Device and methods for applying therapeutic protocols to organs of the cardiopulmonary system

• US 9,114,224 B2
• Filed: 10/11/2009
• Issued: 08/25/2015
• Est. Priority Date: 06/09/2009
• Status: Active Grant

• Current Assignee: RespiNova Ltd
• Original Assignee: RespiNova Ltd
• Inventors: Avni, Yuval
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US13/377,087
• Publication Number:
  US 20120103337A1
• Time in Patent Office: 2,144 Days
• Field of Search: 128/200.24, 128/200.26, 128/204.18, 128/204.21, 128/204.23, 128/205.11, 128/205.23, 128/205.24, 128/206.21, 128/207.14, 128/207.16
• US Class Current: 1/1
• CPC Class Codes: A61M 16/0006 with means for creating vibrations in patients' airways
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/103 the CO2 concentration
• CPC Class Codes: A61M 2016/1035 the anaesthetic agent concentration
• CPC Class Codes: A61M 2021/0088 modulated by a simulated respiratory frequency
• CPC Class Codes: A61M 21/02 for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence

Abstract

A device for the introduction of a fluid into a human'"'"'s airway. The air so introduced has a carefully modulated envelope of pressure vs. time. The envelope generally includes sequences of pressurized air packets of controlled frequency and pressures. The device produces the packets using pressurized air occluded by a shutter action that “chops” and interrupts the fluid stream. The vibrations induced by the device within human organs have been shown to have beneficial effects on various bodily systems, such as an increase in heart rate variability, an increase in absorbed oxygen, and a decrease in absorbed CO2.

Claims

1. An air delivery device for applying a plurality of fluid pressure pulses of air to the airways of a patient for improving patient'"'"'s health comprising:

a. a cassette comprising an electric motor;

an air tube attached to said cassette and comprising an input port and an output port;

b. an airstream source fluidly coupled to said input port and delivering an airstream to said air tube;

a disc located in proximity to said output port and comprising at least one cutout, and

c. a mouthpiece fluidly coupled to said output port and adapted to apply said plurality of fluid pressure pulses to patients'"'"' airways,

wherein said electric motor is mechanically coupled to said disc and spins said disc such that said airstream is occluded in accordance with a predetermined protocol thereby generating said plurality of fluid pressure pulses, and

wherein said plurality of fluid pressure pulses comprises fluid pressure pulses of at least two different frequencies.

2. The air delivery device according to claim 1, wherein said cassette further comprises a controller configured to control the rotation of said electric motor thereby generating said plurality of fluid pressure pulses in accordance with said predetermined protocol.

3. The air delivery device according to claim 2, wherein said plurality of pressure pulses is delivered to patient'"'"'s airways in accordance with patient'"'"'s breathing rhythm said delivery of said plurality of pressure pulses is selected from the group consisting of delivering said plurality of fluid pressure pulses synchronously with patient'"'"'s breathing rhythm and delivering said plurality of fluid pressure pulses asynchronously with patient'"'"'s breathing rhythm.

4. The air delivery device according to claim 2, wherein said plurality of pressure pulses is delivered to patient'"'"'s airways in accordance with patient'"'"'s cardiac cycle said delivery of said plurality of pressure pulses is selected from the group consisting of delivering said plurality of fluid pressure pulses synchronously with patient'"'"'s cardiac cycle and delivering said plurality of fluid pressure pulses asynchronously with patient'"'"'s cardiac cycle.

5. The air delivery device according to claim 2, wherein said controller further comprises:

at least one sensor for measuring at least one health related parameter of patient;

a database storage microprocessor for storing and updating health related data;

at least one analyzing means configured to;

analyze at least one health related parameter;

compare at least one health related parameter with said stored health related data;

select said predetermined protocol from a repertoire of protocols in accordance with said comparison, said repertoire of protocols is stored in a CPU, and instruct said electric motor to spin said disc to generate said fluid pressure pulses in accordance with said predetermined protocol.

6. The air delivery device according to claim 1, wherein said plurality of fluid pressure pulses comprises at least one sequence of fluid pressure pulses.

7. The air delivery device according to claim 1, wherein said plurality of fluid pressure pulses is delivered to patient'"'"'s airways said delivery of said plurality of fluid pulses is selected from the group consisting of delivering said fluid pressure pulses contemporaneously with patient'"'"'s breathing inspirations and breathing expirations and delivering said fluid pressure pulses independently of patient'"'"'s breathing inspirations and breathing expirations.

8. The air delivery device according to claim 1, wherein said predetermined protocol comprises at least one fluid pressure pulse frequency said pulse frequency is selected from the frequency group consisting of:

from about 0.5 Hz to about 5.0 Hz;

from about 5.0 Hz to about 10 Hz;

from about 10 Hz to about 20 Hz;

from about 20 Hz to about 30 Hz;

from about 30 Hz to about 40 Hz;

from about 40 Hz to about 50 Hz;

from about 50 Hz to about 60 Hz;

from about 60 Hz to about 70 Hz;

from about 70 Hz to about 80 Hz;

from about 80 Hz to about 90 Hz;

from about 90 Hz to about 100 Hz, and any multiples thereof.

9. The air delivery device according to claim 1, wherein said predetermined protocol comprises a pulse amplitude, a pressure waveform and a protocol time duration, wherein said pulse amplitude is selected in accordance with clinical efficacy, wherein said pressure waveform is selected from the group consisting of:

10. The air delivery device according to claim 1, wherein said sequences of fluid pressure pulses is accompanied by predetermined humming oscillations for stimulation of nitric-oxide production, said humming oscillations provided independently of said sequence of fluid pressure pulses.

11. The air delivery device according to claim 1, wherein said sequences of fluid pressure pulses is accompanied by predetermined humming oscillations for stimulation of nitric-oxide production, said humming oscillations provided contemporaneously with said sequence of fluid pressure pulses.

12. The air delivery device according to claim 1, wherein said air delivery device is adapted for improving patient'"'"'s health and patient is suffering from at least one of the following ailments:

cystic fibrosis;

chronic obstructive pulmonary disease;

asthma;

pneumonia;

pulmonary hypertension;

nasal congestion;

emphysema;

interstitial fibrosis, pulmonary hypertension, sarcoidosis;

bronchitis;

asbestosis;

radiation fibrosis;

ARDS;

sinusitis;

pharyngitis;

laryngitis;

otitis media;

lung tumors;

coronary heart disease;

cardiomyopathy (CM);

hypertrophic CM;

dilated CM;

hypertensive CM;

congestive heart failure;

inflammatory heart disease;

endocarditis;

myocarditis;

cardiac arrhythmias;

atrial fibrillation;

atrial flutter;

supraventricular tachycardia;

A-V blocks;

systemic;

hypertension;

atherosclerosis;

atherosclerosis of the carotid arteries;

sleep apnea;

fibromyalgia and any combination thereof.

13. The air delivery device according to claim 1, wherein said air delivery device is adapted for improving patient'"'"'s health and patient is suffering from a heart disease said heart disease is selected from the group consisting of heart failure, congestive heart failure, pulmonary oedema, and any combination thereof.

14. The air delivery device according to claim 1, wherein said improvement in patient'"'"'s health comprises determining at least one of the following:

an improvement in patient'"'"'s diffusion capacity as measured by the DLCO test;

an improvement in patient'"'"'s health as measured by the six minute walk test;

an improvement in patient'"'"'s health as measured by the incremental shuttle walking test;

an improvement in patient'"'"'s lung volumes as measured by Lung Plethysmography;

an improvement in patient'"'"'s quality of life as measured by an increase in the patient'"'"'s score on the Chronic Respiratory Questionnaire scale compared to the patient'"'"'s score prior to said treatment, an improvement in patient'"'"'s health as determined by a pulmonary function test;

an improvement in patient'"'"'s health as determined by static lung volume;

an improvement in patient'"'"'s health as determined by a functional exercise capacity;

an improvement in patient'"'"'s health as determined by drug uptake;

an improvement in patient'"'"'s health as determined by heart function;

an improvement in patient'"'"'s health as determined by cardio vascular efficiency;

an improvement in patient'"'"'s health as determined by pulmonary blood pressure;

an improvement in patient'"'"'s health as determined by systemic blood pressure;

an improvement in patient'"'"'s health as determined by blood oxygenation;

an improvement in patient'"'"'s health as determined by nitric oxide production;

an improvement in patient'"'"'s health as determined by a Health Related Quality of Life Questionnaire and any combination thereof.

15. The air delivery device according to claim 1, wherein an improvement in patient'"'"'s quality of life is measured by at least one of the following:

an increase in said patient'"'"'s score of at least about 10 points on the Karnofsky scale compared to the patient'"'"'s score prior to said treatment;

in patient'"'"'s quality of life as measured by an increase in the patient'"'"'s score of at least about 20 points on the Karnofsky scale compared to the patient'"'"'s score prior to said treatment;

an improvement in the patient'"'"'s quality of life is measured by a questionnaire selected from the group consisting of;

St. George'"'"'s Quality of Life Questionnaire, the Karnofsky scale, the WHO QOL questionnaire and any combination thereof;

by an improvement in measures of physical performance;

by an improvement in measures of mental performance;

by an improvement in measures of physical performance and mental performance;

the RMSSD increases by at least 20% after said treatment;

the SDNN increases by at least 10% after said treatment;

the PNN50 increases by at least 5% after said treatment and any combination thereof and wherein said improvement in the patient'"'"'s quality of life is measured by an improvement in the patient'"'"'s symptoms as defined by the Karnofsky score selected from a group comprising of Bedridden to Symptomatic in bed >

50% of day, Symptomatic, in bed >

50% of day to Symptomatic, in bed <

50% of day, or Symptomatic, in bed <

50% of day to Symptomatic, fully ambulatory;

Symptomatic, fully ambulatory to Asymptomatic, normal Function and any combination thereof.

16. A method for applying a plurality of fluid pressure pulses of air to the airways of a patient for improving patient'"'"'s health comprising:

providing a cassette comprising an electric motor;

attaching an air tube to said cassette said air tube comprising an input port and an output port;

delivering an airstream to said input port of said air tube;

locating a disc having at least one cutout in proximity to said output port;

instructing said electric motor to spin said disc to occlude said airstream in accordance with a predetermined protocol thereby generating said fluid pressure pulses, and applying said plurality of fluid pressure pulses to said patients'"'"' airways by means of coupling a mouthpiece to said output port, wherein said plurality of fluid pressure pulses comprises fluid pressure pulses of at least two different frequencies.

17. The method of applying a plurality of fluid pressure pulses of air according to claim 16, further comprising:

measuring at least one health related parameter of patient by means of at least one sensor, and selecting said predetermined protocol from a repertoire of stored protocols in accordance with an analysis of patient'"'"'s at least one health related parameter and a comparison of patient'"'"'s measured at least one health related parameter and health related data stored on a database storage microprocessor.

18. The method of applying a plurality of fluid pressure pulses of air according to claim 16, further comprising controlling said spinning of said electric motor by means of a controller.

19. The method of applying a plurality of fluid pressure pulses of air according to claim 16, further comprising delivering said plurality of pressure pulses to patient'"'"'s airways in accordance with patient'"'"'s breathing rhythm said delivering is selected from the group consisting of delivering said plurality of fluid pressure pulses synchronously with patient'"'"'s breathing rhythm and delivering said plurality of fluid pressure pulses asynchronously with patient'"'"'s breathing rhythm.

20. The method of applying a plurality of fluid pressure pulses of air according to claim 16, further comprising delivering said plurality of pressure pulses to patient'"'"'s airways in accordance with patient'"'"'s cardiac cycle said delivery of said plurality of pressure pulses is selected from the group consisting of delivering said plurality of fluid pressure pulses synchronously with patient'"'"'s cardiac cycle and delivering said plurality of fluid pressure pulses asynchronously with patient'"'"'s cardiac cycle.

21. The method of applying a plurality of fluid pressure pulses of air according to claim 16, wherein said plurality of fluid pressure pulses is delivered to patient'"'"'s airways said delivery of said plurality of fluid pulses is selected from the group consisting of delivering said fluid pressure pulses contemporaneously with patient'"'"'s breathing inspirations and breathing expirations and delivering said fluid pressure pulses independently of patient'"'"'s breathing inspirations and breathing expirations.