Laryngeal mask airway with concentric drainage of oesophagus discharge

• US 5,241,956 A
• Filed: 09/28/1992
• Issued: 09/07/1993
• Est. Priority Date: 05/21/1992
• Status: Expired due to Term

• Current Assignee: Teleflex Life Sciences Pte., Ltd. (Teleflex Incorporated)
• Original Assignee: Archibald I. Brain
• Inventors: Brain, Archibald I. J.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): RACITI, ERIC
• Application Number:
  US07/952,586
• Time in Patent Office: 344 Days
• Field of Search: 128/207.14, 128/207.15, 128/206.26, 128/207.16, 128/200.26, 604/96-103, 604/174
• US Class Current: 128/207.15
• CPC Class Codes: A61M 16/0409 with mean for closing the oesophagus
• CPC Class Codes: A61M 16/0415 with access means to the stomach
• CPC Class Codes: A61M 16/0456 one cuff within another
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes

Abstract

A laryngeal mask airway is described which is fitted with an evacuation or drainage tube which passes through the back of the mask and terminates concentrically within an inflatable-cuff formation at the distal end of the mask. In the case of a laryngeal mask which relies on an inflatable ring to establish a seal around the laryngeal inlet, the inflatable-cuff formation results from sealed passage of the evacuation tube through the distal region of the inflatable ring, the distal end of which is centrally apertured and reentrantly folded into sealed junction with the distal end of the tube. When the mask is inflated, its distal end establishes a cuff, sealing the tube against the upper oesophageal sphincter. In the presently preferred embodiment, an auxiliary inflatable cuff is carried at the back side of the mask and, when inflated, establishes a cushioned reference between the evacuation tube and the posterior wall of the pharynx, enabling more effective sealing of the mask to the laryngeal inlet and of the drainage cuff to the oesophageal sphincter, in the circumstance of negative pressure applied to the evacuation tube.

Claims

1. An artificial airway device to facilitate a patient'"'"'s lung ventilation, comprising an airway tube, an evacuation tube, and a laryngeal mask at one end of said tubes, said mask including a first inflatable-cuff formation of flexible material in a generally elliptical configuration having from a proximal end to a distal end and in generally a single plane which is inclined to the axis of the airway tube at the distal end of the airway tube, a second inflatable-cuff formation carried by said mask on the posterior side of said plane, said mask being configured upon inflation of said cuff formations (1) to form a seal of said airway tube solely around the circumference of the laryngeal inlet and (2) to establish a cushioning action via said second cuff formation between the posterior side of said mask and the posterior wall of the pharynx, the distal end of said cuff formation being configured for entry into and insertional location of said device by engagement with the oesophagus at the upper sphinctral region of the oesophagus when the mask is positioned for sealing the airway tube to the laryngeal inlet, said evacuation tube having an open distal end centrally within and axially short of the distal end of said first cuff formation, inflation-passage means communicating with both said inflatable cuff formations for selective inflation/deflation operation of said cuff formations, whereby (1) to seal said airway tube for communication solely with the laryngeal inlet, (2) to cushion the reference of said mask to the posterior wall of the pharynx, and (3) to seal said evacuation tube solely to the sphinctral region, so that upon evacuation of said evacuation tube after inflation into sealed relation with the sphinctral region of the oesophagus adjacent oesophagus tissue will be induced to locally displace into enhanced sealing engagement with the inflated distal cuff formation, whereby gastric-discharge products can pass only by way of said evacuation tube, thus reducing any chance of gastric leakage into the laryngeal inlet.

5. The artificial airway device of claim 1 or claim 2 or claim 3, in which said airway tube is relatively rigid and curved to follow the airway of a patient.

6. The artificial airway device of claim 1 or claim 2 claim 3, in which said airway tube is relatively rigid and curved to follow the airway of a patient, and an externally projecting substantially rigid handle portion mounted to the end of the airway tube remote from the mask.

7. The artificial airway device of claim 1 or claim 2 or claim 3, in which said airway tube is relatively rigid and curved to follow the airway of a patient, and an externally projecting substantially rigid handle portion detachably connected to the end of the airway tube remote from the mask.

8. The artificial airway device of claim 1 or claim 2 or claim 3, in which said airway tube is relatively rigid and curved to follow the airway of a patient, the bore of said airway tube being of a diameter to selectively accommodate and guide the insertion of an inflatably cuffed endotrachial tube, with the inflatable cuff of the endotrachial tube being insertable through and beyond said mask, for cuffed selective intubation-sealing engagement to the larynegeal inlet at a location which is distal beyond said mask.

9. The artificial airway device of claim 1 or claim 2 or claim 3, in which said evacuation tube is circumferentially reinforced at least in the region of cuff inflation, whereby to avoid evacuation-tube collapse by reason of cuff inflation.

15. The artificial airway device of claim 1 or claim 2 or claim 3 or claim 14, in which said inflation-passage means comprises a single flexible-tube connection to said mask.

16. The artificial airway device of claim 1 or claim 2 or claim 3 or claim 14, in which said inflation-passage means comprises first and second flexible tube connections independently and respectively in communication with said first and second cuff formations.

2. An artificial airway device to facilitate a patient'"'"'s lung ventilation, comprising an airway tube, an evacuation tube, and a laryngeal mask at one end of said tubes, said mask being of generally elliptical configuration having from a proximal end to a distal end and in generally a single plane, said configuration being adapted for support by and around the laryngeal inlet and orienting the distal end of the airway tube at an angle to said plane and in substantial alignment with the axis of the laryngeal inlet when supported by and around the laryngeal inlet, the distal end of said mask having a first cuff formation configured for entry into and insertional location of said device by engagement with the upper sphinctral region of the oesophagus when the mask is positioned for airway-tube alignment with the axis of the oesophagus inlet, said evacuation tube having an open distal end centrally within and axially short of the distal end of said first cuff formation, a second inflatable-cuff formation carried by said mask on the posterior side of said plane, and inflation-passage means communicating with both said cuff formations.

3. An artificial airway device to facilitate a patient'"'"'s lung ventilation, comprising an airway tube, a suction tube, and a laryngeal mask at one end of said tubes, said mask having a proximal end and a distal end and being configured to form a seal of said airway tube solely around the circumference of the patient'"'"'s laryngeal inlet, said distal end being configured for entry into and insertional location of said device at the entrance of the upper sphinctral region of the oesophagus when said mask is positioned for sealing the airway tube to the laryngeal inlet, said evacuation tube having an open distal end centrally within but axially short of the distal end of said mask, and the distal end of said mask including a first inflatable flexible cuff formation for peripherally sealed engagement of the upper sphinctral region to the distal end of said evacuation tube, thus exposing a passage via said mask for airway-tube communication solely with the laryngeal inlet on the anterior side of said mask, while exposing the posterior side of said mask to the posterior wall of the pharynx, a second inflatable-cuff formation carried by the posterior side of said mask for inflated engagement to the posterior wall of the pharynx, and inflation-passage means communicating with both said cuff formations.

4. The artificial airway device of claim 3, in which the laryngeal mask includes an inflatable ring for establishing a seal around the laryngeal inlet and in which said first inflatable cuff formation is the distal portion of the inflatable ring of the laryngeal mask.

10. The method of installing an artificial airway device to facilitate a patient'"'"'s lung ventilation, wherein the method comprises the steps of:

(a) providing an inflatably sealed laryngeal mask at the end of an airway tube, wherein a first inflatable cuff formation is carried on the posterior side of the mask, and wherein the distal end of said mask includes an inflatable-cuff cuff formation for sealed engagement to the upper sphinctral region of the oesophagus, and wherein an evacuation tube has an open distal end terminating within said cuff formation;

(b) inserting said device, in deflated condition to position the distal end of the mask in the sphinctral region of the oesophagus, with the mask positioned for support around the laryngeal inlet, and with posterior side of the mask in confronting relation with the posterior wall of the pharynx;

(c) inflating both said cuff formations to establish a mask seal around the laryngeal inlet with cushioned reference to the posterior wall of the pharynx, as well as a cuff seal of the evacuation tube within the upper sphinctral region of the oesophagus; and

(d) establishing a reduced-pressure suction connection to the evacuation tube, whereby to enhance cuff-formation seal action to tissues of the upper-sphinctral region.

12. The method of claim 10 or claim 11, comprising the additional step of observing suction pressure for retention at a predetermined reduced-pressure level, thus confirming that seal action to the oesophagus is complete.

13. The method of claim 10 or claim 11, comprising the additional step of maintaining a predetermined reduced-pressure level in said evacuation tube for the duration of lung ventilation via the airway tube.

24. The artificial airway device of claim 20 or claim 12 or claim 22, in which said airway tube is relatively rigid and curved to follow the airway of a patient.

11. The method of installing an artificial airway device to facilitate a patient'"'"'s lung ventilation, wherein the method comprises the steps of:

(a) providing a laryngeal mask at the distal end of an airway tube, wherein the mask is adapted for support around the laryngeal inlet such as to align the distal end of the airway tube with the laryngeal inlet when the distal end of the mask engages the upper sphinctral region of the oesophagus, wherein a first inflatable-cuff formation at the distal end of the mask engages within the upper sphinctral region upon achievement of said alignment of the airway tube with the laryngeal inlet, wherein a second inflatable-cuff formation carried on the posterior side of said mask is poised for inflated interposition between said mask and the posterior wall of the pharynx, and wherein an evacuation tube has an open distal end terminating within said cuff formation;

said method comprising the steps of;

(b) inserting said device, in deflated condition to position the distal end of the mask in the sphinctral region of the oesophagus, and with the mask positioned for support around the laryngeal inlet;

(c) inflating said cuff formations to establish a cuff seal of the evacuation tube within the upper sphinctral region of the oesophagus and to establish a cushioning reference on the posterior side of the mask with respect to the posterior wall of the pharynx, and with pressurized loading of the mask toward the laryngeal inlet; and

(d) establishing a reduced-pressure suction connection to the evacuation tube, whereby to enhance cuff-formation seal action to tissues of the upper-sphinctral region.

14. An artificial airway device to facilitate a patient'"'"'s lung ventilation, comprising an airway tube and a laryngeal mask at one end of said tube, said mask including a first inflatable-cuff formation of flexible material in a generally elliptical configuration extending from a proximal end to a distal end and in generally a single plane which is inclined to the axis of the airway tube at the distal end of the airway tube and on the posterior side of said plane, a second inflatable-cuff formation carried by the distal side of said mask in a region intermediate said ends, and inflation-passage means communicating with both said inflatable-cuff formations.

17. The artificial airway device of claim 14, in which the wall thickness of said first inflatable-cuff formation exceeds the wall thickness of said second inflatable-cuff formation.

18. The artificial airway device of claim 17, in which the extent to which wall thickness of said first inflatable-cuff formation exceeds the wall thickness of said second inflatable-cuff formation is in the range 2:

1 to 3;

1.

19. The artificial airway device of claim 14, in which the wall of said second inflatable-cuff formation is more compliant than the wall of said first inflatable-cuff formation.

20. An artificial airway device to facilitate a patient'"'"'s lung ventilation, comprising an airway tube, an evacuation tube and a laryngeal mask at one end of said tubes, said mask including an inflatable annular cuffof flexible material in a generally elliptical configuration which is in generally a single plane, said generally elliptical configuration having a major axis extending from a proximal airway-tube connection end of said cuff to a distal end of said cuff, said single plane being included to the axis of the airway tube at airway-tube connection to said mask, said mask being configured upon inflation to form a seal of said airway tube solely around the circumference of the laryngeal inlet, the distal end of said cuff in deflated condition being configured for entry into and insertional positioning of said device by engagement with the upper sphinctral region of the oesophagus when the mask is positioned for sealing the airway tube to the laryngeal inlet, said evacuation tube having sealed passage within a portion of said cuff and having an open distal end (a) which is peripherally sealed to and (b) which is surrounded by inflatable material of the distal end of said cuff, and means including a third tube communicating with said inflatable cuff for selective inflation/deflation operation of said cuff (1) for sealing said airway tube to communicate solely with the laryngeal inlet and (2) for peripherally sealing said evacuation tube solely to the upper sphinctral region;

whereby, upon evacuation of said evacuation tube after cuff inflation into peripherally sealed relation with the upper sphinctral region of the oesophagus, adjacent oesophagus tissue will be induced to locally displace into enhanced sealing engagement with the inflated cuff, whereby gastric-discharge products can pass only by way of said evacuation tube, thus reducing any chance of gastric leakage into the laryngeal inlet.

25. The artificial airway device of claim 20 or claim 21 or claim 22, in which said airway tube is relatively rigid and curved to follow the airway of a patient, and an externally projecting substantially rigid handle portion mounted to the end of the airway tube remote from the mask.

26. The artificial airway device of claim 20 or claim 21 or claim 22, in which said airway tube is relatively rigid and curved to follow the airway of a patient, and externally projection substantially rigid handle portion detachably connected to the end of the airway tube remote from the mask.

27. The artificial airway device of claim 20 or claim 21 or claim 22, in which said airway tube is relatively rigid and curved to follow the airway of a patient, the bore of said airway tube being of a diameter to selectively accommodate and guide the insertion of an inflatably cuffed endotrachial tube, with the inflatable cuff through and beyond said mask, for cuffed selective intubation-sealing engagement to the laryngeal inlet at a location which is distal beyond said mask.

28. The artificial airway device of claim 20 or claim 21 or claim 22, and a second evacuation tube, said two tubes conforming in angularly spaced relation to said airway tube and being interconnected at said mask to constitute a single tube having said open distal end.

29. The artificial airway device of claim 20 or claim 21 or claim 22, and a second airway tube, said two airway tubes being in side-by-side adjacency and interconnected at said mask to constitute a single distal-end airway passage for generally axial alignment with the axis of the laryngeal inlet.

30. The artificial airway device of claim 20 or claim 21 or claim 22, in which said evacuation tube is circumferentially reinforced at least in the region of cuff inflation, whereby to avoid evacuation-tube collapse by reason of cuff inflation.

21. An artificial airway device to faciliate a patient'"'"'s lung ventilation, comprising an airway tube, an evacuation tube, and a laryngeal mask at one end of said tubes, said mask being of generally elliptical configuration which is in generally a single plane, said generally elliptical configuration having a major axis extending from a proximal airway-tube connection end of said mask to a distal end of said mask, said single plane being inclined to the axis of the airway tube at airway-tube connection to said mask, said configuration being adapted for peripherally sealed support by and around the layrngeal inlet and orienting the distal end of the airway tube at an angle to said plane and in substantial alignment with the axis of the layrngeal inlet when supported by and around the laryngeal inlet, the distal end of said mask having an inflatable cuff formation of flexible material configured for entry into and insertional positioning of said device by engagement within the upper sphinctral region of the oesophagus when the mask is positioned for airway-tube alignment with the axis of the laryngeal inlet, said evacuation tube having sealed passage within a portion of said cuff formation and having an open end that is (a) peripherally sealed to and (b) surrounded by inflatable material of said cuff at the distal end of said mask, means including a third tube communicating with said inflatable cuff formation for selective inflation/deflation operation of said cuff formation, whereby to peripherally seal said evacuation tube solely to the upper sphinctral region, so that upon evacuation of said evacuation tube after cuff inflation into peripherally sealed relation with the sphinctral region of the oesophagus, adjacent oesophagus tissue will be induced to locally displace into enhanced sealing engagement with the inflated-cuff formation, whereby gastric-discharge products can pass only by way of said evacuation tube, thus reducing any chance of gastric leakage into the laryngeal inlet.

22. An artificial airway device to faciliate a patient'"'"'s lung ventilation, comprising an airway tube, a suction tube, and a laryngeal mask at one end of said tubes, said mask being configured to form a seal of said airway tube in generally a single plane and around the circumference of the patient'"'"'s laryngeal inlet, said mask having an elongate axis of symmetry in said plane extending from a proximal airway-tube connection end of said mask to a distal end of said mask, said single plane being inclined to the axis of the airway tube at airway-tube connection to said mask, the distal end of said mask including an inflatable flexible cuff formation for peripherally sealed engagement to the upper sphinctral region, said distal end being configured for entry into and insertional positioning of said device within the entrance of the upper sphinctral region of the oesophagus when said mask is positioned for sealing the airway tube to the laryngeal inlet, said evacuation tube having sealed passage within a portion of said cuff formation and having an open end that is peripherally sealed to and surrounded by inflatable material of said cuff at the distal end of said mask, and means including a third tube communicating with said cuff formation for selective inflation of said cuff formation into peripherally sealed engagement with the inlet to the upper sphinctral region;

whereby, upon evacuation of said evacuation tube after cuff inflation into engaged relation with the inlet to the upper sphinctral region, tissues adjacent said engaged relation will locally displace into enhanced sealing engagement with the inflated cuff formation, so that gastric-discharge products can pass only by way of said evacuation tube, thus reducing any chance of gastric leakage into the laryngeal inlet.

23. The artificial airway device of claim 22, in which the laryngeal mask includes an inflatable ring for establishing a seal around the laryngeal inlet and in which said inflatable cuff formation is a portion of the inflatable ring of the laryngeal mask.

31. The method of faciliating a patient'"'"'s lung ventilation, which method comprises the steps of:

(a) providing an artificial airway device which comprises an inflatable sealed laryngeal mask at the end of an airway tube, said mask including an inflatable-cuff formation for sealed engagement to the upper sphinctral region of the oesophagus, and an evacuation tube having sealed passage within said cuff formation and having an open distal end which is peripherally sealed to and surrounded by inflatable material of the distal end of the cuff formation;

(b) inserting said device, in deflated condition to position the distal end of the mask in the sphinctral region of the oesophagus, and with the mask positioned for support around the laryngeal inlet;

(c) inflating said mask and cuff formation to estabilsh a mask seal around the laryngeal inlet and a cuff seal of the evacuation tube within and to the upper sphinctral region of the oesophagus; and

(d) establishing a reduced-pressure suction connection to the evacuation tube, whereby to enhance cuff-formation seal action to tissues of the upper-sphinctral region.

33. The method of claim 31 or claim 32, comprising the additional step of observing suction pressure for retention at a predetermined reduced-pressure level, thus confirming that seal action to the oeosophagus is complete.

34. The method of claim 31 or claim 32, comprising the additional step of maintaining a predetermined reduced-pressure level in said evacuation tube for the duration of lung ventilation via the airway tube.

32. The method of faciliating a patient'"'"'s lung ventilation, which method comprises the steps of:

(a) providing an artificial airway device which comprises a laryngeal mask having a proximal end engaged to an end of an airway tube, the mask having a distal end and being adapted for support around the laryngeal inlet such as to align the engaged end of the airway tube with the laryngeal inlet when the distal end of the mask engages within the upper sphinctral region of the oesophagus, an inflatable-cuff formation at the distal end of the mask engaging within the upper sphinctral region upon achievement of said alignment of the airway tube with the laryngeal inlet, and an evacuation tube having (i) sealed passage within said cuff formation and having (ii) an open distal end which is peripherally sealed to and surrounded by inflatable material of the cuff formation at the distal end of the mask;

(b) inserting said device, in deflated condition to position the distal end of the mask in the upper sphinctral region of the oesophagus, and with the mask positioned for support around the laryngeal inlet;

(c) inflating said cuff formation to establish a cuff seal of the evacuation tube within the upper sphinctral region of the oesophagus; and

(d) establishing a reduced-pressure suction connection to the evacuation tube, whereby to enhance cuff-formation seal action to tissues of the upper-sphinctral region.