ENDOTRACHEAL TUBE WITH VISUALIZATION CAPABILITIES AND A LARYNGEAL MASK

Abstract

A method for intubation of a patient comprising: providing an LMA and an endotracheal tube, wherein the endotracheal tube comprises a visualization device and wherein the endotracheal tube is adapted for passing through the LMA; positioning the LMA in the patient; and guiding the endotracheal tube with the aid of the visualization device through the LMA for positioning in the trachea of the patient. The method preferably further comprises removing the LMA from the patient following the positioning of the endotracheal tube while leaving the endotracheal tube in position.

Claims

1. A method for intubation of a patient comprising: positioning a laryngeal mask airway (LMA) in the patient, the LMA comprising a tube connected at a distal end thereof to a mask portion; positioning an endotracheal tube in the LMA, the endotracheal tube sized and configured to pass through the tube of the LMA and comprising a visualization device at a distal end of the endotracheal tube, the visualization device structured to provide visual images of a distal space distal of the visualization device; guiding the endotracheal tube through the LMA while visualizing the distal space; and positioning the distal end of the endotracheal tube in the trachea of the patient.

2. The method of claim 1, wherein said endotracheal tube comprises a single ventilation lumen, a fluid injection channel formed in a wall of the endotracheal tube and extending longitudinally adjacent the single ventilation lumen, and a nozzle fluidly coupled to the fluid injection channel, wherein said visualization device comprises a lens at a distal end thereof, wherein said endotracheal tube further comprises an injection connector in fluid communication with said nozzle, the method further comprising injecting a fluid through the injection connector to discharge the fluid through the nozzle to clean said lens.

3. The method of claim 1, further comprising removing said LMA from the patient following said positioning while leaving said endotracheal tube positioned in the trachea.

4. The method of claim 3, further comprising connecting said visualization device to a display device prior to said guiding of said endotracheal tube through said LMA.

5. The method of claim 4, further comprising: connecting said LMA to a ventilator following said positioning of said LMA in the patient; disconnecting said LMA from said ventilator prior to said guiding of said endotracheal tube through said LMA; and connecting said endotracheal tube to said ventilator following said positioning in the trachea of the patient.

6. The method of claim 5, further comprising disconnecting said ventilator and said visualization device from said endotracheal tube prior to said removing of said LMA.

7. The method of claim 6, wherein said mask portion comprises an LMA cuff, further comprising inflating said LMA cuff following said positioning of said LMA in the patient and deflating said LMA cuff prior to said removing of said LMA.

8. The method of claim 7, wherein said endotracheal tube comprises a tracheal cuff, the method further comprising inflating said tracheal cuff following said positioning in the trachea of the patient.

9. The method of claim 8, wherein said endotracheal tube comprises a light source, a single ventilation lumen, and a visualization channel formed in a wall of the endotracheal tube and extending longitudinally adjacent the single ventilation lumen, and wherein said visualization device and said light source are positioned in the visualization channel.

10. The method of claim 8, wherein said endotracheal tube comprises a single ventilation lumen, a fluid injection channel formed in a wall of the endotracheal tube and extending longitudinally adjacent the single ventilation lumen, and a nozzle fluidly coupled to the fluid injection channel, wherein said visualization device comprises a lens at a distal end thereof, wherein said endotracheal tube further comprises an injection connector in fluid communication with said nozzle, the method further comprising injecting a fluid through the injection connector to discharge the fluid through the nozzle to clean said lens.

11. A system for intubation of a patient, the system comprising: a laryngeal mask airway (LMA) including a tube fluidly coupled to a mask portion; and an endotracheal tube including a ventilation lumen, a visualization channel formed in a wall of the endotracheal tube longitudinally adjacent the ventilation lumen, a visualization device, and a light source, the visualization device and the light source positioned in the visualization channel at a distal end thereof, the endotracheal tube sized and configured to pass through the tube of the LMA, whereby said light source illuminates a distal space distal of the visualization device, and the visualization device captures images of tissues in the distal space to aid in guiding the endotracheal tube in the patient via said LMA.

12. The system of claim 11, wherein said endotracheal tube comprises a fluid injection channel formed in a wall of the endotracheal tube and extending longitudinally adjacent the ventilation lumen, and a nozzle fluidly coupled to the fluid injection channel, wherein said visualization device comprises a lens at a distal end thereof, wherein said endotracheal tube further comprises an injection connector in fluid communication with said nozzle, and wherein a fluid injected through the injection connector discharges through the nozzle to clean said lens.

13. The system of claim 12, wherein the nozzle is structured to discharge the fluid at an angle to the ventilation lumen.

14. The system of claim 11, further comprising a display device electrically coupled to the visualization device and configured to present the images.

15. The system of claim 11, wherein the mask portion comprises an inflatable LMA cuff.

16. The system of claim 11, wherein the endotracheal tube includes an inflatable tracheal cuff.

17. The system of claim 11, the endotracheal tube further including a light source and a visualization channel formed in the wall of the endotracheal tube and extending longitudinally adjacent the ventilation lumen, wherein the visualization device and the light source are positioned in the visualization channel adjacent a distal end thereof.

18. The system of claim 11, wherein said endotracheal tube comprises at least two fluid injection channels formed in a wall of the endotracheal tube and extending longitudinally adjacent the ventilation lumen on each side of the visualization lumen, an arc from one of the at least two fluid injection channels to another of the at least two fluid injection channels spanning less than 50% of a periphery of an external surface of the endotracheal tube, and at least two nozzles fluidly coupled to the at least two fluid injection channels, wherein said visualization device comprises a lens at a distal end thereof, wherein said endotracheal tube further comprises an injection connector in fluid communication with said at least two nozzle, and wherein a fluid injected through the injection connector discharges through the at least two nozzles to clean said lens.

19. The system of claim 18, wherein the arc from one of the at least two fluid injection channels to another of the at least two fluid injection channels spans less than 30% of the periphery of the external surface of the endotracheal tube.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The embodiments herein are 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 disclosure 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 embodiments. In this regard, no attempt is made to show structural details of the embodiments in more detail than is necessary for a fundamental understanding of the exemplified embodiments. The description taken with the drawings making apparent to those skilled in the art how the several forms of the disclosed embodiments may be embodied in practice. In the drawings:

[0035] FIG. 1 shows an isometric view of an embodiment of an endotracheal tube;

[0036] FIG. 2 shows another view of the embodiment of the endotracheal tube of FIG. 1;

[0037] FIG. 3A shows an enlarged view of the distal end of the endotracheal tube of FIG. 1;

[0038] FIG. 3B shows a cutaway view of the distal end and inflatable cuff of the endotracheal tube of FIG. 1;

[0039] FIG. 3C shows a partial cutaway view of the endotracheal tube of FIG. 1;

[0040] FIG. 3D shows a cross-section of the tube portion of the endotracheal tube of FIG. 1 illustrating various lumens and channels;

[0041] FIG. 3E is a schematic diagram showing the end-to-end tubes, channels and lumens provided within an endotracheal tube according to some embodiments;

[0042] FIG. 4 shows an embodiment of an LMA;

[0043] FIGS. 5A and 5B show perspective and side views of an endotracheal tube placed within an LMA to form an LMA system 300 according to some embodiments; and

[0044] FIG. 5C is a flow diagram describing a preferred method for intubation of a patient using the LMA system of FIGS. 5A and 5B.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0045] The principles and operation of the disclosed embodiments may be better understood with reference to the drawings and the accompanying description. The following reference labels are used throughout the drawings to refer to objects having similar function, meaning, role, or objective: [0046] Endotracheal intubation system 100 [0047] Endotracheal tube 101 [0048] Visualization device 102 [0049] Tip 103 [0050] Tracheal cuff 104 [0051] Inner tube diameter 105 [0052] Outer tube diameter 106 [0053] Nozzles 107 [0054] Visualization cable 109 [0055] Ventilation lumen 110 [0056] Inflation tube 111 [0057] Inflation connector 112 [0058] Injection tube 113 [0059] Murphy eyes 114 [0060] Proximal end 115 [0061] Distal end 116 [0062] Aperture 117 [0063] Injection port 118 [0064] Visualization connector 119 [0065] Ventilator connector 120 [0066] Lens 121 [0067] Visualization channel 122 [0068] Tracheal cuff inflator port 123 [0069] Tracheal cuff inflator channel 124 [0070] Light source 126 [0071] Pilot balloon 128 [0072] Tube wall 130 [0073] Seal 132 [0074] Injection channels 133 [0075] Display device 140 [0076] Visualization notch 142 [0077] Inflation notch 144 [0078] Injection notch 146 [0079] Stylet 160 [0080] LMA 200 [0081] LMA tube 201 [0082] LMA tracheal opening 202 [0083] LMA outer opening 203 [0084] LMA cuff 204 [0085] LMA connector 208 [0086] LMA inflation tube 211 [0087] LMA inflation connector 212 [0088] Proximal end 215 of LMA 200 [0089] Distal end 216 of LMA 200 [0090] LMA pilot balloon 228 [0091] LMA system 300

[0092] In some embodiments an endotracheal tube with visualization capabilities that also features a laryngeal mask is disclosed. The endotracheal tube preferably has continuous and long term visualization capabilities, such that at least a portion of the patient's airways can be visualized for an extended period of time. By “extended period of time” it is meant at least one hour, two hours and so forth up to twenty-four hours; at least one day, two days, and so forth up to one week; one week, two weeks and so forth up to one month; or any period of time in between measured in at least increments of one minute. The endotracheal tube preferably features a single ventilation lumen.

[0093] The portion of the patient's airways that can be visualized preferably includes (upon entry) the oral cavity, esophagus, larynx and trachea; and (after being placed at the location for the extended period of time) the tracheal carina and at least a portion of a bronchus, optionally and more preferably portions of both bronchi.

[0094] FIGS. 1 and 2 show isometric and side views of an embodiment of an endotracheal intubation system 100 including an endotracheal tube 101 for insertion into a subject (not shown). Endotracheal tube 101 includes a proximal end 115 opposite a distal end 116. As described herein, the terms “proximal” and “distal” are defined with regard to the point of entry to the subject, so that proximal end 115 as shown remains outside the subject, while distal end 116 as shown enters the subject. Endotracheal intubation system 100 optionally also includes a stylet 160.

[0095] A ventilator connector 120 connects endotracheal tube 101 to a breathing circuit coupled to a ventilator (not shown). A tip 103 of endotracheal tube 101 is located at distal end 116. Tip 103 features an aperture 117 for permitting two-way passage of fluids, including but not limited to gasses, into and out of the subject (not shown). The diameter of aperture 117 is defined with regard to an inner diameter of tube 101 as described in greater detail below.

[0096] Endotracheal tube 101 includes a visualization device 102 located at tip 103 for visualizing at least a portion of the airways of the subject as described above. Visualization device 102 may optionally comprise any suitable type of image sensor, including but not limited to a CCD image sensor or CMOS image sensor. Visualization device 102 is optionally in data communication with a visualization connector 119 through a visualization cable 109 (shown in FIG. 3B) to permit image data obtained with a visualization device 102 to be transferred to a display device 140 (shown in FIG. 3E), such as a video monitor. By “data communication” it is meant any type of communication means for transmitting data, including but not limited to wired or wireless (not shown) communication. If visualization connector 119 is not present, optionally visualization device 102 may communicate directly, wirelessly with an external device (not shown). As shown, in a wired connection embodiment, connector 119 is connected to visualization device 102 via visualization cable 109 which passes through the wall 130 (FIG. 3D) of tube 101 as described further below. Visualization cable 109 also provides electrical power to visualization device 102.

[0097] Endotracheal tube 101 also includes a tracheal cuff 104 located between proximal end 115 and distal end 116, but preferably closer to distal end 116. Tracheal cuff 104 is preferably deflated upon insertion of endotracheal tube 101 to the subject and is then inflated once endotracheal tube 101 is in place to maintain the position of endotracheal tube 101 within the subject. Cuff 104 is here shown as inflated. Inflation is controlled through a tracheal cuff connector 112, connected to an inflation tube 111 which is in fluid communication with cuff 104. Connector 112 comprises a pilot balloon 128 which provides an indication of the inflation status of cuff 104. When balloon 128 is inflated, cuff 104 is also inflated.

[0098] Endotracheal tube 101 further includes an injection port 118 connected to injection tubes 113. Optionally and preferably, injection tubes 113 are provided, for example, to permit injection of fluids for cleaning visualization device 102. Injection tubes 113 are in fluid communication with nozzles 107 (described further below with reference to FIG. 3A) positioned adjacent visualization device 102. Optionally only one injection tube is provided.

[0099] Optionally and preferably, endotracheal tube 101 features at least one and preferably a plurality of Murphy eyes 114 to provide adequate airflow performance through the tube since aperture 117 is narrowed due to the presence of visualization device 102. Murphy eyes 114 also permit entry of air to the subject in case aperture 117 becomes blocked. Optional stylet 160 is inserted into endotracheal tube 101 and is used to shape endotracheal tube 101 prior to insertion or during insertion of tube 101 into a patient as known in the art. Stylet 160 is then removed.

[0100] Reference is now made to FIG. 3A which shows an enlarged view of tip 103 of endotracheal tube 101. FIG. 3A shows visualization device 102, including a lens 121, a pair of light sources 126 adjacent lens 121, and a pair of nozzles 107 located on each side of visualization device 102. Visualization device 102 is provided for visualization of the subject as tip 103 is inserted into the subject. After insertion, visualization device 102 is used to confirm that endotracheal tube 101 remains correctly positioned within the subject by visualizing the field (area) surrounding tip 103. Lens 121 covering lenses and an image sensor (not shown). Light source 126 may comprise one or more LEDs, optical fibers, a waveguide, a light guide, or any combination of these. Visualization device 102 preferably has a horizontal angle of view of between 50°-120°, more preferably between 70° and 80° and more preferably 76°. Visualization device 102 preferably has a vertical angle of view of between 50°-120°, more preferably between 50° and 60° and more preferably 56°. The visualization device preferably has a diagonal angle of view of between 50°-120°, more preferably between 90° and 110° and more preferably 100°. The visualization device preferably has a focus range of between 5-150 mm and more preferably between 12-60 mm.

[0101] Nozzles 107 are positioned and angled to aim a stream of fluid, such as a liquid or gas, toward or at visualization device 102 in order to clean lens 121. In one example, visualization device 102 and light sources 126 are positioned in a housing embedded in a channel formed in the wall 130 (shown in FIG. 3D) of endotracheal tube 101. In one example, nozzles 107 comprise the distal ends of fluid injection channels formed in the wall of endotracheal tube 101. In one variation, nozzles 107 are made by forming apertures at an angle to a longitudinal axis of the fluid injection channels and fluidly coupling therewith. The apertures may be made by laser drilling the apertures on the wall of the endotracheal tube 101. The angle at which the nozzles are formed enables aiming of the fluid toward visualization device 102. In another example, nozzle inserts are inserted into the fluid injection channels. A nozzle insert may comprise an aperture formed at an angle to the longitudinal axis of a corresponding fluid injection channel and may be rotated to aim the fluid toward visualization device 102.

[0102] Reference is now made to FIGS. 3B and 3C which show complete and partial cut-away views of the illustrative single lumen endotracheal tube 101 and tracheal cuff 104. As shown, endotracheal tube 101 comprises an external wall 130 with a plurality of internal channels or lumens including a ventilation lumen 110, a visualization channel 122, and an inflation channel 124. Ventilation lumen 110 is provided for conveying gasses into and out of the subject; as such, ventilation lumen 110 is typically the largest lumen within endotracheal tube 101. Ventilation lumen has a proximal end adjacent connector 120 and a distal end at aperture 117.

[0103] Visualization channel 122 is embedded in wall 130 of endotracheal tube 101 and preferably provides a path for cable 109 for connecting visualization device 102 to visualization connector 119. Visualization channel 122 has a proximal end adjacent to ventilator connector 120 and a distal end that houses visualization device 102.

[0104] Tracheal cuff 104 is fixedly attached to the external surface of endotracheal tube 101. Tracheal cuff 104 is inflated through a tracheal cuff inflator port 123 which extends from ventilation channel 124 and opens into the inner volume of cuff 104 as shown. Tracheal cuff inflator port 123 receives air from enclosed tracheal cuff inflator channel 124, which is embedded in the wall 130 of endotracheal tube 101 and which is in fluid communication at its proximal end with inflation tube 111, which in turn receives air through inflation connector 112 as previously described. Tracheal cuff inflator channel 124 is sealed at its distal end by a seal 132. Air may be injected into inflation connector 112 via an injection means such as a syringe or may be via mechanical means. A plurality of Murphy eyes 114 are provided as shown.

[0105] Reference is now made to FIG. 3D which shows a cross-section A-A as shown in FIG. 3B of an endotracheal tube according to some embodiments. FIG. 3D shows channels embedded in the external wall 130 of endotracheal tube 101, including ventilation lumen 110, visualization channel 122, tracheal cuff inflator channel 124, and a pair of fluid injection channels 133 that feed nozzles 107. Injection channels 133 are enclosed channels and are in fluid communication with injection tubes 113. The inner space within endotracheal tube 101 defines ventilation lumen 110.

[0106] More preferably, the outer diameter 106 of the endotracheal tube is in a range of from 10 mm to 11 mm, such that the maximum outer diameter 106 of the endotracheal tube along the its length extending from the proximal end until tip 103 is preferably no more than 11 mm. At the tip 103 of endotracheal tube 101 the diameter is larger to accommodate the visualization device 102 and the maximum diameter of tip 103 preferably does not exceed 13 mm. Optionally, in some embodiments, the outer diameter of endotracheal tube 101 may not exceed 14 mm at any point along its length. In some embodiments, the inner diameter 105 may range from 7 mm to 8 mm.

[0107] Reference is now made to FIG. 3E which is a schematic diagram showing the end-to-end tubes, channels and lumens provided within an endotracheal tube according to some embodiments. As shown, endotracheal tube 101 comprises wall 130 with embedded channels including inflator channel 124 for inflating tracheal cuff 104. Inflator channel 124 is in fluid communication at its proximal end with tube 111 which is connected to connector 112. Inflation tube 111 enters the proximal end of endotracheal tube 101 into wall 130 at inflation notch 144 and is connected thereafter to inflation channel 124. Inflation channel 124 is sealed at its distal end by seal 132 and is in fluid communication with the interior of cuff 104 via inflator port 123.

[0108] Enclosed injection channels 133 are in fluid communication at their distal ends with nozzles 107 and at their proximal ends with injection tubes 113 which in turn are connected to injection port 118. Injection tubes 113 enter the proximal end of endotracheal tube 101 into wall 130 at injection notches 146 and are connected thereafter to injection channels 133.

[0109] Visualization channel 122 provides a path through wall 130 for visualization cable 109 and additionally houses visualization device 102 interior and adjacent to the distal end of visualization channel 122. Cable 109 is connected at its proximal end to connector 119 which is optionally connected to optional display device 140 for displaying still images or video received from visualization device 102. Cable 109 enters channel 122 via visualization notch 142.

[0110] The inner space within endotracheal tube 101 defines ventilation lumen 110 which is provided at its proximal end with connector 120 and at its distal end with aperture 117 and Murphy eyes 114.

[0111] FIG. 4 shows an embodiment of an LMA 200 featuring an LMA tube 201 for bi-directional transmission of fluids, which optionally and preferably include gases. LMA tube 201 comprises an LMA outer opening 203 at a proximal end 215 of LMA 200. Removable LMA connector 208 is shown inserted into opening 203. An LMA tracheal opening 202 is located at a distal end of tube 201, near or at inflatable LMA cuff 204 which is located at a distal end 216 of LMA 200. LMA cuff 204 is connected to LMA inflation tube 211 which in turn is connected to LMA inflation connector 212. Connector 212 further comprises an LMA pilot balloon 228 providing an indication of the inflation status of LMA cuff 204. LMA cuff 204 is inflated by pumping air into inflation connector 212. Outer opening 203 and tracheal opening 202 are in fluid communication via tube 201. LMA 200 preferably has an internal diameter of between 12 and 13 mm.

[0112] FIG. 5A shows endotracheal tube 101 placed within LMA 200 to form an LMA system 300 according to some embodiments. To enable insertion of endotracheal tube 101 into LMA 200, LMA connector 208 (not shown in FIG. 5A) is removed, and cuff 104 is deflated. Use of LMA 200 eases the insertion and positioning of endotracheal tube 101 as LMA 200 provides a guide for endotracheal tube 101 to ease the positioning thereof in the trachea (not shown). Once endotracheal tube 101 is positioned, tracheal cuff 104 is inflated to secure endotracheal tube 101 before LMA 200 is removed from the patient leaving endotracheal tube 101 in position. The external diameter of tube system 100 is such that it can pass completely through the inner diameter of tube 201 of LMA 200 in either direction. Thus LMA 200 can be removed from the patient over endotracheal tube 101 while endotracheal tube 101 is in position. Additionally the positions of notches 142, 144, and 146 are staggered and are not equidistant from the proximal end of endotracheal tube 101 to allow for each of tubes 111 and 113 as well as cable 109 to pass through LMA 200. Further, visualization connector 119 is sized to pass through the inner diameter of LMA tube 201. Connector 120 may be placed on endotracheal tube 101 after LMA 200 has been removed.

[0113] FIG. 5B shows a cut-away view of LMA system 300. Proximal end 216 and distal end 215 of LMA 200 are shown with LMA 200 placed over endotracheal tube 101, such that LMA tube 201 slides over endotracheal tube 101. Proximal end 115 and distal end 116 of endotracheal tube 101 are visible. LMA tracheal opening 202 and a LMA outer opening 203 permit gasses to flow into and out of the patient (not shown) via the inserted tube system 100.

[0114] Reference is now made to FIG. 5C which is a flow diagram describing a preferred method for intubation of a patient using the LMA system described herein according to some embodiments. In the described method of FIG. 5C, the LMA 200 is first positioned in the patient before the tube system 100 is inserted. At this stage the LMA cuff 204 of LMA 200 is deflated. In stage 1, a lubricant is applied to the external surface of the LMA to ease insertion and the LMA 200 is inserted into the patient via the patient's mouth and positioned over the trachea of the patient.

[0115] In stage 2, LMA cuff 204 is inflated to secure LMA 200 in position. At this stage the LMA may be connected to a ventilation device if required. In stage 3 connector 208 is removed along with any ventilation device connection if in place. In stage 4 visualization connector 119 is connected to display device 140 and visualization device 102 of tube system 100 is activated. The display device provides power to the visualization device and displays the image and/or video captured by the visualization device. In stage 5, a lubricant is applied to the external surface of endotracheal tube 101 to ease its insertion through LMA tube 201 and tube system 100 is inserted into the patient via the in-place LMA 200. Optionally stage 4 (connection of the visualization device) may take place after stage 5 or at any time prior to insertion of endotracheal tube 101 into the subject. In stage 6, with the aid of the video feed from device 102 tube system 100 is passed into the trachea of the patient until it is in the correct position.

[0116] With the tube system 100 in place, cuff 104 is now inflated at stage 7. In stage 8 a ventilation device may be connected to ventilator connector 120. Optionally, stage 8 (ventilation) may take place before stage 7 (cuff inflation). Optionally, a fluid is injected through injection port 118 that will exit through nozzles 107 to clean lens 121.

[0117] Once cuff 104 is inflated, tube system 100 is secured in position and in stages 9 to 11 LMA 200 is removed. In stage 9 preparation is made for removal of LMA 200. Stage 9 includes deflation of LMA cuff 204, removal of any connection of a ventilation device from ventilator connector 120, and disconnection of connectors 119 (visualization), injection port 118, and 113 (cuff inflation) from external systems or devices. Then in stage 10, LMA 200 is removed by sliding it off tube system 100. In stage 11, connection is restored to a ventilation device through ventilator connector 120, and connectors 119 (visualization), injection port 118 and 113 (cuff inflation) are reconnected to external systems.

[0118] In stage 12, when endotracheal tube 101 is no longer required, cuff 104 is deflated and endotracheal tube 101 is removed from the patient. Optionally, LMA 200 is left in position with endotracheal tube 101 and stages 9 and 10 are performed along with stage 12 or both LMA 200 and endotracheal tube 101 are removed together.

[0119] Optionally, tube system 100 is inserted into LMA 200 before insertion of LMA system 300 into the patient. In this optional method, visualization device of tube 100 can be used to guide LMA 200 into position in the patient. Once tube system 100 is secured by cuff 104, LMA 200 may optionally be removed from the patient.

[0120] While various embodiments been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the disclosure may be made.