WO2012052908A1

WO2012052908A1 - Tracheal tube

Info

Publication number: WO2012052908A1
Application number: PCT/IB2011/054600
Authority: WO
Inventors: Elias Daher
Original assignee: Etview Ltd.
Priority date: 2010-10-18
Filing date: 2011-10-17
Publication date: 2012-04-26

Abstract

The present invention relates to tubes for medical use generally, and is more specifically related to a tube for insertion into a trachea that includes a germicidal light source (135) and an air barrier (120) located above the proximal end of the cuff.

Description

TRACHEAL TUBE

FIELD OF THE INVENTION

The present invention relates to tubes for medical use generally, and is more specifically related to a tube for insertion into a trachea that includes a germicidal light source and an air barrier located above the proximal end of the cuff.

BACKGROUND OF THE INVENTION

Endotracheal and tracheostomy tubes are used to provide an airway in patients who do not have an adequate airway and therefore require artificial ventilation, do due to various medical conditions. An endotracheal tube is inserted through the mouth and larynx and into the trachea. Tracheostomy tubes are inserted through an incision just above the sternal notch. Once in place, the now intubated patient, may be mechanically, automatically or otherwise ventilated through the tube.

The tube is maintained in place within trachea with an inflatable cuff that is incorporated at the distal end of the tube. The cuff allows

pressurization of the lungs during mechanical ventilation, and prevents aspiration of oral secretions and other contaminants into the lungs. The tube and cuff further suppresses a patient's cough reflex while ventilated for example with a ventilator.

A consequence of the inflated cuff is that secretions pool around the proximal end of the cuff, where undesired bacteria may colonize.

Microaspiration of these secretions around the cuff is a leading cause of

Ventilator Associated Pneumonia ( herein referred to as'VAP') in ventilated patients. Ventilator associated pneumonia (VAP) is one of the most lethal and frequently occurring infections among patients who must be

mechanically ventilated. Most people will typically develop VAP after a traditional tracheal tube is used due to leakage of fluid that has pooled at the back of the throat, regurgitation and aspiration of such secretions into the lungs. These secretions penetrate the lungs from between the cuff and the trachea and through the internal lumen of any tracheal tube, allowing microorganisms to enter the normally sterile lower respiratory tract.

Although the cuff on existing tracheal tubes is inflated to keep the tube in place and to prevent leakage of secretions, however, secretions are still able to penetrate through the folds of the inflated cuff leading into the lungs.

Some tracheal tube, for example Agento I.C. from Bard Medical, attempt to overcome the problem by introducing an anti-bacterial coating. Other tubes, for example US Patent No. 7,159,590 to Rife teaches a tube including a germicidal light source directed at the cuff.

SUMMARY OF THE INVENTION

The present invention overcomes the deficiencies of the background art by providing a tube that most preferably provides at least two and more preferably a plurality of treatments and/or methods for preventing Ventilator Associated Pneumonia ('VAP'). Most preferably the tracheal tube according to the present invention provides a combination of treatments and/or methods for preventing VAP including a germicidal light source and insufflation of a flowing fluid near the proximal surface of the cuff therein preventing subglottic secretion leakage.

The Background art generally provides for only a single treatment and/or method for preventing VAP. Embodiments of the present application provide for, a combination of treatments and/or methods for preventing VAP while assuring patient safety.

An optional embodiment of the present invention provides for a tracheal tube including a central ventilation lumen for ventilating a subject and plurality of peripheral lumen disposed about the central lumen for applying a plurality of different treatments and/or applications, for example including but not limited to insufflations, suctioning, propagation of germicidal light or the like. Optionally at least one or more of the plurality of peripheral lumen may be dedicated for individual treatment and/or application.

An optional embodiment of the present invention provides for a tracheal tube with subglottic secretion leakage prevention, the tracheal tube having a proximal end, medial section and a distal end and a continuous central ventilation lumen along the length of the tube; and an inflatable cuff disposed proximally to the tube distal end; the cuff having a proximal surface and a distal surface; and wherein the cuff may be inflated to its expanded form to hold the tube within a trachea; the tube including a plurality of peripheral lumen disposed about the perimeter of the tube and surrounding the central ventilation lumen wherein the peripheral lumen form a continuous lumen; and

wherein at least one or more of the peripheral lumen may be an optical lumen comprising an optical fiber for propagating a germicidal optical wavelength along the length of the peripheral lumen from the tube proximal end to the distal surface of the cuff; and wherein the optical wavelength may be provided from an optical light source and a waveguide that may be associated with a connector with the tube proximal end; and

wherein at least one or more of the peripheral lumen provides for an insufflation lumen from the tube proximal end to the proximal surface of the cuff including a plurality of insufflation pores; and wherein the insufflation lumen may be accessible to an insufflation source with a connector through the tube proximal end;

wherein at least one or more of the peripheral lumen provides for a suction lumen from the tube proximal end to the proximal surface of the cuff, such that the suction lumen may be accessible to a suction source with a connector through the tube proximal end;

Optionally the tube comprises at least eight peripheral lumen about the central ventilation lumen. Optionally the at least eight peripheral lumen are disposed substantially equally about the central ventilation lumen, substantially assuming the form of an octagon.

Optionally the peripheral lumen are disposed internally to said tube within the tube thickness.

Optionally at least four of the optional eight peripheral lumen are optical lumen each lumen comprising at least one optical fibers for propagating an optical wavelength.

Optionally the optical fibers are incorporated in the optical lumen by co-extrusion. Optionally the lumen compromises a coating.

Optionally the coating may be disposed about at least one or more of the external surface, the central ventilation lumen, the internal surface, the peripheral lumen internal surface, or any combination thereof.

Optionally the coating may be selected from the group consisting of hydrophobic, lipophobic, anti-UV, anti bacterial or any combination thereof.

Optionally the optical fibers are flexible.

Optionally the optical fibers propagate a germicidical light wavelength.

Optionally the optical fibers may be associate and/or disassociated with the peripheral optical lumen.

Optionally the optical fibers may be sterilized.

Optionally the optical fibers are produced out of a polymer.

Optionally the optical fibers are loss less optical fibers that are adapted to propagate germicidal light with a clad specific to the germicidal light.

Optionally, the insufflation lumen may be provided for introducing a flowing fluid from the insufflation source about the tube proximal end to the cuff proximal surface; and wherein the wherein the proximal surface of the cuff includes a plurality of insufflation pores to deliver the flowing fluid.

Optionally the insufflations pores comprise a nozzle to controllably direct the flow of the flowing fluid. Optionally the flowing fluid may be selected form the group consisting of air, gas, liquid, active agent, mixture, medicament, drug or any combination thereof.

Optionally the insufflations of a flowing fluid may be applied in a controllable manner selected from the group consisting of continuous mode, pulsating mode, intermittent mode, or any combination thereof.

Optionally wherein the suction tube may be coupled with a suction lumen wherein the suction lumen leads to the cuff proximal end.

Optionally the lumen comprise notches close to the proximal end of the cuff to apply vacuum to evacuate the secretion accumulated above the proximal surface of the cuff.

Optionally the vacuum may be applied in a controllable manner selected from the group consisting of continuous mode, pulsating mode, intermittent mode, or any combination thereof.

Optionally both the insufflation and suction are provided by the same peripheral lumen.

Optionally the lumen are connected to a double valve port.

Optionally the double valve port compromises one port for insufflation and one for suction.

Optionally the optical connection may be incorporated in the ventilator connector.

Optionally the germicidical light source compromises any kind of UV- C light source.

Optionally the light source operates in controllable manner for example selected from the group consisting of continuous mode, pulsating mode, intermittent mode, or any combination thereof.

Optionally the waveguide may be connected to the optical fibers.

Optionally the waveguide transmits a germicidical light.

Optionally the waveguide transmits a germicidical light from about 100 nm to about 280 nm. Optionally the waveguide transmits a germicidical light from about 100 nm to about 280 nm to a plurality of optical fibers.

Optionally the germicidal light may be propagated at individual optical fibers may be controllable such that each may be at a sufficiently low energy so as to not damage tissue along its path.

Optionally the germicidal light may be activated by interacting with an activation agent such as a drug.

Optionally the germicidal light may be provided to activated a medicament, agent or drug.

Optionally only the cumulative or additive power of the plurality of optical fibers provide sufficient energy to form an effective germicidal light source at a targeted location.

Optionally the targeted location may be the proximal surface of the cuff.

Optionally the external surface of the tube may comprise a notch, pore or opening providing access to and corresponding to the peripheral lumen.

Optionally the notch, pore or opening may be disposed about the tube medial section proximally to the proximal surface of the cuff.

Optionally the notch, pore or opening may be shaped according to a geometric shape selected from the group consisting of circular, cylindrical, elliptical, rectangular, hexagonal, square, conical, helical, spherical, polygonal, triangular, or any combination thereof.

Optionally the notch, pore or opening may be provided such that its surface area if from about 5% to about 30% of the central ventilation lumen surface area.

Optionally the optical fibers illuminate radially.

Optionally the optical fibers support diffused or stray light.

Optionally the cuff may be perforated at the proximal end. Unless otherwise defined the various embodiment of the present invention may be provided to an end user in a plurality of formats, platforms, and may be outputted to at least one of a computer readable memory, a computer display device, a printout, a computer on a network or a user.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting. BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

In the drawings:

FIG. 1A-C are schematic diagrams of an exemplary endotracheal device and apparatus according to the present invention;

FIG. 2A-D are schematic illustrative diagrams of varying cross section views of the endotracheal tube according to optional embodiments of the present invention;

FIG. 3A-B are schematic illustrative diagrams of an optional proximal end of exemplary endotracheal tube device according optional embodiments of the present invention; FIG. 4A-B are schematic illustrative diagrams of longitudinal cross section views of the endotracheal tube medial section; FIG. 4 A showing an optional peripheral lumen comprising a fiber optic according to optional embodiments of the present invention; FIG. 4B showing an opening disposed on the external surface of the tracheal tube providing access to an optional peripheral lumen.

FIG. 5A-B are schematic illustrative diagrams of an optional cuff and distal end of an exemplary endotracheal tube according optional embodiments of the present invention; FIG. 5A depicts a cuff and distal end within a trachea; FIG. 5B depicts a close up view of the proximal end of an optional cuff according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The principles and operation of the present invention may be better understood with reference to the drawings and the accompanying description. The following reference labels listed below are used throughout the drawings to refer to objects having similar function, meaning, role, or objective:

100 Endotracheal Tube (ETT) ;

lOOd ETT distal end;

lOOp ETT proximal end;

102 Tracheal tube wall;

110 ETT body medial tube portion ;

1 lOi ETT tube inner diameter;

1 lOo ETT tube outer diameter;

110L tube central ventilation lumen;

112 intraluminal peripheral lumen

112n intraluminal peripheral lumen notch

112o intraluminal peripheral lumen opening

112p intraluminal peripheral lumen pore

114 anti UV coating;

114i UV coating inner diameter; 114ο UV coating outer diameter;

120 ETT cuff;

120d ETT cuff distal end;

120p ETT cuff proximal end;

122 cuff insufflation pores;

130 ETT Auxiliary devices;

132 Insufflation source and/or device;

132o insufflations opening

134 Pressure source and/or device;

135 Light source/Shortwave UV source and/or device;

135c Light source/UV source connector;

135f Light source fiber ;

135w waveguide;

136 Irrigation source and/or device;

138 Suction source and/or device;

139 Ventilation source and/or device;

139c ventilation source connector;

Figure 1A shows a schematic block diagram of an exemplary endotracheal tube apparatus comprising a tracheal tube 100 and a plurality of optional auxiliary devices 130. Tube 100 comprises a distal end lOOd, a proximal end lOOp that a spanned with a medial tube portion 110 and a cuff 120. Most preferably cuff 120 is provided to fix tube 100 within the trachea by inflating the cuff. Most preferably cuff 120 may be welded with tube 110 near the distal end lOOd. Optional auxiliary devices 130 may for example include but is not limited to an insufflation source 132, Pressure source 134, Light source 135, Irrigation source 136, Suction source 138, Ventilation source 139 or the like. Auxiliary devices may be coupled and/or otherwise associated with tube 100 via an appropriate connector (not shown) through the proximal end lOOp. Most preferably auxiliary devices are utilized to provide a treatment or to manipulate tube 100 through tube 110 at varying locations for example at medial portion 110, distal portion lOOd, cuff 120, proximal surface 120. For example inflation of cuff to fix tube 100 within the trachea may be provided with pressure source 134 that may be connect to the cuff 120 via at least one or more lumen running the length of tube 110.

Most preferably tube 100 may be a multi-lumen tube comprising a central ventilation lumen 110L (FIG. 2A-C) for ventilating a patient, and a plurality of peripheral lumen 112 (FIG. 2A-C) that are optionally provided through the length of tube 100 between the proximal end lOOp and distal end lOOd. Most preferably a peripheral lumen 112 may be accessed through an opening, port, notch or pore at any point along the length of tube 100 or 110. For example an auxiliary device may be connected at tube proximal end lOOp or at a location about the medial portion 110 through an appropriately dedicated opening, port, notch or pore for example 135o, 132o.

Figures IB and 1C provide schematic illustrative diagram of the block diagram shown in Figure 1A, showing tube 100 connected with a plurality of optional auxiliary devices 130, for example including but not limited to Air Supply with Pressure Gauge, Insufflator with Flowmeter, Suction Device, or the like.

Figure 1C shows and tracheal tube according to the present invention, including cuff 120 that may be most preferably welded with tube 110, that may be controllably inflated by insufflation source 132 that may be associated with tube 100 through an through inflation connecting notch, opening and/or pore 132o along the medial portion 110 of tube 100. Most preferably notch 132o provides for accessing at least one or more peripheral lumen 112 optionally dedicated for inflating cuff 120 by an activating insufflation source 132. Optionally peripheral lumen 112 may be provided as a dual functioning lumen both for insufflations and suctioning, .

Tube 100 may be associated with an auxiliary device adapted to provide both insufflation connector 132c and/or suction connector 138c that are associated with medial portion of tube 110 respectively at opening 132o and 138o (not shown), for insufflations and/or suctioning or otherwise controlling a flowing fluid through peripheral lumen 112. Most preferably openings 132o and 138o individually connect to a peripheral lumen dedicated for insuflation and/or suctioning that spans the length of tube 100. Most preferably opening 132o and 138o lead to an opening 112o near the proximal end of cuff 120p to provide for insuflation or suctions of the area about or near the cuff proximal surface 120p. Optionally and preferably insufflation of the cuff proximal surface 120p provides for prevent secretion leakage around cuff 120 where such secretion leakage is a primary cause of VAP. Optionally and preferably suctioning the area about the cuff proximal surface 120p provides for prevent secretion leakage around cuff 120 by suctioning all secretions from the proximal surface 120p a further measure in preventing VAP.

Tube 100 may be further associated with a germicidal light source for preventing VAP. Germicidal light source may be provided about the length of tube 100 through at least one and more preferably a plurality of dedicated peripheral optical lumen 112 that individually include at least one or more optical fiber 135f for propagating a germicidal light through the length of tube 100 in particular the central ventilation lumen 110L and/or the cuff proximal surface 120p. Most preferably a germicidal light source may be provided to through a ventilator connector 139c (FIG 3A-B) adapted to receive a waveguide 135w connected via connector 135c to a light source 135 provided for generating a germicidal light source. Optionally and preferably light source 135 is adapted at producing a controllable optical wavelength for example including but not limited to a germicidal light provided in the wavelength range from about lOOnm to about 280nm. Optionally the light source may be a UV-C light.

Most preferably ventilator connector 139c may be coupled with tube 100 through opening 112o wherein a plurality of optical fibers 135f associated with dedicated peripheral optical lumen 112 wherein they are disposed for propagating a germicidal light along the length of the central ventilation lumen 110L and proximal surface of cuff 120p. Most preferably tube 110 outer surface HOo and internal surface HOi are provided with a rotective coating from the germicidal light for example including but not limited to anti-UVC coating.

Most preferably at least one or more of the plurality of peripheral lumen may be dedicated for optical germicidal purposes and at least one or more of the peripheral lumen may be dedicated as an air passage providing for suctioning and /or insufflations.

Optionally at least one or more of the peripheral lumen may be dedicated to a particular auxiliary device for example including but not limited to a waveguide generator, insufflation, suctioning, drug treatment or the like.

Optionally and preferably the peripheral lumen 112 dedicated for optical germicidal activity and including an optical fiber may be provided such that it spans along the length of tube 100 corresponding to the distance from the proximal end lOOp to the cuff distal surface 120d. Therefore most preferably a germicidal light, for example a UV-C light propagate through the optical fiber entry point opening 112o toward the cuff distal surface 120d for propagating UV light along its length. Most preferably germicidal UV-C light may be propagated along the internal length of the tube without any contact and/or germicidal UV-C light exposure outside of tube 100.

Figures 2A-D show varying cross section views of the medial section of tracheal tube 110 depicting the multi- lumen arrangement. Figure 2 A depicts a face on cross section view of tube 110 showing the outer surface HOo, inner surface HOi forming a central ventilation lumen 110L that is surrounded by a plurality of peripheral lumen 112.

Optionally the plurality of peripheral lumen 112 may be arranged about the perimeter of central ventilation lumen 110L in any manner for example including but not limited to equidistant, anterior, posterior, evenly, unevenly, weighted to a side, or the like. Most preferably peripheral lumen 112 are arranged equally about the perimeter of tube 100. Optionally the peripheral lumen 112 are arranged in a balanced layout about the perimeter of tube 100.

Optionally tube 100 may include a plurality of peripheral lumen 112.

Optionally and preferably tube 100 may comprise at least four peripheral lumen 112. Optionally and preferably tube 100 may comprise at least 4 and up to 10 peripheral lumen 112. Optionally the number of peripheral lumen disposed about the perimeter of tube 100 may for example include 4 lumen,

5 lumen, 6 lumen, 7 lumen, 8 lumen, 9 lumen, 10 lumen, 12 lumen, 14 lumen, 16 lumen, 18 lumen, 20 lumen or the like.

Optionally tube 100 includes eight (8) peripheral lumen 112 arranged such that four (4) are provided for propagating germicidal light and four (4) for insufflation and suction, as shown in Figure 2D.

Optionally the peripheral lumen 112 may be arranged about the perimeter of tube 100 to include eight (8) peripheral lumen 112 arranged such that four (4) are provided and dedicated for propagating germicidal light, two provided and dedicated for insufflation and two (2) are provided and dedicated for suction.

Optionally and preferably the eight peripheral lumen 112 are arranged equidistant in a octagonal arrangement about the center of ventilation lumen 110L. Most preferably a plurality of peripheral lumen 112 are provided for housing and or otherwise associating with fiber optics 135f for propagating germicidal light along the length of the lumen.

Figure 2B depicts a cross sectional view of tube 110 where inner surface HOi and outer surface HOo are provided with a coating 114 disposed about the inner surface 114i and outer surface 114o. Optionally the coating may for example include but is not limited to hydrophobic coating, lipophobic coating, anti-UV coating, anti-UV-C coating, anti bacterial coating, the like or any combination thereof. Optionally a hydrophobic and lipophobic coating may be provided for easing and or otherwise facilitating the process for example including but not limited to tube insertion and/or secretion evacuation. Optionally anti-UV and/or anti-UV-C coating may be provided for containing and/or otherwise controlling the propagation of germicidal light to tissue within tube 100. Optionally inner coating 114i and outer coating 114o may be different type of coatings. Optionally inner coating 114i and outer coating 114o may be the same type of coatings. Optionally inner coating 114i and outer coating 114o may be provided in different coating properties, for example inner coating 114i may be more concentrated that outer coating 114o. For example inner coating 114i may be provided with as wavelength specific filter coating while outer coating 114o may be provided as a broad spectrum filter coating. For example inner coating 114i may be provided with as a broad spectrum filter coating while outer coating 114o may be provided as a wavelength specific filter coating. Optionally coating 114i and 114o may be provided in different concentrations, grades, filter properties or the like.

Figure 2C depicts a perspective cross section view of medial section 110 of tube 100 where a notch, pore or opening 112n is shown along peripheral lumen 112. Most preferably a notch, pore or opening for example 112n, 135o, 132o (as previously described) may be used as access point for optional auxiliary device 130 to access tube 100 in reaching the targeted along the tube 100. Similarly, not, pore or openings may be used for applying a preventative treatment for VAP, for example insufflation, suction and delivery of germicidal light is provided through such an openings. Optionally the notch, pore or opening may be provided such that its surface area if from about 5% to about 30% of the central ventilation lumen 110L surface area, where the size of the central ventilation lumen 110L and tube 100 depends on the patient it is being used for. Optionally the notch , pore or opening may be provided from about 10% to about 25% of the central ventilation lumen 110L surface area. Optionally the notch , pore or opening may be provided from about 5% to about 20% of the central ventilation lumen 110L surface area. Optionally peripheral lumen notch, pore or opening 112o, 112n, 112p may have a surface of about area of about 5mm² to about 10mm². Optionally the pore shape may be provide in any shape for example including but not limited to circular, elliptical, polyhedral, square, hexagonal or the like.

Optionally the notch, pore and/or opening 112o, 112n, 112p of the peripheral lumen dedicated for the insufflations and suctioning about the surface outer surface l lOo of tube 100 may be disposed about the length of tube 100 most preferably about the medial tube section 110. Optionally a plurality of peripheral openings 112o, 112n, 112p opening may be dispersed about the medial tube section 110. Optionally peripheral openings, notches or pores may be dispersed in any manner about the outer surface 110ο either about the circumference or length of tube 100 in any arrangement for example including but not limited to intermittent, uneven, even, balanced, unbalanced, patterned, randomly or the like.

Optionally the peripheral lumen notch, pore or opening 112o, 112n, 112p may be disposed about the tube outer surface l lOo up to about 100mm (millimeters) proximally to the cuff proximal surface 120p. More preferably the peripheral lumen notch, pore or opening 112o, 112n, 112p may be disposed about the tube external surface l lOo up to about 10mm (millimeter) proximal to the cuff proximal surface 120p. Most preferably the peripheral lumen notch, pore or opening 112o, 112n, 112p may be disposed about the tube external surface l lOo (length and perimeter) from about 5mm (millimeter) to about 20mm (millimeter) proximal to the cuff proximal surface 120p.

Figure 2D shows a planar cross section view of an optional and more preferable arrangement of a plurality of peripheral lumen 112 about the perimeter of tube 100. Figure 2D comprises eight peripheral lumen each wherein four lumen (UV) are dedicated for UV-C light propagation, three lumen (INS/SUC) are dedicated for suctioning and/or insufflations and one lumen (Cuff) that may be dedicated for controlling air supply to cuff 120. The eight lumen 112 depicted in Figure 2D provide a depiction of a balanced and equally dispersed lumen about the tube. Figure 2D further shows a preferably UV-C coating 114 preventing UV-C germicidal light from propagating beyond the internal central ventilation lumen 110L, where coating 114 may be provided along the length of tube 100 about its inner diameter HOi with coating 114i and outer diameter HOo with coating 114o. Most preferably coating 114 may be provided in the form of a UV-C filter for example in the form of a film and or coating for containing the UV-C light within the confines of tube 110.

Optionally and preferably the length of the peripheral lumen may be individually controlled. For example, a UV light dedicated peripheral lumen 112UV may be provided in a length from the proximal end lOOp of tube 100 toward the cuff distal surface 120d of cuff 120. For example, the length of peripheral lumen 112 INS/SUC dedicated for insufflations and suctioning may be provided to span the full length of tube 100 from proximal end lOOp to distal end lOOp.

Figures 3A-B are close up schematic illustrative diagrams of ventilator connector 139c coupled to the proximal end lOOp of tracheal tube 100, as previously described. Ventilator connector 139c may be associated with a germicidal light source for example 135 for preventing VAP. Germicidal light may be provided about the length of tube 100 through at least one and more preferably a plurality of dedicated peripheral optical lumen 112 that individually include at least one or more optic fiber 135f for propagating a germicidal light through the length of tube 100 in particular the central ventilation lumen 110L and/or the cuff proximal surface 120p. Most preferably a germicidal light source may be provided to through ventilator connector 139c adapted to receive a waveguide 135w connected via connector 135c to a light source 135 provided for generating a germicidal light source. Optionally and preferably light source 135 may be adapted at producing a controllable optical wavelength for example including but not limited to a germicidal light may be provided in the wavelength range from about lOOnm to about 280nm. Optionally the light source may be a UV-C light.

Most preferably ventilator connector 139c may be coupled with tube 100 through opening 112o, as described and shown in Figure 2C, wherein a plurality of optical fibers 135f associated with dedicated peripheral optical lumen 112 wherein they are disposed for propagating a germicidal light along the length of the central ventilation lumen 110L and proximal surface of cuff 120p. Figures 4A-B are schematic illustrative diagrams of longitudinal cross section views of the tracheal tube 100 about the medial section 110. Figure 4A shows an optional peripheral lumen 112 comprising an optic fiber 135f along its length. Figure 4B shows an opening, notch or pore 112n, as previously describe and shown in Figure 2C, where the notch may be disposed about the outer surface HOo of the tracheal tube providing access to an optional peripheral lumen 112.

Figures 5A-B are schematic illustrative diagrams of an optional cuff 120 and distal end lOOd of an exemplary tracheal tube 100 according optional embodiments of the present invention. Figure 5A depicts a cuff and distal end within a trachea. Figure 5B depicts a close up view of the proximal end 120p of an optional cuff 120 according to the present invention. Optional embodiments according to the present invention provides for a method for reducing the risk of contracting VAP by applying a plurality of treatments to the problematic area about a tracheal tube, specifically the proximal surface 120p of cuff 120p. In order to prevent VAP a preferred embodiment of the present invention provides for a tube 100 including germicidal light, insufflation and suctioning about the proximal cuff surface 120p. Insufflation may be provided with at least one and more preferably a plurality of insufflation cuff pores 122 disposed about the proximal cuff surface 120p where an air barrier may be created by continuously supplying cuff 120 with a flowing fluid for example air. Optionally and preferably insufflation cuff pores 122 may be disposed and /or arranged in any manner about the cuff proximal surface 120p, for example including but not limited to balanced, unbalanced, evenly spaced, equally, intermittently spaced, or the like. Optionally insufflation cuff pores 122 may be provided in varying diameter sizes in the order of microns, optionally and preferably cuff pores may be provided with a diameter of about 150 micron to about 500 micron, for example 150 micron, 200 micron, 250 micron, 300 micron, 350 micron, 400 micron, 450 micron, 500 micron. Optionally the pore diameter sizes may be varied about the surfaces such that a first cuff insufflation pore may be 250 micron while a second pore may be provided with a diameter of 150 micron.

Suctioning and/or insufflation may be provided through at least one or more peripheral lumen notch 112n disposed proximally to proximal cuff surface 120p.

Germicidal light may be provided via optical fiber 135f and dedicated peripheral lumen 112n.

While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made.

Claims

s claimed is:

A tracheal tube with subglottic secretion leakage prevention, comprising a proximal end, medial section and a distal end; a. a central ventilation lumen along the length of said tube;

b. an inflatable cuff disposed proximally to said tube distal end; said cuff having a proximal surface and a distal surface; and wherein said cuff is inflated to its expanded form to hold said tube within a trachea;

c. a plurality of peripheral lumens disposed about the perimeter of said tube and surrounding said central ventilation lumen wherein said peripheral lumens form a continuous lumen; d. an optical lumen comprising at least one or more of said peripheral lumens and further comprising an optical fiber for propagating a germicidal optical wavelength along the length of said peripheral lumen from said tube proximal end to the distal surface of said cuff; and wherein said optical wavelength is provided from an optical light source and a waveguide that is associated with a connector with said tube proximal end;

e. an insufflation lumen comprising at least one or more of said peripheral lumens from said tube proximal end to the proximal surface of said cuff including a plurality of insufflation pores; and wherein said insufflation lumen is accessible to an insufflation source with a connector through said tube proximal end; and

f. a suction lumen comprising at least one or more of said peripheral lumens from said tube proximal end to the proximal surface of said cuff, such that said suction lumen is accessible to a suction source with a connector through said tube proximal end.

2. The tracheal tube of claim 1 wherein said tube comprises at least eight peripheral lumens about said central ventilation lumen.

3. The tracheal tube of claim 2 wherein said at least eight peripheral lumen are disposed substantially equally about said central ventilation lumen, substantially assuming the form of an octagon.

4. The tracheal tube of claim 2 wherein at least four of said eight peripheral lumens are optical lumen each lumen comprising at least one optical fibers for propagating an optical wavelength.

5. The tracheal tube of claim 1 wherein said optical fibers are incorporated in said optical lumen by coextrusion.

6. The tracheal tube of claim 1 wherein said lumen compromise a coating.

7. The tracheal tube of claim 6 wherein said coating is disposed about at least one or more of the external surface, the central ventilation lumen, the internal surface, the peripheral lumen internal surface, or any combination thereof.

8. The tracheal tube of claim 6 wherein said coating is selected from the group consisting of hydrophobic, lipophobic, anti-UV, anti bacterial or any combination thereof.

9. The tracheal tube of claim 1, wherein said optical fibers are flexible.

10. The tracheal tube of claim 1, wherein said optical fibers propagate a germicidical light wavelength.

11. The tracheal tube of claim 1, wherein said optical fibers may be associate and/or disassociated with said peripheral optical lumen.

12. The tracheal tube of claim 11, wherein said optical fibers may be sterilized.

13. The tracheal tube of claim 1, wherein said optical fibers are produced out of a polymer.

14. A tracheal tube of claim 1, wherein said optical fibers are loss less optical fibers that are adapted to propagate germicidal light with a clad specific to said germicidal light.

15. The tracheal tube of claim 1, wherein said insufflation lumen is provided for introducing a flowing fluid from said insufflation source about said tube proximal end to said cuff proximal surface; and wherein said wherein said proximal surface of said cuff includes a plurality of insufflation pores to deliver said flowing fluid.

16. The tracheal tube of claim 12, wherein said insufflations pores comprise a nozzle to controllably direct the flow of said flowing fluid.

17. The tracheal tube of claim 12, wherein said flowing fluid is selected form the group consisting of air, gas, liquid, active agent, mixture, medicament, drug or any combination thereof.

18. The tracheal tube of claim 12, wherein said insufflations of a flowing fluid may be applied in a controllable manner selected from the group consisting of continuous mode, pulsating mode, intermittent mode, or any combination thereof.

19. The tracheal tube of claim 1, wherein said suction tube is coupled with a suction lumen wherein said suction lumen leads to said cuff proximal end.

20. The tracheal tube of claim 16, wherein said lumen comprise notches close to the proximal end of the cuff to apply vacuum to evacuate the secretion accumulated above the proximal surface of the cuff.

21. The tracheal tube of claim 17, wherein said vacuum may be applied in a controllable manner selected from the group consisting of continuous mode, pulsating mode, intermittent mode, or any combination thereof.

22. The tracheal tube of claim 1 wherein both said insufflation and suction are provided by the same peripheral lumen.

23. The tracheal tube of claim 20 wherein said lumen are connected to a double valve port.

24. The tracheal tube of claim 21, wherein said double valved port compromises one port for insufflation and one for suction.

25. A tracheal tube with subglottic secretion leakage prevention as claimed in claim 1, wherein said optical connection is incorporated in the ventilator connector.

26. The tracheal tube of claim 1, wherein said germicidical light source compromises any kind of UV-C light source.

27. The tracheal tube of claim 24, wherein said light source operates in controllable manner for example selected from the group consisting of continuous mode, pulsating mode, intermittent mode, or any combination thereof.

28. The tracheal tube of claim 25, wherein said waveguide is connected to said optical fibers.

29. The tracheal tube of claim 1, wherein said waveguide transmits a germicidical light.

30. The tracheal tube of claim 27, wherein said waveguide transmits a germicidical light from about 100 nm to about 280 nm.

31. The tracheal tube of claim 27, wherein said waveguide transmits a germicidical light from about 100 nm to about 280 nm to a plurality of optical fibers.

32. The tracheal tube of claim 28, wherein the germicidal light is propagated at individual optical fibers is controllable such that each is at a sufficiently low energy so as to not damage tissue along its path.

33. The tracheal tube of claim 31 wherein said germicidal light is activated by interacting with an activation agent such as a drug.

34. The tracheal tube of claim 31 wherein said germicidal light is provided to activated a medicament, agent or drug.

35. The tube of claim 29 wherein only the cumulative or additive power of said plurality of optical fibers provide sufficient energy to form an effective germicidal light source at a targeted location.

36. The tube of claim 30 wherein said targeted location is the proximal surface of said cuff.

37. The tube of claim 1 wherein the external surface of said tube may comprise a notch, pore or opening providing access to and corresponding to said peripheral lumen.

38. The tube of claim 37 wherein said notch, pore or opening may be disposed about said tube medial section proximally to said proximal surface of said cuff.

39. The tube of claim 37 wherein said notch, pore or opening is shaped according to a geometric shape selected from the group consisting of circular, cylindrical, elliptical, rectangular, hexagonal, square, conical, helical, spherical, polygonal, triangular, or any combination thereof.

40. The tube of claim 37 wherein said notch, pore or opening is provided such that its surface area if from about 5% to about 30% of the central ventilation lumen surface area.

41. The tracheal tube of claim 1 wherein said optical fibers illuminate radially. The tracheal tube of claim 1 wherein said optical fibers support diffused or stray light.

The tracheal tube of claim 1 wherein said cuff is perforated at the proximal end.