Abstract: The instant invention relates generally to introducer catheters used to help deliver catheters or other medical devices to locations within the human body. In particular, the instant invention relates to large diameter introducer catheters (introducer catheters with lumens greater than about 6 French) having increased strength, flexibility, and kink resistance. Introducer catheters according to the teachings herein may also include curved distal ends and flared (that is, funnel-like) transition sections within their lumens.

Abstract: Some embodiments of an anchor device may include bendable anchor mechanism that is deployable in a subcutaneous layer to releasably secure the anchor device to a patient's body. Certain embodiments of the anchor mechanism may include one or more barbs that flexibly bend in response to an insertion or removal force. As such, the anchor mechanism may be inserted into a subcutaneous layer, and removed from the subcutaneous layer, without the need for a separate actuation device to extend or retract the barbs.

Abstract: A device for securing and monitoring movement of a catheter includes a film having an adhesive disposed on a body-facing surface for securing the film to a body. The device also includes a base mounted on the film, the base comprising a first portion of a guide channel for receiving the catheter. A cover is coupled to the base via a hinge, the cover comprising a second portion of the guide channel, the cover further comprising a rounded portion extending from a distal end of the cover, wherein in the closed configuration, the catheter is completely enclosed by the rounded portion and the first and second portions of the guide channel. The device also includes a positional shift indicator fixedly attached to the catheter and configured to indicate positional shifts by the catheter within the guide channel.

Abstract: A catheter assembly is disclosed, which includes a catheter, a catheter hub fixed to a base end portion of the catheter, an inner needle having a needlepoint, inserted into the catheter, a needle hub coupled to the inner needle, and a needle support portion for supporting the inner needle through the catheter on a leading end side beyond the catheter hub, wherein the needle support portion has a pair of support arms openable and closeable in a left and right direction, and a restraining portion capable of restraining the pair of support arms in a closed state and releasing a restraint of the pair of support arms, the needle hub having an extension portion extending in a leading end direction beyond the catheter hub, the pair of support arms being laterally disposed between the restraining portion.

Abstract: Method, system and device involving a needle device with a needle safety element with improved stable structure. A frame can surround the needle safety element to provide added stiffening of the needle safety element. The frame can include stays extending laterally of the needle safety element. The needle safety element with the frame can be slidably located on a needle and in a catheter hub in a ready to use position and be removable from the catheter hub in a protective position.

Abstract: Systems and method for using a sleeve for enhanced drug delivery are described. The sleeve may incorporate porous materials and may be coated or treated with various drugs and/or therapeutic agents. The sleeve may be utilized in cooperation with balloon catheters and/or other devices. When acting as a reservoir for holding various drugs and/or therapeutic agents, the drug delivery sleeve provides a means of reducing drug losses as well as a controlled mechanism for drug release. The materials for the sleeve, constructed by various techniques, may be circumferentially distensible, may be elastic, and may have varying degrees of recoil as needed for any particular purpose.

Abstract: One embodiment provides a balloon catheter which has an inner tube having a main lumen and an outer tube which forms an expansion lumen. A part of the inner tube is connected to the outer tube at a position closer to the proximal end than a balloon, a side hole is open at the connection section, and a weak section is provided to the inner tube a position closer to the distal end than the side hole. The weak section has lower rigidity than the remaining portion of the inner tube. When the balloon is expanded by fluid supplied to the expansion lumen, the weak section is pressed by the fluid pressure to thereby close the main lumen of the inner tube.

Abstract: Methods and devices for redirecting at least a portion of a fluid from the mesenteric lymphatic system for elimination from the body are disclosed. The fluid may be redirected for elimination through the urinary system or redirected outside the body. The methods and devices disclosed may prevent a portion of a patient's dietary lipids, including cholesterol, from being absorbed, thereby reducing the total caloric load to assist in weight management.

Abstract: Tissue dilation systems are disclosed. The present systems provide percutaneous access to one or more target structures located in a patient's body. The tissue dilation systems include two or more tissue dilation tubes telescopically arranged and moveable relative to each other. The tissue dilation tubes can be preassembled prior to use by utilizing a dilation tube retention assembly which can maintain the dilation tubes in a substantially fixed position and release the tubes therefrom in order to dilate a patient's tissue. Methods of producing the present systems and using the present systems in surgical procedures are also disclosed.

Abstract: According to an exemplary embodiment, a retainer for therapeutic treatment may be provided. The retainer for therapeutic treatment may include: a retainer that may retain a antimicrobial solution against tissue; a number of heating elements connected to the retainer for therapeutic treatment; a number of power supply cables connected to the number of heating elements; a number of antimicrobial solution delivery elements connected to the retainer for therapeutic treatment that may deliver an antimicrobial solution; a number of pieces of tubing having a first end connected to a antimicrobial solution reservoir and a second end connected to a number of antimicrobial solution delivery elements; a number of fiber optic cables having a first end connected to a light source; and a number of light terminations rigidly connected to the retainer for therapeutic treatment and connected to the second end of the fiber optic cable.

Abstract: A multi-site injection system includes a plurality of medicament delivering needles/microprotrusions, a needle/microprotrusion support, a supply of medicament, and a mechanism for providing the medicament to the plurality of needles/microprotrusions in order to effect delivery into a stratum corneum of a user.

Abstract: Disclosed herein are embodiments of a connector system for releasably connecting together tubes, for example medical tubing, and methods of making and using such a connector system, whereby the connector system includes a female coupler having a first passageway, a male coupler having a second passageway, a catch movably coupled to the female coupler, and a catch-receiving element coupled to the male coupler. The connector system further includes a release element movably coupled to the female coupler, whereby travel of the release element along or over a female coupler outer surface of the female coupler disengages the catch from the catch-receiving element to achieve a disconnected condition of the connector system. Further disclosed herein are embodiments of a connector system for releasably connecting together tubes, whereby the connector system includes at least one valve biased by a valve-biasing member disposed external to or outside of the fluid flow path.

Abstract: The present disclosure describes systems, methods, devices for performing thought-controlled neuromuscular stimulation. Also described are methods for producing a neuromuscular stimulation cuff. The systems and methods generally relate to receiving and processing thought signals indicative of an intended action, and then delivering stimulation to effectuate the intended action through a neuromuscular stimulation cuff. The neuromuscular stimulation cuff includes a flexible printed circuit board having at least one finger and a plurality of electrogel discs disposed on the at least one finger. The neuromuscular stimulation cuff may be produced by providing a layer of polyimide, etching a conductive copper circuit including a plurality of electrodes into the layer of polyimide to form an etched circuit layer, adhering a cover layer onto the etched circuit layer to form a flexible printed circuit board (PCB), and cutting at least one finger from the flexible PCB.

Abstract: Devices, systems, and methods for automated optimization of muscle stimulation energy. In some embodiments the disclosure optimizes stimulation parameters and/or stimulation location.

Abstract: An implantable medical device can include an electrode substrate electrically connected to at least one electrode. The device can have a pseudoporous surface across the electrode substrate and electrode. This surface can result in a real surface area (RSA) greater than the geometric surface area (GSA) of the device. The pseudoporous surface can be a macroporous surface enabling a charge injection capacity greater than 1 mC/cm2 while minimizing rejection of the device by surrounding tissue in chronic implant applications. The electrode can be a thin layer of conductive material, such as platinum or another metal, conformally deposited on the pseudoporous surface of the electrode substrate. A method of making the implantable device can include forming the device having an electrode substrate and at least one electrode electrically coupled to the electrode substrate, and forming a pseudoporous surface on the electrode substrate and electrode.

Abstract: A device (110) for insertion into a human or animal body has a surface (610) which at least partially bears a surface structure (140, 140?), wherein the coefficient of static friction between the surface structure (140, 140?) and an interface within the body is anisotropic.

Abstract: An implantable medical device capable of sensing cardiac signals and delivering cardiac electrical stimulation therapies is enabled to detect a short circuit event. A signal is sensed by a sensing module coupled to electrodes. A controller detects a short circuit event in response to a slope of the sensed signal exceeding a short circuit threshold.

Abstract: Medical lead bodies that are paired each include a braided conductive shield. The braided conductive shield of one lead body has a value for a physical parameter that differs from a value for the physical parameter of the second lead body. The difference in values of the physical parameter for the paired lead bodies results in a reduction in heating from exposure of the lead bodies to radiofrequency energy at electrodes associated with the lead bodies. The lead bodies may be paired by being implanted adjacently to one another. The lead bodies may be further paired by being coupled to a same distal body, such as a paddle containing the electrodes.

Abstract: A system and method are presented that electrically stimulates the phrenic nerve whereby said stimulation results in muscle activation of the diaphragm as observed by a measurement of work or power of breathing associated with the inspiratory portion of a stimulated breath.

Abstract: Systems and related methods for controlling an ear stimulation device with a personal computing device, in response to determination of electrical contact of an electrode in a stimulator earpiece with an ear of a user of the personal computing device, are described. If the electrode is not in good electrical contact with the ear of the user, delivery of the stimulus is prevented and the user is notified of the status of the electrode. In various aspects, the user is instructed to reposition the earpiece or replace, clean, moisten, or apply gel to at least a portion of the electrode.

Abstract: Apparatus for providing transcutaneous electrical nerve stimulation (TENS) therapy to a user, the apparatus comprising: a stimulation unit for electrically stimulating at least one nerve of the user; an electrode array connectable to the stimulation unit, the electrode array comprising a plurality of electrodes for electrical stimulation of the at least one nerve of the user; a monitoring unit electrically connected to the stimulation unit for monitoring the on-skin status of the electrode array; an analysis unit for analyzing the on-skin status of the electrode array to determine the effective on-skin time of the electrode array; and a feedback unit for alerting the user when the analysis unit determine that the effective on-skin time exceeds a threshold.

Abstract: Devices, systems and methods are disclosed that allow a patient to self-treat neurodegenerative diseases, such as dementia, Alzheimer's disease, ischemic stroke, post-concussion syndrome, chronic traumatic encephalopathy and the like by electrical noninvasive stimulation of a vagus nerve. The system comprises a handheld stimulator that is applied to the surface of the patient's neck, wherein the stimulator comprises or is joined to a smartphone. A camera of the smartphone may be used to position and reposition the stimulator to a particular location on the patient's neck. The system may also comprise a base station that is used to meter the charging of a rechargeable battery within the stimulator. The base station and stimulator transmit data to one another regarding the status of a stimulation session.

Abstract: Portable transdermal electrical stimulation (TES) applicators for modifying a subject's cognitive state by applying stimulation to the subject's skin. One or more electrode may be on the subject's mastoid, and/or on or near the back of the subject's neck. The portable applicators are configured and adapted to be lightweight and may be wearable, and to deliver a high-intensity TES able to evoke or enhance a predetermined cognitive effect to stimulate either the trigeminal, facial and/or cervical plexus. These TES applicators may include a pair of electrodes and a TES control module comprising a processor, a timer and a waveform generator.

Abstract: A method for providing electrical stimulation to a user, the method comprising: providing an electrical stimulation device, in communication with a controller, at a head region of the user; with the electrical stimulation device, providing a stimulation treatment having a waveform configured for neuromodulation in the user; with the controller, performing an adjustment to the stimulation treatment, wherein performing the adjustment includes: generating a transformed waveform with application of a transfer function to the waveform, wherein the transfer function scales the waveform and selectively attenuates extreme waveform values while maintaining a frequency characteristic of the waveform in the transformed waveform; and applying the transformed waveform with the electrical stimulation device, thereby modulating the stimulation treatment.

Abstract: A method to provide non-invasive neurostimulation to enhance a subject's proficiency in an exercise includes: (a) engaging a subject in a physical or mental exercise, the subject having no cognitive, physical or emotional impairment; (b) providing intraoral cutaneous stimulation of at least one of the subject's trigeminal nerve, facial nerve or hypoglossal nerve by delivering electrical pulses to one or more stimulators situated within the subject's mouth, the delivery of electrical pulses being (i) contemporaneously with and independent of the subject's engagement in the exercise, and (ii) independent of the subject's surrounding environment; and (c) repeating steps (a) and (b) on a periodic basis.

Abstract: A catheter may include an outer layer defining a plurality of apertures therethrough, and a body defining at least one longitudinal lumen therein. The body may be within the outer layer, and the apertures may be radially outward of the lumen. The catheter may also include a plurality of electrodes positioned in or on the catheter, with each electrode being electrically exposed through an aperture of the plurality of apertures. A ribbon cable may extend through the lumen and include a plurality of leads, with the plurality of leads being electrically connected to the plurality of electrodes. The plurality of leads and electrodes may be formed by the deposition of conductive inks or paints, or by the electrodeposition of copper or other conductive metals or materials.

Abstract: The invention relates to an electrical multichannel system (100) and to a neural stimulation and/or recording device comprising such a system. The multichannel system comprises a plurality of application components (130), e.g. stimulation electrodes, and associated access points (120) that are connected by a plurality of electrical lines (110). The resistances of these lines are adjusted to given target values, for example to equal values, by incorporating appropriate tuning sections (140) into the electrical lines. The lines may for example comprise different geometries and/or materials in the tuning sections.

Abstract: A method for configuring stimulation pulses in an implantable stimulator device having a plurality of electrodes is disclosed, which method is particularly useful in adjusting the electrodes by current steering during initialization of the device. In one aspect, a set of ideal pulses for patient therapy is determined, in which at least two of the ideal pulses are of the same polarity and are intended to be simultaneous applied to corresponding electrodes on the implantable stimulator device during an initial duration. These pulses are reconstructed into fractionalized pulses, each comprised of pulse portions. The fractionalized pulses are applied to the corresponding electrodes on the device during a final duration, but the pulse portions of the fractionalized pulses are not simultaneously applied during the final duration.

Abstract: Implantable medical systems enter an exposure mode of operation, either manually via a down linked programming instruction or by automatic detection by the implantable system of exposure to a magnetic disturbance. A controller then determines the appropriate exposure mode by considering various pieces of information including the device type including whether the device has defibrillation capability, pre-exposure mode of therapy including which chambers have been paced, and pre-exposure cardiac activity that is either intrinsic or paced rates. Additional considerations may include determining whether a sensed rate during the exposure mode is physiologic or artificially produced by the magnetic disturbance. When the sensed rate is physiologic, then the controller uses the sensed rate to trigger pacing and otherwise uses asynchronous pacing at a fixed rate.

Abstract: Systems and methods for programming and logging medical device and patient data are provided. The systems include a handheld device, which is capable of communicating with a medical device, and a base station, which provides connectivity for the handheld device to accomplish various functions such as recharging, programming, data back-up and data entry. The methods comprise the steps of detecting a medical device, obtaining and recording information from the medical device. Additionally, medical device parameters may be modified and the recorded information may be archived for future reference.

Abstract: A wearable device for facilitating neurophysiological treatment of a patient harboring an implanted neural stimulator is provided. The wearable device includes a transmitting antenna configured to accept one or more input signals and to transmit one or more electromagnetic signals to a neural stimulator that is implanted in a patient's body. The wearable device further includes a control circuitry configured to provide the one or more input signals to the transmitting antenna. The wearable device further includes a battery that provides electrical power to at least the control circuitry. The wearable device is configured to be worn outside the patient's body.

Abstract: An identifier apparatus 10 for acquiring a signature signal frequency 12 from an implantable medical device 11 that is internally implanted in a patient. The apparatus 10 identifies the type of implantable medical device 11 and the device manufacturer by the unique signature signal frequency 12 of the manufacturer and device. The apparatus 10 aids healthcare providers with quick and exact knowledge of a patients implanted device.

Abstract: An example of a system for delivering neurostimulation may include a display and an interface control circuit. The interface control circuit may be configured to define a stimulation waveform according to which the neurostimulation is delivered. The stimulation waveform is defined by waveform parameters including one or more user-adjustable parameters. The interface control circuit may include a parameter selector, an effect analyzer, and a parameter generator. The parameter selector may be configured to present values for each user-adjustable parameter on the display and allow the user to select a value for each user-adjustable parameter from the presented values. The effect analyzer may be configured to estimate an interactive effect of different stimuli of the neurostimulation. The parameter generator may be configured to select a rate rule based on the estimated interactive effect and to generate the values for each user-adjustable parameter according to the selected rate rule.

Abstract: One aspect relates to a feedthrough system. The feedthrough system includes a feedthrough and a wire. At least a portion of the feedthrough is made of an insulator and at least one area forming an electrically conductive cermet pathway. The cermet pathway may include an electrically conductive metal. The wire may be at least partially connected to the cermet pathway so that the material of the wire forms a joint microstructure with the electrically conductive material in the cermet pathway.

Abstract: A method and system for supplying energy to an electrically operable medical device (100) implanted in a patient. Wireless energy is transferred from an external energy source (104) located outside the patient to an internal energy receiver (102) located inside the patient and connected to the medical device. An internal control unit (108) determines an amount of energy currently required for the operation of said medical device. A control signal is transmitted to the external energy source, reflecting the required amount of energy. An external control unit (106) controls the amount of transferred energy in response to the control signal, by adjusting the energy transfer efficiency from the external energy source to the internal energy receiver. The energy transfer efficiency is adjusted by adjusting the position of a primary coil, serving as the external energy source, relative to an implanted secondary coil, serving as the internal energy source.

Abstract: Flexible subcutaneous implantable medical device (IMD), including an elongated and flexible body, a plurality of electronic components, at least one rechargeable battery, at least one antenna, at least one lead and at least one transition unit, the antenna for receiving and transmitting electromagnetic radiation and the lead for providing an electric shock, wherein the elongated and flexible body is structured from a plurality of units, wherein a first one of the plurality of units encapsulates the rechargeable battery, wherein each one of the other plurality of units respectively encapsulates a respective one of the plurality of electronic components, wherein the antenna is positioned in the transition unit, wherein the transition unit is covered with a biocompatible polymer, wherein the antenna receives electromagnetic radiation for recharging the rechargeable battery and wherein the antenna includes a copper coil having a generally cylindrical shape.

Abstract: This invention relates to devices and methods for the activation of nerve cells and muscles by magnetic induction, and in particular to devices including moving magnets. The devices disclosed may also have other therapeutic, medical and industrial applications.

Abstract: Phototherapy systems comprising a therapeutic lamp platform for radiant lamps such as LEDs disposed in an assembly including a reflective surface facing towards a patient and a plurality of light apertures substantially aligned with the LEDs for communicating lamp radiation from the lamps to a user. The lamps and associated circuitry are disposed so that the reflective surface is relatively smooth and seamless towards the patient. The walls have a malleable rigidity for flexible adjustability relative to the user and, the device is mounted to the user with a frame.

Abstract: Systems and methods of the present disclosure are directed to systems and methods for treating cognitive dysfunction in a subject in need thereof. The system can include a neural stimulation system that receives an indication of an ambient audio signal detected by a microphone. The system selects, from a profile, an audio signal including a fixed parameter and a variable parameter. The system sets the variable parameter to a first value. The system generates an output signal based on the fixed parameter and the first value, and provides the output signal to the speaker. The system measures a physiological condition of the subject, adjusts the variable parameter to a second value, generates a second output signal based on the fixed parameter and the second value of the variable parameter, and provides the output signal to the speaker to cause the speaker to provide modified sound to the subject.

Abstract: In one embodiment, a verification system for confirming the position of a conduit inserted within a patient may include an elongate control element dimensioned for insertion within the conduit. The control element has a proximal end and a distal end, and a verification element coupled to a distal region. The verification element may be configured to detect the presence of a reference marker associated with the conduit and communicate a signal indicative of the position of the reference marker relative to the verification element. The control element may also be configured to maneuver the verification element along a length of the conduit.

Abstract: The treatment planning engine empowers radiation treatment decision makers, such as a physician, to efficiently identify effective radiation treatment outcomes for a given patient during the contouring stage. Specifically, using the treatment planning engine, the physician may iteratively and in real-time evaluate different treatment outcomes for a patient before selecting an optimal outcome that will guide the delivery of radiation treatment to the patient. By providing real-time information as to potential toxicity and treatment efficacy during the contouring stage, the physician is empowered to make informed decisions at the preliminary contouring stage.

Abstract: A system for facilitating creation of a patient treatment plan includes components configured to receive at least one feature associated with patient data and search a database of previously planned radiation treatments to identify one or more matching plans from the database based on the at least one feature. Parameters corresponding to the identified matching treatment plans may be used to facilitate creation of the patient treatment plan.

Abstract: A therapy planner is configured to construct a therapy plan based on a planning image segmented into segments delineating features of a subject. A predictive plan adaptation module is configured to adjust the segments to represent a foreseeable change in the subject and to invoke the therapy planner to construct a therapy plan corresponding to the foreseeable change. A data storage stores a plurality of therapy plans generated for a subject by the therapy planner and the predictive plan adaptation module based on at least one planning image of the subject. A therapy plan selector is configured to select one of the plurality of therapy plans for use in a therapy session based on a preparatory image acquired preparatory to the therapy session.

Abstract: Systems and methods directed to adaptive radiotherapy planning are provided. In some aspects, provided system and method include producing synthetic images from magnetic resonance data using relaxometry maps. The method includes applying corrections to the data and generating relaxometry maps therefrom. In other aspects, a method for adapting a radiotherapy plan is provided. The method includes determining an objective function based on dose gradients from an initial dose distribution, and generating an optimized plan based on updated images, using aperture morphing and gradient maintenance algorithms without need for organ-at-risk contouring.

Abstract: An object of the present invention is to provide a particle beam treatment system that can realize the reduction of treatment time for a specific patient, compared with treatment time in a conventional type. A control unit of a control system controls a beam routing system and irradiation devices so as to maintain the occupation of an accelerator when a certain treatment room of plural treatment rooms once occupies the accelerator except intentional operation to release the occupation of the accelerator or the occurrence of system failure.

Abstract: A medical system includes a medical device and a controller. The medical device is controlled according to a control protocol. The controller is configured to receive a measured data set containing a current value at a current time and past values at past times of a physiologic signal measured on a recipient, calculate a difference signal at the current time based on the measured data set, and predict a difference value using the difference signal and a prediction algorithm. The difference value is a difference between a predicted future value of the physiologic signal at a future time and the current value. The controller is further configured to calculate the predicted future value based on the difference value and the current value and update the control protocol according to the predicted future value.

Abstract: In an irradiation method, an irradiation plan for irradiating a target volume in phases of motion is provided to a particle therapy system. The particle therapy system comprises a beam delivery device operable to scan a pencil beam of particles over the target volume. The irradiation plan comprises a first field for irradiating the target volume in a first phase of motion and a second field for irradiating the target volume in a second phase of motion. Motion of a tracking device or change of other physical measurement value is monitored and signals continuously indicating the current position of the tracking device or measurement value are provided to the particle therapy system. A pencil beam of particles is applied to the target volume according to the irradiation plan and signals from the tracking system continuously indicating current positions of the target volume. Dosage delivered to the target volume is monitored.

Abstract: The invention relates to radiation therapy system. The system includes a five-degree-of-freedom O-shaped arm radiation therapy device and a six-degree-of-freedom parallel radiation therapy bed. The five-degree-of-freedom O-shaped arm radiation therapy device includes an O-shaped arm movement mechanism, a linear accelerator device, a radiation dose detection device and a double-X-ray machine image positioning mechanism. The O-shaped arm movement mechanism includes an O-shaped arm, an accelerator displacement device, a rotational displacement device, a turning displacement device, a horizontal transverse displacement device, and a horizontal longitudinal displacement device. The double-X-ray machine image positioning mechanism includes an X-ray transmitter and receiver. The six-degree-of-freedom parallel radiation includes a base assembly, a connecting rod assembly and a bed plate assembly.

Abstract: Methods and devices for producing cavitation in tissue are provided. In one embodiment, a shock scattering method of Histotripsy therapy comprises delivering an initiation pressure waveform from an ultrasound therapy transducer into tissue, the initiation pressure waveform being configured to produce at least one bubble in the tissue, delivering a scattering pressure waveform from the ultrasound therapy transducer into the at least one bubble within a life-cycle of the at least one bubble, and producing cavitation nuclei near the at least one bubble with the scattering pressure waveform. The scattering pressure waveform can be delivered during the life-cycle of the at least one bubble. In some embodiments, the scattering pressure waveform is delivered within 5 ?s to 1 s of the initiation pressure waveform. Systems for performing shock scattering Histotripsy therapy are also discussed.

Abstract: A method and apparatus is disclosed for determining the success of a proposed HIFU Treatment, of an ongoing HIFU Treatment, and/or of a completed HIFU Treatment. An energy density of a given HIFU Treatment may be used as a comparison factor between the given HIFU Treatment and other HIFU Treatments and as a predictor of the success of the given HIFU Treatment. One exemplary energy density is the amount of energy deposited in the treatment region divided by the volume of the treatment region. Another exemplary energy density is the amount of energy deposited in the treatment region divided by the pre-treatment mass of the treatment region. A method and apparatus is disclosed to detect the presence of focal hyperechoic features and non-focal hyperechoic features. A method and apparatus is disclosed to detect the presence of an acoustic obstruction.