WO2019155480A1 - Tube intratrachéal à ballonnet dynamique à capacité de ventilation - Google Patents

Tube intratrachéal à ballonnet dynamique à capacité de ventilation Download PDF

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Publication number
WO2019155480A1
WO2019155480A1 PCT/IN2018/050190 IN2018050190W WO2019155480A1 WO 2019155480 A1 WO2019155480 A1 WO 2019155480A1 IN 2018050190 W IN2018050190 W IN 2018050190W WO 2019155480 A1 WO2019155480 A1 WO 2019155480A1
Authority
WO
WIPO (PCT)
Prior art keywords
set forth
outer tube
cuff
tube member
trachea
Prior art date
Application number
PCT/IN2018/050190
Other languages
English (en)
Inventor
Kalyanaraman ANANTHANARAYANAN
Ashish PATYAL
Nirav KOTAK
Original Assignee
Ananthanarayanan Kalyanaraman
Patyal Ashish
Kotak Nirav
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ananthanarayanan Kalyanaraman, Patyal Ashish, Kotak Nirav filed Critical Ananthanarayanan Kalyanaraman
Publication of WO2019155480A1 publication Critical patent/WO2019155480A1/fr

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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • 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
    • A61M16/045—Cuffs with cuffs partially or completely inflated by the respiratory gas
    • A61M16/0452—Cuffs with cuffs partially or completely inflated by the respiratory gas following the inspiration and expiration pressure
    • 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
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0472—Devices for performing a tracheostomy
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • 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
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system
    • A61M2210/1032—Trachea
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies

Definitions

  • the present invention discloses a medical airway device, more specifically a intratracheal tube with superior ventilation capability which aids during emergency ventilation and its specialised sealing system.
  • This intratracheal tube design, its specialised inflation system and the sealing cuff are developed for providing emergency oxygen delivery and Carbon dioxide removal, either using positive pressure ventilation through manual resuscitators, anesthesia machines or mechanical ventilators, mouth to tracheal breathing or via J et ventilation devices and other si mi lar respi ratory support to a human or ani mal .
  • S uch a system can be used i n emergency airway situations as under difficult airway under anaesthesia, patients of choking and patients of mass casualties with upper respiratory tract obstruction.
  • Oxygen delivery into the body (“oxygenation") and Carbon dioxide removal from the body (“ventilation”)is essential for life. Absence of Oxygenation for a 2-3 minutes or absence of ventilation for 30 minutes (even if Oxygenation is maitained by suitable techniues) is usually life threatening.
  • Oxygenation can be well maintained by breathing air with high Oxygen
  • V entilation C arbon di oxi de removal
  • the "respiratory tract" transmits the air/oxygen from the atmosphere and del i vers it into the bl ood for transport to the vari ous organs of the body, and also transmits the Carbon dioxide from the blood for elimination into the atmosphere.
  • the anatomy of the human respiratory tract can be broadly divided into “upper airway” and the "I ower ai rway” .
  • T he upper A i rway starts from the nose/mouth and extends ti 11 the vocal cords.
  • the lower respiratory tract starts from the vocal cords and extends all the way up to the lungs There are several situations where the upper airway can get obstructed.
  • Cricothyroidotomy is one such procedure. This involves the creation of an artificial airway in the space between the thyroid and crycoid cartilages in the neck of the patient . It is performed in situations of upper Airway injury, upper Airway obstruction or inability to ventilate an anaesthetised patient through the nose/mouth.
  • Needle Cricothyrotorry is the insertion of a 16 gauge or larger IV cannula into the trachea through the cricothyroid membrane allowing oxygenation of a patient
  • the cannulaalong with its stylet is connected to the hub of a syringe and is inserted via the cricothyroid membrane into the trachea using a Direct Puncture technique (cannula covering a stylet with a sharp tip)or using the Sel dinger technique (railroading the cannula over a guidewire, using a separate puncture needle).
  • the sty I et ( i n di rect puncture tec hni que) /gui dewi re ( S el di nger rai I road technique) is removed and the cannula is used for ventilating the patient using a J et ventilator device.
  • any attempt at ventilation with an A MB U resuscitator bag or an anesthesia circuit can deliver only a few mL of air into the patient " s airway, and hence the J et ventilation is more suitable.
  • needle cricothyrotomy can maintain oxygenation only for short periods not exceeding 30 minutes, allowing the medical personnel to keep the patient alive till more definitive establishment of ventilation through a tracheostomy tube or other suitable methods are achieved. Since it relies on a cannula for oxygenation, with diameter not exceeding 2 mm, even though Oxygenation is possible for short durations, removal of carbon dioxide from the lungs is impossible, resulting in Carbon dioxide accumulation and toxicity.
  • J et V entilator needs air/Oxygen from a pressurised source like a cylinder and can not be used with atmospheric air.
  • the canula inserted into the trachea through the cricothyroid membrane will be prone to kinking and occlusion since it is made of soft material.
  • cricothyrotomy tube requires and operation theatre like sterile environment and trained personnel who are experienced in procedure. without this to request its surgical
  • cricothyrotomy can cause more harm than good
  • Percutaneous cricothyrotomy To overcome the difficulties experienced in the earlier designs, Percutaneous Cricothyrotomy came into existence. Here, a needle cricothyrotomycanula is inserted into the trachea via the cricothyroid membrane which can be exchanged for a larger cricothyrotomy tube using Seldinger railroad technique. This cricothyrotomy tube
  • the canula inserted into the trachea through the cricothyroid membrane will be prone to kinking and occlusion since it is made of soft material.
  • the surgical cricothyrotomy tube requires, operation theatre like sterile environment and trained personnel who are experienced in procedure, without this to request surgical cricothyrotomy can cause more harm than good.
  • the present invention relates to aemergency airway device for oxygenating and ventilating patients who require positive pressure ventilation and in particular in difficult airway situations where the performance of a cricothyroidotomy can be life saving.
  • It comprises a device which can provide superior Airway seal during positive pressure ventilation and superior elimination of expiratory gases during expiration
  • Device insertion has a short learning curve, enabling non medical and paramedical personnel to learn and perform the procedure outside a hospital setting.
  • the main object of the invention is to give a modified cricothyroidotom airway device with a dynamic cuff which will provide early and better airtight tracheal seal enabling superior ventilating ability.
  • the present invention relates to a device for performing Cricothyrotomy.
  • Figure no 1 Shows the outer cylindrical tube member or catheter as used herein means a hollow flexible tube(1) for insertion into a body cavity or duct with a proximal end(3), distal end(2), a curved middle portion(5) and a dynamic cuff(4) over its middle portion.
  • This tube member may be made of PVC, silicone, plastic, metal or any suitable material.
  • the proximal end of the tube member ends i n a ' universal _ 15 mm standard : connector" (6),enabl i ng it to be connected to ventilator circuits or manual resuscitators, enabling positive pressure mechanical ventilation. It also has a collar(7) for ti ei ng with the tape/ thread, for holding in its place after tube insertion.
  • the resuscitator can ventilate the patient by forming an airtight seal around the hub with his/her mouth and blowing into the device.
  • the hub will have a : swivel" design to ensure that any torsion at the proximal end owing to the position of the ventilator circuit/manual resuscitator wi 11 not be transmitted to the tube member.
  • the distal(2) end of the outer tube member has an inner diameter just exceeding the outer diameter of the proximal end of the dilator(8) . This will ensure the ease of insertion and sliding of the tube member over the dilator, en route to its insertion into the trachea
  • dilators which can be used in series to create a larger orifice on the cricothyroid membrane and the skin over it allowing easy insertion of the tube member through the cricothyroid membrane into the trachea.
  • the dilator (8) is a solid cylindrical structure having a conical distal end(10) and a cylindrical proximal end(9) with a central lumen extending from end to end,of sufficient size to accommodate a guidewire(11) which is used for Seldinger railroading technique and to slide smoothly in and out over the same.
  • the dilator can be made of a stiff but atraumatic material preferable but not limited to PV C, plastic, silicone or other suitable material.
  • a cuff (4) is a inflatable airbag/ balloon which expands with positive pressure and collapses with the atmospheric or sub atmospheric pressures.
  • the 'dynamic cuff, is in fluid
  • T he cuff member has to col I apse compl etely to enabl e easy insertion and very compliant to closely mimic the intraluminal pressures of the tube member.
  • the anaesthetist or the emergency physician can identify the cricothyroid membrane and use the puncture needle to enter into the trachea through the cricothyroid membrane. After confirming the position of the distal tip of the puncture needle by aspiration of air from the trachea, the syringe is removed and the guidewire is inserted through the hub of the puncure needle into the trachea.
  • tine guidewire After tine guidewire reaches the lumen of the trachea it is held firmly in position and the puncture needle is withdrawn outside.After the puncture needle is withdrawn, a small incision is made on the ski n to accommodate the di I ator, whi ch i s threaded over the gui dewi re from the di stal tip that end reaches the tracheal lumen once the proximal end and the middle portion of the dial ator reaches the tracheal lumen the guide wire is removed and the outer cylindrical tube member is threaded over the dilator.
  • the dilatora(8) long with the gui dewire(11) is withdrawn and the tube member is secured using sutures or tape around the neck, using the : collar "(7) present near the proximal end. Then the ventilation circuit or manual resuscitator can be attached to the universal connector which is present at the proximal end of the outer cylindrical tube member and positive pressure ventilation can be started.
  • Figure no 2 Shows the tube in the trachea with cuff inflated as with positive pressure ventilation, the self inflating cuff which is lying over the middle portion of the outer cylindrical tube member gets inflated and it forms a tight seal against the tracheal lumen, hence driving the tidal volume towards the lungs without any leak.
  • F igure no.3 shows the tube i n the trachea with cuff deflated as after the positive pressure phase of the ventilation cycle is over, when the intraluminal pressure drops to atmospheric level, the self inflating cuff cannot hold on to its position any longer and it col I apses.
  • the tracheal seal is absent which results in the beginning of the expiratory phaseJhe internal diameter of the tracheal lumen is about 25 mm and the outer diameter of the tube member is only about 6 mm.
  • the expired gas preferencially escapes the trachea directly through theupper airway (glottis, mouth and nostrils) and only a small fraction exits through the lumen of the outer cylindrical tube member.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif médical pour établir des voies respiratoires d'urgence, plus précisément un tube intratrachéal (cricothyrotomie) qui a un ballonnet auto-gonflant et son mécanisme d'insertion et de gonflage, qui est facile à insérer similaire à la cricothyrotomie à l'aiguille mais permettant la ventilation à la fois par des dispositifs de ventilation à jet ainsi que des réanimateur / ventilateurs mécaniques manuels. Ce dispositif comprend un élément cylindrique externe, un stylet interne et un ballonnet dynamique qui se gonfle pendant une ventilation à pression positive et produit un joint d'étanchéité trachéal étanche à l'air, et permettant ainsi l'oxygénation, et la déflagration pendant l'expiration, permettant ainsi une sortie régulière de dioxyde de carbone et d'autres gaz expirés dans l'atmosphère à travers la trachée et les voies respiratoires supérieures.
PCT/IN2018/050190 2018-02-07 2018-04-04 Tube intratrachéal à ballonnet dynamique à capacité de ventilation WO2019155480A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821004602 2018-02-07
IN201821004602 2018-02-07

Publications (1)

Publication Number Publication Date
WO2019155480A1 true WO2019155480A1 (fr) 2019-08-15

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ID=67548821

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2018/050190 WO2019155480A1 (fr) 2018-02-07 2018-04-04 Tube intratrachéal à ballonnet dynamique à capacité de ventilation

Country Status (1)

Country Link
WO (1) WO2019155480A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5653230A (en) * 1996-01-19 1997-08-05 Cook Incorporated Percutaneous balloon dilational tracheostomy tube
US20150250969A1 (en) * 2012-08-03 2015-09-10 Mondo Medical Devices Pty Ltd Airway opening apparatus and method

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5653230A (en) * 1996-01-19 1997-08-05 Cook Incorporated Percutaneous balloon dilational tracheostomy tube
US20150250969A1 (en) * 2012-08-03 2015-09-10 Mondo Medical Devices Pty Ltd Airway opening apparatus and method

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