WO2012046087A1 - Endotracheal tube with ph indicator - Google Patents
Endotracheal tube with ph indicator Download PDFInfo
- Publication number
- WO2012046087A1 WO2012046087A1 PCT/GR2010/000042 GR2010000042W WO2012046087A1 WO 2012046087 A1 WO2012046087 A1 WO 2012046087A1 GR 2010000042 W GR2010000042 W GR 2010000042W WO 2012046087 A1 WO2012046087 A1 WO 2012046087A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tube
- cuff
- tape
- endotracheal
- aspiration
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0434—Cuffs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0475—Tracheal tubes having openings in the tube
- A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
- A61M16/0484—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids at the distal end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3324—PH measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
- A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
Definitions
- the invention refers to a model of endotracheal tube that is being used for endotracheal intubation of patients.
- pH is a term of expression of the concentration of ions in an aqueous solution. More specifically, pH is the symbol for the negative decimal logarithm of the hydrogen ion concentration [H + ] in the solution. It is a measure of the acidity or alkalinity of a chemical substance.
- HCI solution of 1 mol has pH value of 0, gastric acid has pH value of 1.5, vinegar has pH value of 2.9, tea has pH value of 5.5, clear water has pH value of 7, saliva of a healthy person has pH value between 6.5 and 7.4 and blood has pH value between 7.25 and 7.45.
- indicators The indicators of acids- bases (called electrolytic or proteolytic indicators) are substances of which color changes depending on the PH of the solution, to which they are added.
- the indicator paper for pH measurement is a special paper impregnated with a mixture of indicators.
- the pH indicator comes in contact with the solution that is under investigation, it turns to a specific color.
- the comparison of this color with specific colorimetric tables leads to an approximation of the pH of a solution.
- the airway is the way through which atmospheric air moves to and from the lungs. We could compare it with a tube that begins from the oral and nasal cavity (from where air comes in) and ends by passing successively from pharynx, larynx, trachea and bronchi in the lungs, where the gas exchange between blood gases and atmospheric air (known as breathing) takes place.
- Aspiration is the entry of gastric fluids (fluids from the stomach) into the trachea and then into the lungs causing a very serious lung injury (aspiration pneumonia).
- the extent of the injury depends not only on the volume of the gastric fluid that comes into the lungs but also on its PH. The risk is greater when the fluids being aspirated have a pH value of ⁇ 2.5.
- the endotracheal tube is an elastic plastic tube that is inserted into the trachea of a patient and connects the airway to the anesthetic machine. Its purpose is to secure the supply of oxygen and inhalational anesthetics to the patient and to protect the trachea and the lungs from gastric fluid aspiration.
- the structure of the endotracheal tubes follows specific patterns.
- the endotracheal tubes for adults consist of the following parts: a) the tube b) the connector c) the valve d) the inflating tube e) the pilot balloon and f) the cuff.
- Endotracheal tubes that do not carry a cuff also exist and these are mainly used in children for the minimization of pressure injury to their airway.
- the material usually used in the manufacture of the tubes is polyvinyl chloride (PVC) while there are also endotracheal tubes made of silicon.
- the connector connects the tube with the mechanical respirator.
- the valve prevents air loss after cuff inflation.
- the inflating tube is incorporated into the tube's wall and connects the valve with the cuff.
- the pilot balloon provides an indication of the amount of air in the cuff. After filling the cuff with air, a tracheal seal is being created between the trachea and the tube, thus permitting positive-pressure ventilation and reducing the likelihood for aspiration.
- the tip of the tube is beveled so that it permits visualization and insertion through the vocal cords.
- the tubes may have an additional characteristic (the Murphy eye) which is a hole in the distal part of the tube and its purpose is to minimize the risk of complete occlusion of the tube.
- Endotracheal intubation is the insertion of a tube in the trachea so that an open airway is secured for the gas exchange, i.e. moving of air from and to the lungs in order to properly ventilate them and thus oxygenate the organism.
- the endotracheal intubation is indicated and needed in the following situations:
- Patient has an airway threat, i.e. there is a risk either of occlusion of the airway or the organism cannot protect the airway with a cough reflex from aspiration.
- the advantage of this invention is the presence of the pH measurement indicator paper tape useful in a timely diagnosis of aspiration: a.
- the contact of the distal tape (for tubes with a cuff) or of the tape (for tubes without a cuff), with the secretions of the trachea during an operation will have as a result its coloration with the color that corresponds to the physiologic pH (slightly alkalic).
- a color that corresponds to the acidic pH will be impressed on the indicator paper.
- the color change on the proximal tape indicates that the reflux occurred after the cuff inflation thus raising serious suspicion for aspiration pneumonia in the postoperative period due to possible moving of gastric fluids after deflation of the cuff before extubation.
- This endotracheal tube with cuff as shown on figure No 1 consists of:
- the endotracheal tubes without cuff as shown on figure No2 consist of:
- This type of endotracheal tube does not differ in its usage from a simple endotracheal tube.
- the greatest benefit is the presence of tapes of indicator paper for pH measurement that will reveal the presence of aspiration of gastric content as well as its pH.
- the tape on the distal part of the junction of the cuff with the tube under normal conditions will have a color that corresponds to alcalic or neutral pH. If, however, for some reason gastric fluids have been aspirated, there will be a change in color that will correspond to acidic pH.
- the tape on the proximal part of the junction of the cuff with the tube in the absence of color change in the tape on the distal part, will show that the aspiration occurred after the cuff inflation. In this way, a high risk of suspicion is established for aspiration pneumonia in the postoperative period since a small amount of gastric fluid could be aspirated after deflating of the cuff before the endotracheal tube is removed.
- This modification is useful in all those high risk situations for aspiration as in urgent cases, in trauma patients, in obese patients, in pregnant women, in endoscopic operations, in children and also in non- urgent operations, as an additional parameter of a timely diagnosis of aspiration pneumonia.
Abstract
The endotracheal tube with indicator paper for pH measurement consists of a tube (1), the connector (2), the valve (3), the inflating tube (4), the pilot balloon (5), the cuff (6) and two tapes (7) of indicator paper for pH measurement that will be on the outer side of the tube on the proximal and distal junction of the cuff with the tube, in endotracheal tubes with cuff and one tape of indicator paper for pH measurement that will be on the outer side of the tube on the distal part of the tube, in endotracheal tubes without a cuff. This endotracheal tube gives the advantage of a timely diagnosis of aspiration of gastric fluids as well as the pH of these fluids. The tape on the distal part on the junction of the cuff with the tube under normal conditions will have a color that corresponds to alcalic or neutral pH. If, however, for some reason gastric fluids have been aspirated, there will be a change in color that will correspond to acidic pH. The change of color on the proximal tape, in the absence of color change in the distal tape, will show that the aspiration occurred after the cuff inflation. This invention can be used in all situations involving the risk of aspiration.
Description
ENDOTRACHEAL TUBE WITH pH INDICATOR
The invention refers to a model of endotracheal tube that is being used for endotracheal intubation of patients. Before we proceed to the description of the invention a rapid report on key- terms necessary for its understanding will be offered.
p_H is a term of expression of the concentration of ions in an aqueous solution. More specifically, pH is the symbol for the negative decimal logarithm of the hydrogen ion concentration [H+] in the solution. It is a measure of the acidity or alkalinity of a chemical substance. Nowadays, a pH scale ranging from 0 till 14 is widely used for the determination of the acidity of a solution. Solutions with pH value <7 are characterized as acidic, whereas solutions with pH value > 7 are characterized as alkalic. Solutions with pH value = 7 are characterized neutral. For most of the solutions, their pH value is between 0 and 14 (e.g. HCI solution of 1 mol has pH value of 0, gastric acid has pH value of 1.5, vinegar has pH value of 2.9, tea has pH value of 5.5, clear water has pH value of 7, saliva of a healthy person has pH value between 6.5 and 7.4 and blood has pH value between 7.25 and 7.45. One of the basic ways that pH can be measured is by using indicators. The indicators of acids- bases (called electrolytic or proteolytic indicators) are substances of which color changes depending on the PH of the solution, to which they are added.
The indicator paper for pH measurement is a special paper impregnated with a mixture of indicators. When the pH indicator comes in contact with the solution that is under investigation, it turns to a specific color. The comparison of this color with specific colorimetric tables leads to an approximation of the pH of a solution.
The airway is the way through which atmospheric air moves to and from the lungs. We could compare it with a tube that begins from the oral and nasal cavity (from where air comes in) and ends by passing successively from pharynx, larynx, trachea and bronchi in the lungs, where the gas exchange between blood gases and atmospheric air (known as breathing) takes place.
Aspiration is the entry of gastric fluids (fluids from the stomach) into the trachea and then into the lungs causing a very serious lung injury (aspiration pneumonia). The extent of the injury depends not only on the volume of the gastric fluid that comes into the lungs but also on its PH. The risk is greater when the fluids being aspirated have a pH value of < 2.5.
The endotracheal tube is an elastic plastic tube that is inserted into the trachea of a patient and connects the airway to the anesthetic machine. Its purpose is to secure the supply of oxygen and inhalational anesthetics to the patient and to protect the trachea and the lungs from gastric fluid aspiration.
The structure of the endotracheal tubes follows specific patterns. The endotracheal tubes for adults consist of the following parts: a) the tube b) the connector c) the valve d) the inflating tube e) the pilot balloon and f) the cuff. Endotracheal tubes that do not carry a cuff also exist and these are mainly used in children for the minimization of pressure injury to their airway.
The material usually used in the manufacture of the tubes is polyvinyl chloride (PVC) while there are also endotracheal tubes made of silicon. The connector connects the tube with the mechanical respirator. The valve prevents air loss after cuff inflation. The inflating tube is
incorporated into the tube's wall and connects the valve with the cuff. The pilot balloon provides an indication of the amount of air in the cuff. After filling the cuff with air, a tracheal seal is being created between the trachea and the tube, thus permitting positive-pressure ventilation and reducing the likelihood for aspiration. The tip of the tube is beveled so that it permits visualization and insertion through the vocal cords. The tubes may have an additional characteristic (the Murphy eye) which is a hole in the distal part of the tube and its purpose is to minimize the risk of complete occlusion of the tube. There are several sizes of endotracheal tubes, their size being indicated on the tube.
Endotracheal intubation is the insertion of a tube in the trachea so that an open airway is secured for the gas exchange, i.e. moving of air from and to the lungs in order to properly ventilate them and thus oxygenate the organism.
The endotracheal intubation is indicated and needed in the following situations:
1. Patient is anesthetized and spontaneous ventilation has ceased.
2. Patient is unable for adequate respiratory function by himself due to some disease.
3. Patient has an airway threat, i.e. there is a risk either of occlusion of the airway or the organism cannot protect the airway with a cough reflex from aspiration.
4. Patient needs general anesthesia for the performance of some urgent or scheduled surgical operation.
With the use of the already existing endotracheal tubes there is no possibility of diagnosing a possible reflux of gastric content to the hypopharynx (distal part of the pharynx that is higher from the larynx in the airway- between oropharynx and larynx) and aspiration of this content to the airway below the cuff (trachea- bronchi- lungs). Thus the differential diagnosis becomes difficult and the immediate postoperative
pharmaceutical support is delayed in patients that aspiration occurred while they were intubated.
The reasons that may be responsible for aspiration in intubated patients are:
1. Inadequate sealing of the cuff to the trachea
2. Cuff rupture
3. Misplacement of the tube
4. No cuff, as in pediatric endotracheal tubes
In pediatric endotracheal tubes (without cuff), it is obligatory that there is no complete seal between the tube and the trachea, thus the risk of aspiration is even greater in these cases.
The difference in the already existing endotracheal tubes is that a tape of indicator paper for pH measurement is placed on the outer side of the tube and specifically on the proximal and distal part of the junction of the cuff with the tube. Thus after extubation or change of an endotracheal tube we have an objective indication for the passing or no of gastric fluids (acidic fluids) in the larynx and trachea and furthermore in the rest of the airway.
The advantage of this invention is the presence of the pH measurement indicator paper tape useful in a timely diagnosis of aspiration: a. The contact of the distal tape (for tubes with a cuff) or of the tape (for tubes without a cuff), with the secretions of the trachea during an operation will have as a result its coloration with the color that corresponds to the physiologic pH (slightly alkalic). However, if for some reasons gastric fluids have been aspirated during an operation or when a patient is intubated, then a color that corresponds to the acidic pH will be impressed on the indicator paper.
b. The color change on the proximal tape, in the case of absence of color change in the tape on the distal part, indicates that the reflux occurred after the cuff inflation thus raising serious suspicion for aspiration pneumonia in the postoperative period due to possible moving of gastric fluids after deflation of the cuff before extubation.
This endotracheal tube with cuff as shown on figure No 1 consists of:
1. The tube
2. The connector
3. The valve
4. The inflating tube
5. The pilot balloon
6. The cuff
7. 2 tapes of indicator paper for pH measurement
The endotracheal tubes without cuff as shown on figure No2 consist of:
1. The tube
2. The connector
3. One tape of indicator paper for pH measurement
This type of endotracheal tube does not differ in its usage from a simple endotracheal tube. The greatest benefit is the presence of tapes of indicator paper for pH measurement that will reveal the presence of aspiration of gastric content as well as its pH. The tape on the distal part of the junction of the cuff with the tube under normal conditions will have a color that corresponds to alcalic or neutral pH. If, however, for some reason gastric fluids have been aspirated, there will be a change in color that will correspond to acidic pH. The tape on the proximal part of the junction of the cuff with the tube, in the absence of color change in the tape on the distal part, will show that the aspiration occurred after the cuff inflation. In this way, a high risk of suspicion is established for aspiration pneumonia in the postoperative period since a small amount
of gastric fluid could be aspirated after deflating of the cuff before the endotracheal tube is removed.
This modification is useful in all those high risk situations for aspiration as in urgent cases, in trauma patients, in obese patients, in pregnant women, in endoscopic operations, in children and also in non- urgent operations, as an additional parameter of a timely diagnosis of aspiration pneumonia.
The modification of the already existing endotracheal tubes needs nothing more than the application of two tapes for the common tubes, on the outer side of the tube and specifically on the proximal and distal part of the junction of the cuff with the tube (figure No 1) or one tape (for pediatric tubes) of indicator paper for pH measurement in the distal part of the tube (figure No 2).
Claims
1. The endotracheal tube with indicator paper for pH measurement consists of
a. For the tubes with cuff: the tube (1), the connector (2), the valve (3), the inflating tube (4), the pilot balloon (5), the cuff (6), 2 tapes of indicator paper for pH measurement (7) b. For the tubes without cuff: the tube (1), the connector(2), one tape of indicator paper for pH measurement
2. The endotracheal tube according to claim 1 is characterized that it will bear two tapes of indicator paper for pH measurement that will be on the outer side of the proximal and distal junction of the cuff with the tube, in tubes with cuff and one tape on the outer side of the distal part of the tube in tubes without cuff.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/GR2010/000042 WO2012046087A1 (en) | 2010-10-05 | 2010-10-05 | Endotracheal tube with ph indicator |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/GR2010/000042 WO2012046087A1 (en) | 2010-10-05 | 2010-10-05 | Endotracheal tube with ph indicator |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2012046087A1 true WO2012046087A1 (en) | 2012-04-12 |
Family
ID=44070073
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/GR2010/000042 WO2012046087A1 (en) | 2010-10-05 | 2010-10-05 | Endotracheal tube with ph indicator |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2012046087A1 (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016041331A1 (en) * | 2014-09-18 | 2016-03-24 | 黄志辉 | Trachea cannula |
| GR1010177B (en) * | 2020-12-19 | 2022-02-18 | Συμεων Γεωργιου Γρηγοριου | Articulated tube introducer (bougie) for intubation |
| US11304877B2 (en) * | 2020-05-27 | 2022-04-19 | Glenn Gerald Strawder | Method and apparatus for assisting, checking, and confirming nasogastric and orogastric tube insertion and placement |
| US11471335B2 (en) | 2018-09-05 | 2022-10-18 | University Of South Carolina | Gel-within-gel wound dressing |
| US11698344B2 (en) | 2018-09-05 | 2023-07-11 | University Of South Carolina | PH indicator swabs for biomonitoring and diagnostics |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR1491888A (en) * | 1966-09-07 | 1967-08-11 | Medico-surgical probe | |
| WO1989007957A1 (en) * | 1988-02-26 | 1989-09-08 | Brigham And Women's Hospital | Co2 indicator for placement of tracheal tubes |
| US4879999A (en) * | 1986-03-26 | 1989-11-14 | Board Of Regents, The University Of Texas System | Device for the determination of proper endotracheal tube placement |
| US5124129A (en) * | 1988-07-29 | 1992-06-23 | Mallinckrodt Medical, Inc. | Carbon dioxide indicator |
| DE19628167A1 (en) * | 1995-08-15 | 1997-02-20 | Smiths Industries Plc | Medical-surgical device |
-
2010
- 2010-10-05 WO PCT/GR2010/000042 patent/WO2012046087A1/en active Application Filing
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR1491888A (en) * | 1966-09-07 | 1967-08-11 | Medico-surgical probe | |
| US4879999A (en) * | 1986-03-26 | 1989-11-14 | Board Of Regents, The University Of Texas System | Device for the determination of proper endotracheal tube placement |
| US4879999B1 (en) * | 1986-03-26 | 1996-02-06 | Nellcor Inc | Device for the determination of proper endotracheal tube placement |
| WO1989007957A1 (en) * | 1988-02-26 | 1989-09-08 | Brigham And Women's Hospital | Co2 indicator for placement of tracheal tubes |
| US5124129A (en) * | 1988-07-29 | 1992-06-23 | Mallinckrodt Medical, Inc. | Carbon dioxide indicator |
| DE19628167A1 (en) * | 1995-08-15 | 1997-02-20 | Smiths Industries Plc | Medical-surgical device |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016041331A1 (en) * | 2014-09-18 | 2016-03-24 | 黄志辉 | Trachea cannula |
| US11471335B2 (en) | 2018-09-05 | 2022-10-18 | University Of South Carolina | Gel-within-gel wound dressing |
| US11698344B2 (en) | 2018-09-05 | 2023-07-11 | University Of South Carolina | PH indicator swabs for biomonitoring and diagnostics |
| US11304877B2 (en) * | 2020-05-27 | 2022-04-19 | Glenn Gerald Strawder | Method and apparatus for assisting, checking, and confirming nasogastric and orogastric tube insertion and placement |
| GR1010177B (en) * | 2020-12-19 | 2022-02-18 | Συμεων Γεωργιου Γρηγοριου | Articulated tube introducer (bougie) for intubation |
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