WO2013163267A1 - Appareil de diagnostic de sphincters internes - Google Patents
Appareil de diagnostic de sphincters internes Download PDFInfo
- Publication number
- WO2013163267A1 WO2013163267A1 PCT/US2013/037929 US2013037929W WO2013163267A1 WO 2013163267 A1 WO2013163267 A1 WO 2013163267A1 US 2013037929 W US2013037929 W US 2013037929W WO 2013163267 A1 WO2013163267 A1 WO 2013163267A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- urethral
- inspiration
- les
- sphincters
- muscle
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/22—Ergometry; Measuring muscular strength or the force of a muscular blow
- A61B5/224—Measuring muscular strength
- A61B5/227—Measuring muscular strength of constricting muscles, i.e. sphincters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36135—Control systems using physiological parameters
- A61N1/36139—Control systems using physiological parameters with automatic adjustment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Measuring devices for evaluating the respiratory organs
- A61B5/0823—Detecting or evaluating cough events
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
- A61B5/1107—Measuring contraction of parts of the body, e.g. organ or muscle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
- A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing
- A61B5/1135—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb occurring during breathing by monitoring thoracic expansion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
- A61B5/202—Assessing bladder functions, e.g. incontinence assessment
Definitions
- the present invention relates to diagnosing physiological abnormalities, and more particularly, to diagnosing internal sphincters.
- the flow of contrast agent can be detected at the level of the LES using a fluoroscopic instrument configured to image the contrast agent.
- a chemo-irritant can induce the involuntary reflex cough epoch using a nebulizer. Barium sulfate is a preferred contrast agent that is swallowed by the patient. Typically, the involuntary reflex cough epoch is induced following the administration of that contrast agent.
- a urinary catheter having a pressure sensor is inserted within the bladder.
- An EMG is obtained from the involuntary cough activated intercostais and the data processed from the pressure sensor with the EMG to estimate the severity of the SUI.
- the EMG can be obtained from the paraspinais.
- a muscle contraction device is located on at least one of the urethral and anal sphincters.
- a controller is connected to the muscle contraction device and operative to transmit control signals to the muscle contraction device located on at least one of the urethral and anal sphincters to contract the muscle during an inspiratory phase of respiration.
- Sensors are positioned to detect movement of the ribs indicative of the inspiratory phase of respiration.
- the sensors are positioned using sensors placed at the interior surface of the medial border of the costal margin of ribs 8, 9 or 10.
- a muscle contraction device is located on at least one of the internal and external urethral sphincters.
- the muscle contraction device includes an electrode to stimulate the muscle using an electrical current.
- a controller is operative to transmit control signals to the electrodes to initiate electrical stimulation in another example.
- a controller is embedded in the abdominal wall in an example and microwires connect the controller and electrodes.
- the muscle contraction device may be formed as a mechanical mechanism in another example. The muscle may be contracted during an inspiratory phase of respiration based on inspiration/expiration endpoints of rib cage movement.
- a cough inducing device such as a nebulizer is configured to induce an involuntary reflex cough event within a patient.
- a processor is configured to receive data relating to the contraction of the at least one urethral and anal sphincter and diagnose the functioning of the sphincter.
- FIG. 1 is an anterior view of the human torso showing sensors such as transducers positioned to detect movement of the ribs during inspiration and expiration in accordance with a non-limiting example.
- FIG. 2 is an anterior view of the human thoracic skeleton showing the sensors such as transducers to detect movement of the ribs during inspiration and expiration in accordance with a non-limiting example.
- FIG. 3 is a medial view of a female pelvis showing sensors as transducers, electrodes and a processor as part of a receiver in accordance with the non-limiting example.
- FIG. 4 is a medial view of a female pelvis showing sensors and transducers to detect inspiration and simulate the electrodes and operating wirelessly in accordance with a non-limiting example.
- FIG. 4A is a flowchart showing a basic sequence of operation.
- FIG. 5A are images of the inspiration closure reflex (ICR) and showing the BFV sequences for barium swallow followed by deep inspiration that allows barium to enter the stomach.
- ICR inspiration closure reflex
- FIG. 5B is a nerve conduction pathway circuit diagram for the inspiration closure reflex (ICR) showing how intrinsic sphincter tenacity is regulated during inspiration and expiration in accordance with a non-limiting example.
- ICR inspiration closure reflex
- FIG. 6A are images showing a barium swallow during a breath-hold of a patient and depicting inspiration followed by barium swallow.
- FIG. 66 is a nerve conduction pathway circuit diagram to show the physiology of the breath-hold as in FIG. 6A in accordance with a non-limiting example.
- FIG. 7 are images showing the barium swallow during breath-hold in accordance with a non-limiting example.
- FIG. 8A are images showing the laryngeal expiratory reflex which the LES appear patent during the LER cough epoch in accordance with a non-limiting example.
- FIG. 8B shows a nerve conduction pathway circuit diagram of the stimulation of laryngeal receptors using the involuntary reflex cough test
- FIGS. 9A and 9B are graphs showing pressure recordings of the IUS and LES synchronizes with respiration in accordance with a non-limiting example.
- FIG. 10 is a graph showing relative latencies of the IUS and LES with deep inspiration and expiration in accordance with a non-limiting example.
- FIG. 11 is a graph showing the breath-hold with maintained pressure elevation in the LES and IUS in accordance with a non-limiting example.
- FIGS. 12A and 12B are graphs showing the urodynamic tracing of a series of forceful voluntary coughs in accordance with a non-limiting example.
- FIG. 13 is another nerve conduction pathway circuit diagram showing the inspiration closure reflex in accordance with a non-limiting example.
- FIG. 14 is a flowchart illustrating a sequence of steps for isolating the gastric valve to assess its function in accordance with a non-limiting example.
- FIG. 15 is another flowchart illustrating a sequence of steps for isolating the gastric valve and external urethral sphincter to assess their function in accordance with a non-limiting example.
- FIG. 16A is a fragmentary view of an example of a kit having components for use with the methodology described relative to FIGS. 14 and 15 in accordance with a non- limiting example.
- FIG. 16B is a view showing a system that includes a patient bed as a platform and imaging sensor for performing the methodology of FIGS. 14 and 15.
- FIG. 17 is a simplified plan view of a catheter that can be used for urodynamic and medical diagnostic testing in accordance with a non-limiting example.
- FIG. 18 is a simplified plan view of another example of a catheter similar to that shown in FIG. 17 that can be used for urodynamic and medical diagnostic testing in accordance with a non-limiting example.
- FIG. 19 shows a urinary continence pad that can be used with urodynamic catheters of FIGS. 17 and 18.
- FIG. 20 is a plan view of an Ng/Og device or catheter that can be used for testing for acid reflux.
- FIG. 21 is a fragmentary plan view of a handheld processing device that can be used in conjunction with various catheters and Ng/Og devices or other catheters and/or nebulizers.
- FIG. 22 is a block diagram showing example components of a handheld processing device such as shown in FIG. 21.
- FIG. 23 is a block diagram showing an outline of the laryngeal expiratory reflex (LER) and results with the intrinsic sphincter deficiency and esophageal, urinary and fecal continence.
- LER laryngeal expiratory reflex
- FIGS. 24A and 24B are graphs detailing what occurs during LER with intrinsic sphincter activity (FIG. 24A) and voluntary cough pathways (FIG. 24B).
- the BSV showed closure and relaxation of the LES corresponding to the inspiration and expiration of VC.
- the LES was patent during the LER. There was closure of the LES during the deep inspiration/breath-hold event. Pressure catheters in the LES and IUS showed increased pressure during inspiration.
- ICR inspiration closure reflex
- ICR Inspiration Closure Reflex
- IAP Intra abdominal Pressure
- a processor is programmed to correlate the IA (Intra abdominal) pressure changes and the associated duration of each event (as detected by the pressure transducer) with corresponding stimulation of the smooth muscle of the IUS, and/or the striated muscle of the EUS (external urethral sphincter) and/or AS (anal sphincter).
- Muscle stimulators may be implanted using trans-urethral or trans-vaginal approaches and connected to a processor as part of a receiver either directly such as with microwires or indirectly such as using wireless communication, for example, Bluetooth or other wireless communication.
- a trans-vaginal approach is favored when a microwire is inserted via
- Vaginal palpation occurs at the distal end of the microwire for a muscle stimulator to the IUS, EUS, and/or AS.
- the confirmation of placement may be accomplished by the use of a urethral pressure catheter. It is possible to palpate the wire passing posterior to the vagina and palpate its placement adjacent to the AS surrounding the anus as distal about one inch of the rectum.
- the AS stimulation is confirmed by a rectal pressure catheter.
- the transducer and microprocessor may be connected to the stimulator via a wireless connector.
- a power source and electronic stimulator may be proximate to the targeted sphincter muscles in this system and apparatus.
- the sensors 32a, 32b as transducers in this example are positioned to detect movements of the ribs during inspiration and expiration and are placed at the anterior surface of the medial border of the costal margin of ribs 8, 9 or 10.
- the sensors 32a, 32b In this example are formed as transducers to measure movement.
- These sensors 32a, 32b (either on ore two) are directly or indirectly connected to a control unit 34 operative as a controller having a signal receiver/transceiver, which in this example is embedded in the subcutaneous fat of the lower quadrant of the abdominal wall.
- the control unit 34 controls the electrodes 42, 44 (FIG. 3) that simulate contraction of the internal urethral sphincter (IUS) and internal anal sphincter during the inspiratory phase of respiration.
- IUS internal urethral sphincter
- FIG. 2 shows an anterior view of the human thoracic skeleton 36.
- osteocartilaginous thoracic cage 36 as illustrated includes the sternum, 12 pairs of ribs and associated costal cartilages and 12 thoracic vertebrae and intervertebral discs.
- the position of the superior domes of the diaphragm is indicated by the line 38.
- the sensors 32a, 32b are configured to detect movement of the ribs during inspiration and expiration and are placed on the anterior surface of the medial border of the costal margin of ribs 8, 9 or 10 in this example.
- the sensors 32a, 32b may be placed either unilaterally or bilaterally.
- FIG. 3 is a medial view of the female pelvis 40.
- a microprocessor is part of a control unit 34 and implanted in the fatty layer (Camper's fascia 40a) or in the deep layer (Scarpa's fascia 40b) and against the fascia of the external abdominal oblique muscle in the patient's left or right lower abdominal wall.
- This control unit 34 receives wireless signals from the sensors 32a, 32b regarding movement of the lower rib cage during inspiration.
- the control unit 34 will detect the onset of inspiration and simulate microelectrodes 42, 44 that are implanted in the respective internal urethral sphincter (IUS) 46 and internal anal sphincter (IAS) 48 indicated by the multiple dotted lines on the appropriate sphincter.
- the control unit 34 is connected to the microelectrodes 42, 44 (single or as an array of microelectrodes either directly (via microwire) or indirectly (wireless, radio frequency, Blue-Ray, or similar technology).
- These pelvic devices as the microelectronics may close the IUS or IAS either electronically (muscle simulation) or activate mechanical mechanisms that close the IUS and IAS with or without an intervening processor.
- Microwires 50 if used are placed using a trochar to tunnel through Camper's fascia 40a (subcutaneous fat of the abdominal wall) to the superior border of the pubic bone. There is also illustrated the pubis 40a, urinary bladder 40b, uterus 40c, vagina 40d, and rectum 40e.
- FIG. 4 is a medial view of the female pelvis 40.
- the transducer as sensors 32a, 32b operate wirelessly and transmit wireless signals at the onset of inspiration, and simulate the electrodes 42, 44 and/or mechanical or electronic IUS or IAS devices (indicated by the multiple dotted lines 42, 44 on the appropriate sphincter).
- the attached lines represent that the electrodes could be used or other electronic or mechanical devices to close these sphincters.
- the electrodes 42, 44 close these sphincters during inspiration.
- the electrodes 42, 44 are implanted in or around the internal urethral sphincter (IUS) 46 and internal anal sphincter (IAS) 48.
- IUS internal urethral sphincter
- IAS internal anal sphincter
- the sensor(s) 32a, 32b in this example are connected to the sphincter closure devices and/or either directly (via microwire) or indirectly (wireless, radio frequency, Blue-Ray, or similar technology). These pelvic devices as electrodes 42, 44 or other device may close the IUS or IAS either electronically (muscle simulation) or mechanically such as by pressing inward on the sphincter with or without an intervening processor or control unit.
- Displacement of the diaphragm may be detected by one or two sensors 32a, 32b or other type of transducers, which are implanted at or on the medial costal border of the eighth rib using a trochar device to implant the small, cylindrical transducers.
- These motion sensors 32a, 32b as transducers detect the movement of the lower rib cage during deep inspiration. This movement of the rib cage during inspiration occurs as a result of contraction of the diaphragm and the corresponding expansion of the thoracic cavity and abdominal cavity.
- the costal margins of ribs 8-10 move supero-laterally and the two motion sensors 32a, 32b as illustrated in FIG. 4 may detect an increase in distance between the two devices and thereby rib cage expansion corresponding to inspiration.
- a remote control device or computer 52 that is linked to the control unit 34 and operative as a transmitter/receiver and may be used to set the inspiration/expiration endpoints of the rib cage movement via transmission of signals wireless in this example using a transmitter/receiver circuit 52a in the remote device 52.
- This calibration is performed in the clinical setting by a clinician. The clinician will ask the patient to completely exhale and will then press a [set] button 52b on the remote device 52 at the end of complete exhalation.
- the motion sensors 32a, 32b may be directly or indirectly connected to the devices 42, 44 as electrodes in this example that close the IUS and/or IAS through muscle contraction, which will control intrinsic sphincter closure based on deep inspiration and the associated inspiration closure reflex as a normal neurological event linked to significant inspiration.
- the clinician will ask the patient to deeply inhale (inspiration) and then press the [set] button 52b at the end of deep inspiration.
- the remote device computer 52 is linked by radio frequency, Blue-Ray or other similar communications link such as to the control unit 34 or directly to the sensors 32a, 32b and will record the inspiration/expiration endpoints and the associated range of rib cage movement.
- the mode of transmission of signals from the motion transducers 32a, 32b is transmitted by, but not limited to, direct or indirect communication connections to the implanted control unit 34, which can also act as a communications receiver for signals from the sensors 32a, 32b, and through a transmitter function, initiate one or more devices that cause: (1) electronic simulation of the IUS and/or IAS smooth muscle, which will contract these smooth muscle sphincters and prevent voiding and/or evacuation through electronic means; or (2) mechanical closure of the IUS and/or IAS, which contract these smooth muscle sphincters and prevent voiding and/or evacuation; through mechanical means.
- ICR inspiration closure reflex
- IAP intra-abdominal pressure
- the control unit 34 which is usually implanted, will detect the start of inspiration through the sensors 32a, 32b and initiate corresponding simulation of the
- the device operates through its communications circuitry 35.
- the control unit 34 may be temporarily turned off and permit volitional voiding and/or evacuation of the urinary bladder or bowel, respectively. Pressing an 'on' button again, resets the device to the previous setting for respiration and control of sphincter tone and allows synchronizing of the devices or electrodes 42, 44 with the patient's inspiration.
- FIGS. 1-4 The description relative to FIGS. 1-4 assist in understanding the ICR and use of the sensors as transducers 32a, 32b for diagnosing physiological conditions.
- the system will not usually detect phrenic nerve activity and will not usually use devices to stimulate the inferior hypogastric plexus, which innervates, in part, the internal urethral and internal anal sphincters. That type of device would involve a more invasive surgical procedure and it may be more difficult to control the IUS and IAS as the plexus innervates other pelvic structures.
- the process shown relative to FIGS. 1-4 starts (block 60).
- the involuntary reflex cough test is administered (block 62).
- a determination is made if there is sphincter dysfunction (block 64). If not, then there are no changes made (block 66). If yes, then electrodes are implanted (block 68).
- the inspiration/expiration endpoints are then calibrated (block 70). Sphincters are contracted based on the endpoints during inspiration and expiration (block 72). This process continues until a determination is made that sphincters no longer need to be contracted and the process ends (block 74). It would be rare to have the process end since usually a patient will require the treatment over a long period of time.
- Detection of diaphragmatic contraction is anatomically complicated by its close proximity to adjacent structures. Any implants or electrodes in the diaphragm may damage or injure these structures, e.g., heart, lungs, gastrointestinal tract, abdominal organs, etc., or cause a pneumothorax, hemothorax or similar breech of the pleural cavity. Thus, such a device may not be desirable. The system usually will not use a device to detect electrical activity of the phrenic nerve.
- neuropathy is the cause of the ICR breakdown, it is possible to assume all nerves have some degree of ongoing neuropathy, which may get worse. If the phrenic nerve fails to activate the diaphragm, thus causing shorter movements, it may be assumed that the same process occurs with the Inferior Hypogastric Plexus to the ICR. It is possible to override these deficits to the ICR and reset the closure variables, adjustable over time, using a more reliable method than nerve assessment or activation.
- the phrenic and diaphragm may be adequate but the lumbosacral stenosis injures the nerves that close the IUS. Any closure settings by this detection would be different compared to the phrenic nerve and diaphragm function.
- IUS activation is based in this instance on the present ability to activate the diaphragm, reflected by rib movements. If a subject is restricted in inspiration, COPD, arthritis, kyphosis or restrictive patterns of breathing, the system resets the IUS closure sensitivity to less activation from the ribs.
- These settings may be individually customized by the Urologist and may occur in many different patterns. Based on the ICR deficit, they are adjustable by the urologist in the clinic or with an urodynamics examination.
- the adjustment may be compared to other adjustment technologies, e.g., insulin, pain medicine or intrathecal Baclofen pumps.
- Other adjustment technologies e.g., insulin, pain medicine or intrathecal Baclofen pumps.
- Many other options are possible.
- Tunneling for the microwires 50 to the electrodes 42, 44 is straightforward to the level of the pubis. Connecting a microwire 50 to an electrode 42, 44 (or electrode array arranged on a tape), however, may require another step. It is possible to use a curved trochar or instrument similar to that used for a supra-pubic urinary bladder suspension. The wire is connected to the tape when electrodes are contained on the tape and pulled into place by palpating the placement per vagina.
- FIG. 4 shows a tape 58 in block format that supports the illustrated electrode array 44. It should be understood that the electrodes could be single electrodes, an array of electrodes such as on a tape or other support or other configuration.
- the electrodes 42, 44 adjacent to the IUS and IAS may require a power supply and there may not be room for the power supply in the area of the pelvis, but there are improvements in power supply, especially since MEMS technology may be used for sensors and power supplies.
- the electrodes 42, 44 as stimulators are small and do not migrate. Another consideration for design and placement is the vascular layout of vessels and pathway of nerves, which in this area may be problematic.
- sensors 32a, 32b that are programmed to work with each other and the transponder devices such as the electrodes 42, 44 by movement changes. It is possible to activate the electrodes 42, 44 without wire placements.
- Electrodes may also be activated by sensors directly attached to them so that there are no wires and the sensors/electrodes are formed as integrated units. Possible communication linkages include Bluetooth or similar wireless technology to activate the electrodes from the control unit 34.
- IRCT involuntary reflex cough test
- tracheostomies which are the majority of prolonged intubated patients. There are many variables to the possible scenarios and they require clinical judgment. It is possible to add a micro tube with a transducer that can plug into a processing device, such as the handheld processing device shown in FIGS. 21 and 22 and also Ng/Og or urology tubes as disclosed in commonly assigned patent application Serial Nos. 12/878,257 filed September 9, 2010; Serial No. 12/878,281 filed September 9, 2010; and Serial No. 12/878,316 filed September 9, 2010, the disclosures which are hereby incorporated by reference in their entirety. These devices can be inserted via a percutaneous endoscopic gastrostomy tube (PEG) or Jejunostomy (J-tube) and used to calculate the iRCT cough epoch values for iAP responses to help determine extubation risk.
- PEG percutaneous endoscopic gastrostomy tube
- J-tube Jejunostomy
- the respiratory cycle is modified in many ways and by many influences that also activate the expiratory muscles for respiration.
- pulmonary afferent impulses were conveyed to the brainstem via the Vagus nerve, and these afferent impulses reflexively initiated expiration.
- other pulmonary afferent receptors were stimulated, and their impulses, also conveyed to the brainstem by the Vagus nerve, reflexively initiated the next inspiration.
- Voluntary cough (VC) and the laryngeal expiration reflex (LER) as an involuntary cough have been used for assessment of stress urinary incontinence (SUI) in women and neurological airway protection in humans.
- the urodynamic tracings from SUI clinical trials suggest that the inspiration during VC stimulates pulmonary afferent fibers that may directly activate closure of the internal urethral sphincter (IUS).
- IUS internal urethral sphincter
- the '257, '281 and '316 applications disclose oral-esophageal-gastric devices, some with esophageal cuffs and/or reflux measurement systems that can be used to assess GERD or determine stress urinary incontinence in some examples using the involuntary reflex cough tests alone or in combination with the voluntary cough test.
- the test included a prospective, barium swallow videofluoroscopy (BSV) study.
- BSV barium swallow videofluoroscopy
- Four normal, healthy male subjects participated in the BSV study.
- One of the subjects also underwent evaluation of the iUS and LES using fiberoptic pressure catheters.
- informed consent was obtained from all subjects.
- BSV studies of the LES were performed using only thin barium solution in each subject.
- the subjects were standing for all BSV test maneuvers using a standing anterior-posterior view.
- Videofluoroscopic photomontages were captured at three second intervals and analyzed for each maneuver.
- each subject swallowed a small cup of thin barium solution followed immediately by a deep inspiration and a VC.
- the BSV captured, at the level of the LES, a photomontage of the barium flow during the VC.
- the breath hold maneuver required the subject to perform a deep inspiration and breath hold followed immediately by swallowing a small cup of thin barium solution.
- the BSV captured, at the level of the LES, a photomontage of the barium flow during the breath hold voluntary maneuver. All of the photomontages were visually analyzed to determine the relationship of the barium to the position of the LES and diaphragm.
- the induced reflex cough test is a cough provocation test that stimulates the laryngeal expiratory reflex (LER).
- the LER is a series of expiratory coughs (cough epoch) without a significant preceding inspiration. This LER cough epoch caused 5 coughs (C5) with an average duration of 14.8 seconds.
- the following materials were used to perform the IRCT: a) vial containing a 20% solution of tartaric acid (Nephron Pharmaceutical, Inc; Orlando, FL); b) Pari LCD jet nebulizer (Bonn, Germany); c) oxygen flow meter; d) oxygen tank; and e) gloves and safety mask.
- the jet nebulizer was FDA approved for use in the U.S. and bore the CE Marking designating the manufacturer's compliance with Council Directive 93/68/EEC.
- the subject swallowed 50 mi. of thin barium solution immediately followed by administration of the IRCT.
- the BSV captured, at the level of the LES, a photomontage of the flow of barium, during the LER involuntary cough maneuver.
- One subject also had both nasogastric and urethral fiberoptic, disposable catheters (#10 and #7 French catheters, respectively) with the pressure sensors placed at the level of the LES and IUS, respectively.
- Electromyography (EMG) electrodes were placed at the mid-axillary line of the T7-8 intercostal space and were used to confirm the inspiratory activity of the intercostal muscles.
- the Lumax TS Pro was used to record LES and IUS pressures and EMG activity. All urodynamic (UD) equipment and catheters used in this study were FDA approved for use in the U.S. and bore the CE Marking designating the manufacturer's compliance with Council Directive 93/68/EEC.
- the one subject who participated in the catheter portion of the study, was positioned in a semi-recumbent lithotomy position (approximately 60 degrees head up) such as using the structure shown in FIG. 3B as part of a quantitative analysis of the LES and IUS activity during inspiratory maneuvers.
- the subject performed deep and shallow breathing and breath hold maneuvers with simultaneous recording of LES and IUS pressures, and EMG intercostal inspiratory activity.
- the recordings were saved on the Lumax TS Pro for analysis of pressure waves and EMG activity.
- FIG. 5B shows a nerve conduction pathway diagram for the inspiration closure reflex.
- the BSV sequence in FIG. 5A shows the barium swallow (left frame) followed immediately by deep inspiration (middle frame), which closes the LES and stops the flow of barium in the right frame.
- the expiration during voluntary cough releases the LES and allows barium to enter the stomach.
- the schematic diagram shows that the inspiration closure reflex (ICR) occurs with the activation of pulmonary inspiratory afferent fibers and their termination in the nucleus tractus solitarius (NTS).
- ICR inspiration closure reflex
- the NTS influences the activity of the phrenic nucleus, dorsal motor nucleus of X and the sacral autonomic nucleus via descending pathways.
- This circuit regulates intrinsic sphincter tonicity during inspiration and expiration. This result was reproducible in all subjects.
- FIG. 6B shows a nerve conduction circuit diagram for a barium swallow during the breath-hoid.
- the ICR is demonstrated in the BSV photomontage images in FIG. 6A and the nerve conduction circuit diagram in FIG. 6B.
- the images depict the inspiration followed by swallowing barium.
- the LES closed with deep inspiration and remains closed during the entire duration of breath hold (greater than 20 seconds), which appeared to hold the barium above the LES.
- the barium stayed above the LES until expiration.
- FIG. 7 at the region of the distal esophagus the diaphragm and proximal stomach were magnified using two consecutive images from a breath hold images as photomontages, which are separated by three seconds.
- the arrows at the proximal esophagus indicate the level of barium solution.
- the arrowheads indicate the level of the proximal portion of the LES and the barium solution.
- the barium in the distal esophagus showed a distinctive V-shaped tapering of the esophagus that suggests a cuff-like closure of the LES.
- the dotted line in FIG. 7 in the first image was placed above the diaphragm shadow, which was clearly inferior to the distal tip of the barium solution. This result was reproducible in all subjects.
- FIGS. 8A and 8B show the Laryngeal Expiratory Reflex (LER).
- the BSV photomontage in FIG. 8A was taken during an LER cough epoch and showed no closure of the LES.
- the LES appeared to be patent during the LER cough epoch, which allowed barium to flow into stomach.
- the primary function of the LER is to clear the upper airway when food or fluids have entered the laryngeal vestibule.
- the nerve conduction circuit diagram in FIG. 8B shows that stimulation of laryngeal receptors, using the IRCT, initiates a series of 5 expiratory "coughs" without inspiration, i.e., the LER cough epoch.
- the nucleus tractus soiitarius influences the phrenic nucleus and dorsal motor nucleus of X, which innervate the diaphragm and LES, respectively.
- FIGS. 9B and 9B shows pressure recordings of the IUS and LES synchronized with respiration.
- Simultaneous pressure recordings of the IUS (P IUS ) and LES (P LES ) with respiratory EMG of the intercostal muscles at the T7-8 interspace demonstrated the activity of the ICR during breathing.
- pressure waves indicated the respiratory rate and depth dependent variation.
- FIG. 10 is a graph showing the latencies of the LES and IUS in relation to inspiration.
- the closure and pressure elevation of the IUS (P IUS ) and LES (P LES ) occurred after the initiation of inspiration. These closures (pressure waves) occur before the peak EMG activity, which is before the elevated IAP event in a voluntary respiratory maneuver.
- FIG. 8A the BSV images as photomontages were taken during an LER cough epoch.
- the LES appeared to be patent during the LER cough epoch, which allowed barium to flow into stomach.
- the primary function of the LER is to clear the upper airway when food or fluids have entered the laryngeal vestibule.
- the LER appears to be inhibitory for inspiration and breathing and the associated reflex motor activations, which prevent closure of the LES during the involuntary cough epoch.
- Prevention of closure of the LES, during involuntary elevated IAP may cause reflux of stomach contents in the presence of an incompetent gastric valve.
- FIG. 10 shows an unexpected rapid closure and pressure elevation of the IUS (P IUS ) within one second, after the initiation of each inspiration. This delay may be explained by the fast conduction (30-60 m/sec) of the descending pathway in the spinal cord from the nucleus tractus solitarius (NTS) via the lateral reticulospinal tract to the neurons in the sacral autonomic nucleus at S2-4 of the spinal cord.
- NTS nucleus tractus solitarius
- the 25 cm long, unmyelinated, peripheral nerve component conducts at 0.5 m/sec, and takes less than one second to close the IUS.
- the LES closure was slightly delayed by approximately 1.5 seconds after the initiation of inspiration.
- Control of the LES may be due to upper and lower esophageal reflexes and diaphragmatic reflexes, i.e., a crural reflex.
- Some studies refer to transient relaxation or inhibition of the LES in association with swallowing obstructive sleep apnea, mechanical ventilation and a negative pressure body ventilator.
- respiration pressure "artifacts" in the LES and IUS were not noted or were electronically filtered by manometry instruments. There may be respiratory influences on intrinsic sphincter function that have not been adequately evaluated.
- FIG. 11 A clinical example of the ICR function is shown in the urodynamic (UD) tracing of a series of voluntary and involuntary coughs in a female subject, who has moderate/severe SUI as shown in FIGS. 12A and 12B. The subject had an almost two-fold increase in average IAP with the VC, and each cough was preceded by a deep inspiration (inhalation). During the VC as shown in FIG.
- pulmonary inspiratory afferent fibers to the nucleus tractus solitarius may co-activate the phrenic nucleus, dorsal motor nucleus of X (DMN) and the sacral autonomic nucleus as shown in FIG. 11.
- NTS nucleus tractus solitarius
- LES closure and pressure elevation via the activation of the DMN may coincide with simultaneous activation of the diaphragm. This simultaneous activation may prevent hiatal herniation during elevated intra-abdominal pressure events such as Valsalva maneuver or pushing during labor and delivery.
- FIG. 13 is another nerve conduction circuit diagram showing the inspiration closure reflex. This diagram shows that the ICR occurs with the activation of pulmonary inspiratory afferent fibers and their termination in the Nucleus Tractus Solitarius (NTS). Centrally, the NTS influences the activity of the phrenic nucleus, dorsal motor nucleus of X and the sacral autonomic nucleus via descending pathways. This nerve conduction pathway circuit regulates intrinsic sphincter tonicity during inspiration and expiration.
- control unit 34 as shown, for example, in FIGS. 1-4 that is operative to correlate changes in the intra-abdominal pressure and duration with the depth of inspiration and processes the data for direct microwire or indirect wireless transmission to stimulators of the smooth muscle of the internal urethral sphincter or striated muscle for the external urethral sphincter or anal sphincter.
- a control unit 34 as shown, for example, in FIGS. 1-4 that is operative to correlate changes in the intra-abdominal pressure and duration with the depth of inspiration and processes the data for direct microwire or indirect wireless transmission to stimulators of the smooth muscle of the internal urethral sphincter or striated muscle for the external urethral sphincter or anal sphincter.
- trans-urethral or trans-vaginal implantation of muscle stimulators to the IUS, EUS and/or AS It is possible to test the smooth muscle using intra-urethral electrodes or a pressure transducer catheter.
- FIG. 14 is a flowchart showing a general sequence of steps that can be used for isolating the gastric valve and determine if the gastric valve is competent and
- kit shown in FIG. 16A can include the components for use with this methodology described relative to FIG. 14 and be used with the test system shown in FIG. 16B as explained below.
- the sequence begins with a barium swallow (block 130) immediately followed by the involuntary reflex cough test, i.e., iRCT, such as by inhaling a chemo-irritant such as L-tartrate through a nebulizer in one non-limiting example (block 132).
- the involuntary reflex cough test isolates the gastric valve from the LES.
- a determination is made using video fluoroscopy, for example, if the reflux has occurred (block 134). If not, the gastric valve is competent and correctly functioning (block 136). If reflux occurs, then the gastric valve is incompetent and is malfunctioning since it is allowing the reflux (block 138).
- FIG. 15 is another flowchart showing a sequence of steps used for assessing the competency of the gastric valve and isolating the gastric valve from the LES and also isolating the external urethral sphincter from the internal urethral sphincter to determine stress urinary incontinence.
- the process begins by inserting a urinary catheter in the patient with a pressure sensor in one example and a sensor located at the internal urethral sphincter in an example.
- the Ng/Og tube may include at least one sensor to be positioned at the LES and pH sensor at different positions. EMG pads can also be positioned at appropriate locations at the mid-axillary line of the T7-8 internal space (block 150).
- the bladder is filled such as with saline solution (block 152). Barium or other contrast material is swallowed (block 154) and the involuntary reflex cough test induced (block 156). Two analysis paths are shown. A determination is made whether urine leakage occurred (block 158). If not, then the external urethral sphincter is competent and functioning adequately (block 160). If yes, then the external urethral sphincter leaked indicative of stress urinary incontinence (SUi) (block 162). Some determination of the severity of SUI or other problems can possibly be determined through analyzing the EMG results together with any intraabdominal pressure that has been recorded during the involuntary reflex cough epoch.
- the contrast agent e.g., Barium Sulfate
- a patient kit for assessing the gastric valve in conjunction with fluoroscopy and the EUG can be provided and an example is shown in FIG. 16A at 200. Items in this illustrated kit include:
- Protocol information sheet 210 Protocol information sheet
- this kit 200 is to simplify the assessment of the gastric valve functioning (and/or external urethral sphincter) using the involuntary maneuver, i.e., involuntary reflex cough test (iRCT) to increase the intra-abdominal pressure to isolate the gastric valve while inhibiting the LES and, in some examples, isolating the external urethral sphincter.
- iRCT involuntary reflex cough test
- Evidence of gastric reflux can be observed directly using video fluoroscopy and evidence of SUI determined by isolating the external urethral sphincter to determine when there is urine leakage.
- a handheld processing unit such as described later relative to FIGS. 21 and 22, can be associated with the kit 200 and includes catheter inputs, EMG and other inputs.
- the gastric valve allows food to enter the stomach but prohibits reflux of gastric acid into the esophagus.
- the swivel adapter 208 for the nebulizer such that when the patient is turned over, the nebulizer through use of the swivel adapter can be more readily used by a doctor.
- FIG. 16B shows a patient examining system 250 for imaging any contract agent that can be used to implement the methodology as described.
- the patient examining system includes a bed 252 supported on a swivel/pivot 254 that is typically motor driven and allows the bed to be rotated and pivoted to place the patient in any predetermined position as inclined or turned over, if necessary.
- a nebulizer 256 is supported on a swivel adapter 258 and rotatable into various positions.
- the nebulizer 256 can be removable and could include a separate canister (shown by dotted lines at 215) or have nebulized medicine fed through a support arm 259 associated with the nebulizer and swivel adapter 258.
- Imaging sensor 260 can be positioned adjacent the patient for imaging barium or other contrast agent the patient has swallowed (or been forcibly administered depending on whether the patient is conscious).
- the processing unit 262 includes various inputs as described relative to the processing unit 218.
- the processing unit 262 can be a handheld processing unit or a fixed computer connected to the imaging sensor and various catheters inserted in the patient.
- the imaging sensor 260 in one example is a fluoroscopic instrument configured to image the contrasting agent.
- the imaging sensor is typically connected to the bed and moveable into a position adjacent the patient to image the contrast agent as it flows through the esophagus into the stomach during the involuntary reflex cough epoch.
- Data is transferred to the data processing unit where the data is processed and the amount of reflux that occurs during the involuntary reflex cough epoch measured to estimate the severity of the malfunctioning gastric valve in one example or the extent of the gastric valve adequate functioning. This could be accomplished, for example, by comparing a plurality of photomontages taken by the image sensor during the involuntary reflex cough test.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Radiology & Medical Imaging (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Pathology (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Heart & Thoracic Surgery (AREA)
- Gastroenterology & Hepatology (AREA)
- Physics & Mathematics (AREA)
- Physical Education & Sports Medicine (AREA)
- Physiology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Electrotherapy Devices (AREA)
Abstract
L'invention concerne un appareil de diagnostic d'au moins un sphincter interne. Un dispositif de contraction musculaire est situé sur au moins l'un des sphincters urétral et anal. Une unité de commande est connectée au dispositif de contraction musculaire et fonctionne pour transmettre des signaux de commande au dispositif de contraction musculaire, situé sur au moins l'un des sphincters urétral et anal, afin de contracter un muscle pendant une phase d'inspiration de la respiration.
Applications Claiming Priority (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/456,841 US9005121B2 (en) | 2011-04-29 | 2012-04-26 | System and method of testing the gastric valve and urethral sphincter |
US13/456,841 | 2012-04-26 | ||
US201261738027P | 2012-12-17 | 2012-12-17 | |
US61/738,027 | 2012-12-17 | ||
US201361756246P | 2013-01-24 | 2013-01-24 | |
US61/756,246 | 2013-01-24 | ||
US13/838,196 | 2013-03-15 | ||
US13/838,196 US20130204313A1 (en) | 2011-04-29 | 2013-03-15 | System to diagnose the function of intrinsic sphincters |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2013163267A1 true WO2013163267A1 (fr) | 2013-10-31 |
Family
ID=49483845
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2013/037929 WO2013163267A1 (fr) | 2012-04-26 | 2013-04-24 | Appareil de diagnostic de sphincters internes |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2013163267A1 (fr) |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2016037144A3 (fr) * | 2014-09-04 | 2016-09-15 | AtaCor Medical, Inc. | Système d'implantation de sonde de stimulation cardiaque |
US9636505B2 (en) | 2014-11-24 | 2017-05-02 | AtaCor Medical, Inc. | Cardiac pacing sensing and control |
US10328268B2 (en) | 2014-09-04 | 2019-06-25 | AtaCor Medical, Inc. | Cardiac pacing |
US10743960B2 (en) | 2014-09-04 | 2020-08-18 | AtaCor Medical, Inc. | Cardiac arrhythmia treatment devices and delivery |
US11097109B2 (en) | 2014-11-24 | 2021-08-24 | AtaCor Medical, Inc. | Cardiac pacing sensing and control |
US11666771B2 (en) | 2020-05-29 | 2023-06-06 | AtaCor Medical, Inc. | Implantable electrical leads and associated delivery systems |
US11672975B2 (en) | 2019-05-29 | 2023-06-13 | AtaCor Medical, Inc. | Implantable electrical leads and associated delivery systems |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1990011042A1 (fr) * | 1989-03-20 | 1990-10-04 | Nims, Inc. | Mesure non invasive de la fonction cardiaque |
US6819957B1 (en) * | 2001-08-29 | 2004-11-16 | Tuan Vinh Le | Electrical stimulation apparatus and method |
US20060190051A1 (en) * | 2005-02-23 | 2006-08-24 | Medtronic, Inc. | Implantable medical device providing adaptive neurostimulation therapy for incontinence |
US20100076254A1 (en) * | 2006-06-05 | 2010-03-25 | Ams Research Corporation | Electrical muscle stimulation to treat fecal incontinence and/or pelvic prolapse |
US20110040211A1 (en) * | 2005-10-18 | 2011-02-17 | Pneumoflex Systems, Llc | Oral-esophageal-gastric device to diagnose reflux and/or emesis |
WO2012000681A2 (fr) * | 2010-07-02 | 2012-01-05 | Myopowers Medical Technologies Sa | Dispositif médical comportant une structure contractile artificielle |
US20120277547A1 (en) | 2011-04-29 | 2012-11-01 | Pneumoflex Systems, Llc | System and method of testing the gastric valve and urethral sphincter |
-
2013
- 2013-04-24 WO PCT/US2013/037929 patent/WO2013163267A1/fr active Application Filing
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1990011042A1 (fr) * | 1989-03-20 | 1990-10-04 | Nims, Inc. | Mesure non invasive de la fonction cardiaque |
US6819957B1 (en) * | 2001-08-29 | 2004-11-16 | Tuan Vinh Le | Electrical stimulation apparatus and method |
US20060190051A1 (en) * | 2005-02-23 | 2006-08-24 | Medtronic, Inc. | Implantable medical device providing adaptive neurostimulation therapy for incontinence |
US20110040211A1 (en) * | 2005-10-18 | 2011-02-17 | Pneumoflex Systems, Llc | Oral-esophageal-gastric device to diagnose reflux and/or emesis |
US20100076254A1 (en) * | 2006-06-05 | 2010-03-25 | Ams Research Corporation | Electrical muscle stimulation to treat fecal incontinence and/or pelvic prolapse |
WO2012000681A2 (fr) * | 2010-07-02 | 2012-01-05 | Myopowers Medical Technologies Sa | Dispositif médical comportant une structure contractile artificielle |
US20120277547A1 (en) | 2011-04-29 | 2012-11-01 | Pneumoflex Systems, Llc | System and method of testing the gastric valve and urethral sphincter |
US20120277583A1 (en) | 2011-04-29 | 2012-11-01 | Pneumoflex Systems, Llc | System and method for testing the gastric valve |
Cited By (27)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11051847B2 (en) | 2014-09-04 | 2021-07-06 | AtaCor Medical, Inc. | Cardiac pacing lead delivery system |
US10328268B2 (en) | 2014-09-04 | 2019-06-25 | AtaCor Medical, Inc. | Cardiac pacing |
US9707389B2 (en) | 2014-09-04 | 2017-07-18 | AtaCor Medical, Inc. | Receptacle for pacemaker lead |
US10022539B2 (en) | 2014-09-04 | 2018-07-17 | AtaCor Medical, Inc. | Cardiac pacing |
US10105537B2 (en) | 2014-09-04 | 2018-10-23 | AtaCor Medical, Inc. | Receptacle for pacemaker lead |
US10195422B2 (en) | 2014-09-04 | 2019-02-05 | AtaCor Medical, Inc. | Delivery system for cardiac pacing |
US10315036B2 (en) | 2014-09-04 | 2019-06-11 | AtaCor Medical, Inc. | Cardiac pacing sensing and control |
US11844949B2 (en) | 2014-09-04 | 2023-12-19 | AtaCor Medical, Inc. | Cardiac defibrillation |
US10420933B2 (en) | 2014-09-04 | 2019-09-24 | AtaCor Medical, Inc. | Cardiac pacing |
US10743960B2 (en) | 2014-09-04 | 2020-08-18 | AtaCor Medical, Inc. | Cardiac arrhythmia treatment devices and delivery |
US10905885B2 (en) | 2014-09-04 | 2021-02-02 | AtaCor Medical, Inc. | Cardiac defibrillation |
US11229500B2 (en) | 2014-09-04 | 2022-01-25 | AtaCor Medical, Inc. | Directional stimulation leads and methods |
US11937987B2 (en) | 2014-09-04 | 2024-03-26 | AtaCor Medical, Inc. | Cardiac arrhythmia treatment devices and delivery |
WO2016037144A3 (fr) * | 2014-09-04 | 2016-09-15 | AtaCor Medical, Inc. | Système d'implantation de sonde de stimulation cardiaque |
US11026718B2 (en) | 2014-09-04 | 2021-06-08 | AtaCor Medical, Inc. | Delivery system for cardiac pacing |
US11857380B2 (en) | 2014-09-04 | 2024-01-02 | AtaCor Medical, Inc. | Cardiac arrhythmia treatment devices and delivery |
US12128239B2 (en) | 2014-11-24 | 2024-10-29 | AtaCor Medical, Inc. | Cardiac pacing sensing and control |
US11931586B2 (en) | 2014-11-24 | 2024-03-19 | AtaCor Medical, Inc. | Cardiac pacing sensing and control |
US9636505B2 (en) | 2014-11-24 | 2017-05-02 | AtaCor Medical, Inc. | Cardiac pacing sensing and control |
US11097109B2 (en) | 2014-11-24 | 2021-08-24 | AtaCor Medical, Inc. | Cardiac pacing sensing and control |
US12226641B2 (en) | 2014-11-24 | 2025-02-18 | AtaCor Medical, Inc. | Cardiac pacing sensing and control |
US11672975B2 (en) | 2019-05-29 | 2023-06-13 | AtaCor Medical, Inc. | Implantable electrical leads and associated delivery systems |
US11998736B2 (en) | 2019-05-29 | 2024-06-04 | AtaCor Medical, Inc. | Implantable electrical leads and associated delivery systems |
US11998735B2 (en) | 2019-05-29 | 2024-06-04 | AtaCor Medical, Inc. | Implantable electrical leads and associated delivery systems |
US12208260B2 (en) | 2019-05-29 | 2025-01-28 | Kurin, Inc. | Implantable electrical leads and electrodes |
US11666771B2 (en) | 2020-05-29 | 2023-06-06 | AtaCor Medical, Inc. | Implantable electrical leads and associated delivery systems |
US12121738B2 (en) | 2020-05-29 | 2024-10-22 | AtaCor Medical, Inc | Implantable electrical leads and associated delivery systems |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20130289363A1 (en) | Method for diagnosing the function of intrinsic sphincters | |
US9232917B2 (en) | Urinary catheter system for diagnosing a physiological abnormality such as stress urinary incontinence | |
US11883658B2 (en) | Devices and methods for prevention, moderation, and/or treatment of cognitive injury | |
WO2013163267A1 (fr) | Appareil de diagnostic de sphincters internes | |
AU2010340316B2 (en) | Oral-esophageal-gastric device with esophageal cuff to reduce gastric reflux and/or emesis | |
US20140288612A1 (en) | System to treat at least one of the urethral and anal sphincters | |
AU2010333964B2 (en) | Oral-esophageal-gastric device to diagnose reflux and/or emesis | |
AU2010333963B2 (en) | Improved esophageal airway protection device and use of the airway protection device in an involuntary cough test as a medical diagnostic tool | |
JP7462946B2 (ja) | 呼吸筋を強化するためのシステム及び方法 | |
US20120190938A1 (en) | System and method of diagnosing acid reflux using involuntary reflex cough test | |
US20130204313A1 (en) | System to diagnose the function of intrinsic sphincters | |
WO2015187615A1 (fr) | Système de cathéter urinaire pour le diagnostic d'une anomalie physiologique telle que l'incontinence urinaire à l'effort | |
AU2012207188A1 (en) | System and method of diagnosing acid reflux using involuntary reflex cough test | |
AU2014201221A1 (en) | Oral-esophageal-gastric device with esophageal cuff to reduce gastric reflux and/or emesis | |
AU2014200939A1 (en) | Oral-esophageal-gastric device to diagnose reflux and/or emesis |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 13724043 Country of ref document: EP Kind code of ref document: A1 |
|
DPE1 | Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101) | ||
NENP | Non-entry into the national phase |
Ref country code: DE |
|
122 | Ep: pct application non-entry in european phase |
Ref document number: 13724043 Country of ref document: EP Kind code of ref document: A1 |