US20120145160A1 - Laryngeal mask airway device - Google Patents
Laryngeal mask airway device Download PDFInfo
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- US20120145160A1 US20120145160A1 US13/397,305 US201213397305A US2012145160A1 US 20120145160 A1 US20120145160 A1 US 20120145160A1 US 201213397305 A US201213397305 A US 201213397305A US 2012145160 A1 US2012145160 A1 US 2012145160A1
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- 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
-
- 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
- A61M16/0402—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
- 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
- A61M16/0415—Special features for tracheal tubes not otherwise provided for with access means to the stomach
-
- 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
- A61M16/0443—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. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0434—Cuffs
- A61M16/0445—Special cuff forms, e.g. undulated
- A61M16/0447—Bell, canopy or umbrella shaped
-
- 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
- A61M16/0463—Tracheal tubes combined with suction tubes, catheters or the like; Outside connections
-
- 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
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0816—Joints or connectors
-
- 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
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0875—Connecting 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
- A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
- A61M16/049—Mouthpieces
- A61M16/0493—Mouthpieces with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
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- Health & Medical Sciences (AREA)
- Pulmonology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Emergency Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- External Artificial Organs (AREA)
- Respiratory Apparatuses And Protective Means (AREA)
- Prostheses (AREA)
- Instructional Devices (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
The invention relates to a laryngeal mask airway device (1) for insertion into a patient to provide an airway passage to the patient's glottic opening, the device (1) comprising an airway tube (2), a mask (3) attached to the airway tube (2), the mask (3) comprising a body (4) having a distal end (5) and a proximal end (6), a peripheral inflatable cuff (7), and defining an outlet (8) for gas, the mask (3) being connected to the airway tube (2) for gaseous communication between the tube (2) and the mask, the distal end of the mask being ventrally displaced, relative to the proximal end.
Description
- This application is a continuation of U.S. patent application Ser. No. 11/915,557, filed on Nov. 26, 2007, which claims priority to a PCT Application No. PCT/GB2006/001908, filed on May 24, 2006, which also claims the benefit to priority of United Kingdom Patent Application No. 0510951.7, filed on May 27, 2005, the disclosures of which are hereby incorporated by reference in their entirety.
- 1. Field of the invention
- The present invention relates to a laryngeal mask airway device.
- 2. Description of Related Art Including Information Disclosed under 37 C.F.R. 1.97 and 1.98
- The laryngeal mask airway device is a well known device that is useful for establishing airways in unconscious patients. U.S. Pat. No. 4,509,514 is one of the many publications that describe laryngeal mask airway devices. Such devices have been in use for many years and offer an alternative to the older, even better known endotracheal tube. For at least seventy years, endotracheal tubes comprising a long slender tube with an inflatable balloon disposed at the tube's distal end have been used for establishing airways in unconscious patients. In operation, the endotracheal tube's distal end is inserted through the mouth of the patient, past the patient's trachea. Once so positioned, the balloon is inflated so as to form a seal with the interior lining of the trachea. After this seal is established, positive pressure may be applied to the tube's proximal end to ventilate the patient's lungs. Also, the seal between the balloon and the inner lining of the trachea protects the lungs from aspiration (e.g., the seal prevents material regurgitated from the stomach from being aspirated into the patient's lungs).
- Although they have been enormously successful, endotracheal tubes suffer from several major disadvantages. The principal disadvantage of the endotracheal tube relates to the difficulty of properly inserting the tube. Inserting an endotracheal tube into a patient is a procedure that requires a high degree of skill. Also, even for skilled practitioners, insertion of an endotracheal tube is sometimes difficult or not possible. In many instances, the difficulty of inserting endotracheal tubes has tragically led to the death of a patient because it was not possible to establish an airway in the patient with sufficient rapidity. Also, inserting an endotracheal tube normally requires manipulation of the patient's head and neck and further requires the patient's jaw to be forcibly opened widely. These necessary manipulations make it difficult, or undesirable, to insert an endotracheal tube into a patient who may be suffering from a neck injury.
- In contrast to the endotracheal tube, it is relatively easy to insert a laryngeal mask airway device into a patient and thereby establish an airway. Also, the laryngeal mask airway device is a “forgiving” device in that even if it is inserted improperly, it still tends to establish an airway. Accordingly, the laryngeal mask airway device is often thought of as a “life saving” device. Also, the laryngeal mask airway device may be inserted with only relatively minor manipulation of the patient's head, neck and jaw. Further, the laryngeal mask airway device provides ventilation of the patient's lungs without requiring contact with the sensitive inner lining of the trachea and the size of the airway established is typically significantly larger than the size of the airway established with an endotracheal tube. Also, the laryngeal mask airway device does not interfere with coughing to the same extent as endotracheal tubes. Largely due to these advantages, the laryngeal mask airway device has enjoyed increasing popularity in recent years.
- U.S. Pat. Nos. 5,303,697 and 6,079,409 describe examples of prior art devices that may be referred to as “intubating laryngeal mask airway devices.” The intubating device has the added advantage that it is useful for facilitating insertion of an endotracheal tube. After an intubating laryngeal mask airway device has been located in the patient, the device can act as a guide for a subsequently inserted endotracheal tube. Use of the laryngeal mask airway device in this fashion facilitates what is commonly known as “blind insertion” of the endotracheal tube. Only minor movements of the patient's head, neck and jaw are required to insert the intubating laryngeal mask airway device, and once the device has been located in the patient, the endotracheal tube may be inserted with virtually no additional movements of the patient. This stands in contrast to the relatively large motions of the patient's head, neck and jaw that would be required if the endotracheal tube were inserted without the assistance of the intubating laryngeal mask airway device. Furthermore, these devices permit single-handed insertion from any user position without moving the head and neck of the patient from a neutral position, and can also be put in place without inserting fingers in the patient's mouth. Finally, it is believed that they are unique in being devices which are airway devices in their own right, enabling ventilatory control and patient oxygenation to be continuous during intubation attempts, thereby lessening the likelihood of desaturation.
- Artificial airway devices of the character indicated, are exemplified by the disclosures of U.S. Pat. No. 4,509,514; U.S. Pat. No. 5,249,571; U.S. Pat. No. 5,282,464; U.S. Pat. No. 5,297,547; U.S. Pat. No. 5,303,697; and by the disclosure of the UK Patent 2,205,499. Such devices with additional provision for gastric-discharge drainage are exemplified by U.S. Pat. No. 4,995,388 (FIGS. 7 to 10); U.S. Pat. No. 5,241,956; and U.S. Pat. No. 5,355,879.
- In general, laryngeal mask airway devices aim to provide an airway tube of such cross-section as to assure more than ample ventilation of the lungs, and the designs with provision for gastric drainage have been characterized by relatively complex internal connections and cross-sections calculated to serve in difficult situations where substantial solids could be present in a gastric discharge. As a result, the provision of a gastric discharge opening at the distal end of the mask applicable for direct service of the hypopharynx has resulted in a tendency for such masks to become bulky and unduly stiff, thus making for difficulty in properly inserting the mask. Moreover, undue bulk and stiffness run contrary to the requirement for distal flexibility for tracking the posterior curvature of the patient's throat on insertion, in such manner as to reliably avoid traumatic encounter with the epiglottis and other natural structures of the pharynx.
- A number of problems have been experienced with all of these prior types of device. For example, some prior devices seek to prevent occlusion of the airway outlet by parts of the patient's anatomy, such as the epiglottis, by the provision of bars and the like across the outlet. Although such devices function well in most cases, they can make manufacturing more complex, and can affect the performance of devices in use. This is especially so in devices formed from relatively rigid materials, like PVC, as opposed to the more traditional Liquid Silicon Rubber (LSR).
- In general, devices formed from materials such as PVC are attractive because they are cheaper to make, and can be offered economically as “single-use” devices. However, there are material differences in PVC and PVC adhesives, such as increased durometer hardness as compared to LSR, which affect how the devices perform in use. For example, it has been observed that for a given volume of air, an LSR cuff will expand to a larger size than a comparable PVC cuff. This superior elasticity allows the LSR cuff to provide an anatomically superior seal with reduced mucosal pressure. To close the performance gap, the PVC cuff must be of reduced wall thickness. However, a PVC cuff of reduced wall thickness, deflated and prepared for insertion, will suffer from poor flexural response as the transfer of insertion force through the airway tube to cuff distal tip cannot be adequately absorbed. The cuff assembly must deflate to a thickness that preserves flexural performance i.e. resists epiglottic downfolding, but inflate so that a cuff wall thickness of less than or equal to 0.4 mm creates a satisfactory seal. And where mask backplates are formed from PVC, as well as cuffs, the fact that the increased durometer hardness of PVC is inversely proportional to flexural performance (hysterisis) means that the flexural performance of the device in terms of reaction, response and recovery on deformation is inferior to a comparable LSR device.
- The above described problems are particularly acute in devices which incorporate an oesophageal drain. As mentioned above, in any such device regardless of the material from which it is formed, adding an oesophageal drain in itself adds greatly to complexity of manufacture and can also affect the performance of devices, in terms of ease of insertion, seal formation and prevention of insufflation. These problems can be exacerbated still further if PVC or similarly performing materials are used. For example, the skilled worker will appreciate that in terms of manufacture, the need to provide a drain tube which is sealed from the airway, and which must pass through the inflatable cuff poses a particularly difficult problem. In terms of effects on functionality, the provision of a drain tube can cause unacceptable stiffening of the mask tip area and occlusion/restriction of the airway passage.
- According to the invention there is provided a laryngeal mask airway device for insertion into a patient to provide an airway passage to the patient's glottic opening, the device comprising an airway tube, a mask attached to the airway tube, the mask comprising a body having a distal end and a proximal end, a peripheral inflatable cuff, and defining an outlet for gas, the mask being connected to the airway tube for gaseous communication between the tube and the mask, the distal end of the mask being ventrally displaced, relative to the proximal end. It has been surprisingly found that a ventral displacement of the tip makes insertion of the mask much easier because the tip is presented at an optimum angle as it tracks around the curvature of the airway anatomy.
- It is preferred that the extent of distal displacement is from about 5 mm to about 20 mm, and it is most preferred that the extent of distal displacement is about 10 mm. This has been found to be the optimum range. It has been found that if the extent of displacement is too great, the device will not lie in the correct position at its maximum extent of insertion.
- It is preferred that the body describes a substantially convex curve, from the proximal to distal end. It is further preferred that the mask body comprises a plate, the plate having a dorsal side and a ventral side, the dorsal side being substantially smooth and having a convex curvature across its width. It is also preferred that the dorsal surface of the airway tube corresponds in curvature to the curvature across the width of the plate. All of these expedients assist in making insertion of the mask easier.
- The airway tube preferably comprises a relatively more rigid material than the mask body. Both the airway tube and the mask body preferably comprise a plastics material.
- The device may further including an oesophageal drain tube, and the oesophageal drain tube may be disposed on the ventral side of the body, in order to maintain a smooth profile on the dorsal side, to make insertion easier.
- The invention will further be described by way of example and with reference to the following drawings, in which,
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FIG. 1 is a dorsal three quarter perspective view of a device according to the invention; -
FIG. 2 is a right side view of the device ofFIG. 1 ; -
FIG. 3 is a dorsal view of the device ofFIG. 1 ; -
FIG. 4 is a ventral view of the device ofFIG. 1 ; -
FIG. 4 a is a ventral view of a further embodiment of device according to the invention; -
FIG. 5 is an end view, looking from the proximal towards the distal end of the device ofFIG. 1 ; -
FIG. 6 is an end view, looking from the distal towards the proximal end of the mask of the device ofFIG. 1 ; -
FIG. 7 is an enlarged view of the mask of the device ofFIG. 1 ; -
FIG. 8 is a dorsal view of the device ofFIG. 4 a; -
FIG. 9 is a longitudinal sectional view along line Y-Y inFIG. 8 ; -
FIG. 10 is a side view, enlarged, of the device ofFIG. 4 a; -
FIGS. 11A to 11K are transverse sectional views along lines A-A to K-K inFIG. 10 ; -
FIG. 12 is an exploded dorsal perspective view of a device according to the invention; -
FIG. 13 is an exploded ventral perspective view of a device according to the invention; -
FIG. 14 is a dorsal three quarter perspective view of a device according to the invention; -
FIG. 15 is a right side view of the device ofFIG. 14 ; -
FIG. 16 is a dorsal view of the device ofFIG. 14 ; -
FIG. 17 is a ventral view of the device ofFIG. 14 ; -
FIG. 18 is an end view, looking from the proximal towards the distal end of the mask of the device ofFIG. 14 ; -
FIG. 19 is an end view, looking from the distal towards the proximal end of the mask of the device ofFIG. 14 ; -
FIG. 20 is a dorsal three quarter perspective view of the device ofFIG. 14 ; -
FIG. 21 is a view of section CC-CC inFIG. 20 ; -
FIG. 22 is a view of section VC-VC inFIG. 17 ; -
FIG. 23 is a proximal end view of a part of the device ofFIG. 14 ; and -
FIG. 24 is a distal end view of a part of the device ofFIG. 14 . - Referring now to the drawings, there is illustrated a laryngeal
mask airway device 1 for insertion into a patient to provide an airway passage to the patient's glottic opening, thedevice 1 comprising anairway tube 2, a mask 3 attached to theairway tube 2, the mask 3 comprising abody 4 having a distal end 5 and a proximal end 6, a peripheralinflatable cuff 7, and defining an outlet 8 for gas, the mask 3 being connected to theairway tube 2 for gaseous communication between thetube 2 and the mask, the distal end of the mask being ventrally displaced, relative to the proximal end. - In this embodiment the
device 1 further comprises anoesophageal drain 10, thedrain 10 comprising aconduit 11 extending from anopening 12 at the distal end 5 to a drain outlet 13 disposed to the outside of the patient when thedevice 1 is in place, wherein theconduit 11 is formed integrally in the material of thebody 4. - As can be seen from the drawings, the
device 1, in terms of overall appearance is somewhat similar to prior art devices, in that it consists of the basic parts which make up most if not all laryngeal mask airway devices, i.e. anairway tube 2 and mask 3 which includes abody part 4, and acuff 7. - For the purposes of description it is appropriate to assign reference names to areas of the
device 1 and accordingly with reference toFIGS. 2 to 6 , thedevice 1 has adorsal side 14, aventral side 15, a proximal end 16 (in a sense that this is the end nearest the user rather than the patient) adistal end 17 and right and leftsides - Referring firstly to the
airway tube 2, in the illustrated embodiments the tube comprises a relatively rigid PVC material such as a shore 90A Colorite PVC moulded into an appropriately anatomically curved shape. Thetube 2 has some flexibility such that if it is bent it will return to its original shape. Although it is resiliently deformable in this way, it is sufficiently rigid to enable it to assist in insertion of thedevice 1 into a patient, acting as a handle and guide. In this embodiment theairway tube 2 does not have a circular cross-section as in many prior devices, but instead is compressed in the dorsal/ventral direction which assists in correct insertion of thedevice 1, helps prevent kinking, and assists in comfortable positioning for the patient as the shape generally mimics the shape of the natural airway. In this embodiment eachside airway tube 2 includes a groove orchannel 20 extending for most of the tube's length from the proximal to distal ends. Thesegrooves 20 further assist in preventing crushing or kinking of theairway tube 2. Internally thegrooves 20 form ridges along the inner surfaces of thesides - Referring now to
FIG. 13 , which shows an exploded view of thedevice 1, it can be seen that theairway tube 2 includes a flareddistal end 22 withsurfaces 22 a disposed to allow for attachment of thetube 2 to the mask 3, conveniently by over moulding of the mask 3 onto theairway tube 2. Thus, theairway tube 2 itself can form a pre-mould used in formation of thedevice 1, which substantially simplifies manufacturing. Of particular note is the airway tube's dorsal mould surface 23 (FIG. 13 ). Thissurface 23 is located at the flareddistal end 22, and takes the form of a flat land extending between the outer dorsal surface 2 a and the inner dorsal surface 2 b (FIG. 24 ) of the dorsal wall 2 c. It includes optional through holes 2 d to allow the over moulded backplate 4 to lock onto thetube 2, as will be described later on. This feature helps ensure a secure connection between the different materials making up theairway tube 2 and mask 3. - A further feature of the
airway 2 is theoesophageal drain tube 41. Thisdrain tube 41 is located withinairway tube 2, extending centrally through it from one end to the other, and in this embodiment it is disposed in contact with the inner surface 2 a of the dorsal wall 2 b of theairway tube 2, and bounded on each side by raised, smooth walls (not shown) which form a shallow channel through which it runs. - The proximal end of the
airway tube 2 is provided with aconnector 42, for connection of thedevice 1 to a gas supply and drain (not shown) as shown for example inFIGS. 12 and 13 and in section inFIG. 9 . Theconnector 42 comprises aconnector body 43, anoptional bite block 44 and aconnector plug 45. Theconnector body 43 andbite block 44 correspond in shape and dimension with the internal shape of the proximal end of theairway tube 2 such that they fit inside it. Theconnector body 43 has a perpendicularly extendingperipheral flange 46 which extends at one point on its circumference into atab 47.Connector plug 45 attaches toconnector body 43 by adhesive or other suitable means applied toflange 46. Theconnector plug 45 comprises major andminor bores common atrium 50 at the distal end of theconnector plug 45 where it attaches to theconnector body 43.Drain tube 41 extends into and throughminor bore 49, such that the bore of theairway tube 2 and the bore of thedrain tube 41 are separated from one another. - Turning now to the mask 3, the mask 3 consists of two parts, a
body part 4 often referred to as a back plate, and aperipheral cuff 7. - The
back plate 4 is formed in these embodiments by moulding from a shore 50A Vythene PVC+PU. This material is substantially softer and more deformable than the material ofairway tube 2. - Referring now to
FIG. 23 , theback plate 4 comprises a generally oval moulding when viewed from the dorsal or ventral directions, having a smoothdorsal surface 24, a formedventral surface 24 a (FIG. 17 ), a proximal joining portion 24 b, and adistal tip 61. - The
dorsal surface 24 has a convex curvature from one side to the other, corresponding to the curvature of the dorsal surface of theairway tube 2, and longitudinally, thedorsal surface 24 is also curved, having a curvature beginning at the joining portion 24 b and extending with constant rate of curvature toward thedistal tip 61. As a result thetip 61 is ventrally biased relative to the distal end of the airway tube, in the assembleddevice 1, the extent of displacement of thedistal tip 61 being approximately 20 mm or 10 degrees, in order to produce a curvature in the mask that is suited to the anatomy of the patient. This is shown schematically at X inFIG. 2 . On insertion, this displacement of thetip 61 assists the mask in “turning the corner” in the insertion path. - When viewed from the ventral side, the integrally moulded structures of the
back plate 4 can best be seen (FIGS. 4,7,12,17). The precise shape of theventral side 24 a of the back plate is illustrated particularly in the sectional views shown inFIGS. 11A to 11K and in the enlarged perspective view inFIG. 7 . Referring to the exploded view shown inFIG. 12 , the convex curvature of thedorsal surface 24 of theback plate 4 is mirrored in a corresponding concave curvature on the ventral side. Thus, theventral surface 24 a forms a shallow, elongate channel tapering towards thedistal tip 61. The channel is bounded bywalls 26. Thewalls 26 have correspondingly shaped, longitudinally extending convex outer surfaces 25. Eachwall 26 extends longitudinally substantially the entire length of theback plate 4 from the proximal joining portion 24 b towards thedistal tip 61. Eachwall 26 also has a convexinner surface 28, but rather than terminating at an angle normal to the channel floor, the curve of eachwall 26 is continued, the walls curving back over the channel and terminating in inwardly extending webs 27 (FIGS. 7 and 11 ). Theinner surfaces 28 of theside walls 26 curve down to form the floor of the channel but do not meet, because the base or floor of the channel is bisected by a longitudinally extending, integrally moulded conduit which is anoesophageal drain tube 11 extending along it for its entire length from joining portion 24 b todistal tip 61. Thus, it can be seen that the channel has three longitudinally extending conduits on its inner surface, the two openouter conduits 28 a which are minor gas conduits in the assembleddevice 1, and thecentral drain tube 11, which forms a septum there between. - Referring now in greater detail to the
drain tube 11, it will be seen that thetube 11 has a sufficient diameter such that its upper wall section 11 a, i.e. the wall section furthest from the floor of the channel, is on a similar level with the inwardly extendingwebs 27 of theside walls 26. Furthermore, the upper wall section 11 a itself also has outwardly extendingwebs 30, which taper toward, but do not meet, the correspondingly tapered edges of thewebs 27. Thus, the upper surface 11 b of the upper wall section 11 a of thedrain tube 11, and thewebs surface 11 c shown schematically by a dotted line inFIG. 11 ), below the level of which run all threeconduits - Referring now particularly to
FIG. 7 , it can be seen that although thedrain tube 11 extends the full length of theback plate 4 from its proximal joining portion 24 b todistal tip 61, theconduits 28 a do not extend the full length of theback plate 4, but instead terminate about half way along its length. Thefloors 31 of theconduits 28 a curve gently upwards as they extend towards thedistal tip 61 of theback plate 4 until they terminate at a level approximately equal to the level of thewebs FIG. 4 a, these areas are hollowed out to form depressions 31 b. - As illustrated in
FIG. 12 andFIGS. 21 to 23 ,drain tube 11 extends todistal tip 61, terminating in anopening 12. Thus, an end section 11 e of thedrain tube 11 protrudes past the end ofback plate 4. This end section 11 e is provided with dorsal webbing 11 a which extends to either side of it, and around it to form a hood orpocket 36 a which encloses the end section 11 e around its circumference. The hood orpocket 36 a is attached to the distal end of thedrain tube 11 around thecircumference 12 a of opening 12 (FIG. 22 ). This hood orpocket 36 a is integrally formed in the material of theback plate 4 atdistal tip 61. It completely surrounds and extends from the circumference of thedrain tube opening 12 and the joint therebetween is smooth. As illustrated, the ventral extent of the hood is more limited than the dorsal extent, the dorsal extent being to about midway back towards the proximal end of theback plate 4. Referring to sectional views A-A and B-B inFIG. 11 , it can be seen that thedrain tube 11 is supported on its right and left sides, and on its dorsal surface, by perpendicularly extendingwebs 62. Thesewebs 62 are integrally formed, and extend back from theopening 12 to the point where the end section 11 e meets the extent of theback plate 4. In the illustrated embodiment thedorsal webs 62 extend substantially perpendicularly from the drain tube, but in a preferred embodiment, they may extend to one side or the other, at an angle of less than 90 degrees. - The second part of the mask 3 is the
peripheral cuff 7. Thecuff 7 is in this embodiment blow moulded PVC and takes the form of a generally elliptical inflatable ring having a central aperture 7 a, a relatively deeper proximal end 37 with aninflation port 38 and a relatively shallower distal end 7 b tapering to a “wedge”profile 39. As will be appreciated, particularly from the exploded views shown inFIGS. 12 and 13 , thecuff 7 is integrally formed in one piece. The wedge profile is provided such that the ratio of dorsal to ventral side surface areas favours the dorsal side. Thus, when deflated the distal end 7 b of thecuff 7 will curl with bias from dorsal to ventral side. - In the assembled
device 1,drain tube 41 is inserted intoairway tube 2, such that it protrudes fromproximal end 16. Theconnector 42 is attached to theairway tube 2 by inserting theconnector body 43 andbite block 44 intoproximal end 16. The parts are an interference fit and can be secured by adhesive.Plug 45 is attached toconnector body 43 viaflange 46, such thatdrain tube 41 passes intominor bore 49, terminating at or adjacent its mouth. Thus it will be seen that the minor bore 49 is solely in fluid communication withdrain tube 41, and themajor bore 48 is solely in fluid communication with the interior ofairway tube 2. -
Airway tube 2 is attached to theback plate 4 conveniently by overmoulding theback plate 4 onto the already formedtube 2. Thus, the joining portion 24 b of theback plate 4 is moulded onto the dorsal arc of the airway tube 2 (FIG. 13 ). Secure attachment is facilitated by thesurfaces Drain tube 41 is connected in fluid tight manner to integrally mouldeddrain 11, as demonstrated by arrow Z (FIG. 13 ). - The
cuff 7 is bonded to theback plate 4 as illustrated inFIGS. 12 and 13 by inserting the wedge shaped distal end 7 b of thecuff 7 into the hood orpocket 36 a at thedistal tip 61 of theback plate 4 such that thewedge surface 39 mates with the inner surface 36 b of thehood 36 a, and sections of the inner periphery of thecuff 7 mate with convexouter surfaces 25 ofback plate walls 26. Thecuff 7 is bonded into the hood such that the space between the hood and the cuff is airtight and in this embodiment the cuff is provided with a “pinch off” 40 (FIGS. 21 and 22 ) putting thecuff 7 andhood 36 a into fluid communication so that the air space in the hood can also be inflated, in addition to thecuff 7 itself However thecuff 7 pinch off does not extend the entire distance towards the distal tip of the cuff to prevent the pressure of inflation occluding theopening 12. The proximal dorsal surface of the cuff is bonded to the ventral arc of thedistal end 22 of theairway tube 2. Thus, it will be appreciated that unlike in previous devices incorporating oesophageal drains, in the invention thedrain 11 does not pierce thecuff 7, making manufacturing simpler. Furthermore, in prior devices in which the drain pierces the cuff, the cuff must be securely attached around the circumference of the drain tube at the distal tip. Such a secure attachment, for example with adhesive, can make the tip hard, and prevent the drain tube collapsing in the deflated, flattened device, which is highly desirable to enable the mask to pass easily around the curvature of the anatomy. In addition, the acute curvature of a drain tube to cuff joint would be highly susceptible to cracking In the invention, these problems are avoided because thedrain tube 11 is integrally moulded with thehood 36 a, which in effect forms a second or minor cuff at the distal tip. - As will be appreciated, the airway of the
device 1, which is the conduit through which gas is passed to the patient, is provided by the bore ofairway tube 2, which terminates at flareddistal end 22. Flareddistal end 22 defines, along withback plate 4 andcuff 7, outlet 8 for gas passing fromtube 2 into mask 3. Outlet 8 includes three routes by which gas may pass into the mask, namely a main gas conduit 8 a (FIG. 6 ), and twominor gas conduits 28 a. - In use, the deflated
device 1 is inserted into a patient in the usual manner with devices of this type. As noted above, the relative rigidity of theairway tube 2 allows a user to grip it and use it to guide thedevice 1 into the patient, whilst the relatively softer, more compliant material of the back plate means that the mask will more readily deform to negotiate the insertion path without causing damage to the anatomy, and will return to its optimum shape to ensure that a good seal is achieved at the furthest extent of insertion. The ventral displacement of thedistal tip 61 relative to the join between theback plate 4 andairway tube 2 further enhances ease of insertion, because thedistal tip 61 is thereby presented at the optimum angle to negotiate the “bend” in the insertion path. In devices formed from relatively rigid materials such as PVC, as opposed to the often used LSR these features are particularly important in easing insertion and providing for an enhanced seal. - Referring now to the features of the moulded back
plate 4, it will be seen that by providingdrain tube 11 integrally moulded in the material of theback plate 4, problems of mask stiffness and difficulty of manufacture in prior designs caused by the presence of a separate drain tube bonded in place with adhesive can be mitigated. - Moreover, with the
back plate 4 of the invention, the combination of the centrally locateddrain tube 11 andminor gas conduits 28 a assist in solving the problem of occlusion of the airway by parts of the patient's anatomy. Theminor gas conduits 28 a can be thought of as “nostrils” through which gas may continue to pass into the patient even if the main outlet 8 a becomes occluded by, for example the patient's epiglottis, as the epiglottis will rest upon the septum provided by thedrain tube 11. As illustrated particularly inFIGS. 11I and 11J thewebs conduits 28 a, to assist in preventing structures such as the epiglottis from falling into and blocking theconduits 28 a, and also to make theback plate 4 more resistant to lateral compression. It will be appreciated that in this embodiment, thedrain 11 forms a convenient septum between theconduits 28 a, however, in devices with no oesophageal drain, a solid septum could simply be formed in the material of the back plate by moulding. In addition, a larger number ofconduits 28 a could be provided. - Thus, it can be seen that the above described embodiments address the problems of prior art devices in novel and inventive ways.
Claims (9)
1. A laryngeal mask airway device for insertion into a patient to provide an airway passage to the patient's glottic opening, the device comprising an airway tube, a mask attached to the airway tube, the mask comprising a body having a distal end and a proximal end, a peripheral inflatable cuff, and defining an outlet for gas, the mask being connected to the airway tube for gaseous communication between the tube and the mask, the distal end of the mask being ventrally displaced, relative to the proximal end.
2. A device according to claim 1 , wherein the extent of distal displacement is from about 5 mm to about 20 mm.
3. A device according to claim 2 , wherein the extent of distal displacement is about 10 mm.
4. A device according to any preceding claim 1 , the body describing a substantially convex curve, from the proximal to distal end.
5. A device according to any preceding claim 1 , the mask body comprising a plate, the plate having a dorsal side and a ventral side, the dorsal side being substantially smooth and having a convex curvature across its width.
6. A device according to claim 5 , the airway tube having a dorsal surface, the dorsal surface of the airway tube corresponding in curvature to the curvature across the width of the plate.
7. A device according to any preceding claim 1 , the airway tube comprising a relatively more rigid material than the mask body.
8. A device according to any preceding claim 1 , further including an oesophageal drain tube.
9. A device according to claim 8 , the oesophageal drain tube being disposed on the ventral side of the body.
Priority Applications (1)
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US13/397,305 US20120145160A1 (en) | 2005-05-27 | 2012-02-15 | Laryngeal mask airway device |
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US11/915,556 Abandoned US20090145438A1 (en) | 2005-05-27 | 2006-05-24 | Laryngeal mask airway device |
US11/915,558 Active 2030-03-05 US9522245B2 (en) | 2005-05-27 | 2006-05-24 | Laryngeal mask airway device and method of manufacture |
US11/915,563 Abandoned US20090133701A1 (en) | 2005-05-27 | 2006-05-24 | Laryngeal mask airway device |
US13/267,421 Active US8776797B2 (en) | 2005-05-27 | 2011-10-06 | Laryngeal mask airway device |
US13/397,468 Active US8783256B2 (en) | 2005-05-27 | 2012-02-15 | Laryngeal mask airway device |
US13/397,305 Abandoned US20120145160A1 (en) | 2005-05-27 | 2012-02-15 | Laryngeal mask airway device |
US14/298,310 Active US9662465B2 (en) | 2005-05-27 | 2014-06-06 | Laryngeal mask airway device |
US14/314,247 Active US9498591B2 (en) | 2005-05-27 | 2014-06-25 | Laryngeal mask airway device with a support for preventing occlusion |
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US13/267,421 Active US8776797B2 (en) | 2005-05-27 | 2011-10-06 | Laryngeal mask airway device |
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US14/314,247 Active US9498591B2 (en) | 2005-05-27 | 2014-06-25 | Laryngeal mask airway device with a support for preventing occlusion |
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