WO2025224629A1

WO2025224629A1 - Enteral feeding tube system comprisng stylet with image sensor assembly

Info

Publication number: WO2025224629A1
Application number: PCT/IB2025/054205
Authority: WO
Inventors: Yun-Siung Yeh; Tahua Yang; Charles J. XU
Original assignee: Endovista Inc
Current assignee: Endovista Inc
Priority date: 2024-04-23
Filing date: 2025-04-22
Publication date: 2025-10-30
Anticipated expiration: 2026-10-23

Abstract

An enteral feeding tube system comprises a feeding tube having a first proximal end and a first distal end. A stylet is removably disposed within the feeding tube, which stylet comprises a stylet tube having a second proximal end and a second distal end. The stylet also includes an image sensor assembly mounted on the second distal end of the stylet tube, where the image sensor assembly comprises an image sensor and a light source. A flexible wire is disposed in the stylet tube and operatively connected to the image sensor assembly, and at least one electrical wire is disposed in the stylet tube and operatively connected to the image sensor and light source. The image sensor assembly is configured to reside within the first distal end of the feeding tube when the stylet is fully inserted in the feeding tube.

Description

ENTERAL FEEDING TUBE SYSTEM COMPRISNG STYLET WITH IMAGE SENSOR ASSEMBLY

FIELD

[0001] The present disclosure is generally directed to enteral feeding tubes and, more particularly, to an enteral feeding tube system comprising a stylet with an image sensor assembly.

BACKGROUND

[0002] Small bore enteral feeding tubes are thin and flexible elongated medical tubes inserted into the stomach or small intestine for delivering nutrients, liquids or medications to critically ill patients that have difficulty in taking food orally. The feeding tube is placed by inserting through the patient’s nasal cavity and esophagus and into the stomach or small intestine after passing the pyloric region of the stomach. Currently, placement of this feeding tube is mostly done blind, i.e., with no tube guidance, by clinicians specially trained in feeding tube placement. Studies have shown that 2 - 4% of nasogastric feeding tubes were misplaced which poses an unnecessary safety risk to patients. It has been reported that 1 to 3% of tube misplacement caused serious injuries to patients, including pneumothorax, esophageal perforation, and death.

[0003] All feeding tubes, after placement, must be checked to confirm tube position before patient feeding. The standard of care for checking tube placement is by X-ray, which delays nutrition and medication delivery, and increases patient radiation exposure, especially for children and infants. To reduce the risk of patient safety caused by tube misplacement, several tube guidance systems have been developed to help guide the feeding tube to the desired location and confirm final tube position during the placement procedure. [0004] Current prior art devices are based on electromagnetic (EM) sensors for mapping tube position indirectly or image sensors mounted on the feeding tube for visual guidance. However, both types of devices are not widely adopted clinically due to a number of drawbacks. For example, the accuracy of tube placement based on EM sensing is sensitive to patient movement and is negatively impacted in patients with abnormal anatomical structures. As another example, tubes with integrated image sensors typically have a large distal profile, which is not generally tolerable by patients. Additionally, tube placement based on image sensor technology is often not reliable due to poor field visibility caused by lens soiling. Such prior art devices also have high equipment cost, thereby disincentivizing their use. Further still, both EM- and image-based devices cannot be used for placement verification to replace x-ray confirmation, and are not designed for use in children and infants.

[0005] Therefore, there is a clinical need for an enteral feeding tube guidance system that is reliable in tube placement, having low cost of manufacturing, and that can be used for both adults and children.

SUMMARY

[0006] The instant disclosure describes an enteral feeding tube system that addresses the abovenoted shortcomings. In an embodiment, an enteral feeding tube system, comprises a feeding tube having a first proximal end and a first distal end. A stylet is removably disposed within the feeding tube, which stylet comprises a stylet tube having a second proximal end and a second distal end. The stylet also includes an image sensor assembly mounted on the second distal end of the stylet tube, where the image sensor assembly comprises an image sensor and a light source. A flexible wire is disposed in the stylet tube and operatively connected to the image sensor assembly, and at least one electrical wire is disposed in the stylet tube and operatively connected to the image sensor and light source. The image sensor assembly is configured to reside within the first distal end of the feeding tube when the stylet is fully inserted in the feeding tube.

[0007] In another embodiment, a first connector is attached to the feeding tube at the first proximal end of the feeding tube, and a second connector is attached to the second proximal end of the stylet tube, where the second connector is also configured for removable attachment to the first connector.

[0008] In another embodiment, the image sensor assembly comprises a circuit board supporting and electrically connected to the image sensor and light source as well as a housing at least partially surrounding the circuit board, the image sensor, and/or the light source. The flexible wire may be attached to the circuit board, and the at least one electrical wire may be electrically connected to the circuit board.

[0009] In another embodiment, the image sensor and the light source are oriented in a radial direction relative to the stylet tube. In this embodiment, the feeding tube has a radial opening configured to align with the image sensor and light source when the stylet is fully inserted in the feeding tube. Further to this embodiment, the feeding tube may have at least one additional radial opening configured to be unaligned with the image sensor and light source when the stylet is fully inserted in the feeding tube.

[0010] In another embodiment, the image sensor and the light source are oriented in an axial direction relative to the stylet tube. In this embodiment, the feeding tube has an axial opening configured to align with the image sensor and light source when the stylet is fully inserted in the feeding tube. Further to this embodiment, the feeding tube may also have at least one radial opening.

[0011] In another embodiment, the image sensor assembly comprises at least one encapsulant disposed thereon. In this embodiment, the at least one encapsulant may comprise a first encapsulant configured to cover at least the image sensor and the light source. Furthermore, the at least one encapsulant may also or alternatively comprise a second encapsulant configured to cover at least a portion of the image sensor assembly where the flexible wire and the at least one electrical wire are operatively connected to the image sensor assembly.

[0012] In another embodiment, the feeding tube comprises a tubular body having a third distal end and a third proximal end, and a tubular tip operatively connected to and in fluid connection with the third distal end of the tubular body. The tubular tip may be configured to have a water repellant surface. The tubular tip comprises an opening configured to expose the image sensor and light source when the stylet is fully inserted in the feeding tube. In an embodiment, the opening in the tubular tip is a radial opening. In another embodiment, the opening in the tubular tip is an axial opening and, additionally to this embodiment, the tubular tip may comprise an additional radial opening. In another embodiment, the tubular tip comprises an axially extending tapered bore open at a fourth distal end of the distal tubular tip and at a fourth proximal end of the distal tubular tip. In this embodiment, a diameter of the tapered bore can reduce along its length from the fourth proximal end to the fourth distal end.

[0013] In another embodiment, an interior surface of the feeding tube is coated with a lubricious material. [0014] In another embodiment, the image sensor assembly is coated with a water repellant material.

[0015] In another embodiment, the stylet comprises a video output connector operatively connected to the at least one electrical wire and disposed at the second proximal end of the stylet tube. Further to this embodiment, the enteral feeding tube system of claim may further comprise a video cable operatively connected to the video output connector at a first end of the video cable and a video monitor operatively connected to a second end of the video cable. The video monitor may be configured to provide artificial intelligence-enabled guidance based on video images received from the image sensor.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The foregoing and other features and advantages will be discussed in detail in the following non-limiting description of specific embodiments in connection with the accompanying drawings, in which:

[0017] FIG. 1 is a schematic illustration of an enteral feeding tube system in accordance with the instant disclosure;

[0018] FIG. 2 is a side view of a stylet in accordance with the instant disclosure;

[0019] FIG. 3 is a magnified side view of a distal end of the stylet illustrated in FIG. 2;

[0020] FIG. 4 is a cross-sectional view of a stylet in accordance with the instant disclosure;

[0021] FIG. 5 is a side view of a feeding tube in accordance with the instant disclosure and compatible with the stylet of FIG. 2; [0022] FIG. 6 is a side view of a feeding tube system in accordance with the instant disclosure and illustrating cooperation between the stylet of FIG. 2 and the feeding tube of FIG. 5;

[0023] FIG. 7 is a side view of an alternate embodiment of a stylet in accordance with the instant disclosure;

[0024] FIG. 8 is a magnified side view of a distal end of the stylet illustrated in FIG. 7;

[0025] FIG. 9 is a side view of an alternate embodiment of a feeding tube in accordance with the instant disclosure and compatible with the stylet of FIG. 7;

[0026] FIG. 10 is a side, perspective view of a tubular tip in accordance with the instant disclosure and the feeding tube of FIG. 9;

[0027] FIG. 11 is a side view of an alternate feeding tube system in accordance with the instant disclosure and illustrating cooperation between the stylet of FIG. 7 and the feeding tube of FIG. 9; and

[0028] FIG. 12 is a magnified side view of a distal end of the feeding tube system illustrated in FIG. 11.

DETAILED DESCRIPTION OF THE PRESENT EMBODIMENTS

[0029] As used herein, phrases substantially similar to “at least one of A, B or C” are intended to be interpreted in the disjunctive, i.e., to require A or B or C or any combination thereof unless stated or implied by context otherwise. Further, phrases substantially similar to “at least one of A, B and C” are intended to be interpreted in the conjunctive, i.e., to require at least one of A, at least one of B and at least one of C unless stated or implied by context otherwise. Further still, the term “substantially” or similar words requiring subjective comparison are intended to mean “within manufacturing tolerances” unless stated or implied by context otherwise.

[0030] As used herein, the phrase “operatively connected” refers to at least a functional relationship between two elements and may encompass configurations in which the two elements are directed connected to each other, i.e., without any intervening elements, or indirectly connected to each other, i.e., with intervening elements.

[0031] As used herein, the phrase “fluid communication” refers to a configuration between two or more elements in which fluid is able to flow in at least one direction between such elements.

[0032] As used herein, the term “distal” refers to an end of an element or assembly of elements that is toward the direction of insertion of a feeding tube into a patient, and the term “proximal” refers to an end of an element or assembly of elements that is away from the direction of insertion of a feeding tube into a patient.

[0033] FIG. 1 schematically illustrates an enteral feeding tube system 100 in accordance with the instant disclosure. In most basic form, enteral feeding tube systems in accordance with the instant disclosure, such as system 100 shown in FIG. 1, comprise a feeding tube 110 and stylet 130 configured to be received with the feeding tube 110, as described in further detail below. Although not illustrated to scale throughout this disclosure, the feeding tubes and stylets described herein can be configured to meet French 5 feeding tube requirements, as commonly used in neonatal application, or in larger sizes for pediatric and/or adult use, e.g., French 6, 8, 10 and 12 sizes.

[0034] The feeding tube 110 has a first proximal end 112 and a first distal end 114, and further comprises a tubular body 116 and a tubular tip 118 attached thereto. The feeding tube 110, and more precisely, the tubular tip 118, has at least one opening 120 formed therein, exposing the interior space or lumen of the feeding tube 110 to the external environment. In the example illustrated in FIG. 1, the opening 120 is a radial opening relative to a longitudinal axis of the feeding tube 110, though, as described below, alternative orientations of such openings may be used. A connector 122 is attached to the tubular body 116 at the first proximal end feeding tube 110.

[0035] The stylet 130 has a second proximal end 132 and a second distal end 134 with a stylet tube 136 extending therebetween. A connector 148, configured for removable attachment to the feeding tube connector 122, is attached to the stylet tube 136 at its second proximal end 132, and an image sensor assembly 138 is operatively connected to the stylet tube 136 at the second distal end 134 thereof. The image sensor assembly 138 comprises an image sensor 140 and a light source 142. A flexible wire 144 and at least one electrical wire 146 are disposed in the stylet tube 136 between the connector 148 and the image sensor assembly 138. The flexible wire 144 provides sufficient rigidity, while remaining flexible, to permit the feeding tube 110 and stylet 130 (when fully inserted into the feeding tube 110) to be fully inserted within a patient when deploying the feeding tube 110. The at least one electrical wire 146 provides electrical communication with the image sensor 140 and light source 142.

[0036] In addition to the feeding tube 110 and stylet 130, enteral feeding tube systems in accordance with the instant disclosure (i.e., the embodiments illustrated in FIGs. 2-12) may also comprise further features used during the deployment of the feeding tube 110. Thus, as shown in the example of FIG. 1, the stylet 148 includes a video output connector 150 operatively connected to the at least one wire 146 via the stylet connector 148. Various types of video output connectors 150 can be used, including pin-and-socket circular connectors, pogo pin connectors, card edge connectors, HDMI connectors, etc. Alternatively, the electrical connectors may incorporate magnets to assist in aligning the two connector halves for easier connection. The selection of an appropriate electrical connector depends on several factors, including the number of wires, reliability of the connection, durability of the connector system, ease of cleaning and disinfection, and overall cost. In a presently preferred embodiment, the video output connector 150 is designed as a male HDMI connector to securely mate with a female HDMI connector on a video monitor 152.

[0037] The video output connector 150 may be removably attached to a reusable video cable 154 (which may be cleaned after each use) that, in turn, may be removably attached to the video monitor 152. The reusable video cable 154 is constructed from materials capable of withstanding cleaning and disinfection processes as outlined by the manufacturer's established procedures and in accordance with infection control guidelines in healthcare facilities. In accordance with known techniques, the video cable 154 may include an in-line video adapter with inputs for controlling various functionalities such as photo capture, video recording, image brightness adjustment, etc. In another embodiment, the video output connector 150 may itself be equipped with such a video adapter that connects directly to the video monitor 152, eliminating the need for the video cable 154. Alternatively, the video imaging acquired from the image sensor assembly 138 can be wirelessly transmitted to the video monitor 152 through a reusable wireless transmitter dongle, as known in the art. This dongle connects to the video output connector 150 of the stylet 130 and employs common wireless communication protocols such as Wi-Fi, Bluetooth, RF, and others. [0038] In an embodiment, the video monitor 152, in accordance with known image processing and artificial intelligence (Al) techniques, is configured to provide Al-based guidance according to images provided by the image sensor 140. In an embodiment, the video monitor 152 features a touch-screen display, which may be a liquid crystal display (LCD) or an organic light emitting diode (OLED) display. The video monitor 152 may be equipped with one or more video inputs to receive signals from the stylet 130 and one or more video outputs for real-time transmission to external monitors or devices. Video signals can be transmitted directly via a video cable or indirectly by transferring video files using storage devices such as USB flash drives. Alternatively, video images can be wirelessly transmitted to external monitors, devices, or hospital information network systems using standard wireless communication protocols such as Wi-Fi, Bluetooth, or RF. As with the video cable 154, the video monitor 152 is preferably designed to facilitate easy cleaning and disinfection after single-patient use. To this end, an enclose of the video monitor 152 is constructed from materials resistant to the cleaning agents and disinfectants commonly used in hospital environments, ensuring long-term durability and compliance with hygiene protocols.

[0039] In an embodiment, the video monitor 152 is equipped with an anatomy landmark recognition artificial intelligence (Al) model designed for real-time feeding tube position tracking and placement confirmation. Utilizing a convolutional neural network, as known in the art, the Al model detects and classifies key anatomical landmarks in the upper gastrointestinal tract. In this manner, and as further known in the art, the video monitor 152 provides real-time visual and/or audio feedback on tube position, assisting clinicians during the placement procedure and issuing alerts for prompt corrective actions in the event of tube misplacement. To further enhance accuracy, the Al model can be post-trained with newly acquired images from published endoscopy databases or an institution’s patient image database.

[0040] In an embodiment, the Al-based feeding tube position tracking functionality can be disabled if preferred by clinicians. Additionally, the video monitor 152 can compare live images acquired during tube placement with images from an endoscopy database for anatomy landmark confirmation to verify tube placement. Such endoscopy and patient image databases are accessible via the video monitor’s local area network (LAN) or wireless networking connection to a hospital’s electronic medical record system. This feature, even without Al assistance, provides clinicians with additional support for clinical decision-making, improving patient safety and enhancing tube placement effectiveness.

[0041] Referring now to FIGs. 2 and 3, an embodiment of a stylet 230 in accordance with the instant disclosure is illustrated. Once again, the stylet 230 comprises a stylet tube 236 having a connector 248 at its second proximal end 232 and an image sensor assembly 260 at its second distal end 234. A flexible wire 244 and at least one electrical wire 246 are disposed within the stylet tube 236. As shown in FIG. 2, the connector 248 is a luer lock connector, preferably adhering to a universal standard such an “ENFIT” connector.

[0042] In this embodiment, the integrated image sensor assembly 260, along with its electrical wires 246 and the distal end of the flexible wire 244, is enclosed within a thin-wall housing 264 and encapsulated with adhesive to ensure durability and protection. In one embodiment, the distal end of the flexible wire 244 is attached directly to a printed circuit board 262 of the image sensor assembly 260 to ensure that the image sensor assembly 260 is securely mounted on the stylet 230 for smooth advancing into and removing from the lumen of the feeding tube (not shown). Various methods, such as soldering, adhesives, connectors, or other mechanical means, can be utilized to securely attach the flexible wire 244 and at least one electrical wire 246 to the printed circuit board 262. In another embodiment, the distal end of the flexible wire 244 is attached to an anchor (not shown) embedded within an encapsulating adhesive 268 inside the thin-wall housing. Additionally, the distal end of the flexible wire 244 can be encapsulated in the adhesive 268 without being attached to either the anchor or the printed circuit board 262.

[0043] The thin-wall housing 264 of the image sensor assembly 260 can be fabricated in various shapes using durable materials such as metal, plastic, or ceramic. In one embodiment, the housing 262 takes the form of a stainless-steel microtube with a circular shape, designed to enclose and protect the image sensor assembly 260. Alternatively, the housing may feature a low-profile design with a circular arc-shaped bottom and a flat top surface. This configuration allows air or water to flow over the image sensor assembly 260, efficiently cleaning a lens surface of an image sensor 270 when needed. To encapsulate the image sensor assembly 260, adhesives such as silicone, polyurethane, cyanoacrylate, acrylic-based, or epoxy-based materials may be used. Optically transparent adhesives can also be employed when additional protection for the assembly’s surface is required. In another embodiment, the image sensor assembly 260 is formed using a liquid molding process by injecting liquid polymer inside a sealed mold cavity to encapsulate the image sensor 270, light source 272, printed circuit board 262, stylet tube 236, and wires 244, 246 without the use of a separate thin-wall housing 264.

[0044] The proximal end of the integrated image sensor assembly, where the wire assembly exits, is encapsulated 268 to ensure durability, fluid resistance for the soldered joints, and prevention of wire kinking. This encapsulation 268 can be achieved using processes such as injection molding, liquid molding, dipping, or other liquid dispensing techniques. Suitable encapsulation materials include silicone, polyurethane, epoxy, TPE, acrylic-based, or epoxy-based adhesives.

[0045] The flexible wire 244 can be constructed from various metals and alloys, such as stainless steel, nickel-titanium alloy, or nickel-cobalt alloy. Preferably, the flexible wire 244 is both flexible and bendable, allowing users to pre-shape the distal section of a feeding tube — with the stylet 230 inserted — into a desirable curvature for easier insertion into the nasal cavity. In one embodiment, the distal section of the flexible wire 244 is made from a shapeable material, while the remaining wire is constructed from flexible but non-shapeable material. Alternatively, the distal section of the flexible wire 244 can be rendered shapeable by placing it inside the lumen of a microtube made from shapeable metal. In this scenario, the distal ends of both the flexible wire 244 and the microtube can be encapsulated together within the image sensor assembly 260.

[0046] Both the flexible wire 244 and the electrical wires 246 extending from the image sensor assembly 260 are enclosed in a flexible, thin- wall tubing or sleeve 236 to protect against wire kinking and mishandling during the use of the stylet 230. To reduce the profile of the flexible wire assembly, the electrical wires 246 can be tightly twisted around the flexible wire 244, and the entire assembly can be spiral wrapped with durable tape or inserted into a flexible, heat-shrinkable thin- wall tubing or sleeve 236 (collectively referred to herein as a stylet tube) for mechanical protection. In an alternative embodiment, the electrical wires 246 are separately aligned, tightly packed with the flexible wire 244, and then spiral wrapped with durable tape or enclosed in a flexible, heat- shrinkable thin- wall tubing or sleeve 236. FIG. 4 illustrates a cross-section of the flexible wire assembly as described above. The heat-shrinkable tubing or sleeve 236 can be made from materials such as PTFE, polyolefin, polyurethane, or other heat-shrinkable substances. Preferably, the stylet tube 236 is fabricated from a material with a low coefficient of friction to minimize frictional forces between the video stylet and the feeding tube's lumen wall, facilitating easy insertion and removal.

[0047] The proximal ends of the stylet tube 236, the flexible wire 244 and at least one electrical wire 246 are connected to a female “ENFIT” luer lock connector 248, which may be removably attached to a male “ENFIT” luer lock connector 522 of a feeding tube (FIG. 5). The stylet connector 248 can be prefabricated using injection molding and bonded to the proximal ends of the stylet tube 236, the wires 244, 246 using light-, thermal-, or moisture-cured adhesives. Alternatively, the female “ENFIT” luer lock connector 248 with the embedded proximal ends of the stylet tube 236, the wires 244, 246 can be fabricated through an insert molding process in a single manufacturing step, eliminating the need for adhesives. The connectors can be made from various thermoplastic materials, including ABS, polycarbonate, ABS/polycarbonate blends, polyester, polyamide, PVC, polyolefin, and polyurethane.

[0048] In the illustrated embodiment, the image sensor assembly 260 includes a side-viewing configuration, where the image sensor 270 and light source 272 are oriented in a radial direction relative to a longitudinal axis of the stylet tube 236. This design is specifically intended for use with feeding tubes that have corresponding radially oriented opening for enhanced visibility during tube placement, as described below. An important advantage of the side-viewing configuration is its ability to clear foreign debris from the lens surface of the image sensor 270. This is achieved by injecting air or water through the feeding tube lumen and directing it across the lens, thereby enhancing field visibility. Suitable light sources 272 for illumination are fiber optics or LEDs. Preferably, mini -LEDs of white light with a dimension of 0.65 mm x 0.35 mm x 0.2 mm or smaller can be used. Typical image sensors that can be used are CMOS and CCD image sensors. Preferably, image sensor 270 is a CMOS imaging array such as the image sensor OHOTA or image sensor with integrated optics such as the wafer-level image sensor module OCHTA, both supplied by OmniVision, Santa Clara, California. Other image sensors 270 having a pixel resolution of at least 400 x 400, a field of view between 80° and 120°, and a dimension of less than 0.65 mm x 0.65 mm x 1.2 mm can also be used.

[0049] Referring now to FIG. 5, a feeding tube 510 designed for use with the stylet 230 of FIG. 2 is further illustrated. The disclosed feeding tube 510 comprises a flexible, elongated tubular body 516 for delivering nutrients and medications to patients, which tubular body 510 has third proximal end 513 and a third distal end 515. A distal tubular tip 518 featuring, in the embodiment, one or more side or radially oriented openings 520, is operatively connected to and in fluid communication with the third distal end 515 of the tubular body 516. At its third proximal end 513, the tubular body 516 is operatively connected to and in fluid communication with a connector 522, such as the illustrated male “ENFIT” luer lock connector, thereby enabling removable connections to the stylet 230 and to nutrient and medication sources. Alternatively, though not shown, the feeding tube 510 may include a Y-port design having two male “ENFIT” luer lock connectors to accommodate multiple sources.

[0050] As shown, the tubular tip 518 has a fourth proximal end 521 and a fourth distal end 523, where the tubular tip 518 is operatively connected to and in fluid communication with the tubular body 516 at its fourth proximal end 521. In one embodiment, the tubular tip 518 has a nonweighted, atraumatic tip 525 design to minimize the risk of patient injury during insertion. Alternatively, the tubular tip 518 has a weighted distal tip 525 to facilitate post-pyloric placement of the feeding tube 510 in the small intestine.

[0051] The tubular body 516 is preferably constructed from a flexible polymer, such as polyurethane, which is compounded with radiopaque or radiolucent agents to enhance visibility under fluoroscopy or X-ray imaging. The distal tubular tip 518 may also be loaded with radiopaque materials for improved positional accuracy.

[0052] In all embodiments described herein, to ease the insertion and removal of the stylet 230, the lumen or inner surface of the feeding tube 510 is coated with a lubricious material to reduce friction. This coating can be made from polymeric materials with hydrophilic or hydrophobic chemical moieties. Preferably, the lubricious coating is made from hydrophilic materials including polyvinylpyrrolidone, polyurethane, polyacrylic acid, polyethylene oxide, polysaccharides, hydrogels, or blends of these polymers.

[0053] Additionally, it is desirable that surfaces of the tubular tip 518 and/or the image sensor lens be treated with an optically clear, water-repellent, or self-cleaning coating. This coating helps prevent body fluids from soiling the lens surface of the image sensor 270 situated within the tube lumen. The water-repellent coating is preferably applied using a rapid, low-temperature UV curing process, which is ideal for heat-sensitive image sensors with electronic components. The UV- curable coating formulation typically consists of mono- or multi-functional low-surface-energy monomers — preferably fluorinated acrylate/methacrylate monomers — combined with crosslinkers and photoinitiators. Examples of fluorinated monomers used to create low surface energy coatings include fluorinated methacrylates with varying levels of hydrophobicity and refractive index, such as 2,2,3,4,4,4-hexafluorobutyl methacrylate (HFBMA), 1,1,1,3,3,3-hexafluoroisopropyl methacrylate (HFIPMA), and 2,2,3,3,4,4,4-heptafluorobutyl methacrylate (HTFBMA). Other monomers with low surface energy chemical moiety, such as silicone or fluorine-silicone- containing acrylic monomers, as well as other UV-curable hydrophobic monomers, can also be used in forming the coating.

[0054] To ensure durability and effective water repellency after sterilization and during use, the water repellant coating forms a three-dimensional network through polymerization and crosslinking of mono- and di-functional hydrophobic acrylate/methacrylate monomers and chemical crosslinkers. These crosslinkers are specifically chosen for their chemical stability against body fluids and sterilization. Examples of di- and tri-functional crosslinkers that can enhance coating stability include 1 ,6-hexanediol diacrylate and trimethylolpropane triacrylate. The degree of crosslinking within the coating can be precisely controlled by adjusting the concentration and functionality of the crosslinker, as well as the curing parameters. Photoinitiators commonly used in this coating chemistry include bis(2,4,6-trimethylbenzoyl)-phenylphosphineoxide (Irgacure 819) and 2-hydroxy-2-methyl-phenyl-propane- 1 -one (Irgacure 1173). Other compatible photoinitiators that are compatible with the coating formulation and the UV light source may also be employed. To control the viscosity of the coating solution, additives such as silicone-modified urethane acrylate oligomers can be incorporated into the formulation. Additional additives, such as hydrophobic modified nanoparticles with an average particle size below 100 nm, silicone, or other water-repellent agents, can be included to further enhance the water repellency of the coating. The UV-curable coating can be applied through various thin-film coating processes, such as dip coating or spray coating, followed by UV curing. [0055] FIG. 6 illustrates a feeding tube assembly 600 in which the stylet 230 of FIG. 2 is inserted within the lumen of the feeding tube 510 of FIG. 5. The length of the stylet 230 is specifically preset to ensure that its image sensor assembly 260 aligns with the distal radial opening 520 of the feeding tube 510 when the “ENFIT” connectors 248, 522 are securely mated. When the stylet 230 is fully inserted in the feeding tube 510, the radially oriented image sensor assembly 260 is recessed within the lumen of the tubular tip 518, providing visualization through the radial opening 520. This radially oriented design aids in guiding the placement of the feeding tube 510 into the stomach or small intestine. The recessed position of the image sensor assembly 260 minimizes the risk of contamination of the image sensor 270 lens surface by patient secretions as the feeding tube 510 advances through the nasal cavity, esophagus, and into the gastrointestinal tract. Additionally, the radial orientation configuration enables the removal of foreign debris from the lens surface by injecting air or water through the feeding tube 510 lumen during the placement procedure. To further enhance the cleaning process, the anterior lumen surface of the feeding tube 510, near the proximal end of the radially oriented opening 520 of the tubular tip 518 where the image sensor assembly 260 is seated, can include protrusions or channels. Such channels could be formed on the inner surface of the tubular tip 518, especially the proximal end of the tubular tip 518. These features help direct the air or waterjet across the image sensor assembly's top surface, improving the effectiveness of lens cleaning.

[0056] Referring now to FIGs. 7-12, an alternate embodiment of a feeding tube system 1100 is described. In this embodiment, and with particular reference to FIGs. 7 and 8, a stylet 730 is constructed identically to stylet 230 illustrated in FIG. 2 with the exception that an integrated image sensor assembly 760 is configured such that the image sensor 770 and light source 772 are configured to be axially oriented with respect to the longitudinal axis of the stylet 730 such that forward viewing (i.e., toward the distal direction) is provided. This forward- viewing image sensor assembly 760 is more compact than the side-viewing configuration 260, making it suitable for use with smaller feeding tubes designed for children and infants. The stylet 730 with the forwardviewing configuration is constructed similarly to the side-viewing stylet but is intended for use with feeding tubes that have a distal outlet opening for visualization, as depicted in FIGs. 9-12.

[0057] Referring now to FIGs. 9 and 10, the feeding tube 910 according to the alternate embodiment is constructed identically to the feeding tube 510 illustrated in FIG. 5 with the exception that the tubular tip 918 includes an axial opening 1015 configured to align with image sensor 770 and light source 772. As further shown in FIG. 10, the tubular tip 918 may also have one or more radially oriented openings 920 in addition to the axial opening 1015. Such additional openings 920, though not provided to facilitate use of the image sensor assembly 760, facilitate quicker feeding through the feeding tube 910 and reduce the risk of tube clogging over its use life.

[0058] The distal tubular tip 918 is designed with a smooth, rounded atraumatic profile to minimize tissue damage during tube insertion and features a proximal opening 1017 for attachment to the third distal end 515 of the tubular body 516, as shown in Figure 10. The fourth proximal end 921 of the tubular tip 918 includes an internal annular undercut 1013, which allows secure bonding to the tubular body 516 using adhesives. The inner diameter of the undercut 1013 is precisely matched to the internal diameter of the tubular body 516, ensuring a smooth and seamless joint that facilitates easy insertion and removal of the stylet 730. As illustrated in FIG. 12, the third distal end 515 of the feeding tube 516 is received in the undercut section 1013 of the tubular tip [0059] As best shown in FIGs. 10 and 12, the inner lumen of the tubular tip 918 comprises an axially extending tapered bore 1011 that has a diameter that reduces (tapers) from the fourth proximal end 921 toward the fourth distal end 923, and is designed to prevent the image sensor assembly 760 from exiting the axial opening 1015. In an embodiment, the taper angle is pre-set to position the image sensor assembly 760, by virtue of a press fit, slightly recessed from the axial opening 1015, thereby reducing the risk of lens contamination from secretions and body fluids during tube placement. This recessed position also ensures a clear field of view with minimal interference from the distal tip opening. Additionally, in an embodiment, the exit of the axial opening 1015 of the tubular tip 918 is tapered wider to further minimize obstruction in the image sensor's field of view. Though not depicted in FIGs. 9-12, the axial opening 1015 could also include an inwardly extending flange to act as a positive stop for the image sensor assembly 760 when fully inserted within the feeding tube 910.

[0060] In an alternative embodiment, the portion of the lumen surface of the tubular tip 918 closest to the image sensor assembly 760 can be fabricated with longitudinal protrusions that form channels between the interior lumen surface and the image sensor assembly 760. Such channels guide blown air or waterjets to the distal tip of the forward-viewing image sensor assembly 760, effectively cleaning the front lens surface. FIG. 12 depicts the distal section of the tubular body 516 with the stylet 730 featuring forward-viewing image sensor 770, whereas FIG. 11 shows the feeding tube assembly 1100 in which the stylet 730 and is fully inserted into the feeding tube 910. Though not depicted in the drawings, the front surface of the image sensor assembly 760 and/or the image sensor 770 itself can optionally be angled to enhance viewing capabilities and facilitate lens cleaning. By blowing air or injecting water through the feeding tube 910 lumen and across the top of the image sensor assembly, users can maintain a clear lens surface.

[0061] As described above, enteral feeding tube system in accordance with the instant disclosure provide a number of advantages as compared to prior art systems. These include, but are not limited to real-time visualization for precise gastric and post-pyloric feeding tube placement; clear field visibility throughout the insertion procedure; feeding tubes with smaller, flexible distal tips for enhanced patient comfort and tolerance; Al-assisted tube position tracking to assist clinicians in placement and improve patient safety, and; possible elimination of X-ray placement confirmation.

[0062] While the various embodiments in accordance with the instant disclosure have been described in conjunction with specific implementations thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the preferred embodiments of the invention as set forth herein are intended to be illustrative only and not limiting so long as the variations thereof come within the scope of the appended claims and their equivalents.

Claims

What is claimed is:

1. An enteral feeding tube system, comprising: a feeding tube having a first proximal end and a first distal end; and a stylet removably disposed within the feeding tube, the stylet comprising: a stylet tube having a second proximal end and a second distal end; an image sensor assembly mounted on the second distal end of the stylet tube, and comprising an image sensor and a light source; a flexible wire disposed in the stylet tube and operatively connected to the image sensor assembly; and at least one electrical wire disposed in the stylet tube and operatively connected to the image sensor and light source, wherein the image sensor assembly is configured to reside within the first distal end of the feeding tube when the stylet is fully inserted in the feeding tube.

2. The enteral feeding tube system of claim 1, further comprising: a first connector attached to the feeding tube at the first proximal end of the feeding tube; and a second connector attached to the second proximal end of the stylet tube, the second connector also being configured for removable attachment to the first connector.

3. The enteral feeding tube system of claim 1, wherein the image sensor assembly comprises: a circuit board supporting and electrically connected to the image sensor and light source; and a housing at least partially surrounding the circuit board, the image sensor and/or the light source.

4. The enteral feeding tube system of claim 3, wherein the flexible wire is attached to the circuit board.

5. The enteral feeding tube system of claim 3, wherein the at least one electrical wire is electrically connected to the circuit board.

6. The enteral feeding tube system of claim 1, wherein the image sensor and the light source are oriented in a radial direction relative to the stylet tube.

7. The enteral feeding tube system of claim 6, wherein the feeding tube has a radial opening configured to align with the image sensor and light source when the stylet is fully inserted in the feeding tube.

8. The enteral feeding tube system of claim 7, wherein the feeding tube comprises at least one additional radial opening configured to be unaligned with the image sensor and light source when the stylet is fully inserted in the feeding tube.

9. The enteral feeding tube system of claim 1, wherein the image sensor and the light source are oriented in an axial direction relative to the stylet tube.

10. The enteral feeding tube system of claim 9, wherein the feeding tube has an axial opening configured to align with the image sensor and light source when the stylet is fully inserted in the feeding tube.

11. The enteral feeding tube system of claim 10, wherein the feeding tube comprises at least one radial opening.

12. The enteral feeding tube system of claim 1, wherein the image sensor assembly comprises at least one encapsulant disposed thereon.

13. The enteral feeding tube system of claim 12, wherein the at least one encapsulant comprises a first encapsulant configured to cover at least the image sensor and the light source.

14. The enteral feeding tube system of claim 12, wherein the at least one encapsulant comprises a second encapsulant configured to cover at least a portion of the image sensor assembly where the flexible wire and the at least one electrical wire are operatively connected to the image sensor assembly.

15. The enteral feeding tube system of claim 1, wherein the feeding tube comprises a tubular body having a third distal end and a third proximal end, and a tubular tip operatively connected to and in fluid connection with the third distal end of the tubular body.

16. The enteral feeding tube system of claim 15, wherein the tubular tip has a water repellant surface.

17. The enteral feeding tube system of claim 15, wherein the tubular tip comprises an opening configured to expose the image sensor and light source when the stylet is fully inserted in the feeding tube.

18. The enteral feeding tube system of claim 17, wherein the opening in the tubular tip is a radial opening.

19. The enteral feeding tube system of claim 17, wherein the opening in the tubular tip is an axial opening.

20. The enteral feeding tube system of claim 19, wherein the tubular tip comprises at least one additional radial opening.

21. The enteral feeding tube system of claim 15, wherein the tubular tip comprises an axially extending tapered bore open at a fourth distal end of the distal tubular tip and at a fourth proximal end of the distal tubular tip.

22. The enteral feeding tube system of claim 21 , wherein a diameter of the tapered bore reduces along its length from the fourth proximal end to the fourth distal end.

23. The enteral feeding tube system of claim 1, wherein an interior surface of the feeding tube is coated with a lubricious material.

24. The enteral feeding tube system of claim 1 , wherein the image sensor assembly is coated with a water repellant material.

25. The enteral feeding tube system of claim 1, wherein the stylet comprises a video output connector operatively connected to the at least one electrical wire and disposed at the second proximal end of the stylet tube.

26. The enteral feeding tube system of claim 25, further comprising: a video cable operatively connected to the video output connector at a first end of the video cable; and a video monitor operatively connected to a second end of the video cable.

27. The enteral feeding tube system of claim 26, wherein the video monitor is configured to provide artificial intelligence-enabled guidance based on video images received from the image sensor.