| Breathing disorder detection and therapy device for providing intrinsic breathing -> Monitor Keywords |
|
|
  Breathing disorder detection and therapy device for providing intrinsic breathingRelated Patent Categories: Surgery: Light, Thermal, And Electrical Application, Light, Thermal, And Electrical Application, Electrical Therapeutic Systems, Stimulating Respiration FunctionThe Patent Description & Claims data below is from USPTO Patent Application 20060030894. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] The invention relates to a device and method for detection, diagnosis and treatment of breathing insufficiencies or irregularities and to the management of pulmonary rhythm. Such irregularities may include, for example, hyperventilation, hypoventilation and apnea. The invention also relates to stimulating respiration in response to detecting hypoventilation or apnea. BACKGROUND OF THE INVENTION [0002] Breathing insufficiencies and irregularities may occur in conjunction with or as a result of a variety health related disorders and may further cause or exacerbate health disorders. Such breathing insufficiencies and irregularities may include, for example, hyperventilation, hypoventilation, apnea, and other related breathing disorders. Hyperventilation, which results in hyperoxia, is a condition in which the respiratory rate is pathologically high or is above a desired rate. Hyperventilation may occur due to pulmonary edema or excess fluid built up in the lungs and may ultimately result in apnea episodes. Hypoventilation is a condition in which the respiratory rate is pathologically low or below a desired rate. Apnea (absence of breathing) is a breathing disorder most typically occurring during sleep that can result from a variety of conditions. Sleep apnea typically results in some sort of arousal or wakefulness following cessation of breathing. [0003] Sleep disordered breathing disorders include two types of sleep apnea: obstructive sleep apnea (partial apnea or obstructive apnea) and central sleep apnea. Obstructive sleep apneas result from narrowing of the pharynx with out-of-phase breathing in an effort to create airflow, whereas central sleep apnea arises from reductions in central respiratory drive. During obstructive sleep apnea, respiratory effort increases. In central sleep apnea, respiratory movements are absent or attenuated but in phase. [0004] Disordered breathing may contribute to a number of adverse cardiovascular outcomes such as hypertension, stroke, congestive heart failure, and myocardial infarction. Sleep-related breathing disorders, especially central sleep apnea, have been found to have a relatively high prevalence in patients with heart failure and may have a causative or influencing effect on heart failure. In about 50% of patients with stable congestive heart failure, there is an associated sleep disordered breathing, predominantly central sleep apnea with a minority having obstructive sleep apnea. Furthermore, sleep related breathing disorders are believed to be physiologically linked with heart failure. Central sleep apnea is a known risk factor for diminished life expectancy in heart failure. It is also believed that in view of this link, treatment aimed at relieving sleep related breathing disorders may improve cardiovascular outcomes in patients with heart failure. [0005] Pulmonary edema, a condition in which there is excess fluid in the lungs and often found in heart failure patients, is believed in some circumstances to lead to hyperventilation and hyperoxia or apnea. Most heart failure patients with central sleep apnea, when lying flat, tend to have central fluid accumulation and pulmonary congestion, which stimulates vagal irritant receptors in the lungs to cause reflex hyperventilation. Central Sleep Apneas usually are initiated by reduction in PCO.sub.2 resulting from the increase in ventilation. When PCO.sub.2 falls below the threshold level required to stimulate breathing, the central drive to respiratory muscles and airflow cease or diminish significantly and apnea (or attenuated breathing) ensues until the PCO.sub.2 rises again above the threshold required to stimulate ventilation. Often spontaneous arousal occurs with apnea. [0006] Currently a number of methods are used to treat sleep apnea. For example, supplemental oxygen such as, e.g., with a nasal ventilator, has been used to relieve symptoms of sleep apnea. Non-invasive airway pressure including continuous positive airway pressure (CPAP), bivalve and adaptive pressure support servo-ventilation have been used to treat central sleep apnea and obstructive sleep apnea with varying results. Another method to treat central sleep apnea is using aggressive diuresis to lower cardiac filling and beta-blocker and angiotensin-converting enzymes. However, this treatment does not lead to an optimum therapy since excessive use of diuretics leads to renal complications and patient discomfort. [0007] A method and apparatus for treatment of obstructive sleep apnea has been proposed where an implantable pulse generator stimulates a nerve in the upper airway tract of a patient to elicit a contraction by an innervated muscle through the provision of electrical stimuli. The stimulator is intended to treat the obstructed airway passage to permit breathing. The pulse generator is attached to electrodes placed on the patient's diaphragm for sensing the respiratory effort of a patient whereupon the stimulation is adjusted. The method and apparatus do not provide a satisfactory treatment or central sleep apnea. [0008] Phrenic nerve stimulation has been used to stimulate the diaphragm throughout an overnight period to treat sleep apnea. The device used was turned on at night to stimulate the nerve continuously and then turned off during the day. However, this device was not adapted for situations where patients would breath spontaneously. [0009] Accordingly it would be desirable to provide a method and apparatus for treating breathing disorders such as apnea, and hypoventilation, and especially central sleep apnea. Furthermore it would be desirable to provide treatments for breathing related disorders related pulmonary edema and conditions in heart failure patients. SUMMARY OF THE INVENTION [0010] The present invention provides a method and apparatus for treating breathing disorders by sensing the respiratory parameters of the diaphragm and stimulating an associated body organ or tissue to control movement of the diaphragm and thus manage respiration. In a variation the method and apparatus provide stimulation to the diaphragm to elicit diaphragm movement to cause respiration when respiration ceases or falls below a threshold level. [0011] One embodiment is a device comprising: a sensor for sensing information corresponding to respiratory effort of the diaphragm and a processor for processing the sensed information and delivering electrical stimulating pulses to the associated body organ or tissue based on sensed information. The processor may further determine stimulation parameters based at least in part on sensed information. Also, the processor may determine when to cease stimulation by determining when the body resumes normal respiratory function. [0012] The respiratory effort may be sensed, for example, by sensing the phrenic nerve activity and/or the EMG of the diaphragm, or by detecting movement of the diaphragm or chest. Respiration by, the diaphragm may be stimulated by electrically stimulating the phrenic nerve and/or by stimulating the diaphragm muscle. [0013] A number of different parameters may be programmed into the processor to determine if certain breathing disorders are present, and when and how to stimulate respiration, and when to stop or modify stimulation. [0014] Phrenic nerve or EMG activity sensed may include, for example, amplitude, frequency, and waveform to determine central respiratory efforts, the absence, a decrease in amplitude, abnormalities in frequency and/or amplitude, or waveform morphology of which may indicate the onset of apnea, hyperventilation, or hypoventilation. The nerve activity may be compared to predetermined activity levels or patient historical activity. Similarly, diaphragm EMG amplitude, frequency, waveform morphology and history may be used to determine apnea, hyperventilation and hypoventilation. For example, the nerve activity at the onset of sleep or after a given time in a reclining position, may be used as a baseline or comparison. [0015] An awake sinus zone may be defined as a respiratory rate or range of races programmed into the device for a specific patient when awake, where the respiratory race is considered normal and intrinsic. A preprogrammed EMG amplitude or range may define a normal rance in this state. A sleep sinus may be defined as a respiratory rate or range of rates programmed into the device for a specific patient when asleep where the respiratory rate is considered normal and intrinsic. A preprogrammed EMG amplitude or range may define a normal range in this state. The device may be programmed to match the EMG rate and amplitude to a normal rate and amplitude by auto adjusting the pace output. [0016] Hypoventilation may be detected where the respiratory rate or frequency falls below a programmed rate. Hyperventilation may be detected when the respiratory rate or frequency is above a programmed rate. Complete apnea or central apnea is defined as a condition where there is no effective EMG signal or phrenic nerve signal, i.e. where there is no effective or significant physiological response. Frequently, a hyperventilation episode is followed by loss of diaphragm EMG or phrenic nerve activity. The device may be programmed to first detect the hyperventilation and wait for a preprogrammed time to be considered apnea. For example the time may be set to 10-20 seconds of lost EMG after a hyperventilation episode to detect complete apnea. Partial apnea or obstructive sleep apnea is defined to be present when the EMG or phrenic nerve activity is attenuated and may be detected when the amplitude drops below a programmed amount. For example such amount may be based on the EMG or phrenic nerve amplitude dropping a percentage, e.g. 50% of the Sleep Sinus EMG amplitude. Also the phase of the respiratory cycles in partial apnea may be determined or compared to an in phase cycle. An cut of phase or arrhythmic cycle may also be used to detect partial apnea. [0017] In addition, position sensors may be used to determine degree of patient reclining or standing, e.g., in increments of degrees. Information from the position sensor mart be used as a tool to match respiratory activities and patterns to the position of the patient. Accelerometer information may be used to determine information regarding patient's physical activity, e.g., to match/compare to the respiratory patterns and activities and collect data on related patient activities, respiratory activities, and create or adjust a treatment plan based thereon, (e.g., modification of diuretics or ACE inhibitors). Accelerometer sensors may also be used to determine information regarding movement pattern of the diaphragm muscles, intercostal muscles, and rib movement and thus determine overall respiratory activity and patterns. [0018] According to an embodiment, a stimulator includes an implantable controller coupled through leads to electrodes to be implanted on the diaphragm in the vicinity of the phrenic nerve branches. The electrodes may sense either nerve activity or EMG signals of the diaphragm. The stimulator may further include a pulse generator configured to deliver stimulating pulses, either to the same electrodes used for sensing or to additional stimulation electrodes. The stimulation electrodes may also be placed adjacent the phrenic nerve at some point along its length to provide stimulation pulse to the nerves, which in turn enervate the diaphragm muscle causing contractions and resulting respiration. Alternatively the electrodes may be placed on the phrenic nerve for both sensing and stimulation. [0019] Stimulation of respiration may be initiated when "no" or "attenuated" respiratory activity has been present or detected for a time period (when apnea is detected). The time period may be pre-programmed for a specific patient by the physician, as otherwise preset, or as determined a program in the treatment device. The device may be programmable for other breathing disorders, allowing slow or fast inspiration and visa versa allowing slow or fast expiration. For example, based on programmed parameters of the activity sensor, for patients suffering from hypoventilation, the inspiration rate may be increased or decreased based on the level of activity. [0020] Pacing starts at given intervals. In one embodiment the interval time is initially about 10 seconds. The interval is slowly increased from 11 seconds to about 15 seconds. If the patient does not breath on their own, the pacing begins again at 10-second intervals and this is repeated. If the patient begins breathing on their own, typically where the PO.sub.2 and PCO.sub.2 levels are normalized and the brain resumes sending nerve stimulation. The system then returns to the mode where it is sensing respiratory effort. [0021] An additional feature of the invention may include a patient self-management module. The module can be an external device configured to telemetrically communicate with the implanted device. The module is configured to communicate information with the patient based on what is received from the implantable device. The information may also be communicated with a provider who can upload information regarding the status of the patient including urgent interventions. The device may include, paging, e-mail, fax or other communication capabilities that can send information to a clinician. The device can be worn or carried with the patient while the patient is away from home. The device may be used to prompt the patient to comply with life-style and medication based on programmed parameters by the provider. The device may require the patient to interact with the device confirming compliance. The provider may receive information on patient compliance. Continue reading... Full patent description for Breathing disorder detection and therapy device for providing intrinsic breathing Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Breathing disorder detection and therapy device for providing intrinsic breathing patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Breathing disorder detection and therapy device for providing intrinsic breathing or other areas of interest. ### Previous Patent Application: Means for increasing implantable medical device electrode surface area Next Patent Application: Method for treating degenerative disc disease using noninvasive capacitively coupled electrical stimulation device Industry Class: Surgery: light, thermal, and electrical application ### FreshPatents.com Support Thank you for viewing the Breathing disorder detection and therapy device for providing intrinsic breathing patent info. IP-related news and info Results in 0.14146 seconds Other interesting Feshpatents.com categories: Accenture , Agouron Pharmaceuticals , Amgen , AT&T , Bausch & Lomb , Callaway Golf |
||
