transtracheal lung ventilation using a manual respiration valve -not a patent - free to be produced-...

Transtracheal Lung Ventilation using a Manual Respiration Valve

-Not a patent - free to be produced-

Dragan Pavlovic

Formerly Department of Anaesthesiology, Ernst-Moritz-Arndt-University Greifswald, Germany

Conflict of interests: Dragan Pavlovic and Michael Wendt. A Device for Manual Ventury-Jet Ventilation, German Patent Office N° 202.13.420.2 (August 29, 2002 – EXPIRED in 2012) and Dragan Pavlovic, German Patent Office Nr.: 10 2009 029 959.9 (23.06.2009).

Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology 2003; 98 (5): 1269-77.

Airway Management. Leitlinie der Deutschen Gesellschaft für Anästhesiologie und Intensivmedizin. Anaesth Intensivmed 2004; 45: 302-306.

Recommendations for airway control and difficult airway management.Minerva Anestesiol. 2005, 71(11):617-57.

Recommendations for airway control and difficult airway management in pediatric patient.Minerva Anestesiol. 2006, 72(11):723-48.

“Can not intubate, can not ventilate”:

transtracheal ventilation

Background.

In the extreme and rare emergency, when the patients could be neither intubated nor ventilated (“can not intubate, can not ventilate”) due to upper airway obstruction or in cases of “difficult intubation”, as the last resource, ventilation through a transtracheal cannula is attempted.



Patel, R.G. Percutaneous transtracheal jet ventilation: a safe, quick, and temporary way to provide oxygenation and ventilation when conventional methods are unsuccessful. Chest. (1999), 116: 1689-94

Lung inflation is maintained with a kind of jet ventilation while the lung empties through the upper airways (if they are open – what is not always the case) and through the trans-tracheal cannula.

This is done until help is obtained and ordinary airway assured in a hospital emergency department. If the airway pressure is not monitored, to avoid hyperinflation and lung injury, it is necessary to closely observe the thorax excursions while ventilating the lungs.

O2



Patel, R.G. Percutaneous transtracheal jet ventilation: a safe, quick, and temporary way to provide oxygenation and ventilation when conventional methods are unsuccessful. Chest. (1999), 116: 1689-94.

Existing Systems

„Manujet“(VBM)Price: $430

Existing Systems

„Manujet“

Enk-Set (COOK)

Existing Systems

Price: 88.50 euro

Enk, D., Busse, H., Meissner, A., and Aken, H. van. A new device for oxygen and drug administration by transtracheal jet ventilation, Anesth. Analg. (1998), 86: 203.

Preussler N., Schwarzkopf K., Schreiber T., et al. Ein Vergleich zwischen dem “oxygen flow modulator” und der niederfrequenten Jetventilation zur transtracheale Oxygenierung im Tiermodell. Anästhesiologie & Intensivmedizin (2001), 42: 481

Manual Jet Ventilator(Instrumentation Industries, Inc.)

Price: $140

Existing Systems

time

pulmonary pressure

PEEP

O2

Transtracheal cannula= high flow resistance

Inspiration: very high driving pressure

Expiration = low driving pressure

Problem

Problems With the Existing Systems

Major problem is upper airway obstruction – that may be the very cause for “can not intubate, can not ventilate”!

High inspiratory flow that is followed by law, passive expiratory flow through 1-2mm diametar trans-tracheal cannula may result in:

1. Build up of dynamic PEEP

2. Dangerous hyperinflation

Low respiratory frequency that would permit lung empting will induce:

3. hypoventilation

time

pulmonary pressure

PEEP

Active expiration is needed for the existing systems to function properly

Available devices do not have a facility for active expiration.

The only available device that uses expiratory aid is a full jet ventilator with double lumen trans-tracheal tube, described by Garry B et al.

(B., Garry., Woo, P., Perault, F. D., Shapshay, S., and Wurm, H.. Jet ventilation in upper airway obstruction: description and model lung testing of the new jetting device, (1998) Anesth Analg, 87: 915 – 920., US patent, US005669380, the application filed by

639,167, Apr. 26, 1996)

Existing Systems

A solution?

O2

A solution?

Daniel Bernoulli 1700-1782

2.5mm

1.4mm

5mm

3mm20mm

Giovanni Battista Venturi, (1746–1822)

http://en.wikipedia.org/wiki/Image:BernoullisLawDerivationDiagram.png

2.5mm

1.4mm

5mm

30mm

3mm

20mm

Principle 1

GreifPump

How the venturi system was addapted

(Dragan Pavlovic & Michael Wendt,German Patent Office, N° 202.13.420.2, August 29, 2002)

2.5mm

1.4mm

5mm

30mm

Principle 2

O2

GreifPump



2.5mm

1.4mm

30mm

Principle 3

O2

To the patient

GreifPump



GreifPump. Experimental prototype:Fabrication – metal


GreifPump. Experimental prototype:Fabrication - metal

2.5mm

2.0mm

30mm

3mm

O2

To patient

7mm

1.5-2.0mmdihtung

20mm

4.0mm


GreifPump. Experimental prototype:Fabrication - glass


Our GreifPump

To trachea

O2

Functioning. Manual closure (with finger) of the outlet (c) forces gas to flow back through the side tube (d) (“inspiration”). The close-open maneuvers makes the pump functioning as a blowing-suctioning apparatus. The suctioning power is 2-3 times smaller then blowing and for moving the equal volumes in both directions, suctioning time has to be 2-3 times longer then blowing time.

C

d

GreifPump. How it works


O2

tracheaCartilago cricoidea

Cartilago thyrodidea

GreifPump. How it works:Finger on: inspiration

inspirationO2


O2

trachea

Cartilago thyrodideaCartilago cricoidea

GreifPump. How it works:Finger off (suction): facilitated expiration

Facilitated expiration

O2

O2


Average conditions:

airway resistance (r) = 2mbar/l sec-1,

respiratory system compliance (C) = 0.1 l/mbar

peak inspiratory pressure (Pip) = 10mbar

Experiments in vitro(test lung simulator settings)

1000mlInspiredvolume

20 10 0 10 20 30 40 50 60 time (s)

Spontaneousexpiration

4.0 14.8:31.4 2.124.3 13.7:30.6 2.235.4 11.1:30.5 2.745.6 10.7:29.3 2.746.8 8.8 :30.9 3.4010.0 6.9 :22.2 3.2114.0 4.2 :18.0 4.28

Metall venturiI:E times for 1.0 litre Vt;

16G

Flow (F) (l/min) I:E R

Inspiratory time (*) expiratory time

RESULTS In vitro

300ml

Vt of 300ml O2 may be sufficient for normal oxygenation

Pavlovic, Dragan. A Device for Manual Ventury-Jet Ventilation, German Patent Office N°

202.13.420.2, August 29, 2002

Inspiratory and expiratory time for 1 L (defined as Time "Zero") "Worst" scenario: cannula 16G; R= 128 mbar/L/sec; C= 0,1

L/mba (F in liter)

0

200

400

600

800

1000

1200

-30 -20 -10 0 10 20 30 40 50

Time (sec)

Lung v

olu

me

(L) F=2

F= 4

F=6

F=12

Spontaneous

*) Inspiration time for 1.0 litre=60/F (pre-set value)

Glass venturiI:E times for 1.0 litre Vt

RESULTS In vitro

300ml Vt of 300ml O2 may be sufficient for normal oxygenation

Pavlovic, D, K. Meissner, H.-E. Wagner, U. Bartels, and M. Wendt, Bi-directional Venturi Pump for Emergency Transtracheal Lung Ventilation, Intensiv Medizin und Notfallmedizin 39 (Suppl 1): 49, 2002

K. Meissner, T. I. Usichenko, Ch. Lehmann, M. Wendt and D. PavlovicBi-directional Venturi Pump for Short Term Emergency Transtracheal Lung VentilationASA 2003, San Francisco, USA.

16G inner diameter (about): 0.053in = 1.345mm


Inspiration expiration

Inspiratory and expiratory time to 1,0 L (defined as Time "Zero")."Best" scenario: cannula 12G; R=2 mbar/L/sec; C= 0,01

L/mbar

0

200

400

600

800

1000

1200

-30 -20 -10 0 10 20 30 40 50

Time (sec)

Lung

vol

ume

(L)

F=2

F=4

F=6

F=12

Spont.



RESULTS In vitro

300ml

Vt of 300ml O2 may be sufficient for normal oxygenation




Inspiratory and expiratory time for 1 L (defined as Time "Zero") "Worst" scenario: cannula 16G; R= 128 mbar/L/sec; C= 0,1

L/mba (F in liter)

0

200

400

600

800

1000

1200

-30 -20 -10 0 10 20 30 40 50

Time (sec)

Lung v

olu

me

(L) F=2

F= 4

F=6

F=12

Spontaneous



RESULTS In vitro

300ml


The limiting factor for minute lung ventilation in very comliant lungs and with high airway resistance may be relativelly long expiratory time.

Venturi- Beatmung mittels endotrachealemTubus (cl030917)

7,461 7,451 7,45

40,6 41,237,6

43,53

58,34

47,16

0

10

20

30

40

50

60

70

0 min 7 min, I: E= 2:6 15 min, I: E= 1: 3

pH- Wert

pCO2 [mmHg]

pO2 [10* mmHg]

The GreifPump was also tested in the pigs (32-40kg. N=3) and it was concluded that it provides adequate lung ventilation if the flow of gas (100% of O2 that was used produced even extreme over-oxygenation) is over 6l/min and intratracheal cannula 16G or greater.

Bellow, results of the experiment: Flow: 140ml/sec (8.4l/min), cannula 16G.

RESULTS. In vivo, pilot study (3 pigs)

mmHg

Time following begunining of trans-tracheal ventilation with GreifPump

Animals (pigs, 40kg, n=5) were anesthetized and mechanically ventilated (tidal volume about 10 ml/kg), to be then ventilated through transtracheal 16 G cannula (while the tracheal tube was blocked) using the venturi device.

Predefined inspiration times (0.8, 1.5 and 2 sec) and two different gas flows (12 and 16 l/min) were tested. In addition to blood gas analysis and the recording of arterial, pulmonary artery, central venous and tracheal pressures, continuous cardiac output measures were performed.

Further In-vivo Tests (5 pigs) of a Bi-directional Venturi Pump for Emergency Transtracheal Lung VentilationKonrad Meissner, Thomas Iber, Jan-Patrick Roesner, Christian Mutz, Christina Layher, Christian Lehmann, Michael Wendt, and Dragan PavlovicIn-vivo Tests of a Bi-directional Venturi Pump for Emergency Transtracheal Lung VentilationESA-2005, Vienna

Dragan Pavlovic, Konrad Meissner, Thomas Iber, Jan Roesner, Christian Mutz, Christina Layher, Christian Lehmann, and Michael WendtBi-directional venturi pump can provide satisfactory transtracheal lung ventilation during more then 1 hour in 40kg pigsHAI-2005, Berlin

Konrad Meissner, Thomas Iber, Jan-Patrick Roesner, Christian Mutz, Hans-Erich Wagner, Christina Layher, Utz Bartels, Matthias Gründling, Taras I. Usichenko, Michael Wendt, Christian Lehmann, and Dragan PavlovicSuccessful Transtracheal Lung Ventilation using a Manual Respiration Valve-an in vitro and in vivo Study, Anesthesiology. 2008 Aug;109(2):251-9

ResultsArterial pO2 and pCO2 values for the three conditions tested (A: flow 16 l/min, I/E ratio 0.8/4.5 sec; B: flow 16 l/min, I/E 1.6/8.5 sec, C: flow 12 l/min, I/E ratio 2/8.5 sec) are given in Fig. 3. The other recorded physiologic parameters did not change significantly during venturi ventilation. The tracheal pressures (max 9.4, min 1.8 cm H2O) corresponded to central venous and pulmonary artery pressures. Cardiac output rose from 4.5±1.1 to 5.0±2.2 l/min in the high flow/high frequency experiments (A) but slightly dropped (4.9±1.0 to 3.9±1.1 (B); 5.3±0.9 to 4.1±1.1 (C)) in both low-frequency groups. Occasional PEEP increases were inversely proportional to the cardiac output.

Anesthesiology. 2008 Aug;109(2):251-9

time (min)

0100200300400500600

0 10 20 30 40 50 60

pO2 pCO2

0100200300400500600

0 10 20 30 40 50 60

0100200300400500600

0 10 20 30 40 50 60

art

eria

l blo

od

pa

rtia

l pre

ssu

res

(mm

Hg

)

A

B

C

462.5±75.3

490.5±59.2

470.8±86.8

63.0±7.2

64.9±10.0

84.4±16.8

16 l/min, I/E 0.8/4.5 sec

16 l/min, I/E 1.6/8.5 sec

12 l/min, I/E 2/8.5 sec

After 1 hour

RESULTS summaryWe found that when increasing the flow rate both inflation and deflation times shortened, but I:E ratio (R) increased and deflation time lag progressively behind inflation time, as it was predicted by the mathematical model.

The less favorable conditions were modeled with C set at 0.03 l/mbar (Pip was 30mbar) when time of spontaneous lung emptying approached that achieved with the venturi pump set at F<10 l/min.

Anesthesiology. 2008 Aug;109(2):251-9

Conclusions

With medium gas flow of about 10l/min, and with an I:E ratio of about 1:3.5, we predicted that satisfactory ventilation of the normal adult lungs could be expected with this model.

An adequate ventilation of pathological or smaller lungs (in children) would require adjustment of the flow rate and/or of I:E ratio.

The performance of the venturi pump could be predicted to great extent but a calibration would be needed in order to produce tables that would recommend flow and I:E ration for the given lung volume.Anesthesiology. 2008 Aug;109(2):251-9

Use1. This is self-contained valve that, with a supply with pressurised gas (oxygen), can provide lung insuflation by the closure of one orifice with a finger, and when orifice opened, active expiration true trans-tracheal cannula.

2. The device should be present in every emergency department and every emergency vehicle replacing devices that are in use.

3. This cheep device can be routinely added to the bottles containing medical air or oxygen to be used as a suctioning or for trans-tracheal lung ventilation in cases of emergency.

4. Visual control of thorax movement may give satisfactory insight into ventilation and, in emergency, the use of the GreifPump may be recomanded.

6. Being an emergency device its possible drawbacks (jet injury to the bronchial mucosa, no control of delivered volumes) may be largely ignored.

This device is free, the patent-like protection

expired in 2012

Dr.Enk changed our model probably in order to claim a patent, but weakened its Venturi effects.

Enk, Dietmar. Gas flow reversing element, Deutsche Patent Office, DE 10 2007 013 385 A1 2008.09.18 or under other similar patent registrations: Enk D. Gasstromumkehrelement. Patent application (10 2007, 013 385.7). German Patent Office, March 16, 2007

WO2008113752 A3WO2008113752 A2CA2681121 A1

Let us have a look at the first Patent “Enk, Dietmar. Gas flow reversing element, Deutsche Patent Office, DE 10 2007 013 385”

In documentation from German Patent Office is to find that this Patent was REMOVED (Nicht anhängig/erloschen)! Last registration was 30.01.2013.https://register.dpma.de/DPMAregister/pat/register?AKZ=1020070133857orhttps://register.dpma.de/DPMAregister/pat/PatSchrifteneinsicht?docId=DE102007013385A1&page=1&dpi=150&lang=de

We presume that the DPO removed it because it was identical with our model from 2002.However, Dr. Enk registered the SAME Patent outside of Germany (see above) probably to avoid the problem. (For how long?)

Enk’s replica

https://register.dpma.de/DPMAregister/pat/register?AKZ=1020070133857

https://register.dpma.de/DPMAregister/pat/PatSchrifteneinsicht?docId=DE102007013385A1&page=1&dpi=150&lang=de

https://register.dpma.de/DPMAregister/pat/PatSchrifteneinsicht?docId=DE102007013385A1&page=1&dpi=150&lang=de

The two models are the same in respect to protected characteristics of the model of Pavlovic 2002 (the protection expired in 2012). Dr. Enk used probably larger tubing overall, but, (1) shortened the injector tube and (2) pulled it backwards and (3) prolonged the narrow part of the exit tube, replacing the conical exit tube with an (4) equally narrow tube.

B (Enk 2007)A (Pavlovic 2002)

To lungsTo lungs

Problems of the Enk model

Since the Enk’s patent protects only his trivial changes of our previously protected model,

THEREFORE,the device is free, since its

patent-like protection expired in 2012

Perspectives1. Intermittent airway pressure measurements

by stop-flow at the end of expiration (at every 5-8 cycles, at the end of suctioning; currently used system do not have this facility) would assure that the lungs are at functional residual capacity (FRC) and that ventilation may be continued without danger of over-inflation. However this does not have to be included in standard equipment.

2. Potentially, it can be used as a jet ventilator in ORL surgery if the upper airways are obstructed, assuring complete lung emptying and removing a danger of hyperinflation that is always present when using classical jet ventilators. (Dragan Pavlovic, German Patent Office Nr.: 10 2009 029 959.9

(23.06.2009).

a

b

c

d

O2

Preasure

transducer

patient

Perspectives

(Dragan Pavlovic, German Patent Office Nr.: 10 2009 029 959.9 (23.06.2009).

O2

from patient

Pressure knobSecurity valve

To manometer

… or with variable expiratory-inspiratory flows

Perspectives


O2

To patient


To manometer


Perspectives


O2

from patient


To manometer


Perspectives


O2

To patient


To manometer


Perspectives


To the lungs

O2, high pressure, about 15L/min

B. During inspiration, when squeezed with the hand, flow is reduced.

A. During inspiration, when squeezed with the hand, the outflow is blocked (while the inflow to the venturi nozzle is reduced by the action of the lower part of the handle (B).

The device is hold in a hand and when sqeesed, upper and lower part (A and B) move inwards and reduce the flow (A) and close the outflow (B).

This blocks the gas inflow when moved inwards by squeezing the handle (the extent of movement should be adjustable).

A

B


O2

From the lungs

2.5 mm 3mm

5mm

7mm

10mm


O2

To the lungs

2.5 mm 3mm

5mm

7mm

10mm


O2

To patient


Perspectives


To the patient: LOW FLOW

O2

O2

To patient


Perspectives


From the patien: HIGH FLOW

O2

…surmounting the problem of long expiratory time and permitting any I:E ratio, even inverse ratio ventilation.

Perspectives


O2

GreifPump

Wendt, M. , Meissner, K. , Gründling, M., Usichenko, T.I., C. Layher - VulcanoDepartment of Anaesthesiology, Ernst-Moritz-Arndt-University Greifswald, Germany

Iber, T., Roesner, J.P., Mutz, C., Departmen of Anaesthesiology, Rostock University, Rostock, Germany

Wagner, H.E.Institute of Physics, Ernst-Moritz-Arndt-University Greifswald, Germany

*Bartels, U.Dept. of Anesthesiology and operative Intensive Care Medicine, Hospital of Nürnberg, Prof.-Ernst-Nathan-Str. 1, 90419 Nürnberg, Germany

Conflict of interests: Dragan Pavlovic and Michael Wendt. A Device for Manual Ventury-Jet Ventilation, German Patent Office N° 202.13.420.2 (August 29, 2002, EXPIRED in 2012) and Dragan Pavlovic, German Patent Office Nr.: 10 2009 029 959.9 (23.06.2009).

transtracheal lung ventilation using a manual respiration valve -not a patent - free to be produced-...

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