New Nasal Device Seeks to Give CPAP a Run For Its Money

[Johnny1959]

Just came across this, thought I post website url

http://www.sleepguide.com/profiles/blog ... ks-to-give

[Outlawswife47]

It sure doesn't look like something that would work! Looks like it just fits into the nose. Plus, as a person who recycles, I'm concerned about the idea of using something only for one night and then tossing it into the landfill! Plus -- cost?????? Will be interesting to see if it really works. I DID like the line about doctors' and DMEs doing a better job.....

[Julie]

But how will that keep your airway open (once the air gets past the nose) if there's no pressure? Plus who in their right mind invents new things today that are used once and then thrown away - like Swiffer(s) - it strikes me that kind of thing should be illegal from now on.

[StillAnotherGuest]

This product was discussed briefly in the thread

And Yet Another "Simply Amazing"

[quote="the Ventus Medical Patent For "Nasal respiratory devices for positive end-expiratory pressure" (seriously) "]

Uses of the Respiratory Devices

The respiratory devices and methods described herein may be used for a variety of therapeutic and non-therapeutic purposes, particularly uses in which PEEP would be helpful. A description of some of these uses is given below. The respiratory devices and methods described herein may be used in other ways as well, and these examples are not to be considered exhaustive.

Generally, the respiratory devices described herein may improve the respiratory and cardiovascular function of a person in need thereof (e.g., a patient). Thus, these respiratory devices may be used therapeutically, for example, to cure, treat or ameliorate the symptoms of a variety of medical disease states. Furthermore, the respiratory devices may be useful in generally improving the health and well being of any person.

Disease states which may be treated by the devices and methods described herein include but are not limited to: heart failure (right-sided and/or left-sided), COPD, pulmonary edema, sleep apnea (obstructive and/or central), sleep-disordered breathing, Cheyne-Stokes respiration, insomnia, snoring and other sleep disorders, asthma, bronchomalacia, acute lung injury, ARDS, cystic fibrosis, hypoxemic respiratory failure, gastroesophageal reflux disease, hiatal hernia, heartburn, hypertension, myocardial infarction, arrhythmia, cardiomyopathy, cardiac valve disease (either stenosis or regurgitation of the mitral, aortic, tricuspid, or pulmonic valves), stroke, transient ischemic attack, increased cerebral pressure, a variety of inflammatory diseases, and degenerative neurologic conditions. Moreover, the devices may be beneficial for patients being weaned off mechanical ventilation, as well as post-operative patients.

The increased pressure within the airways may reduce the amount and frequency of pulmonary edema, a common consequence of heart failure. Afterload and preload on the heart may also be affected; for example, afterload and preload may be decreased in patients with heart failure. Filling pressures may be increased or, more likely, decreased. Decreasing filling pressure may potentially benefit patients with failing hearts. Gas exchange may improve in many cases, leading to increases in pO 2 and decreases in pCO 2 . In some cases, the level of pCO 2 may actually increase or become more stable and less likely to fluctuate. This increase in the stability of pCO 2 levels may lead to profound benefits in patients with central sleep apnea and in patients with Cheyne-Stokes breathing, for example. Oxygen saturation levels may improve. Oxygen desaturations which may result from apneas or hypopneas may no longer drop as far. For example there may be fewer oxygen desaturations to the 80-89% range. Fewer oxygen desaturations may drop below 90%. Duration of desturations may also be reduced. The use of the device to reduce oxygen desaturations (perhaps leading to performance enhancement) while awake or asleep may represent a viable market opportunity for the device.

In some cases, the use of a expiratory resistor will interfere with loop gain, and will thus promote more stable breathing. In other cases, the device will reduce the amplitude, duration, and frequency of snoring.

Any location within the body that is exposed to respiratory airflow (including but not limited to the upper airway, trachea, bronchi, nasopharynx, oropharynx, nasal cavity, oral cavity, vocal cords, larynx, tonsils and related structures, back of the tongue, sinuses, and turbinates) may benefit from the increased airway pressure and increased duration of expiratory airflow. In some cases, there will be a reduction in swelling and edema in these locations, leading to increased diameters of the airways and conduits in which the airflow passes. This leads to less of a tendency for these structures to collapse upon inhalation. Moreover, these structures may be less prone to create noise on inspiration or expiration, thereby reducing the quantity and/or quality of snoring. Put another way, the reduction of edema in the airways may make it less likely that these structures will collapse and may reduce the volume and frequency of snoring, apnea, or hypopnea. Furthermore, reduction in swelling and edema and improved lymphatic flow due to these positive pressures may reduce nasal congestion, inflammation, and sinusitis for example.

The respiratory device may also increase lung compliance. For example, lung compliance may increase partly if fluid which might otherwise be in the lung and alveoli is driven away by the increased airway pressure. This increased lung compliance may make it easier to breathe and may require less effort and force on the part of the patient to displace the diaphragm a certain distance to achieve a certain tidal volume. Moreover, increased lung compliance may decrease the pressure differential between the alveoli and mouth. As this pressure differential decreases, it becomes less likely that an inhalation attempt will induce a collapse of the upper airway. Thus, an increase in lung compliance may herald a reduction in the frequency or severity of obstructive sleep apnea or hypopnea episodes. Similarly, snoring frequency and severity (volume) may be reduced for similar reasons.

The respiratory device may also improve ejection fraction. This effect may be mediated via increases in intra-thoracic pressure and alterations in transmural pressures and the beneficial effects on preload and afterload on the failing heart. In addition to left-sided benefits to the heart, there may also be benefits afforded to the right side of the heart. Improving ejection fraction with the respiratory devices described herein may result in positive short- and long-term changes to the energetics and biologic properties of the heart tissue. Some of these positive changes may mimic the positive remodeling changes seen in hearts treated with various complicated cardiac support devices such as those developed by Acorn Cardiovascular (St. Paul, Minn.) and Paracor Medical (Sunnyvale, Calif.). These expiratory resistors use the patient's own intra-thoracic pressure to “support” the patient's heart. Moreover, because the support potentially provided by the respiratory devices described herein is not limited to just the ventricle, it may support the atria, which can also be severely affected by heart failure and other cardiac or pulmonary diseases. There may be reductions in left ventricular and left atrial sizes, both in the shorter and longer term. Furthermore, cardiac sympathetic activation may be reduced, and cardiac output may be increased or decreased depending on the nature of the resistance provided.

There are a variety of other beneficial effects of enhanced expiratory resistance and increases in intra-thoracic pressure that may be achieved with the respiratory devices described herein. Examples include decreased heart rate and blood pressure. There may be a reduction in the number of arrhythmias, including but not limited to atrial/supraventricular and ventricular fibrillation, atrial/supraventricular and ventricular tachycardias, heart block, and other common arrhythmias. Thus, the respiratory devices described herein may also reduce the incidence of sudden cardiac death and other cardiac disorders. Furthermore, coronary perfusion may be expected to increase. Further, expiratory resistance and increased intra-thoracic pressures may lead to improvements in gastroesophageal reflux disease (i.e., heartburn), gastritis, Barrett's esophagus, esophageal cancer, hiatal hernia, and other causes of diaphragmatic hernia. This effect may be mediated by the compression of the esophagus located within the thorax due to the increased intra-thoracic pressures. As a result, food and other stomach contents may no longer be able to reflux superiorly into the esophagus, which is otherwise common when patients are lying down. Furthermore, hernias (primarily hiatal) may be reduced and pushed back into the abdomen by the increased intra-thoracic pressure. The use of these respiratory devices may have beneficial effects on other gastroenterologic conditions beyond those already described.

Cardiac valve disease, including but not limited to mitral, tricuspid, pulmonic and aortic regurgitation, and mitral, tricuspid, pulmonic and aortic stenosis may also benefit from the respiratory devices described herein. In particular, the respiratory device may effect mitral regurgitation and may help prevent further annular dilatation (a byproduct of heart failure and generalized heart dilation).

Use of the respiratory devices described herein will result in a reduction in respiratory rate, which may be very helpful in diseases such as COPD, asthma, hyperventilation, and anxiety disorders including panic attacks, among others. The ratio of inspiratory time to expiratory time (I:E ratio) may be decreased with the device. Tidal volumes may increase as well. For example, in COPD, the increased resistance may facilitate improved expiratory function. This may also allow the patient to benefit from larger tidal volumes and increased minute ventilation. In still other cases, respiratory rate may be increased and in other cases, minute ventilation may be decreased.

The amount of PEEP (or resistance generated by the device) may overcome some, or all, of the intrinsic PEEP that is common in patients with COPD. In patients with COPD or other pulmonary disorders, or even patients without disease, gas exchange may improve. In this case, gas exchange refers to the removal of CO 2 from the body and addition of O 2 into the blood stream from inspired air. Thus, pO 2 may increase and pCO 2 may decrease, particularly in patients with COPD, but more generally in all patients treated with the device. Moreover, oxygen saturation may increase, reflecting an increase of oxygen binding to hemoglobin.

Other benefits offered by the respiratory device may include a reduction in diaphragm fatigue and improved efficiency of the accessory muscles of inspiration. This may make breathing significantly easier in patients with pulmonary disease, and more specifically COPD and cystic fibrosis.

As previously mentioned, the respiratory devices described herein may decrease respiratory rate. It has been shown that slowed breathing techniques can lead to a reduction in blood pressure. Thus, the device may reduce blood pressure in a patient, including patients with hypertension (systemic and pulmonary). The reduction in blood pressure may be systolic and/or diastolic. Reductions in blood pressure may be on the order of 1-70 mm Hg systolic or diastolic. This may bring the patient to normal (<140/80 mm Hg) or near normal (<160/100 mm Hg) levels. In patients who are being treated for hypertension, the device could be used as an adjunctive therapy to drugs or as a stand-alone therapy in some patients. In some versions, a respiratory device as described herein may be used for short periods (minutes, hours, or longer) over a span of days to weeks to months to offer longer term benefits for weeks or months after the cessation of therapy. Treatments may last 15 seconds to 24 hours and may be repeated over a regular or irregular interval, for example, on the order of hours to days. The devices may be worn at night or day, while awake or during sleep, to slow respiratory rate. A reduction in blood pressure and/or heart rate may be seen while the device is in place, or after the device has been removed. This may be due to hormonal influences whose effects last longer than the period in which the device is in place. More specifically, the device may work though either a sympathetic or parasympathetic pathway.

Expiratory resistance may also prolong expiratory time, which may reduce the respiratory rate. Thus, the devices described herein may be used to reduce respiratory rate. This may have benefits in treating insomnia, since it may promote a sense of relaxation in the user, through increased parasympathetic stimulation, decreased sympathetic simulation, and/other hormonal and non-hormonal effects. This may also promote a sense of well being or relaxation that may allow the user to fall asleep easier and quicker and improve sleep quality and quantity. Thus, the respiratory devices described herein represent a novel non-pharmacologic method of treating insomnia and promoting relaxation. The device may be used throughout the day and/or night to promote said relaxation and well being.

The respiratory devices described herein may also be used to treat or ameliorate disorders characterized by ineffective, non-productive, or otherwise disturbed inspiration (including but not limited to obstructive sleep apnea or restrictive pulmonary disease). For example, with the device in place, a patient may be more likely to have slightly elevated lung volumes after exhalation. Put another way, more air than normal may be present in the lungs after exhalation when using some versions of the device. Fewer alveoli may be collapsed; thus inhalation may be easier because it will require less effort to re-open the alveoli during the subsequent breath. Moreover, pulmonary congestion and pulmonary edema may also be reduced, so compliance may be improved. As a result, it may require less effort for patients to inhale. It follows that a smaller pressure differential (between the alveoli and the mouth) will be required. The smaller the pressure differential, the less likely that the patient's conducting airways (including the upper airways and pharyngeal tissues) will collapse, thus reducing the likelihood of obstructive sleep apnea, hypopnea, and snoring.

Infectious diseases may also benefit from the respiratory devices described herein. These diseases include but are not limited to pneumonia (community and hospital acquired), tuberculosis, bronchitis, HIV, and SARS.

The respiratory devices may also be useful in pulmonary or cardiac rehabilitation. For example, the device may find use in patients with chronic pulmonary disease including but not limited to chronic bronchitis, emphysema, asthma, pulmonary fibrosis, cystic fibrosis, and pulmonary hypertension. Alternatively, the devices may benefit patients with cardiac disease, including but not limited to: angina, myocardial infarction, right or left sided heart failure, cardiomyopathy, hypertension, valve disease, pulmonary embolus, and arrhythmia.

Patients with obesity may also benefit from the use of the respiratory devices described herein. Obesity can contribute to exercise intolerance partly because it increases the metabolic requirement during activity and alters ventilatory mechanics by reducing functional residual capacity (FRC) and promoting atelectasis. Obesity may also reduce cardiac reserve, since a higher than normal cardiac output response is required during physical activity. This in turn may cause systemic hypertension, which increases left ventricular afterload. Thus, the device, through its potential reduction in atelectasis and beneficial effects on FRC, cardiac output, and blood pressure may be useful in patients with obesity.

It has been suggested that expiratory positive airway pressure (as induced by the subject devices) may increase neural drive to the muscles that serve to maintain upper airway patency. Furthermore, FRC increases may improve length-tension relationships of the inspiratory muscles, allowing inspiratory pressures to decrease. This reduction of inspiratory pressure would thus make it less likely for the upper airway to obstruct, presumably due to a reduction in the transmural pressure gradient. As previously suggested, positive end expiratory pressure may improve ventilation-perfusion relationships which may improve oxygen saturation.

Furthermore, it is known that the upper airway partially or completely occludes during the expiratory phase of the breaths preceding an occlusive apnea. It is this narrowing of the upper airway at end-expiration that sets the stage for total occlusion during the next inspiration as subatmospheric pressures are generated within the airway. Expiratory positive airway pressure may therefore prevent airway narrowing during expiration, thus reducing the propensity toward total occlusion during inspiration. The phenomena of lung hysteresis may also provide therapeutic benefit.

The subject devices are also expected to improve sleep quality, duration and architecture. For example, there may be increased REM, slow wave, deep and/or stage 3 and 4 sleep and reduced light and/or stage 1 and 2 sleep. Sleep fragmentation may be improved with reduced transitions between sleep stages. There may be fewer arousals and/or awakenings. Subjects may experience REM or slow wave sleep rebound when the device is used. Subjects may have reduced central sleep apnea including central sleep apneas associated with sleep onset. Furthermore, subjects may experience more restful sleep and may awake more refreshed.

The respiratory devices may also be used by athletes, for example, during both aerobic and non-aerobic activities, partially because of the potentially beneficial direct effects on the heart and on gas exchange. In some versions, the respiratory device may be oversized, to increase the amount of inspiratory airflow, potentially increasing the amount of oxygen transmitted to the lungs for gas exchange.

The respiratory devices described herein may also be used for therapeutic and non-therapeutic effects on sleep. Sleep quality may be improved, with more slow-wave sleep, fewer arousals, and improved REM sleep. The user may have more productive sleep and may be less tired during the day. Furthermore, the beneficial effects of the device may extend beyond the period of use, and into the daytime as well, even when the device's use is limited to the night (e.g., when the user is sleeping). In some cases, sympathetic discharge may be reduced and/or parasympathetic discharge may be increased. Thus, the device may have positive benefits on the autonomic nervous system. This may offer beneficial systemic effects as well as local effects, some of which have already been described.

The respiratory devices described herein may also be used in other locations besides the nasal and oral cavities. Indeed, any location in the body that serves as an entry or exit location for respiratory airflow or serves as a conducting airway or conduit for airflow may benefit from the use of the devices described herein. For example, a device may be used within, on the external surface of, or near a stoma site (e.g., for use in a patient after a tracheostromy). Alternatively, devices may be adapted for use in ventilatory circuits within ventililators and other positive pressure breathing means (invasive and non-invasive) and in portable breathing devices such as Ambu-bags and the like.

Inflammation (which is present in a variety of disease states) may also be reduced using the respiratory device, possibly via the aforementioned parasympathetic or sympathetic mediated effects and/or effects of the vagus nerve and its stimulation. The treatment of any condition mediated by an inflammatory cytokine cascade is within the scope of the devices and methods described herein. In some embodiments, the respiratory device is used to treat a condition where the inflammatory cytokine cascade is affected through release of pro-inflammatory cytokines from a macrophage. The condition may be one where the inflammatory cytokine cascade causes a systemic reaction, such as with septic shock. Alternatively, the condition may be mediated by a localized inflammatory cytokine cascade, as in rheumatoid arthritis. Examples of conditions which may be usefully treated using the respiratory devices described herein include, but are not limited to: appendicitis, peptic, gastric or duodenal ulcers, peritonitis, pancreatitis, ulcerative, pseudomembranous, acute or ischemic colitis, diverticulitis, epiglottitis, achalasia, cholangitis, cholecystitis, hepatitis, Crohn's disease, enteritis, Whipple's disease, asthma, allergy, anaphylactic shock, immune complex disease, organ ischemia, reperfusion injury, organ necrosis, hay fever, sepsis, septicemia, endotoxic shock, cachexia, hyperpyrexia, eosinophilic granuloma, granulomatosis, sarcoidosis, septic abortion, epididymitis, vaginitis, prostatitis, urethritis, bronchitis, emphysema, rhinitis, cystic fibrosis, pneumonitis, pneumoultramicroscopicsilicovolcanoconiosis, alvealitis, bronchiolitis, pharyngitis, pleurisy, sinusitis, influenza, respiratory syncytial virus, herpes, disseminated bacteremia, Dengue fever, candidiasis, malaria, filariasis, amebiasis, hydatid cysts, burns, dermatitis, dermatomyositis, sunburn, urticaria, warts, wheals, vasulitis, angiitis, endocarditis, arteritis, atherosclerosis, thrombophlebitis, pericarditis, myocarditis, myocardial ischemia, periarteritis nodosa, rheumatic fever, Alzheimer's disease, coeliac disease, congestive heart failure, adult respiratory distress syndrome, meningitis, encephalitis, multiple sclerosis, cerebral infarction, cerebral embolism, Guillame-Barre syndrome, neuritis, neuralgia, spinal cord injury, paralysis, uveitis, arthritides, arthralgias, osteomyelitis, fasciitis, Paget's disease, gout, periodontal disease, rheumatoid arthritis, synovitis, myasthenia gravis, thryoiditis, systemic lupus erythematosus, Goodpasture's syndrome, Behcets's syndrome, allograft rejection, graft-versus-host disease, diabetes, ankylosing spondylitis, Berger's disease, Retier's syndrome, or Hodgkins disease.

Furthermore, the respiratory devices and methods of using them may be used by or applied to a variety of different types of animals. Representative animals with which the methods and devices find use include, but are not limited to: canines; felines; equines; bovines; ovines; etc. and primates, particularly humans.[/quote]
The one obvious omission (if you can believe that anything could have possibly been omitted) is:

Get rich by selling the patent for some snake-oil scam to an unsuspecting venture capitalist.

Ankylosing spondylitis.

I mean, really.

SAG

[ColinP]

I've got to admit that while I'm, sceptical, I'm curious to see a technical explanation of how it is supposed to work...

[StillAnotherGuest]

The one obvious omission (if you can believe that anything could have possibly been omitted) is:

Get rich by selling the patent for some snake-oil scam to an unsuspecting venture capitalist.

I've got to admit that while I'm, sceptical, I'm curious to see a technical explanation of how it is supposed to work...

OK, these guys (Loomas, Doshi, Pierce, Howard, and Hatanaka) find some unsuspecting guy with a pile of money (like somebody who has just run a successful Ponzi scheme). Then they say, "Look, it's pretty clear that since everybody on the planet would benefit by wearing this every night, and you need a new one every night, if you charge $3.99 apiece for these things, then at the end of a year you will have made $7,953,645,386,546,798,196,718,468,457,853,068.09. So if you pay us, say, like 40 billion dollars for the patent, then you'd still be way ahead of the game."

SAG

[StillAnotherGuest]

In some embodiments, the respiratory device is used to treat a condition where the inflammatory cytokine cascade is affected through release of pro-inflammatory cytokines from a macrophage.

Examples of conditions which may be usefully treated using the respiratory devices described herein include... vaginitis, prostatitis, (and) urethritis...

Man, that's gotta hurt.

SAG

[MrSandman]

LOL

OT: Cute picture SAG !

[Babette]

Clinical trial of Provent Device:

http://clinicaltrials.gov/ct2/show/NCT0 ... ice&rank=1

Cheers,
B.

[Debjax]

I've got to admit that while I'm, sceptical, I'm curious to see a technical explanation of how it is supposed to work...

As I understand the article's description, it will allow air unimpeded "inbound", but probably has a restrictor flow "outbound" to keep the airway pressurized. That would drive me crazy. Once my CPAP pressure has equalized (about 2-3 breaths), it is like breathing freely. That device would feel like I am trying to exhale through a small straw.

[Leonbergergirl]

I have congenital spondylolythesis. Do i stick this item into my structurally impaired lower spine...?
And my Leonbergers bark too loudly....
Leonbergergirl

[ColinP]

I've got to admit that while I'm, sceptical, I'm curious to see a technical explanation of how it is supposed to work...

As I understand the article's description, it will allow air unimpeded "inbound", but probably has a restrictor flow "outbound" to keep the airway pressurized. That would drive me crazy. Once my CPAP pressure has equalized (about 2-3 breaths), it is like breathing freely. That device would feel like I am trying to exhale through a small straw.

I read it that way too. The problem is that my apnea stop the inbound air, not the ootbound, which means that as soon as I stop exhaling, and start inhaling, the pressure drops and I will continue to have apneas. I don't see how it can work, but I'd be happy to be proven wrong.

[Babette]

OMG! I do too!!!! Of course, when I was diagnosed, I asked "Can I just say I have a new Italian lover? That's what it sounds like."

Oy, my back aches just thinking about it...

LOL,
Babs