WO2012077101A1

WO2012077101A1 - Apparatus for facilitating removal of inner layers of a multi- layer endotracheal tube during ventilation

Info

Publication number: WO2012077101A1
Application number: PCT/IL2011/000924
Authority: WO
Inventors: Nir Barkai; Mark Shahar
Original assignee: Tubular Medical Ltd..
Priority date: 2010-12-05
Filing date: 2011-12-04
Publication date: 2012-06-14

Abstract

An apparatus for facilitating removal of at least one inner layer from a multi layer endotracheal tube, the multi layer endotracheal tube includes an outer tube and at least one inner layer that extends substantially within and at least partially along inner length of the outer tube, the inner layer is detachably coupled with an inner surface of the outer tube, the apparatus comprising at least one removal port section for facilitating removal of said at least one inner layer therethrough, said at least one removal port section located at a position along partial length of said outer tube, and at least one removal handle coupled with a respective said at least one inner layer, said at least one removal handle operative to detach respective said at least one inner layer from within said outer tube, so as to enable withdrawal of said at least one inner layer via said respective said at least one removal port section.

Description

APPARATUS FOR FACILITATING REMOVAL OF INNER LAYERS OF A MULTI-LAYER ENDOTRACHEAL TUBE DURING VENTILATION

BARKAI Nir and SHAHAR Mark

FIELD OF THE DISCLOSED TECHNIQUE

The disclosed technique relates to medical devices, in general, and to apparatuses to be employed with multi-layer endotracheal tubes for facilitating removal of inner layers from the multi-layer endotracheal tubes during ventilation, in particular.

BACKGROUND OF THE DISCLOSED TECHNIQUE

Endotracheal tubes (ETTs) are medically employed on intubated individuals for the purposes of establishing and maintaining an unobstructed airway and for providing at least sufficient exchange between the inhaled and exhaled gases involved in respiration. ETTs are typically employed with artificial (e.g., mechanical) ventilation in order to oxygenate the lungs of a patient, remove exhaled carbon dioxide (CO₂), administer medication, monitor gas flow rates, inspect and sample respiratory anatomy, perform suctioning, flushing, aspiration of secretions from the respiratory system and lavage. During such medical procedures, however, the ventilation and supply of oxygen to the lungs may be interrupted or even stopped, the result of which may contribute to increased risks of acquiring, contracting or developing undesirable medical conditions. Utilization of multi-layer ETT tubes may considerably reduce such risks, although care should be taken during removal of inner tube layers that are typically laden with microorganisms, secretions, biofilm, fungi, and other accumulated substances.

Multi-layer endotracheal tubes are known in the art. PCT International Publication Number WO 2011/011437 A2 to the applicants of the present application directs to multi-layer endotracheal tube apparatuses and methods for reducing risks of developing medical complications associated with the use of single layer endotracheal intubation tubes. Further reference is made to Figure 1 , which is a schematic illustration of a prior art multi-layer endotracheal tube apparatus, generally referenced 10. Multi-layer endotracheal tube apparatus 10 includes an outer flexible elongated tube layer 12, a plurality

(not shown) of inner tube layers, where one of these layers is shown as collapsible flexible elongated inner tube layer 14, and a closure mechanism 16. Collapsible flexible inner tube layer 14 extends substantially within, and along the inner length of outer flexible elongated tube layer 12. Outer flexible elongated tube layer 12 has a proximal end

18 and a distal end 20, which define an inner surface 22 therebetween.

Collapsible flexible elongated inner tube layer 14 has a proximal end 24 and a distal end 26, which define an inner surface 28 and an outer surface

30 therebetween. Distal end 26 defines a distal port section 32, which in turn is terminated by rim 34. Rim 34 is detachably coupled along an inner substantially closed circumference of inner surface 28 of outer flexible elongated tube layer 12. According to one of the embodiments, closure mechanism 6 is a string that has a proximal end section 36 and a distal end section 38, which in turn is terminated by a distal end 40. Distal end section 38 of string 16 is wound substantially around the circumference of distal port section 32. The remaining portion of string 16 with outer flexible elongated tube layer 12 is wound helically around outer surface 30 along the length of collapsible flexible elongated inner tube layer 14. Proximal end section 36 is coupled to a withdrawal string 42.

When withdrawal string 42 is pulled, string 16 tightens around collapsible flexible elongated tube layer 14 thereby reducing its internal volume. As tension in string 16 increases distal port section 122 closes, and rim 34 detaches from inner surface 28. Detachment of rim 34 together with continual reduction of the internal volume of collapsible flexible elongated tube layer 14 facilitates withdrawal of collapsible flexible elongated inner tube layer 14 from proximal end 18 of outer flexible elongated tube layer 12. Closure mechanism 16 closes distal port section 32 thus creating a seal that acts to contain biological material within the internal volume of collapsible flexible elongated inner tube layer 14, so that no biological seeps from the latter while it is removed from outer flexible elongated tube layer 12. As collapsible flexible elongated inner tube layer 14 is removed along with biological material enclosed therein, a new uncontaminated layer is exposed underneath, and the process repeats.

SUMMARY OF THE DISCLOSED TECHNIQUE

It is an object of the disclosed technique to provide a novel method and system for facilitating removal of at least one inner layer from a multi-layer endotracheal tube (ETT) during ventilation of an individual, intubated with the multi-layer endotracheal tube, without necessitating the removal or disconnection of the ventilating source from the multi-layer endotracheal tube and thus, from the individual. In accordance with the disclosed technique, there is thus provided an apparatus for facilitating removal of at least one inner layer from a multi-layer endotracheal tube, where the multi-layer endotracheal tube includes an outer tube and at least one inner layer that extends substantially within and at least partially along inner length of the outer tube. The outer tube includes a proximal end and a distal end that define an inner surface therebetween. The inner layer includes a proximal end and a distal end that define an outer surface and an inner volume therebetween. The inner layer is detachably coupled with the inner surface of the outer tube. The apparatus comprises an endotracheal tube connection port section, a ventilation connection port section, at least one removal port section, and at least one removal handle. The endotracheal tube connection port section is for coupling the apparatus with the outer tube. The ventilation connection port section is for coupling the apparatus with an external fluid delivery source. The removal port section facilitates removal of the inner layers therethrough. The removal handle, is at least partially located in the removal port section, and coupled with a respective inner layer. Pulling of the removal handle from its respective removal port, withdraws the respective inner layer via the removal port section. The apparatus enables fluid communication between the external fluid delivery source and the inner volume of the outer tube as well as the inner volume of the innermost inner layer.

In accordance with the disclosed technique, there is thus provided another apparatus for facilitating removal of at least one inner layer from a multi-layer endotracheal tube. The apparatus comprises at least one removal port section and at least one removal handle. The removal port section, which is located at a position along partial length of the outer tube, is for facilitating removal of the inner layer therethrough. The removal handle is coupled with a respective inner layer and is further operative to detach a respective one of the inner layers from within the outer tube, so as to enable withdrawal of the inner layer via the respective removal port section.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:

Figure 1 is a schematic illustration of a prior art multi-layer endotracheal tube apparatus;

Figure 2A is a general longitudinal perspective illustration of an apparatus coupled with a multi-layer endotracheal tube, constructed and operative in accordance with an embodiment of the disclosed technique;

Figure 2B is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 2A in a particular operative state;

Figure 2C is a general longitudinal perspective illustration of the apparatus coupled with the multi-layer endotracheal tube, of Figures 2A and 2B, showing the removal of an inner tube layer from the multi-layer endotracheal tube and through the apparatus;

Figure 2D is a schematic cross-sectional in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 2C;

Figure 2E is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube, showing another operative state;

Figure 3A is a general perspective illustration in a longitudinal cut-away view of an apparatus coupled with a multi-layer endotracheal tube, constructed and operative in accordance with another embodiment of the disclosed technique;

Figure 3B is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 3A in a particular operative state;

Figure 3C is a general longitudinal perspective illustration in partial exploded view of the apparatus coupled with the multi-layer 0924 endotracheal tube, of Figures 3A and 3B, showing the removal of an inner tube layer from the multi-layer endotracheal tube and through the apparatus;

Figure 3D is a schematic cross-sectional illustration in longitudinal section view of Figure 3C, depicting the apparatus coupled with the multi-layer endotracheal tube;

Figure 3E is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube, in another operative state;

Figure 4A is a general perspective illustration in a longitudinal cut-away view of an apparatus, coupled with a multi-layer endotracheal tube, constructed and operative in accordance with a further embodiment of the disclosed technique;

Figure 4B is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 4A in a particular operative state;

Figure 4C is a general longitudinal perspective illustration in partial exploded view of the apparatus coupled with the multi-layer endotracheal tube, of Figures 4A and 4B, showing the removal of an inner tube layer from the multi-layer endotracheal tube;

Figure 4D is a schematic cross-sectional illustration in longitudinal section view of Figure 4C depicting the apparatus coupled with the multi-layer endotracheal tube;

Figure 4E is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube, in another operative state;

Figure 5A is a general perspective illustration in a longitudinal cut-away view of an apparatus, coupled with a multi-layer endotracheal tube, constructed and operative in accordance with another embodiment of the disclosed technique; Figure 5B is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 5A in a particular operative state;

Figure 5C is a general longitudinal perspective illustration in partial exploded view of the apparatus coupled with the multi-layer endotracheal tube, of Figures 5A and 5B, showing the removal of an inner tube layer from the multi-layer endotracheal tube;

Figure 5D is a schematic cross-sectional illustration in longitudinal section view of Figure 5C of the apparatus coupled with the multi-layer endotracheal tube; and

Figure 5E is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube, in another operative state.

1 000924

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The disclosed technique overcomes the disadvantages of the prior art by providing an apparatus for facilitating the removal of inner layers of a multi-layer endotracheal tube (ETT) during ventilation of an individual (hereinafter "patient"), intubated with the multi-layer ETT, without necessitating the disconnection of the ventilating source (e.g., the ventilator) from the multi-layer ETT and consequently, from the patient. According to a preferred embodiment of the disclosed technique, the apparatus includes a body that is constructed such to include an ETT connection port section for coupling to the multi-layer ETT, a ventilation connection port section for coupling with the ventilating source, and at least one removal port sections for facilitating removal of the inner layers therethrough. The interior of the body defines an internal volume through which fluid communication between the aforementioned port sections is viable. The apparatus may typically further include inner layer removers (e.g., inner layer removal handles), where each of which is coupled to a respective inner layer, for facilitating extraction of the latter by a medical practitioner. The use of these different and separate ports, enable the removal of inner layers of the multi-layer ETT without the need to disconnect or substantially interrupt the transport of fluids (e.g., oxygen, C0₂, medication) to and fro the patient.

A description greater in detail is hereby provided with reference that is now made to Figures 2A and 2B. Figure 2A is a general longitudinal perspective illustration of an apparatus, generally referenced 100, coupled with a multi-layer endotracheal tube, constructed and operative in accordance with an embodiment of the disclosed technique. Figure 2B is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 2A in a particular operative state. Figures 2A and 2B illustrate apparatus 100 operatively coupled with a multi-layer ETT 102. The two 4 schematic illustrations shown Figure 2B depict that one (the bottom) is an enlargement of the encircled portion the other (the top).

Apparatus 100 includes a body 104 whose elements include an ETT connection port section 106, a ventilation port section 108, at least one removal port section (i.e., two removal port sections 110 and 112 are shown), and at least one inner layer remover, denoted herein as removal handle (i.e., two removal handles 114 and 116 are shown). Body 104 includes an inner surface 118 (Figure 2B) and an outer surface 120 that define a generally hollow interior structure that allows fluid communication (i.e., free fluid flow) therein between the various aforementioned port sections.

Ventilation port section 108, generally embodied in cylindrical form and typically slightly tapered, includes a protruding radial flange 122 disposed in a proximal end 124 thereof. The interior volume of ventilation port section 108 defines a ventilation port through which ventilation fluids are to be delivered to a patient (not shown). Each of removal handles 14 and 116 include respective head portions 126 and 128, and correspondingly, respective engaging portions 130 and 132 (Figure 2B). Removal port sections 1 0 and 112 each define removal ports through which inner layers of multi-layer ETT 102 may be withdrawn, as detailed hereinbelow. Removal port sections 110 and 112 are formed such that they are oriented at an angle with respect to longitudinal axis A of body 104 and are of such shape to at least partially accommodate respective engaging portions 130 and 132, so as to substantially seal the respective removal ports from fluids. ETT connection port section 106 includes a generally cylindrical engaging portion 134 (Figure 2B), which terminates at an annular edge 136 being of diametrical dimensions selected to accommodate coupling with multi-layer ETT 102 thereon. ETT connection port section 106 defines an ETT port through which fluids are communicated to the patient via multi-layer ETT 102. 11 000924

Apparatus 100 is operatively employed in conjunction with multi-layer ETT 102 that generally includes an outer flexible elongated tube 138 and a plurality (two are shown) of successively layered inner layers, denoted herein as flexible elongated inner tube layers 140 and 142. Outer flexible elongated tube 138 includes a proximal end 144 and a distal end 146 (Figure 2B) that define an inner surface 148 therebetween. Flexible elongated inner tube layers 140 and 142 are detachably coupled with inner surface 148. Flexible elongated inner tube layers 140 and 142 are constructed to include respective proximal ends 150 and 152. Flexible elongated inner tube layers 140 and 142 extend substantially within and along the inner length of outer flexible elongated tube 138. Multi-layer ETT 102 may further include a plurality of closure mechanisms (not shown), each of which is coupled to an extremity of a respective flexible elongated inner tube layer, and which is further operative to substantially seal biological material accumulated within the internal volume and surface of the respective flexible elongated inner tube layer. Although the inner layers and the outer tube are typically tubular in shape (having cylindrical axisymmetric cross-section), flexible and elongated, the disclosed technique applies to inner layers that may assume other shapes (e.g., rectangular cross-sections, sheet material that assumes a variety of shapes and forms).

Apparatus 100 is adapted to be mechanically coupled with outer flexible elongated tube 138 by insertion of ETT connection port section 106 into the opening of proximal end 144 up to where outer flexible elongated tube 138 engages annular edge 136 and where it is held in place by the radial compression provided by outer flexible elongated tube 138. For each removal handle there is provided a respective withdrawal mechanism, which in turn couples with a respective flexible elongated inner tube layer. In particular, removal handle 114 is coupled with proximal end 152 of flexible elongated inner tube layer 142 via withdrawal mechanism 154, and removal handle 116 is coupled with proximal end IL2011/000924

150 of flexible inner elongated tube layer 140 via withdrawal mechanism 156. Withdrawal mechanisms 154 and 156 are typically embodied as cords, strings, cables, filaments, elongated springs, wires, rods, shafts, sheets, threads, and the like. Alternatively, withdrawal mechanisms are made from a material, whose composition is substantially similar to (or same in) composition of the removal handles, a material, whose composition is substantially similar to (or same in) composition of elongated inner tube layers, or a combination thereof.

Withdrawal mechanisms 154 and 156 are respectively coupled with removal handles 114 and 116, such that one end of each of withdrawal mechanisms 154 and 156 is passed through each respective through-hole that extends linearly along the central longitudinal axis of the respective head portions, as shown in Figure 2B. Alternatively, withdrawal mechanisms 154 and 156 are respectively coupled with removal handles 114 and 116 by other methods, such as by use of adhesive materials, and the like. The other ends of withdrawal mechanisms 154 and 156 are respectively coupled to proximal ends 152 and 150. Generally, to each flexible inner tube layer that is intended to be removed, there exists a respective removal handle and corresponding withdrawal mechanism coupled thereto. Thus, the number of removal handles with their corresponding withdrawal mechanisms equate to the number of flexible inner tube layers that are to be removed. Although, for the purposes of elucidating the disclosed technique, this embodiment describes only two sets of removal handles, withdrawal mechanisms and flexible inner tube layers, the disclosed technique is not limited to two, as its principle applies likewise to more.

Operation of apparatus 100 will now be described in conjunction and reference to the Figures. Multi-layer ETT 102, via distal end 146 thereof, as shown in Figure 2B, is partially inserted (not shown) into an airway (e.g., trachea) of the patient during intubation, as it is constructed to be adequately flexible for such purpose. Typically, an inflatable cuff (not 1 000924 shown), coupled to outer flexible elongated tube 138, is inflated once distal end 146 reaches a desired, deployed position within the internal anatomy of the patient, so as to create a substantially airtight seal, as well as to secure the position of multi-layer ETT 102 relative to the deployed position. Ventilation port section 108 is connected to an external fluid delivery source, such as, for example, a medical ventilation machine (i.e., ventilator), a manual ventilator (e.g., anesthesia bag, bag valve mask), and the like. After commencement of ventilation, the inner surface of flexible elongated inner tube layer 42 becomes exposed to ventilation fluids (e.g., air, oxygen, medication) as well as, typically, to microorganisms, secretions, contaminated air, fungi, biofilm formation, and the like. Additionally, the internal volume of flexible elongated inner tube layer 142 may progressively decrease over time to become congested due to accumulation of fluids on the inner surface thereof, thus adversely affecting ventilatory capacity.

A medical practitioner (not shown) may, at any time after initiation of ventilation of the patient, remove the flexible elongated inner tube layers (starting with the innermost layer 142) so as to avert or to at least reduce risk to the patient in acquiring or developing medical conditions typically associated with endotracheal intubation (e.g., ventilator associated pneumonia).

Removal of flexible elongated inner tube layer 142 will now be described in conjunction and with further reference to Figures 2C, 2D and 2E. Figure 2C is a general longitudinal perspective illustration of the apparatus coupled with the multi-layer endotracheal tube, of Figures 2A and 2B, showing the removal of an inner tube layer from the multi-layer endotracheal tube and through the apparatus. Figure 2D is a schematic cross-sectional in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 2C. Figure 2E is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube, showing another operative state. Figures 2C and 2D illustrate removal of flexible elongated inner tube layer 142 from within outer flexible elongated tube 138. Although not explicitly shown in Figures 2C, 2D and 2E, ventilation port section 108 is operatively coupled to a ventilation machine, and the patient is intubated with multi-layer ETT 102. To remove flexible elongated inner tube layer 142, the medical practitioner clasps and pulls head portion 126 of removal handle 114, so as to disengage engaging portion 130 from contact with removal port section 110. As head portion 126 is pulled, flexible elongated inner tube layer 142 is pulled therewith via withdrawal mechanism 154 so as to completely extract flexible elongated inner tube layer 142 from within outer flexible elongated tube 138. While flexible elongated inner tube layer 142 is gradually extracted from removal port section 110, there is no disconnection of the external fluid delivery source, (e.g., the ventilation machine) from ventilation port section 108, and thus, no cessation of ventilation; hence the patient is continuously ventilated. After complete extraction of flexible inner tube layer 142 from outer flexible elongated tube 138, via apparatus 100, a removable port seal, denoted herein as replacement handle 158 (Figure 2E) is repositioned into removal port section 110 so as to substantially seal removal port section 110 from fluids (e.g., ventilation gases) potentially escaping therefrom. Similarly, other inner tube layers may be successively extracted. For example, after extraction of flexible inner tube layer 142, flexible elongated inner tube layer 140 is extracted by removal handle 116 through port section 112. At least a portion of the removal handles (e.g., 114 and 116) may be marked such to denote a removing sequence for the withdrawal of those respective flexible elongated inner tube layers (e.g., 142 and 140). For example, each of the outer faces of head portions may be numbered (not shown) according in an ascending order (e.g., 1 , 2, 3, etc.), representing the successive removing sequence in which the flexible inner tube layers are to be extracted from outer flexible elongated tube 138 via apparatus 100. 11 000924

According to another embodiment of the disclosed technique, the apparatus is of different construction, but of similar utility and function. According to this embodiment, the apparatus includes one removal port section, constructed such that it is substantially axially aligned with a longitudinal axis of ETT connection port section, and further operative to provide a port through which inner tube layers of the multi-layer ETT are to be successively removed. The apparatus further includes a ventilation port section that is oriented at an angle with respect to the removal port section. A description greater in detail is hereby provided with reference that is now made to Figures 3A and 3B. Figure 3A is a general perspective illustration in a longitudinal cut-away view of an apparatus, generally referenced 200, coupled with a multi-layer endotracheal tube, constructed and operative in accordance with another embodiment of the disclosed technique. Figure 3B is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 3A in a particular operative state. The bottom positioned illustration shown in Figure 3B depicts an enlargement of the encircled portion of the top positioned illustration. Similarly to the embodiments described in conjunction with Figures 2A-2E, apparatus 200 is constructed and operative to be coupled with a multi-layer ETT, generally referenced 102. (For the sake of avoiding unnecessary redundancy, all reference numbers relating to multi-layer ETT 102 from the previous embodiment, as well as the description of the elements thereof are hereinafter reused.)

Apparatus 200 includes a body 202, a chamber 204, an ETT connection port section 206, a ventilation port section 208, and a removal port section 210 and at least one removal handle (i.e., two removal handles 212 and 214 are shown). Apparatus may further typically include a removable port seal, denoted as closure cap 216. Body 202 includes an inner surface 218 (Figure 3B) and an outer surface 220. The generally hollow interior construction of chamber 204 permits fluid communication 11 000924 therein between the aforementioned port sections. ETT connection port section 206 includes a generally cylindrical engaging portion 222, the dimensions of which permit secure and hermetic coupling with proximal section 144 of multi-layer ETT 102. ETT connection port section 206 defines an ETT port through which fluids are communicated between chamber 204 and the patient via the multi-layer ETT 102. Removal port section 210 includes an outer surface 224, and is formed on body 202 such it is axially orientated to be substantially aligned with respect to longitudinal axis β of body 202. Alternatively, removal port section 210 is axially orientated such to assume an angle with respect to longitudinal axis 8 of body (not shown). Outer surface 224 of removal port section 210 includes a plurality of N engaging surfaces 226^ to 226_w (where N represents an integer), which may be echeloned (not shown).

The removal handles are constructed such to have dimensions that enable them in to be successively layered over each other, in an incremental manner, from the innermost layer to the outermost layer through a plurality of intermediate layers (not shown) disposed therebetween. In the operative state shown in Figures 3A and 3B, removal handle 214 (innermost) is positioned so as to at least partially engage outer surface 224 of removal port section 210. Removal handle 212 (outermost) set in position on top of removal handle 214 by the engagement with engaging surface 226_N. Closure cap 216 is set in position on top of outermost removal handle 212, by engagement with engaging surface 226^

For each of the removal handles there is provided a respective withdrawal mechanism, which couples with a respective flexible elongated inner tube layer of the multi-layer ETT. In particular, removal handle 212 is coupled with proximal end 152 of flexible elongated inner tube layer 142 via one end of withdrawal mechanism 228, and removal handle 214 is coupled with proximal end 150 of flexible elongated inner tube layer 140 via one end of withdrawal mechanism 230. Withdrawal mechanisms 228 and 230 are similar to withdrawal mechanisms 154 and 156 as described in conjunction with Figure 2B. The other end of each of withdrawal mechanisms 228 and 230 is further coupled, respectively with removal handles 212 and 214, as shown in Figure 3B. Each removal handle with its corresponding withdrawal mechanism is paired with a respective flexible elongated inner tube layer that is to be removed.

The operation of apparatus 200 will now be described in conjunction with Figures 3C, 3D and 3E. Figure 3C is a general longitudinal perspective illustration in partial exploded view of the apparatus coupled with the multi-layer endotracheal tube, of Figures 3A and 3B, showing the removal of an inner tube layer from the multi-layer endotracheal tube and through the apparatus. Figure 3D is a schematic cross-sectional illustration in longitudinal section view of Figure 3C, depicting the apparatus coupled with the multi-layer endotracheal tube. Figure 3E is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube, in another operative state.

As with the previous embodiment (i.e., described in conjunction with Figures 2A-2E), it is taken into account that the patient is intubated with multi-layer ETT 102, via distal end 146 thereof and ventilation port section 208 is connected to an external fluid delivery source (e.g., a ventilator). Flexible elongated inner tube layers 140 and 142 are removed successively, beginning with the innermost layer (142), continuing through a plurality of intermediate inner tube layers (not shown), and ending with the outermost layer (140). For this purpose, closure cap 216 is preliminarily removed and removal handle 212 is revealed underneath, as shown in Figures 3C and 3D. The medical practitioner grasps and pulls removal handle 212, along with flexible elongated inner tube layer 142 that is pulled via withdrawal mechanism 228, concomitantly. Removal handle 214 is revealed underneath, as shown in Figure 2C, and the process repeats, with the next successive inner layer, namely, flexible elongated 2011/000924 inner tube layer 140 (Figure 3B) pulled via withdrawal mechanism 230. During extraction of the inner tube layers via removal port section 210, there is no cessation of ventilation to the patient (i.e., no disconnection of the external fluid delivery source (e.g., the ventilator) from ventilation port section 208).

Typically after the complete extraction of each flexible elongated inner tube layer, closure cap 216 is set in position such that it seals the opening of removal port section 210. Figure 3E illustrates that removal handle 214 along with flexible elongated inner tube layer 140 and withdrawal mechanism 230 remain after removal handle 212 along with flexible elongated inner tube layer 142 and withdrawal mechanism 228 have been removed. Other flexible inner tube layers may similarly be successively extracted. Closure cap 216 is placed in position, thus hermetically sealing the opening of removal port section 210 from potential entry and exit of fluids (e.g., ventilation gases, exhaled CO₂ of the patient).

According to a further embodiment of the disclosed technique, inner tube layers of the multi-layer endotracheal tube are successively extracted from a removal port that is situated at a position along the length of the outer flexible elongated tube. A description greater in detail is hereby provided with reference that is now made to Figures 4A and 4B. Figure 4A is a general perspective illustration in a longitudinal cut-away view of an apparatus, generally referenced 300, coupled with a multi-layer endotracheal tube, constructed and operative in accordance with a further embodiment of the disclosed technique. Figure 4B is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 4A in a particular operative state. The bottom illustration in Figure 4B depicts an enlargement of the encircled portion of the top illustration. The current embodiment, as with previous described embodiments, hereinabove, is constructed and operative to be coupled with multi-layer ETT 102. 0924

Apparatus 300 includes at least one removal port section 302, at least one removal handle (two removal handles 304 and 306 are shown in Figures 4A and 4B), and at least one removable port seal, denoted herein as closure cap 308. Generally, for each removal section there is provided a respective closure cap. Removal port section 302 is situated at a position along the length of the general longitudinal axis C of outer flexible elongated tube 138, between a proximal end 144 and a distal end 146 thereof. Removal port section 302 is embodied as an aperture 310 within outer flexible elongated tube 138, through which inner layers of multi-layer ETT 102 can be removed. Aperture 310 and removal port section 302 are of such dimensions as to accommodate removal handles 304 and 306, (i.e., as well as being considerably shorter in length in comparison with the length of multi-layer ETT 102). Each removal handle is coupled with a respective proximal end of a flexible elongated inner tube layer. Specifically, removal handle 304 is coupled with flexible elongated inner tube layer 142 at proximal end 152 thereof, and removal handle 306 is coupled with flexible elongated inner tube layer 140 at proximal end 150. This coupling is typically made adhesively. Alternatively, this coupling is achieved by employing other fastening techniques, such as mechanical fastening (e.g., via riveting), and the like. Flexible elongated inner tube layers 140 and 142 are constructed to extend substantially within and along the inner length of outer flexible elongated tube 138 (Figure 4A). In the operational state illustrated in Figures 4A and 4B, closure cap 308 securely covers aperture 310 of removal port section 302, thus defining a closed configuration, in which aperture 310 is hermetically sealed from potential entry and exit of fluids (e.g., ventilation gases). In an alternative, optional embodiment (not shown) a plurality of removal port sections (not shown) are situated at different length-wise positions along the length of outer flexible elongated tube 138.

The operation of apparatus 300 will now be described in conjunction with Figures 4C, 4D and 4E. Figure 4C is a general P T/IL2011/000924 longitudinal perspective illustration in partial exploded view of the apparatus coupled with the multi-layer endotracheal tube, of Figures 4A and 4B, showing the removal of an inner tube layer from the multi-layer endotracheal tube. Figure 4D is a schematic cross-sectional illustration in longitudinal section view of Figure 4C of the apparatus coupled with the multi-layer endotracheal tube. Figure 4E is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube, in another operative state.

While the patient is intubated (not shown) with multi-layer ETT 102, via distal end 146 thereof, and ventilated by an external fluid delivery source (e.g., a ventilator), via proximal end 144, flexible elongated inner tube layers may be successively removed from multi-layer ETT 102, through removal port section 302. Figures 4C and 4D illustrate the procedure of removing flexible elongated inner tube layer 142 through removal port section 302, following initial removal of closure cap 308 from the closed configuration. Closure cap 308 is now depicted as being in an open configuration, detached from removal port section 302. By pulling removal handle 304, flexible elongated inner tube layer 142, being the innermost layer, is removed first, along with accumulated biological material (not shown) contained within and that is adhered to the inner surface thereof. Figures 4C and 4D show the partial extraction of flexible elongated inner tube layer 142 from containment within outer flexible elongated tube 138. In this manner, successively layered inner tube layers are sequentially removed. For example, flexible elongated inner tube layer 140 may subsequently be removed by gradually pulling its respective removal handle 306, until its complete extraction (not shown) from outer flexible elongated tube 138 through removal port section 302. During the withdrawal of the flexible elongated inner tube layers, there is no cessation of ventilation to the patient (i.e., no disconnection of the external fluid delivery source (e.g., the ventilator) from multi-layer ETT 102. 2011/000924

Following withdrawal of one of the flexible elongated inner tube layers, closure cap 308 may be set to the closed configuration, where it seals aperture 310 of removal port section 302, and until it is time to withdraw a next inner tube layer. Figure 4E illustrates closure cap 308 being in a closed configuration after extraction of both flexible elongated inner tube layer 142 and its associated removal handle 304 from within multi-layer ETT 102. Flexible elongated inner tube layer 140 and its associated removal handle 306 remains within the confines of outer flexible elongated tube 138, removal port section 302 and closure cap 308.

According to another embodiment of the disclosed technique, an apparatus having a plurality of coaxially layered tubular removal covers is provided for facilitating sequential extraction of inner tube layers of a multi-layer ETT. A more detailed description is hereby provided with reference that is now made to Figures 5A and 5B. Figure 5A is a general perspective illustration in a longitudinal cut-away view of an apparatus, generally referenced 400, coupled with a multi-layer endotracheal tube, constructed and operative in accordance with another embodiment of the disclosed technique. Figure 5B is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube of Figure 5A in a particular operative state. The bottom illustration in Figure 4B depicts an enlargement of the encircled portion of the top illustration. As with embodiments described hereinabove, the current embodiment is constructed and operative to be coupled with multi-layer ETT 102.

Apparatus 400 includes an external tubular removal cover 402, a plurality of coaxially layered tubular inner removal covers (two are shown and numbered 404 and 406), an endotracheal tube (ETT) coupling adapter 408, a ventilation port adapter 410, and a plurality of withdrawal mechanisms 412 and 414. ETT coupling adapter 408 is shaped such to include an inner engaging portion 416, an outer engaging portion 418, an annular flange 420, and an external removal cover engagement portion 422. External tubular removal cover 402 includes a fastener 424 formed on an outer peripheral edge thereof. Coaxially layered tubular inner removal covers 404 and 406 are preferably constructed to be of tubular form, however, their shape is not particularly limited to such geometry (i.e., they may assume other forms, for example, they may be faceted).

Figures 5A and 5B illustrate apparatus 400 in its initial operative state, such that it is coupled with proximal end 144 of outer flexible elongated tube 138 of multi-layer ETT 102. Particularly, ETT coupling adapter 408 is securely mounted (i.e., coupled) onto proximal end 144 such that inner engaging portion 416 engages and presses against inner surface 148 and outer engaging portion 418 engages and presses against the outer surface of outer flexible elongated tube 138 so as to provide a cooperative engagement therebetween to prevent inadvertent removal (i.e., decoupling). Apparatus 400 is constructed such that the outermost tubular inner removal cover 404 encapsulates (i.e., substantially encloses) the successive layered tubular inner removal cover 406 (innermost) along the axial direction, defined by the longitudinal axis D of apparatus 400, so that each engages annular flange 420. Ventilation port adapter 410 is coupled with external tubular removal cover 402 along the axial direction, as shown in Figures 5A and 5B. Ventilation port adapter 410 defines a passageway 426 through which ventilation gases (as well as medication) are transported to and fro the patient via multi-layer ETT 102. Although, only two coaxially layered tubular inner removal covers are shown for the sake of simplicity, the disclosed technique is not limited to two, as principally it applies to more.

Generally, each coaxially layered tubular inner removal cover is coupled with a respective withdrawal mechanism. Particularly, tubular inner removal cover 404 is coupled with withdrawal mechanism 412, which in turn is coupled to proximal end 152 of flexible elongated inner tube layer 142. Likewise, tubular inner removal cover 406 is coupled with withdrawal mechanism 414, which in turn is coupled to proximal end 150 of flexible elongated inner tube layer 140. Withdrawal mechanisms 412 and 414 are similar in construction and operation to withdrawal mechanisms 154 and 156 (Figure 2B). External tubular removal cover 402 encases the coaxially layered tubular inner removal covers, thereby defining a closed state, so as to provide a substantially airtight sealing from the exposure of fluids (e.g., ventilation gases) and biological material (e.g., microorganisms, bacteria, secretions). In the closed state of external tubular removal cover 402, fastener 424 superimposes over external removal cover engagement portion 422, so as to lock and retain the relative positions of external tubular removal cover 402 and ETT coupling adapter 408, to prevent inadvertent removal during ventilation.

The procedure of extracting the flexible elongated inner tube layers from within multi-layer ETT 102 by employing apparatus 400 will now be described in conjunction with Figures 5C, 5D and 5E. Figure 5C is a general longitudinal perspective illustration in partial exploded view of the apparatus coupled with the multi-layer endotracheal tube, of Figures 5A and 5B, showing the removal of an inner tube layer from the multi-layer endotracheal tube. Figure 5D is a schematic cross-sectional illustration in longitudinal section view of Figure 5C of the apparatus coupled with the multi-layer endotracheal tube. Figure 5E is a schematic cross-sectional illustration in longitudinal section view of the apparatus coupled with the multi-layer endotracheal tube, in another operative state. The bottom positioned illustrations in Figures 5D and 5E depict enlargements of a respective encircled portion to their respective top positioned illustrations.

The extraction of flexible elongated inner tube layers from within multi-layer ETT 102 is typically performed while the patient is intubated (not shown) with multi-layer ETT 102, via distal end 146 thereof, and ventilated by a ventilating machine via passageway 426 of ventilation port adapter 410. To extract (the innermost) flexible elongated inner tube layer 142, external tubular removal cover 402 has to be initially decoupled from ETT coupling adapter 408, by disengaging fastener 424 from the coupling with external removal cover engagement portion 422. External tubular removal cover 402 may typically further include internal threads 428 for screwing onto complementary external threads 430 (Figures 5C and 5B) helically formed on annular flange 420. Figures 5C and 5D illustrate that external tubular removal cover 402 is in an open state (i.e., decoupled from ETT coupling adapter 408).

Following the removal of external tubular removal cover 402, tubular inner removal cover 404 is exposed and may be removed by the medical practitioner. Figures 5C and 5D show the partial extraction of flexible elongated inner tube layer 142, together with its associated withdrawal mechanism 412, by the pulling of tubular inner removal cover 404 from attachment to ETT coupling adapter 408. As tubular inner removal cover 404 is being removed the next coaxially layered tubular inner removal cover 406 is revealed underneath, and the process may repeat until expiration (not shown) of all of the tubular inner removal covers and flexible elongated inner tube layers associated therewith.

Subsequent to the withdrawal of each flexible elongated inner tube layer, external tubular removal cover 402 may be repositioned in the closed state, until it is time to withdraw the next inner tube layer. Figure 5E illustrates external tubular removal cover 402 being in a closed state, where it hermetically encloses the remaining tubular inner removal cover 406.

Although the foregoing description of the embodiments each detail the extraction of one flexible elongated inner tube layer at a time (i.e., the preferred extraction method), apparatuses 00, 200, 300 and 400 are also operational, and not limited to, in the case of simultaneous extractions of a plurality of flexible elongated inner tube layers.

It will be appreciated by persons skilled in the art that the disclosed technique is not limited to what has been particularly shown and described hereinabove. Rather the scope of the disclosed technique is defined only by the claims, which follow.

Claims

An apparatus for facilitating removal of at least one inner layer from a multi-layer endotracheal tube, the multi-layer endotracheal tube includes an outer tube and at least one inner layer that extends substantially within and at least partially along inner length of the outer tube, the outer tube includes a proximal end and a distal end that define an inner surface therebetween, the inner layer includes a proximal end and a distal end that define an outer surface and an inner volume therebetween, the inner layer is detachably coupled with the inner surface of the outer tube, the apparatus comprising:

an endotracheal tube connection port section for coupling said apparatus with said outer tube;

a ventilation connection port section for coupling said apparatus with an external fluid delivery source;

at least one removal port section for facilitating removal of said at least one inner layer therethrough; and

at least one removal handle at least partially located in said at least one removal port section, each of said at least one removal handle coupled with a respective said at least one inner layer, wherein pulling of said at least one removal handle from respective said at least one removal port withdraws said at least one inner layer via said respective said at least one removal port section, wherein said apparatus enabling fluid communication between said external fluid delivery source and said inner volume.

The apparatus according to claim 1 , wherein said at least one removal handle is coupled with a respective said at least one inner layer via a withdrawal mechanism.

The apparatus according to claim 2, wherein said withdrawal mechanism is selected from a list consisting of: material whose composition is substantially similar to composition of said removal handle;

material whose composition is the same as composition of said removal handle;

material whose composition is substantially similar to composition of said at least one inner layer;

material whose composition is the same as composition of said at least one inner layer;

cord;

string;

cable;

filament:

spring;

wire;

rod;

shaft;

sheet; and

thread.

4. The apparatus according to claim 1 , further comprising a removable port seal for coupling with said at least one removal port section, after removal of respective said removal handle along with said respective said at least one inner layer.

5. The apparatus according to claim 1 , wherein at least a portion of said at least one removal handle is marked such to denote a removing sequence for withdrawal of the respective said at least one f inner layer.

6. The apparatus according to claim 1 , wherein each of said at least one removal handle is constructed to be successively layered, one over the respective other said at least one removal handle, in an incremental manner.

7. The apparatus according to claim 1 , further comprising a removable port seal for substantially sealing a respective opening of said at least one removal port section from fluids.

8. An apparatus for facilitating removal of at least one inner layer from a multi-layer endotracheal tube, the multi-layer endotracheal tube includes an outer tube and at least one inner layer that extends substantially within and at least partially along inner length of the outer tube, the outer tube includes a proximal end and a distal end that define an inner surface therebetween, the inner layer includes a proximal end and a distal end that define an outer surface and an inner volume therebetween, the inner layer is detachably coupled with the inner surface of the outer tube, the apparatus comprising:

at least one removal port section for facilitating removal of said at least one inner layer therethrough, said at least one removal port section located at a position along partial length of said outer tube; and

at least one removal handle coupled with a respective said at least one inner layer, said at least one removal handle operative to detach respective said at least one inner layer from within said outer tube, so as to enable withdrawal of said at least one inner layer via said respective said at least one removal port section.

9. The apparatus according to claim 8, further comprising a removable port seal for substantially sealing a respective opening of said at least one removal port section from fluids.