WO2009047632A2 - Laryngeal mask airway device including parylene - Google Patents

Laryngeal mask airway device including parylene Download PDF

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Publication number
WO2009047632A2
WO2009047632A2 PCT/IB2008/003197 IB2008003197W WO2009047632A2 WO 2009047632 A2 WO2009047632 A2 WO 2009047632A2 IB 2008003197 W IB2008003197 W IB 2008003197W WO 2009047632 A2 WO2009047632 A2 WO 2009047632A2
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WO
WIPO (PCT)
Prior art keywords
airway device
laryngeal mask
parylene
mask airway
laryngeal
Prior art date
Application number
PCT/IB2008/003197
Other languages
French (fr)
Other versions
WO2009047632A3 (en
Inventor
Ronald Craig Wight
Original Assignee
The Laryngeal Mask Company Limited
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 The Laryngeal Mask Company Limited filed Critical The Laryngeal Mask Company Limited
Publication of WO2009047632A2 publication Critical patent/WO2009047632A2/en
Publication of WO2009047632A3 publication Critical patent/WO2009047632A3/en

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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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular 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. mouth-to-mouth respiration; 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D1/00—Processes for applying liquids or other fluent materials
    • B05D1/60—Deposition of organic layers from vapour phase
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J7/00—Chemical treatment or coating of shaped articles made of macromolecular substances
    • C08J7/04—Coating
    • C08J7/043—Improving the adhesiveness of the coatings per se, e.g. forming primers
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J7/00—Chemical treatment or coating of shaped articles made of macromolecular substances
    • C08J7/04—Coating
    • C08J7/046—Forming abrasion-resistant coatings; Forming surface-hardening coatings
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J7/00—Chemical treatment or coating of shaped articles made of macromolecular substances
    • C08J7/04—Coating
    • C08J7/06—Coating with compositions not containing macromolecular substances
    • C08J7/065—Low-molecular-weight organic substances, e.g. absorption of additives in the surface of the article
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09D—COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR
    • C09D165/00—Coating compositions based on macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain; Coating compositions based on derivatives of such polymers
    • C09D165/04—Polyxylylenes
    • 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
    • A61M2205/0222—Materials for reducing friction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
    • B05D3/04—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by exposure to gases
    • B05D3/0493—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by exposure to gases using vacuum
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2327/00—Characterised by the use of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Derivatives of such polymers
    • C08J2327/02—Characterised by the use of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Derivatives of such polymers not modified by chemical after-treatment
    • C08J2327/04—Characterised by the use of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Derivatives of such polymers not modified by chemical after-treatment containing chlorine atoms
    • C08J2327/06—Homopolymers or copolymers of vinyl chloride
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2465/00—Characterised by the use of macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain; Derivatives of such polymers
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2465/00—Characterised by the use of macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain; Derivatives of such polymers
    • C08J2465/04—Polyxylylenes

Definitions

  • the present invention relates to a laryngeal mask airway device including parylene.
  • Laryngeal mask airway devices are well known and useful for establishing airways in or administering and monitoring anaesthesia in unconscious patients.
  • the Laryngeal Mask Company Ltd. has marketed a popular laryngeal mask airway device commercially for many years as the "Classic".
  • Such devices are described for example in U.S. Patent No. 4,509,514 and generally comprise a mask portion and an airway tube which, when in the fully inserted configuration, establishes an airway in a patient.
  • the term "fully inserted configuration" shall be used herein to refer to a laryngeal mask airway device that has been inserted into a patient and has the following characteristics: (1) the distal end of the mask portion is pressed against the patient's normally closed esophageal sphincter; (2) the cuff forms a seal around the patient's glottic opening; and (3) the airway tube extends from a proximal end located outside the patient's mouth to a distal portion that is coupled to the mask portion, the tube extending through the patient's mouth and the patient's natural upper airway so that the device provides a sealed airway extending from the tube's proximal end to the patient's lungs.
  • lubricating jelly reduces friction between the airway device and the patient's natural airway, improving the ease of insertion of the artificial airway device.
  • supply of individual portions of lubricating jelly with each device has proven time-consuming, complicated and expensive.
  • the process of individually packaging single portions of lubricant into sachets is inconvenient and the manufacturers commonly experience problems such as explosions or spillages. This creates the general problems of waste and associated increases of cost, as well as a health and safety related risk of factory personnel slipping on the spilled jelly and injuring themselves.
  • a factory for manufacture of medical devices must be a sterile environment and spillages of lubricating jelly must therefore be cleaned up, at great cost and inconvenience, to prevent bacterial growth or trapping of dirt and dust.
  • a laryngeal mask airway device to facilitate lung ventilation in an unconscious patient, comprising a curved or flexible tube opening at one end into the interior of a hollow mask portion, the mask portion including a backplate and a cuff, the mask portion shaped to conform to and to fit readily into the actual and potential space behind the larynx and to seal around the circumference of the laryngeal inlet without penetrating into the interior of the larynx, characterized in that at least a portion of the surface of the device includes parylene.
  • the parylene provides a low- friction surface for improved insertion of the artificial airway device.
  • the cuff is inflatable. This feature can be inflated in use to improve the seal around the glottic opening of the patient so that the effectiveness of the airway by reducing leaks through which air could escape instead of being channelled through to the lungs.
  • the portion including parylene is the mask portion.
  • a reduced friction coating at this position on the laryngeal mask will increase the ease with which the device can be inserted, because the first and widest part of the device will be less likely to generate friction against the natural airway of the patient.
  • the portion including parylene is the cuff. This would provide the benefits of reduced friction against the laryngeal side and pharyngeal side of the patient's airway, and may provide a cost benefit as less of the area of the mask portion would require parylene coating.
  • the portion coated in a parylene film is the outer surface of the airway tube. The reduction of friction generated along the entire length of the airway tube has a substantial effect on the ease with which the laryngeal mask airway device may be inserted into the patient. Furthermore, if friction between the natural airway and the tube of the laryngeal mask airway device is reduced, the 'sore throat' which is commonly experienced by patients after intubation may be reduced.
  • the mask portion is formed of flexible rubber or plastics material with a tubular element of the same material forming its inflatable periphery and/or posterior part.
  • the mask portion is made separately from the curved or flexible tube and is secured thereto in an airtight manner. This feature ensures convenience of manufacture and adaptation of the device.
  • the end of the tube that opens into the interior of the mask portion is cut off at an angle to the length of the tube.
  • the end of the airway tube therefore can advantageously provide a semirigid spine to the mask.
  • a method for manufacture of a laryngeal mask airway device comprising providing a laryngeal mask airway device, exposing at least a portion of the laryngeal mask airway device to a parylene vapour in a vacuum chamber and allowing the parylene vapour to polymerise at room temperature on the exposed surface of the laryngeal mask airway device. Since the parylene coat will cure at room temperature, it is not necessary for the laryngeal mask airway device to be subjected to high temperatures, solvents and cure stresses that are often required when coating a surface with a polymer.
  • the surface to be coated with parylene is pre-treated to enhance adhesion of the parylene film.
  • surface to be coated with parylene is pre-treated using a silane adhesion enhancement process.
  • Figure IA shows a side view of a prior art laryngeal mask airway device together with a sachet of lubricating jelly
  • Figure IB shows a perspective view of the pharyngeal side of a prior art laryngeal mask airway device
  • Figure 1C shows a side view of a the laryngeal side of a prior art intubating laryngeal mask airway device
  • Figure 2 shows a laryngeal mask airway device in fully inserted configuration, with an endotracheal tube inserted therein, indicating the location of the lubricating jelly in use;
  • Figure 3A shows a side view of the laryngeal mask airway device of the present invention, in which the whole mask portion includes parylene;
  • Figure 3B shows a side view of the laryngeal mask airway device of the present invention, in which the cuff includes parylene;
  • Figure 3 C shows a side view of the laryngeal mask airway device of the present invention, in which the outside of the airway tube includes parylene; and Figure 3D shows a side view of the laryngeal mask airway device of the present invention, in which the inside of the airway tube includes parylene.
  • Figure IA shows a side view of a prior art disposable laryngeal mask airway device 100, along with a sachet of lubricating jelly 101 as supplied with the prior art device.
  • Figure 2 shows a partially sectional side view of device 100 when inserted into a patient, indicating various examples of the location of the lubricating jelly in use 102.
  • device 100 includes an airway tube 110 and a mask portion 130.
  • Mask portion 130 includes a flat plate 112 and may include an inflatable cuff 134.
  • Mask portion 130 extends from a proximal end 136 to a distal end 138.
  • Mask portion 130 is attached to a distal portion 1 12 of airway tube 110.
  • the device 100 will also include an inflation line 190 and a check valve 192 for selectively inflating and deflating cuff 134.
  • the lubricating jelly 102 is applied to at least a portion of the laryngeal mask airway device and the mask portion is then inserted through the patient's mouth into the patient's pharynx.
  • the device is preferably positioned so that distal end 138 of mask portion 130 rests against the patient's normally closed oesophagus and so that the open end 140 of mask portion 130 is aligned with the entryway of the patient's trachea (i.e., the patient's glottic opening).
  • the mask portion After the mask portion is so positioned, if the mask portion includes an inflatable cuff then said cuff is inflated and forms a seal around the patient's glottic opening 212, establishing a sealed airway extending from a proximal end 114 of airway tube 110 to the patient's trachea.
  • Figure 2 shows a laryngeal mask airway device 100 in the fully inserted configuration.
  • the distal end of the mask portion 130 is pressed against the patient's esophageal sphincter 210.
  • the open end of the mask portion forms a seal around the glottic opening 212 thereby enabling the device 100 to provide fluid communication with the trachea 214.
  • the location of the lubricating jelly 102 can be seen around the mask portion and airway tube of the device, although this is an example and it may be applied elsewhere on the mask to assist insertion.
  • the mask portion 130 is inserted through the patient's mouth into the patient's pharynx.
  • Figures 3A to 3D show a variety of views of an improved laryngeal mask airway device 300 constructed according to the invention.
  • Device 300 includes an airway tube 310 and a mask portion 334.
  • the mask 334 extends from a proximal end 336 to a distal end 338. If the mask portion includes an inflatable peripheral ring, device 300 will include an inflation line, coupled to proximal end of the cuff, and a check valve for selectively inflating the inflatable portion of a mask portion.
  • the device 300 may also include a posterior inflatable portion.
  • the device includes parylene, as indicated, in various locations, such as the mask portion 334, the inflatable peripheral ring 336, the outside of the airway tube 310 or the inside of the airway tube 310 ( Figures 3A-3D respectively).
  • Parylene is a polymer dimer that can be used to coat many different types of surfaces.
  • the coating process initially involves heating the polymer dimer so that it forms a vapour.
  • the vapour is transferred to a vacuum chamber containing the surface of the product to be coated.
  • the vapour As the vapour enters the chamber it is attracted to the cooler substrate (the surface of the product to be coated), which it coats uniformly (usually approximately 1 micron thickness) before cooling.
  • Various types of parylene exist, for example parylene N, parylene C and parylene D (sold by Para Tech Coating Inc.), which have respectively reduced abilities to penetrate crevices. Parylene is surprisingly ideal for coating parts of the laryngeal mask airway device for a number of reasons.
  • the parylene film is biocompatible and biostable and therefore suitable for placement inside a patient.
  • the gaseous deposition process allows an extremely thin, uniform conformal film to be formed over all of the elements of the device, especially the smaller parts, cavities and other difficult to reach areas. Because there is no liquid phase involved, the parylene does not exhibit capillary action and it will not therefore accumulate in tubes or crevices. Furthermore, the parylene coat will cure at room temperature, it is not necessary for the laryngeal mask airway device to be subjected to potentially damaging high temperatures, solvents and cure stresses that are often required when coating a surface with a polymer. Parylene can also be sterilized, so it may be used as a coat on a device that is to be reused, as well as single-use devices.
  • parylene coat may bind to different types of surfaces with varying strengths. As a result, some surfaces may require an additional treatment before exposure to the parylene vapour. For example, it may be necessary to include a silane adhesion enhancement process to enhance binding of the parylene film to a PVC portion of a device. On the other hand, parylene binds extremely well to silicone and therefore no additional treatment is required before the deposition is performed.
  • the parylene coat provides numerous benefits to the laryngeal mask airway device. Dry lubricity of the device is increased so that the device may be inserted without lubricating jelly. This addresses the problem discussed hereinabove, relating to the expensive, complicated and wasteful process of supplying individual sachets of lubricating jelly with every airway device. Furthermore, due to reduced friction, the device is easier for the medical practitioner to insert, so that an artificial airway may be established more rapidly. Once inserted into the patient's airway, the portions of the device that are coated in parylene will rub against the skin of the patient less. The parylene coat therefore provides benefits to both the medical practitioner and to the survival and comfort of the patient. The parylene coat provides a hydrophobic, chemically resistant coating and therefore may also help to protect parts of the airway device that could otherwise be susceptible to corrosion due to gastrointestinal fluids that may reflux during anaesthesia.

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Abstract

The invention relates to a laryngeal mask airway device (300) to facilitate lung ventilation in an unconscious patient, comprising a curved or flexible tube (310) opening at one end into the interior of a hollow mask portion (330), the mask portion including a backplate (312) and a cuff (334), the mask portion shaped to conform to and to fit readily into the actual and potential space behind the larynx and to seal around the circumference of the laryngeal inlet without penetrating into the interior of the larynx, characterized in that at least a portion of the surface of the device includes parylene. The parylene provides a low-friction surface for improved insertion of the artificial airway device.

Description

LARYNGEAL MASK AIRWAY DEVICE INCLUDING PARYLENE
The present invention relates to a laryngeal mask airway device including parylene.
Laryngeal mask airway devices are well known and useful for establishing airways in or administering and monitoring anaesthesia in unconscious patients. For example, the Laryngeal Mask Company Ltd. has marketed a popular laryngeal mask airway device commercially for many years as the "Classic". Such devices are described for example in U.S. Patent No. 4,509,514 and generally comprise a mask portion and an airway tube which, when in the fully inserted configuration, establishes an airway in a patient. For convenience of exposition, the term "fully inserted configuration" shall be used herein to refer to a laryngeal mask airway device that has been inserted into a patient and has the following characteristics: (1) the distal end of the mask portion is pressed against the patient's normally closed esophageal sphincter; (2) the cuff forms a seal around the patient's glottic opening; and (3) the airway tube extends from a proximal end located outside the patient's mouth to a distal portion that is coupled to the mask portion, the tube extending through the patient's mouth and the patient's natural upper airway so that the device provides a sealed airway extending from the tube's proximal end to the patient's lungs.
Establishment of an artificial airway in a patient by insertion of an artificial airway device can be difficult due to friction generated against the patient's natural airway. Where an intubating laryngeal mask airway is to be used for guiding insertion of an endotracheal tube, friction is created between the inside of the tube of the laryngeal mask airway device and the outside of the endotracheal tube. In a medical situation, it is often necessary to quickly and easily establish and maintain an effective airway. This is important both in relation to convenience of use for the medical practitioner and also for the survival of the patient. To assist with these objectives, laryngeal mask airway devices are commonly supplied with an individual sachet of lubricating jelly, which is applied to the airway device before insertion.
The application of lubricating jelly reduces friction between the airway device and the patient's natural airway, improving the ease of insertion of the artificial airway device. However, the supply of individual portions of lubricating jelly with each device has proven time-consuming, complicated and expensive. The process of individually packaging single portions of lubricant into sachets is inconvenient and the manufacturers commonly experience problems such as explosions or spillages. This creates the general problems of waste and associated increases of cost, as well as a health and safety related risk of factory personnel slipping on the spilled jelly and injuring themselves. In addition, a factory for manufacture of medical devices must be a sterile environment and spillages of lubricating jelly must therefore be cleaned up, at great cost and inconvenience, to prevent bacterial growth or trapping of dirt and dust.
Further disadvantages exist in relation to the use, by the medical practitioner, of the airway device with lubricating jelly. For example, the application of lubricating jelly to the airway device adds a step to the process of insertion and therefore increases the length of time required to establish the airway in the patient. In particular, this can be a problem in emergency medical situations, where rapid establishment of an artificial airway may be crucial to the survival of a patient. Even once the airway has been established, the lubricating jelly can be absorbed into the patient's natural airway or may dry up, so that the device may rub the skin lining the patient's natural airway, and the patient may experience soreness after the procedure. There remains a need for artificial airway devices that can be easily inserted and remain in place in the patient without the need for lubricating jelly. It is an object of the present invention to provide compositions, additives, methods and apparatuses that seek to mitigate one or more of the above- mentioned disadvantages.
In a first aspect of the invention there is provided a laryngeal mask airway device to facilitate lung ventilation in an unconscious patient, comprising a curved or flexible tube opening at one end into the interior of a hollow mask portion, the mask portion including a backplate and a cuff, the mask portion shaped to conform to and to fit readily into the actual and potential space behind the larynx and to seal around the circumference of the laryngeal inlet without penetrating into the interior of the larynx, characterized in that at least a portion of the surface of the device includes parylene. The parylene provides a low- friction surface for improved insertion of the artificial airway device.
Preferably, the cuff is inflatable. This feature can be inflated in use to improve the seal around the glottic opening of the patient so that the effectiveness of the airway by reducing leaks through which air could escape instead of being channelled through to the lungs.
Preferably, the portion including parylene is the mask portion. A reduced friction coating at this position on the laryngeal mask will increase the ease with which the device can be inserted, because the first and widest part of the device will be less likely to generate friction against the natural airway of the patient.
Preferably, the portion including parylene is the cuff. This would provide the benefits of reduced friction against the laryngeal side and pharyngeal side of the patient's airway, and may provide a cost benefit as less of the area of the mask portion would require parylene coating. Preferably, the portion coated in a parylene film is the outer surface of the airway tube. The reduction of friction generated along the entire length of the airway tube has a substantial effect on the ease with which the laryngeal mask airway device may be inserted into the patient. Furthermore, if friction between the natural airway and the tube of the laryngeal mask airway device is reduced, the 'sore throat' which is commonly experienced by patients after intubation may be reduced.
Preferably, the mask portion is formed of flexible rubber or plastics material with a tubular element of the same material forming its inflatable periphery and/or posterior part.
Preferably, the mask portion is made separately from the curved or flexible tube and is secured thereto in an airtight manner. This feature ensures convenience of manufacture and adaptation of the device.
Preferably, the end of the tube that opens into the interior of the mask portion is cut off at an angle to the length of the tube. The end of the airway tube therefore can advantageously provide a semirigid spine to the mask.
In a second aspect of the invention, there is provided a method for manufacture of a laryngeal mask airway device, comprising providing a laryngeal mask airway device, exposing at least a portion of the laryngeal mask airway device to a parylene vapour in a vacuum chamber and allowing the parylene vapour to polymerise at room temperature on the exposed surface of the laryngeal mask airway device. Since the parylene coat will cure at room temperature, it is not necessary for the laryngeal mask airway device to be subjected to high temperatures, solvents and cure stresses that are often required when coating a surface with a polymer. Preferably, the surface to be coated with parylene is pre-treated to enhance adhesion of the parylene film.
Preferably, surface to be coated with parylene is pre-treated using a silane adhesion enhancement process.
An embodiment of the invention will now be described by way of example with reference to the accompanying figures, in which:
Figure IA shows a side view of a prior art laryngeal mask airway device together with a sachet of lubricating jelly;
Figure IB shows a perspective view of the pharyngeal side of a prior art laryngeal mask airway device;
Figure 1C shows a side view of a the laryngeal side of a prior art intubating laryngeal mask airway device;
Figure 2 shows a laryngeal mask airway device in fully inserted configuration, with an endotracheal tube inserted therein, indicating the location of the lubricating jelly in use;
Figure 3A shows a side view of the laryngeal mask airway device of the present invention, in which the whole mask portion includes parylene;
Figure 3B shows a side view of the laryngeal mask airway device of the present invention, in which the cuff includes parylene;
Figure 3 C shows a side view of the laryngeal mask airway device of the present invention, in which the outside of the airway tube includes parylene; and Figure 3D shows a side view of the laryngeal mask airway device of the present invention, in which the inside of the airway tube includes parylene.
Figure IA shows a side view of a prior art disposable laryngeal mask airway device 100, along with a sachet of lubricating jelly 101 as supplied with the prior art device. Figure 2 shows a partially sectional side view of device 100 when inserted into a patient, indicating various examples of the location of the lubricating jelly in use 102. Referring to Figure 1, device 100 includes an airway tube 110 and a mask portion 130. Mask portion 130 includes a flat plate 112 and may include an inflatable cuff 134. Mask portion 130 extends from a proximal end 136 to a distal end 138. Mask portion 130 is attached to a distal portion 1 12 of airway tube 110. As indicated in Figure IB, where the mask portion 130 of device 100 includes an inflatable cuff 134, the device 100 will also include an inflation line 190 and a check valve 192 for selectively inflating and deflating cuff 134.
In operation, the lubricating jelly 102 is applied to at least a portion of the laryngeal mask airway device and the mask portion is then inserted through the patient's mouth into the patient's pharynx. The device is preferably positioned so that distal end 138 of mask portion 130 rests against the patient's normally closed oesophagus and so that the open end 140 of mask portion 130 is aligned with the entryway of the patient's trachea (i.e., the patient's glottic opening). After the mask portion is so positioned, if the mask portion includes an inflatable cuff then said cuff is inflated and forms a seal around the patient's glottic opening 212, establishing a sealed airway extending from a proximal end 114 of airway tube 110 to the patient's trachea.
Figure 2 shows a laryngeal mask airway device 100 in the fully inserted configuration. As shown, the distal end of the mask portion 130 is pressed against the patient's esophageal sphincter 210. Also, the open end of the mask portion forms a seal around the glottic opening 212 thereby enabling the device 100 to provide fluid communication with the trachea 214. The location of the lubricating jelly 102 can be seen around the mask portion and airway tube of the device, although this is an example and it may be applied elsewhere on the mask to assist insertion. In use, the mask portion 130 is inserted through the patient's mouth into the patient's pharynx.
Figures 3A to 3D show a variety of views of an improved laryngeal mask airway device 300 constructed according to the invention. Device 300 includes an airway tube 310 and a mask portion 334. The mask 334 extends from a proximal end 336 to a distal end 338. If the mask portion includes an inflatable peripheral ring, device 300 will include an inflation line, coupled to proximal end of the cuff, and a check valve for selectively inflating the inflatable portion of a mask portion. The device 300 may also include a posterior inflatable portion. The device includes parylene, as indicated, in various locations, such as the mask portion 334, the inflatable peripheral ring 336, the outside of the airway tube 310 or the inside of the airway tube 310 (Figures 3A-3D respectively).
Parylene is a polymer dimer that can be used to coat many different types of surfaces. The coating process initially involves heating the polymer dimer so that it forms a vapour. The vapour is transferred to a vacuum chamber containing the surface of the product to be coated. As the vapour enters the chamber it is attracted to the cooler substrate (the surface of the product to be coated), which it coats uniformly (usually approximately 1 micron thickness) before cooling. Various types of parylene exist, for example parylene N, parylene C and parylene D (sold by Para Tech Coating Inc.), which have respectively reduced abilities to penetrate crevices. Parylene is surprisingly ideal for coating parts of the laryngeal mask airway device for a number of reasons. The parylene film is biocompatible and biostable and therefore suitable for placement inside a patient. The gaseous deposition process allows an extremely thin, uniform conformal film to be formed over all of the elements of the device, especially the smaller parts, cavities and other difficult to reach areas. Because there is no liquid phase involved, the parylene does not exhibit capillary action and it will not therefore accumulate in tubes or crevices. Furthermore, the parylene coat will cure at room temperature, it is not necessary for the laryngeal mask airway device to be subjected to potentially damaging high temperatures, solvents and cure stresses that are often required when coating a surface with a polymer. Parylene can also be sterilized, so it may be used as a coat on a device that is to be reused, as well as single-use devices.
Although any type of laryngeal mask airway device can be coated with parylene, the person skilled in the art will appreciate that a parylene coat may bind to different types of surfaces with varying strengths. As a result, some surfaces may require an additional treatment before exposure to the parylene vapour. For example, it may be necessary to include a silane adhesion enhancement process to enhance binding of the parylene film to a PVC portion of a device. On the other hand, parylene binds extremely well to silicone and therefore no additional treatment is required before the deposition is performed.
The parylene coat provides numerous benefits to the laryngeal mask airway device. Dry lubricity of the device is increased so that the device may be inserted without lubricating jelly. This addresses the problem discussed hereinabove, relating to the expensive, complicated and wasteful process of supplying individual sachets of lubricating jelly with every airway device. Furthermore, due to reduced friction, the device is easier for the medical practitioner to insert, so that an artificial airway may be established more rapidly. Once inserted into the patient's airway, the portions of the device that are coated in parylene will rub against the skin of the patient less. The parylene coat therefore provides benefits to both the medical practitioner and to the survival and comfort of the patient. The parylene coat provides a hydrophobic, chemically resistant coating and therefore may also help to protect parts of the airway device that could otherwise be susceptible to corrosion due to gastrointestinal fluids that may reflux during anaesthesia.

Claims

CLAIMS:
1. A laryngeal mask airway device to facilitate lung ventilation in an unconscious patient, comprising an airway tube opening at one end into the interior of a hollow mask portion, the mask portion including a backplate and a cuff, the mask portion shaped to conform to and to fit readily into the actual and potential space behind the larynx and to seal around the circumference of the laryngeal inlet without penetrating into the interior of the larynx, characterized in that at least a portion of the surface of the device includes parylene.
2. A laryngeal mask airway device according to claim 1, wherein the cuff is inflatable.
3. A laryngeal mask airway device according to claim 1, wherein the portion including parylene is the mask portion.
4. A laryngeal mask airway device according to claim 1, wherein the portion including parylene is the cuff.
5. A laryngeal mask airway device according to claim 1, wherein the portion including parylene is the outer surface of the airway tube.
6. A laryngeal mask airway device according to claim 1, wherein the mask portion is formed of flexible rubber or plastics material with a tubular element of the same material forming its cuff.
7. A laryngeal mask airway device according to claim 1, wherein the mask portion is made separately from the curved or flexible tube and is secured thereto in an airtight manner.
8. A laryngeal mask airway device according to claim 5 wherein the end of the tube that opens into the interior of the mask portion is cut off at an angle to the length of the tube.
9. A laryngeal mask airway device as described substantially herein.
10. A method of manufacturing a laryngeal mask airway device as described in any preceding claim, comprising;
a. providing a laryngeal mask airway device; b. exposing at least a portion of the laryngeal mask airway device to a parylene vapour in a vacuum chamber; c. allowing the parylene vapour to polymerise at room temperature on the exposed surface of the laryngeal mask airway device.
11. A method according to claim 12, wherein the surface to be coated with parylene is pre-treated to enhance adhesion of the parylene film.
12. A method according to claim 13, wherein the surface to be coated is pre-treated using a silane adhesion enhancement process.
13. A method of manufacturing a laryngeal mask airway device as described substantially herein.
PCT/IB2008/003197 2007-10-12 2008-10-13 Laryngeal mask airway device including parylene WO2009047632A2 (en)

Applications Claiming Priority (2)

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GB0719996.1 2007-10-12
GB0719996A GB2456747A (en) 2007-10-12 2007-10-12 Laryngeal mask airway device with a parylene coating

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WO2009047632A2 true WO2009047632A2 (en) 2009-04-16
WO2009047632A3 WO2009047632A3 (en) 2009-05-28

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CN217472518U (en) * 2021-02-20 2022-09-23 浙江简成医疗科技有限公司 Medical laryngeal mask
CN114177448B (en) * 2021-12-20 2023-12-15 河南亚太医疗用品有限公司 Medical laryngeal mask with contact epidermis anti-drying structure based on medical use

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AR068842A1 (en) 2009-12-09
WO2009047632A3 (en) 2009-05-28
GB0719996D0 (en) 2007-11-21
CN101422636A (en) 2009-05-06
GB2456747A (en) 2009-07-29
TW200924808A (en) 2009-06-16

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