Methods and apparatus for reducing tracheal infection
First Claim
1. An integrated system providing an improved mechanical and chemical barrier against the spread of acidic or infected secretions into the distal trachea comprising an endotracheal tube, wherein the endotracheal tube comprises:
- a thin walled, compliant outer sheath;
defining a suction channel concentric with an outer wall of the endotracheal tube for removing acidic or infected secretions from a subglottic region below the vocal cords and above an inflated cuff, the outer sheath terminating immediately above the inflated endotracheal tube cuff; and
an irrigation channel integral with the outer wall for delivering a non-viscous liquid to the subglottic region for tissue hydration and the dilution of bacterial inoculum, used in combination with an outer sleeve suction channel to provide a mechanical irrigation and drainage of the subglottic region in a manner similar to surgical management of an infected body space, whereby topical delivery of an antibiotic and antifungal solution to the subglottic region provides a chemical barrier against the distal spread of infected secretions, thereby significantly decreasing the number of bacteria and the degree of infectivity of those liquid secretions that pass the inflated cuff, and further, the irrigation channel also provides for the irrigation and drainage of a dilute solution of topical local anesthetic, whereby the local anesthetics produce a numbing field block for awake intubated patients, thereby providing an integrated system for the topical delivery of therapeutic medication requiring rapid access to a highly vascular mucous membrane, such as antihypertensive and antianginal medications, the system further comprising an electronic and mechanical control device for regulating and integrating irrigation, suction, and cuff pressure, wherein subglottic irrigation will cease if suction or cuff pressure regulation malfunction and wherein an alarm condition is indicated if any one of irrigation, suction and cuff pressure regulation are not functional.
1 Assignment
0 Petitions
Accused Products
Abstract
An integrated system providing a mechanical and chemical barrier against the spread of infected secretions into the distal trachea is disclosed. An endotracheal tube is used for patient airway management and provides a means to conveniently irrigate and drain the subglottic region below the vocal cords and above an inflated cuff. The subglottic region accumulates liquid secretions that may channel past an inflated endotracheal tube cuff, providing the necessary bacterial inoculum leading to bronchitis and nosocomial pneumonia. An irrigation channel delivers liquids such as saline or antibiotic and antifungal medications for mucosal hydration, and bactericidal action against infected subglottic secretions. An outer sleeve surrounding the endotracheal tube forms a suction lumen for removing the secretions. Electronic and mechanical controls provide regulated volume infusion and regulated suction.
364 Citations
45 Claims
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1. An integrated system providing an improved mechanical and chemical barrier against the spread of acidic or infected secretions into the distal trachea comprising an endotracheal tube, wherein the endotracheal tube comprises:
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a thin walled, compliant outer sheath;
defining a suction channel concentric with an outer wall of the endotracheal tube for removing acidic or infected secretions from a subglottic region below the vocal cords and above an inflated cuff, the outer sheath terminating immediately above the inflated endotracheal tube cuff; andan irrigation channel integral with the outer wall for delivering a non-viscous liquid to the subglottic region for tissue hydration and the dilution of bacterial inoculum, used in combination with an outer sleeve suction channel to provide a mechanical irrigation and drainage of the subglottic region in a manner similar to surgical management of an infected body space, whereby topical delivery of an antibiotic and antifungal solution to the subglottic region provides a chemical barrier against the distal spread of infected secretions, thereby significantly decreasing the number of bacteria and the degree of infectivity of those liquid secretions that pass the inflated cuff, and further, the irrigation channel also provides for the irrigation and drainage of a dilute solution of topical local anesthetic, whereby the local anesthetics produce a numbing field block for awake intubated patients, thereby providing an integrated system for the topical delivery of therapeutic medication requiring rapid access to a highly vascular mucous membrane, such as antihypertensive and antianginal medications, the system further comprising an electronic and mechanical control device for regulating and integrating irrigation, suction, and cuff pressure, wherein subglottic irrigation will cease if suction or cuff pressure regulation malfunction and wherein an alarm condition is indicated if any one of irrigation, suction and cuff pressure regulation are not functional. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A system for intubating a patient with a tracheal tube having a proximal and a distal end and having an inflatable cuff disposed near the distal end of the tracheal tube, a subglottic suction lumen having a distal end terminating at an opening proximal of and superior to the inflatable cuff, and an irrigation lumen having a distal end terminating at an opening proximal of and superior to the inflatable cuff, comprising:
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a cuff pressure regulator for controlling the pressure in the inflatable cuff and having a compressor and a relief valve adaptable to be in flow communication with the inflatable cuff and an electronic pressure regulator adaptable to cycle the compressor and supply pressure to the cuff if pressure within the cuff is less than a predetermined minimum pressure and open the relief valve if pressure within the cuff exceeds a predetermined maximum pressure; a suction regulator, for controlling the suction through the subglottic suction lumen that is adaptable to suction in a suglottic region exterior to the tracheal tube and proximal to the inflatable cuff, the suction regulator having a pump in flow communication with the subglottic suction lumen; and a control device for regulating and integrating irrigation through the irrigation lumen, suction through the subglottic suction lumen, and cuff pressure in the inflatable cuff, wherein subglottic irrigation will cease if suction or cuff pressure regulation malfunction and wherein an alarm condition is indicated if any one of irrigation, suction and cuff pressure regulation are not functional. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25)
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26. A method of intubating a patient comprising the steps of:
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inserting a tracheal tube having an outer wall, a distal end and an inflatable pressure cuff near the distal end into the patient; inflating the inflatable pressure cuff to a predetermined pressure; regulating the pressure in the inflatable pressure cuff; applying suction with a subglottic suction lumen disposed between the outer wall of the tracheal tube and a compliant outer sleeve disposed around the outer wall of the tracheal tube, the sleeve having a distal end at a point proximal to the inflatable cuff, thereby forming an opening between the outer wall and the sleeve at the distal end of the compliant outer sleeve; and irrigating a region superior to the inflatable cuff by flowing a liquid through an irrigation lumen contained within the tracheal tube. - View Dependent Claims (27)
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28. A tracheal tube having a proximal end and a distal end, comprising:
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an airway lumen defined by an outer wall, an inflatable cuff disposed near the distal end of the tracheal tube and around the outer wall and connected to a cuff pressure line; a subglottic suction lumen disposed between the outer wall of the airway lumen and a compliant outer sleeve surrounding the outer wall, the sleeve terminating at a distal end to form an annular opening between the sleeve and the outer wall of the airway lumen proximate to the inflatable cuff; and an irrigation lumen having a distal end terminating at an opening proximal of and superior to the inflatable cuff. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35)
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36. A system for intubating a patient, comprising:
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(a) a tracheal tube having a distal end and a proximal portion and an outer wall, comprising, an inflatable cuff disposed near the distal end of the tracheal tube and around the outer wall of the tracheal tube; a compliant outer sleeve, extending from the proximal portion of the tracheal tube to a point proximate of the inflatable cuff and having a distal end, the outer sleeve being disposed around the outer wall of the tracheal tube and terminating at the distal end of the outer sleeve in an opening that defines an annulus between the outer wall of the tracheal tube and the compliant outer sleeve, and wherein a subglottic suction lumen is thereby defined between the compliant outer sleeve and the outer wall of the tracheal tube; an airway lumen extending to the distal end of the tracheal tube and extending through the inflatable cuff; an irrigation lumen having a distal end terminating at an opening proximal of and superior to the inflatable cuff; (b) a pressure regulator in flow communication with the inflatable cuff; (c) a suction regulator in flow communication with the subglottic suction lumen; and (d) a control device for regulating and integrating irrigation through the irrigation lumen, suction through the subglottic suction lumen, and cuff pressure in the inflatable cuff, wherein subglottic irrigation will cease if suction or cuff pressure regulation malfunction and wherein an alarm condition is indicated if any one of irrigation, suction and cuff pressure regulation are not functional. - View Dependent Claims (37)
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38. An improved tracheal tube, having a proximal portion and a distal end, comprising:
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(a) an outer tracheal wall extending from the proximal portion to the distal end of the tracheal tube; (b) an inflatable cuff located near the distal end of the tracheal tube; (c) an airway lumen within the tracheal tube extending through the inflatable cuff and to the distal end of the tracheal tube; (d) a compliant outer sleeve, extending from the proximal portion of the tracheal tube to a point proximate of the inflatable cuff and having a distal end, the outer sleeve being disposed around the outer wall of the tracheal tube and terminating at the distal end of the outer sleeve in an opening that substantially defines an annulus between the outer wall of the tracheal tube and the outer sleeve, and wherein a subglottic suction lumen is thereby defined between the outer sleeve and the outer wall of the tracheal tube. - View Dependent Claims (39, 40, 41, 42)
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43. A method for intubating a patient, comprising the steps of:
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(a) inserting a tracheal tube having a proximal portion and a distal end into the patient, the tracheal tube comprising; (i) an outer tracheal wall extending from the proximal portion of the tracheal tube to the distal end of the tracheal tube; (ii) an inflatable cuff located near the distal end of the tracheal tube; (iii) an airway lumen within the tracheal tube extending through the inflatable cuff and to the distal end of the tracheal tube; (iv) a compliant outer sleeve, extending from the proximal portion of the tracheal tube to a point proximate of the inflatable cuff and having a distal end, the outer sleeve being disposed around the outer wall of the tracheal tube and terminating at the distal end of the outer sleeve in an opening that substantially defines an annulus between the outer wall of the tracheal tube and the outer sleeve, and wherein a subglottic suction lumen is thereby defined between the outer sleeve and the outer wall of the tracheal tube; (b) inflating the inflatable cuff; and (c) suctioning fluids from a point proximal to the inflated cuff through the subglottic suction lumen. - View Dependent Claims (44, 45)
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Specification