JP6039098B2 - Catheter with imaging assembly and console with reference library and methods related thereto - Google Patents

Description

  The present invention relates to catheters, and more particularly to an imaging catheter system having a display console with reference material.

  Some medical procedures involve placing a catheter, such as a feeding tube or endoscope, within the patient through the patient's nose, mouth, or other opening. In many procedures, accurate placement of the catheter is important for the success of the procedure and / or for patient safety. For example, a nasogastric (NG) feeding tube passes through the nose, past the throat, down into the stomach, or past the stomach to deliver food to the patient via the tube. Can be inserted into. If the feeding tube is accidentally placed in the patient's lungs, the nutrient solution is delivered to the patient's lungs, causing a critical and possibly fatal result.

X-ray imaging devices and procedures have therefore been used to confirm the correct positioning of a feeding tube or other type of catheter within a patient. Specifically, an X-ray image of the patient is taken after the feeding tube is first positioned in the patient. The x-ray image is examined to determine if the feeding tube has been properly positioned or if repositioning is necessary. The x-ray imaging procedure is repeated until the feeding tube is properly positioned. However, X-ray imaging procedures are generally expensive and time consuming. In addition, because patients often use a feeding tube for a significant amount of time, X-ray imaging procedures ensure that the feeding tube is not moving or moving, Must be repeated periodically.
U.S. Patent Application Publication No. 2012/0065469 described a catheter having an imaging assembly. The catheter is used with a console for viewing and / or storing images acquired from the catheter. The catheter can be a feeding tube assembly. The imaging assembly on the feeding tube assembly allows the user to confirm the placement of the feeding tube assembly in the patient's gastrointestinal tract.

  One or more aspects of the invention can involve a catheter having an imaging assembly. The catheter can be a feeding tube with an imaging assembly. According to one aspect of the present invention, an imaging catheter system can include an imaging catheter including an imaging assembly having an imaging device for generating an imaging signal corresponding to an image of a patient's anatomy. The imaging assembly transmits an imaging signal generated by the imaging device. The system also includes a console adapted to receive an imaging signal transmitted by the imaging assembly and present an image generated from the imaging signal on a display. The console is optionally adapted to present a reference menu including menu items on the display. The menu items correspond to reference material comprising any one or more of photos, video recordings, audio recordings, schematics, animations, and text. Materials include anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter features, console preparation, console operation, console features, system operation, system features, contact information, help information, and support information Provide information about any one or more of them. The console can be further configured to present a reference menu on the display simultaneously with the image generated from the imaging signal. The console is typically configured to present a graphical user interface on the display. In some cases, the display is a touch screen display that is adapted to present icons for control of the system by touching the display. In a further configuration, the console can be configured to present the reference material on the display simultaneously with the image generated from the imaging signal. In further cases, each reference material is preferably located in a directory having a name corresponding to the corresponding reference material. The display can be adapted to present a reference menu when the user touches the display twice during a preselected period. The period can be, for example, within about 1 second. Furthermore, at least some of the reference material is read-only and in some cases can be modified by updating the system software. The imaging catheter system can comprise a feeding tube assembly that includes a feeding tube for delivering enteral nutrient fluid to a patient, the tube extending between the inlet, the outlet, and the inlet and the outlet. An imaging catheter is positioned adjacent to an outlet for generating an imaging signal corresponding to the patient's gastrointestinal tract, and the imaging assembly includes an enteral nutrient liquid in the supply passage. It is sealed from the supply passage so as to prevent it from entering. The system typically further comprises an interface cable that connects an imaging catheter to the console for use in transmitting imaging signals generated by the imaging device to the console.

  One or more aspects of the present invention include an inlet connectable to a nutrient fluid source, an outlet distal to the inlet and fluidly connected thereto through a supply passage, and disposed proximate to the outlet. An imaging device having an imaging device configured to generate and transmit an imaging signal corresponding to an image of a patient's anatomy, a display, and a photo, video recording, audio An imaging catheter system comprising a console, comprising a memory, having a plurality of reference materials stored therein, selected from the group consisting of records, schematics, videos, text, and combinations thereof can do. In some cases, each of the plurality of reference materials includes anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter feature, console preparation, console operation, console feature, system operation, system feature, and Information regarding at least one of the contact information may be provided. Preferably, the console receives the imaging signal, presents on the display at least a portion of at least one image corresponding to the imaging signal, and includes a menu item corresponding to at least one of the reference materials Is configured to be presented on the display. At least one of the plurality of reference materials can include a photograph showing anatomical landmarks. The anatomical landmark can be one of bronchi, larynx, tracheal ring, cardia, pyloric sphincter or pylorus, cricoid cartilage, bronchial bifurcation, esophageal junction, gastrostomy, duodenal fistula, and pyloric ostium.

  According to another aspect of the invention, an imaging device for generating an imaging signal corresponding to an image of a patient's anatomy, and a console adapted to present an image generated from the imaging signal on a display; A method of operating a medical system having a medical device includes accessing reference material on a display. The material includes an image of an exemplary anatomy showing proper placement of the medical device within the patient.

  One or more aspects of the present invention can be directed to a method of facilitating the use of a feeding tube assembly. In one or more embodiments according to such aspects of the invention, the method includes an inlet connectable to a nutrient fluid source and distally from the inlet and fluidly connected thereto through a supply passage. Providing a feeding tube having an outlet and an imaging device disposed proximate to the outlet, wherein the imaging device generates and transmits an imaging signal corresponding to an image of the patient's anatomy A plurality of steps stored in and selected from the group consisting of audiovisual data such as video, audio and pictures, text data such as schematics, videos and text, and combinations thereof, comprising: Providing a console comprising a display and a memory having a reference material. According to some specific embodiments, each of the reference materials is anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter feature, console preparation, console operation, console feature, system operation, Information regarding at least one of system features and contact information may be provided. In some cases, the console receives an imaging signal, presents at least a portion of at least one image corresponding to at least a portion of the imaging signal on a display, and a menu corresponding to at least one of the reference materials. A reference menu including the item can be configured to be presented on the display. In some cases, the console can be configured to simultaneously present on the display photos from multiple reference materials and video images corresponding to the image signals from the imaging assembly, Provide representative anatomical markers. According to a further aspect of the present invention, the method comprises the steps of storing additional reference material in memory, removing at least one of the reference material from the memory, and replacing the memory with an updated memory. And the updated memory may include at least one of the following steps with updated reference material stored therein. The method, according to another further case, includes receiving a console from a user, storing additional reference material in memory after receiving the console, and removing at least one reference material from memory. And replacing the memory with updated memory, the updated memory comprising at least one of the steps having at least one updated reference material stored therein Can do.

In one aspect, an imaging catheter system generally includes an imaging catheter and a console. The imaging catheter includes an elongated body having first and second ends on opposite sides. The imaging assembly is at a first end of the elongate body and includes an imaging device for generating an imaging signal indicative of an image of the anatomy of the subject. The imaging assembly is adapted to transmit an imaging signal generated by the imaging device. The electronic memory component has a predetermined identifier of the imaging catheter written thereon. The console includes a display. The console is configured to receive an imaging signal from the imaging assembly and display an image generated from the imaging signal on a display. The console is configured to read a predetermined identifier from the electronic memory component.
For example, the present invention provides the following items.
(Item 1)
A method for facilitating the use of a feeding tube assembly comprising:
An inlet connectable to a nutrient fluid source; an outlet distally from the inlet and fluidly connected thereto through a supply passage; and an imaging device disposed proximate to the outlet Providing a feeding tube, wherein the imaging device is configured to generate and transmit an imaging signal corresponding to an image of a patient's anatomy;
A console comprising a display and a memory having a plurality of reference materials selected from the group consisting of photos, video recordings, audio recordings, schematics, animations, text, and combinations thereof stored therein. Each of the plurality of reference materials includes: anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter feature, console preparation, console operation, console feature, system operation, system Providing information relating to at least one of features and contact information, wherein the console receives the imaging signal and presents at least a portion of at least one image corresponding to the imaging signal on the display; Memories corresponding to at least one of the reference materials. Including Yuaitemu is configured to reference the menu to present on the display, at least one of the plurality of reference material includes an image showing the typical anatomical markers or indicia, comprising the steps
Including a method.
(Item 2)
The console is configured to simultaneously present the image showing a representative anatomical marker or indicia on the display and a video image corresponding to the image signal from the imaging assembly. The method according to 1.
(Item 3)
Storing additional reference material in the memory; removing at least one reference material from the memory; and replacing the memory with an updated memory, the updated memory comprising: The method of claim 1, further comprising: at least one of: having updated reference material stored therein.
(Item 4)
The method of claim 1, wherein at least one of the plurality of reference materials includes a schematic diagram including a correct and incorrect path contrast for inserting the feeding tube into the patient.
(Item 5)
An imaging catheter system positioned adjacent to a feeding tube assembly, comprising a feeding tube for delivering enteral nutrient fluid to a patient,
An imaging catheter including an imaging assembly having an imaging device for generating an imaging signal corresponding to an image of a patient's anatomy, wherein the imaging assembly transmits the imaging signal generated by the imaging device An imaging catheter;
A console adapted to receive the imaging signal transmitted by the imaging assembly and present an image generated from the imaging signal on a display, wherein the console is a photograph on the display; Selectively presenting a reference menu including a menu item corresponding to the reference material, selected from the group of reference materials, comprising at least one of a video recording, an audio recording, a schematic diagram, a video, and text. Each of the documents is of anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter characteristics, console preparation, console operation, console characteristics, system operation, system characteristics, and contact information Provide information on at least one of the above, At least one of the irradiation article includes an image showing the typical anatomical markers or indicia, and the console
An imaging catheter system comprising:
(Item 6)
6. The imaging catheter system according to item 5, wherein the console presents an image generated from the imaging signal on the display simultaneously with the reference menu.
(Item 7)
6. The imaging catheter system according to item 5, wherein the console presents an image generated from the imaging signal on the display simultaneously with the reference material.
(Item 8)
6. The imaging catheter system of item 5, wherein each of the reference materials is located in a directory having a name corresponding to the corresponding reference material.
(Item 9)
6. The imaging catheter system of item 5, wherein the display is adapted to present the reference menu when the user touches the display twice during a preselected time period.
(Item 10)
Item 10. The imaging catheter system of item 9, wherein the reference material is modified by updating system software.
(Item 11)
The feeding tube has an inlet, an outlet, and a supply passage extending between the inlet and the outlet, and the imaging catheter generates an imaging signal corresponding to the patient's digestive tract 6. The item of claim 5, wherein the imaging assembly is positioned adjacent to the outlet and the imaging assembly is sealed from the supply passage to prevent enteral nutrient fluid in the supply passage from entering the imaging assembly. Imaging catheter system.
(Item 12)
6. The imaging catheter system of item 5, wherein the console is configured to present a graphical user interface on the display.
(Item 13)
13. The imaging catheter system of item 12, wherein the display is a touch screen display adapted to present icons for control of the system by touching the display.
(Item 14)
13. The imaging catheter system of item 12, wherein the console is configured to simultaneously present reference material and video image signals from the imaging assembly on the display.
(Item 15)
6. The imaging catheter system of item 5, further comprising an interface cable that connects the imaging catheter to the console for use in transmitting the imaging signal generated by the imaging device to the console.

FIG. 1 is a schematic diagram illustrating a perspective view of an imaging feeding tube assembly in accordance with one or more aspects of the present invention. FIG. 2 is a schematic diagram illustrating a perspective view of the feeding tube assembly of FIG. 1 in accordance with one or more aspects of the present invention. 3 is a schematic diagram illustrating a side view of an imaging feeding tube system and console including the imaging feeding tube assembly and interface cable of FIG. 1 according to one or more aspects of the present invention. 4A is a schematic diagram illustrating a perspective view of the console connector of the feeding tube assembly of FIG. 1 showing internal components and including the feeding tube section of the feeding tube according to one or more aspects of the present invention. FIG. 4B is a schematic diagram illustrating another embodiment of an inlet adapter for an imaging feeding tube assembly in accordance with one or more aspects of the present invention. FIG. 5 is a schematic illustrating an enlarged partial perspective view of the distal end portion of the feeding tube assembly of FIG. 1 including a disassembled imaging assembly, an imaging assembly connector, and a portion of the feeding tube according to one or more aspects of the present invention. FIG. 6 is a schematic diagram illustrating an enlarged cross-sectional view of a feeding tube of the feeding tube assembly of FIG. 1 in accordance with one or more aspects of the present invention. 7 is a schematic diagram illustrating a top perspective view of the flex circuit assembly of the imaging assembly of FIG. 5 in a folded configuration in accordance with one or more aspects of the present invention. FIG. 8 is a schematic diagram illustrating a bottom perspective view of the flex circuit assembly of the imaging assembly of FIG. 4 in a folded configuration, according to one or more aspects of the present invention. FIG. 9 is a schematic diagram illustrating a partial view of the imaging assembly of FIG. 5 in accordance with one or more aspects of the present invention. 10 is a schematic diagram illustrating a perspective view of the cap of the imaging assembly of FIG. 5, in accordance with one or more aspects of the present invention. FIG. 11 is a block diagram of the flex circuit of FIG. 7 in accordance with one or more aspects of the present invention. 12 and 13 are circuit schematics of the embodiment of the flex circuit of FIG. 11 in accordance with one or more aspects of the present invention. 12 and 13 are circuit schematics of the embodiment of the flex circuit of FIG. 11 in accordance with one or more aspects of the present invention. 14 is a schematic diagram illustrating a top view of the flex circuit assembly of the imaging assembly of FIG. 7 in an unfolded configuration, in accordance with one or more aspects of the present invention. 15 is a schematic diagram illustrating a top view of a first substrate of the flex circuit assembly of FIG. 14 in accordance with one or more aspects of the present invention. FIG. 16 is a block diagram of a flex circuit assembly in accordance with one or more aspects of the present invention. FIG. 17 is a block diagram of a flex circuit assembly in accordance with one or more aspects of the present invention. FIG. 18 is a block diagram of an exemplary feeding tube system in accordance with one or more aspects of the present invention. FIG. 19 is a flow diagram illustrating an exemplary graphical user interface screen flow according to one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. 20-31 are schematic diagrams illustrating exemplary graphical user interface screens that can be displayed by a console in accordance with one or more aspects of the present invention. FIG. 32A is a schematic diagram illustrating a perspective view of an imaging feeding tube assembly according to one or more aspects of the present invention. 32B is a schematic diagram illustrating an exploded perspective view of the imaging nutrient tube assembly of FIG. 32A in accordance with one or more aspects of the present invention. 33 is a schematic diagram illustrating a cross-sectional view of a feeding tube of the imaging feeding tube assembly of FIG. 32A in accordance with one or more aspects of the present invention. 34 is a schematic diagram illustrating an exploded perspective view of the imaging assembly of the imaging feeding tube assembly of FIG. 32A in accordance with one or more aspects of the present invention. FIG. 35 is a schematic diagram illustrating a perspective view of a rigid flex circuit assembly in accordance with one or more aspects of the present invention. FIG. 36 is a schematic diagram illustrating a top view of a rigid flex circuit in accordance with one or more aspects of the present invention. FIG. 37 is a schematic diagram illustrating a side view of a rigid flex circuit in accordance with one or more aspects of the present invention. 38 is a schematic diagram illustrating a perspective view of an imaging assembly connector of the imaging nutrition tube assembly of FIG. 32A in accordance with one or more aspects of the present invention. FIG. 39 is a schematic diagram illustrating a perspective view of the imaging assembly of FIG. 34 with the housing removed therefrom to show internal components in accordance with one or more aspects of the present invention. 40 is a schematic diagram illustrating a longitudinal cross-sectional view of the housing of the imaging assembly of FIG. 34 in accordance with one or more aspects of the present invention. FIG. 41 is a schematic diagram illustrating an imaging assembly according to one or more aspects of the present invention. FIG. 42 is a schematic diagram illustrating a cross-sectional view of a console connector of an imaging feeding tube assembly in accordance with one or more aspects of the present invention. FIG. 43 is a schematic diagram illustrating an interface cable according to one or more aspects of the present invention. FIG. 44 is a schematic diagram illustrating a perspective view of a flex circuit assembly with a flex circuit in a folded configuration in accordance with one or more aspects of the present invention. 45 is a schematic diagram illustrating a perspective view of the flex circuit of FIG. 44 in an unfolded or flat configuration in accordance with one or more aspects of the present invention. FIG. 46 is a schematic diagram illustrating a partial perspective view of an imaging catheter system in accordance with one or more aspects of the present invention. FIG. 47 is a schematic diagram illustrating a front elevation view of a console of an imaging catheter system in accordance with one or more aspects of the present invention. FIG. 48 is a schematic including a copy of a photograph showing an exemplary marker representing inaccurate and accurate pathways. 49A-49C are photocopies of exemplary markers, FIG. 49A shows a photocopy of a bronchus, 49B shows a photocopy of a portion of the stomach, and FIG. 49C shows a tracheal ring Show a copy of the photo. 49A-49C are photocopies of exemplary markers, FIG. 49A shows a photocopy of a bronchus, 49B shows a photocopy of a portion of the stomach, and FIG. 49C shows a tracheal ring Show a copy of the photo. 49A-49C are photocopies of exemplary markers, FIG. 49A shows a photocopy of a bronchus, 49B shows a photocopy of a portion of the stomach, and FIG. 49C shows a tracheal ring Show a copy of the photo.

  Corresponding reference characters indicate corresponding parts throughout the drawings.

  In another aspect, the feeding tube assembly generally includes first and second longitudinal ends on opposite sides, a longitudinal axis extending between the first and second longitudinal ends, and a first And a flexible feeding tube having a feed passage defined therein extending along a longitudinal axis between the second longitudinal end. The inlet adapter is adjacent to the second longitudinal end of the tube in fluid communication with the supply passage. The inlet adapter is configured for fluid connection to the enteral nutrient liquid source to fluidly connect the enteral nutrient liquid source to the supply passage. The imaging assembly includes an imaging device. The imaging assembly is configured to generate and transmit an imaging signal indicative of an image of the subject's digestive tract. The imaging assembly is secured to the tube adjacent the first longitudinal end of the tube and is sealed from the supply passage to prevent enteral nutrient fluid in the supply passage from entering the imaging assembly. . The supply outlet is proximate to the imaging assembly and is in fluid communication with the supply passage for delivering enteral nutrient fluid to the subject. The console connector is communicatively connected to the imaging assembly, and the console connector is configured for use in communicatively connecting the imaging assembly to the console to allow transmission of imaging signals to the console. .

  In yet another aspect, the feeding tube system generally comprises a feeding tube assembly and a console. The feeding tube assembly includes a feeding tube having first and second ends on opposite sides and a supply passage that fluidly connects the first and second ends. The inlet adapter is adjacent to the second end of the tube in fluid communication with the supply passage. The inlet adapter is configured for fluid connection to the enteral nutrient liquid source to fluidly connect the enteral nutrient liquid source to the supply passage. The imaging assembly includes an imaging device and is configured to generate and transmit an imaging signal indicating that an image of the subject's digestive tract is available. The imaging assembly is secured to the tube adjacent the first end of the tube and is sealed from the supply passage so as to prevent enteral nutrient fluid in the supply passage from entering the imaging assembly. The supply outlet is intermediate the inlet adapter and the imaging assembly and is in fluid communication with the supply passage for delivering enteral nutrient fluid to the subject. The console includes a display and is operably coupled to the feeding tube assembly and configured to receive an imaging signal transmitted by the imaging assembly and display an image generated from the imaging signal on the display.

  In another embodiment, the feeding tube assembly is generally defined therein extending between opposite first and second longitudinal ends and between the first and second longitudinal ends. A flexible feeding tube having a feed passage that is provided. The inlet adapter is adjacent to the second longitudinal end of the tube in fluid communication with the supply passage. The inlet adapter is configured for fluid connection to the enteral nutrient liquid source. The imaging assembly includes an imaging device for generating and transmitting an imaging signal indicative of an image of the subject's digestive tract. The imaging assembly is secured to the feeding tube adjacent to the first end of the tube and is fluidly isolated from the supply passage. The console connector is secured to the feeding tube in proximity to the inlet adapter. The console connector is communicatively connected to the imaging assembly and is configured for use in communicatively connecting the imaging assembly to the console to allow transmission of imaging signals to the console.

  In yet another embodiment, an imaging catheter assembly generally has an elongate body having a first body end and an opposing second body end and imaging secured to the first body end. An assembly. The imaging assembly includes a first imaging assembly end remote from the first body end, a second imaging assembly end adjacent to the first body end, and first and second imaging assembly ends. An imaging assembly having a longitudinal axis extending therebetween. The imaging assembly includes an electronic component mounting portion that extends along an imaging assembly longitudinal axis from an adjoining second imaging assembly end to a first imaging assembly end, and the first imaging assembly. A rigid flexible circuit having a camera mounting portion adjacent to the end and extending generally perpendicular to the imaging assembly; The electronic component mounting portion includes first and second rigid sections spaced longitudinally and a first flexible section disposed between the first and second rigid sections. The first electronic component is mounted on the first rigid section of the electronic component mounting portion. The second electronic component is mounted on the second rigid section of the electronic component mounting portion. The camera is mounted on the camera mounting portion, and the camera is communicatively connected to the first and second electronic components. The rigid flexible circuit is disposed in the housing. The housing surrounds at least a part of the rigid flexible circuit in the circumferential direction. The first flexible section of the electronic component mounting portion includes an electronic component mounted thereon so that the rigid flexible circuit can be bent in the first flexible section. Absent.

  In another aspect, an imaging catheter system for use in performing a medical procedure generally includes an imaging catheter and a console. The imaging catheter includes an elongated body having first and second ends on opposite sides. The imaging assembly at the first end of the body is adapted to be inserted into the subject. The imaging assembly includes an imaging device for generating an imaging signal that represents an image of the anatomy of the subject when the imaging assembly is inserted into the subject. The imaging assembly is adapted to transmit an imaging signal generated by the imaging device. The imaging catheter includes an electronic memory component. The console includes a display and is configured to receive an imaging signal transmitted by the imaging assembly and display an image generated from the imaging signal on the display. The console is configured to write data to the electronic memory component during use of the imaging catheter.

  In another aspect, an imaging catheter system for use in performing a medical procedure generally includes an imaging catheter and a console. The imaging catheter includes an elongated body having first and second ends on opposite sides. The imaging assembly at the first end is adapted to be inserted into the subject. The imaging assembly includes an imaging device for generating an imaging signal that represents an image of the anatomy of the subject when the imaging assembly is inserted into the subject. The imaging assembly is adapted to transmit an imaging signal generated by the imaging device. The console includes a display. The console is configured to receive an imaging signal transmitted by the imaging assembly and display an image generated from the imaging signal on a display. The console is configured to simultaneously present an image previously received by the console from the imaging assembly and a current image from the image data currently received by the console from the imaging assembly.

  Referring now to the drawings, and specifically to FIGS. 1-3, an imaging catheter is generally indicated at 10. As disclosed herein, an imaging catheter can be a medical device configured for insertion into a subject, eg, a human or non-human subject, when the medical device is inserted into the subject. In addition, and / or after the medical device is installed in the subject, it may be configured to provide an image of the anatomy of the subject, eg, a digital video. In the illustrated embodiment, the imaging catheter is configured as a feeding tube assembly 10 and is illustratively shown as a nasogastric feeding tube assembly. The nasogastric feeding tube assembly 10 allows the feeding tube assembly to be positioned within the subject as the feeding tube assembly is inserted into the subject and facilitates confirmation of proper placement of the feeding tube assembly within the subject. Can be configured to provide a digital image of the subject's digestive tract or portion thereof. The nasogastric feeding tube assembly 10 may also view the acquired digital image from the imaging feeding tube assembly, such as after a user, eg, a physician, confirms proper placement of the feeding tube assembly in the subject. It can also be configured to deliver liquid nutrients into the digestive tract of a subject by enteral nutrition. The imaging catheter 10 may be configured as a different type of feeding tube, such as a transgastric feeding tube or a jejunal feeding tube, or different, such as an endoscope or heart catheter, eg, a balloon catheter or other type of heart catheter. It is understood that it may be configured as a type of medical device.

  The illustrated feeding tube assembly 10 generally has a longitudinal axis A (FIG. 6), an open first longitudinal end, or a distal end, and an open second longitudinal end, or near. An elongated generally flexible body in the form of a feeding tube, generally designated 12, having a distal end. The supply passage 14 (FIGS. 4-6) defined by the inner surface of the feeding tube 12 is longitudinally between the longitudinal ends of the tube, for example, to deliver nutrients in the form of enteral nutrient solution to the subject. Extend. In other embodiments, such as a catheter that is not a feeding tube, the elongate body may have other components and may not have a longitudinal passage for delivering fluid to the patient. An inlet adapter, generally indicated at 16, for delivering liquid nutrients into the supply passage 14, is attached to the second end of the tube and provides real-time images of the patient's digestive tract during and / or after intubation, eg, An imaging assembly, indicated generally at 18, for generating and transmitting live video is attached to the first end of the tube 12 by an imaging assembly connector, generally indicated at 20. As used herein with a reference point that is a source, the inlet adapter 16 defines the proximal end of the feeding tube assembly 10 and the imaging assembly 18 defines the distal end. The feeding tube assembly 10 also provides communication between the imaging assembly and the console 23 (FIG. 3), where images acquired by the imaging assembly 18 as described herein may be displayed. In addition, a console connector, generally indicated at 22, in communication with the imaging assembly 18 may be included. In the illustrated embodiment, the feeding tube assembly 10, the console 23, and the interface cable 242 that communicatively connects the feeding tube assembly to the console together form an imaging catheter system, more specifically an imaging feeding tube system.

  1-4, the illustratively illustrated feeding tube 12 includes a first tube section 12a that extends between the imaging assembly connector 20 and the console connector 22, and a console connector and inlet adapter 16. Two tube segments are provided, such as a second tube segment 12b extending therebetween. As disclosed in further detail below, the first and second tube sections 12 a, 12 b are in fluid communication with each other such that the first and second tube sections at least partially define the supply passage 14. As shown, it can be fixed to the console connector 22. In other embodiments of the invention, the tube 12 may be formed as an integral one-piece component.

  Tube 12 may be provided with indicia, such as a scale (not shown), that indicate or provide a relative indication of insertion depth to facilitate proper intubation. In one embodiment, the tube 12 may have a length between about 36 inches and about 55 inches, but may have other lengths without departing from the scope of the present invention.

  As shown in FIG. 6, the first tube section 12a typically includes one or more conductors 24 (in a broad sense, signal transmission) disposed within the tube wall of the first tube section. Typically). The second tube section 12b may not include such a conductor. The conductor 24 of the first tube section 12a extends longitudinally along the first tube section, such as along the longitudinal axis of the supply passage 14 or in parallel. At least some of the electrical conductors 24 can be configured to transmit imaging signals between the imaging assembly 18 and the console 23, such as through the console connector 22 and interface cable 242. Other conductors 24 may be configured to transmit power from console 23 to imaging assembly 18 and provide ground. Still other conductors 24 may be configured to provide other communications, including, but not limited to, bidirectional communications between console 23 and imaging assembly 18. The first tube section 12a may include different types of signal transmission components, such as fiber optic cables or other signal transmission components, to achieve transmission of signals between the imaging assembly 18 and the console connector 22. Good. In one or more embodiments of the present invention, at least one of the electrical conductors 24 is configured to supply power to the imaging assembly 18 from a power supply that can be a console 23, but with its own power source. Other methods of powering the imaging assembly, including the assembly, do not depart from the scope of the present invention.

  As illustrated by way of example, the conductor 24 may be such that the conductor is physically separated from the supply passage 14 or at least so as to prevent or reduce the possibility of nutrient solution in the supply passage contacting the conductor. It can be placed in the conductor passage 26 of the feeding tube 12 so as to be fluidly isolated. As shown in FIG. 6, the inner surface defining a portion of the supply passage 14 in the first tube section 12a extends inwardly and extends longitudinally along the longitudinal dimension of the feeding tube assembly or section. It has a generally circular cross section with an arcuate portion 28. The conductor 24 may be disposed within the tube wall of the first tube section 12a between the inner arcuate portion 28 and the outer surface of the tube section, as disclosed above, with the conductor 24 and Physical separation between the enteral nutrient solution in the supply passage 14 can be allowed and the area or volume of the supply passage can be maximized. The longitudinal axis A passes through the supply passage 14. As such, this configuration promotes fluid flow in the supply passage 14 and reduces the possibility of blockage in the supply passage. A substantially uniform wall thickness around the passageway 14, as shown in FIG. 5, can reduce the amount of material confinement that may occur, or at least reduce the likelihood of occlusion formation. it can. It will be appreciated that the first tube section 12a may have other configurations without departing from the scope of the present invention.

For example, the feeding tube 12 including the first and second tube sections 12a, 12b is a radiation such as, but not limited to, an aromatic polyether-based thermoplastic polyurethane, and barium. It may be formed from an impermeable material. The first and second tube sections 12a, 12b may be formed by an extrusion process. The tube 12 may be formed from other materials and may be formed in other ways without departing from the scope of the present invention. In one non-limiting example, the conductor 24, or other signal transmission component, may be co-extruded with the first tube section 12a to embed a conductor in the first tube section. In another embodiment, conductor 24, or other signal transmission component, may be supplied through conductor passage 26 after forming first tube section 12a. Introducing any of the one or more conductors 24 can be facilitated, for example, by internally pressurizing the passageway 26 with a fluid prior to insertion therein. Other methods of forming the first tube section 12a and / or tube 12 do not depart from the scope of the present invention.

  Referring again to FIGS. 1 and 2, the illustrated inlet adapter 16 typically includes first and second inlet ports 30, 32, respectively, in fluid communication with a single outlet port 34. . The inlet adapter 16 illustrated as an example may be referred to as a Y port. The first inlet port 30 may be used to connect to a liquid nutrient source such as enteral nutrient solution. For example, a barbed connector (not shown) in fluid communication with the enteral nutrient solution source may be inserted into the first inlet port 30 and secured therein by a friction fit. Thus, aspects of the invention may involve a configuration where the nutrient fluid is in fluid communication with the nutrient tube assembly. An optional cap 35 anchored on the inlet adapter 16 may be removably receivable within the first inlet port 30 so as to close the inlet port when not in use. The second inlet port 32 may be used to connect to a drug source. Optional tethered first and second caps 36, 37 each provide a second inlet port 32 as a connection or port to various or different connectors, typically used with various drug sources. Can be variably configured. For example, the first cap 36 may be removably receivable in the second inlet port 32 that provides a central opening therethrough that is sized and shaped to mate with a catheter syringe. The second cap 37 is removably receivable within the central opening in the first cap 36 and is thereby sized and shaped specifically to mate with the tip of the oral syringe. Department can be provided. The inlet adapter 16 may have other shapes, sizes, and configurations, or may be omitted completely without departing from the present invention.

  The inlet adapter 16 is secured to the second or proximal end of the tube 12 in adapter welding, generally indicated at 38, such that the outlet port 34 of the adapter 16 is in sealed fluid communication with the feeding tube supply passage 14. Can do. The adapter weld 38 typically tapers distally from the adapter 16 to the tube 12 so that the weld has a smooth and substantially continuously decreasing diameter. It should be understood that adapter 16 may be secured to tube 12 in other ways without departing from the scope of the present invention. For example, the inlet adapter 16 may be secured to the tube 12 by solvent bonding or other securing techniques. The adapter 16 may be made of the same material as the feeding tube 12, or a mixture of materials, or a different but compatible material. In one embodiment, adapter 16 is comprised of a mixture of polyvinyl chloride and polyurethane elastomer. In another embodiment, adapter 16 is constructed from an aromatic polyether-based thermoplastic polyurethane or PVC without DEHP. The adapter 16 may be formed from other types of materials within the scope of the present invention.

  With reference to FIGS. 1, 2, and 5, the imaging assembly connector 20 is secured to a first edge, such as a distal edge, secured to the imaging assembly 18, and to the first edge of the first tube section 12a. Has a second edge, such as a proximal edge. The imaging assembly connector 20 typically defines a supply outlet 40 that is in fluid communication with the supply passage 14 of the tube 12. The supply outlet 40 may include one or more openings that extend laterally through the side of the imaging assembly connector 20 (only one such side opening is shown). In the illustrated embodiment, the imaging assembly at the second or proximal end of the imaging assembly connector such that the first or distal end of the tube 12 provides fluid communication between the supply passage 14 and the supply outlet 40. Received and secured within the connector 20. The imaging assembly connector 20 can be closed adjacent to the first or distal end to prevent nutrient solution in the supply passage 14 from entering the imaging assembly 18. Accordingly, the imaging assembly 18 is typically sealed from the supply passage 14 and is not in fluid communication therewith. Instead, the nutrient solution typically flows laterally from the outlet 40 with respect to the nutrient tube 12. When it is determined that the feeding tube assembly 10 is properly installed in the patient, nutrient or other desired liquid supplied into the inlet adapter 16 passes through the supply passage 14 of the tube 12 and exits 40. Through and into the subject's digestive tract. As illustrated in FIG. 5, the first edge of the imaging assembly connector 20 can have a connecting portion 42 that is shaped and sized to fit within the imaging assembly 18. The imaging assembly connector 20 may be integrally formed with the imaging assembly 18 or may be omitted without departing from the scope of the present invention.

  The conductor 24 is embedded or otherwise received in the wall of the imaging assembly connector 20 such that the conductor is sealed from the supply outlet 40 and the supply passage 14 to prevent nutrient solution from contacting the conductor. May be. In one embodiment, the imaging assembly connector 20 may include two distinct parts that are assembled together. The first component may define a supply outlet 40 that receives liquid from the tube 12 and a conductor passage (not shown) that is separate from the supply passage outlet, as described above. The second part is within the first part to facilitate the connection portion 42 and the connection of the imaging assembly 18 and the tube 12 or to carry the electrical conductor 24 between the imaging assembly 18 and the tube 12. A conductor passage may be defined that extends to the other conductor passage. The imaging assembly connector 20 may be omitted or may have other shapes, sizes, and configurations. The imaging assembly 18 may also be secured to the tube 12 in other ways without departing from the scope of the present invention.

  In one example, the imaging assembly connector 20 may be injection molded onto the end of the feeding tube 12. The direct connection of the imaging assembly connector 20 to the feeding tube provides strain relief for the conductor 24 that extends out of the end of the feeding tube 12 to the imaging assembly.

  With reference to FIG. 5, the imaging assembly 18 includes a tubular housing 50, a flexible circuit (“flex circuit”) assembly 60 disposed within the tubular housing, and a transparent or translucent cap 70 secured to the tubular housing 50. Can be included. A flex circuit typically includes a deformable circuit element and components mounted on the deformable circuit element. The deformable circuit element can be bent or otherwise deformed, and at least deformed, including electrical conductors for making electrical connections between the various components that can be mounted on the substrate. It may be a flat substrate before being applied. The deformable circuit element may be deformable only partially within the scope of the present invention, for example only at the discrete bend lines. Among other functions, the tubular housing 50 can provide protection for the flex circuit assembly 60, and the housing is water resistant to prevent liquid entry into the imaging assembly 18. It may be. Tubular housing 50 has an inner surface that defines an axial passage 52 that is shaped and sized to accommodate a flex circuit assembly 60 in a folded configuration. In one embodiment, the tubular housing 50 provides protection for the flex circuit assembly 60 and allows the imaging assembly 18 to bend to facilitate maneuverability of the feeding tube assembly 10. Formed from material. A second end, such as the proximal end of the tubular housing 50, can be configured to receive the connection portion 42 of the imaging assembly connector 20 and adhere to it to secure the imaging assembly to the feeding tube 12. can do. Tubular housing 50 is formed from an opaque white material to reflect illumination from a light source, such as internal LED 96, and to direct illumination outward from the distal end of imaging assembly 18, eg, to the field of view. Or may be substantially opaque by having an opaque material applied thereon.

  The flex circuit assembly 60 typically includes a flex circuit 80 and an electronic component (not labeled), described below, attached thereto. In the partially assembled or folded configuration shown illustratively in FIGS. 5, 7, and 8, the flex circuit assembly 60 is at the first longitudinal end, eg, the distal end, and the opposite side. It may have a length with some second longitudinal end, for example a proximal end. The conductor 24 can be connected to the second longitudinal end of the flex circuit assembly 60, for example, the proximal end. The camera mounting portion 82 is typically disposed at the first longitudinal end of the flex circuit assembly 60, eg, the distal end. An imaging device, such as a digital camera, generally indicated at 84, can be mounted on the camera mounting portion 82. The camera 84 can have a cuboid housing 86 with a base 86A, side surfaces 86B, 86C, 86D, 86E, and a top or first surface 86F, as shown in FIG. The upper surface 86F of the camera 84 can include a lens 88. The lens 88 defines a field of view that protrudes generally outward from the distal end of the imaging assembly 18. According to one or more embodiments of the present invention, the camera 84 comprises an imaging device, such as a CMOS imaging device. In further embodiments of the present invention, the camera 84 may comprise a different type of solid state imaging device, such as a charge coupled device (CCD) or another type of imaging device. Other methods of configuring the electronics and other components of the imaging assembly 18 may be implemented as alternative embodiments thereof without departing from the scope of the present invention. For example, in another embodiment, the flex circuit assembly 60 may be replaced with a rigid printed circuit board (PCB).

  The flex circuit assemblies 60 each typically have a power mounting portion 90 (FIGS. 5 and 7) that extends from the camera mounting portion 82 at a fold toward the first longitudinal end of the flex circuit assembly 60. And a control or data placement portion 92 (FIG. 8). As will be described in more detail, the power supply component is typically located on the power mounting portion 90 and the camera control component is typically on the data mounting portion 92. Be placed.

  Referring to FIGS. 7 and 9, the optical mounting portion 94 of the flex circuit 60 can be disposed on the side surface 86 </ b> C of the camera 84. The optical mounting portion 94 is illustratively depicted as extending vertically from the side edge of the flex circuit toward the camera 84 at the fold of the power mounting portion 90. One or more light sources 96 may be disposed, for example, on the light mounting portion 94 to illuminate an area or region adjacent to the top surface 86F of the camera housing 86. In the illustrated embodiment, the light source is a light mounting portion 94 such that the LED is positioned on the side 86C of the camera housing and below or close to the top surface 86F of the camera housing. A light emitting diode (LED) 96 disposed on the top. In the illustrated embodiment, the LED 96 has a light emitting surface 98 that is generally perpendicular to the light mounting portion 94 for projecting light outward from the distal end of the imaging assembly 18. According to the illustrated embodiment (FIG. 9), the LED 96 and light mounting portion 94 have a light emitting surface 98 of the LED 96 that is lower than the upper surface 86F of the camera housing 86 at a relatively short distance, eg, 0.408 millimeters. It is installed with respect to the camera 84 and the camera mounting part 82 so that it may be on the side. Typically, the LED 96 has an illumination zone that at least partially coincides with the optional lens 88 over the imaging zone or field of view of the camera 84.

  In another embodiment, one or more LEDs may be located distal to the camera. As shown in FIG. 44, one embodiment of a flex circuit assembly is indicated generally by the reference numeral 60 '. As illustrated in a folded or at least partially assembled configuration, the flex circuit 80 ′ of the flex circuit assembly 60 ′ is mounted on the camera on which the electrical component mounting portion 90 ′ and the camera 84 ′ are mounted. A mounting portion 82 ′ and an LED mounting portion 94 ′ on which one or more light sources, such as the four illustrated LEDs 96 ′, can be mounted. The LED mounting portion 94 'is typically configured to rest on the top surface of the camera 84' so that the LED 96 'is distal or offset from the camera. The LED mounting portion 94 'can include an opening 95' aligned with a camera lens (not shown) so that the LED mounting portion 94 'does not interfere with the field of view of the camera 84'. FIG. 45 shows a flex circuit 80 'in an unfolded or flat configuration. The flex circuit may have other configurations and provide an alternative location for camera and light source placement.

  With reference to FIGS. 9 and 10, camera 84 and LED 96 are illustratively shown as being disposed within light transmissive cap 70. The cap 70 diffuses light emitted from any of the one or more LEDs 96 and, in some cases, filters the emitted light into a range of frequencies or a specific frequency. Can be configured. The cap 70 has a cylindrical mounting portion 100 configured to couple or mate with the distal end of the tubular housing 50 and a dome-shaped portion 102 that extends outwardly or protrudes from the tubular housing. It can have an outer surface. In one example, the cylindrical mounting portion 100 can be shaped and sized so that a snug fit is formed with the inner surface of the tubular housing 50. A binder may be used to further secure the cylindrical mounting portion 100 to the tubular housing 50. The connection between the cap 70 and the housing 50 may be substantially water resistant to prevent liquid from entering the imaging assembly 18.

  In some embodiments according to one or more aspects of the present invention, the cap 70 has an interior surface that defines a cavity extending inwardly from the proximal end of the cap. The cavity can provide or define a camera receiving portion 104 and an LED receiving portion 106. The camera receiving portion 104 can be correspondingly sized and shaped to snugly or securely receive the sides 86B, 86C, 86D, 86E of the camera 84, and further the camera can be proximal to the cap 70. Have a depth (shown as “D” in FIG. 9) that is less than the height of the camera (shown as “h” in FIG. 9) to extend out of the camera receiving portion 104 at the end. it can. This tight fit of the camera 84 in the camera receiving portion 104 prevents the camera from moving relative to the cap 70 and promotes proper alignment of the cap 70 with the camera 84. The position of the cap 70 relative to the camera 84 may be adjusted or configured to at least partially reduce any effects that undesirably affect the quality of the image produced by the imaging assembly 18. In an exemplary embodiment, the protruding portion of the camera housing that extends outside the camera receiving portion may facilitate assembly by allowing the use of a fixture for precise placement of the camera and cap. it can. In other variations, the cap may utilize a different configuration for interfacial contact with the housing or other components of the imaging assembly. For example, one or more alternative embodiments may involve having a circular cylindrical volume that surrounds any one or more of the light source and the imaging device.

  With further reference to FIG. 9, the interior of the cap 70 can be further configured to reduce unwanted light emanating from the LED 96 entering the camera 84 and being sensed or detected by the camera. In order to minimize or at least partially reduce unwanted light reflections into the camera 84, the internal camera facing surface 108 of the cap 70 opposite the top surface 86F of the camera housing 86 is: It can be oriented or constructed substantially parallel to the top surface 86F of the camera housing. Further, the internal light facing surface 110 of the cap 70 on the opposite side of the light emitting surface 98 of the LED 96 can be arranged to be separated from the camera facing surface 108 of the cap in the vertical direction, that is, distally. . A relatively acute angle, eg, a right angle, may be defined by the camera facing surface 108 and the inner surface 112 of the cap 70 that connects the inner surface 110 to the inner surface 108. This configuration should reduce undesirable internal reflections of the light emitted by the LED 96 into the camera 84.

  With further reference to FIG. 10, the dome-shaped portion 102 of the outer surface of the cap 70 includes a central distal portion 116 that can be substantially flat, eg, substantially planar. The side edges that extend from the distal portion 116 to the base, eg, the proximal end of the dome-shaped portion, are round and generally smooth. The base of the cap 70 has a cross-sectional size and shape that can be substantially the same as the cross-sectional size and shape of the housing 50 so that the cap smoothly transitions to the housing. Overall, the general shape of this cap 70 is referred to herein as a truncated dome shape. The flat central distal portion 116 should minimize or at least reduce field distortion. In the illustrated embodiment, the flat central distal portion 116 has a generally circular circumference and an area that is the same size or larger than the field of view to further minimize field distortion. Also, the portion of the inner surface of the cap 70 opposite the flat central portion 116 of the outer surface and the upper surface 86F of the camera 84 can also be flat and can be substantially parallel to the flat central portion of the outer surface. , It should further minimize or at least reduce field distortion. The rounded edge of the cap 70 facilitates insertion of the distal portion of the feeding tube assembly 12 into the subject and promotes comfort during intubation.

  FIG. 11 illustrates an electrical block diagram directed to an exemplary electrical system 200 of flex circuit assembly 60, according to one or more embodiments of the present invention. 12 and 13 exemplarily show circuit diagrams of an exemplary electrical system 200. The electrical system 200 can include a conductor connector 202, such as a crimp connector for receiving the conductor 24 from the outlet adapter 20. According to the illustrated embodiment, the conductor 24 includes six signal lines. The six signal lines in the illustrated embodiment have two power supply lines, for example, a power line 5V, and a ground line GND, two serial communication lines, for example, a serial clock line SCL and a serial data line SDA, And a differential pair, for example, a low voltage difference signal positive line LVDS_P and a low voltage difference signal negative line LVDS_N. The power supply lines (5V and GND) are electrically connected to the LED 96 to energize the LED 96. In the illustrated circuit system 200, the power supply line provides 5 volts power to a white light LED, eg, part number LW QH8G or LW VH8G, available from OSRAM Opto Semiconductor GmnH, Germany. The power supply lines (5V and GND) are also electrically connected to a dual voltage regulator 204, or power supply, to provide power to it. The dual voltage regulator 204 generates two different voltage lines from the power provided by the power supply line. In the illustrated circuit system 200, a dual voltage regulator 204, such as part number ISL9016IRUJCZ-T available from Intersil Corporation, Milpitas, California, is 2.8 volt power signal, eg, analog supply voltage signal VAA, and 1 Generate a .8 volt power signal, eg, a digital supply voltage signal VDD. Dual voltage regulator 204 is configured and electrically connected to provide the voltage generated therefrom to oscillator 206, serial communication device 208, and camera 84. In the exemplary electrical system 200, the camera 84 is connected to the Aptina Imaging Corp. , San Jose, California, part number MTV9124M01. However, other cameras or image sensors may be used without departing from the scope of the present invention.

An oscillator 206, such as a 22 MHz oscillator, can be configured to connect to the camera 84 and provide a timing signal (EXTCLK) thereto. Philips Semiconductor or NXP B.E. A serial communication device 206, such as an I ² C bus repeater available from V, Germany, allows a serial communication line (such as non-image data to be transmitted back and forth through the camera 84). SDA, SCL) and camera 84 are electrically connected. For example, the serial communication lines (SDA, SCL) may be connected to an external computer device via the console connector 22. The external computing device receives data representing one or more camera settings such as resolution and frame rate. Camera settings can be communicated to camera 84 via serial communication lines (SDA, SCL) and serial communication device 208. The camera 84 acquires an image of the anatomy of the subject in the field of view during and / or after its intubation and serializes the digital from the acquired image as a function of the camera settings communicated via the serial communication device 208. An imaging signal such as a video signal is generated. The operations performed by camera 84 are synchronized as a function of the timing signal (EXTCLK) provided by oscillator 206. The camera 84 outputs a signal, for example, a serialized digital video signal, to the differential pair line (LVDS_N, LVDS_P) for transmission to the console connector 22 and the console 23. The image acquired by the camera 84 may then be delivered, processed and viewed via the console 23.

  FIG. 14 illustrates a flex circuit 80 in an unfolded or flat, eg, planar configuration. In the unfolded configuration, the camera mounting portion 82, the power mounting portion 90, the data mounting portion 92, and the optical mounting portion 94 are all generally located in the same plane and have a single plane, eg, a mounting surface. Form. In one embodiment, when the flex circuit is in an unfolded configuration, all of the electrical components for the imaging assembly 18, eg, the electrical components of the electrical system 200, can be Attach to 250. Thus, the electrical components may be attached to the flex circuit 80 while in an unfolded configuration to facilitate manufacturing.

The relative positions of the electrical components of the exemplary electrical system 200 described above are shown in FIG. Specifically, the conductor connector 202, such as a pressure contact connector, and the power supply 204, such as a dual voltage regulator, can be attached to the mounting surface 250 of the power mounting portion 90. Configurations such as the illustrated configuration where the power supply 204 is typically located relatively close to the input conductor 24 minimizes or reduces noise on the ground line (GND). An oscillator 206, such as a timing generator, and a serial communication device 208, such as an I ² C bus repeater, can be attached to the mounting surface 250 of the data mounting portion 92. The camera 84 can be attached to the placement surface 250 of the camera placement portion 82. Serial communication signals transmitted between the serial communication device 208 and the conductor connector 202, such as serial data and serial clock signals, have a lower bandwidth than the video signal transmitted from the camera 84 to the conductor connector 202. Thus, the exemplary illustrated configuration places serial communication device 208 farther from conductor connector 202 than camera 84. The LED 96 is attached to the light placement portion 94. The camera mounting portion 82 is shaped and configured so that when the flex circuit assembly 60 is in the folded configuration described above, the optical mounting portion 94 can be placed flush with the side 86C of the camera housing. Is done.

  In one embodiment, flex circuit 80 of flex circuit assembly 60 is a two-layer circuit. Specifically, flex circuit 80 includes a first substrate and a second substrate, each having a top surface and a bottom surface. The first and second substrates may be made of a flexible polyimide film. A conductive material, eg, copper, that is selectively disposed on the top surface of the first substrate forms a first circuit pattern, eg, a plurality of selectively connected wires. FIG. 15 illustrates a first circuit pattern of an exemplary electrical system 200 according to some aspects of the present invention. A conductive material selectively disposed on the top surface of the second substrate forms a second circuit pattern. The first and second substrates are disposed, for example, stacked in parallel with each other such that the top surface of the first substrate directly faces the bottom surface of the second substrate. The first circuit pattern and the second circuit pattern are electrically connected together, for example by using vias, and are connected to electrical components attached to the flex circuit to form a two-layer circuit. . The flex circuit 80 may be made of other materials and may be formed in other ways without departing from the scope of the present invention.

  In one embodiment, the optical mounting portion 94 of the flex circuit 80 is configured to function as a heat sink. The conductive material on the top surface of the first substrate and the conductive material on the top surface of the second substrate use, for example, vias to conduct heat from the first substrate to the second substrate Can be connected together. The wiring formed on the second substrate on the optical mounting portion of the flex circuit can be wider than the wiring formed on other portions of the first and second substrates. For example, the wider wiring may have a width of about 0.008 inches. This configuration can minimize or reduce the potential for temperature rise due to the heat generated by the LED 96, damage to the LED 96, and damage to the patient caused by undesirable or unacceptable high temperatures. More current can be allowed to be provided to the LED 96 so as to maximize or increase the illumination capability generated by the LED 96 while preventing or reducing the possibility of.

  With reference to FIGS. 7, 8, and 14, to convert the flex circuit assembly 60 from a flat configuration to a folded configuration, the power mounting portion 90 and the data mounting portion 92 are between the fold 97 and the camera mounting surface 82. Are folded toward each other at a first fold 97 (FIGS. 7 and 8). The power mounting portion 90 and the data mounting portion 92 can be folded twice at the second fold 99 so that the two portions are substantially parallel and in opposition to each other. The optical mounting portion 94 can also be folded inward toward the camera mounting portion 82.

  There is no component located on the inner or rear surface of the flex circuit, ie, the component is mounted on the mounting surface, thus facilitating alignment of the power mounting portion 90 and the data mounting portion 92 during assembly can do. The alignment of the power mounting portion 90 and the data mounting portion 92 can also improve the alignment of the camera to the desired orientation. Stresses or forces associated with folds 97 and 99 on either side of camera mounting surface 82 balance each other. As a result, the equivalent or reaction stress or force guides the placement of the camera 84 in a particular orientation so that the lens 88 is aligned with the cap 70 and the field of view of the lens 88 can coincide with the axis of the tubular housing 50. To do.

FIG. 16 is a block diagram of an exemplary flex circuit electrical system, according to an alternative embodiment of the present invention. As shown, the conductor includes four cables that constitute four signal lines. The four signal lines in the illustrated embodiment include two power supply lines, eg, a 5V power line and a ground line GND, and a differential pair, eg, a low voltage difference signal positive line LVDS_P and a low voltage difference. Signal negative line LVDS_N. A microcontroller 210 cooperates with the camera 84 to allow integration into the feeding tube assembly 10. The camera 84 includes, for example, an I ² C command / control interface and a serialized digital video output interface. Rather than transmitting command and control signals over the length of the tube, the microcontroller 210 can send these signals directly to the camera 84. Other operating parameters described herein, such as the exemplary embodiments associated with FIGS. 11-13, may be implemented in this variation.

  In FIG. 17, the conductor 24 includes four cables comprising four signal lines according to one or more further embodiments of the present invention. The camera 84 can be customized to operate automatically and / or autonomously with a predetermined operating protocol when turned on or energized. In this embodiment, the camera 84 does not use or rely on external incoming command / control signals. The operating parameters of the camera 84, such as but not limited to exposure, white balance, etc., can be pre-programmed, preset, or permanently, for example, custom or adjusted values for a particular or predetermined application Can be set to In one embodiment, for example, custom values are typically stored in an associated memory structure. The camera 84 includes a sequencer (not shown) such as a microcontroller integrated into the camera module itself, having a one-time programmable memory (OTPM) (not shown) that can be programmed with custom values. be able to. Alternatively, the camera 84 can include a hardware register (not shown) with custom values stored therein, in which case the sequencer may optionally be operable. Other operating parameters described herein may be implemented in this example.

  FIG. 18 illustrates yet another embodiment of an exemplary flex circuit electrical system. As shown in FIG. 18, the conductor 24 includes two cables that form two signal lines. The two signal lines in the illustrated embodiment include two power supply lines for supplying power from the console to the flex circuit 60, for example, a power line 5V and a ground line GND. The console 23 can energize or provide power to the flex circuit 60 and adjust the voltage as necessary to power the radio 212A and the camera 84 and other components of the flex circuit 60. Can do. Next, the camera 84 can wirelessly transmit an imaging signal such as video data to the corresponding wireless 212B located on the console via the wireless 212A. In an alternative embodiment, console 23 and camera 84 may communicate bi-directionally over wireless 212A, 212B, for example, to exchange non-video data. Providing power to the camera 84 in this manner can eliminate the need for a finite capacity energy source such as a battery in the camera module itself.

  Reducing the number of signal lines as shown in FIGS. 16-18, particularly when combined with a flex circuit, may reduce costs and improve assembly reliability and ease. Furthermore, fewer conductors may reduce the possibility of inadvertently switching lines during assembly and connecting them.

  With reference to FIGS. 2 and 4A, the illustrative console connector 22 includes a connector housing 228 and a printed circuit board (PCB) 230 secured to the connector housing. The PCB 230 faces away from the housing 228 so that the electrical component mounting portion of the PCB can be placed in the connector housing 228 and the edge connector is exposed and thus can be generally accessible to connect to it. An extending edge connector 232 is included. In the illustrated embodiment, the connector housing 228 is secured with an adhesive or the like so that the first and second tube sections 12a, 12b fluidly connect the first and second tube sections. A tube connection opening 234 is defined. The tube connection opening 234 may partially define the supply passage 14 or the supply passage may be completely defined by the tube sections 12a, 12b. In one non-limiting example, a one-piece tube 12 that incorporates or replaces sections 12a and 12b so that the supply passage is completely defined by the tube and is not in fluid communication with any portion of the console connector 22. , Extending through the tube connection opening 234. The tube 12 may be fixed in the tube connection opening 234 with an adhesive or the like. The console connector may have other configurations and may be secured to the feeding tube assembly elsewhere.

  The conductor 24 extends from the first tube section 12 a into the connector housing 228 and is electrically connected to the PCB 230. Interface cable 242, or other signal transmission component, may be removably connectable to edge connector 232 to achieve communication and data exchange between console 23 and imaging assembly 18. As will be described in more detail below, an electronic memory component 243, such as an electrically erasable read only memory (EEPROM), is used to store information and / or data thereon and / or It may be mounted on the PCB 230 to allow access by the console 23, i.e. the microprocessor 254 of the console 23, or another external device. The PCB 230 may have additional or different electrical components mounted thereon, or the PCB may be omitted so that electrical conductors are operably connected to the PCB 230.

  In another embodiment, a console connector may be formed on or secured to the inlet adapter. Referring to FIG. 4B, in one embodiment of the present invention, the housing 228 'of the console connector 22' is integrally formed with the inlet adapter 16 '. Console connector housing 228 'extends laterally outwardly from outlet port 34' of inlet adapter 16 '. As in previous embodiments, the current console connector 22 'optionally includes a PCB 230' along with an edge connector 232 'for use in communicatively connecting the imaging assembly with the console. Electronic memory components, such as an EEPROM (not shown), may be mounted on the PCB 230 'as disclosed above and described in further detail below. The feeding tube assembly may include different types of connections for connecting the imaging assembly 18 to the console 23.

  Referring to FIG. 3, the illustrated interface cable 242 includes first and second interface connectors 244, 246 on opposite longitudinal ends of the cable. The first interface connector 244 is releasably engageable with and electrically connectable to the edge connector 232, the second interface connector 246 is releasably engageable with the console 23, and It can be electrically connected to it. One or both of the interface connectors 244, 246 may be prominent or non-universal connectors that only mate and connect with respective connectors associated with the feeding tube assembly 10 and the console 23. Also, the edge connector 232, or other connector, may be disposed in a socket having a shape that selectively and differentially mates with a corresponding, for example, complementary, first interface connector 244. . The socket and first interface connector 244 may include an engagement structure such as a rib or other component that provides a friction fit between the connector and the socket to prevent accidental disconnection. The connection between the interface cable 242 and the console connector 22 may have other configurations without departing from the scope of the present invention.

Still referring to FIG. 3, the interface cable 242 includes buttons 248, etc. to allow the user to record a still image of the real-time video displayed on the console 23, for example, to take a snapshot. A control device may be included. Activating the button 248 or other control device sends a signal to the console 23 that instructs the console to record image information, eg, a still image, along with associated temporal information. In one embodiment, the control device 248 can be proximate to or on the first interface connector 244, for example, the control device is closer to the first interface connector than the second interface connector 246. possible. In one or more exemplary embodiments of the invention, the control device can be provided on the first interface connector or within 12 inches of the first interface connector. The console 23 also allows the user to take and record a snapshot image using the console, optionally stored in a memory structure, and may include auxiliary information such as date and time. It may include snapshot control functions, such as icons, buttons, or activation devices. In some situations or embodiments, it is envisioned that during insertion of the feeding tube assembly 10 into a patient, the console 23 may be located at a distance that is beyond the reach of a user, such as a physician. Thus, although an image, eg, a video, may be visible on the console 23, the user can manually access the console to perform additional actions or functions on the console during insertion of the feeding tube assembly 10. May not arrive. Thus, by providing a control device 248 on the interface cable 242, and more specifically, by providing a control device adjacent to the first interface connector 244, the user does not need to reach the console 23. , Snapshot images can be taken and recorded. It will be appreciated that the interface cable 242 may have other configurations without departing from the scope of the present invention.

As shown in FIG. 3, the illustrated console 23 includes a console housing 250, a console display 252 such as an LCD or other electronic display that is secured to the housing, and a micro that is disposed within the housing. A processor 254. In the illustrated embodiment, the microprocessor 254 communicates with the imaging assembly 18 through the interface cable 242 and the conductor 24. The microprocessor 254 can be configured to receive an imaging signal or video signal transmitted by the imaging assembly 18 and display a real-time image associated with the imaging signal on a display. As disclosed in further detail below, the microprocessor 254 can optionally be configured to display a graphical user interface on the console display 252 or a different display. The console 23 can include one or more user input devices to allow a user or operator to communicate with the microprocessor 254 and perform various operations using the console 23. Display 252 may be a touch screen such as a touch screen LCD or other type of display that also functions as a user input device. In one embodiment, the touch screen allows the image to be scaled up or down by touching the screen with two fingers and releasing it to zoom in or pulling it down to reduce the image size. Other user input devices such as a mouse, keyboard, joystick, or other user input device may be provided in addition to or instead of the touch screen display 252 . Some other devices may include, but are not limited to, the ability to accept and act on voice commands or clinician gestures. These latter input devices have the advantage of not requiring that the console can be touched. Other auxiliary components may be utilized with the console 23, including but not limited to a power supply subsystem and a serial bus.

  Referring to FIG. 4A as disclosed above, the console connector 22 on the feeding tube assembly 10 is accessible by the console 23 or other internal or external device associated with the feeding tube assembly, such as an enteral feeding pump. An electronic memory component 243, such as an EEPROM, for storing and / or writing data thereon may be included. One or more of the following types of information may be provided on or written to the electronic memory component in one or more embodiments of the invention.

  In one non-limiting example, data regarding the feeding tube assembly 10 may be written, stored, or otherwise incorporated into the electronic memory component 243. For example, data indicating a lot code and / or item code, such as a serial number, may be written into the electronic memory component 243 and collected by the console 23 as a predetermined identifier. A proprietary verification code is also included in the electronic memory component 243 to provide the console 23 with information that can facilitate verification that the feeding tube assembly 10 is an effective feeding tube used with the console. Also good. The console 23 verifies that the feeding tube assembly is an acceptable, proper, unexpired or compatible feeding tube assembly, for example, before allowing operation or additional operations. As such, it may be configured, for example, by executing instructions. Without proper verification, for example, if the feeding tube assembly 10 does not have valid information, such as an acceptable code or an acceptable predetermined identifier, the console 23 will display an image on the console. You may stop. Further, data indicating whether the feeding tube assembly 10 has been sterilized may be written to the electronic memory component 243. Other information regarding the feeding tube assembly 10 may also be written into the electronic memory component 243 or otherwise incorporated. Thus, the electronic memory component may serve as a verification assembly or key that provides one or more predetermined identification information, eg, a predetermined identifier, that can be utilized by the console before or during its operation. Good.

  In another non-limiting example, data indicating the time for the feeding tube assembly 10, ie, a time stamp, may be written to the electronic memory component 243. For example, the date of manufacture of the feeding tube assembly 10 may be written into the electronic memory component 243. When the feeding tube assembly 10 is connected to the console 23 by an interface cable 242 or the like, the console may read data indicating the date of manufacture. In one non-limiting example, the console 23 may use the date of manufacture to determine if the feeding tube assembly 10 has exceeded its shelf life. If the feeding tube assembly 10 has exceeded its prescribed shelf life, the console 23 will trigger an alarm, communicate a message indicating that the shelf life has been exceeded, and prevent viewing of the image from the imaging assembly 18. May be configured to execute programmed instructions that perform at least one of the following: In another example, upon connection of the feeding tube assembly 10 with the console 23, the console may be programmed to write the service start date or first use date of the electronic memory component 243. This start date may be used as a reference to determine that the predetermined service life of the feeding tube assembly 10 has been exceeded or is about to expire. For example, after writing the start date to the electronic memory component 243, the console 23 determines the usage duration or life of the feeding tube assembly and compares the elapsed usage duration to the expiration date (and time) It may be configured to determine whether the remaining service life or life of the feeding tube assembly, usage time, or both have expired or have expired. Other variations may include determining periodically, continuously, or continuously whether the current date or date of use exceeds the expiration date. If the console 23 determines that the service life of the feeding tube assembly 10 has expired, the console will trigger an alarm and a message indicating that the service life has expired is transmitted. It may be programmed to do at least one of making a record and preventing viewing of the image from the imaging assembly 18. The accumulated usage time may be determined by writing a time stamp to the electronic memory component 243 to determine the actual number of usage hours.

  The console 23 may be configured to write other information to the electronic memory component 243. For example, the console 23 may allow other devices such as other consoles and enteral feeding pumps to read the electronic memory component 243 and determine which console was used with the selected feeding tube assembly 10. May be programmed to write a serial number or other identifier associated with the console. In another non-limiting example, the console may include, for example, the subject's, eg, the patient's name, the subject's identification code, the type of enteral product delivered to the patient, and the patient's supply schedule, supply duration Patient specific information may be configured to be written to the electronic memory component 243, including but not limited to other information about the patient, including but not limited to time, related supply settings, or other historical information. Patient information may be written to the electronic memory component 243 before the feeding tube assembly 10 is connected to the console 23, and the console may be programmed to read patient information. Alternatively, the user may use the console 23 to write patient information to the electronic memory component 243. Patient information may be encrypted to ensure patient confidentiality.

  In yet another non-limiting example, a placement confirmation timestamp or some other confirmation identifier is stored in the electronic memory component 243 to indicate that the proper placement of the feeding tube assembly 10 in the patient has been confirmed. May be written. The console 23 may be configured to write a time stamp to the electronic memory component 243 when the user indicates to the console that the feeding tube assembly is properly positioned. For example, the user may press a button or perform some other action to confirm proper placement. In addition to a time stamp or other confirmation identifier, a user name or other user identification can be written to the electronic memory component 243.

  Figures 19-31 illustrate one or more features relating to an exemplary graphical user interface of the console. One or more of the features described herein may be incorporated into various embodiments of the invention. FIG. 19 is a flowchart illustrating the operation of the graphical user interface when the console 23 is powered for the very first time or when the console is activated after a period of non-use by a given user. The predetermined period of non-use can be one month, six months, or one year. Another trigger condition that can affect the initial start may be a loss of power.

  As shown, the user interface screen prompts the user to indicate whether the user is the very first user of the console 23 (“initial user”) or whether the user is already associated with the console. If the user is an initial user, the console 23 provides an initial user administrator status along with associated privileges to access all or specified features of the console. Accordingly, at 302, the initial user is prompted to select the language (labeled “Language”) displayed on the user interface screen that communicates with the user. At 304, the initial user is prompted to enter the current date and time, and optionally specify a format for displaying the time (labeled "Date / Time"). At 306, the initial user is optionally prompted to enter time tracking options for display by the user interface. The initial user tracks and displays the current time being tracked and displayed by the console 23, for example, the amount of time elapsed for the current procedure being performed by the feeding tube assembly 10 when patient data is entered. One of the options can be selected such that both the current time and the amount of elapsed time of the current procedure being performed are tracked and displayed by the console. At 308, the initial user is optionally prompted to set up an administrator account by entering a username and password.

  If the user indicates that the user is not the very first user of console 23, the console presents a login user interface screen to the user at 310. The user enters a user name and password. If the user enters a valid username and password associated with it, the user is logged in. If the console 23 determines that the username and password are not valid, the console presents the user with a login retry, i.e. a message or another opportunity to log in. In one embodiment, after a predetermined number of login attempts, the console 23 may be reset, all patient data, user data, and device data may be deleted, locked, or otherwise It becomes inaccessible. If the user has successfully logged in, at 312, the user is presented with a primary selection user interface screen. The primary selection user interface screen can present the user with one or more of navigation options such as utility functions, procedure screens, file functions, and logout. Navigation options may be presented via text and / or graphic icons. In addition, a portion of the main selection user interface screen (labeled “Preview Video” or represented schematically, for example, as a movie reel icon) is displayed when the main selection user interface screen is being accessed. When video data is being received from the imaging assembly 18, it is dedicated to providing video data to the user. As will be described below, this generally occurs when the user selects the primary selection user interface screen after initiating the procedure.

  In one embodiment, console 23 is configured to recognize multiple classes or positions of users and to limit operations that may be performed by the console as a function of the class associated with each user. . For example, the console 23 may be configured to recognize four user classes, such as an operator, an administrator, an approver, and a maintainer. The console 23 may be configured to give an operator class user authority to view video data received from the imaging assembly 18. Console 23 is configured to create a user account or other operator account with each associated data storage infrastructure and to authorize an administrator class user to view video data received from imaging assembly 18. can do. The console 23 provides authority to an approver class user to view video data or imaging data received from the imaging assembly 18 and annotate approval data on the video data or imaging data received from the imaging assembly. Configured. The console 23 can be configured to give the user maintenance class authority to perform maintenance functions such as software updates. However, the console 23 only gives the user's maintenance class authority to operate the console when the console does not store any patient data, for example, the maintenance user gives authority to operate the console. Patient data must be deleted from the console before it can be done.

  When the user selects a practical function from the main selection user interface screen, the practical function user interface screen can be presented to the user. The options presented to the user on the utility function user interface screen are typically based on the class or status associated with the user. When the user is an operator or approval, the practical function user interface screen can be presented to the user. The console can then provide the user with a “language” option and the “preview video” feature discussed above. The utility user interface screen also gives the user a “user manager” option that allows the user to navigate to the user manager navigation user interface screen that allows the user to change their password. It can also be provided. If the user is an administrator, the practical function user interface screen presented to the user will have the “language”, “date / time”, “time display”, and “preview video” options discussed above. . A “user manager” option may also be provided that allows the user to navigate to a user manager user interface screen. A user manager user interface for administrators allows an administrator to add users via the user interface. Practical function user interface screens presented to the administrator can also reset the console, eg, delete or delete patient data, user data, and device data, eg, delete patient data and device data You may also have an option labeled “Reset / Clear Console” to do and an option to perform a software update labeled “SW Update”. In addition to the options presented to the administrator user, the utility function user interface screen presented to the maintainer user additionally provides an option to perform the maintainer function (labeled “maintenance function”) for the maintainer user. I will provide a. For example, the “maintenance person function” may include a software debugging function.

  Referring back to the main selection user interface screen, if the user selects the “procedure screen” option, the patient information user interface screen is displayed to the user via the console 23. The patient information user interface screen prompts the user to enter the name and identification of the patient on whom the procedure is being performed. If the user enters the patient's name and identification, the main user interface screen of the procedure is displayed to the user and the console 23 is removed from the imaging assembly 18 of the feeding tube assembly 10 as long as the feeding tube assembly 10 is properly connected to the console. Start receiving video data. If the user does not enter the patient name and identification, for example, if the patient name and patient ID fields are left blank, the user is presented with a blank patient information user interface screen. The blank patient information user interface screen allows the user to proceed without entering patient information or to enter patient information. If the user chooses to enter patient information, the user can be redirected to a patient information user interface screen. If the user chooses to proceed without entering patient information, the console 23 will image the feeding tube assembly as long as the main user interface screen of the procedure is displayed to the user and the feeding tube assembly 10 is properly connected to the console. Begin receiving video data from assembly 18. If the feeding tube assembly 10 is not connected or is incorrectly connected to the console, the user is presented with an error message.

  In one embodiment, patient information may be manually entered by a user. In another embodiment, the console 23 may include a barcode scanner (not shown) for scanning the patient's barcode wristband to obtain patient information. In yet another embodiment, patient information may be provided on the electronic memory component 243. After communicatively connecting the feeding tube assembly 10 to the console 23, the console may read and record patient information from the electronic memory component 243. This embodiment provides a patient verification to ensure that the correct medical procedure, eg enteral nutrition, is provided to the correct patient, and / or a bar code scanner embodiment and / or a manual input implementation. It may be combined with the form.

As illustrated in FIGS. 20 and 21, an alternative procedure primary user interface screen may display video data or rendered or processed imaging data being received by console 23 from imaging assembly 18. . The main user interface screen of the procedure also displays at 350 the current time when selected by the user, and displays the patient name and identification number when entered by the user at 352 and 354, respectively. Then, at 356, any of the elapsed time for the current procedure when selected by the user can be performed. The time elapsed for the current procedure begins when the user enters the patient name and identification or chooses to proceed without entering the patient name and identification. The main user interface screen of the procedure also includes an option to take a snapshot at 358, eg, an icon or button with text. Snapshot option 358 allows the user to select to store the current frame of video data or rendered imaging data collected by the console from imaging assembly 18. Identifying information about the snapshot may be provided and / or entered automatically by the user on the console for subsequent identification of the snapshot. As discussed above, interface cable 242 may include a control device 248 that may be provided in addition to or instead of snapshot option 358 on console 23. At 360, the procedure's primary user interface screen allows the user to access a function option (labeled “File Function” or illustrated as a folder icon) that allows the user to access files stored by the console. To provide. The “File Function” option may also be accessed directly from the main selection user interface screen. For example, selecting the “File Function” option from either the main user interface screen of the procedure of FIGS. 20 and 21 or the main selection user interface screen directs the user to the file function user interface screen.

  The file function user interface screen presents the user with a list of directories stored on the console and includes the “Preview Video” feature discussed above. Each directory represents video data or rendered imaging data stored in association with one particular feeding tube assembly 10. In one embodiment, the console 23 can read a serial number or other unique identifier from the console connector 22. The serial number or other identifier may be unique to the feeding tube assembly 10 to distinguish it from all other feeding tube assemblies. In the illustrated embodiment, the console connector 22 includes an electronic memory component 243 that stores the identifier of the feeding tube assembly 10. All of the data received from the feeding tube assembly 10 with a specific serial number or other identifier can be stored under a single directory in the console 23. Data received from the feeding tube assembly 10 with different serial numbers or other identifiers can be stored under different directories.

  The user may select a directory for viewing and / or editing from the file function user interface screen. When a directory is selected from the file function user interface screen, the user is directed to the file function directory selection user interface screen (alternative embodiment illustrated in FIGS. 22 and 23). This user interface presents a list of files, eg, image files, associated with the selected directory. The image file represents an image selected by the user via the snapshot option. The user selects at least one file from the image directory, exports the file via the “Export” option 380, renames the file via the “Rename” option 382, and the “Delete” option. The file can be deleted via 384 and the file can be annotated or displayed via the “Annotate / Display” option 386.

  If the user selects the “Export” option 380 from the file function user interface screen, a raw / JPEG user interface screen (alternative embodiment illustrated in FIGS. 24 and 25) is displayed. The user interface presents a list of files associated with the previously selected directory and allows the user to select one or more files. The user interface allows the user to specify a particular console universal serial bus (USB) port at 390 through which the selected file is exported. Any suitable number of buses may be provided. In one embodiment, two stacked buses are provided. In another embodiment, the console 23 may additionally or alternatively export the selected file wirelessly to a receiving device and / or receive the selected file via an Ethernet connection. It may be configured to export to a device. At 392, the user is also presented with an option at 392 to delete the selected file from the console once the selected file has been exported. At 394 and 396, respectively, the user is prompted to select whether to export the file as an uncompressed file, eg, a raw file, or to export the file as a compressed file, eg, a JPEG file.

If the user selects the “Rename” option 382 from the file function user interface screen, the user is presented with a rename user interface screen to allow the user to rename the file. . In one embodiment, the default format of the file is DATE_SUD-SN_PT-NAME_PTID_TIME_SEQ #. img, where
DATE = current date (eg, date) set on the console via the “Date / Time” feature
SUD-SN = Serial number of disposable device (for example, identifier taken out by console 23 from console connector 22)
PT-NAME = patient name as entered by the user via patient information user interface screen PT-ID = patient identifier as entered by the user via patient information user interface screen TIME = “Date / Time” feature The current time set on the console via (for example, hour, minute, second)
SEQ # = image number as received from the imaging assembly, the first image transmitted from the imaging assembly has an image number of 1, and the image number of each image subsequently received is 1 Incremented.

  In one embodiment, the “rename” option 382 allows the user to change only the SEQ # portion of the file name.

  If the user selects the “Delete” option 384 from the file function user interface screen, a user interface screen to delete is presented to the user to allow the user to delete the file. The user interface screen to delete can provide the user with a list of files contained in a previously selected directory. The user can select one or more files from the directory and then select an option to delete, eg, a delete button or icon. When the user selects the delete option from the delete user interface screen, the user is prompted via the delete confirmation user interface screen to confirm that the selected file should be deleted from the console. Once the user confirms that the selected file should be deleted, the selected file is deleted from the console.

  If the user selects the “Annotate / Display” option 386 from the file function user interface screen, a user interface screen to display is displayed, as shown in the alternative embodiment of FIGS. The displayed user interface screen can display the image stored in the selected file. The displayed user interface screen may also provide the user with an “annotate” option at 400 and a “compare to video” option at 402. If the user selects the “compare to video” option at 402, the console 23 presents the user interface screen to be compared to the user (alternative embodiment illustrated in FIGS. 28 and 29). The first portion 404 of the user interface screen to compare displays the image stored in the selected file. A second portion 406 of the user interface screen to compare may display video data or rendered imaging data that is currently received by the console from the imaging assembly 18. Images on both the first and second portions 404, 406 can be zoomed or panned in one embodiment. By comparing a previously captured image illustrating the previous tube placement within the patient body with current video data illustrating the current tube placement within the patient body, the user can determine whether the tube has moved within the patient body. Can decide. In addition, or alternatively, the user can display an image of a previously placed tube that represents the current tube placement so as to facilitate an assessment of whether the tube is currently considered properly placed. Can be compared with information. While the first portion 404 and the second portion 406 of the user interface screen to be compared are shown as being horizontally aligned, the first and second portions 404 and 406 may alternatively be relative to each other. It should be noted that, for example, it may be arranged vertically and may be modified by the user, for example, aligned vertically and without departing from the scope of the present invention.

  The user interface screen to compare provides the user with an “annotate” option at 408 and a “procedure screen” option at 410. If the user selects the “Procedure Screen” option 410, the console redirects the user to the patient information user interface screen described above. If the user selects the “Annotate” option 408 from the comparing user interface screen (FIGS. 28 and 29) or the “Annotate” option 400 from the displaying user interface screen (FIGS. 26 and 27), the console Annotated user interface screens are presented to the user, illustrated in the alternative embodiment of FIGS. The annotating user interface screen includes a “text” option at 420, a “line” option at 422, an “approval” option at 424, an “undo” option at 426, and an “undo all” option at 428. To present.

If the user selects the “text” option 420 , the annotating user interface screen is where the user touches, for example, the portion of the image displayed on the annotating user interface screen where the user wants to place the center of the text. Allows to show by clicking or clicking. After receiving user input indicating the location of the text, the annotating user interface screen displays additional options to the user. Specifically, the annotating user interface screen provides the user with an option to select text that names the anatomical structure from a text list of the anatomical structure. The annotating user interface also provides the user with an option to add free text to the image. If the user selects text that names the anatomy from the text list, the selected text appears on the screen centered on the user selected text location. If the user chooses to add free text to the image, the annotating user interface screen adds a keyboard to the annotating user interface screen and allows the user to enter text accordingly. If the keyboard on the user interface screen to be annotated covers the text location selected by the user, the text entered by the user is moved upward until the user finishes entering the text. Once the text entry is complete, the entered text can be displayed on a screen centered on the text location selected by the user.

  When the user selects the “Line” option 422, the annotating user interface screen displays the portion of the image displayed on the annotating user interface screen where the user wants to place the first end of the line segment. Allowing the user to indicate, for example, by touching or clicking. The user may then indicate where the second end of the line segment should be located on the annotating user interface screen, eg, via a drag and drop operation. If the “Undo” option 426 is selected, the last unsaved annotated item, eg, text, line segment, is removed from the image. This operation can be repeated until there are no unsaved items remaining in the image. If the “Undo All” option 428 is selected, all unsaved annotated items are removed from the image.

If the user selects the “Approve” option 424, the user can be redirected to the approver user interface screen. The approver user interface screen prompts the user to enter his user name and password. Once the username and password are entered, the console attempts to authenticate the user as being associated with the approver status. If the user is authenticated, a message such as “Approved by USERNAME to DATE TIME” is added to the image at the top left of the image, eg under patient identification information, where:
USERNAME = user name of current user as entered on approver user interface screen DATE = current date (eg, date) set in console via “Date / Time” feature
TIME = current time set on the console via the “Date / Time” feature (eg, hour, minute, second)
It is.

  Once the approver user indicates to approve tube placement, the patient is allowed to be provided with nutrients via the feeding tube assembly 10. For example, the console may be configured to provide a signal that enables operation of the nutrient pump.

  The execution or performance of operations in the embodiments of the invention illustrated and described herein is not required unless otherwise specified. That is, unless otherwise specified, operations may be performed in any order, and embodiments of the invention may include additional or fewer operations than those disclosed herein. For example, it is contemplated that performing or performing a particular operation before, simultaneously with, or after another operation is within the scope of aspects of the invention.

  Embodiments of the invention may be implemented using computer-executable instructions. Computer-executable instructions may be organized into one or more computer-executable components or modules. Aspects of the invention may be implemented using any number and organization of such components or modules. For example, aspects of the invention are not limited to the specific computer-executable instructions or the specific components or modules illustrated in the figures and described herein. Other embodiments of the invention may include different computer-executable instructions or components that have more or less functionality than shown and described herein.

  Referring to FIGS. 32A-42, another embodiment of an imaging feeding tube assembly is generally designated 510. This embodiment is similar to the various embodiments disclosed above, and similar components are indicated by corresponding reference numerals plus 500. Referring to FIGS. 32A and 32B, an imaging feeding tube assembly 510 includes a feeding tube 512, an inlet adapter generally indicated at 516 adjacent the second longitudinal end of the tube, ie, the proximal end, and the tube An imaging assembly, generally designated 518, adjacent to the first longitudinal end, ie, the distal end, and a console connector, generally designated 522, secured to the tube midway between the inlet adapter 516 and the imaging assembly 518; including. Imaging feeding tube assembly 510 may be used with console 23 or a different console or display to display one or more images generated by imaging assembly 518 as disclosed above. The inlet adapter 516 is similar to the inlet adapter 16 and, therefore, reference is made to the previous inlet adapter for a description of the various features of the inlet adapter 516. Unless otherwise specified below, the disclosure relating to the components of the previous feeding tube assembly embodiment 10 described hereinabove also applies to the current feeding tube assembly embodiment 512 components. To do.

  Tube 512 can be a one-piece tube. Referring to FIG. 33, a conductor 524 (in a broad sense, a signal transmission component) extends longitudinally from the imaging assembly 518 to the console connector 522 substantially along the entire length of the tube 512. In the illustrated embodiment, there are six electrical cables 524 for powering the imaging assembly 518 and transmitting data between the console, eg, the console 23 and the imaging assembly, but depart from the scope of the present invention. There may be more or fewer cables without. In the illustrated embodiment, cable 524 is disposed in three separate distinct conductor paths 526. Cables 524 are provided in pairs, each pair being disposed within the same conductor passage 526 in the tube wall. In one example, cable 524 and tube 512 may be co-extruded so that the cable is embedded in the tube wall. After coextrusion, the cables 524 are laser ablated to remove the respective jackets and / or expose the wires so that the cables can be electrically connected to the imaging assembly 518 and the console connector 522. It may be peeled mechanically.

  Referring to FIGS. 34-37, an imaging assembly 518 is shown generally at 560 (FIG. 35), which includes an elongated housing 550 and a camera 584 and a light source 596 mounted thereon and received within the housing. And a cap 570 that is attached to the camera at the first longitudinal end of the imaging assembly, eg, the distal end. In this embodiment, the flex circuit 580 of the flex circuit assembly 560 can be a rigid flexible circuit that includes one or more spaced rigid structures 561 mounted on the flex circuit that prevent bending. Electrical components, such as those described above with respect to previous embodiments, are mounted on rigid structure 561. The rigid flexible circuit 560 is bent between the rigid structures 561 so that the rigid flexible circuit can be selectively deformed only at the bent locations 581 along the length of the folded rigid flexible circuit. Can be bent. The light source 596 and camera 584 are mounted on the same distal camera mounting portion 582 of the rigid flexible circuit 560 that extends generally perpendicular to the longitudinal axis of the imaging assembly 518. In the illustrated embodiment, the camera mounting portion 582 can have one of the rigid structures 561 mounted thereon to which the camera 584 and the light source 596 can be secured.

  The electrical components for operating the imaging assembly 518 may be similar or the same as the electrical components disclosed above for operating previous embodiments of the imaging assembly 18. In addition to these electrical components, the rigid flexible circuit 560 includes a decoupling capacitor, generally indicated at 598, for providing a stable supply voltage with low noise to the camera 84. In the illustrated embodiment, the decoupling capacitor 598 is embedded in the camera mounting portion 582 of the rigid flexible circuit 560 between the layers. In this way, decoupling capacitor 598 is directly adjacent to camera 584.

Referring to FIGS. 40 and 42, the cavity in cap 570 is typically sized to accept only camera 584 without camera and light source 596 as in the previous embodiment. The cap 570 may be similar to the cap 70 except that it is molded. In addition, referring to FIG. 40, the cap 570 includes a plurality of radial locking ribs 589 that are received in corresponding radial locking grooves 600 formed on the inner surface of the housing 550. Engagement between the locking rib 589 and the locking groove 600 prevents longitudinal movement between the housing 550 and the cap 570. The cap 570 may have other configurations without departing from the scope of the present invention.

In one non-limiting example (FIG. 40), the housing 550 may be molded with longitudinally spaced reinforcing structures 591, ie, wall portions of the housing 550 with increased thickness and reinforcement. Bending locations 593 disposed between the structures, which may include locations with a wall thickness of the housing 550 that is less than the thickness of the structure 591. While the reinforcing structure 591 is typically disposed between the electronic components on the rigid flexible circuit 580 and the rigid structure, the bend location 593 is typically at the bend location on the rigid flexible circuit. Adjacent to each other. Through this configuration, the housing 550 further promotes bending of the imaging assembly 518 at selected locations along its length and prevents bending at the longitudinal location where the electronic components are located. The difference in wall thickness of housing 550 with respect to structure 591 and location 593 can be less than about 25%, less than about 10%, or less than about 5%.

  In another non-limiting example (FIG. 41), the housing 550 may be molded over the cap 570, the rigid flexible circuit assembly 560, and the imaging assembly connector 520 to form an integral imaging assembly 518. . For example, the cap 570, the rigid flexible circuit assembly 560, and the imaging assembly connector 520 may be placed in fixation during the outer covering process, and the housing 550 may then be molded over the components. The material for the outer coating may include urethane or other materials. In yet another embodiment, the housing 550 may be pre-formed and the cap 570 and imaging assembly connector 520 are secured to respective ends of the housing, such as by solvent bonding or other suitable method. May be.

  Referring to FIGS. 32A, 32B, 38, and 39, like the previous feeding tube assembly 10, the current feeding tube assembly 510 includes an imaging assembly connector, generally indicated at 520. FIG. As in previous embodiments of the imaging assembly connector 20, the current imaging assembly connector 520 defines a supply passage outlet 540 that is in fluid communication with the supply passage 514 of the tube 512. In the illustrated embodiment, the first longitudinal end of tube 512 is received and secured within supply passage outlet 540 of imaging assembly connector 520 to provide fluid communication therebetween. The outlet 540 is closed adjacent to prevent liquid nutrients from entering the imaging assembly 518. Accordingly, the imaging assembly 518 is not in fluid communication with the supply passage 514. Instead, nutrient solution is dispensed laterally from the outlet 540 to the patient (only one such side opening is shown in FIGS. 32 and 38).

  Referring to FIGS. 38 and 39, the first longitudinal end, eg, the distal end, of the imaging assembly connector 520 defines an alignment slot 521 for receiving the proximal end of the rigid flexible circuit assembly 560. The alignment slot 521 facilitates proper placement of the rigid flexible circuit assembly 560 relative to the imaging assembly connector 520. The imaging assembly connector 520 may have other configurations without departing from the scope of the present invention.

  Referring to FIG. 42, the console connector 522 can be secured to the feeding tube 512 and can extend laterally outward therefrom. The illustrated console connector 522 includes a housing 728, a PCB 730, an inlet adapter connector 800, and a feeding tube connector 802 secured to the housing. A connector, such as a USB port connector 532, may be placed on the PCB 730 to communicatively connect the interface cable to the PCB 730. In another embodiment, the PCB 730 may include an edge connector as disclosed above with respect to previous embodiments. The electronic memory component 743 may be mounted on the PCB 730. The housing 728 can define a socket 736 having a size and shape for matingly receiving an interface connector (not shown) having a corresponding size and shape. The connector cap 737 can be anchored to the housing 728 to selectively close the socket 736 when not in use.

  Housing 728 may be molded over inlet adapter connector 800 and feeding tube connector 802 to secure the connector to the housing. The proximal end of the feeding tube 12 is secured within a connection passage 804 in the feeding tube connector 802. The inlet adapter connector 800 connects the inlet adapter 516 to the console connector 522 and defines a passage 806 that fluidly connects the inlet adapter 516 to the feeding tube 512. In another embodiment (not shown), the one-part feeding tube 512 may pass through an opening in the console connector 522 and connect directly to the inlet adapter 516. The housing 728 may be secured to the feeding tube 512 using an adhesive or otherwise. The housing 728 may be secured to the inlet adapter 516, more specifically to the distal end of the inlet adapter, such that the housing is adjacent to the inlet adapter. The console connector 522 may have other configurations without departing from the scope of the present invention.

  Referring to FIG. 43, another embodiment of an interface cable for connecting the feeding tube assemblies 10, 510 to the console 23 is shown at 742. The interface cable 742 is similar to the interface cable 242 of the previous embodiment. As with the previous interface-capable embodiment 242, the interface cable 742 can include first and second interface connectors 744, 746 on opposite ends of the cable. The illustrated first interface connector 744 mates with the socket 736 of the console connector 522, for example, to be selectively inserted therein, and to the USB port connector 532, or an edge connector or another associated with the console connector. Sized and shaped to connect with the connector. The first interface connector 744 engages the inner surface of the socket 736 to prevent fluid ingress into the socket and forms a substantially liquid tight seal therewith, an annular rib or bead 770. including. The second interface connector 746 is sized and shaped to mate with a corresponding socket on the console 23, for example, to be selectively inserted therein and to connect with the console. The first and second interface connectors 744, 746 and the corresponding socket 736 are such that the first interface connector 744 is not matable with the socket on the console 23, and the second interface connector 746 is not connected to the socket 736 of the console connector 522. It can be configured so that it is not meshable. The interface cable 742 may have other configurations without departing from the scope of the present invention.

In the illustrated embodiment, the first interface connector 744 provides an imaging signal buffer component 750, eg, I ² C, that drives an imaging signal, eg, an I ² C signal, between the imaging assemblies 18, 518 and the console. A buffer component can be included. By installing the imaging signal buffer component 750 in the first interface connector 744, the capacitance is increased within the feeding tube assembly 10, 510, such as conductors 24, 524, such as wires in cables, The interface cable 742 is divided approximately equally between conductors such as wires. This configuration minimizes or reduces the capacitance in any one section of the system and maximizes or improves the image signal strength. Also, since the console connectors 22, 522 can only be engaged with the first interface connector, not the second interface connector 746, the first interface connector 744 and the imaging signal buffer component 750 are preferably nutritional. Adjacent to the tube assembly 10,510. The interface cable 742 may not include the imaging signal buffer component 750 and may have other configurations without departing from the scope of the present invention.

  One or more aspects of the invention can involve a catheter, which can be a feeding tube having an imaging assembly with an imaging device or sensor. The imaging assembly can generate and transmit imaging signals generated by the imaging device. The system can include a console adapted to receive an imaging signal and present an image corresponding to the imaging signal on a display. In addition, the console can optionally be configured to present a reference menu including menu items on the display. The menu items correspond to reference material comprising any one or more of photos, video recordings, audio recordings, schematics, animations, and text. Materials include anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter features, console preparation, console operation, console features, system operation, system features, contact information, help information, and support information Provide information about any one or more of them. One or more aspects of the present invention include an inlet connectable to a nutrient fluid source, an outlet distal to the inlet and connected to flow therethrough through a supply passage, and disposed proximate to the outlet. An imaging device having an imaging device configured to generate and transmit an imaging signal corresponding to an image of a patient's anatomy, a display, video, audio, photographs, etc. And a console having a plurality of reference materials stored therein selected from the group consisting of audiovisual data, textual data such as schematics, videos, and text, and combinations thereof The imaging catheter system can be targeted. In some cases, each of the plurality of reference materials includes anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter feature, console preparation, console operation, console feature, system operation, system feature, and Information regarding at least one of the contact information may be provided. Preferably, the console receives the imaging signal, presents on the display at least a portion of at least one image corresponding to the imaging signal, and includes a menu item corresponding to at least one of the reference materials Is configured to be presented on the display. At least one of the plurality of reference materials can include a photograph showing anatomical landmarks. The anatomical landmark can be one of bronchi, larynx, tracheal ring, cardia, pyloric sphincter or pylorus, cricoid cartilage, bronchial bifurcation, esophageal junction, gastrostomy, duodenal fistula, and pyloric ostium.

  One or more further aspects of the present invention can be directed to methods of facilitating or providing use of a feeding tube assembly. The method includes an inlet connectable to a nutrient fluid source, an outlet distally from the inlet and fluidly connected thereto through a supply passage, and an imaging device disposed proximate to the outlet. Providing a feeding tube, wherein the imaging device is configured to generate and transmit an imaging signal corresponding to an image of the patient's anatomy, a display, and stored therein Providing a console comprising a memory having a plurality of reference materials selected from the group consisting of: photographs, video recordings, audio recordings, schematics, animations, text, and combinations thereof. it can. According to some specific embodiments, each of the reference materials is anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter feature, console preparation, console operation, console feature, system operation, Information regarding at least one of system features and contact information may be provided. In some cases, the console receives an imaging signal, presents at least a portion of at least one image corresponding to the imaging signal on a display, and includes a menu item corresponding to at least one of the reference materials The menu can be configured to be presented on a display. In some cases, the console can be configured to simultaneously present on the display photos from multiple reference materials and video images corresponding to the image signals from the imaging assembly, Provide representative anatomical markers or landmarks. According to a further aspect of the invention, the method comprises the steps of storing additional reference material in the memory, removing at least one reference material from the memory, and replacing the memory with an updated memory. And the updated memory may include at least one of the following steps having at least one updated reference material stored therein. The method includes, according to another further case, receiving a console from a user, storing an additional reference material in memory after receiving the console, and removing at least one reference material from the memory. And replacing the memory with updated memory, the updated memory comprising at least one of the steps having at least one updated reference material stored therein Can do.

  With reference to FIG. 46, an imaging catheter system (in a broad sense, a medical system) is generally designated generally by the reference numeral 810. The system 810 generally includes an imaging catheter designated as 812 and a console 814 that is operatively coupled to the imaging catheter, for example, by an interface cable 816. The imaging catheter 812 can include an imaging assembly 820 having an imaging device 822 to generate an imaging signal corresponding to an object in its field of view. The imaging device is typically an optical sensor and can be a camera or an optical fiber. The imaging assembly may also include elements such as LEDs to illuminate the field of view or provide illumination. The imaging assembly can further comprise one or more components, such as a processor, a memory device, etc., to facilitate capture, conversion of the field of view image into the imaging signal, and transmission of the imaging signal. The imaging device generates an imaging signal and transmits it to the console 814 over cable 816 or wirelessly through any suitable communication technique or protocol. Other cables may be used without departing from the scope of the present invention.

  The console receives the imaging signal from the imaging assembly, converts it, and presents the image on a display 830 in the console housing 832. As exemplarily shown in FIG. 47, the console may also optionally include a power switch 834 for energizing the console. Other consoles may be used without departing from the scope of the present invention. The display preferably activates and presents one or more menus in response to one or more user inputs or commands, eg, a double tap on the display, resulting in multiple selections for operating the console and imaging assembly. To do. For example, one of the user inputs causes the display to present a reference menu as illustrated in FIG.

Selections or entries 840a, 840b , and 840c may be presented for selection and retrieval of stored images of previous procedures performed using the present system. As shown in FIG. 47, the console 814 selects the title “reference_library” from memory that invokes a reference menu that includes menu items corresponding to a library or reference materials stored in the console memory. 842 and can be configured to provide. For example, a library of reference materials, which may include one or more groups of reference materials, may include, for example, photographs, video records, audio records, schematics, animations, and / or text. Reference material includes anatomy, patient preparation, preparation for use of imaging catheter, placement of imaging catheter in patient, console preparation, console operation, console features, overall system behavior, overall system features, and / or Or provide any one or more of the information regarding contact information, such as address and / or telephone number, that can be used to access further help. Other selections or information that may be provided in the menu may be viewed by manipulating a scroll bar 844 positioned in proximity to selections 840a-840c and 842 on the display. In some embodiments, commands, instructions, and / or navigation icons such as back icon 850 and view icon 852 can be provided along the bottom of the display.

  In some embodiments (not shown), it is envisioned that the display 830 simultaneously presents a reference menu and an image generated from the imaging signal provided by the imaging device. In other embodiments (not shown), the display 830 presents a reference menu in response to sensing a unique input, such as when the user touches the display twice within a pre-selected time period. It is assumed that In yet another embodiment (not shown), it is envisioned that display 830 presents an icon that presents a reference menu when selected by the user. Alternatively, console 814 may include a button that can be pressed to cause display 830 to present a reference menu.

In some embodiments, the console may present an image generated from the imaging signal simultaneously with reference material such as those identified above. For example, as exemplarily illustrated in FIG. 29, a photograph of a typical anatomical feature or marker may be displayed on a portion of the display and is generated from the imaging signal transmitted by the imaging assembly Live video may be displayed on another part of the display. Thus, the user identifies where the imaging assembly is located in the patient by comparing the live video generated from the imaging signal transmitted by the imaging assembly with a reference photo containing anatomical features or anatomical landmarks can do. Further, as exemplarily shown in FIG. 31, one or more text references or reference materials such as photographs 864 provide identifying information or descriptions, such as the name of the target anatomical feature or anatomical marker. It may be presented on the display along with indicia 866. The anatomical marker can be any one of bronchi, larynx, tracheal ring, cardia, pyloric sphincter, and pyloric ostium. Visual reference material may be presented on only a portion of the display, or on the entire display, as will become more apparent from a comparison of FIGS. When only a portion of the display is used to present visual reference material, as shown in FIG. 29 , icons 420, 422, 424, 426, and 428 and one or more visual status identifiers 872a. Other indicators such as, 872b, and 872c may be shown on the display. Alternatively, as shown in FIG. 31, any one or more of icons 420, 422, 424, 426, and 428 as well as visual when the entire display is used to present visual reference material. Any one or more of the visual status identifiers 772a-872c may be presented on the visual reference material. In other cases, for example, the console is illustratively presented in a copy of a representative bronchial photograph, as illustratively presented in FIG. 49A, without any identifiers or indicia, FIG. 49B. As shown in FIG. 49C, a copy of a representative stomach photo with gastrostomy and, as illustratively presented, is operated by selecting a menu to display a copy of the photograph be able to.

  The reference material may also provide instructional guidance. For example, the console can be configured to be operated to display a schematic diagram that includes a comparison of exact and inaccurate paths, as shown in FIG. Further embodiments contemplate simultaneous presentation of the schematic diagram of FIG. 48 adjacent to real-time or live video images from the imaging device to provide further guidance during use.

  In some embodiments of the invention, the material may be located or stored in a directory having a name corresponding to a particular reference material. For example, a portion of the system operation manual may be stored in a directory titled “System_Operation_Manual”. In some embodiments, the reference material may be saved as a read-only file to ensure that the content remains unchanged. Alternatively, verbal comments, marginal notes, and other notes are entered into the reference material, with specific associations or links to any one or more of each of the reference materials in the reference library, or Instead, it may be stored as a new file.

  It is further envisioned that the reference material file may be modified when updating the software. Thus, each software release can also be used to update and improve reference material for the system. In other cases, the system used in the field may store additional reference information by the user with or without removing any stored or existing reference material, or part thereof. It can be sent to a maintenance, manufacturing, or repair facility that can be contained within. In other cases, a system received at a maintenance, manufacturing, or repair facility may be updated by replacing memory components therein, thereby providing updated reference material.

  Depending on the particular procedure in which the imaging catheter system is used, the system may also include a conventional feeding tube assembly having, for example, a feeding tube for delivering enteral feeding fluid to the patient. Generally, conventional feeding tubes include a supply passage that extends between an inlet and an outlet. An imaging catheter may be positioned adjacent to the outlet of the feeding tube to generate an imaging signal corresponding to a particular portion of the patient's gastrointestinal tract, eg, the patient's stomach. In some cases, it may be desirable to seal the imaging assembly from the feeding passage of the feeding tube and prevent enteral nutrient fluid in the feeding passage from entering the imaging assembly and causing potential damage. . In use, reference materials such as videos, photos, or schematics are periodically accessed on the display to verify proper placement of the medical device within the patient.

  One or more further aspects of the present invention are directed to a computer-readable medium accessible by a console and having a plurality of data structures corresponding to reference material in a reference library stored thereon. Each of the reference materials can be audiovisual information, including, for example, photographs, video files, audio files, and combinations thereof, and text or graphical information, including, for example, schematics, sketches, and text information it can. Reference material in a reference library in a computer readable medium includes information about at least one of an anatomical reference or feature or anatomical landmark, operating instructions of at least one of an imaging catheter, a console, a feeding tube, and a system Providing contact information regarding at least one of the feeding tube and the console. A still further aspect is to have multiple data structures including a reference library of reference material stored thereon, and to add an addition to an existing reference material, or an updated or revised reference material with it. By swapping, it can be directed to provide a computer readable medium that updates a reference library of reference material. Non-limiting examples of computer readable media include memory devices and can be optical and magnetic based media, both of which can be erasable, programmable, or permanent.

  None of the reference materials in the reference library include, but are not limited to, aiff, wav, xmf, fits, tiff, avi, asf, wma, wmv, 3gp, flv, f4v, iff, jpg, bmp, mpeg, mp4, rm, It can be stored in any format or file type, such as ogg, pdf, rtf, and txt, any of which can be in either native or compressed form. Any such reference material can be protected from field modifications or deletions by the health care provider, but can be modified, revised, or by a qualified technician, for example, at a repair or manufacturing facility or maintenance facility. Can be deleted.

  As described, the console may be configured to recognize multiple classes of users, i.e., status, and to limit the actions that can be performed by the console as a function of the class associated with each user. Good. For example, the console may be configured to recognize four user classes: operator, administrator, approver, and maintainer. Depending on the user class, the reference menu may be modified to adapt to the user's technology and needs. For example, the console can be configured to create a user account or other operator account with each associated data storage infrastructure and to authorize an administrator class user to view video data. The console may be configured to give an approver class user authority to view the video data and annotate the approval data on the video data. The console can be configured to give maintenance class users authority to perform maintenance functions on the console, such as software updates and time adjustments. The console can be programmed to give only the maintenance class user authority to operate the console if patient data is not stored on the console.

Having described aspects of the invention in detail, it will be apparent that modifications and variations are possible without departing from the scope of the invention as defined in the claims. Since various modifications can be made to the structure, product, and method described above without departing from the scope of the aspects of the invention, all matters contained in the above description and shown in the accompanying drawings are limited. It is intended to be interpreted as illustrative rather than in a meaningful sense. For example, simultaneous display of the reference anatomical marker indicated that the operator or user has identified the current reference anatomical marker by capturing a photographic image from the imaging system and optionally annotating it. Later, it may involve gradually showing the expected next or sequential marker. When introducing an element of an aspect of the invention or embodiment thereof, the articles “a”, “an”, “the”, and “said” may mean that one or more of the elements are present. Intended. The terms “comprising”, “including”, and “having” are intended to imply and imply that there are additional elements other than the listed elements.
(Item 1)
A method for facilitating the use of a feeding tube assembly comprising:
An inlet connectable to a nutrient fluid source; an outlet distally from the inlet and fluidly connected thereto through a supply passage; and an imaging device disposed proximate to the outlet Providing a feeding tube, wherein the imaging device is configured to generate and transmit an imaging signal corresponding to an image of a patient's anatomy;
A console comprising a display and a memory having a plurality of reference materials selected from the group consisting of photos, video recordings, audio recordings, schematics, animations, text, and combinations thereof stored therein. Each of the plurality of reference materials includes anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter feature, console preparation, console operation, console feature, system operation, system Providing information relating to at least one of features and contact information, wherein the console receives the imaging signal and presents at least a portion of at least one image corresponding to the imaging signal on the display; Memories corresponding to at least one of the above references Including Yuaitemu configured reference menu to present on the display, and a step method.
(Item 2)
The console is configured to simultaneously present on the display a picture from the plurality of reference materials and a video image corresponding to the image signal from the imaging assembly, wherein the picture is representative anatomical. The method of item 1, wherein the marker is provided.
(Item 3)
Storing additional reference material in the memory; removing at least one reference material from the memory; and replacing the memory with an updated memory, the updated memory comprising: The method of claim 1, further comprising: at least one of: having updated reference material stored therein.
(Item 4)
Storing additional reference material in the memory; removing at least one reference material from the memory; and replacing the memory with an updated memory, the updated memory comprising: The method of claim 1, further comprising: at least one of: having at least one updated reference material stored therein.
(Item 5)
An imaging catheter system positioned adjacent to a feeding tube assembly, comprising a feeding tube for delivering enteral nutrient fluid to a patient,
An imaging catheter including an imaging assembly having an imaging device for generating an imaging signal corresponding to an image of a patient's anatomy, wherein the imaging assembly transmits the imaging signal generated by the imaging device An imaging catheter;
A console adapted to receive the imaging signal transmitted by the imaging assembly and present an image generated from the imaging signal on a display, wherein the console is a photograph on the display; Selectively presenting a reference menu including a menu item corresponding to the reference material, selected from the group of reference materials, comprising at least one of a video recording, an audio recording, a schematic diagram, a video, and text. Each of the above documents is for anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter characteristics, console preparation, console operation, console characteristics, system operation, system characteristics, and contact information. Provide information about at least one of the And a sole, an imaging catheter system.
(Item 6)
6. The imaging catheter system according to item 5, wherein the console presents an image generated from the imaging signal on the display simultaneously with the reference menu.
(Item 7)
6. The imaging catheter system according to item 5, wherein the console presents an image generated from the imaging signal on the display simultaneously with the reference material.
(Item 8)
6. The imaging catheter system according to item 5, wherein each of the reference materials is located in a directory having a name corresponding to the corresponding reference material.
(Item 9)
6. The imaging catheter system of item 5, wherein the display is adapted to present the reference menu when the user touches the display twice during a preselected time period.
(Item 10)
10. The imaging catheter system of item 9, wherein the reference material is modified by updating system software.
(Item 11)
The feeding tube has an inlet, an outlet, and a supply passage extending between the inlet and the outlet, and the imaging catheter generates an imaging signal corresponding to the patient's digestive tract Item 5, wherein the imaging assembly is positioned adjacent to the outlet and the imaging assembly is sealed from the supply passage to prevent enteral nutrient fluid in the supply passage from entering the imaging assembly. Imaging catheter system.
(Item 12)
6. The imaging catheter system of item 5, wherein the console is configured to present a graphical user interface on the display.
(Item 13)
13. The imaging catheter system of item 12, wherein the display is a touch screen display adapted to present icons for control of the system by touching the display.
(Item 14)
13. The imaging catheter system of item 12, wherein the console is configured to simultaneously present reference material and video image signals from the imaging assembly on the display.
(Item 15)
6. The imaging catheter system according to item 5, further comprising an interface cable for connecting the imaging catheter to the console for use in transmitting the imaging signal generated by the imaging device to the console.

Claims (12)

A IMAGING catheter system,
A including imaging catheter imaging assembly that having a capturing device for generating an image signal corresponding to an image of the patient's anatomy, the imaging assembly, transmits the imaging signal generated by the imaging device An imaging catheter;
A console adapted to receive the imaging signal transmitted by the imaging assembly and present an image generated from the imaging signal on a display, the console selecting a reference menu on the display is adapted to presenting, the reference menu, photographs, video recording, audio recording, schematic, videos, at least one reference material that will be selected from the group of reference material that Ru comprising of text look including the corresponding menu item, each of said article, anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter, wherein the console ready, console operation, the console features, system operation, the system characterized , providing information on at least one of the contact information , At least one of said reference material comprises a partial schematic diagram, including a comparison with the exact path and incorrect path for inserting the imaging catheter into said patient, each path, respectively At least one distinct representative anatomical image located along the path of the correct path, wherein the at least one anatomical image of the exact path includes an image located along the gastrointestinal tract and the inaccurate An imaging catheter system comprising: a console , wherein the image of at least one anatomy of the simple pathway includes an image located along the respiratory pathway . The imaging catheter system according to claim 1 , wherein the console presents an image generated from the imaging signal on the display simultaneously with the reference menu. The imaging catheter system according to claim 1 , wherein the console presents an image generated from the imaging signal on the display simultaneously with the reference material. Each said reference material, located in a directory having a name corresponding to said corresponding reference materials, imaging catheter system according to claim 1. The display, when a user during a pre-selected time Touch twice the display, Ru adapted Tei to present the reference menu, imaging catheter system according to claim 1. The reference material is modified by the updating the system software, imaging catheter system according to claim 5. The imaging catheter has an inlet, an outlet, and a supply passage extending between the inlet and the outlet, the imaging assembly for generating an imaging signal corresponding to the patient's digestive tract the outlet positioned adjacent said imaging assembly, Ru Tei sealed from the supply passage as enteral nutrition fluid in the supply passage is prevented from entering the imaging assembly, according to claim 1 An imaging catheter system according to claim 1. The console, Ru Tei is configured to present a graphical user interface on the display, the imaging catheter system according to claim 1. 9. The imaging catheter system of claim 8 , wherein the display is a touch screen display adapted to present icons for control of the system by touching the display. The console, Ru Tei is configured simultaneously to present the video image signals from the reference material and the imaging assembly on the display, the imaging catheter system according to claim 8. Further comprising, imaging catheter system according to claim 1 for use, the interface cable to connect the imaging catheter into the console when transmitting the image signal generated by said imaging device to said console. The imaging catheter system according to claim 1, wherein the console is configured to simultaneously display the schematic diagram and an image generated from the imaging signal in response to a command.