AU632913B2

AU632913B2 - An apparatus for oxygenating a patient

Info

Publication number: AU632913B2
Application number: AU73532/91A
Authority: AU
Inventors: Friedrich Mertzlufft; Rolf Zander
Original assignee: Friedrich Mertzlufft; Rolf Zander
Priority date: 1990-03-21
Filing date: 1991-03-15
Publication date: 1993-01-14
Anticipated expiration: 2011-03-15
Also published as: DK0447844T3; EP0447844B1; EP0447844A3; DE59103558D1; EP0447844A2; CA2036897A1; AU7353291A; DE4009008A1; JPH04250170A; ES2063989T3; GR3015126T3; AT114248T

Description

632913 S F Ref: 155910 FORM COMMONWEALTH OF AUSTRALIA PATENTS ACT 1952 COMPLETE SPECIFICATION

(ORIGINAL)

FOR OFFICE USE: Class Int Class Complete Specification Lodged: Accepted: Published: Priority: Related Art: Name and Address of Applicant: Rolf Zander Luisenstrasse 17 DE-6500 Mainz FEDERAL REPUBLIC OF GERMANY Friedrich Mertzlufft Katzenberg 31 6500 Mainz 21 FEDERAL REPUBLIC OF GERMANY Spruson Ferguson, Patent Attorneys Level 33 St Martins Tower, 31 Market Street Sydney, New South Wales, 2000, Australia Address for Service: Complete Specification for the invention entitled: An Apparatus for Oxygenating a Patient The following statement Is a full description of this invention, including the best method of performing it known to me/us 5845/5

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1 An Apparatus for Oxygenating a Patient Warm blood cells rely on a continuous and adequate demandorientated supply of oxygen so that even brief interruption in the supply of oxygen can cause irreparable demage in and on the cells, particularly of the central nervous system and the cardiac circulatory system.

A shortage of oxygen, hypoxia, can be caused principally by inadequate supply, disorders of the pulmonary function, disorders in the conveyance of oxygen through the blood or a lack of haemoglobin and also by disorders in the cardiac circulatory e* e* system. In emergency medicine as well as in internal clinical supply, therefore, it is standard practice to supply oxygen to a patient. Within the framework of what is referred to as preoxygenation, above all before any intubation, it is vitally necessary to cover the patient's oxygen demand in the dangerous period prior to completion of the intubation or in the event of intubation complications.

S. In such and other cases, it is vital to enrich the storage space in the lungs with pure oxygen and at the same time also to ensure that other gases present in the body or in the inspired air, above all nitrogen, are as far as possible kept completely .away. In most cases, this is either not achieved at all or is S achieved only very inadequately by conventional pre-oxygenation methods. Known oxygenation apparatuses are masks, pharyngeal tubes and nasal-pharyngeal tubes, referred to as just tubes.

The disadvantages of these apparatus, described in the literature g. R. G. Sandersen The Cardiac Patient, Philadelphia, W. B. Saunders, 1972, pages 310), are above all

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insufficient humidification and warming of the gas, oxygen concentration is never 100 re-inhalation of respired air (CO 2 and N 2 -enrichment), leaks in the system (absorption of and a very high oxygen flow.

The problem on which the invention is based therefore resides in providing an apparatus for supplying oxygen to a patient (oxygenation), by means of which, simultaneously with the enrichment of oxygen, undesired other gases couldas far as possible be kept completely out of the pulmonary space.

In addition, it is intended to eliminate the above-mentioned drawbacks of prior art apparatus.

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According to the invention, this apparatus of oxygenating a patient is provided with an oxygen applicator for supplying oxygen via the nose and is characterized in that the oxygen applicator is so constructed that it supplies pure oxygen in a directed flow (nasoral) solely via the nose (nasal) and in that the apparatus additionally comprises a one-way valve adapted to be inserted at least substantially in sealing-tight fashion into the mouth (oral) of the patient and which opens only during gas outflow, otherwise closing and allowing excess oxygen and respired air to escape solely through the mouth.

In principle, it is possible with this apparatus to ensure on the one hand a directed flow, namely a separation of inhalation (100 02 via the nose) and exhalation (excess 02, N 2 and CO 2 via the oral valve), i. e. a "nasoral" system is achieve, and a physiological flow, namely humidification and heating, is ic, i_ .111_~ 0 0 00 04

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9* 0 0 .5 3 retained via the nose without increasing the dead space and avoiding any re-inhalation.

This apparatus ensures that if breathing is present or in the process of ceasing (apnoea) only pure (warmed and humidified) oxygen can reach the patient's respiratory passages and lungs, all gases which should be eliminated (nitrogen, laughing gas, carbon dioxide) are completely NO) or physiologically (CO 2 dicharged through the oral valve.

Even if the patient is unable to breathe independently, this apparatus is capable of allowing the patent to "inhale" only pure oxygen (referred to as apnoic oxygenation), since the oneway valve prevents the uncontrolled and undesired penetration of ambient air and thus large quantities of nitrogen. This functions for an unlimited period. As soon as respiration ceases, intentionally (for untubation) or unintentionally (an emergency), the oral valve can be removed if it is ensured that excess oxygen escapes through tba mouth. In this situation, thereapeutic measures can be undertaken via the mouth g. vacuum extraction, intubation, haemostasis), but also diagnostic measures are possible g. bronchoscopy, laryngoscopy).

Doctor, nurse or auxiliary also have both hands free for any necessary routine or acutely desired measure such as for example in an emergency the setting up of instruments for artificial respiration and the corresponding drugs or also the provision of a peripherovenous access for the administration of life saving or also anaesthesiologically vital medicaments or blood or blood substitutes. Also, doctor, lay helper or auxiliary will have both hands free for resuscitation measures such as for example extrathoracic cadiac massage, defibrillation, injections or infusions. A further advantage of the apparatus resides in the fact that it even allows a lay person significantly and without risk to increase the existing supply of oxygen which is minimal -j~

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c~ 4 under normal conditions, which is of great benefit over the entire range of extraclinical and intraclinical patent care for daily routine work. Assitance on the part of the patient is unnecessary. Thus, the apparatus can be advantageously used in cases of hypoxia of varying origin or for pre-oxygenation prior to intubation. With these cases, the apparatus according to the invention will a priori reduce the overall risk which exists especially by reason of possible obstacles to intubation.

The same apparatus can be used universally, namely both in emergency medicine (patient conscious or unconscious, breathing present or faltering) and also in anaesthesiology (pre-operative: pre-oxygenation, post-operative: recovery room), in intensi- S ve care (weaning of respirator), in otorhinolaryngology (laryngoscopy), in pulmology (bronchoscopy) and in dental, oral and S* maxillary treatment (oral surgery).

An essential feature of the apparatus according to the invention is that the introduction of the oxygen takes place solely via the nose. Oxygen overflow and exhalation pass through the mouth which is prevented from drawing in air by the one-way valve.

0 The oxygen applicator can be constructed in various ways and its supply part can for example take the form of a nasal catheter.

Expediently, however, an oxygen applicator in the form of a mask will be used, the mask covering only the nose. Preferably, this mask is so constructed that it can be placed over the nose in a i> substantially sealing-tight manner.

In per se known manner, the oxygen applicator can be connected to an oxygen bag interposed between the oxygen source and the oxygen applicator, allowing the inhalation process to be observed. In addition to or instead of the oxygen bag, an acoustic or visual signal may be provided on the oxygen applicator and/or on the one-way valve, to be triggered when the desired inhalation or exhalation takes place or when gas is flowing in or out.

In order to guarantee a unique (innerhospital and prehospital) application of the oxygen bag the setting as described below should be followed: The oxygen bag connected to the oxygen tube 2 of the oxygen applicator 1 comprises a 22 mm 0 connection (DIN-ISO 5356 part I) allowing for direct connection to both the oxygen applicator 1 as well *1 as to any endotracheal intubation tubes, the comprised 6 and 15 mm 0 combined connection to the oxygen source additionally allows for both direct connection to the central oxygen supply via the 15 mm 0 connection (DIN-ISO 7228) to the installed ventilation system and, via the integrated 6 mm connector (ISO 594/1) to mobile oxygen supply sources (eg oxygen cylinders). Both connections being part of the oxygen bag.

After performance of endotracheal intubatlon (one-way valve 3 removed), clamped-sealing and deconnection of the oxygen bag from the oxygen tube 2, the described setting provides the possibility to maintain oxygenatlon/denitrogenation (mobile oxygenation, eg for transport of patients from the Induction room to the operation theatre and from operation theatre to the recovery room or intensive care unit, goo for any measure of patent positioning).

As stated above, the one-way valve is so constructed that it can be inserted in substantially sealing-tight manner into the patient's mouth. For this purpose, the one-way valve is expediently provided with 25 a flexible sealing plate which is introduced into the patient's mouth in front of the top and bottom jaws and between them and the lips. It is especially expedient if there is adjacent to this sealing plate a I tubular member which projects Into the pharyngeal space a~nd on which the patient is able to bite in order to maintain the sealing plate in a sealing-tight position.

However, it is of course also possible for the one-way valve to be sealed in other ways such as for example by a possibly inflatable rubber balloon which fits tightly in the mouth opening during inflation, The two devices which form part of the apparatus according to the invention, the oxygen applicator and the one-way valve, can be provided separately from each other, as a set. However, it is expedient for them to be connected to each other so that the user, the doctor, the nurse or pL14 the auxiliary, always has both devices available together, ready for use.

I, q1 R/97 I The accompanying drawing shows an embodiment of the apparatus according to the invention diagrammatically and In vertical section.

The apparatus according to the invention consists of the oxygen applicator 1 and the one-way valve 3. The oxygen applicator device 1 takes the form of a mask with two sealing lips 7 and 8 which are applied above and below the nose and allow oxygen to be supplied solely via the nose. The oxygen applicator 1 is connected via its oxygen tube 2 to an oxygen cylinder.

The one-way valve 3 has a flexible sealing plate 5 which can be inserted in a substantially sealing-tight manner between the lips and jaws (teeth) of the patient. Adjacent to this sealing plate 5 is a tubular member 6 on which the patient bites. In the widened out front part of the one-way valve which is outside the mouth, there are the valve members 4 which are so constructed that they spread apart from one another during exhalation or during gas outflow, whereas they are otherwise pressed In sealing-tight manner on one another (for example during the inhalation process) and prevent the ingress of ambient air.

Under clinical conditions the denitrogenatlon as well as the ventilation of the patient can be controlled by endexpiratory gas S 20 sampling using either mass spectrometry (02, CO 2

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2 or t Scapnometry (02, CO 2 For this occasion the one-way valve 3 comprises a special and closable gas outlet 9 allowing for the connection of the respective analysing system (ISO 594/1) and thus for continuous gas sampling (side stream).

t*oo HRF/0987c

Claims

1. An apparatus for oxygenating a patient, comprising an oxygen applicator for supplying oxygen via the nose, characterized in that the oxygen applicator is so constructed that it supplies pure oxygen in a directed flow and solely via the nose and in that the apparatus additionally comprises a one-way valve which can be inserted in substantially sealing-tight manner into the mouth of the patient, the one-way valve opening only upon gas outflow, otherwise closing and allowing excess oxygen and expired air to escape solely through the mouth.

2. An apparatus according to claim 1, characterized in that the oxygen applicator is constructed as a mask which only covers the nose.

3. An apparatus according to claim 1 or 2, characterized in that the one-way valve comprises a flexible sealing plate adapted to be introduced between the lips and the jaws or teeth of the patient.

4. An apparatus according to claim 3, characterized in that the one-way valve comprises a tube portion adjacent the sealing plate.

5. An apparatus according to one of the claims 1 to 4, characterized in that the one-way valve comprises flexible plates which are spread apart from one another only upon gas outflow, being otherwise (eg during inhalation) pressed against one another in substantially sealing-tight manner.

6. An apparatus according to one of claims 1 to 5, characterized in that the oxygen applicator aiid the one-way valve are connected to each other. S S S S S S S S

7. An apparatus according to one of claims 1 to 6, characterized in that the one-way valve generates a visual or acoustic signal for the period during which it is open.

8. An apparatus according to one of claims 1 to 6, characterized in that the one-way valve generates a visual or acoustic signal upon being opened and closed.

9. An apparatus according to one of claims 1 to 6, characterized in that the one-way valve contains a closable gas outlet (connection 6 mm 0, according to ISO 594/1) allowing continuous endexpiratory gas sampling for gas analysis, An apparatus according to one of claims 1 to 2, characterized in that an oxygen bag Is interposed between the oxygen source and the oxygen applicator and that the oxygen bag proximal to the oxygen tube of (VNA1, RF/0987c sj h i- -8- the oxygen applicator comprises a connection with 22 mm 0 (DIN-ISO 5356 Part I).

11. An apparatus according to one of claims 1 to 2, characterized in that an oxygen bag is interposed between the oxygen source and the oxygen applicator and that the oxygen bag distal to the oxygen tube of the oxygen applicator comprises a combined connection of 6 (according to ISO 594/1) and 15 mm 0 (according to DIN-ISO 7228): the 6 mm connector being part of a 15 mm connector.

12. An apparatus for oxygenating a patient substantially as hereinbefore described with reference to the accompanying drawings. DATED this FOURTH day of NOVEMBER 1992 Rolf Zander "Friedrich Mertzlufft Patent Attorneys for the Applicants SPRUSON FERGUSON Patent Attorneys for the Applicants SPRUSON FERGUSON 9* 9 9 8 I I I I I