Device and method for post extubation dysphagia, antibacterial therapy, and detection and drainage of pharyngeal secretions

Abstract

A drainage device includes an elongate flexible conduit comprising a proximal end opening, a distal end opening and a lumen disposed therebetween. A multi-layer distal portion coaxially surrounding the lumen and having a porous outer surface layer, a porous interior layer and an intermediate absorbent layer therebetween. A drainage system and a device and method for treating dysphagia are also disclosed.

Description

DEVICE AND METHOD FOR POST EXTUBATION DYSPHAGIA, ANTIBACTERIAL THERAPY, AND DETECTION AND DRAINAGE OF PHARYNGEAL SECRETIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. provisional application No. 63 / 512,358, filed July 7, 2023, and U.S. provisional application No. filed on 63 / 640,342, filed April 30, 2024, both of which are incorporated herein by reference in their entireties.BACKGROUND OF THE INVENTION

[0002] When an endotracheal tube (ET), a breathing tube is inserted to support the respiration of a patient (using artificial breathing, i.e.; ventilation), it impairs the normal swallowing and clearance mechanisms that keep bacteria from entering the airway.Aspiration of oral colonization has been identified as one of the common causes of ventilatory associated pneumonia (VAP) in the ICU as a result of poor oral care. Whenever an ET is in place, most defenses against pneumonia are impaired. The ET tube bypasses normal filtration and physical capture functions as there is no nasal warming or humidification. The mucociliary defense mechanism is also compromised by the ET tube. The ET tube disrupts normal mucus clearance and there is a collection of secretions above the cuff, which contaminates the subglottic pool. Contaminated secretions can drain into the trachea and can be aspirated into lungs.

[0003] These issues lead to VAP in up to 25% of the ventilated patients and causes death in up to 50% of ventilated patients. VAP results from a microbial invasion of thenormally sterile lower respiratory tract and lung parenchyma, which can then overwhelm the host’s defenses to establish infection. The primary route of bacterial entry into the lower respiratory tract is via aspiration of bacteria-contaminated secretions which accumulate above the endotracheal tube cuff. The repeated micro-aspirations of these secretions, so-called subglottic secretions occurs in upwards of 75% of intubated patients.

[0004] One cubic millimeter of dental plaque contains about 100 million bacteria (Thoden van Velzen et al, 1984) and may serve as a persistent reservoir for potential pathogens, both oral and respiratory bacteria. It is likely that oral and respiratory bacteria in the dental plaque are shed into the saliva and are then aspirated into the lower respiratory tract and the lungs to cause infection (Scannapieco,1999; Scannapieco et al, 2001 ). Cytokines and enzymes induced from the periodontally inflamed tissues by the oral biofilm may also be transferred into the lungs where they may stimulate local inflammatory processes preceding colonization of pathogens and the actual lung infection (Scannapieco, 1999; Scannapieco et al, 2001 ). Other possible mechanisms of pulmonary infection are inhalation of airborne pathogens or translocation of bacteria from local infections via bacteremia.

[0005] In a healthy subject, the respiratory tract is able to defend against aspirated bacteria. Patients with diminished salivary flow, decreased cough reflex, swallowing disorders, poor ability to perform good oral hygiene, or other physical disabilities have a high risk for pulmonary infections. Mechanically ventilated patients in ICUs with no ability to clear oral secretions by swallowing or by coughing, are at risk for VAP especially if the ventilation lasts for more than 48 hours (Estes and Meduri, 1995). Oralbacterial load increases during intubation and higher dental plaque scores predict risk of pneumonia (Munro et al, 2006). Anaerobic bacteria are frequently found to colonize the lower respiratory tract in mechanically-ventilated patients (Estes and Meduri, 1995; Robert et al, 2003). Colonization of bacteria in the digestive tract has been suggested to be a source for nosocomial pneumonia, but recently oral and dental bacterial colonization has been proposed to be the major source of bacteria implicated in the etiology of VAP (Garcia, 2005). In the institutionalized elderly the aspiration of saliva seems to be the main route of bacteria into the lungs causing aspiration pneumonia. Dysphagia seems to be an important risk factor, even a predictor, for aspiration pneumonia (Langmore et al, 1998). The major oral and dental risk factors for aspiration pneumonia in veteran residents of nursing homes were number of decayed teeth, periodontitis, oral S. aureus colonization, and requirement of help feeding (Terpenning et al, 2001 ). Inadequate oral care and swallowing difficulties were associated with pneumonia in 613 elderly nursing home patients (Quagliarello et al, 2005).

[0006] Animal models, 3D printed models of human CT scans and extensive review of CT imaging data shows that there is pooling of secretions as shown for example in Fig. 1 with the subject head 20 at a 30-degree elevation. An endotracheal tube 10 is shown terminating distally just above the upper esophageal sphincter 12. Secretions 14 gather in the posterior pharynx 16 behind the nasal cavity 18. Animal studies on rats and pigs show that when this space is aspirated and kept clean, there is no soiling of the trachea and lungs. Mathematically constructed CT scans show that even at 30- degree elevation of the head (standard of care to prevent VAP), there is substantialaspiration of the contents in the space shown in Fig. 1 . When medical professionals suction using conventional devices, the tip rarely reaches this section, thus they are unable to prevent the pooling and soiling of the lungs which leads to VAP. Additionally repeated insertion of oral suction / sponge catheters lead to mucosal trauma and interruption of suctioning to prevent blood loss.

[0007] Further, difficulty to swallow after removal of a breathing tube is a common occurrence in patients who need prolonged mechanical ventilation. This leads to aspiration and complications associated with aspiration pneumonia, reduced oxygen saturation bronchospasm, obstruction of the breathing airways and collapse of the lung. Difficulty in swallowing also results in malnutrition, prolonged hospital stays, increased financial burden and increase in risk of death. The reasons for swallowing difficulty can include mechanical causes, cognitive disturbances and residual effects of medications like narcotics and anxiolytic medications. The mechanical causes can be attributed to the prolonged duration of the breathing tube that can lead to inflammation of the mucosa and atrophy of the oropharyngeal muscles because of disuse during the phase when they are on the breathing tube and their mouth is kept open. Additionally, reduction in the laryngeal sensation, reduction in proprioception and injury to the larynx such as swelling granuloma formation or vocal call paralysis can happen. Traumatic brain injury or critical illness and muscle atrophy may also lead to swallowing disorders. Other things in combination cause impaired regulation of the swallowing reflex and may lead to difficulty swallowing after removal of the breathing tube. Each additional day of mechanical ventilation increases the risk of swallowing difficulty by approximately 15%in patients who are older than 55 and overall a 35% increased risk of dysphagia compared to younger patients.

[0008] Patients who have a breathing tube down their throat primarily pose issues with pulling of the secretions from the nasal and oropharyngeal areas and aspiration of these secretions which can lead to spilling over of the secretions into the lungs. In addition, bacterial colonization is a major problem in these areas of sinuses. Prolonged pulling of the secretions in the posterior pharynx act as a nidus for bacteria to grow which in turn spills over the breathing tube of the patient and causes pneumonia.

[0009] What is needed in the art is a system and device that can address the issues described above caused by oral secretions to keep this space dry and reduce the incidence of VAP. Embodiments of the system and device described below fit this need.SUMMARY OF THE INVENTION

[0010] In one embodiment, a drainage device includes an elongate flexible conduit comprising a proximal end opening, a distal end opening and a lumen disposed therebetween, and a multi-layer distal portion coaxially surrounding the lumen and having a porous outer surface layer, a porous interior layer and an intermediate absorbent layer therebetween. In one embodiment, the porous interior layer comprises a multi-channel structure. In one embodiment, each channel of the multi-channel structure is in fluid communication with a drainage conduit extending proximally at least to the proximal end opening. In one embodiment, the multi-channel structure is a non- collapsible structure. In one embodiment, the porous outer surface layer is ahydrophobic layer. In one embodiment, the intermediate absorbent layer comprises a cellulose material. In one embodiment, the drainage device is coaxially loaded over a feeding tube. In one embodiment, a system includes the drainage device and a negative pressure source in fluid communication with channels of the porous interior layer. In one embodiment, the drainage device includes a sleeve configured to coaxially load over the drainage device and compress the multi-layer distal portion. In one embodiment, the multi-layer distal portion includes multiple struts. In one embodiment, the struts include a shape-memory material. In one embodiment, the plurality of struts includes three struts. In one embodiment, the struts are configured to initiate trifoliate compaction upon rotation. In one embodiment, the multi-layer distal portion is configured to reduce in diameter upon actuation of a twisting motion. In one embodiment, the drainage device includes multiple surface electrodes at least partially surrounding the lumen. In one embodiment, at least one of the surface electrodes is disposed on the porous outer surface layer. In one embodiment, the drainage device includes a controller configured to generate a suction signal upon detecting a threshold impedance from at least one of the plurality of surface electrodes. In one embodiment, the drainage device includes a light source configured to apply visible blue light in 400 to 470 nm spectra within the lumen. In one embodiment, a plurality of electrodes on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal. In one embodiment, the controller is configured to generate the electrode treatment signal at a frequency of 3Hz. In one embodiment, the controller is configured to generate the electrode treatment signal at a frequency between 2.9Hz and 3.1 Hz. In one embodiment, the controller is configured to generatethe electrode treatment signal at a frequency between 2.5Hz and 3.5Hz. In one embodiment, the controller is configured to generate the electrode treatment signal utilizing a pulse width of 300pS. In one embodiment, the controller is configured to generate the electrode treatment signal utilizing a pulse width between 290pS and 310pS. In one embodiment, the controller is configured to generate the electrode treatment signal utilizing a pulse width between 280pS and 320pS. In one embodiment, the controller is configured to generate the electrode treatment signal from 1 mA to 20mA. In one embodiment, the controller is configured to generate the electrode treatment signal for a 10-minute duration. In one embodiment, the controller is configured to generate the electrode treatment signal for a 9 to 11 minute duration. In one embodiment, the controller is configured to generate the electrode treatment signal for an 8 to 12 minute duration. In one embodiment, the controller is configured to modify the electrode treatment signal based on an audio feedback signal from an audio sensor indicative of soundwaves generated by the pharynx. In one embodiment, the controller is configured to modify the electrode treatment signal based on a physiological feedback signal from an EMG sensor indicative of electrical activity in the pharyngeal muscles.

[0011] In one embodiment, a device for treating dysphagia includes an elongate flexible conduit comprising a proximal end opening, a distal end opening and a lumen disposed therebetween, and a plurality of electrodes on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal. In one embodiment, the controller is configured to generate the electrode treatment signal at a frequency of 3Hz. In one embodiment, the controller is configuredto generate the electrode treatment signal at a frequency between 2.9Hz and 3.1 Hz. In one embodiment, the controller is configured to generate the electrode treatment signal at a frequency between 2.5Hz and 3.5Hz. In one embodiment, the controller is configured to generate the electrode treatment signal utilizing a pulse width of 300pS. In one embodiment, the controller is configured to generate the electrode treatment signal utilizing a pulse width between 290pS and 310pS. In one embodiment, the controller is configured to generate the electrode treatment signal utilizing a pulse width between 280pS and 320pS. In one embodiment, the controller is configured to generate the electrode treatment signal from 1 mA to 20mA. In one embodiment, the controller is configured to generate the electrode treatment signal for a 10-minute duration. In one embodiment, the controller is configured to generate the electrode treatment signal for a 9 to 11 minute duration. In one embodiment, the controller is configured to generate the electrode treatment signal for an 8 to 12 minute duration. In one embodiment, the controller is configured to modify the electrode treatment signal based on an audio feedback signal from an audio sensor indicative of soundwaves generated by the pharynx. In one embodiment, the controller is configured to modify the electrode treatment signal based on a physiological feedback signal from an EMG sensor indicative of electrical activity in the pharyngeal muscles.

[0012] In one embodiment, a method for treating dysphagia includes the steps of advancing a plurality of electrodes into the posterior pharynx; and delivering electrical stimulation from 1 mA to 20mA to the pharyngeal muscles, at a frequency between 2.5Hz and 3.5Hz and pulse width between 280pS and 320pS. In one embodiment, the frequency is 3Hz. In one embodiment, the frequency is between 2.9Hz and 3.1 Hz. Inone embodiment, the pulse width is 300pS. In one embodiment, the pulse width is between 290pS and 310pS. In one embodiment, the treatment duration is 10 minutes. In one embodiment, the treatment duration is 9 to 11 minutes. In one embodiment, the treatment duration is 8 to 12 minutes. In one embodiment, the method includes the step of modifying the electrode treatment signal based on an audio feedback signal from an audio sensor indicative of soundwaves generated by the pharynx. In one embodiment, the method includes the step of modifying the electrode treatment signal based on a physiological feedback signal from an EMG sensor indicative of electrical activity in the pharyngeal muscles.

[0013] In one embodiment, a drainage device includes an elongate flexible conduit having a proximal end opening, a distal end opening and a lumen disposed therebetween, and liquid crystal polymer electrodes on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are included to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:

[0015] Figure 1 is an anatomical diagram showing where secretions typically gather during use of an ET tube.

[0016] Figure 2A is an anatomical diagram showing a drainage device inserted according to one embodiment, Figure 2B is an anatomical diagram showing removal of a drainage device though the nostril according to one embodiment, Figure 2C is cross- sectional view of a distal portion of the drainage device (top) according to one embodiment and a perspective view of a negative pressure source (bottom) according to one embodiment and Fig. 2D is a top view of a suction device according to one embodiment.

[0017] Figure 3A shows several views of Nitinol strut members integrated into the PTFE tube for initiating trifoliate compaction upon rotation according to one embodiment, and Figure 3B shows several views of a longitudinal twist mechanism for compaction according to one embodiment.

[0018] Figure 4A shows several views of surface electrodes having a winding geometry on the conduit according to one embodiment, and Figure 4B shows several views of surface electrodes having a spiral geometry on the conduit according to one embodiment.

[0019] Figures 5A-5E show a device for treating dysphagia; Fig. 5A an anatomical diagram showing position for electrical stimulation and sensor feedback according to one embodiment, Fig. 5B a block diagram showing device components according to one embodiment, Fig. 5C showing a circuit diagram according to one embodiment, and Figs. 5D and 5E showing alternate prototype testing modules each according to one embodiment.

[0020] Figure 6A shows a sensing and control block diagram for a device for treating dysphagia according to one embodiment, Figure 6B shows a sensor feedback graph before swallowing according to one embodiment, and Figure 6C shows a sensor feedback graph during swallowing according to one embodiment.DETAILED DESCRIPTION OF THE INVENTION

[0021] It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a more clear comprehension of the present invention, while eliminating, for the purpose of clarity, many other elements found in devices, systems and methods for sub-glottic drainage systems. Those of ordinary skill in the art may recognize that other elements and / or steps are desirable and / or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

[0022] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described.

[0023] As used herein, each of the following terms has the meaning associated with it in this section.

[0024] The articles “a” and “an” are used herein to refer to one or to more than one ( / '.e. , to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.

[0025] “About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1 %, and ±0.1 % from the specified value, as such variations are appropriate.

[0026] Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Where appropriate, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1 , 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

[0027] Referring now in detail to the drawings, in which like reference numerals indicate like parts or elements throughout the several views, in various embodiments, presented herein is a sub-glottic drainage system and device.

[0028] In one embodiment, a specially designed catheter is inserted from one of the nostrils and advanced to the back of throat, where secretions accumulate in recumbentposition. This catheter has a telescoping design exposing a microporous sponge end which allows for immediate soakage and subsequent suctioning / vacuuming of the sub glottic secretions. The specially designed microporous end has multiple channels and allows for safe suctions without injuring the mucosa which is the case when the back of the throat is suctioned by current methods, which frequently leads to bleeding and interruption of suctioning due to fear of exacerbating further bleeding. The suction can be continuous or intermittent and is physician directed based on the individual need of the patient. The telescoping part of the catheter is designed to be peel away and can be discarded. When no more suction is needed the tube is simply removed.

[0029] Advantageously, embodiments of the system and device have the ability to (1 ) clear all retropharyngeal secretion pooling, (2) act as a retainer and eliminate dead space, (3) instill antibacterial solution, (4) give a continuous lavage, (5) avoid mucosal trauma and bleeding, and (6) eliminate the pool that leads to subglottic aspiration.There are also several economic advantages. Five million Americans get admitted to the ICU every year, and two and half million get a breathing tube. Of those, 750,000 get VAP and 187,500 die each year due to VAP. The cost of VAP averages 48,000 USD per patient and requires 7 to 9 days of extended hospital stay. This amounts to a 36 Billion USD per year cost and a 5.25 million hospital bed loss due to VAP. Access to embodiments of the system and device described herein can significantly minimize this loss of resources. Further, embodiments of a device utilize electrodes on an exoskeleton tube advanced into the posterior pharynx and stimulated using electrical energy with an external chin-based sensor acting as an efficacy control.

[0030] In one embodiment, with reference now to Figs. 2A-2C, a feeding tube has a modified drainage device with specially designed layers. For reference first to Figs. 2A and 2B, subject anatomy includes the head 160 at 30-degree elevation and depictions of the tongue 162, epiglottis 164, trachea 166, esophagus 168 and the space where secretions gather 170. An endotracheal tube 152 is shown inserted. The drainage device 100 can be telescoped or coaxially loaded over the feeding tube 150, integrated into the manufacture of the feeding tube, or used as a standalone device. Fig. 2C shows a schema of how the layers of the drainage device 100 are arranged according to one embodiment. The outermost layer is hydrophobic but porous 102, allowing for seepage of the secretions which are soaked by an intermediate absorbent layer 104 composed of biologically acceptable substance such as cellulose. The innermost layer is non-collapsible 106 and connected to a suction device 180, which is self-contained. A secretions and suction channel 120 coaxially surrounds the feeding tube 150. With reference to Fig. 2D, the suction device 180 can include a pump 186, microcontroller 190, a display 184, a power source 182 such as batteries, a tube connector 188 and a container 192 to hold the secretions. The innermost layer and the suction device can be connected by a separate aspiration conduit, channel or tube, or for example the space 120 formed by a gap between the feeding tube and the drainage device. Having dedicated access to the space where secretions collect eliminates the need for repeated suction by a nurse, further eliminating the introduction of bacterial organisms by contamination. The drainage sleeve can be used as standalone drainage catheter device or coaxially loaded over a feeding tube.

[0031] With reference now to Fig. 3A, in one embodiment, a rigid circular cylindrical tube 300 supported by nitinol struts 302 can be folded to reduce insertion size. The trifoliate design allows the tube 300 to collapse centrally and compact via rotation as shown in the progression of Fig. 3A. A longitudinal twist can be generated on the tube 300 to that is collapses 302 such as during insertion and sheath loading, then it can be deployed back to its expanded state where it holds shape. For example, insertion size can be reduced to about 10 Fr. With reference now to Fig. 3B, in one embodiment, an alternative to further reduce diameter by longitudinal twist is shown in a collapsed state 310, 320 and an expanded state 312, 326. Once deployed, the device can be automatically expanded. In one embodiment, expansion is between 14 and 20 Fr. and is only applied to the part above the upper esophagus sphincter. This section can include a series of longitudinal tubes 314 around the feeding tube 324, an intermediate layer of absorbent cellulose fibers 316, and finally a membrane 318 which will allows liquids to enter the absorbent layer to be suctioned via the non-collapsible tube layer. The stiff tubes 314 and expanded state 326 are conducive for optimizing suction via the suction channel 322. The membrane can be a porous biocompatible membrane to allow one-way entry of mucus secretions.

[0032] Accordingly, in one embodiment, a drainage device includes an elongate flexible conduit having a proximal end opening, a distal end opening and a lumen disposed therebetween. A multi-layer distal portion can coaxially surrounding the lumen, having a porous outer surface layer, a porous interior layer and an intermediate absorbent layer therebetween. In one embodiment, the porous interior layer includes a multi-channel structure. In one embodiment, each channel of the multi-channelstructure is in fluid communication with a drainage conduit extending proximally at least to the proximal end opening. In one embodiment, the multi-channel structure is a non- collapsible structure. In one embodiment, the porous outer surface layer is a hydrophobic layer. In one embodiment, the intermediate absorbent layer comprises a cellulose material. In one embodiment, the drainage device is coaxially loaded over a feeding tube. In one embodiment, a system includes the drainage device and a negative pressure source in fluid communication with channels of the porous interior layer. In one embodiment, the drainage device includes a sleeve configured to coaxially load over the drainage device and compress the multi-layer distal portion. In one embodiment, the multi-layer distal portion includes multiple struts. In one embodiment, the struts include a shape-memory material. In one embodiment, the plurality of struts includes three struts. In one embodiment, the struts are configured to initiate trifoliate compaction upon rotation. In one embodiment, the multi-layer distal portion is configured to reduce in diameter upon actuation of a twisting motion.

[0033] Embodiments described herein remove secretions from saliva, sinuses and infected material from oral cavity. This is actuated via a diaphragm pump connected to a disposable container for keeping the system closed. In certain embodiments, a telescoping sheath can be withdrawn to expose the expanded portion. A one-way suction system is implemented without a pressure drop or damage to the mucosal surface.

[0034] In one embodiment, the elongate flexible conduit features multiple surface electrodes configured to detect fluid buildup. For example, patients lying on their back may have fluid collect at the back of the throat. Electrodes sitting in an air-filed cavitywill detect a different impedance level than electrodes sitting in a fluid-filled cavity. This change in impedance can be used to detect a throat cavity free of fluid buildup and when a fluid buildup starts occurring. Electrodes can be placed along the tube surface and within the cavity to detect a change in impedance. Information such as fluid location, amount of buildup and fluid types can be detected. Detecting fluid around the tube is a valuable tool that can be used to automatically trigger suction without delays normally attributed to manual detection from human intervention. The electrodes are used as a sensor that can be connected to a controller that automates turning on suction once a threshold impedance level is detected. The amount of suction may depend on for example real-time feedback from one or more electrodes, and may continue until impedance drops below a certain threshold level. In one embodiment, at least one or multiple surface electrodes at least partially surround the lumen and are disposed on an outer surface of the tube, in fluid communication with a patient anatomical cavity. The surface electrodes can be positioned on the porous outer surface layer. A controller can be configured to generate a suction signal upon detecting a threshold impedance from at least one of the plurality of surface electrodes. The surface electrodes can be various shapes or patterns as shown for example in Figs. 4A and 4B, such as spiral, winding or turning patterns, or some other pattern. The surface electrode pattern be implemented to maximize surface area exposure for better detection. Accordingly, the patient can get immediate relief from otherwise drowning in their own secretions while freeing nurse time to attend to other tasks.

[0035] In one embodiment, the surface electrodes are manufactured using liquid crystal polymer (LCP). LCP is a thermoplastic polymer material with unique structuraland physical properties. It demonstrates simultaneously exceptional performance with respect to electrical, thermal, mechanical and chemical properties. LCP is an ideal match for technically demanding high frequency, harsh environments and direct implantable applications. Due to its thermoplastic characteristics it can be thermoformed, even as a complex multilayer flex with embedded thin film traces, to various shapes. Thus in one embodiment, a drainage device includes an elongate flexible conduit having a proximal end opening, a distal end opening and a lumen disposed therebetween, and liquid crystal polymer electrodes on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal

[0036] LCP has superior dielectric characteristics enabling high-frequency applications up to 110 GHz. Combinations of high-Tg LCP with high Tg LCP bondply or low-Tg LCP can be used as adhesive for high multilayer build-ups up to 10 layers. LCP is a cost-competitive high-frequency FPC technology (relative to PTFE). Mixed-material combinations (LCP-Polyimide or LCP-BT-Epoxy) can be implemented. Thin film vacuum coating of special materials can be used for sensor functionalities. LCP is fully biocompatible according to ISO 10993-5 (in vitro cytotoxicity). Adhesiveless multilayer build-ups result in homogeneous structures up to 4-layers. It can also be used for thin film vacuum coating of noble metals. Applications include ultra-HDI structuring supported by thin film technology. LCP is light-weight with high flexural endurance. It also features low moisture absorption and low moisture permeability (near-hermetic). LCP is optimal for 3D forming to various shapes, and additional applications include formation of cavities, fold-lines, thinned bending zones and ultra-fine line flex cables.

[0037] Advantageously, utilizing LCP for the surface electrodes cuts down manufacturing time from several hours to minutes, is able to wrap around round surfaces with gaps with high flexural tolerances and endurances, is easy to incorporate into 3-dimensional shapes and has superior biocompatibility.

[0038] In one embodiment, the antimicrobial activity of visible blue light in 400 to 470 nm spectra is incorporated into the device. Visible blue light, ranging from 400 to 470 nm, exhibits microbicidal properties. This effect is mediated by photoexcitation of endogenous or exogenous photosensitizers like porphyrins and flavins within microbes or their surrounding biological medium. This photoexcitation results in the release of reactive oxygen species, which exert microbicidal activity. Factors such as prolonged exposure and pre- or co-treatment with quinine hydrochloride have been linked to enhanced microbicidal action. Visible blue light has also demonstrated efficacy against fungal and viral pathogens, multidrug-resistant bacteria, and bacterial biofilms. It has proven effective in eliminating foodborne pathogens on food and processing surfaces, as well as in clinical settings to reduce nosocomial infections. In clinical medicine and public health, visible blue light is emerging as a safer alternative to conventional ultraviolet light technologies.

[0039] In one embodiment, delivery of the blue light is in the form of alternating wavelength from 400 to 470 nm. In one embodiment, the dose is calculated in Joules / Cm2, up to 250 J / cm2. In one embodiment, the light is applied over time as either a continuous or intermittent pulsed operation. In one embodiment, irradiance is calculated as mW / cm2, up to 1000mW / Cm2. In one embodiment, frequency and duty cycles are applied up to 200 or more Hz. The blue light can be incorporated usingLEDs and controlled by an optical diffusion protocol. Using a controller, the frequency, duty cycles, irradiance and dose can be varied. Areas targeted via the tube can include nasal sinuses, pharynx, larynx and esophagus. This can include one or more of a continuous versus pulsed operation. Embodiments of the device can include impedance-based detection of fluid in laryngopharyngeal area and automatic suction initiation till impedances reach normal values. The background visible blue light is safe and forms the visible spectrum which will be used for antimicrobial properties. The light can be sent for example from a proximal end of the tube through the tube lumen, or for example via wire carrying the light or emitters advanced through the tube.

[0040] With reference now to Figs. 5A-5E, a device utilizing electrodes on an exoskeleton tube advanced into the posterior pharynx and stimulated using electrical energy with an external chin-based sensor acting as an efficacy control is disclosed according to one embodiment. Embodiments described in the following figures can be combined with embodiments described above or as standalone embodiments.Embodiments of the device operate at a frequency of 3Hz, utilizing a pulse width of 300pS. The controlled current range, based on stimulation level calculations, spans from 1 mA to 20mA. Employing a square wave waveform, the device adheres to a 10- m inute per session duration. With an input voltage of 5V, the device is powered by a 9V DC battery and is controlled by an Atmega328p microcontroller. The controlled threshold and tolerance range for current modulation are maintained between 1 mA and 20mA. In one embodiment, the device operate at a frequency between 2Hz and 4Hz, between 2.5Hz and 3.5Hz, or between 2.9Hz and 3.1 Hz. In one embodiment, the device utilizes a pulse width of between 200pS and 400pS, between 250pS and 350pS,between 280pS and 320pS, or between 290pS and 310pS. In one embodiment, the device adheres to a session duration of 5-15 minutes, 8-12 minutes, or 9-11 minutes.The input voltage and power voltage may also range up or down by about 30% in certain embodiments.

[0041] In one embodiment, a device for treating dysphagia includes an elongate flexible conduit having a proximal end opening, a distal end opening and a lumen disposed therebetween. Multiple electrodes (e.g. the electrodes of previous embodiments) are disposed on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal. The controller can be configured to modify the electrode treatment signal based on an audio feedback signal from an audio sensor indicative of soundwaves generated by the pharynx. The controller can also be configured to modify the electrode treatment signal based on a physiological feedback signal from an EMG sensor indicative of electrical activity in the pharyngeal muscles.

[0042] Advantageously, the device has the unique feature of an ability to precisely modulate the current within a controlled threshold and tolerance range (1 mA-20mA). This ensures patient safety and allows for personalized treatment based on individual needs. Embodiments of the device utilize electrodes placed on an exoskeleton tube inserted into the posterior pharynx. It delivers controlled electrical stimulation to the pharyngeal muscles, with an external chin-based sensor acting as an efficacy control mechanism. The integration of an electrode on an exoskeleton tube and an external chin-based sensor ensures targeted and controlled stimulation. The exoskeleton tube precisely positions the electrodes in the posterior pharynx, while the chin sensorprovides real-time feedback on the efficacy of the stimulation, allowing for adjustments as needed.

[0043] In one embodiment, the device consists of the following components (as shown for example in Fig. 5B) according to one embodiment:

[0044] Microcontroller: An Atmega328p microcontroller controls all of the device's functions. The controller accepts inputs including selected functional inputs and sensor inputs, and determines outputs for the electrodes. Power Supply: The device is powered by a 9V DC battery, with an input voltage of 5V. Pulse Generator: The pulse generator generates a square wave waveform with a frequency of 3Hz and a pulse width of 300pS. Current Regulator: The current regulator controls the amount of current that is delivered to the electrodes, within a range of 1 mA to 20mA. Electrodes: The electrodes are placed on an exoskeleton tube inserted into the posterior pharynx. Sensor: An external chin-based sensor provides real-time feedback on the efficacy of the stimulation. Display Screen: The display screen shows the stimulation status, voltage / current, power on / off status, therapy session time, battery status, intensity status, and waveform.

[0045] Sensing and Processing (see e.g. Figs. 6A-6C):

[0046] Sound Sensor: Picks up sound waves generated by the pharynx, potentially snoring or breathing sounds. This amplifies the sound and converts it to an electrical signal. EMG Sensor: Measures electrical activity in the pharyngeal muscles. Amplifier: Boosts the weak electrical signals from the sensors. Filter: Eliminates unwanted noisefrom the amplified signal. ADC: Converts the analog signal from sensors / amplifier into a digital format for computer processing.

[0047] Delivery and Monitoring:

[0048] Current Regulator: Ensures safe stimulation by limiting current delivered to the electrodes (1mA to 20mA). Electrodes: Placed on a tube inserted into the back of the pharynx to deliver electrical stimulation. External Chin Sensor: Provides real-time feedback on the effectiveness of the stimulation.

[0049] Device operation:

[0050] The user selects the desired stimulation intensity on the control panel. The microcontroller generates a square wave signal with the selected frequency and pulse width. The current regulator modulates the current to the desired level within the safe range. The electrical stimulation is delivered to the pharyngeal muscles through the electrodes. The chin sensor monitors the effectiveness of the stimulation and sends feedback to the microcontroller. The microcontroller can adjust the stimulation parameters as needed based on the sensor feedback.

[0051] Safety Features:

[0052] The device has a number of safety features to protect the user from harm. These features include: Controlled current range: The current is limited to a safe range of 1mA to 20mA. Real-time feedback: The chin sensor provides real-time feedback on the efficacy of the stimulation, allowing for adjustments to be made as needed.Automatic shut-off: The device has an automatic shut-off timer that turns off the device after 10 minutes of use.

[0053] Additional embodiments of the device may include: The device can be controlled by a smartphone / remote control. The device has a timer function. The device can be used with personalized treatment algorithms. The device can be integrated with ARA / R consoles for monitoring and gamification of therapy.

[0054] A method for treating dysphagia includes the steps of advancing electrodes into the posterior pharynx, and delivering electrical stimulation from 1 mA to 20mA to the pharyngeal muscles, at a frequency between 2.5Hz and 3.5Hz and pulse width between 280pS and 320pS. In one embodiment, the frequency is 3Hz. In one embodiment, the frequency is between 2.9Hz and 3.1 Hz. In one embodiment, the pulse width is 300pS. In one embodiment, the pulse width is between 290pS and 310pS. In one embodiment, the treatment duration is 10 minutes. In one embodiment, treatment duration is 9 to 11 minutes. In one embodiment, the treatment duration is 8 to 12 minutes. In one embodiment, the method includes modifying the electrode treatment signal based on an audio feedback signal from an audio sensor indicative of soundwaves generated by the pharynx. In one embodiment, the method includes modifying the electrode treatment signal based on a physiological feedback signal from an EMG sensor indicative of electrical activity in the pharyngeal muscles.

[0055] Clinical Applications: Embodiments of the device have the potential to improve swallowing function in a variety of patients with dysphagia. The device may be particularly beneficial for patients who have weak or paralyzed pharyngeal muscles.

[0056] Experimental Results: Initial testing of the device demonstrates its effectiveness in addressing dysphagia following stroke and during the impost estivation stage. Controlled electrical stimulation to the posterior pharynx leads to significant improvements in pulmonary care, nutritional requirements, and reduced hospitalization durations. The maintained threshold and tolerance range ensure precision in current modulation, contributing to the device's effectiveness.

[0057] Embodiments of the device present a compelling solution for managing dysphagia associated with stroke and Impostor Syndrome. It provides a unique combination of precise current modulation within a safe range, an exoskeleton- integrated electrode on a tube, and an external chin sensor allows for targeted and controlled stimulation. This user-friendly device offers a high degree of customization to address individual patient needs. Early trials suggest significant improvements in patient outcomes, highlighting the device's potential to substantially improve quality of life for dysphagic patients.

[0058] The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention.

Claims

CLAIMSWhat is claimed is:1 . A drainage device comprising: an elongate flexible conduit comprising a proximal end opening, a distal end opening and a lumen disposed therebetween; and a multi-layer distal portion coaxially surrounding the lumen and having a porous outer surface layer, a porous interior layer and an intermediate absorbent layer therebetween.

2. The drainage device of claim 1 , wherein the porous interior layer comprises a multi-channel structure.

3. The drainage device of claim 2, wherein each channel of the multi-channel structure is in fluid communication with a drainage conduit extending proximally at least to the proximal end opening.

4. The drainage device of claim 2, wherein the multi-channel structure is a non- collapsible structure.

5. The drainage device of claim 1 , wherein the porous outer surface layer is a hydrophobic layer.

6. The drainage device of claim 1 , wherein the intermediate absorbent layer comprises a cellulose material.

7. drainage system comprising: the drainage device of claim 1 coaxially loaded over a feeding tube.

8. A drainage system comprising:the drainage device of claim 1 ; and a negative pressure source in fluid communication with channels of the porous interior layer.

9. A drainage system comprising: the drainage device of claim 1 ; and a sleeve configured to coaxially load over the drainage device and compress the multi-layer distal portion.

10. The drainage device of claim 1 , wherein the multi-layer distal portion comprises a plurality of struts.11 . The drainage device of claim 10, wherein the plurality of struts comprise a shapememory material.

12. The drainage device of claim 10, wherein the plurality of struts comprises three struts.

13. The drainage device of claim 10, wherein the plurality of struts are configured to initiate trifoliate compaction upon rotation.

14. The drainage device of claim 1 , wherein the multi-layer distal portion is configured to reduce in diameter upon actuation of a twisting motion.

15. The drainage device of claim 1 further comprising: a plurality of surface electrodes at least partially surrounding the lumen.

16. The drainage device of claim 15, wherein at least one of the plurality of surface electrodes is disposed on the porous outer surface layer.

17. The drainage device of claim 16 further comprising: ia controller configured to generate a suction signal upon detecting a threshold impedance from at least one of the plurality of surface electrodes.

18. The drainage device of claim 1 further comprising: a light source configured to apply visible blue light in 400 to 470 nm spectra within the lumen.

19. The drainage device of claim 1 further comprising: a plurality of electrodes on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal.

20. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal at a frequency of 3Hz.21 . The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal at a frequency between 2.9Hz and 3.1 Hz.

22. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal at a frequency between 2.5Hz and 3.5Hz.

23. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal utilizing a pulse width of 300pS.

24. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal utilizing a pulse width between 290pS and 310pS.

25. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal utilizing a pulse width between 280pS and 320pS.

26. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal from 1mA to 20mA.

27. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal for a 10-m inute duration.

28. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal for a 9 to 11 minute duration.

29. The drainage device of claim 19, wherein the controller is configured to generate the electrode treatment signal for an 8 to 12 minute duration.

30. The drainage device of claim 19, wherein the controller is configured to modify the electrode treatment signal based on an audio feedback signal from an audio sensor indicative of soundwaves generated by the pharynx.31 . The drainage device of claim 19, wherein the controller is configured to modify the electrode treatment signal based on a physiological feedback signal from an EMG sensor indicative of electrical activity in the pharyngeal muscles.

32. A device for treating dysphagia comprising: an elongate flexible conduit comprising a proximal end opening, a distal end opening and a lumen disposed therebetween; and a plurality of electrodes on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal.

33. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal at a frequency of 3Hz.

34. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal at a frequency between 2.9Hz and 3.1 Hz.

35. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal at a frequency between 2.5Hz and 3.5Hz.

36. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal utilizing a pulse width of 300pS.

37. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal utilizing a pulse width between 290pS and 310pS.

38. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal utilizing a pulse width between 280pS and 320pS.

39. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal from 1mA to 20mA.

40. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal for a 10-m inute duration.41 . The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal for a 9 to 11 minute duration.

42. The drainage device of claim 32, wherein the controller is configured to generate the electrode treatment signal for an 8 to 12 minute duration.

43. The drainage device of claim 32, wherein the controller is configured to modify the electrode treatment signal based on an audio feedback signal from an audio sensor indicative of soundwaves generated by the pharynx.

44. The drainage device of claim 32, wherein the controller is configured to modify the electrode treatment signal based on a physiological feedback signal from an EMG sensor indicative of electrical activity in the pharyngeal muscles.

45. A method for treating dysphagia comprising: advancing a plurality of electrodes into the posterior pharynx; and delivering electrical stimulation from 1 mA to 20mA to the pharyngeal muscles, at a frequency between 2.5Hz and 3.5Hz and pulse width between 280pS and 320pS.

46. The method of claim 45, wherein the frequency is 3Hz.

47. The method of claim 45, wherein the frequency is between 2.9Hz and 3.1 Hz.

48. The method of claim 45, wherein the pulse width is 300pS.

49. The method of claim 45, wherein the pulse width is between 290pS and 310pS.

50. The method of claim 45, wherein the treatment duration is 10 minutes.51 . The method of claim 45, wherein treatment duration is 9 to 11 minutes.

52. The method of claim 45, wherein the treatment duration is 8 to 12 minutes.

53. The method of claim 45 further comprising: modifying the electrode treatment signal based on an audio feedback signal from an audio sensor indicative of soundwaves generated by the pharynx.

54. The method of claim 45 further comprising: modifying the electrode treatment signal based on a physiological feedback signal from an EMG sensor indicative of electrical activity in the pharyngeal muscles.

55. A drainage device comprising: an elongate flexible conduit comprising a proximal end opening, a distal end opening and a lumen disposed therebetween; anda plurality of liquid crystal polymer electrodes on a distal portion of the elongate flexible conduit coupled to a controller configured to generate an electrode treatment signal.

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