WO2017201645A1 - Dispositif de masque laryngé - Google Patents

Dispositif de masque laryngé Download PDF

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Publication number
WO2017201645A1
WO2017201645A1 PCT/CN2016/082978 CN2016082978W WO2017201645A1 WO 2017201645 A1 WO2017201645 A1 WO 2017201645A1 CN 2016082978 W CN2016082978 W CN 2016082978W WO 2017201645 A1 WO2017201645 A1 WO 2017201645A1
Authority
WO
WIPO (PCT)
Prior art keywords
cuff
recited
laryngeal mask
airway tube
mask device
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2016/082978
Other languages
English (en)
Inventor
Dang XIE
Allen MA
Renny ZHOU
Justina ZHU
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Covidien LP
Original Assignee
Covidien LP
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 Covidien LP filed Critical Covidien LP
Priority to PCT/CN2016/082978 priority Critical patent/WO2017201645A1/fr
Priority to CN201720581087.5U priority patent/CN207785612U/zh
Publication of WO2017201645A1 publication Critical patent/WO2017201645A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0443—Special cuff-wall materials
    • 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. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0409—Special features for tracheal tubes not otherwise provided for with mean for closing the oesophagus
    • 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
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • 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
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking

Definitions

  • ETT endotracheal tube
  • LM device laryngeal mask device
  • the ETT ventilation device comprises an elongate conduit constituted as tracheal tube, which is provided with an inflatable balloon at the distal end of the elongated tube.
  • the distal end of the ETT is inserted into the patient’s mouth, after the patient’s throat inlet (or glottis opening) , and into the patient’s trachea.
  • the balloon and the internal passage of the trachea form a seal.
  • the ETT ventilation device is ventilated at the proximal end of the conduit to exert positive pressure to the patient’s lungs.
  • One of advantages of such ETT ventilation is that it can withstand greater sealing pressure, with less leakage.
  • the main flaw is that it is difficult to properly insert the conduit, the technical requirements for the operator are too high.
  • a LM device generally includes a flexible airway tube structure defining an airway to direct oxygen or air from a source and a mask with an inflatable cuff structure, which is connected to the airway tube structure at its distal end and is able to be inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis, so as to allow a secure airway to be managed by a health care provider.
  • One of the common circumstances is that the leading end of the device, i.e., the distal end of the fully deflated cuff structure becomes folded over on itself, presenting the more rigid distal end of the mask to catch the inside of the throat and subject the patient to undesirable forces.
  • the airway tube structure having 360°access to the head and neck area of a patient. That is, it is desirable that an operator can place or secure the airway tube structure of the LM device in any direction to the head/or neck area of a patient. This requires that the airway tube structure has a degree of flexibility/softness. At the same time, it is not desirable that the sectional area of the airway defined by the airway tube structure is changed during the access to the head or neck area of a patient, that is, it is not desirable for the airway tube structure to kink.
  • the LM device it is desirable for the LM device to have good push-ability. That is, it is desirable to easily or conveniently push the mask with the cuff structure into the patient’s mouth and to the top of the glottis, which requires that the LM device, especially the airway tube structure has a degree of rigidity/stiffness.
  • a configuration in which reinforcing spring 9 is added within the wall of airway tube structure, has been proposed, for example in a latest Chinese utility model CN204972582U.
  • the flexibility and push-ability are not compatible. In other words, they are contradictory. If a LM device has good flexibility, it may have poor push-ability. If a LM device can be inserted easily, it may have poor flexibility. It is still difficult to get a balance between the flexibility and push-ability of the LM device.
  • a flexible airway tube structure for a laryngeal mask device having a mask with cuff structure, wherein the flexible airway tube structure comprises a distal part capable of being connected to or formed integrally with the mask and an opposite proximal part, and wherein the distal part being more rigid than the proximal part.
  • the distal part comprises a thermally shrunk tube thereon.
  • the flexible airway tube structure is a hollow tubular shape and the distal part has the same inner diameter as the proximal part and has a greater outer diameter than the proximal part.
  • the reinforcing structure comprises axial wires.
  • the distal part is made more rigid than the proximal part by chemical soaking of the distal part.
  • the flexible airway tube structure comprises a PVC tube with plasticizer, and wherein the distal part of the PVC tube is soaked into ether for a predetermined period to dissolve the plasticizer to rigidify the distal part.
  • the length of the distal part of the flexible airway tube structure is about 20%to 40%of the total length of the flexible airway tube structure.
  • the length of the distal part of the flexible airway tube structure is about 5 mm.
  • the flexible airway tube structure comprises a spiral spring structure to control the flexibility of the airway tube structure.
  • the flexible airway tube structure comprises an intermediate part, which is located between the proximal part and the distal part and has a rigidity more than that of the proximal part and less than the distal part.
  • the distal part, together with the mask is substantially inserted into the mouth of a patient, and the proximal part is substantially outside of the mouth of the patient
  • it may provide a method for preparing a flexible airway tube structure for a laryngeal mask device having a mask with cuff structure, wherein the flexible airway tube structure comprises a distal part capable of being connected to or formed integrally with the mask and an opposite proximal part, wherein the method comprising a step of making the distal part of the flexible airway tube structure more rigid than the proximal part thereof.
  • the laryngeal mask device has both good flexibility and good push-ability and can be easily inserted into the throat of a patient by an operator. Furthermore, the laryngeal mask device has 360° access to the head and neck area of a patient. In addition, the flexible airway tube structure and the laryngeal mask device can be manufactured easily.
  • a cuff structure for a laryngeal mask device comprising: an inner-layer cuff that defines an annular main chamber of the cuff structure to be inflated or self-inflated; an outer-layer cuff that surrounds the inner-layer cuff; wherein the outer-layer cuff has a higher elongation rate and/or a thinner thickness than the inner-layer cuff so that the cuff structure can comply with the tissue structure of the patient very even.
  • a space is defined between the outer-layer cuff and the inner-layer cuff, and wherein the space is at substantially environmental pressure.
  • Fig. 1 schematically shows a perspective view of a LM device according to the present disclosure.
  • Fig. 2 schematically shows a top view of the LM device according to the present disclosure.
  • Fig. 3 schematically shows a partial sectional view of the portion A in Fig. 2.
  • Fig. 4 schematically shows a partial sectional view of the portion B in Fig. 2.
  • Fig. 5 schematically shows a mask of the LM device from the bottom.
  • Fig. 6 schematically shows a portion of the inflatable cuff structure of the LM device according to the present disclosure in a perspective view.
  • Fig. 7 schematically shows the cross-section of the inflatable cuff structure of the LM device according to the present disclosure in an enlarged perspective view.
  • proximal is used with reference to a position closer to an operator or user of the LM device
  • distal is used with a position farther from the operator or user of the LM device.
  • the LM device 100 includes a flexible airway tube structure 10 and a mask 20 that is connected to or formed integrally with distal end of the airway tube structure.
  • the airway tube structure 10 defines an airway 10c therein for supplying oxygen, air or anaesthesia gas and the like (see Fig. 3) .
  • the airway tube structure 10 is connected to a source of oxygen, air or anaesthesia gas and the like at its proximal end, such as a breathing machine.
  • the mask 20 includes a supporting plate 20a and an inflatable cuff structure 20b.
  • the supporting plate 20a functions to support the cuff structure 20b and is connected to the airway tube structure 10.
  • the inflatable cuff structure 20b is self-inflated and is generally kept in an inflated state.
  • the cuff structure 20 has an elliptical or pear shape, which is close to the shape of inlet of the larynx, and can be inflated further or in a controlled manner after insertion through the inflating passage to establish a seal against the larynx, and can be deflated for easy removal from the larynx.
  • the inflating passage can be formed by a separate tube, which is generally positioned outside of the cuff structure 20 and in communication with the chamber of the cuff structure.
  • the inflating passage includes a first inflating passage portion 20c, which is connected with the inflating passage 10d of the airway tube structure 20, and a second inflating tube 20d, which communicates or reaches into the chamber of cuff structure 20.
  • the second inflating tube 20d reaches into the chamber of the cuff structure and is more rigid or stiffer than the cuff structure so that the front end of the cuff structure will be prevented from folding over itself during the insertion of the LM device.
  • Fig. 3 shows a partial sectional view of portion A of the airway tube structure 10.
  • the airway tube structure 10 includes a tube wall that defines the interior of airway.
  • the inflating passage 10d is provided to communicate with the first inflating passage 20c of the cuff structure so that the cuff structure 20 can be inflated further or in a controlled manner or be deflated by an outside inflating/deflating device (not shown) .
  • a spiral spring structure 10e can be embedded in the wall of the airway tube structure 10 to reinforce the airway tube structure and also to keep the sectional area of the airway constant when it is bent or even kinked.
  • the LM device As described in the section of Technical Background, it is desirable for the LM device to have both good flexibility for 360°access to the head or neck area of a patient and good push-ability for easy insertion of the LM device.
  • the inventors find that when inserting the LM device into the throat, the flexibility of the part of the airway tube structure 10, which is relatively close to the cuff structure 20, affects the push-ability more. That is, if this part is flexible, the LM device will have a poor push-ability due to for example the bending of this part. And, if this part is relatively rigid/stiffness, the LM device may have good push-ability. On the other hand, when an operator places or secures the airway tube structure to the head or neck area of a patient, the LM device would have good access to the head or neck area, if the part, which is close to the operator, in particular the part, which is outside of the mouth of the patient, is sufficiently flexible.
  • the airway tube structure 10 includes a proximal part 10a and a distal part 10b.
  • the proximal part 10a is flexible for ease of the bending of the airway tube structure, and the distal part 10b is less flexible or more rigid or stiffer than the proximal part 10b for ease of the insertion of the LM device.
  • the length of the distal part 10b is no more than 50%of the total length of the airway tube structure and is preferably 20%-40%of the total length of the airway tube structure.
  • the total length of the airway tube structure is about 20 cm, and the distal part 10b is about 5 cm in length.
  • the airway tube structure may have an intermediate part (un-shown in Figures) , which is between the proximal part 10a and the distal part 10b and has a rigidity/stiffness between that of the proximal part and that of the distal part. That is, the intermediate part is more rigid than the proximal part and less rigid than the distal part.
  • the distal part 10b of the airway tube structure has an additional thermally shrunk tube 10f onto it (as shown in Fig. 4) .
  • the material for thermal shrinkable tube can improve the rigidity or stiffness of the distal part of the airway tube structure.
  • the wall of the distal part 10b of the airway tube structure may have a greater thickness than the wall of the proximal part 10a.
  • the distal part 10b has the same inner diameter as the proximal part but has a greater outer diameter than the proximal part.
  • the distal part 10b of the airway tube structure may additionally have longitudinal (axial) reinforcing structure, such as longitudinal wires.
  • thermal shrinkable tube may be a preferable implementation.
  • thermal shrinkable tube onto the distal part of the airway tube structure and then subject the thermal shrinkable tube to heat, so that the thermal shrinkable tube will shrink and bond to the airway tube structure.
  • the present disclosure has disclosed some implementations to achieve this type of airway tube structure having sections or parts with different rigidity/stiffness.
  • an additional structural feature such as a step between the distal part of the airway tube structure, having a thermal shrinkable tube or greater thickness, and the proximal part of the airway tube structure, or longitudinal reinforcing structure will be added to the airway tube structure.
  • the flexible airway tube structure may comprise a PVC (HY-VIN XH 79214 CLP42) tube with an outer diameter of about 11-12 mm, hardness of Shore A of about 68 ⁇ 3 and with about 35%wt of plasticizer. The tube was soaked into around 100%analysis grade ether at room temperature for around 10 minutes, and then the hardness was distinctly improved.
  • PVC HY-VIN XH 79214 CLP42

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

La présente invention concerne une structure de manchon (20b) pour un dispositif de masque laryngé (100) comprenant un manchon de couche interne (20b1) qui définit une chambre principale annulaire de la structure de manchon (20b) à gonfler ou se gonflant automatiquement, et un manchon de couche externe (20b2) qui entoure le manchon de couche interne (20b1). Le manchon de couche externe (20b2) a un taux d'allongement plus élevé et une épaisseur plus mince que le manchon de couche interne (20b1), de telle sorte que la structure de manchon se conforme à la structure tissulaire du patient. Avec cette structure de manchon à double couche (20a), la résistance aux fuites du dispositif de masque laryngé (100) sera améliorée.
PCT/CN2016/082978 2016-05-23 2016-05-23 Dispositif de masque laryngé Ceased WO2017201645A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/CN2016/082978 WO2017201645A1 (fr) 2016-05-23 2016-05-23 Dispositif de masque laryngé
CN201720581087.5U CN207785612U (zh) 2016-05-23 2017-05-23 用于喉罩装置的套箍结构和喉罩装置

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2016/082978 WO2017201645A1 (fr) 2016-05-23 2016-05-23 Dispositif de masque laryngé

Publications (1)

Publication Number Publication Date
WO2017201645A1 true WO2017201645A1 (fr) 2017-11-30

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PCT/CN2016/082978 Ceased WO2017201645A1 (fr) 2016-05-23 2016-05-23 Dispositif de masque laryngé

Country Status (2)

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CN (1) CN207785612U (fr)
WO (1) WO2017201645A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1771067A (zh) * 2003-04-11 2006-05-10 阿姆布股份有限公司 喉罩及其制造方法
US20130037035A1 (en) * 2006-09-29 2013-02-14 Covidien Lp Endotracheal cuff and technique for using the same
CN202740564U (zh) * 2012-08-22 2013-02-20 浙江曙光科技有限公司 罩囊
CN203001631U (zh) * 2013-01-09 2013-06-19 谢文吉 一种自充气式的喉罩
CN103429291A (zh) * 2011-02-02 2013-12-04 梅田有限公司 改进的人工气道
WO2015138932A1 (fr) * 2014-03-14 2015-09-17 H. Lee Moffitt Cancer Center And Research Institute, Inc. Tubes endotrachéaux et systèmes et procédés pour évaluer la respiration
CN105107072A (zh) * 2015-09-21 2015-12-02 济南沙之聚商贸有限公司 一种喉罩

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1771067A (zh) * 2003-04-11 2006-05-10 阿姆布股份有限公司 喉罩及其制造方法
US20130037035A1 (en) * 2006-09-29 2013-02-14 Covidien Lp Endotracheal cuff and technique for using the same
CN103429291A (zh) * 2011-02-02 2013-12-04 梅田有限公司 改进的人工气道
CN202740564U (zh) * 2012-08-22 2013-02-20 浙江曙光科技有限公司 罩囊
CN203001631U (zh) * 2013-01-09 2013-06-19 谢文吉 一种自充气式的喉罩
WO2015138932A1 (fr) * 2014-03-14 2015-09-17 H. Lee Moffitt Cancer Center And Research Institute, Inc. Tubes endotrachéaux et systèmes et procédés pour évaluer la respiration
CN105107072A (zh) * 2015-09-21 2015-12-02 济南沙之聚商贸有限公司 一种喉罩

Also Published As

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