Devices and methods to activate swallowing muscles to promote recovery of dysphagia in nervous system diseases

Abstract

Devices and methods for treating dysphagia associated with neurological diseases and promoting swallowing. The device includes a tube having an inner diameter greater than an outer diameter of a standard nasogastric tube / intestinal tube and can be advanced on a standard nasogastric tube / intestinal tube platform through the oropharynx and esophagus into the stomach. The device sequentially stimulates the muscles involved in swallowing (swallowing) to monitor and promote the recovery of dysphagia. Another iteration uses a long sleeve placed circumferentially around a standard nasogastric / intestinal tube. The sleeve may be inflated in the proximal end portion with an agent of air or another solution, and the agent may be moved downward along the sleeve under urging of oropharyngeal and esophageal muscle contractions, where segmentation is ensured at regular intervals by valves or adhesion.

Description

Technical Field

[0001] The present invention relates to a device and a treatment method for promoting swallowing recovery in patients with dysphagia secondary to a neurological disorder. Background Art

[0002] Dysphagia affects more than 50% of stroke survivors and is associated with a two-fold 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). There has previously been no effective treatment for dysphagia (Geeganage, C, Beavan, J, Ellender, S, Bath, PM. Cochrane Database Syst Rev 2012;10:CD000323). Dysphagia associated with neurological disorders is unique because there is no mechanical obstruction and the muscles involved are structurally intact. Rehabilitation techniques such as oral and speech exercises tend to focus on strength and endurance but require voluntary effort and are unable to mimic the dynamic process of swallowing. Neuromuscular stimulation of the oropharynx using surface stimulation has been shown to improve dysphagia, but most stimulation is too weak or the depth of penetration is insufficient to stimulate the muscles responsible for 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. Dyspagia 2006 doi:10.1007 / s00455-006-9029-4). The proposed method and device allow the reproduction of the dynamic characteristics of swallowing and involve the activation of both the oropharyngeal and esophageal segments.

[0003] There is a need for a device and method for effectively treating dysphagia in patients with neurological disorders. Summary of the Invention

[0004] Embodiments of the present invention address the need for devices and methods for effectively treating dysphagia in patients suffering from neurological disorders. Patients suffering from neurological disorders with dysphagia will undergo placement of a nasogastric / enteral tube for the purpose of ingesting nutrition, hydrates, and medications. The dysphagia treatment device described herein can be used in conjunction with a standard nasogastric / enteral tube to ensure that no additional new device needs to be inserted into the oropharynx. The dysphagia treatment device is placed over the already positioned standard nasogastric tube through the oropharynx and esophagus, and the position can be confirmed using a combination of bedside testing and radiography. The dysphagia treatment device focuses on providing mechanical stimulation to the muscles involved in swallowing and in another embodiment provides light stimulation to sequentially stimulate these muscles, thereby promoting the restoration of strength and coordination. With or without simultaneous electrical stimulation, the improvement of the device for mechanical or light stimulation multiple times a day with various iterations is synonymous with the active and passive activation of other paralyzed muscles of neurological patients forming the basis of rehabilitation. The activation can be performed at the bedside without the need for complex equipment or imaging techniques.

[0005] In an embodiment, a device for treating dysphagia includes an elongate tubular body having a proximal end, a distal end, and defining a first lumen and a second lumen. The first lumen is oriented along the longitudinal axis of the tubular body and is adapted to receive a nasogastric / enteral tube therein such that the elongate tubular body can be selectively displaced in a slidable manner relative to the nasogastric / enteral tube, and the second lumen is oriented parallel to the first lumen. The dysphagia treatment device is disposed adjacent the distal end of the elongate tubular body, and the dysphagia treatment device can be selectively actuated when the elongate tubular body slides over the nasogastric / enteral tube.

[0006] In an embodiment, the dysphagia treatment device is an inflatable sac that can be selectively inflated with fluid supplied through the second lumen. At least one pressure sensor for measuring the fluid pressure in the sac can be provided, and the at least one pressure sensor can be communicatively coupled to an external display. The tubular body can include a port disposed adjacent the proximal end of the tubular body and fluidly coupled to the second lumen for supplying fluid to and removing fluid from the second lumen and the sac. The second lumen can be concentric with the first lumen.

[0007] In an embodiment, a dysphagia treatment device can include at least one air nozzle extending from a second lumen to an outer surface of a tubular body, the at least one air nozzle being oriented transverse to a longitudinal axis of the tubular body. At least one pressure sensor can be disposed at a distal end of the elongated tubular body and communicatively coupled to an external display. A port can be disposed near a proximal end of the tubular body and fluidly coupled to the second lumen for supplying air to the second lumen and the at least one air nozzle. The second lumen can be concentric with a first lumen.

[0008] In an embodiment, a dysphagia treatment device includes at least one light emitter arranged to emit light in a direction transverse to a longitudinal axis of a tubular body. The at least one light emitter can emit light pulses having a wavelength in a range of about 400 nm to about 600 nm and a duration in a range 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 sensor disposed at a distal end of the elongated tubular body, and the at least one pressure sensor can be communicatively coupled to an external display. A high-resolution imaging device can be disposed at the distal end of the tubular body, and the imaging device is communicatively coupled to a video display. The second lumen can be concentric with the first lumen.

[0009] In an embodiment, a device for treating dysphagia includes a nasogastric tube / gastrostomy tube and a sleeve disposed on an outer surface of the nasogastric tube / gastrostomy tube. The sleeve is formed of an elastic, flexible polymeric material and is divided into a plurality of inflatable chambers by a plurality of dividers, each of the plurality of chambers being partially separated from an adjacent one of the plurality of chambers by a respective one of the dividers, a proximal end of the sleeve being fluidly coupled to an injection port for injecting fluid into the sleeve. Each of the plurality of dividers can be a non-compliant ring of polymeric material. In another embodiment, each of the plurality of dividers can be a portion of the sleeve adhered to the outer surface of the nasogastric tube / gastrostomy tube. In another embodiment, each of the plurality of dividers can be a flexible diaphragm extending from an inner surface of the sleeve toward the outer surface of the nasogastric tube / gastrostomy tube. At least one pressure sensor can be disposed on the sleeve or the nasogastric tube / gastrostomy tube. And the at least one pressure sensor can be communicatively coupled to an external display. A suction port can be fluidly coupled to a distal end of the sleeve.

[0010] In another embodiment, a method for treating dysphagia includes providing a dysphagia treatment device that includes an elongate tubular body having a proximal end, 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 is adapted to receive a nasogastric / enteral tube therein such that the elongate tubular body is selectively displaceable in a slidable manner relative to the nasogastric / enteral tube. The second lumen is oriented parallel to the first lumen, and the dysphagia treatment device is disposed adjacent the distal end of the elongate tubular body. The proximal end of the nasogastric / enteral tube disposed in the patient's nasopharynx and esophagus is introduced into the first lumen at the distal end of the elongate tubular body. The elongate tubular body is slid over the nasogastric / enteral tube to advance the elongate tubular body into the patient's nasopharynx and esophagus while periodically actuating the dysphagia treatment device to stimulate the muscles that control swallowing in the patient's nasopharynx and esophagus.

[0011] In an embodiment, the dysphagia treatment device can include an inflatable bladder, and the step of actuating the dysphagia treatment device can include inflating the bladder with fluid.

[0012] In another embodiment, the dysphagia treatment device includes at least one air nozzle, and the step of actuating the dysphagia treatment device includes applying an air pulse to the patient's nasopharynx and esophagus using the at least one air nozzle. The air pulse can have a pressure in the range of about 70 mmHg to about 110 mmHg.

[0013] In another embodiment, the dysphagia treatment device can include at least one light emitter, and the step of actuating the dysphagia treatment device can include applying a light pulse to the patient's nasopharynx and esophagus using the at least one light emitter. The light pulse can have a wavelength in the range of about 400 nm to about 600 nm and a duration in the range of about 10 ms to about 100 ms.

[0014] In another embodiment, a method for treating dysphagia includes providing a dysphagia treatment device that includes a nasogastric / enteral tube and a sleeve disposed on an outer surface of the nasogastric / enteral tube. The sleeve is formed of an elastic, flexible polymeric material and is divided into a plurality of inflatable chambers by a plurality of dividers, each of the plurality of chambers being partially separated from an adjacent one of the plurality of chambers by a respective one of the dividers. The proximal end of the sleeve is fluidly coupled to an injection port for injecting fluid into the sleeve. The nasogastric / enteral tube having the sleeve is disposed in the patient's nasopharynx and esophagus, and fluid is injected into the most proximal one of the plurality of chambers to inflate the chamber.

[0015] The foregoing summary is not intended to describe every illustrated embodiment or every implementation of the subject matter of the present disclosure. The following drawings and detailed description more particularly illustrate various embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The subject matter of the present invention can be more fully understood in connection with the following detailed description of various embodiments, considered in conjunction with the accompanying drawings, in which:

[0017] Figure 1 depicts the anatomy of the oropharynx and esophagus, where muscle contractions assist swallowing;

[0018] Figure 2 is an isometric view of a device for treating dysphagia according to an embodiment of the present invention;

[0019] Figure 3 is an isometric view of a device for treating dysphagia according to another embodiment of the present invention;

[0020] Figure 4 is an isometric view of a device for treating dysphagia according to an embodiment of the present invention, where the device includes a selectively expandable sac near the distal end of the device;

[0021] Figure 5 is at Figure 4 a cross-sectional view of the device taken at cross-section 5-5 of Figure 4 the device;

[0022] Figure 6 is at Figure 4 a cross-sectional view of the device taken at cross-section 6-6 of Figure 4 the device;

[0023] Figure 7 is at Figure 4 a cross-sectional view of the device taken at cross-section 7-7 of Figure 4 the device;

[0024] Figure 8 depicts Figure 4 the first stage of the device of

[0025] Figure 9 being advanced onto a standard nasogastric tube into the oropharynx and esophagus; Figure 4 the second stage of the device of

[0026] Figure 10 depicts Figure 4 the third stage of the device of

[0027] Figure 11 is Figure 4Isometric view of a device that includes a display for showing the pressure within an inflatable bladder;

[0028] Figure 12 Isometric view of a device for treating dysphagia according to another embodiment of the present invention, wherein the device includes a port near the distal end of the device for applying air pulses to the oropharynx and esophagus;

[0029] Figure 13 Is at Figure 12 Cross-sectional view of the device taken at section 13-13 of Figure 12 the device;

[0030] Figure 14 Depicts Figure 12 the first stage of the device of

[0031] Figure 15 Depicts Figure 12 the second stage of the device of

[0032] Figure 16 Depicts Figure 12 the third stage of the device of

[0033] Figure 17 Is Figure 12 Isometric view of a device that includes a display for showing the pressure or velocity of air pulses applied by the device;

[0034] Figure 18 Isometric view of a device for treating dysphagia according to another embodiment of the present invention, wherein the device includes a light emitter near the distal end of the device for applying light to the oropharynx and esophagus;

[0035] Figure 19 Is at Figure 18 Cross-sectional view of the device taken at section 19-19 of Figure 18 the device;

[0036] Figure 20 Depicts Figure 18 the first stage of the device of

[0037] Figure 21 Depicts Figure 18 the second stage of the device of

[0038] Figure 22 Depicts Figure 18 the third stage of the device of

[0039] Figure 23 Is an isometric view of a device for treating dysphagia according to an embodiment of the present invention, wherein the device includes a camera device located at the distal end of the device and a display for displaying an image from the camera device;

[0040] Figure 24 Is an isometric view of a device for treating dysphagia according to an embodiment of the present invention, wherein the device includes a sleeve received on a standard nasogastric tube;

[0041] Figure 25 Is an isometric view of another device for treating dysphagia according to an embodiment of the present invention, wherein the device includes a sleeve received on a standard nasogastric tube;

[0042] Figure 26 Is at Figure 27 A cross-sectional view of another device for treating dysphagia according to an embodiment of the present invention taken at section 26-26 thereof, wherein the device includes a sleeve received on a standard nasogastric tube;

[0043] Figure 27 Is Figure 26 An isometric view of the device;

[0044] Figure 28 Is an isometric view of a sleeve that can be received on a standard nasogastric tube, the sleeve including an adhesion portion that fixes an outer portion of the sleeve to a central lumen of the device;

[0045] Figure 29 Is at Figure 28 A cross-sectional view taken at section 29-29 thereof;

[0046] Figure 30 Is at Figure 28 A cross-sectional view taken at section 30-30 thereof;

[0047] Figure 31 Is an isometric view of a sleeve that can be received on a standard nasogastric tube, wherein a diaphragm is defined between an outer portion of the sleeve and the central lumen;

[0048] Figure 32 Is at Figure 31 Of Figure 31 A cross-sectional view of the device taken at section 32-32 thereof;

[0049] Figure 33 Is Figures 24 to 32 An isometric view of the sleeve, wherein an air / brine agent has been introduced into the sleeve;

[0050] Figure 34 Is Figure 33An isometric view of the device, where the air / brine agent moves further along the sleeve due to esophageal muscle contraction; and

[0051] Figure 35 is Figure 33 An isometric view of the device, where the air / brine agent moves even further along the sleeve due to esophageal muscle contraction.

[0052] Although various embodiments can be modified into various modifications and alternative forms, the details of various embodiments have been shown by way of example in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the claimed invention to the specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter defined by the claims. Detailed Description

[0053] In Figure 1 a cross-section of a human anatomical structure is depicted, which includes the tongue 100, palate 102, epiglottis 104, trachea 106, oropharynx 107, esophagus 108, stomach 110, and muscle 112. During the process of swallowing, the muscle 112 contracts sequentially as depicted by the arrows, such that food and water can move from the oropharynx 107 through the esophagus 108 to the stomach 110.

[0054] Figure 2 A dysphagia treatment device 114 according to an embodiment of the present invention is depicted. The device 114 generally includes a tubular body 116 defining a lumen 118. The inner diameter of the lumen 118 is sized to receive a standard nasogastric / intestinal tube 120 with a diameter of 12 to 18 French (4 mm to 6 mm) passing therethrough, such that the device 114 can slide over 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 can have a length of 42 inches to 50 inches and markings (not depicted) at 18, 22, 26, and 30 inches to help ensure proper insertion and placement in the oropharynx and esophagus. A port 126 is provided to inject air or a liquid such as brine into a second lumen (not depicted) as will be further described below. In Figure 3 an alternative embodiment, the tubular body 116 defines a hole 128 that is connected to the lumen 118, such that the nasogastric tube 120 can extend through the hole 128 rather than through the proximal end 122.

[0055] In use, by introducing the proximal end 130 of the nasogastric / intestinal tube 120 that is already in place in the oropharynx 107 and esophagus 108 into the lumen 118 at the distal end 124, Figure 2The device can be advanced into the oropharynx 107 and the esophagus 108. Then, the dysphagia treatment device 114 can slide over the nasogastric / enteral tube 120 until the proximal end 130 of the nasogastric / enteral tube 120 as depicted extends from the proximal end 122 and the distal end 132 of the nasogastric / enteral tube 120 extends from the distal end 124. In Figure 3 an alternative embodiment, the proximal end 130 of the nasogastric / enteral tube 120 is introduced into the lumen 118 at the distal end 124, but the proximal end 130 of the nasogastric / enteral tube 120 exits through the hole 128 as the dysphagia treatment device 114 slides over the nasogastric / enteral tube 120. In both embodiments, the proximal end 122 of the dysphagia treatment device 114 and the proximal end 130 of the nasogastric / enteral tube 120 remain outside the oropharynx 107.

[0056] In Figures 4 to 11 the depicted embodiment, the dysphagia treatment device 114 has an inflatable bladder 134 disposed near the distal end 124. The bladder 134 can be coated with sugar to mimic the taste of food. A second lumen 136 is defined between the inner wall 138 and the outer wall 140 of the tubular body 116. The second lumen 136 is fluidly coupled to the inflatable bladder 134 through the port 142 and is fluidly coupled to the port 126. It will be understood that although the second lumen 136 is depicted as concentric with the lumen 118, the second lumen 136 can be non - centrally disposed and extend parallel to the lumen 118 in other embodiments.

[0057] In use as Figures 8 to 10 depicted, the dysphagia treatment device 114 is advanced into the oropharynx 107 and the esophagus 108 by introducing the proximal end 130 of the nasogastric / enteral tube 120 into the lumen 118 at the distal end 124. As Figure 8 depicted, once the bladder 134 is inside the oropharynx 107, the bladder 134 is inflated with a fluid such as pressurized air that is supplied through the port 126 and enters the second lumen 136 and then enters the bladder 134 through the port 142. It will be understood that other fluids such as saline or other liquids can be used in place of pressurized air. As Figure 11As depicted, one or more pressure sensors 144 may be disposed inside the balloon 134 and communicatively coupled to an external display 146 to monitor and record the air pressure inside the balloon 134 as the dysphagia treatment device 114 is further advanced along the nasogastric / enteral tube 120 into the oropharynx 107 and esophagus 108. This enables the measurement and tracking of pressure changes caused by contractions of the muscles 112 in the oropharynx 107 and esophagus 108 as part of swallowing in response to the forward movement of the balloon. It will be understood that although the external display 146 is depicted as being coupled to the pressure sensor 144 by a line 148, the external display 146 may also be coupled by a wireless connection.

[0058] As Figures 9 to 10 depicted, when the dysphagia treatment device 114 is further advanced into the esophagus 108, the inflated balloon 134 contacts and mechanically stimulates the muscles 112 along the esophagus 108 to cause sequential contractions that mimic the swallowing process. Once the balloon 134 reaches the stomach 110, the balloon 134 may be deflated through the port 126 and the dysphagia treatment device 114 may be removed by sliding it in the opposite direction along the nasogastric / enteral tube 120. This process may be repeated as needed.

[0059] In Figures 12 to 17 another embodiment of the dysphagia treatment device 114 as depicted, the balloon 134 is replaced by one or more radially oriented nozzles 150 fluidly coupled to a second lumen 136, where the second lumen 136 is fluidly coupled to the port 126 as before. As the dysphagia treatment device 114 is advanced on the nasogastric / enteral tube 120 through the oropharynx 107 and esophagus 108, rapid, small-volume, intermittent air pulses 152 supplied through the port 126 may be ejected through the nozzles 150 to mechanically stimulate the muscles 112. In a non-limiting embodiment, the air pulses may have a pressure in the range of about 70 millimeters (mm) Hg to about 110 mm Hg, and the air pressure pulse profile may have a Gaussian shape.

[0060] Again, in as Figures 14 to 16 depicted 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 / enteral tube 120 into the lumen 118 at the distal end 124. As Figure 14 depicted, once the nozzle 150 is in place inside the oropharynx 107, air pulses 152 may be applied by injecting air through the port 126. As Figure 17As depicted, one or more pressure sensors 154 may be disposed at the distal end 124 and communicatively coupled to an external display 146 to be able to monitor and record air pressure for measuring and tracking pressure changes caused by contractions resulting from the muscles 112 in the oropharynx 107 and esophagus 108 in response to the forward movement of the dysphagia treatment device 114 as part of swallowing. During the air pulse 152, the pressure will increase according to the contraction of the muscles and the consequent reduction in the space around the distal end 124. As Figures 15 to 16 As depicted, when the dysphagia treatment device 114 is further advanced into the esophagus 108, an air pulse 152 is applied to the interior of the esophagus 108 to mechanically stimulate the muscles 112 along the esophagus 108, thereby causing sequential contractions mimicking the swallowing process. Once the distal end 124 reaches the stomach 110, the dysphagia treatment device 114 can be removed by sliding it in the opposite direction along the nasogastric / enteral tube 120. This process can be repeated as needed.

[0061] In Figures 18 to 23 In yet another embodiment of the dysphagia treatment device 114 as depicted, one or more light emitters, such as light-emitting diodes (LEDs) 156, are disposed near the distal end 124 of the dysphagia treatment device 114. The LEDs 156 are connected to a suitable power source by leads 158 that extend through the second lumen 136. It will be understood that other light-emitting devices may replace the LEDs 156. The power source may be included in the controller / display 160 or may be separate. When the dysphagia treatment device 114 is advanced through the oropharynx 107 and esophagus 108 on the nasogastric / enteral tube 120, the LEDs 156 can be actuated to emit light pulses 162 to stimulate the muscles 112. In a non-limiting embodiment, the light pulses 162 may be light having a wavelength in the range of about 400 nanometers (nm) to about 600 nm, predominantly blue, and a pulse duration in the range of about 10 milliseconds (ms) to 100 ms. However, those skilled in the art will understand that light of other wavelengths and durations may be effectively applied while remaining within the scope of the present invention.

[0062] Again, in use as Figures 20 to 22 As depicted, the dysphagia treatment device 114 is advanced into the oropharynx 107 and esophagus 108 by introducing the proximal end 130 of the nasogastric / enteral tube 120 into the lumen 118 at the distal end 124. As Figure 20 As depicted, once the LEDs 156 are in place inside the oropharynx 107, the light pulses 162 can be applied by actuating the LEDs 156. As Figures 21 to 22As depicted, when the dysphagia treatment device 114 is further advanced into the esophagus 108, light pulses 162 are applied to the interior of the esophagus 108 to stimulate the muscles 112 along the esophagus 108, thereby causing sequential contractions that mimic the swallowing process. Once the distal end 124 reaches the stomach 110, the dysphagia treatment device 114 can be removed by sliding it in the opposite direction along the nasogastric / enteral tube 120. This process can be repeated as needed.

[0063] In addition, as Figure 23 depicted, a high-resolution imaging device 164 having an illumination piece 166 can be disposed at the distal end 124 and communicatively coupled to the controller / display 160 such that contractions of the muscles 112 in the oropharynx 107 and esophagus 108 that are part of swallowing in response to forward movement of the dysphagia treatment device 114 can be visualized on the controller / display 160.

[0064] In Figures 24 to 35 other embodiments of the dysphagia treatment device 168 are depicted. The device 168 generally includes a sleeve 170 disposed on and secured to the outer surface 172 of the nasogastric / enteral tube 120. The sleeve 170 is flexible, elastic, and expandable and can be formed as a thin layer of a bioplastic polymer, such as polyethylene or polylactic acid, although other polymeric materials capable of forming a thin expandable structure can also be used while remaining within the scope of the present invention. The length of the sleeve 170 will generally be from about 40 mm to about 70 mm and is positioned along the standard nasogastric / enteral tube 120 to correspond to the oropharynx 107 and esophagus 108 when the nasogastric / enteral tube 120 is placed in a patient. The sleeve 170 is sealed to the outer surface 172 of the nasogastric / enteral tube 120 at the proximal end 174 and the distal end 176. Air / saline agents injected into the sleeve 170 at the proximal end 174 can move downward along the sleeve 170 and be pushed toward the stomach 110 by sequential contractions of the muscles 112 of the oropharynx and esophagus.

[0065] In an embodiment of the present invention as Figures 26 to 32 depicted, the sleeve 170 is divided into sections that form a plurality of expandable chambers 178 longitudinally along the nasogastric / enteral tube 120. In Figure 26 and Figure 27In the depicted embodiment, spacers in the form of non-compliant rings 180 made of polymeric material are provided at spaced intervals along the sleeve 170. In a preferred embodiment, the rings 180 will have a longitudinal dimension X of from about 3 cm to about 5 cm and will be spaced apart by a longitudinal dimension Y of from about 3 cm to about 7 cm. The rings 180 may be secured to the outer surface 181 of the sleeve 170 with an adhesive. An injection port 183 is provided to enable air, a liquid such as saline, or a composition of air and liquid to be injected into the most proximal chamber 185 of the chamber 178.

[0066] In Figures 28 to 30 the depicted embodiment, the sleeve 170 is partially adhered to the outer surface 172 of the nasogastric / enteral tube 120 at the adhesion regions 182 to form a spacer, for example by fusing the plastic materials of the sleeve 170 and the nasogastric / enteral tube 120 or using a separate adhesive for adhesion. Again, the adhesion regions may be spaced apart by a longitudinal distance Y of from about 3 cm to about 7 cm along the sleeve 170. An injection port 183 is provided to enable air, a liquid such as saline, or a composition of air and liquid to be injected into the most proximal chamber 185 of the chamber 178.

[0067] In Figure 31 and Figure 32 the embodiment, flexible partial diaphragms 184 project inwards from the sleeve 170 towards the outer surface 172 of the nasogastric / enteral tube 120. The free end 187 of each diaphragm 184 is freely deflectable to enable an air / liquid agent 188 to pass through. As Figure 32 depicted, the diaphragms 184 may be slightly inclined towards the distal end 176. An injection port 183 is provided to enable air, a liquid such as saline, or a composition of air and liquid to be injected into the most proximal chamber 185 of the chamber 178.

[0068] As Figure 24 depicted, the port 183 may have a proximal end 186 adapted to receive a syringe (not depicted) to enable air, liquid or an air / liquid agent 188 to be injected into the most proximal chamber 185. A suction port 190 may be provided which is connected to a small tube 192 extending through the sleeve 170 to the most distal chamber 194 to enable the air / liquid agent 188 to be withdrawn after it reaches the distal end 176 of the sleeve 170. The proximal end 198 of the suction port 190 may be adapted to receive a syringe (not depicted) to enable the agent 188 to be withdrawn. Alternatively, as Figure 25 depicted, the distal end 176 of the sleeve 170 may be provided with a hole 196 to enable the air / liquid agent 188 to be discharged into the stomach 110.

[0069] In any of the above-described embodiments of the dysphagia treatment device 168, a pressure sensor (not depicted) may be disposed within the sleeve 170 to be able to monitor and record the pressure inside the sleeve 170, thereby evaluating the contractions of the muscles 112 in the oropharynx 107 and esophagus 108 as part of swallowing.

[0070] In use, the nasogastric / enteral tube 120 and the sleeve 170 are placed in the oropharynx 107 and esophagus 108, and the medicament 188 is injected into the most proximal chamber 185 through the port 183. Preferably, a sufficient amount of air / liquid is injected such that the medicament 188 expands the chamber 185 by a lateral dimension Z of about 2 mm to about 5 mm. As Figures 33 to 35 depicted, the medicament 188 is advanced from the proximal end 174 through the successive chambers 178 to the distal end 176 by the contractions of the muscles 112 in the oropharynx 107 and esophagus 108. The ring 180, the adhesion area 182, or the diaphragm 184 inhibits the backflow of the medicament 188 toward the proximal end 174. Once the medicament 188 reaches the distal end 176, the medicament 188 may be discharged through the aspiration port 190 or drained into the stomach 110 through the aperture 196.

[0071] Various embodiments of systems, devices, and methods have been described herein. These embodiments are given by way of example only and are not intended to limit the scope of the claimed invention. In addition, it should be understood that the various features of the described embodiments can be combined in various ways to produce many additional embodiments. Moreover, while various materials, dimensions, shapes, configurations, locations, etc. have been described for use with the disclosed embodiments, other materials, dimensions, shapes, configurations, and locations other than those disclosed can be utilized without exceeding the scope of the claimed invention.

[0072] One of ordinary skill in the relevant art will recognize that the subject matter of the present disclosure may include fewer features than those shown in any of the above-described individual embodiments. The embodiments described herein are not meant to be an exhaustive representation of the ways in which the various features of the subject matter of the present disclosure can be combined. Thus, the embodiments are not mutually exclusive combinations of features; rather, as will be understood by one of ordinary skill in the art, the various embodiments can include combinations of different individual features selected from different individual embodiments. In addition, unless otherwise stated, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments.

[0073] Although dependent claims may recite particular combinations with one or more other claims in the claim, other embodiments may also include combinations of a dependent claim with the subject matter of each other dependent claim or combinations of one or more features with other dependent claims or independent claims. Such combinations are presented herein unless it is stated that a particular combination is not intended.

[0074] Any incorporation by reference of the above - cited documents is limited such that no subject matter contrary to the explicit disclosure herein is incorporated. Any incorporation by reference of the above - cited documents is further limited such that the claims included in the documents are not incorporated by reference into this application. Any incorporation by reference of the above - cited documents is further limited such that any limitation provided in the documents is not incorporated by reference into this application, unless explicitly included herein.

[0075] For purposes of interpreting the claims, the provisions of 35 U.S.C.§112(f) are expressly not applicable unless a particular term “means for...” or “step for...” is recited in the claim.

Claims

1. An apparatus for treating dysphagia, the apparatus comprising: An elongated tubular body having a proximal end, a distal end and defining a first lumen and a second lumen, the first lumen being oriented along a longitudinal axis of the tubular body, the first lumen being adapted to receive a nasogastric tube / intestinal tube therein such that the elongated tubular body can be selectively displaced relative to the nasogastric tube / intestinal tube in a slidable manner, the second lumen being oriented parallel to the first lumen; And A dysphagia treatment device disposed near the distal end of the elongated tubular body, wherein the dysphagia treatment device can be selectively actuated when the elongated tubular body slides on the nasogastric tube / intestinal tube.

2. The device according to claim 1, wherein The dysphagia treatment device includes an inflatable sac that can be selectively inflated with fluid supplied through the second lumen.

3. The apparatus according to claim 2, further comprising at least one pressure sensor for measuring the fluid pressure in the sac.

4. The device according to claim 3, wherein, The at least one pressure sensor is communicatively coupled to an external display.

5. The device according to claim 1, wherein, The tubular body includes a port disposed near the proximal end of the tubular body and fluidly coupled to the second lumen for supplying fluid to and removing fluid from the second lumen and the sac.

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

7. The device according to claim 1, wherein, 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 transversely to the longitudinal axis of the tubular body.

8. The apparatus according to claim 7, further comprising at least one pressure sensor disposed at the distal end of the elongated tubular body.

9. The device according to claim 8, wherein, The at least one pressure sensor is communicatively coupled to an external display.

10. The apparatus according to claim 7, wherein, The tubular body includes a port disposed near the proximal end of the tubular body and fluidly coupled to the second lumen for supplying air to the second lumen and the at least one air nozzle.

11. The apparatus according to claim 7, wherein, The second lumen is concentric with the first lumen.

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

13. The device according to claim 12, wherein, The at least one light emitter emits light pulses having a wavelength in the range of about 400 nm to about 600 nm and a duration in the range of about 10 ms to about 100 ms.

14. The device according to claim 12, wherein, The at least one light emitter is a light emitting diode.

15. The apparatus according to claim 12, further comprising at least one pressure sensor disposed at the distal end of the elongated tubular body.

16. The apparatus according to claim 15, wherein, The at least one pressure sensor is communicatively coupled to an external display.

17. The apparatus according to claim 12, further comprising a high-resolution imaging device disposed at the distal end of the tubular body, the imaging device being communicatively coupled to a video display.

18. The apparatus according to claim 12, wherein, The second lumen is concentric with the first lumen.

19. A device for treating dysphagia, the device comprising: A nasogastric tube / enteral tube; And A sleeve disposed on an outer surface of the nasogastric tube / enteral tube, the sleeve formed of an elastic, flexible polymeric material and divided by a plurality of dividers into a plurality of expandable chambers, each of the plurality of chambers being partially separated from an adjacent one of the plurality of chambers by a respective one of the dividers, a proximal end of the sleeve being fluidly coupled to an injection port for injecting fluid into the sleeve.

20. The apparatus according to claim 19, wherein, Each of the plurality of dividers is a non-compliant ring of polymeric material.

21. The device according to claim 19, wherein, Each of the plurality of dividers includes a portion of the sleeve adhered to the outer surface of the nasogastric tube / enteral tube.

22. The device according to claim 19, wherein, Each of the plurality of dividers includes a flexible diaphragm extending from an inner surface of the sleeve toward the outer surface of the nasogastric tube / enteral tube.

23. The device according to claim 19, further comprising at least one pressure sensor disposed on the sleeve or the nasogastric tube / enteral tube.

24. The apparatus according to claim 23, wherein The at least one pressure sensor is communicatively coupled to an external display.

25. The device according to claim 19, further comprising a suction port fluidly coupled to a distal end of the sleeve.

26. A method for treating dysphagia, the method comprising: Providing a dysphagia treatment device, the dysphagia treatment device comprising: An elongate tubular body having a proximal end, a distal end and defining a first lumen and a second lumen, the first lumen being oriented along a longitudinal axis of the tubular body, the first lumen adapted to receive a nasogastric tube / enteral tube therein such that the elongate tubular body is selectively displaceable relative to the nasogastric tube / enteral tube in a slidable manner, the second lumen being oriented parallel to the first lumen; and A dysphagia treatment device disposed adjacent the distal end of the elongate tubular body; Introducing a proximal end of a nasogastric tube / enteral tube placed in a patient's nasopharynx and esophagus into the first lumen at the distal end of the elongate tubular body; Sliding the elongate tubular body over the nasogastric tube / enteral tube to advance the elongate tubular body into the patient's nasopharynx and esophagus while periodically actuating the dysphagia treatment device to stimulate muscles controlling swallowing in the patient's nasopharynx and esophagus.

27. The method according to claim 26, wherein, The dysphagia treatment device includes an inflatable bladder, and the step of actuating the dysphagia treatment device includes inflating the bladder with fluid.

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

29. The method according to claim 28, wherein, The air pulses have a pressure in the range of about 70 mmHg to about 110 mmHg.

30. The method according to claim 26, wherein The dysphagia treatment device includes at least one light emitter, and the step of actuating the dysphagia treatment device includes applying light pulses to the nasopharynx and esophagus of the patient using the at least one light emitter.

31. The method according to claim 30, wherein, The light pulses have a wavelength in the range of about 400 nm to about 600 nm and a duration in the range of about 10 ms to about 100 ms.

32. A method for treating dysphagia, the method comprising: providing a dysphagia treatment device, the dysphagia treatment device comprising: a nasogastric tube / enteral tube; and a sleeve disposed on an outer surface of the nasogastric tube / enteral tube, the sleeve being formed of an elastic, flexible polymeric material and divided into a plurality of inflatable chambers by a plurality of dividers, each of the plurality of chambers being partially separated from an adjacent one of the plurality of chambers by a respective one of the dividers, a proximal end of the sleeve being fluidly coupled to an injection port for injecting fluid into the sleeve; positioning the nasogastric tube / enteral tube having the sleeve in the nasopharynx and esophagus of a patient; and injecting fluid into a most proximal one of the plurality of chambers to inflate the chamber.

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