Patent Application
20250058172
Not applicable.
The COVID-19 virus outbreak was first reported in the city of Wuhan, China, in 2019. To date, COVID-19 has been reported in over 200 countries, more than 650 million people have been infected with COVID-19, and more than 6 million people have died from COVID-19. Specificities of the COVID-19 outbreak include:
Respiratory viral droplets infect ACE-2 expressing epithelial, endothelial, neuronal and immune cells. Viral replication triggers dysfunctional innate immune response. Systemic inflammation can cause a cytokine storm and may lead to multiple organ failure. See e.g., Machhi J, Herskovitz J, Senan A M, et al. The Natural History, Pathobiology, and Clinical Manifestations of SARS-CoV-2 Infections [published online ahead of print, 2020 Jul. 21]. J Neuroimmune Pharmacol. 2020; 1-28.
In healthy adults, respiratory muscle capacity (indicated by maximum inspiratory pressure or MIP) is 2.5 to 3 times larger than required for ventilation during normal breathing—making breathing highly effective. In people with reduced respiratory muscle performance (e.g., due to age, obesity, lung disease, heart failure), the demand on the respiratory muscles is increased up to 3-fold, increasing the work of breathing. During respiratory infection, the work of breathing may also be increased. When the airways are inflamed, the patient may experience severe cough and thoracic discomfort. Inflammation of the lower airways may compromise ventilation further, leading to profound dyspnea, hypoxemia and with increasing alveolar damage, acute respiratory distress syndrome (ARDS). Pre-morbid impairment of respiratory muscles may exacerbate dyspnea and respiratory distress during the acute phase and may prolong recovery.
A German study on 100 patients who recovered from COVID-19 revealed long-term (71 days post positive test) cardiac sequelae. Symptoms included atypical chest pain, palpitations, SOB, and fatigue. Cardiac Sequelae comprised ongoing myocardial inflammation in 60% of patients (abnormal native T1/T2 measures, reduced LVEF, LGE). Presence of sequelae was independent of
Post-COVID-19 rehabilitation may be long-term and multidisciplinary, supporting pulmonary and cardiac recovery.
See jamanetwork.com/journals/jamacardiology/fullarticle/2768916.
Prevalence of symptoms and dysfunctions at 6 weeks post discharge of hospitalized Covid 19 patients included:
Prevalence of symptoms and dysfunctions at 12 weeks post discharge included:
Such symptoms have been referred to as COVID-19 “Long-Haul Syndrome”. See e.g., Greg Vanichkachorn MD, MPH et al, “Post-COVID-19 Syndrome (Long Haul Syndrome): Description of a Multidisciplinary Clinic at Mayo Clinic and Characteristics of the Initial Patient Cohort”, Mayo Clinic Proceedings Volume 96, Issue 7, Pages 1782-1791 (July 2021).
As stated above, more than 50% of COVID-19 patients had persistent symptoms 6 weeks after hospital discharge, primarily dyspnea and cough—and 88% revealed lung damage from inflammation on a CT scan. Much has been explored on how to help such patients. Generally, important aspects of pulmonary rehabilitation post-COVID-19 include:
But potential barriers exist as well:
Preliminary findings from an ongoing study following 86 COVID-19 patients up to 24 weeks post discharge showed:
Such findings suggest:
Consequences of infections with respiratory pathogens can include a variety of symptoms, many of which are amenable to breathing reset and cRMT. Prior and current research has shown that
A cost-effective way to provide RMT in the home and in the clinic is using The Breather® device manufactured and sold by PN Medical of Cocoa Beach, Florida. The Breather® apparatus is the first drug-free, evidence-based respiratory muscle training (RMT) device designed to serve patients with COPD, CHF, dysphasia, stroke, hypertension, Parkinsons disease, and other neuromuscular disease. Its purpose for use is to improve respiratory muscle weakness, dyspnea, quality of life, and speech and swallow performance.
The Breather® was invented by therapist Peggy Nicholson in 1980—long before anyone envisioned COVID-19 or “Long Haul Syndrome”—and described in U.S. Pat. No. 4,739,987, incorporated herein by reference. The '987 patent describes a respiratory exerciser having a hollow body with three openings. One opening provides access for the user to breathe through the device. The other two openings regulate the inhalation and exhalation resistance, by the use of an aperture in each of two partitions which cover the openings to be brought into and out of alignment with an appropriate orifice in each of two rotatable caps, one cap for each partition. Independent inhalation and exhalation are achieved by the use of a diaphragm which acts as a one way check valve to prevent inhaling air from passing through the hole but allows exhaling air to pass through the hole.
Since 1985 when The Breather® was introduced to the market, more than 1 million patients have used the respirator training device. The current design of The Breather® was based on the principles of Nicholson's original design and strives to meet the needs of patients worldwide. The body (and in particular the inhale and exhale metering controls) was redesigned to accommodate patients with poor hand strength. The inspiratory and expiratory dials now work independently of each other, and provide a range from −50 cm to +55 cm of water pressure. The mouthpiece provides a superior seal for patients with a weak mouth grip.
In more detail, The Breather® RMT device main body inhale and exhale controls each adjust the size of respective separate inhalation and exhalation metering orifices. A diaphragm in the main body acting as a one-way check valve allows air exhaled through The Breather® RMT device to exit the device through a metered exhale vent only and does not allow exhaled air to exit through an inhale vent. A diaphragm in the main body acting as a one-way check valve similarly allows ambient air to be sucked into the device through a metered inhale vent and does not allow inhaled air to be sucked in through the exhale vent. Thus, the diaphragms enable the inhale and exhale vent metering controls to independently control resistance for inspiration and expiration, respectively.
The Breather® allows a patient to adjust the inhale and exhale resistance levels independently so they can train their lungs in a way that is specific to their needs. To use The Breather® takes 10 minutes a day training from home:
It has been found that The Breather® can be effective to help COVID-19 patients suffering from long haul syndrome. While inspiratory muscle training is very important, the Breather® provides both inspiratory and expiratory muscle strengthening. The expiratory activation is very important for phonation, for airway clearance, and upper airway integrity. So, both are important, and both aspects should be addressed in the subacute state. Muscle atrophy, especially after mechanical ventilation, affects both parts—if there is inspiratory muscle disuse atrophy, one can defer that there will be some degree of expiratory atrophy as well. The Breather® addresses both aspects. Strengthening the expiratory part as well not only facilitates better cough and bronchial hygiene, but also facilitates phonation and helps with swallow function.
Patient compliance with The Breather® tends to be high because the patients feel quality of life improvements within days. Evidence results of RMT with a device such as The Breather® include increased MIP and MEP, improved oxygen saturation, reduced hyperinflation, improved laryngeal function including speech and swallowing, and improved delivery and distribution of inhaled medications. All this leads to faster weaning from mechanical ventilation, shorter length of stay and lowered probability of hospital readmissions.
While The Breather® is widely adjustable to provide a range of different inspiration and expiration pressures, those with substantially decreased respiratory function such as those who are recovering from COVID-19 or those who suffer from Long-Haul Syndrome may still have trouble with even the lowest resistance setting. It's not uncommon for new users to feel short of breath or lightheaded when they are new to RMT. These should subside quickly with a break and are expected to stop occurring after a week or two of training as the patient's body adjusts to the increased exchange of oxygen and carbon dioxide. When these symptoms occur during a session, the patient may pause for several minutes, breathing normally without the device, then the patient may continue. But if the lightheadedness or significant shortness of breath persists, the patient may need to discontinue use of the RMT device and contact their healthcare provider. This is not a desired outcome if the reason relates to the patient having insufficient capability to perform the training.
It would be highly desirable to enable new RMT patients with low pulmonary functioning due to recovering from Covid-19 and/or long haul syndrome for example to begin using The Breather® more effectively and realize its benefits. Additionally, it is desirable to extend the functionality of The Breather® by providing automated monitoring and signal processing.
This specification provides certain additions and improvements to The Breather® RMT device that has been sold for a number of years by PN Medical as shown and described at pnmedical.com/product/the-breather, including variations of said products, including but not limited to BREATHER FIT™, BREATHER VOICE™ and BREATHER RECOVER™. See for example “THE BREATHER ONE DEVICE MANY THERAPIES” PROTOCOL BY USE CASE (PN Medical 10/16/17 Version: 4.0) available at eadn-wc02-8525791.nxedge.io/cdn/media/8d/db/2e/1673076064/eff330a5a7bbe229f50e0a744 fa341787f310f9f_product_brochure_breather.pdf. Except as might be stated herein, each of the structures and techniques described below or combinations thereof can be employed or combined with any prior Breather™ device to provide advantageous results.
For example, the example non-limiting embodiments provide a new “recover” mouthpiece to The Breather® RMT device that augments/enhances the device's functions by extending the resistance range and number of resistance settings of the device without requiring the basic device to be altered. A new patient just starting out with RMT or a patient with chronic decreased respiratory muscle strength may benefit from the decreased amount of effort required to breathe in and out through the RMT device with the new “recover” mouthpiece while still realizing training results and working up to increased resistance of the device with the standard mouthpiece.
The new mouthpiece—which in some embodiments is insertable/removable from the device and interchangeable with a standard mouthpiece—includes one or a plurality of graduated air inlet and/or outlet metering orifices. These metering orifices are sized and configured to relieve or decrease expiration backpressure and/or inspiration resistance in order to make the assembled RMT device easier to breathe into and out of. The additional metering orifices work in conjunction with the adjustable inspiration and expiration metering controls on The Breather® device to provide an extended range and number of resistance settings patient can train on—enabling a new host of training protocols.
In one embodiment, the main body metering orifice controls of The Breather® RMT device are adjustable in a plurality of discrete steps such as five steps numbered 1, 2, 3, 4 and 5, respectively for exhale and six steps numbered 1, 2, 3, 4, 5 & 6, respectively for inhale. In one embodiment, the “1” setting of the exhale metering control provides no occlusion of a metering orifice, the “2” setting occludes about 25% of the metering orifice (i.e., a substantial increase in resistance), the “3” setting occludes about 38% of the metering orifice (slightly more than the “2” setting), and so on. Similar functionality applies for the inhale metering control and associated orifice. These metering adjustments are stepwise and discrete rather than continuous in order to provide precisely repeatable stepped metering amounts that work well with training protocols.
However, it has been found that new patients suffering from long-haul syndrome at least initially may not have the requisite respiratory function to be able to use The Breather® even on its lowest resistance settings. Furthermore, even if such patients are able to use the device with its metering controls on the “1” settings (very little resistance), they may not be able to inhale and exhale through the device metering controls on the “2” setting because of the substantial increase in resistance from the “1” setting to the “2” setting. In other words, depending on the patient, the “1” setting may provide too much or too little resistance to provide effective respiratory muscle training, whereas the “2” setting is in many case too much resistance for “long COVID” and other classes of patients. These patients could eventually benefit from the resistance offered by the “2” setting with the standard mouthpiece but will need to work up to it.
In example non-limiting embodiments, a substitute “recover” mouthpiece having supplemental metering orifices provides a solution to this problem. The Breather® Recover mouthpiece has openings that reduce generated training pressure (compared to training pressures generated using the standard mouthpiece) and increase the airflow. The Breather Recover® mouthpiece is suitable for all users who are at that moment unable to generate the lowest target pressures (settings 1) using the standard mouthpiece, due to symptoms and consequences of respiratory infection. The Breather Recover® mouthpiece is intended as a therapeutic addition to the Breather to expand the indication of cRMT for those with respiratory impairment.
Supplemental metering orifices provided by this substitute mouthpiece decrease the device resistance at each inhale metering setting and each exhale metering setting of The Breather® RMT device, making each discrete metering setting “easier” (lower resistance) to breathe through. Additionally, the supplemental metering orifices of the replacement mouthpiece increase the total number of metering settings available from the device—extending its resistance range and providing additional resistance settings. This allows a wider range of protocols that can be customized to a wider variety of patients to provide more effective training.
While the new mouthpiece's supplemental metering orifices decrease resistance when the device metering controls are set to “1” or “least resistance”, the very large metering orifices of the device main metering controls at these lowest settings may still dominate in some embodiments. When the device's main metering controls are set to “2”, the metering provided by the device overall becomes more of a blend of the metering provided by the main device metering controls and the metering provided by the new mouthpiece's additional metering orifices. This blend provides less resistance than when the device metering controls are set to “2” with a standard mouthpiece, but more resistance than if the device metering controls were set to “1” with a standard mouthpiece. Such an intermediate resistance levels can benefit training of patients who cannot yet manage a “2” resistance setting with a standard mouthpiece. Furthermore, because of the new resistance levels, such a modified device with a substitute, supplemental metering mouthpiece enables a host of new training protocols such as resets, decision trees, new protocols, lower pressures, and updates to a coaching app—including a step up approach using the Breather Recover mouthpiece, and working up to the standard mouthpiece.
For example, “Reset Breath” involves resetting a patient's breathing pattern to a functional breathing pattern (restores a functional breathing pattern), which improves HRV (marker for nervous system health) and post-infection symptoms. Resetting the breathing pattern also increases the effectiveness of cRMT using the Breather Recover device.
In the example shown, just like the prior art, RMT device 100 includes a main body 200 and a detachable mouthpiece 300. In the example shown in
As in the prior art, the bulbous portion 202 has an inhale metering assembly 206 disposed on a left side surface 208, and an exhale metering assembly 210 disposed on a right side surface 212 (
As discussed above, the inhale and exhale metering assemblies 206, 210 meter the amount of air they pass based on user adjustable controls. In one embodiment, the inhale metering assembly 206 includes a rotatable ring 214 with six rotatable settings corresponding to six different effective metering orifice diameters, and the exhale metering assembly 210 includes a rotatable ring 216 having five rotatable settings corresponding to five different effective metering orifice diameters (other arrangements are possible).
Main body 200 is configured to accept differently-configured replaceable/interchangeable mouthpieces (see
While mouthpiece 300 in this example resembles a prior art mouthpiece in shape and structure (compare the two mouthpieces in
In one example embodiment, these mouthpiece metering channels 310 are configured as directional air channels as best shown in
Meanwhile however, as best seen in
In one embodiment, even though the through-holes on opposite (top and bottom) sides of the mouthpiece are in registry with one another, as shown in
In one embodiment, the first channel sloped toward the part of the mouthpiece that is placed into the mouth is disposed on the top surface of the mouthpiece, and the second channel sloped away from the part of the mouthpiece that is placed into the mouth is disposed on the bottom surface of the mouthpiece.
The effect of such mouthpiece supplemental metering channels on the operation of the device overall depends in part on how the user is operating the device—and in particular, how much air pressure the user's lungs is forcing into the device on exhale or how much vacuum pressure the user's lungs are pulling from the device on inhale. Generally, the supplemental metering channels reduce the “resistance” of the device as the user breathes into and out of the device, e.g., by acting as a pressure (or vacuum) relief vent(s) and also modifying the air flow within the device.
As shown in
Similarly, as shown in
In one embodiment, the channels and associated through-holes are located near an end of the mouthpiece that mates with the RMT device stem 204. For example, in one specific embodiment, each of the through-holes may be disposed ˜1-⅜″ from the end of the mouthpiece that the patient places into their mouth, but other distances are possible. As shown in
The effect of the new mouthpiece with additional metering orifices is to increase the total number of metering settings the overall device provides—essentially providing lower resistance aliases of the main body metering settings that a patient with decreased capacity can use to effectively train themselves to work up to the resistance settings of the device without the new mouthpiece. In example embodiments, the amount of metered resistance reduction the new mouthpiece provides may be calibrated for example to effectively double the number of exhale resistance settings the device provides using the new and old mouthpieces:
The number of inhale resistance settings are similarly doubled using the new mouthpiece with supplemental metering and the prior art mouthpiece without supplemental metering:
Furthermore, in use, it is also possible for the patient to use their digits to selectively partially or completely occlude one, the other, or both supplemental metering channels of the mouthpiece in the style of finger holes of a recorder, to vary the amount of supplemental metering the new mouthpiece provides. This usage can triple or quadruple the effective number of resistance settings as compared to the standard device with the standard mouthpiece (e.g., if the plural metering channels and associated through-holes of the new mouthpiece are sized differently.
Or, the patient can position their hands and digits to avoid occluding both supplemental metering channels so that the inspiration and expiration pressure characteristics of the device are determined by a combination of the supplemental metering channels on the mouthpiece and the device's inspiration and expiration metering controls.
On First Use: Place BREATHER RECOVER mouthpiece on the white body of your device. Set both dials to setting #1. You will increase dial settings over time as you train IN THE FLOW.
Getting Started: Position yourself with a straight back and hold the mouthpiece between your lips. Do not clench the mouthpiece with your teeth. Breathe in and out through the mouthpiece (not the nose) using diaphragmatic breathing (belly breathing). Inhale effortfully 2-3 seconds, pause, exhale effortfully 2-3 seconds, pause. Repeat this rhythm to complete your set.
Training Plan: 6 days per week, 1-2 sessions per day (morning and/or evening). For each session do 4 sets of 5 breaths. Break for at least 1 to 2 minutes between sets.
Changing Mouthpiece: Once you progress both dial settings to #3, remove the BREATHER RECOVER mouthpiece and replace it with the Standard mouthpiece. Start with both dials at 1. As you get stronger, adjust dials upward while remaining IN THE FLOW. Continue to monitor for excessive fatigue, and return to the BREATHER RECOVER mouthpiece or the Breathing Reset sessions if needed.
Important Tips For Success: Breathe through your Breather Recover with a controlled effort. Use optimal effort (IN THE FLOW). Lastly, use the diaphragmatic breathing technique while training.
Protocol can cover the breathing reset, and the step up training plan using the Breather Recover mouthpiece followed by the standard mouthpiece.
Breather Coach app—training plan for recover [heart] [medication]
Pneumonia, Flu, Long COVID, sickness causing reduced respiratory capacity and they need to rebuild their system.
Following above, user may choose to
Aspect of the Breather Recover Training Plan is the prior restoration of a functional breathing pattern, which has therapeutic value in itself, and which also increases the effectiveness of the subsequent cRMT using the Breather Recover device.
Begin Breather Recover RMT session in am & Breathing Reset session in PM:
24-hour assessment (before next morning RMT session): Since yesterday, do you feel your symptoms are:
Following user completion of 1 week of RMT with the Breather, before morning RMT session:
When inhale and exhale settings are equal or more than 3, send notification:
Based on prior evidence from the Breather as well as from external sources, cRMT can be expected to have the following impact on recovery from Long Covid and similar infections and their sequelae:
The device functionality can be extended by providing an electronic interface that automatically collects measurements (e.g., sounds, air pressure, air temperature, CO2 level) and analyzes the measurements and/or communicates them to a remote device such as a smartphone. In one embodiment, an intermediate component is added between the mouthpiece and the main body. This intermediate component provides a central cavity that allows the mouthpiece to communicate air with the main body without any (or at least any significant) obstruction. In other words, the air pressure resistance functions of the mouthpiece and main body operate the same with our without the intermediate component. Internal sensors communicate with the inside of the central cavity within the intermediate component to allow various parameters associated with the air flowing through the intermediate component to be measured, analyzed, communicated and/or stored.
As one can see from the Figures, the intermediate component shown is detachable from both the main body and the mouthpiece. However, in other embodiments, the intermediate component could be constructed to be integrally part of the main body and/or the mouthpiece.
In example embodiments, the intermediate component contains electronic and electrical components, namely input devices, output devices, sensors, a power source, and wireless communications. In more detail, the intermediate component contains sensors such as an air pressure sensor, a CO2 sensor, a temperature sensor and a sound sensor (microphone) that measure parameters associated with the air flowing through the intermediate component. A processor internal to the intermediate component collects data from these sensors and, in one embodiment, analyzes the data using stored firmware. As one example, the data analysis can include one or more trained neural networks that are structured to recognize patterns and correlations between the sensed parameters. The intermediate component can generate outputs sensible by the user holding the device (e.g., haptic outputs, visual outputs, audible outputs, etc.). The intermediate component can also generate signals for communication with a remote device such as a smartphone running a “coaching” app.
In example embodiments, the sensor data may be analyzed to provide neurocontrol of breathing, preload and afterload breathing for heart and blood pressure (BP), and anxiety control through breathing. In addition, machine learning may be used to train neural networks to recognize conditions, patterns, and correlations and generate corresponding alerts or informative displays or other sensible indicia.
In one embodiment, a user interface that includes haptic actuator(s) and visual indicator(s) in the intermediate component can be used to provide coaching and feedback such as a training plan builder, a study builder, a questionnaire builder, a first to burst, and respiratory screening/fitness testing. Data collected by the intermediate component could be used many things including a host of research or scientific studies.
One example embodiment will include a Breather Coach (a smart phone app) with gaming features and protocols and ability to do clinical studies inside the app as well as manage regular users.
A further embodiment includes a CO2 sensor, and artificial intelligence (AI) using existing technology. Such embodiments have the ability for additional mouthpieces to connect to your face hands free and to add a vibrating mouthpiece. As you breathe, the mouthpiece vibrates so mucus comes up from your lungs. Such embodiments can sense variable pressure during a breath.
Optionally, one or more additional actuators (not shown) such as miniature motors, pumps, fans, etc. may be used to actively control, affect, assist or impede the flow of air through the intermediate component from the mouthpiece to the main body or vice versa under control of the processor(s) 1010.
Each patent and publication cited above is incorporated herein by reference for all purposes as if expressly set forth.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
This application claims priority from US design application no. 29886797 filed Mar. 13, 2023, U.S. provisional application No. 63/490,950 filed Mar. 17, 2023; and US design application no. 29/927,842 filed Feb. 6, 2024, each of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63490950 | Mar 2023 | US | |
| 63550516 | Feb 2024 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 29886797 | Mar 2023 | US |
| Child | 18608766 | US | |
| Parent | 29927842 | Feb 2024 | US |
| Child | 18608766 | US |
