Method for Treating Coronavirus Infection Using a Stimulating Device for Improvement of Respiratory Function
20200337942 · 2020-10-29
Inventors
Cpc classification
A61H1/00
HUMAN NECESSITIES
A61H2011/005
HUMAN NECESSITIES
International classification
Abstract
A method for treating a human patient with a coronavirus infection improves the respiratory function of the patient to resist the onset of pneumonia or other severe respiratory distress that would require mechanical ventilation, or to improve respiratory function after the patient is removed from a mechanical ventilator. The method includes the step of stimulating the diaphragm of the patient using a stimulating device. The method may be initiated prior to or after the patient exhibiting symptoms of respiratory distress, and/or may be initiated after the patient has been removed from a mechanical ventilator.
Claims
1. A method for treating a human patient infected with a coronavirus infection, the patient having a thoracic diaphragm, the method comprising the steps of: (a) providing a stimulating device being operable to stimulate a human thoracic diaphragm when fastened to the patient; (b) fastening the stimulating device to the patient; and (c) operating the stimulating device when fastened to the patient and while the patient is breathing, the patient's diaphragm expanding the patient's lungs to draw air into the lungs while the patient is breathing, whereby operation of the stimulating device stimulates the diaphragm during the patient's breathing.
2. The method of claim 1 wherein the stimulating device is configured to stimulate the diaphragm when attached to an abdomen of a human being and step (b) comprises the step of fastening the stimulating device to the patient's abdomen.
3. The method of claim 1 including the steps of: (d) removing the stimulating device from the patient; and (e) repeating steps (a)-(d) multiple times during the course of the patient's infection.
4. The method of claim 1 wherein, immediately before initiating the method, the patient has not been diagnosed with and/or does not exhibit symptoms of pneumonia or other severe respiratory distress that calls for mechanical ventilation of the patient.
5. The method of claim 4 wherein the patient has not been diagnosed with and/or does not exhibit symptoms of hyperventilation, shortness of breath, and/or low blood oxygen levels immediately before initiating the method.
6. The method of claim 1 wherein the patient was on a mechanical ventilator during the course of the infection and has been removed from the mechanical ventilator prior to initiating the method.
7. The method of claim 1 wherein the stimulating device comprises a belt containing at least two vibration modules and a control panel, wherein each of the at least two vibration modules comprises a pod with a casing, the casing enclosing a vibration pad, a vibration motor with a flywheel, and at least one motor housing mounting the vibration motor to the vibration pad, and the control panel operating said vibration motors of the at least two vibration modules.
8. The method of claim 7 wherein step (b) comprises the step of: fastening the belt of the stimulating device to the abdomen of the patient.
9. The method of step 8 wherein, immediately before initiating the method, the patient has not been diagnosed with and/or does not exhibit symptoms of pneumonia or other severe respiratory distress that calls for mechanical ventilation of the patient.
10. The method of claim 8 wherein the patient has not been diagnosed with and/or does not exhibit symptoms of hyperventilation, shortness of breath, and/or low blood oxygen levels immediately before initiating the method.
11. The method of claim 8 wherein the patient was on a mechanical ventilator during the course of the infection and has been removed from the mechanical ventilator prior to initiating the method.
12. The method of claim 8 repeated multiple times during the course of the patient's infection.
13. The method of claim 7 wherein for each pod of the stimulating device, the vibration motor is spaced away from the vibration pad via the motor housing.
14. The method of claim 7 wherein for each pod of the stimulating device, the motor housing is mounted to the vibration pad via a snap-fit connection.
15. The method of claim 7 wherein for each pod of the stimulating device, each motor housing is at least partly designed in a complementary manner to the vibration motor for holding and supporting the vibration motor.
16. The method of claim 7 wherein the belt of the stimulating device comprises a strap having at least one belt fastening attachment.
17. The method of claim 7 wherein for each pod of the stimulating device, the casing comprises a main casing and a back casing, the vibration pad in the casing being arranged within the back casing and the main casing being arranged with a front panel.
18. The method of claim 17 wherein the belt of the stimulating device comprises a strap having at least one belt fastening attachment; and wherein the main casing and/or the back casing of each pod of the stimulating device comprises at least one attachment means for engagement with and through the strap and engagement with the other of the back casing or the main casing.
19. The method of claim 7 wherein the control panel of the stimulating device operates said vibration motors with an amplitude from around 0.3 G to 1.0 G and frequency ranging from 16 Hz to 45 Hz complementary to a voltage 0.6V to 1.3V.
20. The method of claim 19 wherein the control panel of the stimulating device operates said vibration motors with an amplitude around 0.3 G at a frequency of 20 Hz (0.8V) to an amplitude 0.62 G at a frequency 37 Hz (1.0V).
21. The method of claim 7 wherein the belt of the stimulating device is flexible and/or adjustable to a patient's anatomy.
22. The method of claim 7 wherein at least one of the flywheels of the stimulating device has a diameter of about 12 millimeters and a thickness of about 8 millimeters.
23. The method of claim 7 wherein at least one of the flywheels of the stimulating device has a weight of between 7 grams and 8 grams and/or is spaced about between 1 millimeter and 5 millimeters from the motor.
24. The method of claim 7 wherein the stimulating device comprises a display being configured to display the vital signs of the patient, the method comprising the steps of monitoring the vital signs of the patient, and displaying the vital signs of the patient on the display of the stimulating device.
25. The method of claim 1 wherein the patient is infected with the SARS-CoV-2 coronavirus.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0062] While the present disclosure may be susceptible to embodiments in different forms, the drawings show, and herein will be described in detail, embodiments with the understanding that the present description is to be considered an exemplification of the principles of the disclosure and is not intended to be exhaustive or to limit the disclosure to the details of construction, the arrangements of the components, or the order of method steps set forth in the following description or illustrated in the drawings.
[0063]
[0064] Generally, an embodiment of a stimulating device usable with the disclosed method applies a mechanical vibration to the patient's body through the contact of vibration pads of a respective pod comprising vibration motors. The device may consist of at least two vibration modules, each housing a vibrating motor. The vibration modules are engaged with a strap, creating a belt, for contacting the abdomen of a patient to stimulate the diaphragm. The motors are controlled by an electronic circuit. The electronic circuit is controlled by a control panel, which may be powered by a battery that is optionally rechargeable. The control panel controls the voltage and time that the motors run for. The belt may be worn by a patient any time during the day or night. The belt may be worn only for the amount of time that the patient or the patient's physician wishes for the diaphragm to be stimulated, or it may be worn for an extended period of time under a physician's care and the vibration motors activated intermittently throughout the extended period of time. The belt may be used in any position by a patient, for instance sitting, standing, or in a supine position.
[0065]
[0066] The strap 1 of belt 10 may be constructed of a variety of suitable materials, including lycra, any material containing spandex, neoprene, elastic, cotton, nylon webbing, StretchBands, silicone, ethylene propylene diene monomer (M-class) rubber, urethane, Chloroprene, Hypalon, natural rubber, leather, cloth, plastics and the like. In an embodiment, the strap 1 is stretchable and made of materials such as including lycra, any material containing spandex, neoprene, elastic, nylon webbing, StretchBands, silicone, ethylene propylene diene monomer (M-class) rubber, urethane, Chloroprene, Hypalon or natural rubber. In yet another embodiment, strap 1 is made of a combination of neoprene, elastic and nylon webbing. Strap 1 may be of varying lengths and widths suitable for the size of the respective patient. Strap 1 may be constructed of an inner strap, closest to the abdomen of a patient, and an outer strap away from a patient. Between the inner strap and outer strap are paths of the wires leading from a control panel to the motors. Alternatively, the path of the wires may be integrated in the strap.
[0067] Belt 10 further includes a belt fastening attachment 2, 3 for closure around a patient. The belt fastening attachment 2, 3 may be selected from a variety of off the shelf buckles such as quick-release clips, simple buckles, adjuster buckles, belt buckles and the like. In other embodiments, the belt securing attachment 2, 3 may comprise snaps, clips, zippers, buttons, clasps, clips, knots, ties, Velcro, pins, hooks or any other fastening means known in the art.
[0068] Vibration modules 5, 7 and 9 each contain a removable pod 4, which contains a vibration motor. Pod 4 is advantageously removable for repair or exchange of the pod or vibration motor. In an embodiment, the motor sits in a plastic housing that clicks into place, and the outer casing of the removable pod(s) 4 is screwed over the complete casing 6. The pod can also be glued to casing 6. Said pod 4 may be made by injection molding of materials such as plastic, metal, silicone, synthetic fabric and the like. The dimension of the pod may vary. Smaller pods may be used for smaller belts and larger pods may be used for larger belts. In an embodiment, the pods may be about 6-8 cm in width; about 8-9 cm in Length; and about 2.5-3.5 cm in depth depending on the size of the motor to be housed.
[0069] Relating to
[0070]
[0071] Vibration motors may be off the shelf and equivalent to Precision Microdrives, Model 320-100, Uni-Vibe, 20 mm Vibration Motor25 mm Type. A variety of motors may be used, as generally illustrated in
[0072] Surprising results were seen related to a small change in the flywheel size/dimension and weight, which had a significant effect on stimulating the diaphragm in an effective manner. In addition, an optimal range of the frequency-amplitude was determined, outside of which effectiveness in stimulating the diaphragm significantly decreases. Therefore, the frequency-amplitude relationship is very critical to cause activation of the diaphragm. Activation of the diaphragm can be measured as a change in breathing pattern, i.e., shallow breathing versus slower deep belly breathing. This can be quantified by slower breathing (rate/min) and also heart rate.
[0073] The flywheel was of 12 mm diameter, 8 mm thickness and 7-8 g. The motor is Precision Microdrives, Model 320-100.
Table:
[0074] Effects on diaphragm quantified as below:
[0075] +++ is strong activation of deep belly (diaphragm) breathing; the breathing rate is deeper and slower as measured by breaths per minute (reduction greater than 20% of normal previous breathing)
[0076] + is only slight effect on diaphragm breathing i.e., a 10% or less reduction of breathing rate [0077] No effect on diaphragm activation or breathing rate
TABLE-US-00001 Voltage Amplitude Frequency Effect on diaphragm 1.2 V 0.95 G 43 Hz +++ 1.0 V 0.62 G 37 Hz +++ 0.8 V 0.4 G 30 Hz +++
Precision Microdrives, Model 2 (320-105 standard). This has exactly the same motor as above, but different flywheel (18 mm diameter6 mm thickness, but is only a half circle, i.e., not complete).
TABLE-US-00002 Voltage Amplitude Frequency Effect 1.2 V 1.0 G 45 Hz 1.0 V 0.8 G 35 Hz + 0.8 V 0.5 G 28 Hz +
Model 3. Same motor but flywheel slightly different (10 mm diameter, 3.5 mm thickness)
TABLE-US-00003 Voltage Amplitude Frequency Effect 1.2 V 0.8 G 55 Hz 1.0 V 0.54 G 45 Hz 0.8 V 0 34 G 37 Hz
[0078] Effects on respiratory function were notable within the range from 0.3 G at 20 Hz to 1.00 at 45 Hz. Optimal effects were observed in the range from 0.8V (30 Hz at 0.4 G) to 1.0V (37 Hz at 0.62 G). Optimal effects are quantified as clear changes in breathing pattern to deep, slow rhythmic diaphragm breathing and quantified as reduction in breathing rate of 20% or more. The amplitude was measured using a closed-loop control (accelerometer) and accurate motor speed measurement device. An NEVA 7361 triple axis accelerometer from Freescale was used and mounted on a PCB with several external components. The vibration motor and accelerometer were mounted together. These were then mounted with a 100 g mass (sled). This target mass has a direct influence on the measured vibration amplitude and helps to standardize the measurements. This was done as described by Precision Microdrives of UK.
[0079] The device may include a single control panel PCBA, which includes a number of TACT switches and LED's. The control panel may be used to control the speed of the motors by varying the voltage supplied to the motors. The control panel may also control the time the motors run for and have pre-programmed functions that control the time for different motor speeds.
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[0083] The control panel may be programmed with different variations in voltage and time to provide a patient or treating physician with varied options depending on need. Programs may start the rotating motors for any length of time, but the best results have been seen with at least 10 minutes of use. Motors may be programmed to pulsate or provide intermittent stimulation of the diaphragm, of varying duration, throughout the day for a patient that wears the device throughout the day or night. Examples of programs selectable on the control panel are as follows:
TABLE-US-00004 Program 1 Voltage Time (min) 1.0 V 10 0.9 10 0.8 10
TABLE-US-00005 Program 2 Voltage Time (min) 1.0 V 5 0.9 10 0.8 15
TABLE-US-00006 Program 3 Voltage Time (min) 1.2 V 2 1.0 10 0.9 10 0.8 10
TABLE-US-00007 Program 4 Voltage Time (min) 1.2 V 5 1.0 5 0.9 10 0.8 10
TABLE-US-00008 Program 5 Voltage Time (min) 0.8 10 0.7 10 0.6 10 0.7 5 0.8 5
TABLE-US-00009 Program 6 Voltage Time (min) 0.9 10 0.8 10 0.7 10 0.6 10 0.8 5
TABLE-US-00010 Program 7 Voltage Time (min) 1.0 10 None 5 1.0 10 None 5 0.8 10 This cycle repeats for 1 hr
TABLE-US-00011 Program 8 - For Sleep Apnea Patients Voltage Time (min) 1.0-1.2 10 0.9 V 5 0.8 V 5 Off 10 0.8 10-20 seconds every 2-5 minutes This cycle repeats for 2-3 hours
[0084] Clinical results indicating the effectiveness and health benefit of the disclosed stimulating device were obtained for patients having respiratory deficiencies. In one trial, 68 COPD grade patients were tested. These patients used the stimulating device three times per day, for 20 minutes, and for 10 days. The results were as follows:
1. 62 patients reduced their breathing rate from 18 to 14 breaths/minute.
2. 62 patients improved their blood p02 from an average 92% to 97%.
3. 58 patients described their breathing as more comfortable.
[0085] 18 patients received treatment with the stimulating device for 2 weeks. Of those patients, 14 could walk without shortness of breath and 11 could reduce their medication needs after the 2 week course of treatment.
[0086] A small study with 3 patients suffering from sleep apnea was able to show that when the patients stopped breathing, activation of the disclosed stimulating device only for a few seconds caused the patients to immediately start breathing. The sleep apnea patients could subsequently continue to sleep without any disruption.
[0087] In geriatric patients treated with the disclosed stimulating device, muscle relaxation in regions of the legs, belly region and chest were clearly observed, as well as a more relaxed and slow breathing rhythm. This enabled the patients to feel better and allow physical movement
[0088] Obese patients with a coronavirus infection may also benefit from the disclosed method since they may have a limited lung volume due to greater adipose tissue around the lungs, which reduces the bronchioles, limits lung capacity and increases the breathing rate, leading to less oxygen intake.
[0089] In addition, patients with a coronavirus infection and also suffering insomnia may also benefit from the disclosed method to have significantly longer and better quality sleep to better resist progression of the infection.
[0090] In yet another study, ten patients with COPD were treated with the disclosed stimulating device for fifteen minutes. After a single use of the belt, the lung volume of all ten patients significantly increased as indicated in the chart shown in
[0091] Another patient who used the disclosed stimulating device belt, a self-reported strong smoker, had consistent coughing and wheezing prior to using the device. The patient reported a cessation of coughing and wheezing for three days after a single use of the device for 15 minutes.
[0092] The disclosed stimulating device may also be used for monitoring specific vital functions of a patient with a coronavirus infection. A display of vital functions can be integrated via an appropriate interface. An embodiment of the stimulating device has at least one interface that supports the exchange of information. The information can be present in the form of physical units (e.g., as electrical voltage, current strength) or logical variables (data), whereas the exchange can be analog or digital. The interface includes data interfaces (interfaces for data transmission in general), general interfaces, machine interfaces (interfaces between physical systems), hardware interfaces (interfaces between physical systems of computer technology), network interfaces (interfaces between network components), software interfaces (interfaces between programs) and/or user interfaces (interfaces between man and machine). Preferred interfaces include radio or infrared interface or wired interfaces (for example USB). Using the interface, a secure and fast connection can be established and information exchanged. In addition, the device may be connected to other devices for monitoring vital functions, allowing a check of the safe and efficient operation of the device. It may also be preferred that the information (e.g. data) is saved on a storage medium or is transmitted from a computer based systema transmitterto the recipient via a network-based transmission or a long distance data transmission. The transmission medium is preferably the telephone network, radio or light, whereby a rapid and secure transfer of information is possible. Advantageously, the device itself has a memory that can store the data, such as duration of use and rotation speed selected. The device may transfer the data to an external storage medium. The data can be advantageously used for the analysis of the application, thereby allowing optimization of the application.
[0093]
[0094] On the inner surface of the trough of the vibration pad 12/24 two tabs 87 are provided on both sides that extend approximately in parallel to one of the slits 91. The tabs 87 are provided for secure engagement of the motor housing 22 with the vibration pad 12/24. For this engagement the motor housing 22 includes on both its lower end sides slits complementary to the tabs 87 for a snap fit connection when passing the tabs 87. Further, in some embodiments also suitable adhesives, e.g. silicone glue may be added on the mounting area to improve this connection. The motor housing 22 is further designed in a u-like shape, complementary to motor 20 for receiving and holding the motor 20. When the motor 20 is mounted via the motor housing 22 to the vibration pad 12/24 it is kept at a distance to the inner surface of the vibration pad 12/24 such that the flywheel 28 can move within the casing 6 and back casing 26 freely without any contact to the casing 6 and back casing 26 (compare
[0095]
[0096] In a step 112, a stimulating device is provided. The stimulating device is configured to be usable in stimulating the thoracic diaphragm of the patient. The stimulating device may be a stimulating device as described above and as shown in
[0097] In a step 114, the stimulating device is attached to the patient. The stimulating device may configured to stimulate the diaphragm when attached over or on a particular part of the patient's body, for example, the abdomen.
[0098] In a step 116, the stimulating device is operated while fastened to the patient's body to stimulate the patient's diaphragm. The patient uses his/her diaphragm to expand the lungs and create suction drawing air into the lungs. The stimulating device stimulates the diaphragm as described above.
[0099] In an optional step 118, the stimulating device may include and be controlled through a control panel. The control panel may enable the patient, the administrating physician, or facility personnel to set or adjust operation of the stimulating device as described above. The control panel may also display or transmit data concerning the vital functions of the patient, start time, end time, and elapsed time in use, and the like.
[0100] In the step 120, the stimulating device is turned off and removed from the patient. The duration of treatment may be according to a preset schedule or preset operating mode of the stimulating device, or may be determined by feedback from the patient, the vital signs of the patient or by some other criterion to end the method at the end box 121.
[0101] As represented in the start boxes 122, 124, 126, the method 110 may first be initiated at different points in the course of the patient's infection.
[0102] In the start box 122, the method is initiated prior to any diagnosis and/or symptoms of respiratory distress. The method may be initiated as a precautionary measure to improve respiratory function as early as possible in the course of the infection to minimize the risk of mechanical ventilation as much as possible.
[0103] In the start box 124, the method is initiated after a diagnosis and/or presentation of systems of respiratory distress, but before the need for a mechanical ventilator. Symptoms of respiratory distress may include, but are not limited to, hyperventilation, shortness of breath, and/or low blood oxygen levels.
[0104] In the start box 126, the method is initiated after removal of the patient from a mechanical ventilator. The patient may require weaning from the mechanical ventilator to unassisted breathing, or it may be felt that improved respiratory function would improve the patient's outcome after mechanical ventilation.
[0105] The method may be initiated and utilized multiple times during the course of the patient's infection as indicated by the dashed line 128 to maintain respiratory function or to improve respiratory function. The supervising physician may choose to change the frequency, duration, and other parameters of the method in view of the patient's response to the method and to changes in the patient's other medical conditions, pharmaceuticals, and the like during the course of the infection.
[0106] While this disclosure includes one or more illustrative embodiments described in detail, it is understood that the one or more embodiments are each capable of modification and that the scope of this disclosure is not limited to the precise details set forth herein but include such modifications that would be obvious to a person of ordinary skill in the relevant art including (but not limited to) changes in material selection, size, operating ranges, environment of use, as well as such changes and alterations that fall within the purview of the following claims.