Patent Application
20230211101
The present invention relates generally to lung ventilation devices, and specifically to laryngeal mask airway devices.
Laryngeal mask airway devices are useful in facilitating lung ventilation by forming a low-pressure seal around the patient's laryngeal inlet, thereby avoiding the known harmful effects of endotracheal tube (ETT) devices, which form a seal within the trachea. Laryngeal mask airway devices have become standard medical devices, instead of ETT devices, for rapidly and reliably establishing an unobstructed airway in a patient in emergency situations and in the administration of anesthetic gases. Some laryngeal mask airway devices further include a drainage tube, which opens into the distal tip of the mask and emerges from the mouth of the patient.
During general anesthesia, pulmonary ventilation is secured with an ETT device or by a laryngeal mask airway device, and attention to the risk of complications related to a high intracuff pressure is important. When the cuff-to-tracheal wall pressure exceeds the tracheal capillary pressure (130-140 cm H2O) for approximately 15 minutes, the tracheal mucous membrane becomes ischemic. The intracuff pressure approximates the cuff-to-tracheal wall pressures in high volume/low pressure cuffs, and a cuff pressure below 120 cm H2O is recommended to prevent ischemic injury. In addition, recurrent laryngeal nerve palsy has been demonstrated in up to 5% of patients after intubation, and a high cuff pressure is suspected as contributing to this complication. Similarly, in patients provided with a laryngeal mask, a high cuff pressure may lead to palsy of the lingual, hypoglossal, and recurrent laryngeal nerves, and postoperative sore throat.
The risk during anesthesia with nitrous oxide (NO) is further complicated by the fact that NO gases penetrate the cuff, thereby gradually increasing the cuff pressure above the initial setting at which the cuff was inflated.
U.S. Pat. Nos. 8,783,256, 5,632,271, and 7,305,985, all to Brain, describe laryngeal mask airway devices.
Rokamp K Z et al., in “Tracheal tube and laryngeal mask cuff pressure during anaesthesia—mandatory monitoring is in need,” BMC Anesthesiology December 2010 10:20, describe “a prospective quality-control study,” in which “201 patients undergoing surgery during anaesthesia (without the use of nitrous oxide) were included for determination of the cuff pressure of the tracheal tubes and laryngeal masks” (abstract).
A “Quick Reference Guide,” Teleflex (Triangle Park, N.C., USA), 2013, lists various laryngeal mask airway Airways, having different sizes and maximum cuff volumes.
Some embodiments of the present invention provide a laryngeal mask airway device, which comprises an inflatable balloon, which is shaped so as to define at least an inflatable annular cuff and a proximal inflatable pharyngeal portion. The inflatable balloon is insertable through an anterior opening of an oral cavity of a patient. The inflatable annular cuff shaped so as to define a cuff anterior side that is configured to stabilize the inflatable annular cuff with respect to a laryngeal inlet of the patient when the inflatable balloon is disposed at an insertion location within a throat of the patient.
The laryngeal mask airway device further comprises a shaft, which is installed through the anterior opening of the oral cavity. The shaft has (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end portion that is fixed to the inflatable balloon. The laryngeal mask airway device further comprises an airway tube, which passes through at least a longitudinal portion of the shaft, such as through an entirety of a length of the shaft. The proximal inflatable pharyngeal portion of the inflatable balloon forms an air-tight seal with an external surface of the shaft (such as by gluing or welding).
For some applications, the inflatable balloon is configured such that when an inflatable chamber thereof is filled with air at a pressure of 10 cm H2O and unconstrained, a volume of the air in a proximal one-third of the inflatable chamber equals at least 200% of a volume of the air in a distal one-third of the inflatable chamber, such as at least 300%, e.g., at least 350%, such as at least 400% of the volume of the air in the distal one-third of the inflatable chamber. Typically, the proximal inflatable pharyngeal portion of the inflatable balloon provides at least a portion of, such as all of, the proximal one-third of inflatable chamber.
By contrast, in convention laryngeal mask airway cuffs, the volume in the proximal one-third of the inflatable chamber of the cuff is approximately equal to the volume in the distal one-third of the inflatable chamber, when inflated at a pressure of 10 cm H2O, as well as at other pressures, including 20 and 25 cm H2O.
For some applications, the cuff anterior side, along a proximal side of the inflatable annular cuff, is shaped so as to define a posteriorly-recessed portion, i.e., a portion that is recessed in a posterior direction. Optionally, the posteriorly-recessed portion of the cuff anterior side is curved. The posteriorly-recessed portion prevents the inflatable annular cuff from applying excessive pressure to a posterior portion of the patient's tongue, which might cause tissue damage.
For some applications, an inflation tube of the laryngeal mask airway device comprises an inflation valve that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, for holding a given inflation of the inflatable balloon. The laryngeal mask airway device is configured such that when the inflatable balloon, while the inflation valve is closed and the pressure within the inflatable balloon equals ambient pressure, is inserted from outside the oral cavity to the insertion location within the throat without opening the inflation valve, the pressure within the inflatable balloon increases from the ambient pressure to an inserted-location pressure, the inserted-location pressure less than 60 cm H2O, such as less than 45 cm H2O, e.g., less than 30 cm H2O.
There is therefore provided, in accordance with an Inventive Concept 1 of the present invention, a laryngeal mask airway device including:
an inflatable balloon, which is (a) shaped so as to define at least an inflatable annular cuff and a proximal inflatable pharyngeal portion, and (b) insertable through an anterior opening of an oral cavity of a patient, the inflatable annular cuff shaped so as to define a cuff anterior side that is configured to stabilize the inflatable annular cuff with respect to a laryngeal inlet of the patient when the inflatable balloon is disposed at an insertion location within a throat of the patient;
a shaft having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end portion that is fixed to the inflatable balloon;
an airway tube, which passes through at least a longitudinal portion of the shaft, and has (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end that is open through the inflatable annular cuff, wherein the proximal inflatable pharyngeal portion of the inflatable balloon forms an air-tight seal with an external surface of the shaft; and
an inflation tube having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end that is coupled in fluid communication with an inflatable chamber defined by the inflatable balloon, for supplying air to the inflatable chamber,
wherein the inflatable balloon is configured such that when the inflatable chamber is filled with air at a pressure of 10 cm H2O and unconstrained, a volume of the air in a proximal one-third of the inflatable chamber equals at least 200% of a volume of the air in a distal one-third of the inflatable chamber,
wherein the inflation tube includes an inflation valve that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and
wherein the laryngeal mask airway device is configured such that when the inflatable balloon, while the inflation valve is closed and the pressure within the inflatable balloon equals ambient pressure, is inserted from outside the oral cavity of the patient to the insertion location within the throat without opening the inflation valve, the pressure within the inflatable balloon increases from the ambient pressure to an inserted-location pressure, the inserted-location pressure less than 60 cm H2O.
Inventive Concept 14. The laryngeal mask airway device according to Inventive Concept 13, wherein the inserted-location pressure is less than 45 cm H2O.
Inventive Concept 15. The laryngeal mask airway device according to Inventive Concept 14, wherein the inserted-location pressure is less than 30 cm H2O.
Inventive Concept 16. The laryngeal mask airway device according to any one of Inventive Concepts 1-12,
wherein the inflatable annular cuff is shaped so as to define a distal tip portion that includes a distal end of the inflatable annular cuff,
wherein the distal tip portion is configured to form a seal against an upper esophageal sphincter when the inflatable balloon is disposed at the insertion location, and
wherein a distal wall of the distal tip portion has a thickness of at least 2 mm.
Inventive Concept 17. The laryngeal mask airway device according to Inventive Concept 16, further including a drainage tube that (a) extends from a gastric channel having a distal gastric opening through the distal tip portion, and (b) has a proximal drainage port at location outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location.
Inventive Concept 18. The laryngeal mask airway device according to any one of Inventive Concepts 1-12,
wherein the laryngeal mask airway device includes a distal tip portion located distal to the inflatable annular cuff, and
wherein the distal tip portion is configured to form a seal against an upper esophageal sphincter when the inflatable balloon is disposed at the insertion location.
Inventive Concept 19. The laryngeal mask airway device according to Inventive Concept 18,
wherein the laryngeal mask airway device includes an inner support, which is mostly covered by the inflatable balloon,
wherein the inflatable balloon is shaped so as to define a distal inflatable tip portion, which is in fluid communication with the rest of the inflatable chamber of the inflatable balloon, and
wherein the distal inflatable tip portion entirely surrounds a longitudinal portion of the distal tip portion.
Inventive Concept 20. The laryngeal mask airway device according to Inventive Concept 19, wherein a distal end of the longitudinal portion is at a distance from a distal-most tip of the distal tip portion, the distance between 1 and 5 mm.
Inventive Concept 21. The laryngeal mask airway device according to Inventive Concept 19, wherein the longitudinal portion has a length of between 1 and 5 cm.
Inventive Concept 22. The laryngeal mask airway device according to Inventive Concept 21, wherein the length is between 1 and 3 cm.
Inventive Concept 23. The laryngeal mask airway device according to Inventive Concept 21, wherein the length is between 2 and 4 cm.
Inventive Concept 24. The laryngeal mask airway device according to Inventive Concept 19, wherein the longitudinal portion has a greatest width, measured from side to side of the inflatable balloon, of no more than 20 mm along a length of the longitudinal portion.
Inventive Concept 25. The laryngeal mask airway device according to Inventive Concept 19, wherein the distal tip portion includes a distal-most non-balloon-covered tip portion, defined by the inner support.
Inventive Concept 26. The laryngeal mask airway device according to Inventive Concept 19, wherein a proximal end of the distal inflatable tip portion is at least partially coupled to the inner support, so as to restrict air flow between the distal inflatable tip portion and the inflatable annular cuff, without entirely blocking the air flow.
Inventive Concept 27. The laryngeal mask airway device according to Inventive Concept 19, further including a drainage tube that:
extends from a gastric channel that is defined by the inner support,
has a distal gastric opening through the distal tip portion, and
has a proximal drainage port at location outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location.
Inventive Concept 28. The laryngeal mask airway device according to any one of Inventive Concepts 1-12, wherein the laryngeal mask airway device is configured such that when the inflatable chamber is filled with the air at the pressure of 10 cm H2O and unconstrained, a portion of the proximal inflatable pharyngeal portion of the inflatable balloon bulges posteriorly with respect to the external surface of the shaft.
Inventive Concept 29. The laryngeal mask airway device according to any one of Inventive Concepts 1-12, wherein a distal portion of the shaft passes through at least a portion of the proximal inflatable pharyngeal portion of the inflatable balloon, such that, when the inflatable chamber is filled with the air at the pressure of 10 cm H2O and unconstrained, a portion of the inflatable chamber defined by the proximal inflatable pharyngeal portion surrounds 360 degrees of the distal portion of the shaft.
Inventive Concept 30. The laryngeal mask airway device according to any one of Inventive Concepts 1-12, wherein the laryngeal mask airway device is configured such that when the inflatable balloon is disposed at the insertion location and the proximal inflatable pharyngeal portion of the inflatable balloon is inflated at the pressure of 25 cm H2O, the inflatable annular cuff spans both (a) a vertical space between a tongue and a pharyngeal back wall of the throat and (b) a lateral space between left and right tonsils, thereby forming a proximal seal between the oral cavity and a pharyngeal space distal to the proximal inflatable pharyngeal portion of the inflatable balloon.
Inventive Concept 31. The laryngeal mask airway device according to any one of Inventive Concepts 1-12,
wherein the laryngeal mask airway device is configured such that when a volume of 5 cc of ambient air, the volume measured at standard atmospheric pressure, is introduced into the inflation tube while the inflatable balloon is unconstrained, disposed in ambient air that is at standard atmospheric pressure, and is at an inflation pressure of 30 cm H2O:
a proximal coupling portion, which is shaped so as to define one or more couplers that are configured to removably couple the proximal coupling portion to the shaft proximally to the inflatable pharyngeal portion of the inflatable balloon, and
a distal protection portion, which is shaped so as to partially cover a posterior external surface of the inflatable balloon when the proximal coupling portion is removably coupled to the shaft, so as to protect the inflatable balloon from puncture during insertion thereof into the patient's oral cavity.
Inventive Concept 33. The laryngeal mask airway system according to Inventive Concept 32, wherein the one or more couplers are shaped so as to form snap-on couplings to the shaft.
Inventive Concept 34. The laryngeal mask airway system according to Inventive Concept 32, wherein the elongate sheet of material of the insertion posterior protector is further shaped so as to define a proximal handle, which is shaped so as to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location.
There is further provided, in accordance with an Inventive Concept 35 of the present invention, a laryngeal mask airway system including:
laryngeal mask airway device, which includes:
an insertion posterior protector, which includes an elongate sheet of material that is shaped so as to define:
wherein the inflatable annular cuff is shaped so as to define a distal tip portion that includes a distal end of the inflatable annular cuff,
wherein the distal tip portion is configured to form a seal against an upper esophageal sphincter when the inflatable balloon is disposed at the insertion location, and
wherein a distal wall of the distal tip portion has a thickness of at least 2 mm.
Inventive Concept 39. The laryngeal mask airway device according to Inventive Concept 38, further including a drainage tube that (a) extends from a gastric channel having a distal gastric opening through the distal tip portion, and (b) has a proximal drainage port at location outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location.
Inventive Concept 40. The laryngeal mask airway system according to Inventive Concept 35, wherein the cuff anterior side is configured to form a seal around the laryngeal inlet of the patient when the inflatable balloon is disposed at the insertion location.
Inventive Concept 41. The laryngeal mask airway system according to any one of Inventive Concepts 35-40,
wherein the inflatable balloon is shaped so as to define at least the inflatable annular cuff and a proximal inflatable pharyngeal portion, which are insertable through the anterior opening of the oral cavity,
wherein the proximal inflatable pharyngeal portion of the inflatable balloon forms an air-tight seal with an external surface of the shaft.
Inventive Concept 42. The laryngeal mask airway system according to Inventive Concept 41, wherein the inflatable balloon is configured such that when the inflatable chamber is filled with air at a pressure of 10 cm H2O and unconstrained, a volume of the air in a proximal one-third of the inflatable chamber equals at least 200% of a volume of the air in a distal one-third of the inflatable chamber,
the proximal one-third of the inflatable chamber extending distally from a proximal end of the inflatable chamber along one third of a length of the inflatable chamber,
the distal one-third of the inflatable chamber extending proximally from a distal end of the inflatable chamber along one third of the length of the inflatable chamber, and
the length measured along a straight line segment connecting (a) a distal centroid of the distal end of the inflatable chamber and (b) a proximal centroid of the proximal end of the inflatable chamber.
Inventive Concept 43. The laryngeal mask airway device according to Inventive Concept 42, wherein the proximal inflatable pharyngeal portion extends in both lateral directions away from the straight line segment.
Inventive Concept 44. The laryngeal mask airway device according to Inventive Concept 43, wherein the proximal inflatable pharyngeal portion is reflectionally symmetric about a plane of symmetry that extends in an anterior/posterior direction, wherein the straight line segment falls in the plane of symmetry.
Inventive Concept 45. The laryngeal mask airway system according to Inventive Concept 41, wherein the inflatable balloon is configured such that the proximal inflatable pharyngeal portion of the inflatable balloon forms the air-tight seal entirely around a longitudinal portion of the shaft.
Inventive Concept 46. The laryngeal mask airway system according to Inventive Concept 41, wherein the laryngeal mask airway device is configured such that when the inflatable chamber is filled with air at a pressure of 10 cm H2O and unconstrained, a portion of the proximal inflatable pharyngeal portion of the inflatable balloon bulges posteriorly with respect to the external surface of the shaft.
Inventive Concept 47. The laryngeal mask airway system according to Inventive Concept 41, wherein a distal portion of the shaft passes through at least a portion of the proximal inflatable pharyngeal portion of the inflatable balloon, such that, when the inflatable chamber is filled with air at a pressure of 10 cm H2O and unconstrained, a portion of the inflatable chamber defined by the proximal inflatable pharyngeal portion surrounds 360 degrees of the distal portion of the shaft.
There is still further provided, in accordance with an Inventive Concept 48 of the present invention, a laryngeal mask airway device including:
an inflatable balloon, which is (a) shaped so as to define at least an inflatable annular cuff, and (b) insertable through an anterior opening of an oral cavity of a patient, the inflatable annular cuff shaped so as to define a cuff anterior side that is configured to surround a laryngeal inlet of the patient when the inflatable annular cuff is disposed at an insertion location within a throat of the patient, wherein the cuff anterior side, along a proximal side of the inflatable annular cuff, is shaped so as to define a posteriorly-recessed portion;
an airway tube, which extends proximally from the inflatable balloon, and which has (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable annular cuff is disposed at the insertion location, and (b) a distal end that is open through the inflatable annular cuff; and
an inflation tube having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable annular cuff is disposed at the insertion location, and (b) a distal end that is coupled in fluid communication with an inflatable chamber of the inflatable balloon, for supplying air to the inflatable chamber.
Inventive Concept 49. The laryngeal mask airway device according to Inventive Concept 48, wherein the posteriorly-recessed portion of the cuff anterior side is curved.
Inventive Concept 50. The laryngeal mask airway device according to Inventive Concept 48, wherein the anterior side of the laryngeal mask airway device is configured to form a seal around the laryngeal inlet of the patient when the inflatable annular cuff is disposed at the insertion location.
There is additionally provided, in accordance with an Inventive Concept 51 of the present invention, a laryngeal mask airway device including:
an inflatable balloon, which is insertable through an anterior opening of an oral cavity of a patient;
an airway tube, which (i) is coupled to the inflatable balloon, and (ii) has a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at an insertion location within a throat of the patient, wherein an anterior side of the laryngeal mask airway device is configured to stabilize the laryngeal mask airway device with respect to a laryngeal inlet of the patient when the inflatable balloon is disposed at the insertion location; and
an inflation tube (i) having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end that is coupled in fluid communication with an inflatable chamber defined by the inflatable balloon, for supplying air to the inflatable balloon, and (ii) including an inflation valve that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location,
wherein the laryngeal mask airway device is configured such that when the inflatable balloon, while the inflation valve is closed and a pressure within the inflatable balloon equals ambient pressure, is inserted from outside the oral cavity of the patient to the insertion location within the throat without opening the inflation valve, the pressure within the inflatable balloon increases from the ambient pressure to an inserted-location pressure, the inserted-location pressure less than 60 cm H2O.
Inventive Concept 52. The laryngeal mask airway device according to Inventive Concept 51, wherein the inserted-location pressure is less than 45 cm H2O.
Inventive Concept 53. The laryngeal mask airway device according to Inventive Concept 52, wherein the inserted-location pressure is less than 30 cm H2O.
Inventive Concept 54. The laryngeal mask airway device according to Inventive Concept 51, wherein the anterior side of the laryngeal mask airway device is configured to form a seal around the laryngeal inlet of the patient when the inflatable balloon is disposed at the insertion location.
Inventive Concept 55. The laryngeal mask airway device according to Inventive Concept 51,
wherein the inflatable balloon is shaped so as to define at least an inflatable annular cuff and a proximal inflatable pharyngeal portion, the inflatable annular cuff shaped so as to define a cuff anterior side that is configured to stabilize the inflatable annular cuff with respect to the laryngeal inlet of the patient when the inflatable balloon is disposed at the insertion location,
wherein the laryngeal mask airway device further includes a shaft having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end portion that is fixed to the inflatable balloon,
wherein the airway tube passes through at least a longitudinal portion of the shaft,
wherein the proximal inflatable pharyngeal portion of the inflatable balloon forms an air-tight seal with an external surface of the shaft, and
wherein the inflatable balloon is configured such that when the inflatable chamber is filled with air at a pressure of 10 cm H2O and unconstrained, a volume of the air in a proximal one-third of the inflatable chamber equals at least 200% of a volume of the air in a distal one-third of the inflatable chamber,
wherein the laryngeal mask airway device is configured such that when a volume of 5 cc of ambient air, the volume measured at standard atmospheric pressure, is introduced into the inflation tube while the inflatable balloon is unconstrained, disposed in ambient air that is at standard atmospheric pressure, and is at an inflation pressure of 30 cm H2O:
There is yet additionally provided, in accordance with an Inventive Concept 57 of the present invention, a laryngeal mask airway device including:
an inflatable balloon, which is (a) shaped so as to define at least an inflatable annular cuff, and (b) insertable through an anterior opening of an oral cavity of a patient, the inflatable annular cuff shaped so as to define:
an airway tube having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end that is open through the inflatable annular cuff; and
an inflation tube having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end that is coupled in fluid communication with an inflatable chamber of the inflatable balloon, for supplying air to the inflatable chamber.
Inventive Concept 58. The laryngeal mask airway device according to Inventive Concept 57, further including a drainage tube that (a) extends from a gastric channel having a distal gastric opening through the distal tip portion, and (b) has a proximal drainage port at location outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location.
There is also provided, in accordance with an Inventive Concept 59 of the present invention, a method including:
inserting an inflatable balloon of a laryngeal mask airway device through an anterior opening of an oral cavity of a patient, the inflatable balloon shaped so as to define at least an inflatable annular cuff and a proximal inflatable pharyngeal portion, and disposing the inflatable balloon at an insertion location within a throat of the patient, such that (a) a proximal end of an inflation tube is disposed outside the patient's oral cavity, wherein a distal end of the inflation tube is coupled in fluid communication with an inflatable chamber defined by the inflatable balloon, for supplying air to the inflatable balloon, (b) a proximal end of a shaft of the laryngeal mask airway device is disposed outside the patient's oral cavity, wherein a distal end portion of the shaft is fixed to the inflatable balloon, (c) a proximal end of an airway tube of the laryngeal mask airway device is disposed outside the patient's oral cavity, the airway tube passing through at least a longitudinal portion of the shaft, and having a distal end that is open through the inflatable annular cuff, wherein the proximal inflatable pharyngeal portion of the inflatable balloon forms an air-tight seal with an external surface of the shaft, and (d) a cuff anterior side of the inflatable annular cuff stabilizes the inflatable annular cuff with respect to a laryngeal inlet of the patient; and
ventilating lungs of the patient using the laryngeal mask airway device,
wherein the inflatable balloon is configured such that when the inflatable chamber is filled with air at a pressure of 10 cm H2O and unconstrained, a volume of the air in a proximal one-third of the inflatable chamber equals at least 200% of a volume of the air in a distal one-third of the inflatable chamber,
There is further provided, in accordance with an Inventive Concept 60 of the present invention, a method including:
inserting an inflatable balloon of a laryngeal mask airway device through an anterior opening of an oral cavity of a patient, the inflatable balloon shaped so as to define at least an inflatable annular cuff, and disposing the inflatable balloon at an insertion location within a throat of the patient, such that (a) a proximal end of an inflation tube is disposed outside the patient's oral cavity, wherein a distal end of the inflation tube is coupled in fluid communication with an inflatable chamber defined by the inflatable balloon, for supplying air to the inflatable balloon, (b) a proximal end of a shaft of the laryngeal mask airway device is disposed outside the patient's oral cavity, wherein a distal end portion of the shaft is fixed to the inflatable balloon, (c) a proximal end of an airway tube of the laryngeal mask airway device is disposed outside the patient's oral cavity, the airway tube passing through at least a longitudinal portion of the shaft, and having a distal end that is open through the inflatable annular cuff, and (d) a cuff anterior side of the inflatable annular cuff stabilizes the inflatable annular cuff with respect to a laryngeal inlet of the patient; and
ventilating lungs of the patient using the laryngeal mask airway device,
wherein inserting the inflatable balloon and disposing the inflatable balloon at the insertion location includes inserting the inflatable balloon and disposing the inflatable balloon at the insertion location while:
wherein the method further includes, after inserting the inflatable balloon and disposing the inflatable balloon at the insertion location, decoupling the insertion posterior protector from the shaft and removing the insertion posterior protector from the patient's oral cavity while the inflatable balloon remains disposed at the insertion location.
Inventive Concept 61. The method according to Inventive Concept 60, wherein the one or more couplers are shaped so as to form snap-on couplings to the shaft.
Inventive Concept 62. The method according to Inventive Concept 60, wherein inserting the inflatable balloon and disposing the inflatable balloon at the insertion location includes inserting the inflatable balloon and disposing the inflatable balloon at the insertion location using a proximal handle of the elongate sheet of material, while the proximal handle is disposed outside the patient's oral cavity.
There is still further provided, in accordance with an Inventive Concept 63 of the present invention, a method including:
inserting an inflatable balloon of a laryngeal mask airway device through an anterior opening of an oral cavity of a patient, the inflatable balloon shaped so as to define at least an inflatable annular cuff, and disposing the inflatable balloon at an insertion location within a throat of the patient, such that (a) a proximal end of an inflation tube is disposed outside the patient's oral cavity, wherein a distal end of the inflation tube is coupled in fluid communication with an inflatable chamber defined by the inflatable balloon, for supplying air to the inflatable balloon, (b) a proximal end of an airway tube of the laryngeal mask airway device is disposed outside the patient's oral cavity, wherein the airway tube has a distal end that is open through the inflatable annular cuff, and (c) a cuff anterior side of the inflatable annular cuff surrounds a laryngeal inlet of the patient; and
ventilating lungs of the patient using the laryngeal mask airway device,
wherein the cuff anterior side, along a proximal side of the inflatable annular cuff, is shaped so as to define a posteriorly-recessed portion.
There is additionally provided, in accordance with an Inventive Concept 64 of the present invention, a method including:
inserting an inflatable balloon of a laryngeal mask airway device through an anterior opening of an oral cavity of a patient and disposing the inflatable balloon at an insertion location within a throat of the patient, such that (a) a proximal end of an inflation tube is disposed outside the patient's oral cavity, wherein a distal end of the inflation tube is coupled in fluid communication with an inflatable chamber defined by the inflatable balloon, for supplying air to the inflatable balloon, (b) an inflation valve of the inflation tube and a proximal end of an airway tube of the laryngeal mask airway device are disposed outside the patient's oral cavity, the airway tube coupled to the inflatable balloon, and (c) an anterior side of the laryngeal mask airway device stabilizes the laryngeal mask airway device with respect to a laryngeal inlet of the patient; and
ventilating lungs of the patient using the laryngeal mask airway device,
wherein inserting the inflatable balloon includes inserting the inflatable balloon, while the inflation valve is closed, from outside the oral cavity of the patient to the insertion location within the throat without opening the inflation valve, and
wherein the laryngeal mask airway device is configured such that when the inflatable balloon, while the inflation valve is closed and a pressure within the inflatable balloon equals ambient pressure, is inserted from outside the oral cavity of the patient to the insertion location within the throat without opening the inflation valve, the pressure within the inflatable balloon increases from the ambient pressure to an inserted-location pressure, the inserted-location pressure less than 60 cm H2O.
Inventive Concept 65. The method according to Inventive Concept 64, wherein inserting the inflatable balloon includes inserting the inflatable balloon such that when the inflatable balloon is disposed at the insertion location, a proximal inflatable pharyngeal portion of the inflatable balloon spans both (a) a vertical space between a tongue and a pharyngeal back wall of the throat and (b) a lateral space between left and right tonsils, thereby forming a proximal seal between the oral cavity and a pharyngeal space distal to the proximal inflatable pharyngeal portion of the inflatable balloon.
Inventive Concept 66. The method according to Inventive Concept 64, wherein inserting the inflatable balloon while the inflation valve is closed includes inserting the inflatable balloon while the inflation valve is closed and the pressure within the inflatable balloon equals ambient pressure.
Inventive Concept 67. The method according to Inventive Concept 64, wherein inserting the inflatable balloon while the inflation valve is closed includes inserting the inflatable balloon while the inflation valve is closed without deflating the inflatable balloon before inserting the inflatable balloon.
Inventive Concept 68. The method according to Inventive Concept 64, wherein the method does not include measuring the pressure within the inflatable balloon.
Inventive Concept 69. The method according to Inventive Concept 64, wherein the method does not include adding air to or removing air from the inflatable balloon after inserting the inflatable balloon to the insertion location.
Inventive Concept 70. The method according to Inventive Concept 64, wherein the method does not include adjusting the pressure within the inflatable balloon after inserting the inflatable balloon to the insertion location.
Inventive Concept 71. The method according to Inventive Concept 64, wherein the inserted-location pressure is less than 45 cm H2O.
Inventive Concept 72. The method according to Inventive Concept 71, wherein the inserted-location pressure is less than 30 cm H2O.
Inventive Concept 73. The method according to Inventive Concept 64, wherein the anterior side of the laryngeal mask airway device is configured to form a seal around the laryngeal inlet of the patient when the inflatable balloon is disposed at the insertion location.
Inventive Concept 74. The method according to Inventive Concept 64,
wherein the inflatable balloon is shaped so as to define at least an inflatable annular cuff and a proximal inflatable pharyngeal portion, the inflatable annular cuff shaped so as to define a cuff anterior side that is configured to stabilize the inflatable annular cuff with respect to the laryngeal inlet of the patient when the inflatable balloon is disposed at the insertion location,
wherein the laryngeal mask airway device further includes a shaft having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end portion that is fixed to the inflatable balloon,
wherein the airway tube passes through at least a longitudinal portion of the shaft,
wherein the proximal inflatable pharyngeal portion of the inflatable balloon forms an air-tight seal with an external surface of the shaft, and
wherein the inflatable balloon is configured such that when the inflatable chamber is filled with air at a pressure of 10 cm H2O and unconstrained, a volume of the air in a proximal one-third of the inflatable chamber equals at least 200% of a volume of the air in a distal one-third of the inflatable chamber,
There is yet additionally provided, in accordance with an Inventive Concept 75 of the present invention, a method including:
inserting an inflatable balloon of a laryngeal mask airway device through an anterior opening of an oral cavity of a patient, the inflatable balloon shaped so as to define at least an inflatable annular cuff, and disposing the inflatable balloon at an insertion location within a throat of the patient, such that (a) a proximal end of an inflation tube is disposed outside the patient's oral cavity, wherein a distal end of the inflation tube is coupled in fluid communication with an inflatable chamber defined by the inflatable balloon, for supplying air to the inflatable balloon, (b) a proximal end of an airway tube of the laryngeal mask airway device is disposed outside the patient's oral cavity, the airway tube having a distal end that is open through the inflatable annular cuff, (c) a cuff anterior side of the inflatable annular cuff stabilizes the inflatable annular cuff with respect to a laryngeal inlet of the patient, and (d) a distal tip portion, which includes a distal end of the inflatable annular cuff, forms a seal against an upper esophageal sphincter, wherein a distal wall of the distal tip portion has a thickness of at least 2 mm; and
ventilating lungs of the patient using the laryngeal mask airway device.
Inventive Concept 76. The method according to Inventive Concept 75, wherein the laryngeal mask airway device further includes a drainage tube that (a) extends from a gastric channel having a distal gastric opening through the distal tip portion, and (b) has a proximal drainage port at location outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location.
There is also provided, in accordance with an Inventive Concept 77 of the present invention, a method of manufacturing a laryngeal mask airway device, the method including:
attaching an inflatable balloon to a shaft while the inflatable balloon is inverted, by sealing at least a portion of a perimeter of a lateral opening of the inverted inflatable balloon to the shaft, such that the inverted inflatable balloon extends anteriorly from the shaft; and
thereafter, inverting the inverted inflatable balloon such that a posterior portion of the inflatable balloon covers at least a portion of a posterior region of the shaft,
wherein the inflatable balloon is configured to be inserted through an anterior opening of an oral cavity of a patient and disposed at an insertion location within a throat of the patient, and wherein the shaft has a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location within the throat.
Inventive Concept 78. The method according to Inventive Concept 77, further including, after inverting the inverted inflatable balloon, sealing the inflatable balloon with an air-tight seal with an external surface of the shaft.
Inventive Concept 79. The method according to Inventive Concept 77,
wherein the inverted inflatable balloon is shaped so as to define a proximal end opening, which, after the inverted inflatable balloon is attached to the shaft and before the inflatable balloon is inverted, is not in direct contact with any portions of the laryngeal mask airway device other than the inverted inflatable balloon,
wherein inverting the inverted inflatable balloon includes passing, in a distal-to-proximal direction, the proximal end opening of the inflatable balloon over and around a distal end opening of the shaft, until the proximal end opening of the inflatable balloon surrounds the shaft, and
wherein the method further includes, after inverting the inverted inflatable balloon, sealing the proximal end opening of the inflatable balloon to an external surface of the shaft.
There is further provided, in accordance with an Inventive Concept 80 of the present invention, a laryngeal mask airway device prepared by a process including the steps of:
attaching an inflatable balloon to a shaft while the inflatable balloon is inverted, by sealing at least a portion of a perimeter of a lateral opening of the inverted inflatable balloon to the shaft, such that the inverted inflatable balloon extends anteriorly from the shaft; and
thereafter, inverting the inverted inflatable balloon such that a posterior portion of the inflatable balloon covers at least a portion of a posterior region of the shaft,
wherein the inflatable balloon is configured to be inserted through an anterior opening of an oral cavity of a patient and disposed at an insertion location within a throat of the patient, and wherein the shaft has a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location within the throat.
There is still further provided, in accordance with an Inventive Concept 81 of the present invention, a laryngeal mask airway device including:
an inflatable balloon, which is (a) shaped so as to define at least an inflatable annular cuff, and (b) insertable through an anterior opening of an oral cavity of a patient, the inflatable annular cuff shaped so as to define a cuff anterior side that is configured to stabilize the inflatable annular cuff with respect to a laryngeal inlet of the patient when the inflatable balloon is disposed at an insertion location within a throat of the patient;
a shaft having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end portion that is fixed to the inflatable balloon;
an airway tube, which passes through at least a longitudinal portion of the shaft, and has (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end that is open through the inflatable annular cuff;
an inflation tube having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location, and (b) a distal end that is coupled in fluid communication with an inflatable chamber defined by the inflatable balloon, for supplying air to the inflatable chamber;
a distal tip portion, which is located distal to the inflatable annular cuff, and which is configured to form a seal against an upper esophageal sphincter when the inflatable balloon is disposed at the insertion location; and
an inner support, which is mostly covered by the inflatable balloon,
wherein the inflatable balloon is shaped so as to define a distal inflatable tip portion, which is in fluid communication with the rest of the inflatable chamber of the inflatable balloon, and
wherein the distal inflatable tip portion entirely surrounds a longitudinal portion of the distal tip portion.
Inventive Concept 82. The laryngeal mask airway device according to Inventive Concept 81, wherein a distal end of the longitudinal portion is at a distance from a distal-most tip of the distal tip portion, the distance between 1 and 5 mm.
Inventive Concept 83. The laryngeal mask airway device according to Inventive Concept 81, wherein the longitudinal portion has a length of between 1 and 3 cm.
Inventive Concept 84. The laryngeal mask airway device according to Inventive Concept 83, wherein the length is between 2 and 4 cm.
Inventive Concept 85. The laryngeal mask airway device according to Inventive Concept 84, wherein the length is between 1 and 3 cm.
Inventive Concept 86. The laryngeal mask airway device according to Inventive Concept 81, wherein the longitudinal portion has a greatest width, measured from side to side of the inflatable balloon, of no more than 20 mm along a length of the longitudinal portion.
Inventive Concept 87. The laryngeal mask airway device according to Inventive Concept 81, wherein the distal tip portion includes a distal-most non-balloon-covered tip portion, defined by the inner support.
Inventive Concept 88. The laryngeal mask airway device according to Inventive Concept 81, wherein a proximal end of the distal inflatable tip portion is at least partially coupled to the inner support, so as to restrict air flow between the distal inflatable tip portion and the inflatable annular cuff, without entirely blocking the air flow.
Inventive Concept 89. The laryngeal mask airway device according to Inventive Concept 81, further including a drainage tube that:
extends from a gastric channel that is defined by the inner support,
has a distal gastric opening through the distal tip portion, and
has a proximal drainage port at location outside the patient's oral cavity when the inflatable balloon is disposed at the insertion location.
Inventive Concept 90. The laryngeal mask airway device according to any one of Inventive Concepts 81-89, wherein the inflatable balloon is shaped so as to further define a proximal inflatable pharyngeal portion, which forms an air-tight seal with an external surface of the shaft.
Inventive Concept 91. The laryngeal mask airway device according to any one of Inventive Concepts 81-89,
wherein the laryngeal mask airway device is configured such that when a volume of 5 cc of ambient air, the volume measured at standard atmospheric pressure, is introduced into the inflation tube while the inflatable balloon is unconstrained, disposed in ambient air that is at standard atmospheric pressure, and is at an inflation pressure of 30 cm H2O:
There is additionally provided, in accordance with an Inventive Concept 92 of the present invention, a laryngeal mask airway device including:
an inflatable annular cuff, which is insertable through an anterior opening of an oral cavity of a patient and is shaped so as to define:
a shaft having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable annular cuff is disposed at the insertion location, and (b) a distal end portion that is fixed to the inflatable annular cuff;
an airway tube, which passes through at least a longitudinal portion of the shaft, and has (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable annular cuff is disposed at the insertion location, and (b) a distal end that is in fluid communication with the ventilation port; and
an inflation tube having (a) a proximal end that is configured to be disposed outside the patient's oral cavity when the inflatable annular cuff is disposed at the insertion location, and (b) a distal end that is coupled in fluid communication with an interior of the inflatable annular cuff.
Inventive Concept 93. The laryngeal mask airway device according to Inventive Concept 92, wherein the length of the distal tip is at least 30 mm, when the inflatable annular cuff is filled with the air at the pressure of 5 cm H2O and unconstrained.
Inventive Concept 94. The laryngeal mask airway device according to Inventive Concept 92, wherein the length of the distal tip is less than 40 mm, when the inflatable annular cuff is filled with the air at the pressure of 5 cm H2O and unconstrained.
Inventive Concept 95. The laryngeal mask airway device according to Inventive Concept 92, wherein the cuff anterior side is configured to form a seal around the laryngeal inlet of the patient when the inflatable annular cuff is disposed at the insertion location.
Inventive Concept 96. The laryngeal mask airway device according to Inventive Concept 92, wherein the distal tip is configured to form a seal against an upper esophageal sphincter when the inflatable annular cuff is disposed at the insertion location.
Inventive Concept 97. The laryngeal mask airway device according to any one of Inventive Concepts 92-96, further including a drainage tube that (a) extends from a gastric channel having a distal gastric opening through the distal tip, and (b) has a proximal drainage port at location outside the patient's oral cavity when the inflatable annular cuff is disposed at the insertion location.
Inventive Concept 98. The laryngeal mask airway device according to any one of Inventive Concepts 92-96,
wherein the laryngeal mask airway device is configured such that when a volume of 5 cc of ambient air, the volume measured at standard atmospheric pressure, is introduced into the inflation tube while the inflatable annular cuff is unconstrained, disposed in ambient air that is at standard atmospheric pressure, and is at an inflation pressure of 30 cm H2O:
There is yet additionally provided, in accordance with an Inventive Concept 99 of the present invention, a method including:
inserting an inflatable annular cuff of a laryngeal mask airway device through an anterior opening of an oral cavity of a patient, the inflatable annular cuff shaped so as to define (a) a cuff anterior side that is shaped so at to define and surround a ventilation port, and (b) a distal tip that has a length, measured between a distal end of the distal tip and a proximal straight border of the distal tip, of at least 25 mm, when the inflatable annular cuff is filled with air at a pressure of 5 cm H2O and unconstrained, wherein the proximal straight border of the distal tip is located at a longitudinal location along the inflatable annular cuff at which the inflatable annular cuff has a width of 29 mm, measured from side to side of the inflatable annular cuff;
disposing the inflatable annular cuff at an insertion location within a throat of the patient, such that:
ventilating lungs of the patient using the laryngeal mask airway device.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
Reference is made to
Reference is also made to
Reference is also made to
As mentioned above, laryngeal mask airway device 20 comprises inflatable balloon 30. Inflatable balloon 30 is shaped so as to define at least an inflatable annular cuff 32 and a proximal inflatable pharyngeal portion 34. Inflatable balloon 30 is insertable through an anterior opening 140 of an oral cavity 142 of a patient, as described hereinbelow with reference to
For some applications, inflatable balloon 30 comprises a highly elastic material, such as silicone, latex, or TPE. For these applications, inflatable balloon 30 may optionally have a Shore hardness of between oo-20 and A-30, such as between oo-20 and A-20. For other applications, inflatable balloon 30 comprises a material having minimal elasticity as commonly used in medical device cuff technology, e.g., PVC or polyurethane. For these applications, inflatable balloon 30 may optionally have a Shore hardness of between OO-30 and A-15.
For some applications, cuff anterior side 36 of inflatable annular cuff 32 has an average wall thickness that equals at least 200% (e.g., at least 300%, such as at least 500%) of an average wall thickness of all portions of inflatable balloon 30 other than cuff anterior side 36 of inflatable annular cuff 32. Alternatively or additionally, for some applications:
Laryngeal mask airway device 20 further comprises a shaft 40, which is installed through anterior opening 140 of oral cavity 142. Shaft 40 has (a) a proximal end 41 that is configured to be disposed outside the patient's oral cavity 142 when inflatable balloon 30 is disposed at insertion location 154, and (b) a distal end portion that is fixed to inflatable balloon 30. For some applications in which laryngeal mask airway device 20 comprises drainage tube 84, such as described hereinbelow, a distal end 210 (labeled in
Laryngeal mask airway device 20 further comprises an airway tube 38, which passes through at least a longitudinal portion of shaft 40, such as through an entirety of a length of shaft 40, as shown in the drawings. For some applications, shaft 40 is shaped, e.g., molded, so as to define at least a portion of airway tube 38 within the shaft.
Airway tube 38 has (a) a proximal end 42 that is configured to be disposed outside the patient's oral cavity 142 when inflatable balloon 30 is disposed at insertion location 154, and (b) a distal end 44 that is open through inflatable annular cuff 32. Proximal end 42 is typically defined by an airway connector port 43, which is configured for connection to air or other ventilating apparatus for the patient's lungs.
For some applications, elongate shaft 40 comprises a PVC, silicone, or TPE. For these applications, elongate shaft 40 may optionally have a Shore A hardness of at least 30, typically between A40 and A80.
Proximal inflatable pharyngeal portion 34 of inflatable balloon 30 forms an air-tight seal 46 with an external surface 48 of shaft 40 (such as by gluing or welding). For some applications, inflatable balloon 30 and shaft 40 are configured such that proximal inflatable pharyngeal portion 34 of inflatable balloon 30 forms air-tight seal 46 entirely around a longitudinal portion 69 of shaft 40. For example, longitudinal portion 69 may have a length, measured along airway tube 38, of between 0.1 and 10 mm.
For some applications, proximal inflatable pharyngeal portion 34 extends in both lateral directions away from a straight line segment 68 (labeled in
For some applications, proximal inflatable pharyngeal portion 34 is reflectionally symmetric about a plane of symmetry that extends in an anterior/posterior direction, straight line segment 68 (labeled in
Laryngeal mask airway device 20 further comprises an externally-accessible inflation tube 50, for supplying air to and extracting air from the inflatable balloon 30. Inflation tube 50 has (a) a proximal end 52 that is configured to be disposed outside the patient's oral cavity 142 when inflatable balloon 30 is disposed at insertion location 154, and (b) a distal end that is coupled in fluid communication with inflatable chamber 56, for supplying air to the inflatable chamber. (For clarity of illustration, inflation tube 50 is shown only in
For some applications, inflation tube 50 comprises an inflation tube proximal port connector that comprises a male conical fitting with a taper. For some applications, the taper is at least a 5% taper. For some applications, the taper is a 6% taper, and the male conical fitting with the 6% taper complies with International Standard ISO 594-1:1986, which is the standard for connections to conventional inflation lumen proximal ports of laryngeal mask airway masks.
For some applications, inflation tube 50 comprises an inflation valve 80 that is configured to be disposed outside the patient's oral cavity 142 when inflatable balloon 30 is disposed at insertion location 154, for holding a given inflation of inflatable balloon 30. Optionally, inflation valve 80 comprises a check-valve.
Typically, a distal portion of shaft 40 extends into inflatable chamber 56, such that a portion of external surface 48 of shaft 40 is in fluid communication with inflatable chamber 56 (external surface 48 is external with respect to shaft 40, but not necessarily with respect to other elements of laryngeal mask airway device 20, such as inflatable balloon 30). The distal portion of shaft 40 typically passes through at least a portion, such as all, of proximal inflatable pharyngeal portion 34 of inflatable balloon 30, such that, when inflatable chamber 56 is filled with the air at the pressure of 10 cm H2O and unconstrained, a portion of inflatable chamber 56 defined by proximal inflatable pharyngeal portion 34 surrounds 360 degrees of the distal portion of shaft 40. Optionally, a distal portion of shaft 40 may be considered to define a backplate.
For some applications, as labeled in
Alternatively or additionally, for some applications, inflatable balloon 30 is configured such that when inflatable chamber 56 is filled with air at a pressure of 20 cm H2O and unconstrained, the volume of the air in proximal one-third 60 of inflatable chamber 56 equals at least 200% of a volume of the air in a distal one-third 62 of inflatable chamber 56, such as at least 300%, e.g., at least 350%, such as at least 400% of the volume of the air in distal one-third 62 of inflatable chamber 56.
Further alternatively or additionally, for some applications, inflatable balloon 30 is configured such that when inflatable chamber 56 is filled with air at a pressure of 25 cm H2O and unconstrained, the volume of the air in proximal one-third 60 of inflatable chamber 56 equals at least 200% of a volume of the air in a distal one-third 62 of inflatable chamber 56, such as at least 300%, e.g., at least 350%, such as at least 400% of the volume of the air in distal one-third 62 of inflatable chamber 56.
For some applications, inflatable balloon 30 is configured such that when inflatable chamber 56 is filled with the air at the pressure of 10 cm H2O and unconstrained:
Alternatively or additionally, for some applications, inflatable balloon 30 is configured to have the volumes mentioned immediately above when inflatable chamber 56 is filled with the air at a pressure of 20 cm H2O and unconstrained.
Further alternatively or additionally, for some applications, inflatable balloon 30 is configured to have the volumes mentioned immediately above when inflatable chamber 56 is filled with the air at a pressure of 25 cm H2O and unconstrained.
As used in the present application, including in the claims and the Inventive Concepts, “unconstrained” means not constrained by the patient's anatomy, a delivery tool, or anything else.
For some applications, inflatable annular cuff 32 is shaped so as to define a distal tip portion 90 that includes a distal end 82 of inflatable annular cuff 32. Distal tip portion 90 is configured to form a seal against an upper esophageal sphincter, typically at the level of the cricoid cartilage ring, or the first tracheal cartilage ring immediately below the cricoid cartilage ring when inflatable balloon 30 is disposed at insertion location 154. Typically, a distal wall 92 (labeled in
In some applications of the present invention, such as shown in the figures, laryngeal mask airway device 20 is of the gastro-laryngeal mask (GLM) type, in which a drainage tube 84 (a) extends from a gastric channel 85 (labeled in
Reference is again made to
For some applications in which laryngeal mask airway device 20 is of the GLM type, as described above, inner support 26 is shaped so as to define gastric channel 85 therethrough.
For some applications, laryngeal mask airway device 20 is configured such that when inflatable chamber 56 is filled with the air at the pressure of 10 cm H2O and unconstrained, a portion 94 of proximal inflatable pharyngeal portion 34 of inflatable balloon 30 bulges posteriorly with respect to external surface 48 of shaft 40.
Reference is now made to
For some applications, the one or more couplers 106 are shaped so as to form snap-on couplings to shaft 40, such as illustrated. For other applications, the one or more couplers 106 are shaped as to otherwise mechanically or chemically removably couple the proximal coupling portion to shaft 40 proximally to inflatable balloon 30.
For some applications, elongate sheet of material 102 of insertion posterior protector 100 is further shaped so as to define a proximal handle 112, which is shaped so as to be disposed outside the patient's oral cavity 142 when inflatable balloon 30 is disposed at insertion location 154. Proximal handle 112 may be used to decouple insertion posterior protector 100 from shaft 40 and remove insertion posterior protector 100 from the patient's oral cavity 142 after inflatable balloon 30 has been disposed at insertion location 154.
For some applications, elongate sheet of material 102 has an average thickness of between 0.5 and 2 mm. For some applications, elongate sheet of material 102 comprises a polymer (e.g., PVC, ABS, or polyurethane) or a metal.
Reference is now made to
Reference is now made to International Application PCT/IL2019/050405, filed Apr. 11, 2019, which published as PCT Publication WO 2019/198081, and to FIG. 12C of U.S. application Ser. No. 16/423,974, filed May 28, 2019, which published as US Patent Application Publication 2019/0282774, and which is a continuation of the '405 PCT application. Both of these applications are assigned to the assignee of the present application and are incorporated herein by reference.
As shown in the figures of these two patent applications, in particular in
For some applications, the posteriorly-recessed portion is curved, such as shown in
Laryngeal mask airway device 900 of these two patent applications further comprises:
For some applications, the anterior side of laryngeal mask airway device 900 of these two patent applications is configured to form a seal around laryngeal inlet 158 of the patient when inflatable annular cuff 910 is disposed at the insertion location.
Reference is now made to
For some applications, cuff anterior side 36 is configured to form a seal around laryngeal inlet 158 of the patient when inflatable balloon 30 is disposed at insertion location 154. Alternatively, the anterior side of laryngeal mask airway device 20 is not configured to form a seal around laryngeal inlet 158 of the patient when inflatable annular cuff 32 is disposed at insertion location 154 thereby causing less irritation of soft tissue and causing inflatable annular cuff 32 to be less sensitive to inter-personal variations of anatomy.
For some applications, laryngeal mask airway device 20 is configured such that when inflatable balloon 30 is disposed at insertion location 154 and proximal inflatable pharyngeal portion 34 of inflatable balloon 30 is inflated at the pressure of 10 cm H2O, inflatable annular cuff 32 spans both (a) a vertical space 160 between a tongue 162 and a pharyngeal back wall 164 of throat 144 and (b) a lateral space between left and right tonsils, thereby forming a proximal seal between oral cavity 142 and a pharyngeal space 166 above the glottis, distal to proximal inflatable pharyngeal portion 34 of inflatable balloon 30.
Reference is still made to
The experiment measured pressures within the cuff/balloon of the following laryngeal mask airway devices after insertion of the cuff/balloon into an adult doll ventilation-simulation model:
All the cuffs/balloons were inflated to ambient room pressure prior to insertion. They were then inserted into the doll model, while their respective inflation valves were closed. Pressure was measured after insertion. The graph shows the full range of outcomes for each device. As can be seen, the pressures measured in the Teleflex and AMBU cuffs were significantly above 60 cm H2O. By contrast, the pressure measured in the laryngeal mask airway device similar to laryngeal mask airway device 20 described herein was significantly below 30 cm H2O.
These experimental results show that the design of laryngeal mask airway device 20, unlike those of the prior art cuffs tested, prevents excess pressure from developing in the cuff/balloon, even when the cuff/balloon is inserted with the inflation valve closed, and the cuff/balloon has not been deflated. The inventor believes that in practice many users insert laryngeal mask airway devices without deflating and without opening the inflation valve, despite explicit user instructions to deflate before insertion, and then reinflate after insertion to a proper pressure below 60 cm H2O. Many users also do not measure the pressure after insertion, also despite user instructions requiring this safety procedure. As is known in the art, pressures over 40 cm H2O may cause tissue damage if the cuff/balloon remains inserted for more than 60 minutes.
Particular aspects of the design of laryngeal mask airway device 20 that may contribute to prevention of this excess pressure include (a) the relatively high ratio of the volume of the air in proximal one-third 60 of inflatable chamber 56 to the volume of the air in distal one-third 62 of inflatable chamber 56, described hereinabove with reference to
For some applications, laryngeal mask airway device 20 is configured such that when inflatable balloon 30, while inflation valve 80 is closed and the pressure within inflatable balloon 30 equals ambient pressure of ambient air 99 (labeled in
In an application of the present invention, a method is provided that comprises:
For some applications, inserting inflatable balloon 30 comprises inserting inflatable balloon 30, while inflation valve 80 is closed, from outside oral cavity 142 to insertion location 154 within throat 144 without opening inflation valve 80. For some applications, laryngeal mask airway device 20 is configured such that when inflatable balloon 30, while inflation valve 80 is closed and a pressure within inflatable balloon 30 equals ambient pressure, is inserted from outside oral cavity 142 to insertion location 154 within throat 144 without opening inflation valve 80, the pressure within inflatable balloon 30 increases from the ambient pressure to an inserted-location pressure, the inserted-location pressure less than 60 cm H2O, such as less than 45 cm H2O, e.g., less than 30 cm H2O.
For some applications, inserting inflatable balloon 30 while inflation valve 80 is closed comprises inserting inflatable balloon 30 while inflation valve 80 is closed and the pressure within inflatable balloon 30 equals ambient pressure.
For some applications, inserting inflatable balloon 30 while inflation valve 80 is closed comprises inserting inflatable balloon 30 while inflation valve 80 is closed without deflating inflatable balloon 30 before inserting inflatable balloon 30.
For some applications, the method does not comprise measuring the pressure within inflatable balloon 30. For other applications, the pressure is measured.
For some applications, the method does not comprise adding air to or removing air from inflatable balloon 30 after inserting inflatable balloon 30 to insertion location 154. For other applications, air is added to or removed from inflatable balloon 30 after inserting inflatable balloon 30 to insertion location 154, such as for applications in which the pressure is measured, as described above, and found to be too low or too high, respectively.
For some applications, the method does not comprise adjusting the pressure within inflatable balloon 30 after inserting inflatable balloon 30 to insertion location 154. For other applications, the pressure is adjusted within inflatable balloon 30 after inserting inflatable balloon 30 to insertion location 154, such as for applications in which the pressure is measured, as described above, and found to be too low or too high.
Reference is now made to
As shown in
As shown in
Typically, thereafter, inflatable balloon 30 (such as proximal inflatable pharyngeal portion 34 thereof, if provided) is sealed with air-tight seal 46 with external surface 48 of shaft 40 (such as by gluing or welding). For some applications, inflatable balloon 30 forms air-tight seal 46 entirely around longitudinal portion 69 of shaft 40.
For some applications in which inflatable annular cuff 32 is shaped so as to define distal tip portion 90, a distal end opening 212 of inflatable balloon 30 is sealed to distal tip portion 90 after inflatable balloon 30 has been inverted.
For some applications, inverted inflatable balloon 30 is shaped so as to define a proximal end opening 208, which, after the inverted inflatable balloon is attached to shaft 40 and before inflatable balloon 30 is inverted, such as shown in
Reference is made to
Reference is also made to
Reference is also made to
Other than as described hereinbelow, laryngeal mask airway device 320 is generally similar to laryngeal mask airway device 20, described hereinabove with reference to
Inflatable balloon 330 is shaped so as to define at least an inflatable annular cuff 332 (labeled in
For some applications, laryngeal mask airway device 320 comprises a distal tip portion 391 located distal to inflatable annular cuff 332. Distal tip portion 391 is configured to form a seal against an upper esophageal sphincter when inflatable balloon 330 is disposed at insertion location 154. For some applications, distal tip portion 391 and proximal inflatable pharyngeal portion 334 of inflatable balloon 330 together seal esophagus 152, such as for applications in which the anterior side of laryngeal mask airway device 320 is not configured to form a seal around laryngeal inlet 158 of the patient when inflatable annular cuff 32 is disposed at insertion location 154.
For some applications, laryngeal mask airway device 320 comprises an inner support 326 (labeled in
For some applications in which laryngeal mask airway device 320 is of the GLM type, as described above, inner support 26 is shaped so as to define gastric channel 85 therethrough.
For some applications, inflatable balloon 330 is shaped so as to define a distal inflatable tip portion 328, which is typically in fluid communication with the rest of inflatable chamber 56 defined by inflatable balloon 330 (labeled for inflatable balloon 30 in
For some applications, a proximal end 388 of distal inflatable tip portion 328 is at least partially coupled (e.g., by gluing or welding) to inner support 326, so as to restrict air flow between distal inflatable tip portion 328 and inflatable annular cuff 332, without entirely blocking the air flow. This coupling may prevent distal inflatable tip portion 328 from being drawn too far proximally during insertion of distal tip portion 391 into esophagus 152. If not for this coupling, distal inflatable tip portion 328 might become so tightened that it does not inflate when inflatable balloon 330 is inflated after insertion of inflatable annular cuff 332 to insertion location 154. Thus this coupling results in distal inflatable tip portion 328 becoming inflated when inflatable annular cuff 332 is inflated after insertion.
Optionally, proximal end 388 of distal inflatable tip portion 328 is at least partially coupled to inner support 326 at a proximal end 389 of distal tip portion 391.
Optionally, an external surface of inner support 326 is shaped so as to define one or more indentations, such as elongate grooves, for providing fluid communication between inflatable annular cuff 332 and distal inflatable tip portion 328 at the location of coupling described above.
Reference is now made to
Reference is now made to
The experiment measured pressures within the cuff/balloon of the following laryngeal mask airway devices:
All the cuffs/balloons were inflated to an inflation pressure of 30 cm H2O. Thereafter, 5 cc of ambient air was drawn into a syringe and introduced into each of the respective cuffs/balloons. The inflation pressure in the balloon of the laryngeal mask airway device similar to laryngeal mask airway device 320 increased from the initial 30 cm H2O to 33.1 cm H2O (an increase of about 3 cm H2O), while the inflation pressures in the cuffs/balloons of the Teleflex and Ambu® devices increased from the initial 30 cm H2O to 80.6 cm H2O and 111.2 cm H2O, respectively (increases of about 51 and 81 cm H2O, respectively).
These experimental results show that the design of laryngeal mask airway device 320, unlike those of the prior art cuffs tested, prevents excess pressure from developing in the cuff/balloon. This relatively low pressure increase upon moderate additional inflation reduces the risk of damage to soft tissue that might be caused by higher pressures within inflatable balloon 330. As is known in the art, pressures over 40 cm H2O may cause tissue damage if the cuff/balloon remains inserted for more than 60 minutes.
Particular aspects of the design of laryngeal mask airway device 320 that may contribute to prevention of this excess pressure include.
For some applications, laryngeal mask airway device 320 is configured such that when a volume of 5 cc of ambient air, the volume measured at standard atmospheric pressure, is introduced into externally-accessible inflation tube 50 while inflatable balloon 330 is unconstrained, disposed in ambient air that is at standard atmospheric pressure (i.e., air pressure at sea level), and at is an inflation pressure of 30 cm H2O:
(Waiting the one minute allows the pressure in inflatable balloon 330 to stabilize.)
The ability of laryngeal mask airway device 320 to be thus configured is supported by the experimental results described hereinabove with reference to
For some applications, laryngeal mask airway device 20, described hereinabove with reference to
For some applications, laryngeal mask airway device 420, described hereinbelow with reference to
Reference is now made to
In the present application, including in the claims and the Inventive Concepts, all pressures are gauge pressures that are zero-referenced against ambient air 99 pressure.
Typically, but not necessarily, as is conventional in the laryngeal mask airway cuff art, inflatable balloons 30 and 330 (including inflatable annular cuffs 32 and 332) are single-layer balloons, i.e., have only a single wall, as can be seen in the cross-sectional figures. The wall thicknesses of inflatable balloons 30 and 330 and inflatable annular cuffs 32 and 332 described relate to the thickness of this single layer, i.e., single wall.
Reference is made to
Reference is also made to
Reference is further made to
Inflatable annular cuff 432 is insertable through an anterior opening of an oral cavity of the patient. Cuff anterior side 422 of inflatable annular cuff 432 is configured to stabilize inflatable annular cuff 432 with respect to laryngeal inlet 158 of the patient when inflatable annular cuff 432 is disposed at insertion location 440 within throat 144 of the patient, as shown in
Inflatable annular cuff 432 is also shaped so as to define a distal tip 450 that has a tip length T, measured between a distal end 452 of distal tip 450 and a proximal straight border 453 of distal tip 450, of at least 25 mm (e.g., at least 30 mm) and optionally less than 40 mm, when inflatable annular cuff 432 is filled with air at a pressure of 5 cm H2O and unconstrained, such that distal tip 450 forms a seal within an upper part 454 of esophagus 152 (optionally an upper esophageal sphincter) when inflatable annular cuff 432 is disposed at insertion location 440. Proximal straight border 453 of distal tip 450 is located at a longitudinal location 458 along inflatable annular cuff 432 at which inflatable annular cuff 432 has a width of 29 mm, measured from side to side of inflatable annular cuff 432.
Inflatable annular cuffs of conventional laryngeal mask airway devices known in the art, such as shown in
Reference is again made to
Typically, cuff anterior side 422 is configured to form a seal around laryngeal inlet 158 when inflatable annular cuff 432 is disposed at insertion location 440.
For some applications, laryngeal mask airway device 420 further comprises a drainage tube 480 that (a) extends from a gastric channel 482 having a distal gastric opening 484 through distal tip 450, and (b) has a proximal drainage port at location outside the patient's oral cavity when inflatable annular cuff 432 is disposed at insertion location 440.
For some applications, inflatable annular cuff 432 comprises a highly elastic material, such as silicone, latex, or TPE. For other applications, inflatable annular cuff 432 comprises a material having minimal elasticity as commonly used in medical device cuff technology, e.g., PVC or polyurethane.
All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the patent specification, including definitions, will prevail. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
In an embodiment, techniques and apparatus described in one or more of the following applications, which are assigned to the assignee of the present application and incorporated herein by reference, are combined with techniques and apparatus described herein:
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present application claims priority from U.S. Provisional Application 63/035,057, filed Jun. 5, 2020, U.S. Provisional Application 63/079,639, filed Sep. 17, 2020, and U.S. Provisional Application 63/171,516, filed Apr. 6, 2021, all of which are assigned to the assignee of the present application and incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2021/050653 | 6/2/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63171516 | Apr 2021 | US | |
| 63079639 | Sep 2020 | US | |
| 63035057 | Jun 2020 | US |
