Device and method for activating swallowing muscles to promote recovery from swallowing disorders in neurological disorders

Abstract

This device and method treats dysphagia associated with neurological disorders and promotes swallowing. The device includes a tube with an inner diameter larger than the outer diameter of a standard nasogastric / enteric tube. It can be advanced through the oropharynx and esophagus to the stomach on a standard nasogastric / enteric tube platform. The device sequentially stimulates the muscles involved in swallowing to monitor and promote recovery from dysphagia. In separate iterations, a long sleeve is placed around the standard nasogastric / enteric tube. The sleeve can be inflated proximally with a bolus of air or another solution, and the bolus is propelled down the sleeve by contractions of the oropharyngeal and esophageal muscles, with segmental articulation secured by valves or adhesives at regular intervals.

Description

[Technical Field]

[0001] The present invention relates to an apparatus and a treatment method for promoting recovery of swallowing function in patients with dysphagia caused by neurological disease. [Background technology]

[0002] Dysphagia affects more than 50% of stroke survivors and is associated with a twofold increased risk of pneumonia and death (Cohen DL, Roffe C, Beavan J, et al., International Journal of Stroke. 2016;11(4):399–411; Speyer, R, Baijens, L, Heijen, M, Zwijnenberg, I. Dysphagia 2010;25:40–65). Effective treatments for dysphagia have been lacking (Geeganage, C, Beavan, J, Ellender, S, Bath, PM. Cochrane Database Syst Rev 2012;10:CD000323). Neurological dysphagia is unique in that there is no mechanical impairment and the involved muscles are structurally intact. Rehabilitation techniques, such as oral and tongue exercises, tend to focus on muscle strength and endurance but require voluntary effort and cannot mimic the dynamic process of swallowing. Although oropharyngeal neuromuscular stimulation using superficial stimulation has been shown to provide some improvement in dysphagia, most stimulation is too weak or does not penetrate deep enough to stimulate the muscles involved in swallowing (Bulow M, Speyer R, Baijens L, Woisard V, Ekberg O. Dysphagia. 2008;23(3):302-309; Ludlow CL, Humbert I, Saxon K, Poletto C, Sonies B, Crujido L. Dysphagia. 2006 doi:10.1007 / s00455-006-9029-4). The methods and devices of the present invention are able to mimic the dynamic nature of swallowing and activate both oropharyngeal and esophageal components.

[0003] There is a need for devices and methods for effectively treating dysphagia in neurological patients. Summary of the Invention

[0004] One embodiment of the present invention addresses the need for devices and methods for effectively treating dysphagia in patients with neurological disorders. Neurological patients with dysphagia may be treated with a nasogastric / enteric tube for nutritional support, hydration, and medication administration. The dysphagia treatment device described herein can be used simultaneously with a standard nasogastric / enteric tube, eliminating the need for an additional device inserted into the oropharynx. The dysphagia treatment device is placed through the oropharynx and esophagus via a standard nasogastric tube already in place, and its placement can be confirmed using a combination of bedside testing and radiography. This dysphagia treatment device focuses on providing mechanical or, in other embodiments, optical stimulation to the muscles involved in swallowing, continuously stimulating these muscles to promote the recovery of strength and coordination. Evolving the device with various repetitions of mechanical or optical stimulation, with or without simultaneous electrical stimulation, multiple times per day, is synonymous with active and passive activation of other paralyzed muscles in neurological patients and is the foundation of rehabilitation. This activation can be performed at the bedside without complex equipment or imaging techniques.

[0005] In one embodiment, an apparatus for treating dysphagia includes an elongated tubular body having a proximal end and a distal end and defining a first lumen and a second lumen. The first lumen is oriented along a longitudinal axis of the tubular body and receives a nasogastric / intestinal tube therein. The elongated tubular body is selectively slidable relative to the nasogastric / intestinal tube, and the second lumen is oriented parallel to the first lumen. A dysphagia treatment device is positioned adjacent the distal end of the elongated tubular body. The dysphagia treatment device is selectively actuable as the elongated tubular body slides over the nasogastric / intestinal tube.

[0006] In one embodiment, the dysphagia treatment device is an inflatable balloon, the balloon being selectively inflatable with fluid supplied from the second lumen. At least one pressure transducer is provided for measuring fluid pressure within the balloon, the at least one pressure transducer being communicatively coupled to an external display. The tubular body includes a port, the port being positioned adjacent to the proximal end of the tubular body and in fluid communication with the second lumen for supplying and removing fluid to and from the second lumen and the balloon. The second lumen can be concentric with the first lumen.

[0007] In one embodiment, the dysphagia treatment device includes at least one air nozzle extending from the second lumen to the outer surface of the tubular body. The at least one air nozzle is oriented transversely to the longitudinal axis of the tubular body. At least one pressure transducer is disposed at the distal end of the elongated tubular body and communicatively coupled to an external display. A port is disposed adjacent to the proximal end of the tubular body and is in fluid communication with the second lumen to supply air to the second lumen and the at least one air nozzle. The second lumen can be concentric with the first lumen.

[0008] In one embodiment, the dysphagia treatment device includes at least one light emitter positioned to emit light transversely to the longitudinal axis of the tubular body. The at least one light emitter can emit light pulses having a wavelength of about 400 nm to about 600 nm and a duration of about 10 ms to about 100 ms. The at least one light emitter can be an LED. The device can include at least one pressure transducer positioned at the distal end of the elongated tubular body. The at least one pressure transducer can be communicatively coupled to an external display. A high-resolution camera is positioned at the distal end of the tubular body, the camera being communicatively coupled to the video display. The second lumen can be concentric with the first lumen.

[0009] In one embodiment, the dysphagia treatment device includes a nasogastric / intestinal tube and a sleeve disposed on the outer surface of the nasogastric / intestinal tube. The sleeve is formed of a resilient, flexible polymer material and is divided into a plurality of inflatable chambers by a plurality of partitions. Each of the plurality of chambers is partially separated from an adjacent one of the plurality of chambers by a partition. The proximal end of the sleeve is fluidly connected to an injection port for injecting a fluid into the sleeve. Each of the plurality of partitions may be a non-compliant ring of polymer material. In another embodiment, each of the plurality of partitions may be a portion of the sleeve secured to the outer surface of the nasogastric / intestinal tube. In another embodiment, each of the plurality of partitions may be a flexible septum extending from the inner surface of the sleeve toward the outer surface of the nasogastric / intestinal tube. At least one pressure transducer may be disposed in the sleeve or the nasogastric / intestinal tube. The at least one pressure transducer may be communicatively coupled to an external display. A suction port may be fluidly connected to the distal end of the sleeve.

[0010] In another embodiment, a method for treating dysphagia includes providing a dysphagia treatment device including an elongated tubular body having a proximal end and a distal end and defining a first lumen and a second lumen. The first lumen is oriented along the longitudinal direction of the tubular body and receives a nasogastric / intestinal tube therein. The elongated tubular body is selectively slidable relative to the nasogastric / intestinal tube. The second lumen is oriented parallel to the first lumen, and a dysphagia treatment device is positioned adjacent to the distal end of the elongated tubular body. The proximal end of the nasogastric / intestinal tube, which is positioned within the patient's nasopharynx and esophagus, is introduced into the first lumen from the distal end of the elongated tubular body. The elongated tubular body is slid over the nasogastric / intestinal tube to advance the elongated tubular body into the patient's nasopharynx and esophagus while periodically actuating the dysphagia treatment device to stimulate muscles that control swallowing in the patient's nasopharynx and esophagus.

[0011] In one embodiment, the dysphagia treatment device includes an inflatable balloon, and the step of activating the dysphagia treatment device includes inflating the balloon with a fluid.

[0012] In another embodiment, the dysphagia treatment device includes at least one air nozzle, and activating the dysphagia treatment device includes applying air pulses to the patient's nasopharynx and esophagus using the at least one air nozzle, the air pulses having a pressure of about 70 mmHg to about 110 mmHg.

[0013] In another embodiment, the dysphagia treatment device includes at least one light emitter, and activating the dysphagia treatment device includes applying pulses of light to the patient's nasopharynx and esophagus using the at least one light emitter, the pulses of light having a wavelength of about 400 nm to about 600 nm and a duration of about 10 ms to about 100 ms.

[0014] In another embodiment, a method for treating dysphagia includes providing a dysphagia treatment device including a nasogastric / intestinal tube and a sleeve disposed on the exterior of the nasogastric / intestinal tube. The sleeve is formed from a resilient, flexible polymeric material and is divided into a plurality of inflatable chambers by a plurality of partitions. Each of the plurality of chambers is partially separated from an adjacent chamber by one of the partitions. The proximal end of the sleeve is fluidly connected to an injection port for injecting a fluid into the sleeve. The sleeved nasogastric / intestinal tube is inserted into the patient's nasopharynx and esophagus, and a fluid is injected into the most proximal of the plurality of chambers to inflate the chamber.

[0015] The above summary is not intended to describe each illustrated embodiment or every embodiment of the subject matter of this specification. The figures and detailed description that follow more particularly exemplify various embodiments. [Brief explanation of the drawings]

[0016] The present invention will be more fully understood from consideration of the following detailed description of various embodiments in conjunction with the accompanying drawings.

[0017] [Figure 1] Anatomy of the oropharynx and esophagus, showing muscle contractions facilitating swallowing. [Figure 2] 1 is a perspective view of a dysphagia treatment device according to an embodiment of the present invention. [Figure 3] FIG. 10 is a perspective view of a dysphagia treatment device according to another embodiment of the present invention. [Figure 4] FIG. 1 is a perspective view of a dysphagia treatment device according to one embodiment of the present invention, including a selectively inflatable balloon near the distal end of the device. [Figure 5] 5 is a cross-sectional view of the device of FIG. 4 taken along the line 5-5. [Figure 6] 6 is a cross-sectional view of the device of FIG. 4 taken along line 6-6. [Figure 7] 7 is a cross-sectional view of the device of FIG. 4 taken along line 7-7. [Figure 8]The device of Figure 4 is shown in the first stage of advancement through a standard nasogastric tube into the oropharynx and esophagus. [Figure 9] The device of Figure 4 is shown in the second stage of advancement through a standard nasogastric tube into the oropharynx and esophagus. [Figure 10] The device of Figure 4 is shown in the third stage as it is advanced through a standard nasogastric tube into the oropharynx and esophagus. [Figure 11] FIG. 5 is a perspective view of the device of FIG. 4, including a display that displays the pressure within the inflatable balloon. [Figure 12] FIG. 10 is a perspective view of a dysphagia treatment device according to another embodiment of the present invention, with ports near the distal end of the device for applying air puffs to the oropharynx and esophagus. [Figure 13] 13 is a cross-sectional view of the device of FIG. 12 taken along line 13-13. [Figure 14] The device of Figure 12 is shown in the first stage of advancement through a standard nasogastric tube into the oropharynx and esophagus. [Figure 15] The device of Figure 12 is shown in the second stage of advancement through a standard nasogastric tube into the oropharynx and esophagus. [Figure 16] The device of Figure 12 is shown in the third stage of advancement through a standard nasogastric tube into the oropharynx and esophagus. [Figure 17] FIG. 13 is a perspective view of the device of FIG. 12, including a display that displays the pressure or rate of air puffs applied by the device. [Figure 18] FIG. 10 is a perspective view of a dysphagia treatment device according to another embodiment of the present invention, including a light emitter near the distal end of the device for applying light to the oropharynx and esophagus. [Figure 19] 19 is a cross-sectional view of the device of FIG. 18 taken along line 19-19. [Figure 20] The device of Figure 18 is shown in the first stage of advancement through a standard nasogastric tube into the oropharynx and esophagus. [Figure 21] The device of Figure 18 is shown in the second stage of advancement through a standard nasogastric tube into the oropharynx and esophagus. [Figure 22] The device of Figure 18 is shown in the third stage of advancement through a standard nasogastric tube into the oropharynx and esophagus. [Figure 23] 1 is a perspective view of a dysphagia treatment device according to one embodiment of the present invention, including a camera at the distal end of the device and a display for displaying images from the camera. [Figure 24] 1 is a perspective view of a dysphagia treatment device according to one embodiment of the present invention, including a sleeve that fits over a standard nasogastric tube. [Figure 25] 1 is a perspective view of another dysphagia treatment device according to an embodiment of the present invention, including a sleeve that fits over a standard nasogastric tube. [Figure 26] 26 is a cross-sectional view taken along line 26-26 of FIG. 27 of another dysphagia treatment device according to an embodiment of the present invention, including a sleeve that fits onto a standard nasogastric tube. [Figure 27] FIG. 27 is a perspective view of the device of FIG. 26. [Figure 28] FIG. 1 is a perspective view of a sleeve that can be attached to a standard nasogastric tube, including adhesive for securing the outer portion of the sleeve to the central lumen of the device. [Figure 29] 29 is a cross-sectional view taken along the line 29-29 in FIG. 28. [Figure 30] FIG. 30 is a cross-sectional view taken along the line 30-30 in FIG. 28. [Figure 31] FIG. 1 is a perspective view of a sleeve attachable to a standard nasogastric tube, the sleeve defining a septum between an outer portion and a central lumen of the sleeve. [Figure 32] 32 is a cross-sectional view of the device of FIG. 31 taken along line 32-32. [Figure 33] FIG. 33 is a perspective view of the sleeve of FIGS. 24-32 with an air / saline bolus introduced into the sleeve. [Figure 34] FIG. 34 is a perspective view of the device of FIG. 33, showing the air / saline bolus displaced further along the sleeve by contraction of the esophageal muscle. [Figure 35]FIG. 34 is a perspective view of the device of FIG. 33, showing the air / saline bolus displaced further along the sleeve by contraction of the esophageal muscle.

[0018] Various embodiments are susceptible to various modifications and alternative forms, specific embodiments of which are illustrated in the drawings and described in detail. However, the invention is not limited to the specific embodiments described below, but is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter defined by the claims. DETAILED DESCRIPTION OF THE INVENTION

[0019] 1 depicts an anatomical cross section of the human body including the tongue 100, palate 102, epiglottis 104, trachea 106, oropharynx 107, esophagus 108, stomach 110, and muscle 112. During the process of swallowing, muscle 112 contracts sequentially as indicated by the arrows, allowing food and water to move from oropharynx 107, through esophagus 108, and into stomach 110.

[0020] FIG. 2 illustrates a dysphagia treatment device 114 according to one embodiment of the present invention. The device 114 generally includes a tubular body 116 defining a lumen 118. The lumen 118 has an inner diameter sized to accept a standard nasogastric / intestinal tube 120 having a diameter of 12-18 French (4-6 mm) so that the device 114 can be slidably fitted onto the nasogastric / intestinal tube 120. The lumen 118 extends from a proximal end 122 to a distal end 124. In a non-limiting embodiment, the tubular body 116 is 42-50 inches long and may have markings (not shown) at 18, 22, 26, and 30 inches to ensure proper insertion and placement in the oropharynx and esophagus. As will be described in more detail below, a port 126 is provided for injecting a liquid, such as air or saline, into a second lumen (not shown). In the alternative embodiment of FIG. 3, the tube 116 has an opening 128 in communication with the lumen 118 so that the nasogastric tube 120 can pass through the opening 128 rather than through the proximal end 122 .

[0021] 2 can be advanced into the oropharynx 107 and esophagus 108 by introducing the proximal end 130 of the nasogastric / intestinal tube 120, already within the oropharynx 107 and esophagus 108, into the distal end 124 of the lumen 118. Then, as shown, the dysphagia treatment device 114 is slid over the nasogastric / intestinal tube 120 until the proximal end 130 of the nasogastric / intestinal tube 120 protrudes from the proximal end 122 of the lumen 118 and the distal end 132 of the nasogastric / intestinal tube 120 protrudes from the distal end 124 of the lumen 118. In the alternative embodiment of FIG. 3, the proximal end 130 of the nasogastric / intestinal tube 120 is introduced into the lumen 118 through the distal end 124 of the lumen 118. The dysphagia treatment device 114 then slides over the nasogastric / intestinal tube 120, with the proximal end 130 emerging from the opening 128. In both embodiments, the proximal end 122 of the dysphagia treatment device 114 and the proximal end 130 of the nasogastric / intestinal tube 120 remain outside the oropharynx 107.

[0022] In the embodiment shown in FIGS. 4-11, the dysphagia treatment device 114 includes an inflatable balloon 134 near the distal end 124. The balloon 134 may be coated with sugar to mimic the taste of food. Between an inner wall 138 and an outer wall 140 of the tubular body 116 is a second lumen 136. The second lumen 136 is in fluid communication with the inflatable balloon 134 via a port 142 and is also in fluid communication with the port 126. In this embodiment, the second lumen 136 is concentric with the lumen 118; however, in other embodiments, the second lumen 136 may be non-concentric and extend parallel to the lumen 118.

[0023] As shown in FIGS. 8-10 , in use, the dysphagia treatment device 114 is advanced into the oropharynx 107 and esophagus 108 by introducing the proximal end 130 of the nasogastric / intestinal tube 120 into the distal end 124 of the lumen 118. As shown in FIG. 8 , once the balloon 134 is within the oropharynx 107, it is inflated with a fluid, such as pressurized air, supplied through port 126 and to the second lumen 136 and balloon 134 through port 142. Other liquids, such as saline, may be used instead of pressurized air. As shown in FIG. 11 , one or more pressure transducers 144 may be positioned within the balloon 134 and communicatively coupled to an external display 146 to monitor and record the air pressure within the balloon 134 as the dysphagia treatment device 114 advances along the nasogastric / intestinal tube 120 through the oropharynx 107 and esophagus 108. This allows pressure changes due to the oropharynx 107 and esophagus 108 muscles 112 contracting during swallowing in response to the advancement of the balloon to be measured and tracked. An external display 146 is coupled to the pressure transducer 144 via wires 148, although a wireless connection may also be used.

[0024] 9-10 , as the dysphagia treatment device 114 advances further within the esophagus 108, the inflated balloon 134 contacts and mechanically stimulates the muscles 112 along the esophagus 108, causing successive contractions that mimic the swallowing process. Once the balloon 134 reaches the stomach 110, the balloon 134 can be deflated through the port 126 and withdrawn by sliding it in the opposite direction along the nasogastric / intestinal tube 120. This process can be repeated as needed.

[0025] 12-17, another embodiment of the dysphagia treatment device 114 replaces the balloon 134 with one or more radial nozzles 150 fluidly coupled to the second lumen 136. As the dysphagia treatment device 114 advances through the oropharynx 107 and esophagus 108 via the nasogastric / intestinal tube 120, rapid, small, intermittent air pulses 152, delivered from the port 126, are ejected from the nozzles 150 to mechanically stimulate the muscle 112. In a non-limiting embodiment, the air pulse pressure is between about 70 millimeters (mm) Hg and about 110 mm Hg, and the air pressure pulse profile is Gaussian.

[0026] As shown in FIGS. 14-16, the dysphagia treatment device 114 is advanced through the oropharynx 107 and esophagus 108 by introducing the proximal end 130 of the nasogastric / intestinal tube 120 into the distal end 124 of the lumen 118. As shown in FIG. 14, once the nozzle 150 is in place within the oropharynx 107, an air pulse 152 can be applied by injecting air through the port 126. As shown in FIG. 17, one or more pressure transducers 154 can be positioned at the distal end 124 and communicatively coupled to an external display 146 to monitor and record air pressure to measure and track changes in pressure due to contraction of the muscles 112 of the oropharynx 107 and esophagus 108 in response to forward movement of the dysphagia treatment device 114 during swallowing. During the air pulse 152, pressure increases in response to muscle contraction and the resulting decrease in space around the distal end 124. 15-16, as the dysphagia treatment device 114 advances further within the esophagus 108, air pulses 152 are applied to the interior of the esophagus 108, mechanically stimulating the muscles 112 along the esophagus 108 and causing successive contractions that mimic the swallowing process. Once the distal end 124 reaches the stomach 110, the dysphagia treatment device 114 can be withdrawn by sliding it in the opposite direction along the nasogastric / intestinal tube 120. This process can be repeated as needed.

[0027] In yet another embodiment of the dysphagia treatment device 114 shown in FIGS. 18-23, one or more light emitters, such as a light-emitting diode (LED) 156, are provided near the distal end 124 of the dysphagia treatment device 114. The LED 156 is connected to a power source via a lead 158 extending through the second lumen 136. Other light-emitting devices may be used in place of the LED 156. The power source may be included in the controller / display 160 or may be separate. The LED 156 emits light pulses 162 that stimulate the muscles 112 as the dysphagia treatment device 114 passes through the oropharynx 107 and esophagus 108 via the nasogastric / intestinal tube 120. In a non-limiting embodiment, the light pulses 162 are primarily blue light with a wavelength of about 400 nanometers (nm) to about 600 nm, and the pulse duration is about 10 milliseconds (ms) to 100 ms. However, one skilled in the art will recognize that other wavelengths and durations of light may be effectively applied within the scope of the present invention.

[0028] 20-22, in use, the dysphagia treatment device 114 can be advanced into the oropharynx 107 and esophagus 108 by introducing the proximal end 130 of the nasogastric / intestinal tube 120 into the distal end 124 of the lumen 118. As shown in FIG. 20, once the LED 156 is positioned in place within the oropharynx 107, a light pulse 162 can be applied by activating the LED 156. As shown in FIGS. 21-22, as the dysphagia treatment device 114 advances further within the esophagus 108, the light pulse 162 is applied to the interior of the esophagus 108, stimulating the muscles 112 along the esophagus 108 and causing successive contractions that mimic the swallowing process. Once the distal end 124 reaches the stomach 110, the dysphagia treatment device 114 can be withdrawn by sliding it in the opposite direction along the nasogastric / intestinal tube 120. This process can be repeated as necessary.

[0029] Additionally, as shown in FIG. 23, a high resolution camera 164 with illumination 166 may be positioned at the distal end 124 and communicatively coupled to the controller / display 160 so that contractions of the oropharynx 107 and esophagus 108 muscles 112 as part of swallowing can be visualized on the controller / display 160 in response to forward movement of the dysphagia treatment device 114.

[0030] 24-35 illustrate a further embodiment of a dysphagia treatment device 168. The device 168 generally includes a sleeve 170 positioned and secured over the outer surface 172 of the nasogastric / intestinal tube 120. The sleeve 170 is flexible, resilient, and expandable, and is formed from a thin layer of a bioplastic polymer, such as polyethylene or polylactic acid. Other polymeric materials that can be formed into a thin, expandable structure may also be used within the scope of the present invention. The sleeve 170 is typically about 40 to about 70 mm in length and is positioned along a standard nasogastric / intestinal tube 120 to correspond to the oropharynx 107 and esophagus 108 when the nasogastric / intestinal tube 120 is inserted into the patient's body. The proximal and distal ends 174 and 176 of the sleeve 170 are sealed to the outer surface 172 of the nasogastric / intestinal tube 120. An air / saline bolus injected into the sleeve 170 at the proximal end 174 is propelled down the sleeve 170 toward the stomach 110 by successive contractions of the oropharyngeal and esophageal muscles 112 .

[0031] In the embodiment of the invention shown in Figures 26-32, sleeve 170 is divided into segments that form a plurality of expandable chambers 178 longitudinally along nasogastric / intestinal tube 120. In the embodiment shown in Figures 26 and 27, non-compliant ring 180 segments formed of a polymeric material are spaced apart along sleeve 170. In a preferred embodiment, rings 180 have a longitudinal dimension X of about 3 cm to about 5 cm and are spaced apart by a longitudinal dimension Y of about 3 cm to about 7 cm. Rings 180 may be adhesively secured to outer surface 181 of sleeve 170. An injection port 183 is provided to allow for the injection of air, a liquid such as saline, or a combination thereof into proximal-most one of chambers 178, chamber 185.

[0032] 28-30, sleeve 170 forms a partition, for example, by fusing the plastic material of sleeve 170 and nasogastric / intestinal tube 120 together, or by partially adhering with an adhesive to outer surface 172 of nasogastric / intestinal tube 120 at adhesive regions 182. Again, adhesive regions are spaced apart along sleeve 170 by a longitudinal dimension Y of about 3 cm to about 7 cm. Infusion ports 183 are provided to allow for the infusion of air, a liquid such as saline, or a combination thereof, into proximal-most chamber 185 of chambers 178.

[0033] In the embodiment of Figures 31 and 32, flexible partial septa 184 project inwardly from sleeve 170 toward the exterior surface 172 of nasogastric / intestinal tube 120. The free end 187 of each septum 184 is free to flex to allow the passage of an air / liquid bolus 188. As shown in Figure 32, septa 184 may be slightly angled toward distal end 176. An injection port 183 is provided to allow the injection of air, liquid such as saline, or a combination thereof into the proximal-most chamber 185 of chambers 178.

[0034] As shown in FIG. 24 , port 183 has a proximal end 186 adapted to receive a syringe (not shown) to inject air, liquid, or an air / liquid bolus 188 into the proximal-most chamber 185. A suction port 190 may be provided and connected to a thin tube 192 extending through the sleeve 170 to the distal-most chamber 194 to allow extraction of the air / liquid bolus 188 that reaches the distal end 176 of the sleeve 170. The suction port 190 has a proximal end 198 adapted to receive a syringe (not shown) to allow extraction of the bolus 188. Alternatively, as shown in FIG. 25 , a hole 196 may be provided in the distal end 176 of the sleeve 170 to allow the air / liquid bolus 188 to be drained into the stomach 110.

[0035] In any of the above embodiments of the dysphagia treatment device 168, a pressure transducer (not shown) may be provided within the sleeve 170 to monitor and record pressure within the sleeve 170 to assess contraction of the oropharynx 107 and esophagus 108 muscles 112 as part of the swallowing act.

[0036] In use, with the nasogastric / enteric tube 120 and sleeve 170 positioned in the oropharynx 107 and esophagus 108, a bolus 188 is injected through port 183 into the proximal-most chamber 185. Preferably, a sufficient amount of air / liquid is injected so that the bolus 188 expands the chamber 185 by approximately 2 mm to approximately 5 mm in the transverse dimension Z. As shown in FIGS. 33-35 , contraction of the muscles 112 of the oropharynx 107 and esophagus 108 propels the bolus 188 through successive chambers 178 from the proximal end 174 to the distal end 176. The ring 180, adhesive region 182, or septum 184 inhibits reflux of the bolus 188 back into the proximal end 174. Once the bolus 188 reaches the distal end 176, it is expelled through the suction port 190 or through the hole 196 into the stomach 110.

[0037] While systems, devices, and methods have been described herein in various embodiments, these embodiments are provided by way of example and are not intended to limit the scope of the claims. Furthermore, various features of the described embodiments can be combined in various ways to create numerous additional embodiments. Furthermore, while various materials, dimensions, shapes, configurations, locations, etc., have been described for use with the disclosed embodiments, others than those disclosed may be utilized without departing from the scope of the claimed invention. Elements described with respect to one embodiment may also be implemented in other embodiments, unless otherwise specified.

[0038] Those skilled in the relevant arts will recognize that the inventive subject matter may be comprised of fewer features than those shown in the individual embodiments described above. The embodiments described herein are not intended to be an exhaustive list of ways in which various features of the inventive subject matter may be combined. Thus, embodiments may be comprised of combinations of different individual features selected from different individual embodiments, as would be understood by one skilled in the art. Furthermore, elements described with respect to one embodiment may be implemented in other embodiments, even if not described, unless otherwise specified.

[0039] Although a dependent claim may refer to a specific combination with one or more other claims in the claims, other embodiments may also include combinations of the dependent claim with the subject matter of other dependent claims, or combinations of one or more features with other dependent or independent claims, and such combinations are suggested herein unless it is expressly stated that a particular combination is not intended.

[0040] The incorporation by reference of the above documents is limited so that no subject matter contrary to the express disclosure of this specification is incorporated. The incorporation by reference of the above documents is further limited so that no claims contained in the documents are incorporated herein by reference. The incorporation by reference of the above documents is further limited so that no definitions set forth in the documents are incorporated herein by reference, unless expressly included herein.

[0041] For purposes of claim interpretation, it is expressly intended that the provisions of 35 U.S.C. § 112(f) shall not apply unless the claim specifically recites the words "means for" or "step for."

Claims

1. A dysphagia treatment device, comprising: an elongate tubular body having a proximal end and a distal end and defining a first lumen and a second lumen, the first lumen oriented along a longitudinal axis of the tubular body, the first lumen receiving the nasogastric / intestinal tube such that the elongate tubular body is selectively slidable relative to the nasogastric / intestinal tube, and the second lumen oriented parallel to the first lumen; a dysphagia treatment device disposed proximate the distal end of the elongated tubular body, the dysphagia treatment device being selectively actuable as the elongated tubular body slides over the nasogastric / intestinal tube; An apparatus comprising:

2. The dysphagia treatment device according to claim 1, The dysphagia treatment device includes an inflatable balloon, the balloon being selectively inflatable with fluid provided from the second lumen.

3. The dysphagia treatment device according to claim 2, The dysphagia treatment device further includes at least one pressure transducer for measuring fluid pressure within the balloon.

4. The dysphagia treatment device according to claim 3, The at least one pressure transducer is communicatively coupled to an external display.

5. The dysphagia treatment device according to claim 1, A dysphagia treatment device, the tubular body including a port disposed adjacent a proximal end of the tubular body and in fluid communication with the second lumen for supplying and removing fluid to the second lumen and the balloon.

6. The dysphagia treatment device according to claim 1, The second lumen is concentric with the first lumen.

7. The dysphagia treatment device according to claim 1, The dysphagia treatment device includes at least one air nozzle extending from the second lumen to an outer surface of the tubular body, the at least one air nozzle being oriented transverse to a longitudinal axis of the tubular body.

8. The dysphagia treatment device according to claim 7, The dysphagia treatment device further includes at least one pressure transducer disposed at the distal end of the elongate tubular body.

9. The dysphagia treatment device according to claim 8, A dysphagia treatment device, wherein the at least one pressure transducer is communicatively coupled to an external display.

10. The dysphagia treatment device according to claim 7, A dysphagia treatment device, the tubular body including a second lumen and a port positioned adjacent a proximal end of the tubular body and fluidly connected to the second lumen for supplying air to the at least one air nozzle.

11. The dysphagia treatment device according to claim 7, The second lumen is concentric with the first lumen.

12. The dysphagia treatment device according to claim 1, A dysphagia treatment apparatus, wherein the dysphagia treatment device includes at least one light emitter positioned to emit light transverse to a longitudinal axis of the tubular body.

13. The dysphagia treatment device according to claim 12, The at least one light emitter emits a light pulse having a wavelength of about 400 nm to about 600 nm and a duration of about 10 ms to about 100 ms.

14. The dysphagia treatment device according to claim 12, A dysphagia treatment device, wherein at least one light emitter is an LED.

15. The dysphagia treatment device according to claim 12, The dysphagia treatment device further includes at least one pressure transducer disposed at the distal end of the elongate tubular body.

16. The dysphagia treatment device according to claim 15, The at least one pressure transducer is communicatively coupled to an external display.

17. The dysphagia treatment device according to claim 12, The dysphagia treatment device further includes a high-resolution camera disposed at the distal end of the tubular body, the camera communicatively coupled to the video display.

18. The dysphagia treatment device according to claim 12, The second lumen is concentric with the first lumen.

19. A dysphagia treatment device, comprising: a nasogastric / enteric tube; a sleeve disposed on the exterior of the nasogastric / intestinal tube, the sleeve being formed from a resilient, flexible polymeric material and divided into a plurality of inflatable chambers by a plurality of partitions, each of the plurality of chambers being partially separated from an adjacent one of the plurality of chambers by a partition, the proximal end of the sleeve being in fluid communication with an injection port for injecting fluid into the sleeve; A swallowing disorder treatment device comprising:

20. 20. The dysphagia treatment device according to claim 19, A dysphagia treatment device in which the plurality of compartments are non-compliant rings of polymeric material.

21. 20. The dysphagia treatment device according to claim 19, A dysphagia treatment device in which a plurality of compartments comprise a portion of a sleeve secured to the exterior surface of a nasogastric / intestinal tube.

22. 20. The dysphagia treatment device according to claim 19, A dysphagia treatment device in which multiple compartments are flexible septa extending from the inner surface of the sleeve to the outer surface of the nasogastric / intestinal tube.

23. 20. The dysphagia treatment device according to claim 19, The dysphagia treatment device further includes at least one pressure transducer disposed in the sleeve or nasogastric / intestinal tube.

24. The dysphagia treatment device according to claim 23, The at least one pressure transducer is communicatively coupled to an external display.

25. 20. The dysphagia treatment device according to claim 19, The dysphagia treatment device further includes a suction port in fluid communication with the distal end of the sleeve.

26. A method for treating dysphagia, comprising: an elongate tubular body having a proximal end and a distal end and defining a first lumen and a second lumen, the first lumen oriented along a longitudinal axis of the tubular body, the first lumen receiving the nasogastric / intestinal tube such that the elongate tubular body is selectively slidable relative to the nasogastric / intestinal tube, and the second lumen oriented parallel to the first lumen; a dysphagia treatment device disposed proximate a distal end of the elongated tubular body and selectively actuable as the elongated tubular body slides over the nasogastric / intestinal tube; providing a dysphagia treatment device comprising: introducing a proximal end of a nasogastric / intestinal tube positioned within the patient's nasopharynx and esophagus through the distal end of the elongate tubular body and into the first lumen; sliding the elongated tubular body over the nasogastric / intestinal tube to advance the elongated tubular body into the patient's nasopharynx and esophagus while periodically activating the dysphagia treatment device to stimulate the patient's nasopharyngeal and esophageal muscles that control swallowing; A method for treating dysphagia, comprising:

27. 27. The method for treating dysphagia according to claim 26, A method for treating dysphagia, wherein the dysphagia treatment device includes an inflatable balloon, and the step of activating the dysphagia treatment device includes inflating the balloon with a fluid.

28. 27. The method for treating dysphagia according to claim 26, A method for treating dysphagia, wherein the dysphagia treatment device includes at least one air nozzle, and the step of activating the dysphagia treatment device includes applying air pulses to the patient's nasopharynx and esophagus using the at least one air nozzle.

29. 29. The method for treating dysphagia according to claim 28, A method for treating dysphagia, wherein the pressure of the air pulse is from about 70 mmHg to about 110 mmHg.

30. 27. The method for treating dysphagia according to claim 26, A method for treating dysphagia, wherein the dysphagia treatment device includes at least one light emitter, and the step of activating the dysphagia treatment device includes applying light pulses to the patient's nasopharynx and esophagus using the at least one light emitter.

31. 31. The method for treating dysphagia according to claim 30, A method for treating dysphagia, wherein the light pulse has a wavelength of about 400 nm to about 600 nm and a duration of about 10 ms to about 100 ms.

32. 1. A method of treating dysphagia, comprising: providing a dysphagia treatment device, the dysphagia treatment device comprising: a nasogastric / enteric tube; A sleeve disposed on the exterior of a nasogastric / intestinal tube, comprising: a sleeve formed from a resilient, flexible polymeric material and divided into a plurality of inflatable chambers by a plurality of partitions, each of the plurality of chambers being partially separated from an adjacent chamber by one of the partitions, a proximal end of the sleeve being in fluid communication with an injection port for injecting a fluid into the sleeve; inserting a sleeved nasogastric / intestinal tube into the patient's nasopharynx and esophagus; injecting a fluid into a most proximal chamber of the plurality of chambers to expand the chamber; A method for treating dysphagia, comprising:

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