AU2013406220A1

AU2013406220A1 - Endobronchial tube apparatus

Info

Publication number: AU2013406220A1
Application number: AU2013406220A
Authority: AU
Inventors: Wenjeng Li
Original assignee: Medtronic Xomed LLC
Current assignee: Medtronic Xomed LLC
Priority date: 2012-11-29
Filing date: 2013-11-27
Publication date: 2015-07-09
Anticipated expiration: 2033-11-27
Also published as: CA2893048C; AU2013406220B2; WO2015080721A1; CA2893048A1; EP3079577A1; CN104955389A

Abstract

Concepts presented herein include an apparatus for monitoring EMG signals of a patient's laryngeal muscles. The apparatus includes an endobronchial tube having an exterior surface and two lumens for providing ventilation. Conductive ink electrodes are formed on the exterior surface of the endobronchial tube. The conductive ink electrodes are configured to receive the EMG signals from the laryngeal muscles when the endotracheal tube is placed in a trachea of the patient. At least one conductor is coupled to the conductive ink electrodes and is configured to carry the EMG signals received by the conductive ink electrodes to a processing apparatus.

Description

PCT M190.524.1 I 1/C00003563.WOU2 ENDOBRONCHIAL TUBE APPARATUS Background [ll Endobronchial tubes (also known as dual-lumen endotracheal tubes) provide an open airway for patient ventilation during surgery. In particular, endobronchial tubes are used during surgical procedures to provide ventilation to individual lungs separately. Current endobronchial tubes include a first, tracheal lumen and a second, bronchial lumen. Each lumen includes an associated inflatable cuff, the cuff associated with the tracheal lumen being positioned within the trachea and the cuff associated with the bronchial lumen being positioned within one ofthe bronchus. Summary 1021 Concepts presented herein include an apparatus for monitoring EMG signals of a patient's laryngeal muscles. The apparatus includes an endobronchial tube having an exterior surface and two lumens for providing ventilation. Conductive ink electrodes are formed on the exterior surface of the endobronchial tube. The conductive ink electrodes are configured to receive the EMG signals from the laryngeal muscles when the endotracheal tube is placed in a trachea of the patient. At least one conductor is coupled to the conductive ink electrodes and is configured to carry the EMG signals received by the conductive ink electrodes to a processing apparatus. Brief Description of the Drawings [03] Fig. I is a schematic view of an EMG endobronchial tube. [041 Figs. 2A and 2B are different side views of an endobronchial tube. [05] Fig. 2C is a sectional view of the endobronchial tube illustrated in Fig. 2A. - 1- PCT M190.524.1 I 1/C00003563.WOU2 [06] Fig. 3 is a partial side view of an endobronchial tube having an electrode cuff. Detailed Description [07] Figure I shows an EMG endobronchial tube 100 made from extruded polymer. Endobronchial tube 100 includes solid wires 102, a bronchial fitting 104, a tracheal fitting 106, a y-connector 108, a bronchial cuff inflating conduit 110, a tracheal cuff inflating conduit 112, extruded polymer tube 114, electrodes 116, bronchial cuff 120 and tracheal cuff 122. Solid wires 102 arc connected to electrodes 116 at an interconnection 124. Tube 114 transports gases to and from the lungs. In particular, tube 114 defines a first, bronchial lumen 126 extending from bronchial fitting 104 to an opening 128 distal the bronchial cuff 120 and a second, tracheal lumen 130 extending from tracheal fitting 106 to an opening 132 distal the tracheal cuff 122. The Y-connector 108 fluidly couples the bronchial fitting 104 and tracheal fitting 106 to bronchial lumen 126 and tracheal lumen 130, respectively. [081 Fittings 104 and 106 are configured to be connected to a respirating machine (not shown) for injecting air into the lungs and withdrawing air from the lungs. Cuff inflating conduits 110 and 112 are configured to be connected to a source of compressed air (not shown) for inflating cuffs 120 and 122. Cuff inflating conduit 110 communicates with a lumen located in the wall of tube 114, and the lumen communicates with bronchial cuff 120. Likewise, tracheal cuff inflating conduit 112 communicates within a lumen located in the wall of tube 114, and the lumen communicates with tracheal cuff 122. During use, one of the fittings (e.g., bronchial fitting 104) is configured to inject air into one lung while the other fitting (e.g., tracheal fitting 106) is configured to injected air into the other lung. For example, cuff 120 can be positioned into the left bronchus and cuff 122 positioned into the trachea. In this case, opening 126 is positioned to direct air into the left lung from bronchial fitting 104 while opening 132 is positioned to direct air into the right lung from tracheal fitting 106. Selectively, air can be provided to only one of the fittings 104, 106 so as to provide air to only -2- PCT M190.524.1 I 1/C00003563.WOU2 a single lung and collapsing the other lung. In such a case, a surgeon can operate proximate the collapsed lung or on the collapsed lung. After endobronchial tube 100 is inserted into the trachea of a patient, electrodes 116 sense EMG signals, which are output to an EMG processing machine, such as nerve integrity monitor (NIM) device 140, via solid wires 102. Die cut tape may be used to tape tube 114 to a patient's mouth to secure the tube and keep it appropriately positioned. [09] In one embodiment, the NIM 140 is configured to determine when the electrodes 116 are in contact with the vocal folds, and is configured to provide an alert to the surgeon when such contact is lost. In one embodiment, the NIM 140 is also configured to determine whether the electrodes I 16 arc in contact with muscle or tissue based on the received signals [101 In one embodiment, tube 114 is a braided tube that is more flexible than conventional solid polymer tubes, and that reduces kinking. Tube 114 according to one embodiment is formed from a braided polymer or nitinol within a thin walled tube, and reduces or eliminates rotation of the tube at the vocal folds, while allowing a proximal portion of the tube to rotate. [III Figure 2A shows a first side view (posterior side) of endobronchial tube 114 with four electrodes 116. Figure 2B shows a second side view (rotated 90 degrees from the view shown in Figure 2A) of the endobronchial tube 114 shown in Figure 2A. Figure 2C is a diagram illustrating a cross-sectional view of the endobronchial tube 114 shown in Figures 2A and 2B. [12] Electrodes 116 include four electrodes I16A-116D, which are formed around a circumference of the tube 114 and extend in a longitudinal direction of the tube 114. Electrodes 116A and I16B are positioned entirely on the posterior side of the tube 114 and are also referred to herein as posterior electrodes I 16A and I16B. Electrodes I16C and II.6D are positioned entirely on the anterior side of the tube 114 and are also referred to as anterior electrodes I 16C and I 16D. The anterior side of the tube 114 is the bottom half of the tube 114 shown in Figure 2C, and the posterior side of the tube 114 is the top half of the tube 114 -3- PCT M190.524.1 I 1/C00003563.WOU2 shown in Figure 2C. Each of the electrodes 116A-116D is coupled to a respective trace 150A-150D (trace 150D is not visible in the Figures). Traces 150A-150D are positioned in a protected (masked) region 152 of tube 114. Posterior electrodes 116A and I16B are positioned in an exposed (unmasked) region 154 of tube 114. Anterior electrodes I 16C and I 16D are positioned in an exposed (unmasked) region 156 of tube 114. [13] In one embodiment, each of the electrodes l I6A-116D has a length of about one inch, and extends laterally around a circumference of the tube for a distance corresponding to an angle 160 of about 60 degrees (i.e., each of the electrodes l16A-l16D has a width of about 16.67 percent of the total circumference of the tube). The electrodes are laterally spaced apart around the circumference of the tube by a distance corresponding to an angle 160 of about 30 degrees (i.e., the lateral spacing between each of the electrodes 116A-116D is about 8.333 percent of the total circumference of the tube). The posterior electrodes I16A and I16B are longitudinally offset or displaced from the anterior electrodes 116C and I16D. The posterior electrodes 116A and 116B are positioned closer to the distal end (right side in Figures 2A and 2B) of the tube 114 than the anterior electrodes 116C and ] 16D, and the anterior electrodes I I6C and 116D are positioned closer to the proximal end (left side in Figures 2A and 2B) of the tube 114 than the posterior electrodes 116A and I 16B. [141 Tube 114 includes an overlap region 166 where a proximal portion of the posterior electrodes 116A and I16B longitudinally overlap with a distal portion of the anterior electrodes 1l16C and 116D. The electrodes 116 do not physically overlap each other since they are laterally offset from each other. In one embodiment, the overlap region 166 is about 0.1 inches long, and the overall length from a proximal end of the anterior electrodes I 16C and I 16D to a distal end of the posterior electrodes I I 6A and I 16B is about 1.9 inches. In another embodiment, the overlap region 166 is about 0.2 inches long, and the overall length from a proximal end of the anterior electrodes I I6C and I 16D to a distal end of the posterior electrodes I 16A and I I6B is about 1.8 inches. Tube 114 is configured to be positioned such that the vocal folds of a patient are positioned in -4- PCT M190.524.1 I 1/C00003563.WOU2 the overlap region 166. Thus, the configuration of the electrodes 116 above the vocal folds is different than the configuration below the vocal folds. The posterior electrodes I16A and 116B are configured to be positioned primarily below the vocal folds, and the anterior electrodes I16C and I16D are configured to be positioned primarily above the vocal folds, In one embodiment, electrodes 116A and 116C are used for a first EMG channel, and electrodes I 16B and !16D are used for a second EMG channel. [151 In an alternate embodiment, all four surface printed electrodes, I12A, I 12B, 112C and I 12D, are equal in length. This will allow the finish product to be placed with little concerns of rotational alignment. [16] As illustrated in Fig. 2C, conduits 110 and 112 are formed in a thickness of the tube 114 to carry compressed air to bronchial cuff 120 and tracheal cuff 122, respectively. Additionally, inside tube 114 are formed bronchial lumen 126 and tracheal lumen 130. During use, one of the lumens 126 and 130 can be used to inject gases into a particular lung while the other lumen is sealed from injecting gases into the opposite lung. [171 With reference to Fig. 3, another embodiment includes an electrode cuff 170 positioned proximal the tracheal cuff 122. In the embodiment of Fig. 3, cuff 122 is ofa different shape than that illustrated in Figs. l-2C. Other shapes for the cuffs 122 and 170 can be utilized. Electrodes 116 are applied directly to the electrode cuff 170 and are similar to that discussed above. Cuffs 122 and 170 are sized so as to both provide suitable scaling between the trachea and cuff 122 yet provide suitable compliance of electrode cuff 170 in contact with the vocal folds of a patient when inflated by pressurized fluid provided within inflating conduit 110. Upon inflation, the tracheal cuff 122 has a larger diameter DI than a diameter D2 of electrode cuff 170. In some embodiments, the diameter D2 is selected to be approximately half the diameter Dl. In one example, Dl is about 20 millimeters, whereas D2 is about 9 millimeters. In yet a further embodiment, DI is approximately 27 millimeters, whereas D2 is approximately 14 millimeters. Moreover, a length LI of the cuff 170 is selected to be greater than a length L2 -5- PCT M190.524.1 I 1/C00003563.WOU2 for cuff 122. In one embodiment, the LI is approximately 1.875 inches. In another embodiment, LI is in a range from approximately 1.5 inches to 2.5 inches. In a further embodiment, a ratio of D1:LI is selected to be in a range from approximately 15:100 to 30:100. [181 Furthermore, a compliance for cuff 170 is selected so as to prevent trauma due to cuff 170 contacting the vocal folds of the patient. In one embodiment, the cuff 170 is formed of a semi-compliant balloon. The semi-compliant balloon will increase in diameter about 10 to 20 percent from a nominal pressure to a rated burst pressure for the balloon. In a further embodiment, cuff 170 is formed of a compliant balloon such that the balloon will increase in diameter from 20 to 200 percent from a nominal pressure to a rated burst pressure of the balloon. In a further embodiment, the cuff 170 is formed of a compliant material that has a greater compliance than a material selected for cuff 122. In one embodiment, cuff 122 has a compliance defined as increasing in diameter about 20 to 200 percent from a nominal pressure to a rated burst pressure for the cuff 122. [191 Inflating conduit 110 extends along the length of tube 114 to electrode cuff 170 and continues in extension to the tracheal cuff 122. Due to relative compliance of the cuffs 122 and 170, cuff 122 is configured to fluidly seal the trachea of a patient when positioned, whereas electrode cuff 170 inflates to contact the vocal folds of the patient so as to prevent trauma from occurring due to contact between the cuff 170 and the vocal folds. Furthermore, by selecting diameters D I and D2 of cuffs 122 and 170, tension exerted on an exterior surface of each cuff is adjusted. In one embodiment, thickness and diameter for cuffs 122 and 170 am selected such that cuff 122 will absorb pressure and reduce pressure on cuff 170. In this configuration, cuff 170 can conform to a shape of vocal folds and ensure sufficient electrical contact between the electrodes 112 and the vocal folds without causing irritation by exerting too much pressure on the vocal folds. [201 Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can -6- PCT M190.524.1 I 1/C00003563.WOU2 be made in form and detail without departing from the spirit and scope of the present disclosure. -7-

Claims

1. An apparatus for monitoring electromyographic signals of a patient's laryngeal muscles, comprising: an endobronchial tube defining first and second lumens; a first cuff coupled to the endobronchial tube and positioned proximate a first opening fluidly coupled with the first lumen, the first cuff sized to be positioned within a bronchus of the patient; a second cuff coupled to the endobronchial tube and positioned proximate a second opening fluidly coupled with the second lumen the second cuff configured to be positioned within a trachea of the patient; and conductive ink electrodes positioned on an exterior surface of the endobronchial tube and proximate the proximal cuff.

2. The apparatus of claim 1, wherein the electrodes include four electrodes positioned around a circumference of the exterior surface.

3. The apparatus of claim 1, further comprising a Y-connector coupled to the endobronchial tube, the Y-connector fluidly coupling first and second fittings to the first and second lumens, respectively.

4. The apparatus of claim 1, further comprising an interconnection coupled to the tube and conductive traces electrically connecting electrodes with the interconnection.

5. The apparatus of claim 1, further comprising first and second inflating conduits fluidly coupled to the first and second cuffs, respectively.

6. The apparatus of claim 5, wherein the exterior surface includes an electrode cuff fluidly coupled to the second inflating conduit and having the conductive ink electrodes positioned thereon. -8- PCT M190.524.11 1/C00003563.WOU2

7. A method for monitoring electromyographic signals of a patient's laryngeal muscles, comprising: providing an endobronchial tube defining first and second lumens, the endobronchial tube including conductive ink electrodes positioned on an exterior surface thereof; positioning a bronchial cuff within a bronchus of the patient, the bronchial cuff being coupled to the endobronchial tube; positioning a tracheal cuff within a trachea of the patient, the tracheal cuff coupled to the endobronchial tube; and measuring signals of the patient using the conductive ink electrodes.

8. The method of claim 7, wherein the electrodes include four electrodes positioned around a circumference of the exterior surface.

9. The method of claim 7, further comprising: coupling a Y connector to the endobronchial tube, the Y connector fluidly coupling first and second fittings to the first and second lumens, respectively.

10. The method of claim 7, further comprising electrically connecting the electrodes to an interconnection on the endobronchial tube with conductive traces.

11. The method of claim 7, further comprising: inflating the first and second cuffs using first and second inflating conduits, respectively.

12. The method of claim 11, further comprising: providing an electrode cuff fluidly coupled to the second inflating conduit and providing the conductive ink electrodes on the electrode cuff. -9-