Patent Application
20220161030
The present disclosure is directed generally to devices, systems, and methods for treating and preventing disease. Particular embodiments include treating dysphagia by applying electrical stimulation to a target neural population of the patient.
Dysphagia is the condition whereby a patient has difficulty in swallowing or is unable to swallow safely. Dysphagia may be caused, for example, by stroke, neurodegenerative diseases, brain tumors or in some cases by other co-morbidities, such as respiratory disorders. It has been reported that between 7 and 10% of all adults older than 50 years of age present with clinically significant dysphagia. Of those over the age of 60, this increases to 14%. In total, 10 million Americans are evaluated each year in clinics and hospitals for swallowing difficulties. It has also been reported that over 51% of institutionalized elderly patients present with oropharyngeal dysphagia.
Swallowing is a rigidly ordered sequence of events that results in the propulsion of food from the mouth through the pharynx and esophagus to the stomach. At the same time, respiration is inhibited and food is prevented from entering into the trachea. Swallowing can be initiated voluntarily, but thereafter it is almost entirely under reflex control. The swallow reflex is typically initiated by sensory impulses from tactile receptors (particularly those located near the opening of the pharynx) being transmitted to certain areas in the medulla. The central integrating areas for swallowing lie in the medulla and lower pons; they are collectively called the swallowing center. Motor impulses travel from the swallowing center to the musculature of the pharynx and upper esophagus via various cranial nerves. This lower swallowing center in the brainstem is under regulatory control by higher center in the cerebral cortex. These higher swallowing centers or regions control the voluntary initiation and modulation of the swallow.
Swallowing occurs in three stages. In the oral or voluntary phase, food is moved towards the back of the mouth by the tongue, and forced into the pharynx, where it stimulates the tactile receptors that initiate the swallowing reflex. In the pharyngeal stage of swallowing, food passes through the pharynx by constriction of the walls of the pharynx, backward bending of the epiglottis, and an upward and forward movement of the larynx and trachea. During the pharyngeal stage, respiration is reflexively inhibited. In the esophageal stage of swallowing, food moves down the esophagus and into the stomach, assisted by one or more peristaltic waves.
Although the main function of swallowing is the propulsion of food from the mouth into the stomach, swallowing also serves as a protective reflex for the upper respiratory tract, preventing unwanted particles from entering the tract. Food or liquid that enters into the airways may act as a locus for infection and this type of infection can be life threatening. For instance, dysphagia after a stroke can be a devastating problem, as it carries a six-fold increased risk of aspiration pneumonia.
Complications that have been associated with dysphagia include pneumonia, malnutrition, dehydration, poorer long-term outcome, increased length of hospital stay, increased rehabilitation time and the need for long-term care assistance, increased mortality, and increased health care costs. These complications impact the physical and social wellbeing of patients, quality of life of both patients and caregivers, and the utilization of health care resources.
In view of the above, there remains a need for improved devices and methods that can treat dysphagia.
The present technology relates to electrical stimulation devices and associated systems and methods. In particular embodiments, the present technology comprises electrical stimulation devices configured to perform pharyngeal electrical stimulation (PES) to treat one or more conditions. Several embodiments of the present disclosure, for example, are configured to perform PES to treat a patient suffering from neurogenic dysphagia. Electrical stimulation of nerves proximate the patient's pharynx increases activity in the motor cortex and other areas of the brain to facilitate a functional reorganization of the centers in the brain responsible for controlling and coordinating swallow function. In some embodiments, the present technology is configured to reduce a patient's risk of developing aspiration pneumonia by removing a pharyngeal substance from the patient's pharynx and/or preventing or inhibiting colonization of the pharyngeal substance by one or more pathogens. The subject technology is illustrated, for example, according to various aspects described below, including with reference to
Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.
The pharynx is the part of the digestive system situated posterior to the nasal and oral cavities and posterior to the larynx. It is therefore divisible into nasal, oral, and laryngeal parts: the (1) nasopharynx, (2) oropharynx, and (3) laryngopharynx. With reference to
The pharynx is the common channel for deglutition (swallowing) and respiration, and the food and air pathways cross each other in the pharynx. In the anesthetized patient, the passage of air through the pharynx is facilitated by extension of the neck.
The nasopharynx, at least in its anterior part, may be regarded as the posterior portion of the nasal cavity, with which it has a common function as part of the respiratory system. The nasopharynx communicates with the oropharynx through the pharyngeal isthmus, which is bounded by the soft palate, the palatopharyngeal arches, and the posterior wall of the pharynx. The isthmus is closed by muscular action during swallowing. The choanae are the junction between nasopharynx and the nasal cavity proper.
A mass of lymphoid tissue, the nasopharyngeal tonsil is embedded in the mucous membrane of the posterior wall of the nasopharynx. Enlarged nasopharyngeal tonsils are termed “adenoids” and may cause respiratory obstruction. Higher up, a minute pharyngeal hypophysis (resembling the adenohypophysis) may be found.
The oropharynx extends inferiorward from the soft palate to the superior border of the epiglottis. It communicates anteriorly with the oral cavity by the faucial (oropharyngeal) isthmus, which is bounded superiorly by the soft palate, laterally by the palatoglossal arches, and inferiorly by the tongue. This area is characterized by a lymphatic ring composed of the nasopharyngeal, tubal, palatine, and lingual tonsils.
The mucous membrane of the epiglottis is reflected onto the base of the tongue and onto the lateral wall of the pharynx. The space on each side of the median glosso-epiglottic fold is termed the epiglottic vallecula.
The laryngopharynx extends from the superior border of the epiglottis to the inferior border of the cricoid cartilage, where it becomes continuous with the esophagus. Its anterior aspect has the inlet of the larynx and the posterior aspects of the arytenoid and cricoid cartilages. The pyriform sinus, in which foreign bodies may become lodged, is the part of the cavity of the laryngopharynx situated on each side of the inlet of the larynx.
A. Muscles
The pharynx consists of four coats of muscles, from within outward: (1) a mucous membrane continuous with that of the auditory tubes and the nasal, oral, and laryngeal cavities; (2) a fibrous coat, that is thickest in its superior extent (pharyngobasilar fascia) and that forms a median raphe posteriorly; (3) a muscular coat, described below; and (4) a fascial coat (buccopharyngeal fascia) covering the outer surface of the muscles.
The wall of the pharynx is composed mainly of two layers of skeletal muscles. The external, circular layer comprises three constrictors. The internal, chiefly longitudinal layer consists of two levators: the stylopharyngeus and the palatopharyngeus.
The chief action in which the muscles of the pharynx combine is deglutition (or swallowing), a complicated, neuromuscular act whereby food is transferred from (1) the mouth through (2) the pharynx and (3) the esophagus to the stomach. The pharyngeal stage is the most rapid and most complex phase of deglutition. During swallowing, the nasopharynx and vestibule of the larynx are sealed but the epiglottis adopts a variable position. Food is usually deviated laterally by the epiglottis and ary-epiglottic folds into the piriform recesses of the laryngopharynx, lateral to the larynx. The pharyngeal ridge is an elevation or bar on the posterior wall of the pharynx inferior to the level of the soft palate; it is produced during swallowing by transverse muscle fibers.
B. Innervation and Blood Supply
The motor and most of the sensory supply to the pharynx is by way of the pharyngeal plexus, which is formed by the pharyngeal branches of the vagus and glossopharyngeal nerves and also by sympathetic nerve fibers. The motor fibers in the plexus are carried by the vagus (although they likely represent cranial accessory nerve components) and supply all the muscles of the pharynx and soft palate except the stylopharyngeus (supplied by cranial nerve IX) and tensor veli palatini (supplied by cranial nerve V). The sensory fibers in the plexus are from the glossopharyngeal nerve, and they supply the greater portion of all three parts of the pharynx. The pharynx is supplied by branches of the external carotid (ascending pharyngeal) and subclavian (inferior thyroid) arteries.
As shown in
In some embodiments, the device 100 includes a connector 116 coupled to the proximal portion 102a of the first shaft 102 and having one or more ports, such as port 119, configured to be coupled to one or more accessory devices or systems. For example, the port 119 may be configured to be releasably coupled to an enteral feeding set (not shown) for delivering nutrients through the first elongated shaft 102 into the patient's stomach. Additionally or alternatively, the port 119 can be configured to be releasably coupled to a guidewire assembly. For example, the port 119 can be configured to receive a guidewire (not visible) therethrough to assist with inserting the device 100 into the patient. The guidewire assembly can include a guidewire grip 121 coupled to the proximal end portion of the guidewire. In some embodiments, the connector 116 includes one or more additional ports, such as a port configured to be fluidly coupled to a syringe or other fluid source and/or pressure source. The connector 116 may further comprise a cap 117 tethered to the connector 116 and configured to be secured over the port 119 when not in use.
As previously mentioned, the first shaft 102 is configured to be inserted through a lumen of the second shaft 104. In use, the distal portion 102b of the first shaft 102 can be inserted into an opening at the proximal portion 104a of the second shaft 104 that is fixed to the hub 110. In some embodiments, the device 100 includes a sealing member (not visible) at the hub 110 that engages the first and second shafts 102, 104 to prevent fluid from within a patient being drawn up within a space between the first and second shafts 102, 104 by way of capillary action when the second shaft 104 is removed from the patient. The sealing member may also be configured to clean any matter off of the first shaft 102 as it is withdrawn from the patient.
The first shaft 102 can have an atraumatic distal tip for patient comfort and ease of inserting the first shaft 102 into the patient. The first shaft 102 can have an opening 128 at its distal end and/or one or more apertures 126 extending through the sidewall along the distal portion 102b of the first shaft 102. Nutrients can be dispersed from the first shaft 102 into the patient's stomach via the one or more apertures 126 and/or the opening 128.
Each of the conductive elements 108 may comprise an electrode, an exposed portion of a conductive material, a printed conductive material, and other suitable forms. In some embodiments, for example as shown in
The device 100 may include one or more conductive leads (not visible) extending between a proximal portion of the device 100, such as the hub 110, and the conductive elements 108. In some embodiments, for example, the conductive leads comprise two wires, each extending distally from the hub 110 through a channel (the same channel or different channels) in the second shaft 104 to a corresponding one of the conductive elements 108. The channel(s), for example, can extend longitudinally within a sidewall of the shaft 104. The conductive leads can be insulated along all or a portion of their respective lengths.
In some embodiments, the device 100 is configured such that a position of the second shaft 104 can be fixed relative to a position of the first shaft 102 (or vice versa). The position of the first shaft 102 relative to the second shaft 104 may be adjusted prior to insertion of the device 100 into the patient. Once adjustment is complete, the relative positions of the first shaft 102 and second shaft 104 may be substantially fixed. For example, as shown in
The retaining structure 130 may be fixed to one of the first shaft 102 or the second shaft 104 and, at least in the open configuration, allow movement of the other of the first shaft 102 and the second shaft 104. In some embodiments, for example as shown in
In any case, the portion of the retaining structure 130 configured to engage the first and/or second shafts 102, 104 can comprise a high friction thermoplastic elastomer liner that engages the proximal portion of the first shaft 102 when the second portion is in the closed position. The liner can be configured to reduce the compressive force required to fix the first shaft 102 and thereby prevent pinching of the first shaft 102. Other suitable shapes, materials, positions, and configurations for the retaining structure 130 are possible. For example, the retaining structure 130 can comprise one or more magnets, a screw and threaded insert, a radial compression clip, and/or others to fix the proximal portion of the first shaft 102 to the retaining structure 130, the hub 110, and/or the second shaft 104.
As previously mentioned, the proximal portion of the device 100 and/or second shaft 104 is configured to be electrically coupled to a current generator 120 for delivering electric current to the conductive elements 108. The current generator 120, for example, can include a power source and a controller. The controller includes a processor coupled to a memory that stores instructions (e.g., in the form of software, code or program instructions executable by the processor or controller) for causing the power source to deliver electric current according to certain parameters provided by the software, code, etc. The power source of the current generator 120 may include a direct current power supply, an alternating current power supply, and/or a power supply switchable between a direct current and an alternating current. The current generator 120 can include a suitable controller that can be used to control various parameters of the energy output by the power source or generator, such as intensity, amplitude, duration, frequency, duty cycle, and polarity. Instead of or in addition to a controller, the current generator can include drive circuitry. In such embodiments, the current generator can include hardwired circuit elements to provide the desired waveform delivery rather than a software-based generator. The drive circuitry can include, for example, analog circuit elements (e.g., resistors, diodes, switches, etc.) that are configured to cause the power source to deliver electric current according to the desired parameters. For example, the drive circuitry can be configured to cause the power source to deliver periodic waveforms. In some embodiments, the drive circuitry can be configured to cause the power source to deliver a unipolar square wave.
The current generator 120 may be configured to provide a stimulation energy to the conductive elements 108 that has an intensity, amplitude, duration, frequency, duty cycle, and/or polarity such that the conductive elements 108 apply an electric field at the treatment site that promotes neuroplasticity in the areas of the brain associated with swallowing control. Without being bound by theory, it is believed that the treatment energy of the present technology induces and accelerates a cortical reorganization process whereby responsibility for the control and coordination of swallowing activity is moved from the damaged area of the brain to a complementary area of the cortical centers with intact function. The treatment energy of the present technology may also increase local levels of swallow-related neurotransmitters in the pharynx, such as in the oropharynx.
The controller can automatically vary the voltage (to a maximum of 250V) in order to deliver the set current. In some embodiments, the only user adjustable parameter is the stimulation intensity which is derived during treatment level optimization prior to every treatment. Patient specific threshold levels are determined by establishing a sensory threshold followed by measurement of the maximum tolerated stimulation intensity. The controller may automatically calculate the correct stimulation level from the sensory threshold and maximum tolerated stimulation intensity and sets this as the output. The current generator 120 can provide, for example, a current of about 1 mA to about 50 mA, about 1 mA to about 40 mA, about 1 mA to about 30 mA, about 1 mA to about 20 mA, or about 1 mA to about 10 mA, at a frequency of about 1 Hz to about 50 Hz, about 1 Hz to about 40 Hz, about 1 Hz to about 30 Hz, about 1 Hz to about 20 Hz, about 1 Hz to about 10 Hz, about 2 Hz to about 8 Hz, about 1 Hz, about 2 Hz, about 3 Hz, about 4 Hz, about 5 Hz, about 6 Hz, about 7 Hz, about 8 Hz, about 9 Hz, or about 10 Hz, and having a pulse width of about 150 μS to about 250 μS, about 175 μS to about 225 μS, or about 200 μS.
The current generator 120 may also be configured to monitor contact quality between the conductive elements 108 and patient tissue during treatment set up/optimization and throughout the treatment process. In some embodiments, the current generator 120 records and stores patient information and includes a USB port to enable downloading of patient data. The current generator may include a touch screen user interface and software to guide a user through the treatment process.
Without being bound by theory, it is believed that increasing peripheral (sensory) feedback to higher brain centers is a key factor to swallowing rehabilitation. As such, the device 100 of the present technology is configured to stimulate sensory nerves associated with swallowing, thereby inducing and accelerating a cortical reorganization process whereby responsibility for the control and coordination of swallowing activity is moved from the damaged area of the brain to a complementary area of the cortical centers of the brain with intact function. It is also believed that the stimulation energy of the present technology can increase local levels of swallow-related neurotransmitters in the pharynx, such as in the oropharynx.
In some embodiments, the first and/or second shafts 102, 104 can comprise one or more indicators (such as indicators 120, 122, and 124 in
When the conductive elements 108 are in a desired position, stimulation energy is delivered to the treatment site. In some embodiments, the delivered current is a unipolar square wave having an amplitude between 1 mA and 50 mA, a frequency of 5 Hz, and a pulse duration of 200 μS. Each treatment session can have a duration between 5 minutes and 20 minutes. For example, the treatment session can have a duration of 10 minutes. In some embodiments, a patient can undergo a single treatment per day over the course of multiple days of treatment. For example, a patient can undergo one treatment session per day for three to six consecutive days. In some embodiments, the patient may undergo multiple treatment sessions per day and/or per week. Still, other current parameters and treatment parameters are possible.
In some embodiments, the device 100 does not include the first elongated shaft 102. In such embodiments, the device 100 may only include the second elongated shaft 104. For example, the device 100 may comprise a stimulation device comprising an elongated member having one or more lumens extending therethrough and does not include a feeding tube. For example, the one or more lumens may be used for transporting a fluid as described herein with reference to
While the etiology of aspiration pneumonia is multifactorial, there is a strong association between dysphagia and the development of aspiration pneumonia. Routine clearance of secretions, an intact cough reflex, and adequate expiratory pressure are usually adequate defenses against aspiration (entry of material into the airway below the level of the true vocal cords). Approximately half of all healthy adults aspirate small amounts of oropharyngeal secretions during sleep. The low virulent bacterial burden of normal pharyngeal secretions, together with forceful coughing, active ciliary transport, and normal humoral and cellular immune mechanisms result in clearance of the inoculum without sequelae. In dysphagic patients, however, poor oral hygiene is common and normal microbial flora are often replaced by opportunistic pathogens. Moreover, there is frequently pooling of secretions in the pharyngeal recesses (e.g., the valleculae, the pyriform sinuses) due to an absent swallow, a missing or weak cough reflex, and discoordination of the airway closure mechanisms. Collectively these conditions can result in aspiration of the pooled secretions into the airways and subsequent infection.
The present technology may be configured to treat a pharyngeal substance to reduce a patient's risk of developing aspiration pneumonia. As used herein, “treating” or “treatment of” a pharyngeal substance refers to preventing and/or inhibiting colonization of a pharyngeal substance by one or more pathogens, reducing an amount of the pharyngeal substance in the pharynx, and/or removing the pharyngeal substance from the pharynx. As used herein, the term “pathogen” refers to a primary pathogen and/or an opportunistic pathogen. A pharyngeal substance may include saliva, mucous, food residue, an ingested liquid, a physiologic fluid, and/or combinations thereof. Moreover, a “pooled” pharyngeal substance can refer one or more pharyngeal substances that have collected in a certain location within the patient's pharynx. For example, a pooled pharyngeal substance can be located in a pharyngeal recess (e.g., vallecula, pyriform sinus), on a wall of the pharynx, and/or at a base of the patient's tongue. Treatment of a “pooled” pharyngeal substance can mean treating a pharyngeal substance while it remains pooled in the collection location, or can mean treating a pharyngeal substance that had once been pooled but at the time of treatment has been displaced (e.g., by the dynamic environment of the throat, by interaction with the stimulation device or another device, etc.).
In some embodiments, a device of the present technology is configured to locally deliver a therapeutic agent to the pharyngeal substance. The therapeutic agent can be configured to prevent and/or inhibit colonization of the pharyngeal substance by a pathogen so that if a patient aspirates the pharyngeal substance there is a lower risk of infection. For example, a portion of the device can carry the therapeutic agent such that, when the device is inserted into the patient's pharynx, the portion of the device carrying the therapeutic agent is positioned within the patient's pharynx and releases the therapeutic agent at or near the pharyngeal substance. In some embodiments, the device is configured to selectively release the therapeutic agent. For example, the device may be configured to only release the therapeutic agent when the therapeutic agent is in contact with the pharyngeal substance. In some embodiments, an amount of the therapeutic agent released can depend on a degree of pooling of the pharyngeal substance (e.g., a larger pooled pharyngeal substance will cause the device to release a greater amount of the therapeutic agent). Accordingly, the device can be configured to release the therapeutic agent to the locations with the greatest risk of pathogen colonization and with low unproductive release of the therapeutic agent. Such controlled release enables a high concentration of the therapeutic agent to be delivered over an extended period of time with reduced risk of clinical complications. In some embodiments, the therapeutic agent is disposed on or impregnated within a portion of the device. In some embodiments, the device is configured to deliver a fluid carrying a therapeutic agent directly to a pharyngeal substance via a lumen and sidewall opening in the device. Alternatively or additionally, the device can be configured to draw a pharyngeal substance into and proximally through a lumen of the device to remove the pharyngeal substance from the patient's pharynx.
In some embodiments, for example as shown in
The therapeutic region 140 can be positioned distal of the conductive elements 108 (see
The therapeutic agent may be any substance (or combination of substances) that provides a therapeutic effect in a patient in need thereof. In some embodiments, the therapeutic agent is an antimicrobial agent and/or an antibiotic agent and is configured to prevent and/or inhibit colonization of the pharyngeal substance by a pathogen. The therapeutic agent can have antibacterial, antiviral, fungicidal, and/or antiprotozoal properties. The therapeutic agent can be microbicidal (e.g., configured to kill pathogens) and/or biostatic (e.g., configured to inhibit pathogen growth). In some embodiments, the therapeutic agent can comprise a metal or metal alloy (e.g., silver, copper, zinc, etc.). Examples of suitable antibiotics and antimicrobials include, but are not limited to, amoxicillin, amoxicillin/clavulanate, cephalexin, ciprofloxacin, clindamycin, metronidazole, azithromycin, levofloxacin, sulfamethoxazole/trimethoprim, tetracycline(s), minocycline, tigecycline, doxycycline, rifampin, triclosan, chlorhexidine, penicillin(s), aminoglycides, quinolones, fluoroquinolones, vancomycin, gentamycin, cephalosporin(s), carbapenems, imipenem, ertapenem, antimicrobial peptides, cecropin-mellitin, magainin, dermaseptin, cathelicidin, α-defensins, and α-protegrins.
In some embodiments, the therapeutic region 140 comprises a portion of the sidewall of the second shaft 104 that has been impregnated with a therapeutic agent. For example, the sidewall of the second shaft 104 can be impregnated with silver nanoparticles. Additionally or alternatively, the therapeutic agent can be disposed on an outer surface of the second shaft 104 via covalent bonding, physical adsorption, surface initiated immobilization, and/or other suitable methods. For example, silver can be deposited on the outer surface of the second shaft 104 via ion beam deposition. The therapeutic region can extend completely or partially around a circumference of the second shaft 104.
In some embodiments, the device 100 can include one or more therapeutic members disposed on the outer surface of the second shaft 104. The therapeutic member can contain a therapeutic agent. The therapeutic member can comprise, but is not limited to, a coating, a film, a sheet, a strip, a ribbon, a capsule, a matrix, a wafter, a pellet, or other pharmaceutical delivery apparatus or a combination thereof. The therapeutic element can be adhered to, coupled to, deposited on, monolithic with, or otherwise joined to an outer surface of the second shaft 104.
The therapeutic agent can be configured to be selectively released from the second shaft 104 and/or therapeutic member in a controlled manner. In some embodiments, the therapeutic agent is configured to be released only when the therapeutic agent is positioned within the treatment distance TD of the pharyngeal substance PS. For example, release of the therapeutic agent can be initiated when the therapeutic member and/or therapeutic region 140 is positioned in fluidic contact with the pharyngeal substance PS. In some embodiments, the therapeutic region 140 and/or member comprises one or more control features configured to regulate the release of the therapeutic agent. For example, the therapeutic member and/or region 140 can comprise a biodegradable coating that does not include the therapeutic agent so that the therapeutic agent is not released until the biodegradable coating has degraded.
As pooling of pharyngeal substances in the patient's pharynx can occur continuously and over an extended period, the therapeutic region 140 and/or member can be configured to release the therapeutic agent over a desired period of time. For example, the desired period of time can be at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days, at least 7 days, at least 8 days, at least 9 days, at least 10 days, at least 11 days, at least 12 days, at least 13 days, at least 14 days, at least 15 days, at least 16 days, at least 17 days, at least 18 days, at least 19 days, at least 20 days, at least 21 days, at least 22 days, at least 23 days, at least 24 days, at least 25 days, at least 26 days, at least 27 days, at least 28 days, at least 29 days, or at least 30 days. In some embodiments, the therapeutic region 140 can be configured to release the therapeutic agent in a selective manner (e.g., only when the therapeutic region 140 is in contact with the pharyngeal substance PS). In some embodiments, the therapeutic region 140 can be configured to release the therapeutic agent in a continuous manner at a constant rate and/or a rate based, at least in part, on a condition of the environment surrounding the therapeutic region 140 (e.g., contact with the pharyngeal substance PS, a humidity of the environment, a temperature of the environment, etc.).
The therapeutic agent carried by the therapeutic region 140 and/or the second shaft 104 may be highly concentrated. By containing the therapeutic region 140 and/or agent to discrete portions of the second shaft 104 and by releasing the therapeutic agent directly to the pharyngeal substance PS, a strong dose of the therapeutic agent can be delivered with low risk of subsequent clinical complications. In some embodiments, the therapeutic region 140 and/or member comprises a low payload of the therapeutic agent. As the therapeutic element may be configured to release the therapeutic agent in a controlled manner (e.g., when in the presence of a pharyngeal substance PS), a lower total dose of the therapeutic agent may be required over the course of treatment.
Although
When the device 100 is inserted into the patient's pharynx and the conductive elements 108 are positioned at or adjacent a treatment site (see
In some embodiments, the device 100 is configured to aspirate the pharyngeal substance PS into the device 100 and out of the patient's body. The pressure source 134 can be configured to generate a negative pressure (i.e., suction) within the second lumen 160 to draw the pharyngeal substance into the aperture 162 and proximally through the second lumen 160 to the pressure source 134. In some embodiments, the pressure source 134 includes a container configured to collect the pharyngeal substance PS. Removing the pharyngeal substance PS from the patient's pharynx can prevent or reduce aspiration of the pharyngeal substance PS and thereby reduce the patient's risk of developing an airway infection. As pharyngeal substances PS may pool in a generally continuous manner, the device 100 may be used to aspirate pharyngeal substances PS multiple times while the device 100 is inserted into the patient. For example, in some embodiments the device 100 is used to aspirate pharyngeal substances PS once per day, twice per day, three times per day, or more. The device 100 may also be used to aspirate pharyngeal substances PS less frequently (e.g., once every other day, once per week, etc.).
In some embodiments, the device 100 is configured to deliver a fluid carrying the therapeutic agent to the pharyngeal substance PS via the second lumen 160 and aperture 162. The device 100 can include a reservoir containing the fluid, and the reservoir can be fluidically coupled to the second lumen 160. The pressure source 134 can be configured to generate a positive pressure within the second lumen 160 to push the fluid carrying the therapeutic agent distally through the second lumen 160 and out of the aperture 162 to the pharyngeal substance PS. As described herein, the therapeutic agent can have antimicrobial properties such that the therapeutic agent is configured to prevent or inhibit colonization of the pharyngeal substance PS by a pathogen. The aperture 162 can be positioned at or adjacent the pharyngeal substance PS and/or in contact with the pharyngeal substance PS such that the therapeutic agent is delivered directly to the pharyngeal substance PS. In some embodiments, the aperture 162 is positioned proximal of the pharyngeal substance PS such that the therapeutic agent travels distally through the patient's nasal cavity and/or pharynx to the pharyngeal substance PS. The fluid carrying the therapeutic agent can be delivered to the pharyngeal substance PS a single time or multiple times.
In some embodiments, the device 100 is configured to both aspirate pharyngeal substances PS and deliver fluid carrying the therapeutic agent to the pharyngeal substances PS. For example, in some embodiments it may be advantageous to first deliver the fluid carrying the therapeutic agent to the pharyngeal substance PS and then aspirate any excess fluid and pooled pharyngeal substance PS out of the patient. In some embodiments it may be advantageous to first aspirate a pharyngeal substance PS out of the patient and then deliver the fluid carrying the therapeutic agent. Still, in some embodiments the device 100 may be configured to perform only one of the above-noted functions.
Although many of the embodiments are described above with respect to systems, devices, and methods for electrically stimulating a pharynx of a patient to treat a patient suffering from dysphagia, the technology is applicable to other applications and/or other approaches. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above.
The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.
The present application claims the benefit of priority to U.S. Provisional Patent Application No. 63/198,913, titled DEVICES, SYSTEMS, AND METHODS FOR TREATING AND PREVENTING DISEASE, filed Nov. 20, 2020, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63198913 | Nov 2020 | US |
