Enteral feeding tube system comprisng stylet with image sensor assembly

Abstract

An enteral feeding tube system includes a feeding tube having a first proximal end and a first distal end. A guidewire is detachably disposed within the feeding tube, the guidewire including a guidewire cannula having a second proximal end and a second distal end. The guidewire also includes an image sensor assembly mounted on the second distal end of the guidewire cannula, wherein the image sensor assembly includes an image sensor and a light source. A flexible wire is disposed within the guidewire cannula and operatively connected to the image sensor assembly, and at least one electrical wire is disposed within the guidewire cannula and operatively connected to the image sensor and the light source. The image sensor assembly is configured to reside within the first distal end of the feeding tube when the guidewire is fully inserted into the feeding tube.

Description

[Technical Field]

[0001] The present invention generally relates to enteral feeding tubes, and more particularly to an enteral feeding tube system comprising a guidewire with an image sensor assembly. [Previous Technology]

[0002] Small-bore enteral feeding tubes are long, flexible medical tubes inserted into the stomach or small intestine to deliver nutrients, fluids, or medications to critically ill patients who have difficulty taking oral food. The tube is inserted through the patient's nasal cavity and esophagus, passing through the pylorus of the stomach before entering the stomach or small intestine. Currently, most nasogastric tube placements are performed blindly by clinicians with specialized training in tube placement (i.e., without any tube guidance). Studies have shown that 2% to 4% of nasogastric tubes are misplaced, posing unnecessary safety risks to patients. Reports indicate that 1% to 3% of tube misplacements have caused serious harm to patients, including pneumothorax, esophageal perforation, and death.

[0003] All feeding tubes must be checked after placement to confirm tube positioning before feeding the patient. The standard care practice for checking tube placement is by X-ray, which delays nutrient and medication delivery and increases patient radiation exposure, especially for children and infants. To reduce patient safety risks caused by misplaced tubes, several tube guidance systems have been developed to assist in guiding the feeding tube to the desired location and confirming final tube positioning during placement.

[0004] Current prior art devices are based on electromagnetic (EM) sensors for indirect mapping of tube placement, or image sensors mounted on the feeding tube for visual guidance. However, both types of devices have not been widely adopted in clinical practice due to several drawbacks. For example, the accuracy of tube placement based on EM sensing is highly sensitive to patient movement and can negatively impact patients with anatomical abnormalities. As another example, tubes with integrated image sensors typically have a large distal profile, which is generally intolerable to patients. Furthermore, tube placement based on image sensor technology is often unreliable due to poor visibility caused by lens contamination. Such prior art devices also have high equipment costs, which hinders their use. Moreover, neither EM-based nor image-based devices can be used for placement verification to replace X-ray confirmation, and they are not specifically designed for children and infants.

[0005] Therefore, there is an urgent clinical need in this field for an enteral feeding tube guidance system that is reliable in tube placement, has low manufacturing cost, and can be used for both adults and children. [Summary of the Invention]

[0006] The present invention discloses an enteral feeding tube system that addresses the aforementioned drawbacks. In a specific embodiment, the enteral feeding tube system includes a feeding tube having a first proximal end and a first distal end. A guidewire is detachably disposed within the feeding tube, the guidewire including a guidewire cannula having a second proximal end and a second distal end. The guidewire also includes an image sensor assembly mounted on the second distal end of the guidewire cannula, wherein the image sensor assembly includes an image sensor and a light source. A flexible wire is disposed within the guidewire cannula and operatively connected to the image sensor assembly, and at least one electrical wire is disposed within the guidewire cannula and operatively connected to the image sensor and the light source. The image sensor assembly is configured to reside within the first distal end of the feeding tube when the guidewire is fully inserted into the feeding tube.

[0007] In another specific embodiment, the first connector is attached to the feeding tube at the first proximal end of the feeding tube, and the second connector is attached to the guide wire tube at the second proximal end, wherein the second connector is also configured for detachable attachment to the first connector.

[0008] In another embodiment, the image sensor assembly includes a circuit board that supports and is electrically connected to the image sensor and a light source, and a housing that at least partially surrounds the circuit board, the image sensor, and / or the light source. The flexible cable is attachable to the circuit board, and the at least one wire is 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 guidewire. In this embodiment, the feeding tube has a radial opening configured to align with the image sensor and the light source when the guidewire is fully inserted into the feeding tube. Further in this embodiment, the feeding tube may have at least one additional radial opening configured to not align with the image sensor and the light source when the guidewire is fully inserted into the feeding tube.

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

[0011] In another embodiment, the image sensor assembly includes at least one encapsulant disposed thereon. In this embodiment, the at least one encapsulant may include a first encapsulant configured to cover at least the image sensor and the light source. Alternatively, the at least one encapsulant may also include a second encapsulant configured to cover at least a portion of the image sensor assembly, wherein the flexible wire and the at least one electrical system are operatively connected to the image sensor assembly.

[0012] In another embodiment, the feeding tube includes a tubular body having a third distal end and a third proximal end, and a tubular tip operatively connected to and fluidly connected to the third distal end of the tubular body. The tubular tip may be configured to have a waterproof surface. The tubular tip includes an opening configured to expose the image sensor and light source when the guidewire is fully inserted into the feeding tube. In one 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 in addition to this embodiment, the tubular tip may include an additional radial opening. In another embodiment, the tubular tip includes an axially extending tapered orifice opening at a fourth distal end of one of the distal tubular tips and at a fourth proximal end of one of the distal tubular tips. In this embodiment, the diameter of the tapered orifice may decrease along its length from the fourth proximal end to the fourth distal end.

[0013] In another specific embodiment, the inner surface of the feeding tube is coated with a lubricating material.

[0014] In another specific embodiment, the image sensor assembly is coated with a waterproof material.

[0015] In another embodiment, the guidewire includes a video output connector operatively connected to the at least one wire and disposed at the second proximal end of the guidewire tube. Further, regarding this embodiment, the enteral feeding tube system of the claimed claim may further include a video cable operatively connected to the video output connector at a first end of one of the video cables, and a video monitor operatively connected to a second end of one of the video cables. The video monitor is configurable to provide artificial intelligence-enabled guidance based on video images received from the image sensor.

Implementation Method

[0029] As used herein, phrases substantially similar to "at least one of A, B, or C" are intended to be interpreted as disjunctive, meaning that A, B, or C, or any combination thereof, are required, unless otherwise stated or implied by the context. Similarly, phrases substantially similar to "at least one of A, B, and C" are intended to be interpreted as conjunctive, meaning that at least one of A, at least one of B, and at least one of C are required, unless otherwise stated or implied by the context. Furthermore, the use of the term "substantially" or similar words that require a subjective comparison are intended to mean "within manufacturing tolerances," unless otherwise stated or implied by the context.

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

[0031] As used herein, the phrase “fluid communication” refers to an arrangement between two or more elements in which a fluid system is capable of flowing in at least one direction between such elements.

[0032] As used herein, the term "distal" refers to the end of a component or a component of a component facing the direction in which the feeding tube is inserted into the patient's body, while the term "proximal" refers to the end of a component or a component of a component facing away from the direction in which the feeding tube is inserted into the patient's body.

[0033] Figure 1 schematically illustrates an enteral feeding tube system 100 according to the present invention. In its most basic form, the enteral feeding tube system according to the present invention (system 100 shown in Figure 1) includes a feeding tube 110 and a guidewire 130 configured to be housed together with the feeding tube 110, as described in further detail below. Although not illustrated to scale throughout this disclosure, the feeding tube and guidewire system described herein can be configured to meet French 5 feeding tube requirements, as commonly used in neonatal applications, or in larger sizes for pediatric and / or adult use, such as 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 includes 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, thereby exposing the internal space or lumen of the feeding tube 110 to the external environment. In the example illustrated in FIG1, the opening 120 is a radial opening relative to the longitudinal axis of the feeding tube 110; however, alternative orientations of such openings may be used, as explained below. The connector 122 is attached to the tubular body 116 at the first proximal end of the feeding tube 110.

[0035] The guidewire 130 has a second proximal end 132 and a second distal end 134, and a guidewire cannula 136 extends therebetween. A connector 148 (configured for detachable attachment to a feeding tube connector 122) is attached to the guidewire cannula 136 at its second proximal end 132, and an image sensor assembly 138 is operatively connected to the guidewire cannula 136 at its second distal end 134. The image sensor assembly 138 includes an image sensor 140 and a light source 142. A flexible wire 144 and at least one electrical wire 146 are disposed in the guidewire cannula 136 between the connector 148 and the image sensor assembly 138. The flexible wire 144 provides sufficient rigidity while maintaining flexibility to allow the feeding tube 110 and the guidewire 130 (when fully inserted into the feeding tube 110) to be fully inserted into the patient's body during deployment of the feeding tube 110. At least one wire 146 provides electrical communication with the image sensor 140 and the light source 142.

[0036] In addition to the feeding tube 110 and guidewire 130, the enteral feeding tube system according to the present invention (i.e., the specific embodiments illustrated in Figures 2 to 12) may also include further features used in the deployment of the feeding tube 110. Thus, as shown in the example of Figure 1, the guidewire 130 includes a video output connector 150 operably connected to at least one wire 146 via a guidewire connector 148. Various types of video output connectors 150 can be used, including pin-and-socket circular connectors, pogo pin connectors, edge connectors, high-definition multimedia interface (HDMI) connectors, etc. Alternatively, such electrical connectors may incorporate magnets to aid in the alignment of the two connector halves for easier connection. The selection of a suitable electrical connector depends on several factors, including the number of wires, the reliability of the connection, the durability of the connector system, the ease of cleaning and sterilization, and the overall cost. In the present preferred embodiment, the video output connector 150 is designed as a male HDMI connector to securely mate with the female HDMI connector on the video monitor 152.

[0037] The video output connector 150 may be detachably attached to a reusable video cable 154 (which can be cleaned after each use), which in turn may be detachably attached to a video monitor 152. The reusable video cable 154 is constructed of materials capable of withstanding cleaning and disinfection procedures outlined in the manufacturer's established process and in accordance with infection control guidelines of a healthcare institution. According to known art, 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 itself may be equipped with such a video adapter that connects directly to the video monitor 152, thereby eliminating the need for the video cable 154. Alternatively, the video image acquired from the image sensor assembly 138 may be wirelessly transmitted to the video monitor 152 via a reusable wireless transmitter dongle, as is known in the art. This hardware dongle connects to the video output connector 150 of the guide wire 130 and uses common wireless communication protocols, such as Wi-Fi, Bluetooth, and radio frequency (RF).

[0038] In a specific embodiment, based on known image processing and artificial intelligence (AI) technologies, the video monitor 152 is configured to provide AI-based guidance based on the image provided by the image sensor 140. In a specific embodiment, the video monitor 152 features a touchscreen 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 guidewire 130, and one or more video outputs for real-time transmission to an external monitor or device. The video signal may be transmitted directly via a video cable, or indirectly by transferring video files using a storage device such as a USB flash drive. Alternatively, the video image may be wirelessly transmitted to an external monitor, device, or hospital information network system using standard wireless communication protocols such as Wi-Fi, Bluetooth, or RF. If a video cable 154 is used, the video monitor 152 is preferably designed to facilitate easy cleaning and disinfection after use by a single patient. For this purpose, the enclosed portion of the video monitor 152 is constructed of materials resistant to cleaning agents and disinfectants commonly used in hospital environments, thereby ensuring long-term durability and compliance with hygiene protocols.

[0039] In a specific embodiment, the video monitor 152 is equipped with an anatomical landmark recognition artificial intelligence (AI) model specifically designed for real-time feeding tube positioning tracking and placement confirmation. Utilizing convolutional neural networks as known in the art, the AI ​​model detects and classifies key anatomical landmarks in the upper gastrointestinal tract. In this way, and as further known in the art, the video monitor 152 provides real-time visual and / or audio feedback on tube positioning, thereby assisting clinicians during placement and issuing alerts for immediate corrective action in the event of tube misplacement. To further improve accuracy, the AI ​​model can be post-trained using images recently acquired from published endoscopic databases or institutional patient image databases.

[0040] In a specific embodiment, the AI-based feeding tube positioning and tracking functionality can be disabled if preferred by the clinician. Furthermore, the video monitor 152 can compare synchronous images acquired during tube placement with images from an endoscopic database for anatomical landmark confirmation to verify tube placement. This endoscopic and patient image database can be accessed via the video monitor's local area network (LAN) or wireless network connection to the hospital's electronic medical record system. This feature provides clinicians with additional support for clinical decision-making even without AI assistance, thereby improving patient safety and enhancing the efficiency of tube placement.

[0041] Referring now to Figures 2 and 3, a specific embodiment of the guidewire 230 according to the present invention is illustrated. Again, the guidewire 230 includes a guidewire 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 wire 246 are arranged within the guidewire tube 236. As shown in Figure 2, the connector 248 is a Luer lock connector, preferably conforming to a common standard, such as an "ENFIT" connector.

[0042] In this specific embodiment, the integrated image sensor assembly 260 (along with its wires 246 and the distal end of the flexible wire 244) is enclosed within a thin-walled housing 264 and coated with an adhesive to ensure durability and protection. In one embodiment, the distal end of the flexible wire 244 is directly attached to the printed circuit board 262 of the image sensor assembly 260 to ensure that the image sensor assembly 260 is securely mounted on the guide wire 230 for smooth advance into and removal from the lumen of the feeding tube (not shown). Various methods (such as soldering, adhesives, connectors, or other mechanical means) can be used to securely attach the flexible wire 244 and at least one 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 adhesive-coated 268 inside the thin-walled housing. Furthermore, the distal end of the flexible wire 244 can be encased in adhesive 268 without having to be selectively attached to the anchor or printed circuit board 262.

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

[0044] The proximal end (where the wire assembly exits) of the integrated image sensor assembly is covered 268 to ensure durability, fluid resistance to the solder joints, and to prevent wire kinking. This cover 268 can be achieved using processes such as injection molding, liquid molding, impregnation, or other liquid dispensing techniques. Suitable cover materials include polysiloxane, polyurethane, epoxy, thermoplastic elastomer (TPE), acrylic, 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 the user to pre-shape the distal portion of the feeding tube (with the guide wire 230 inserted) to the desired curvature for easier insertion into the nasal cavity. In one embodiment, the distal portion of the flexible wire 244 is made of a malleable material, while the remaining wire is constructed of a flexible but non-malleable material. Alternatively, the distal portion of the flexible wire 244 can be malleable by placing it inside the lumen of a microtube (made of malleable metal). In this case, the distal ends of both the flexible wire 244 and the microtube can be encased together within the image sensor assembly 260.

[0046] The flexible wires 244 and 246 extending from the image sensor assembly 260 are enclosed in a flexible thin-walled tubing or sleeve 236 to protect against wire kinking and mishandling during the use of the guidewire 230. To reduce the profile of the flexible wire assembly, the 246 may be tightly wound around the flexible wire 244, and the entire assembly may be spirally wrapped with durable tape or inserted into the flexible heat-shrinkable thin-walled tubing or sleeve 236 (collectively referred to herein as the guidewire tubing) for mechanical protection. In an alternative embodiment, the 246 are separately aligned and tightly packaged from the flexible wire 244, and then spirally wrapped or enclosed in the flexible heat-shrinkable thin-walled tubing or sleeve 236 with durable tape. Figure 4 illustrates a cross-section of the flexible wire assembly as described above. The heat-shrink tubing or sleeve 236 can be made of materials such as polytetrafluoroethylene (PTFE), polyolefin, polyurethane, or other heat-shrinkable materials. Preferably, the guide wire tube 236 is made of a material with a low coefficient of friction to minimize the friction between the video guide wire and the inner wall of the feeding tube, thereby facilitating easy insertion and removal.

[0047] The proximal ends of the guide tube 236, flexible wire 244, and at least one wire 246 are connected to a female "ENFIT" Luer lock connector 248, which may be a male "ENFIT" Luer lock connector 522 detachably attached to the feeding tube (FIG. 5). The guide tube connector 248 may be pre-molded using injection molding and bonded to the proximal ends of the guide tube 236, the wires 244, and 246 using a light-curing, heat-curing, or moisture-curing adhesive. Alternatively, the female "ENFIT" Luer lock connector 248 with the embedded proximal ends of the guide tube 236, the wires 244, and 246 may be manufactured in a single manufacturing step through an insert molding process, thus eliminating the need for adhesives. These connectors can be made of various thermoplastic materials, including acrylonitrile butadiene styrene (ABS), polycarbonate, ABS / polycarbonate blends, polyester, polyamide, polyvinyl chloride (PVC), polyolefins, and polyurethane.

[0048] In the illustrated embodiment, the image sensor assembly 260 includes a side-view configuration in which the image sensor 270 and the light source 272 are oriented in a radial direction relative to one of the longitudinal axes of the guide tube 236. This design is specifically intended for use with a feeding tube having a corresponding radially oriented opening to improve visibility during tube placement, as explained below. A key advantage of this side-view configuration is its ability to remove foreign matter from the lens surface of the image sensor 270. This is achieved by injecting air or water through the lumen of the feeding tube and guiding it across the lens, thereby improving field of view visibility. A suitable light source 272 for illumination is an optical fiber or an LED. Preferably, a mini LED with white light and a size of 0.65 mm x 0.35 mm x 0.2 mm or smaller can be used. Common image sensors that can be used are CMOS and CCD image sensors. Preferably, the image sensor 270 is a CMOS imaging array, such as the OH0TA image sensor or an image sensor with integrated optical elements (such as the wafer-level image sensor module OCHTA), both supplied by OmniVision in Santa Clara, California, USA. Other image sensors 270 series with a pixel resolution of at least 400 x 400, a field of view between 80° and 120°, and a size of less than 0.65 mm x 0.65 mm x 1.2 mm may also be used.

[0049] Referring now to FIG5, a feeding tube 510 designed specifically for use with the guidewire 230 of FIG2 is further illustrated. The disclosed feeding tube 510 includes a flexible, elongated tubular body 516 for delivering nutrients and medications to a patient, the tubular body 516 having a third proximal end 513 and a third distal end 515. In this specific embodiment, a distal tubular tip 518 characterized by one or more lateral 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 detachable connection to the guidewire 230 and to sources of nutrients and medications. Alternatively, although not shown, the feeding tube 510 may include a Y-type connector design with 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, wherein 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 specific embodiment, the tubular tip 518 has a non-weighted, atraumatic tip 525 designed to minimize the risk of injury to the patient during insertion. Alternatively, the tubular tip 518 has a weighted distal tip 525 to facilitate placement of the feeding tube 510 behind the pylorus in the small intestine.

[0051] The tubular body 516 is preferably constructed of a flexible polymer (such as polyurethane), which is combined with a radiopaque or radiolucent agent to improve visibility under fluoroscopy or X-ray imaging. The distal tubular tip 518 may also be loaded with a radiopaque material to improve positioning accuracy.

[0052] In all the specific embodiments described herein, the inner cavity or inner surface of the feeding tube 510 is coated with a lubricating material to reduce friction for easy insertion and removal of the guide wire 230. This coating may be made of a polymer material having hydrophilic or hydrophobic chemical moieties. Preferably, the lubricating coating is made of a hydrophilic material, including polyvinylpyrrolidone, polyurethane, polyacrylic acid, polyethylene oxide, polysaccharides, hydrogels, or blends of these polymers.

[0053] Furthermore, the surfaces of the tubular tip 518 and / or the image sensor lenses are required to be treated with an optically clear, waterproof, or self-cleaning coating. This coating helps prevent bodily fluid contamination of the lens surface of the image sensor 270 within the tubular cavity. The waterproof coating is preferably applied using a rapid, low-temperature ultraviolet (UV) curing process, which is ideal for heat-sensitive image sensors with electronic components. The UV-curable coating formulation typically contains single or multifunctional low-surface-energy monomers combined with crosslinkers and photoinitiators, preferably fluorinated acrylate / methacrylate monomers. Examples of fluorinated monomers used to create low surface energy coatings include fluorinated methacrylates with hydrophobic and refractive index variations, 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 chemistry, such as polysiloxane or fluorinated polysiloxane acrylate monomers, as well as other UV-curable hydrophobic monomers, can also be used to form this coating.

[0054] To ensure durability and effective waterproofing after sterilization and during use, the waterproof coating forms a three-dimensional network structure through the polymerization and crosslinking of mono- and bi-functional hydrophobic acrylate / methacrylate monomers and chemical crosslinking agents. Specifically, these crosslinking agents are selected to provide chemical stability against body fluids and sterilization. Examples of bi- and tri-functional crosslinking agents that can improve 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 crosslinking agent, as well as these curing parameters. In this coating chemistry, commonly used photoinitiators include bis(2,4,6-trimethylbenzoyl)-phenylphosphine oxide (Irgacure 819) and 2-hydroxy-2-methyl-phenyl-propane-1-one (Irgacure 1173). Other compatible photoinitiator systems compatible with this coating formulation and the UV light source may also be used. To control the viscosity of the coating solution, additive systems such as modified urethane acrylate oligomers may be incorporated into the formulation. Additional additive systems such as hydrophobic modified nanoparticles with an average particle size of less than 100 nm, polysiloxane, or other waterproofing agents may be included to further enhance the waterproofness 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] Figure 6 illustrates the feeding tube assembly 600 in which the guide wire 230 of Figure 2 is inserted into the lumen of the feeding tube 510 of Figure 5. Specifically, the length of the guide wire 230 is preset to ensure that its image sensor assembly 260 is aligned with the distal radial opening 520 of the feeding tube 510 when the "ENFIT" connectors 248, 522 are securely engaged. When the guide wire 230 is fully inserted into the feeding tube 510, the radially oriented image sensor assembly 260 is recessed within the lumen of the tubular tip 518, thereby providing visualization through the radial opening 520. This radially oriented design helps guide the placement of the feeding tube 510 into the stomach or small intestine. As the feeding tube 510 is advanced through the nasal cavity, esophagus, and into the digestive tract, the recessed positioning of the image sensor assembly 260 minimizes the risk of contamination of the image sensor 270 lens surface by patient secretions. Furthermore, this radially oriented configuration allows for the removal of foreign matter from the lens surface during placement by injecting air or water through the inner cavity of the feeding tube 510. To further enhance the cleaning process, the front inner 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 located) may include protrusions or channels. Such channels may be formed on the inner surface of the tubular tip 518, particularly at the proximal end of the tubular tip 518. These features help direct the air or water jet across the top surface of the image sensor assembly, thereby improving the effectiveness of lens cleaning.

[0056] Referring now to Figures 7 to 12, an alternative embodiment of the feeding tube system 1100 will be described. In this embodiment, and particularly with reference to Figures 7 and 8, the guidewire 730 is constructed equivalent to the guidewire 230 illustrated in Figure 2, except that the integrated image sensor assembly 760 is configured such that the image sensor 770 and the light source 772 are oriented axially with respect to the longitudinal axis of the guidewire 730, resulting in a forward view (i.e., towards the distal direction). This forward-looking image sensor assembly 760 is more compact than the side-looking configuration 260, making it suitable for use with smaller feeding tubes designed for children and infants. The guidewire 730 with this forward-looking configuration is constructed similarly to the side-looking guidewire, but is intended for use with feeding tubes having a distal outlet opening for visualization, as depicted in Figures 9 to 12.

[0057] Referring now to Figures 9 and 10, the feeding tube 910 according to this alternative embodiment is constructed equivalently to the feeding tube 510 illustrated in Figure 5, except that the tubular tip 918 includes an axial opening 1015 configured to align with the image sensor 770 and the light source 772. As further shown in Figure 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 faster feeding through the feeding tube 910 and reduce the risk of tube clogging during its service life.

[0058] The distal tubular tip 918 is designed with a smooth, rounded, damage-resistant profile to minimize tissue damage during tubular insertion and features a proximal opening 1017 for attachment to the third distal end 515 of the tubular body 516, as shown in FIG10. The fourth proximal end 921 of the tubular tip 918 includes an internal annular undercut 1013, which allows for a secure attachment to the tubular body 516 using an adhesive. The inner diameter of the undercut 1013 precisely matches the inner diameter of the tubular body 516, thereby ensuring a smooth and seamless connection that facilitates easy insertion and removal of the guidewire 730. As illustrated in FIG12, the third distal end 515 of the tubular body 516 is housed within the undercut section 1013 of the tubular tip 918.

[0059] As best shown in Figures 10 and 12, the inner cavity of the tubular tip 918 includes an axially extending tapered aperture 1011 having a diameter that tapers (decreases) from the fourth proximal end 921 toward the fourth distal end 923, and is designed to prevent the image sensor assembly 760 from leaving the axial opening 1015. In a specific embodiment, the tapered angle is preset to slightly recess the image sensor assembly 760 from the axial opening 1015 by press-fit positioning, thereby reducing the risk of secretions and bodily fluids contaminating the lens during tubular placement. This recessed positioning also ensures a clear field of view while minimizing interference from the distal tip opening. Furthermore, in a specific embodiment, the outlet of the axial opening 1015 of the tubular tip 918 gradually widens to further minimize obstruction in the field of view of the image sensor. Although not depicted in Figures 9 through 12, the axial opening 1015 may also include an inwardly extending flange to serve as a positive stop for the image sensor assembly 760 when fully inserted into the feeding tube 910.

[0060] In an alternative embodiment, the inner surface of the tubular tip 918 closest to the image sensor assembly 760 may be provided with longitudinal protrusions that form a channel between the inner surface of the tubular tip 918 and the image sensor assembly 760. Such channels guide the blown air or water jet to the distal tip of the forward-facing image sensor assembly 760, thereby effectively cleaning the front lens surface. Figure 12 depicts the distal segment of the tubular body 516, with the guide wire 730 characterized by the forward-facing image sensor 770; however, Figure 11 shows the guide wire 730 fully inserted into the feeding tube assembly 1100 within the feeding tube 910. Although not depicted in these figures, the front surface of the image sensor assembly 760 and / or the image sensor 770 itself may be angled as needed to improve visibility and facilitate lens cleaning. By blowing air or injecting water through the inner cavity of the feeding tube 910 and across the top of the image sensor assembly, the user can maintain the clarity of the lens surface.

[0061] As described above, the enteral feeding tube system disclosed in this invention offers several advantages compared to prior art systems. These include, but are not limited to, immediate visualization of precise placement of the feeding tube behind the stomach and pylorus; clear visibility throughout the insertion process; a smaller, more flexible distal tip to improve patient comfort and tolerance; AI-assisted tube positioning and tracking to assist clinicians in placement and improve patient safety; and the potential to eliminate the need for X-ray confirmation of placement.

[0062] Although the various specific embodiments disclosed in this invention have been described in conjunction with their specific implementations, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Accordingly, the preferred embodiments of the invention described herein are intended to be illustrative rather than restrictive, provided that such variations fall within the scope of the appended claims and their equivalents. [Simplified Explanation of the Diagram]

[0016] The foregoing content and other features and advantages will be discussed in detail in relation to the accompanying drawings, in the following non-limiting description of specific embodiments, wherein:

[0017] Figure 1 is a schematic illustration of an enteral feeding tube system according to the present invention;

[0018] Figure 2 is a side view of a guidewire disclosed in accordance with the present invention;

[0019] Figure 3 is an enlarged side view of the distal end of the guidewire illustrated in Figure 2;

[0020] Figure 4 is a cross-sectional view of the guidewire disclosed in this invention;

[0021] Figure 5 is a side view of a feeding tube that is compatible with the guidewire of Figure 2 according to the present invention;

[0022] Figure 6 is a side view of a feeding tube system in accordance with the present invention and illustrating the cooperation between the guide wire of Figure 2 and the feeding tube of Figure 5;

[0023] Figure 7 is a side view of an alternative specific embodiment of the guidewire disclosed in this invention;

[0024] Figure 8 is an enlarged side view of the distal end of the guidewire illustrated in Figure 7;

[0025] Figure 9 is a side view of an alternative specific embodiment of a feeding tube that is compatible with the guidewire of Figure 7 according to the present invention;

[0026] Figure 10 is a side perspective view of the tubular tip of the feeding tube as disclosed in the present invention and in Figure 9;

[0027] Figure 11 is a side view illustrating an alternative feeding tube system according to the present invention and demonstrating the cooperation between the guidewire of Figure 7 and the feeding tube of Figure 9; and

[0028] Figure 12 is an enlarged side view of the distal end of the feeding tube system illustrated in Figure 11.

Claims

1. An enteral feeding tube system comprising: a feeding tube having a first proximal end and a first distal end; and a guidewire detachably disposed within the feeding tube, the guidewire comprising: a guidewire tube having a second proximal end and a second distal end; an image sensor assembly mounted on the second distal end of the guidewire tube and including an image sensor and a light source; a flexible wire disposed in the guidewire tube and operatively connected to the image sensor assembly; and at least one wire disposed in the guidewire tube and operatively connected to the image sensor and the light source, wherein the image sensor assembly is configured to reside within the first distal end of the feeding tube when the guidewire system is fully inserted into the feeding tube; wherein the image sensor and the light source are oriented in a radial direction relative to the guidewire tube; and wherein the feeding tube has a radial opening configured to align with the image sensor and the light source when the guidewire system is fully inserted into the feeding tube.

2. The enteral feeding tube system of claim 1 further comprises: 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 guidewire tube, the second connector also being configured for detachable attachment to the first connector.

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

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

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

6. The enteral feeding tube system of claim 1, wherein the feeding tube includes at least one additional radial opening configured to be misaligned with the image sensor and the light source when the guidewire system is fully inserted into the feeding tube.

7. The enteral feeding tube system of claim 1, wherein the image sensor assembly includes at least one encapsulation material disposed thereon.

8. The enteral feeding tube system of claim 7, wherein the at least one encapsulation material comprises a first encapsulation material configured to cover at least the image sensor and the light source.

9. The enteral feeding tube system of claim 7, wherein the at least one encapsulation material includes a second encapsulation material configured to cover at least a portion of the image sensor assembly, wherein the flexible wire and the at least one electrical wire are operatively connected to the image sensor assembly.

10. 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 communication with the third distal end of the tubular body.

11. The enteral feeding tube system of claim 10, wherein the tubular tip has a waterproof surface.

12. The enteral feeding tube system of claim 10, wherein the tubular tip includes an opening configured to expose the image sensor and the light source when the guidewire system is fully inserted into the feeding tube.

13. The enteral feeding tube system of claim 12, wherein the opening in the tubular tip is a radial opening.

14. The enteral feeding tube system of claim 12, wherein the tubular tip includes at least one additional radial opening.

15. The enteral feeding tube system of claim 1, wherein one inner surface of the feeding tube is coated with a lubricating material.

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

17. The enteral feeding tube system of claim 1, wherein the guidewire includes a video output connector operable to the at least one wire and disposed at the second proximal end of the guidewire tube.

18. The enteral feeding tube system of claim 17 further comprises: a video cable operably connected to the video output connector at a first end of the video cable; and a video monitor operably connected to a second end of the video cable.

19. The enteral feeding tube system of claim 18, wherein the video monitor is configured to provide AI-supported guidance based on video images received from the image sensor.

Images