal end including the tissue tensioner and injection orifice is positionable within a urethral lumen so that when the tissue tensioner is deployed, tissue of the urethra is tensioned at a location for injection of fluid from the injection orifice into the tissue of the urethra.

Abstract: A needle-free transdermal transport device for transferring a substance across a surface of a biological body includes a reservoir for storing the substance, a nozzle in fluid communication with the reservoir and a controllable electromagnetic actuator in communication with the reservoir. The actuator, referred to as a Lorentz force actuator, includes a stationary magnet assembly and a moving coil assembly. The coil assembly moves a piston having an end portion positioned within the reservoir. The actuator receives an electrical input and generates in response a corresponding force acting on the piston and causing a needle-free transfer of the substance between the reservoir and the biological body. The magnitude, direction and duration of the force are dynamically controlled (e.g., servo-controlled) by the electrical input and can be altered during the course of an actuation cycle. Beneficially, the actuator can be moved in different directions according to the electrical input.

Abstract: A nipple coating member and a milking device for gathering mother's milk effectively. The pad of a milking device comprises a tubular frame having a large diameter side opening for inserting the nipple formed on one end side and a small diameter side opening formed on the other end side, a first flexible portion provided at a part in the circumferential direction between the large diameter side opening and the small diameter side opening of the tubular frame, and a second flexible portion provided at a position opposing the first flexible portion independently thereof. The first flexible portion can be deformed inward of the tubular frame by a pressing force from the outside of the pad, and the second flexible portion can be deformed outward of the tubular frame by a pressing force from the inside of the pad.

Abstract: The present invention relates generally to an oral device, or mouthpiece, for delivering a fluid to the mouth or oropharynx of a user. In one embodiment, the oral device includes an intraoral portion, an extraoral portion, and an auxiliary support device that serves to stabilize the oral device. In various embodiments, the auxiliary support device may be configured with ear loops, a support band, a support frame and/or a support member. The intraoral portion generally includes at least one outlet port through which the fluid is delivered to the oral cavity or oropharynx. A method of dispensing a fluid using the oral device is also provided.

Abstract: An apparatus comprises a plunger able to fit in a cartridge or syringe. The plunger includes an outer portion and a deflection portion. The outer portion is able to engage the body of the cartridge or syringe. The outer portion is operable to apply a first radial force to the cartridge or syringe. The deflection portion is positioned within the outer portion and is movable between a locked position and an unlocked position. The deflection portion in the unlocked position causes the outer portion to apply a second radial force to the cartridge or syringe.

Abstract: A control mechanism for use with a steerable medical device allows for single-handed operation of at least a distal portion of the medical device. The device can be a catheter or an endoscope, for example.