Method and Device for Assisting and Enforcing a breathing process

Abstract

The present invention relates to the art of automatic regulation of pulmonary devices for assisting and/or enforcing the breathing process by converting Bag-Valve-Mask (BVM) apparatus are also known as manual resuscitators to automatic system by pneumatic matter with the goal to enhance both phases of breathing: inhalation and exhalation. It also replaces a mechanical chest compression for automatic pneumatic compression, could be complimented with the use of the TENs unit and can be used for extended periods of time with a high level of reliability, simplicity, efficacy and low cost.

This portable and light device is recommended to be used as a resuscitator attached to the patients with mild to extremely suppressed or without respiratory drive.

The source of power can be electrical, battery operated, manual or a combination thereof.

That feature is extremely critical for its use in a combat zone or during a power failure.

Claims

1. A portable pneumatic device for converting a manually operated BVM into automatic system for assisting and/or enforcing breathing process through the nose and/or mouth of the patients with mild to extremely suppressed or without respiratory drive, comprising: a compressor with negative pressure and connected to a filter and having a pipe that is attached to an inlet of a monitor with internal rotating distributor which regulates time and pressure of extracted portions of the air from a patient, where the regulation is achieved by constant or variable negative pressure inside a rigid durable container with said bag that expelling air through an outlet from the individual's nose and/or mouth to implement an expiration (E).

2. The device of claim 1, wherein the compressor with negative pressure encompassed by a compressor with a positive pressure that is having a pipe connected to an inlet of a monitor with internal rotating distributor which regulates time and pressure of delivered portions of the air to said patient through said bag, deflated by a positive pressure inside durable pressure chamber where the regulation is achieved by changing amount of air, the frequency of it delivery and duration of each compression to supply air to the individual's nose and/or mouth to implement an expiration (E) followed by an inspiration (I).

3. The device of claim 1, wherein the compressor with negative pressure encompassed by a compressor with a positive pressure that is having a pipe connected to an inlet of a monitor with internal rotating distributor which regulates time and pressure of delivered portions of the air to said chest cuff on the patient, where the regulation to the patient's chest is achieved by changing a pressure inside said chest cuff which tightly attached on the patient's chest to implement an expiration (E) followed by an inspiration (I) when the pressure from said chest cuff is released.

4. The device of claim 2, wherein the depth of expiration and inspiration phases restricted by said control valve.

5. The device of claim 2, wherein the breathing gas in the mask of BVM is pure oxygen or its combination with other therapeutic vapors to be directed to the nose and/or mouth of the patient from mild to extremely suppressed or without respiratory drive.

6. The device of claim 2, wherein said engines of said devices receive a power from a mechanical source, for example, a pedaling system.

7. The device of claim 2, further comprising an air or a liquid based filter for filtering the air/gas from or/and to the individual.

8. The device of claim 2, further comprising a thermo unit in front of the outlet of the monitor in the way that air will pass said unit on the way out during inhalation.

9. The device of claim 2, wherein said monitor and regulator of said devices are replaced with a solenoid serving the same functions.

10. A medical method for treating individuals from mild to extremely suppressed or without respiratory drive who can benefit from repeatedly applied negative-positive pressure in the thorax, the method comprising: Implementing a negative pressure to induce an expiration (E) immediately followed by a positive pressure to induce an inspiration (I); Implementing and modifying inverse ratio ventilation (IRV). This is achieved by modifying the inspiratory to expiratory (I:E) ratio, with the intention to increase oxygenation by increasing the mean airway pressure (MAP); Implementing Volume Control and Pressure Control ventilation modes using I:E ratios of 1:2, and up as high as 1:6 in certain populations in these cases with expiratory phase is set longer than the inspiratory phase to more closely mimic normal physiologic breathing; Implementing Inverse Ratio Ventilation using I:E ratios of 2:1, 3:1, 4:1, and so on, up as high as 10:1, with inspiratory times that exceed expiratory times.

11. The method of claim 10, further comprising a medical method for treating individuals from mild to extremely suppressed or without respiratory drive who can benefit from repeatedly applied positive pressure on the thorax, the method comprising: delivering a positive pressure into the chest cuff applied on the person during his/her expiration phase; deflating a pressure in the chest cuff applied on the person during his/her inspiration phase;

12. A medical method for treating individuals with extremely suppressed or without respiratory drive who can benefit from a negative pressure to the thorax complimenting by TENS unit or similar to it device operating with the same as TENS parameters and applied to individual's core muscles, the method comprising: delivering electric signals through electrodes applied to the core muscles of the patient; regulating the width, frequency and power of said signals.

12. A medical method for treating individuals from mild to extremely suppressed or without respiratory drive who can benefit from a BVM complimenting inflating and deflating the ball of said BVM through changing ambient pressure outside of the ball inside said rigid durable pressure chamber that contains said ball with no mechanical contact with the ball of said BVM.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The following detailed description of preferred embodiments of the invention will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.

[0025] FIG. 1 is an illustration of the system that provides a positive or a negative pressure inside the durable pressure chamber with BVM, which affects the air flow in the mask attached to a nose and/or mouth of the person according to one embodiment.

[0026] FIG. 2 is a system diagram of the device according to the second embodiment.

[0027] FIG. 3 is a system diagram of the device according to the third embodiment.

[0028] FIG. 4 is a system diagram of the device according to the fourth embodiment.

[0029] FIG. 5 is a system diagram of the device according to the fifth embodiment.

[0030] FIG. 6 is a diagram with a therapeutic gas chamber according to an exemplary embodiment of the device.

[0031] FIG. 7 is a diagram with the independent pump and membrane to regulate an inspiration and expiration of a patient according to an exemplary embodiment of the device.

[0032] FIG. 8 is a system diagram of the device complimented with a chest cuff according to the eighth embodiment.

[0033] FIG. 9 is a system diagram of the device reequipped with a solenoid according to the ninth embodiment.

DETAILED DESCRIPTION

[0034] It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements found in the field of artificial lungs or lung assist devices for individuals without respiratory drive. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

Definitions

[0035] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although any methods and materials similar or equivalent to those described herein can be used in testing the present invention, the preferred materials and methods are described herein.

[0036] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0037] The terms “patient,” “subject,” “individual,” and the like are used interchangeably herein, and refer to any animal amenable to the systems, devices, and methods described herein. Preferably, the patient, subject or individual is a mammal, and more preferably, a human. The description of “positive” pressure means that it is above the ambient one “negative” pressure means below the ambient pressure.

[0038] Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

[0039] The present invention relates to the art of automatic pneumatic regulation of pulmonary devices for assisting and/or enforcing the breathing process which can be used for extended periods of time with a high level of reliability, simplicity and efficacy not by a specially trained technician, but by volunteers, family members or by a patient.

[0040] The following is a detailed description of the best presently known mode of carrying out said invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The scope of the invention is defined by the appended claims.

[0041] Referring to FIG. 1 the air flow Compressor 1 with negative air pressure, having a filter 2 to disinfect the air coming from pipe 3 connected to the inlet 4 of said monitor 5 with internal rotating distributor 6 which regulates time and pressure of discharging portions of the air exhaled from the patient 11 through said BVM 10, which operated in said durable pressure chamber 15 under constant or variable level of negative pressure, and into said monitor 5, where the regulation is achieved according to said O.sub.2/CO.sub.2 censor 13 and by certain speed of said distributor 6 and certain size of said bilateral adjustable windows 12 on said distributor 6 through the outlet 8 from the nose and/or mouth of the patient 11 with a mild to extremely suppressed or without respiratory drive.

[0042] Referring to FIG. 2 the air flow from said compressor 1 through said pipe 3 with preset constant or variable level of compressed air connected to an inlet 4 of said monitor 5 with said distributor 6 that regulates time and pressure of supplying portions of the air/gas from outlet 8 through pipe 9 to the BVM 10, which operated in said durable pressure chamber 15 under positive pressure with a constant or variable level directed to the patient 11, where the regulation provided according to a said O.sub.2/CO.sub.2 censor 13 and by said distributor 6 and said shift 7 fed by an energy support system 14 and by certain size of bilateral adjustable windows 12 on said distributor 6.

[0043] Referring to FIG. 3 the air supply with a positive pressure enters rigid durable pressure chamber 15 through inlet 9.1 to make a compression of a flexible ball 16 of BVM 10 inside said chamber 15 without a mechanical contact and forcing the air flow from BVM 10 to the patient 11 to initiate an inhalation action while valve 17 is open and valve 18 is closed. In turn, when a positive pressure is off valve 17 is closed and valve 18 is opened a negative pressure through outlet 9.2 engaged an exhalation as a result of expending of said ball 16 of said BVM. When a positive pressure exceeds the maximum preset level or negative pressure plunges below minimum preset level a control valve 19 temporally opens to normalize the pressure inside the pressure chamber 15 within preset comfort pressure zone.

[0044] Referring to FIG. 4 a combination of the first and second embodiment is set up as one process, inhalation, followed by another exhalation in repetitive cycling motions where ABC air circulation line depicts the position of said BVM 10 in said firm durable pressure chamber 15 which receives a positive pressure from Line D and negative pressure from Line E to simulate a breathing cycle for the patient by manipulating said flexible ball 16.

[0045] Referring to FIG. 5 the air flow compressor 1 with negative air pressure, having a filter 2 to disinfect the air coming from pipe 3 connected to the inlet 4 of said monitor 5 with said distributor 6 which regulates time and pressure of discharging portions of the air exhaled from the patient 11 through said BVM 10, which operated in said rigid durable pressure chamber 15, and into said monitor 5, where the regulation is achieved according to said O.sub.2/CO censor 13 and by certain speed of said distributor 6 and certain size of said bilateral adjustable windows 12 on said distributor 6 through the outlet 8 from the nose and/or mouth of said patient 11 who's exhalation process is stimulated by attached to the patient's body TENS unit 17 controlled by a timer 29.

[0046] Referring to FIG. 6 the air flow alternated by therapeutic gas from a chamber 13.1 to said compressor 1 through said pipe 3 to an inlet 4 of said monitor 5 passing outlet 8 through thermo unit 18 following through the adjustable windows 12 to the nose and/or mouth of the patient's 11 mask through said BVM 10, which operated in said rigid durable pressure chamber 15, and said mask is supplied by O.sub.2 and censored for a proper setting by said O.sub.2/CO.sub.2 censor 13.

[0047] Referring to FIG. 7 the compressor 1 produces an air flow through an inlet 3 into a pump 20 where it moves a valve 23 in the pump 20 in closing position and presses movable membrane 21 against spring 25 while air flow produced by said membrane 21 and it closes on its way prior opened valve 21 and 27 and delivers air through the outlet 25 to nose and/or mouth of said patient 11. It imitated an inhalation phase of the breathing. When air pressure from said compressor 1 stops, the upper valve 23 gets open by gravity and by the force of the spring 26 of said membrane 21 which is pushed back by said spring 26, empting the part of the pump 20 from air into opened outlet 24 and at the same time sucking in air from said patient 11 and supplying inlet 28 into opened outlet 24. It imitates an exhalation phase of the breathing. The dimension D3+D1=D2 where the adjustable membranes on the outlets 3, 25 and 28 regulate the duration and ratio of the inspiration (I) and expiration (E) phases of the breathing process and I/E ratio to the right or to the left of this equation.

[0048] Referring to FIG. 8 the air flow from said compressor 1 with preset level of positive/negative constant or variable pressure air connected through said pipe 3 to an inlet 4 of said monitor 5 with said distributor 6 that regulates time and pressure of supplying portions of the air from outlet 8 through pipe 9 to a chest cuff 10.1 on the patient's 11 chest. The parameters are according to a O.sub.2/CO.sub.2 censor 13 and by said distributor 6 and said shift 7 fed by an energy support system 14 and by certain size of bilateral adjustable windows 12 on said distributor 6.

[0049] Referring to FIG. 9 the air flow compressor 1 with negative air pressure, having a filter 2 to disinfect the air coming from pipe 3 connected to the inlet 4 of said monitor 5 and said distributor 6 which regulates time and pressure of discharging portions of the air exhaled from the patient 11 through said BVM 10, which operates in said rigid durable pressure chamber 15, and said solenoid 5.1 regulates air flow through the pipe 9 from the nose and/or mouth of the patient 11 and/or air flow from said chest cuff 10.1.

[0050] In one embodiment of the present invention, ambient air, i.e., air in the environment immediately surrounding the device is used as the sweep gas feed to said device. Ambient air typically comprises 20.95% oxygen and less than 0.04% carbon dioxide by volume. By using ambient air as the gas feed for the device of the present invention eliminates the need for an oxygen tank or other source of oxygen, thereby increasing the portability of the device. Alternatively, in another embodiment, ambient air can be mixed with oxygen from an oxygen source prior to be supplied to the oxygenator in order to increase the concentration of oxygen in the gas feed, thereby increasing the rate of oxygen transfer to the blood.

[0051] In various embodiments, the device of the present invention may comprise additional components that will improve the performance of blood oxygenation and lung assistance. Such components include, but are not limited to: a thermo unit, humidifier, therapeutic gas, at least one sensor, an air filter, and a control panel or other means for controlling the device.

[0052] In one embodiment, the device of the present invention may comprise a thermo unit. In such an embodiment, the thermo unit is used to maintain the temperature of the air supply at or close to the subject's natural body temperature in order to prevent or reduce the potential for causing adverse health effects or for a medically supervised increase in core temperature for the purposes of eradicating viral colonies/clusters.

[0053] In various embodiments, the device of the present invention comprises at least one sensor for measuring variables related to the operation of the device. In one embodiment, the device comprises an oxygen sensor for determining the level of oxygen in the subject's blood. In another embodiment, the device comprises a carbon dioxide sensor for determining the level of carbon dioxide in the subject's blood. In one embodiment, the oxygen and/or carbon dioxide sensors can be used for measuring the concentration of a gas in the blood entering the device, i.e., pre-oxygenation. In another embodiment, the oxygen and/or carbon dioxide sensors can be used for measuring the concentration of a gas in the blood returning to the patient, i.e., post-oxygenation. In one embodiment, the device comprises at least one sensor for determining the composition of oxygen and/or carbon dioxide in the sweep gas. In one embodiment, the device comprises at least one flow sensor for measuring the flow rate of blood at a desired location in the system. In one embodiment, the device comprises a flow sensor for measuring the flow rate of sweep gas in the oxygenator. In one embodiment, the device comprises temperature sensors for determining the temperature of the air at a desired location in the device, for example, the temperature of the inhaled air delivered to the patient.

[0054] In one embodiment, the device comprises an air filter for filtering particulates or other impurities from the gas being supplied to or out of the patient. In one embodiment, the filter is capable of filtering about 95% of particles that are 0.3 microns or larger.

[0055] In various embodiments, the device of the present invention may comprise means for controlling the device, for example, to control variables such as, but not limited to, the flow rate of air through the device, the composition of sweep gas, and the temperature of air flowing through the device. In one embodiment, the control means is a compact controller integrated with the device, comprising a touch screen or other means for entering and/or displaying data. In another embodiment, the control means may comprise a computer processor integrated with the device that can be controlled via a wireless connection to a computer that is not physically connected to the device.

[0056] The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.