TWI526190B - Catheter with imaging assembly and console with reference library and related methods therefor - Google Patents

Description

Catheter with imaging assembly and console with reference library and related method

The present invention relates to catheters and in particular to imaging catheter systems for display consoles having reference materials.

Several medical procedures involve placing a catheter (such as an irrigation tube or endoscope) in a patient through the nose, mouth or other opening of the patient. Accurate placement of the catheter is critical to the success of the procedure and/or the safety of the patient in many procedures. For example, a nasogastric (NG) feeding tube can be inserted through the nose, which passes through the throat and down into the stomach, or through the stomach into the small intestine of the patient to deliver food to the patient via the tube. If the filling tube is incorrectly placed in the patient's lungs, the feeding fluid will be delivered to the patient's lungs, causing severe and potentially fatal consequences.

Accordingly, x-ray imaging devices and procedures have been used to confirm the exact location of an irrigation tube or other type of catheter in a patient. In particular, the x-ray image of the patient is taken after initial placement of an irrigation tube in the patient. Check the x-ray image to determine if the tube is properly placed or if it needs to be repositioned. Repeat the x-ray imaging procedure until the tube is properly placed. However, x-ray imaging procedures are often expensive and time consuming. In addition, because a patient typically uses a tube for a relatively long period of time, the x-ray imaging procedure must be repeated periodically to ensure that the tube is not moved or moved.

One or more aspects of the invention may relate to a catheter having an imaging assembly. The catheter can be a feeding tube having an imaging assembly. According to an aspect of the invention, an imaging guide The tube system can include an imaging catheter that includes an imaging assembly having an imaging device for generating an imaging signal corresponding to an anatomical image of a patient. The imaging assembly transmits an imaging signal produced by the imaging device. The system also includes a console adapted to receive an imaging signal transmitted by the imaging assembly and to present an image of the self-imaged signal on a display. The console is adapted to selectively present a reference menu containing one of the menu items on the display. The menu item corresponds to a reference material that includes any one or more of photographs, video recordings, audio recordings, graphics, animations, and text. Materials provide information on 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 Any one or more of the information. The console can be further configured to simultaneously present a reference menu and an image that produces a self-imaged signal on the display. 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 an illustration for controlling the system by touching the display. In a further configuration, the console can be configured to simultaneously present the reference material and the image from the imaged signal on the display. In still further cases, each of the reference materials is preferably positioned in a directory having a name corresponding to one of the respective reference materials. The display can be adapted to present a reference menu when a user touches the display twice during a pre-selection period. This period can be, for example, within about one second. Further, at least a portion of the reference material is read-only and in some cases may be modified by updating the system software. The imaging catheter system can include an irrigation tube assembly including a feeding tube for delivering a gut feeding liquid to the patient, the tube having an inlet and an outlet and one of extending between the inlet and the outlet A channel, the imaging catheter is placed adjacent to the outlet to produce an imaging signal corresponding to one of the patient's digestive tracts, and the imaging assembly is sealed from the feeding channel to inhibit intestinal feeding fluid in the feeding channel from entering the imaging assembly. The system typically further includes connecting the imaging catheter to the console for transmitting an imaging signal generated by the imaging device to one of the console interface cables.

One or more aspects of the present invention may be directed to an imaging catheter system comprising: a feeding tube having an inlet connectable to a source of feeding liquid, at the end of the inlet and fluidly connected to the feeding channel through a feeding channel An exit device, and an imaging device adjacent to the outlet configuration, the imaging device configured to generate and transmit an imaging signal corresponding to an image of one of a patient's anatomy; and a console including a display and storage therein There is a memory of a plurality of reference materials selected from the group consisting of photographs, video recordings, audio recordings, graphics, animations, text, and combinations thereof. In some cases, each of the plurality of reference materials can provide information regarding anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter features, console preparation, console operation, console features, system operation Information on at least one of the system features and contact information. Preferably, the console is configured to receive an imaging signal, present at least a portion of the at least one image corresponding to the imaging signal on the display, and present on the display a reference item comprising at least one of the reference materials corresponding to the reference material Menu. At least one of the plurality of reference materials can include a photo showing one of the anatomical landmarks. The anatomical landmarks may be one of a bronchus, a larynx, a tracheal ring, a cardia, a pyloric sphincter or a pylorus, a ring cartilage, a bronchial segmentation, an esophageal junction, a gastric fold, a duodenal fold, and a pyloric hole.

In accordance with another aspect of the present invention, a method of operating a medical system having a medical device includes accessing a reference material on a display, the medical device including imaging for generating an imaging signal corresponding to an anatomical image of a patient The device is a console that is adapted to present an image produced from the imaging signal on the display. The material contains an image of an exemplary anatomy indicating the correct placement of the medical device in the patient.

One or more aspects of the present invention may be directed to one method of promoting the use of an irrigation tube assembly. In one or more embodiments of the aspect of the invention, the method can include providing an irrigation tube having an inlet connectable to a source of feeding fluid, at the end of the inlet and through a The feeding channel is fluidly connected to one of the inlets of the inlet, and an imaging device is disposed adjacent to the outlet, the imaging device being configured to generate and transmit a solution corresponding to a patient An imaging signal of one of the images; and providing a console comprising a display and a memory storing a plurality of reference materials selected from the group consisting of audiovisual materials (such as video, audio, and photos), text A group of materials (such as charts, animations, and text) and combinations thereof. According to certain particular embodiments, each of the reference materials can provide for anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter manipulation, imaging catheter features, console preparation, console operation, console features, Information on at least one of system operations, system features, and contact information. In some cases, the console can be configured to receive an imaging signal, present at least a portion of the at least one image corresponding to at least a portion of the imaging signal on the display, and present on the display to include at least one of the reference materials One of the menu items is a reference menu. In some cases, the console can be configured to simultaneously present a photo from one of the plurality of reference materials and a video image corresponding to the image signal from the imaging component on the display, wherein the photo provides a representative anatomical landmark. A method according to a further aspect of the invention may comprise at least one of storing additional reference material into the memory, removing at least one reference material from the memory, and replacing the memory with an updated memory (updated) The updated reference material is stored in the memory). According to other further aspects, the method may include: receiving a console from a user; and after receiving the console, performing at least one of: storing additional reference material into the memory, removing at least one reference material from the memory, And replacing the memory with an updated memory (at least one updated reference material is stored in the updated memory).

In one aspect, the imaging catheter system typically includes an imaging catheter and a console. The imaging catheter includes an elongated tubular body having an opposing first end and a second end. An imaging assembly is located at the first end of the elongated tubular body and includes an imaging device for generating an imaging signal indicative of an anatomical image of a patient. The imaging assembly is adapted to transmit an imaging signal produced by the imaging device. An electronic memory component has a predefined identifier of one of the imaging conduits written thereon. The console contains a display. The console is configured to receive from the imaging assembly Imaging the image and displaying the image produced from the imaging signal on the display. The console is configured to read the predefined identifier from the electronic memory component.

10‧‧‧ imaging catheter / irrigation tube assembly / nasogastric tube assembly

12‧‧‧Feed tube/tube

12a‧‧‧First tube section

12b‧‧‧Second section

14‧‧‧ feeding channel

16‧‧‧Inlet connector/Y interface

16'‧‧‧Inlet connector

18‧‧‧ imaging components

20‧‧‧ imaging component connector / outlet connector

22‧‧‧ console connector

22'‧‧‧ console connector

23‧‧‧ console

24‧‧‧Electronic conductor

26‧‧‧ conductor channel

28‧‧‧ arched part

30‧‧‧First entrance

32‧‧‧Second inflow

34‧‧‧Single outflow

34'‧‧‧Exit

35‧‧‧Optional cover

36‧‧‧ first cover

37‧‧‧second cover

38‧‧‧ joint solder joints

40‧‧‧feeding exports

42‧‧‧Connected section

46‧‧‧Electronic conductor

50‧‧‧Tubular casing

52‧‧‧Axial channel

60‧‧‧Flexible circuit components/flex circuit assemblies/flex circuits

60'‧‧‧Flexible circuit components

70‧‧‧Transparent or translucent cover/optical transparent cover/cover

80‧‧‧Flexible circuit

80'‧‧‧Flexible circuit

82‧‧‧ Camera Mounting / Camera Mounting Surface

82'‧‧‧ Camera installation section

84‧‧‧ imaging device/camera

84'‧‧‧ camera

86‧‧‧ camera housing

86A‧‧‧Base

86B‧‧‧ side

86C‧‧‧ side

86D‧‧‧ side

86E‧‧‧ side

86F‧‧‧Upper surface/first surface

88‧‧‧ lens

90‧‧‧Power installation section

90'‧‧‧Electronic components installation

92‧‧‧Control or data installation section

94‧‧‧Light source installation

94'‧‧‧LED installation part

95'‧‧‧ openings

96‧‧‧Internal LED/light source

96'‧‧‧ four LEDs

97‧‧‧First fold line

98‧‧‧Light surface

99‧‧‧second fold line

100‧‧‧Cylinder attachment section

102‧‧‧Dome-shaped part

104‧‧‧ Camera storage section

106‧‧‧LED storage part

108‧‧‧Internal camera relative surface/internal surface

110‧‧‧Internal light relative surface/internal surface

112‧‧‧Internal surface

116‧‧‧Central distal part / flat central part

200‧‧‧Electronic System / Circuit System

202‧‧‧Electronic conductor connector

204‧‧‧Double voltage regulator

206‧‧‧Oscillator

208‧‧‧Serial communication device

210‧‧‧Microcontroller

212A‧‧‧ radio

212B‧‧‧Related radio

228‧‧‧Connector housing

228'‧‧‧Shell/console connector housing

230‧‧‧ Printed Circuit Board (PCB)

230'‧‧‧PCB

232‧‧‧Edge connector

232'‧‧‧Edge connector

234‧‧‧ pipe connection opening

242‧‧‧Interface cable

243‧‧‧Electronic memory components

244‧‧‧First interface connector

246‧‧‧Second interface connector

248‧‧‧ button/control device

250‧‧‧General flat mounting surface / console housing

252‧‧‧ console display

254‧‧‧Microprocessor

302‧‧‧ language

304‧‧‧Date/Time

306‧‧‧ time display

308‧‧‧Enter username and password/set administrator account

310‧‧‧Login user interface screen

312‧‧‧Main Menu User Interface Screen

350‧‧‧ Current time selected by the user

352‧‧‧ patient name

354‧‧‧identification number

356‧‧‧Time lost by the current procedure

358‧‧‧Snapshot options

360‧‧‧File function options

380‧‧‧Export option

382‧‧‧Rename option

384‧‧‧Delete option

386‧‧‧Marking/Viewing Options

390‧‧‧Serial Bus (USB)埠

392‧‧‧Options for deleting selected files from the console

394‧‧‧Release the file as an uncompressed file

396‧‧‧Release the file as a compressed file

400‧‧‧Marking options

402‧‧‧Compar with video options

404‧‧‧Compare the first part of the user interface screen

406‧‧‧Compare the second part of the user interface screen

408‧‧‧Marking options

410‧‧‧Program screen options

420‧‧‧Text Options/Indicators

422‧‧‧Dash option/indicator

424‧‧‧Approved option/indicator

426‧‧‧Restore options/indicators

428‧‧‧All recovery options/indicators

510‧‧Another embodiment of an imaging feeding tube assembly

510‧‧‧ imaging tube assembly

512‧‧‧Feed tube/fed tube assembly/tube

514‧‧‧ feeding channel

516‧‧‧Inlet joint

518‧‧‧ imaging components

520‧‧‧ imaging component connector

522‧‧‧ console connector

524‧‧‧Cable wire/cable

526‧‧‧ conductor channel

532‧‧‧Common Serial Bus (USB) 埠 Connector

540‧‧‧feeding channel exit

550‧‧‧Slim case

560‧‧‧Flexible circuit components

561‧‧‧Rigid structure

570‧‧‧ Cover

580‧‧‧Flexible circuit

581‧‧‧Bend position

582‧‧‧ Camera installation section

584‧‧‧ camera

589‧‧‧radial locking ribs

591‧‧‧Strengthen structure

593‧‧‧Bend position

596‧‧‧Light source

598‧‧‧Decoupling capacitors

600‧‧‧radial locking slot

728‧‧‧Shell

730‧‧‧Printed circuit board (PCB)

736‧‧‧ socket

742‧‧‧Interface cable

743‧‧‧Electronic memory components

744‧‧‧First interface connector

746‧‧‧Second interface connector

750‧‧‧Signal Buffer Unit

770‧‧‧Ring ribs or rounded edges

800‧‧‧inlet connector

802‧‧‧Feed tube connector

804‧‧‧Connection channel

806‧‧‧ channel

810‧‧‧ imaging catheter system

812‧‧‧ imaging catheter

814‧‧‧ console

816‧‧‧Interface cable/cable

820‧‧‧ imaging components

822‧‧‧ imaging device

830‧‧‧ display

832‧‧‧ Shell

834‧‧‧Power switch

840a‧‧‧Selection or project

840b‧‧‧Selection or project

840c‧‧‧Options or projects

842‧‧‧Selection/Reference Library

844‧‧‧ reel

850‧‧‧Return icon

852‧‧‧ inspection view

864‧‧‧Photos

866‧‧‧Text reference or mark

872a‧‧ visual status identifier

872b‧‧‧Visual Status Identifier

872c‧‧‧Visual Status Identifier

A‧‧‧ vertical axis

D‧‧‧Deep camera depth

H‧‧‧ Camera height

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of a perspective view of one of the imaged feeding tube assemblies in accordance with one or more aspects of the present invention; Figure 2 is a perspective view of the feeding tube assembly of Figure 1 in accordance with one or more aspects of the present invention. Figure 1 is a schematic illustration of a side view, an elevational view of an imaging gavage tube assembly of Figure 1, and an interface cable, and an imaging irrigation tube system of a console, in accordance with one or more aspects of the present invention. Figure 4A is a schematic illustration of a perspective view of one of the console connectors of the feeding tube assembly of Figure 1 showing an internal component and including a feeding tube for a feeding tube, in accordance with one or more aspects of the present invention. Figure 4B is a schematic illustration of one embodiment of an inlet joint for imaging an irrigation tube assembly in accordance with one or more aspects of the present invention; Figure 5 is a representation of one or more aspects of the present invention. 1 is a schematic enlarged view of a fragmentary perspective view of a distal end portion of the filling tube assembly of FIG. 1 including an exploded imaging assembly, an imaging assembly connector, and a portion of a feeding tube; FIG. 6 is in accordance with one or both of the present invention BRIEF DESCRIPTION OF THE DRAWINGS FIG. 7 is a schematic illustration of an enlarged cross-sectional view of one of the feeding tubes of the filling tube assembly of FIG. 1; FIG. 7 is an illustration of the imaging assembly of FIG. 5 in a folded configuration in accordance with one or more aspects of the present invention. One of the flexible circuit assemblies is a schematic top view of one of the perspective views; and FIG. 8 is a view showing one of the flexible circuit assemblies of the imaging assembly of FIG. 4 in a folded configuration in accordance with one or more aspects of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 9 is a schematic illustration of a fragmentary view of an imaging assembly of FIG. 5 in accordance with one or more aspects of the present invention; Figure 10 is a schematic illustration of a perspective view of one of the imaging assemblies of Figure 5 in accordance with one or more aspects of the present invention; Figure 11 is a flexible circuit of Figure 7 in accordance with one or more aspects of the present invention. 1 is a block diagram of a flexible circuit embodiment of FIG. 11 in accordance with one or more aspects of the present invention; FIG. 14 is shown in accordance with one or more aspects of the present invention. One of the top plan views of a flexible circuit assembly of the imaging assembly of FIG. 7 in an unfolded configuration is schematically illustrated; FIG. 15 is a diagram showing one of the flexible circuit assemblies of FIG. 14 in accordance with one or more aspects of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 16 is a block diagram of a flexible circuit assembly in accordance with one or more aspects of the present invention; and FIG. 17 is a flexible circuit assembly in accordance with one or more aspects of the present invention. Figure 18 is a block diagram of an exemplary irrigation tube system in accordance with one or more aspects of the present invention; Figure 19 is an illustration of an exemplary graphical user interface in accordance with one or more aspects of the present invention. One of the flow charts of the screen flow; Figure 20 to Figure 31 A schematic illustration of an exemplary graphical user interface screen displayable by a console in accordance with one or more aspects of the present invention; FIG. 32A illustrates one of an imaging catheter assembly in accordance with one or more aspects of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 32B is a schematic illustration of an exploded perspective view of an imaged feeding tube assembly of FIG. 32A in accordance with one or more aspects of the present invention; FIG. 33 is a diagram of one or more aspects of the present invention. FIG. 32A is a schematic cross-sectional view showing one of the filling tubes of the imaging filling tube assembly of FIG. 32A; Figure 34 is a schematic illustration of an exploded perspective view of one of the imaging pack components of Figure 32A in accordance with one or more aspects of the present invention; Figure 35 is a perspective view of one or more aspects of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 36 is a schematic illustration of a top plan view of a rigid flexible circuit in accordance with one or more aspects of the present invention; FIG. 37 is a perspective view of the present invention. Or a plurality of aspects showing one of a side view and an elevation view of a rigid flexible circuit; FIG. 38 is a view showing one of the imaging component connectors of the imaged feeding tube assembly of FIG. 32A in accordance with one or more aspects of the present invention; A schematic view of one of the perspective views; FIG. 39 is a schematic illustration of a perspective view of one of the imaging assemblies of FIG. 34 in accordance with one or more aspects of the present invention, wherein a housing is removed from the imaging assembly to reveal internal components Figure 40 is a schematic illustration of one longitudinal cross-sectional view of the housing of the imaging assembly of Figure 34 in accordance with one or more aspects of the present invention; Figure 41 is a diagram showing one of the imaging assemblies in accordance with one or more aspects of the present invention. Figure 42 is a schematic illustration of one of the cross-sectional views of one of the console connectors of the imaging irrigation tube assembly in accordance with one or more aspects of the present invention; Figure 43 is a diagram of one or more aspects in accordance with the present invention. A schematic illustration of one of the interface cables is shown; and FIG. 44 is a schematic illustration of a perspective view of one of the flexible circuit assemblies having one of the flexible circuits in a folded configuration in accordance with one or more aspects of the present invention. And Figure 45 is a schematic illustration of one of the perspective views of the flex circuit of Figure 44 in an unfolded or flat configuration in accordance with one or more aspects of the present invention; Figure 46 is in accordance with one or both of the present invention Multiple patterns show one part of an imaging catheter system BRIEF DESCRIPTION OF THE DRAWINGS FIG. 47 is a schematic illustration of one of the front elevational views of one of the consoles of the imaging catheter system in accordance with one or more aspects of the present invention; FIG. 48 includes a representation of the error and the correct route. One of the photocopies of the exemplary indicia is schematically illustrated; and Figures 49A-49C are photocopies of exemplary indicia, wherein Figure 49A shows a copy of one of the bronchial photographs, and Figure 49B shows one of the portions of a stomach. A copy of the photo, and Figure 49C shows a copy of one of the photo of the tracheal ring. Corresponding reference characters throughout the figures indicate corresponding parts.

In another aspect, a feeding tube assembly generally includes: a flexible irrigation tube having one of a first longitudinal end and a second longitudinal end; a longitudinal axis extending between the first longitudinal end and the second longitudinal end; And a feeding channel defined therein and extending along a longitudinal axis extending between the first longitudinal end and the second longitudinal end. An inlet joint is adjacent the second longitudinal end of the tube fluidly coupled to the feeding channel. The inlet fitting is configured for fluid connection to a source of intestinal feeding liquid to fluidly connect the intestinal feeding liquid source to the feeding channel. The imaging assembly includes an imaging device. The imaging assembly is configured to generate and transmit an imaging signal indicative of an image of a patient's digestive tract. The imaging assembly is secured to the tube adjacent the first longitudinal end of the tube and seals the imaging assembly from the feeding channel to inhibit intestinal feeding fluid in the feeding channel from entering the imaging assembly. An irrigation outlet approaches the imaging assembly and is in fluid communication with the feeding channel to deliver the intestinal feeding fluid to the patient. A console connector is communicatively coupled to the imaging assembly, the console connector configured to communicatively connect the imaging assembly to a console to permit transmission of the imaging signal to the console.

In yet another aspect, an irrigation tube system generally includes an irrigation tube assembly and a console. The irrigation tube assembly includes a feeding tube having a first end and a second end opposite the fluid and one of the first end and the second end of the feeding channel. An inlet joint adjacent to and feeding The second end of the tube in fluid communication with the channel. The inlet fitting is configured for fluid connection to a source of intestinal feeding liquid to fluidly connect the intestinal feeding liquid source to the feeding channel. An imaging assembly can be utilized that includes an imaging device and is configured to generate and transmit an imaging signal indicative of an image of a patient's digestive tract. The imaging assembly is secured to the tube adjacent the first end of the tube and seals the imaging assembly from the feeding channel to inhibit intestinal feeding fluid in the feeding channel from entering the imaging assembly. An irrigation outlet is intermediate the inlet fitting and the imaging assembly and is in fluid communication with the feeding channel to deliver the intestinal feeding fluid to the patient. The console includes a display operatively coupled to the irrigation tube assembly and configured to receive an imaging signal transmitted by the imaging assembly and to display an image produced by the imaging signal on the display.

In another embodiment, a feeding tube assembly generally includes: a flexible irrigation tube having a first longitudinal end and a second longitudinal end; and one of the first end and the second end defined therein and extending between the first end and the second end Feeding channel. An inlet joint is adjacent the second longitudinal end of the tube in fluid communication with the feeding channel. The inlet fitting is configured for fluid connection to a source of intestinal feeding liquid. The imaging assembly includes an imaging device for generating an imaging signal indicative of an image of a patient's digestive tract. The imaging assembly is secured to the irrigation tube adjacent the first end of the tube and fluidly isolates the imaging assembly from the feeding channel. A console connector is secured to the feeding tube adjacent the inlet fitting. A console connector is communicatively coupled to the imaging assembly and configured to connect the imaging assembly to a console to allow transmission of imaging signals to the console.

In still another embodiment, an imaging catheter assembly generally includes: an elongated tubular body having a first tubular body end and an opposite second tubular body end; and an imaging assembly secured to the first tubular body end. The imaging assembly has one of a first imaging assembly end located at one end of the first tubular body, a second imaging assembly end adjacent to the first tubular body end, and one extending between the first imaging assembly end and the second imaging assembly end The longitudinal axis of the imaging assembly. The imaging assembly includes: a flex circuit having one of the electronic component mounting portions extending along a longitudinal axis of the imaging assembly from an end adjacent the second imaging assembly toward the end of the first imaging assembly; and adjacent the first imaging assembly end and substantially transverse to the imaging The component extends one of the camera mounting sections. Electronic components The mounting portion includes a longitudinally spaced first rigid section and a second rigid section and a first flexible section disposed between the first rigid section and the second rigid section. A first electronic component is mounted on the first rigid section of the electronic component mounting portion. A second electronic component is mounted on the second rigid section of the electronic component mounting portion. A camera is mounted on the camera mounting portion, and the camera is communicatively coupled to the first electronic component and the second electronic component. The rigid flexible circuit is disposed within a housing. The outer casing circumferentially surrounds at least a portion of the rigid flexible circuit. The first flexible section of the electronic component mounting portion has no electronic components mounted thereon such that the flex circuit can flex in the first flexible section.

In another aspect, an imaging catheter system for performing a medical procedure typically includes an imaging catheter and a console. The imaging catheter includes an elongated tubular body having an opposing first end and a second end. An imaging assembly at one of the first ends of the tubular body is adapted for insertion into a patient. The imaging assembly includes an imaging device for generating an imaging signal representative of an anatomical image of the patient when the imaging assembly is inserted into the patient. The imaging assembly is adapted to transmit an imaging signal produced by the imaging device. The imaging catheter includes an electronic memory component. The console includes a display configured to receive an imaging signal transmitted by the imaging assembly and display an image produced 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 performing a medical procedure typically includes an imaging catheter and a console. The imaging catheter includes an elongated tubular body having an opposing first end and a second end. An imaging assembly at one of the first ends of the tubular body is adapted for insertion into a patient. The imaging assembly includes an imaging device for generating an imaging signal representative of an anatomical image of the patient when the imaging assembly is inserted into the patient. The imaging assembly is adapted to transmit an imaging signal produced by the imaging device. The console contains a display. The console is configured to receive an imaging signal transmitted by the imaging assembly and display an image produced from the imaging signal on the display. The console is configured to simultaneously present: one of the images previously received by the console from the imaging component; and one of the current images from the image data currently received by the console from the imaging component image.

Referring now to the drawings and in particular to Figures 1 through 3, an imaging catheter is generally indicated at 10. As disclosed herein, an imaging catheter can be a medical device configured to be inserted into a patient (eg, a human or non-human patient) and configured to be inserted into a patient's body and/or in medical care An anatomical image of the patient (eg, digital video) is provided after the device is positioned in the patient. In the illustrated embodiment, the imaging catheter is configured as an irrigation tube assembly 10 and is illustratively depicted as a nasogastric tube assembly. The nasogastric tube assembly 10 can be configured to provide a digital image of the patient's digestive tract (or portion thereof) when the feeding tube assembly is inserted into the patient and after the feeding tube assembly is positioned in the patient to aid in confirming the patient's internal feeding tube assembly Place it correctly. The nasogastric tube assembly 10 can also be configured, such as by a user (e.g., a medical practitioner) to confirm the correct placement of the esophageal assembly in the patient by examining the digital image acquired from the imaging gavage tube assembly, by the intestine The system feeds the nutrient solution to the digestive tract of the patient. It will be appreciated that the imaging catheter 10 can be configured as a different type of feeding tube (such as a gastric feeding tube, or a jejunal feeding tube), or can be configured as a different type of medical device (such as an endoscope, or a cardiac catheter (eg, a ball) Balloon catheter or cardiac catheter)).

The illustrated irrigation tube assembly 10 generally comprises an elongated, generally flexible tubular body (indicated generally by 12) in the form of an irrigation tube having a longitudinal axis A (Fig. 6), an open first longitudinal end or a a distal end, and an open second longitudinal end or a proximal end. One of the feeding channels 14 (Figs. 4-6) defined by one of the inner surfaces of the feeding tube 12 extends longitudinally between the longitudinal ends of the tube to deliver nutrients (e.g., in the form of an enteral feeding solution) to the patient. In other embodiments (such as embodiments of catheters that are not filled with a tube) the elongated tubular body can have other configurations and may not have a longitudinal passage for delivering fluid to one of the patients. An inlet port for delivering nutrient solution into the feeding channel 14 (indicated generally by 16) is attached to the second end of the tube for use in generating and delivering the patient's digestive tract during and after intubation An imaging component (indicated generally by 18) of an instant image (e.g., live video) is attached to the first end of tube 12 by an imaging assembly connector (indicated generally by 20). As used herein, the feeding source is used as a reference point. The mouthpiece 16 defines the proximal end of the irrigation tube assembly 10 and the imaging assembly 18 defines the distal end. As described in detail herein, the feeding tube assembly 10 can also include a console connector (indicated generally by 22) in communication with the imaging assembly 18 to provide communication between the imaging assembly and a console 23 (FIG. 3), Images obtained by imaging assembly 18 can be displayed on the console. In the illustrated embodiment, the irrigation tube assembly 10, the console 23, and an interface cable 242 (which communicatively connect the irrigation tube assembly to the console) together form an imaging catheter system, and more specifically, an imaging irrigation Esophageal system.

Referring to Figures 1 through 4, an exemplary illustrated feeding tube 12 includes two tube sections: a first tube section 12a extending between the imaging assembly connector 20 and the console connector 22, and a second tube section. 12b extends between the console connector and the inlet connector 16. As described in greater detail below, the first tube section 12a and the second tube section 12b can be in fluid communication with one another via the fixation to the console connector 22 to at least partially define the feeding channel 14. In other embodiments of the invention, tube 12 can be formed as a unitary, one-piece component.

Tube 12 may include a symbol such as a scale (not shown) that displays or provides an indication of one of the insertion depths to aid in proper cannulation. In one example, tube 12 can have a length of between about 36 inches and about 55 inches, although it can be other lengths without departing from the scope of the invention.

As shown in Figure 6, the first tube section 12a typically includes one or more electronic conductors 24 (generally, a signal transmitting component) that are typically disposed within the wall of the first tube section. The second tube section 12b may be free of such electronic conductors. The electronic conductor 24 of the first tube section 12a extends longitudinally along the first tube section, such as along or parallel to one of the longitudinal axes of the feeding channel 14. At least some of the electronic 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 the interface cable 242. Other electronic conductors 24 can be configured to transfer power from the console 23 to the imaging assembly 18 and provide a ground. Other electronic conductors 24 may also be configured to provide other communications between console 23 and imaging assembly 18, including but not limited to two-way communication. The first tube section 12a may comprise a different type of signal transmission component (such as a fiber optic cable or other signal transmission component) to enable interfacing between the imaging component 18 and Transmission of signals between the stage connectors 22. In one or more embodiments of the invention, at least one of the electronic conductors 24 is configured to supply power from a power source (which may be the console 23) to the imaging assembly 18, while other methods of powering the imaging assembly ( The inclusion of the imaging component with its own source of electrical power does not depart from the scope of the invention.

As exemplarily illustrated, the electronic conductor 24 can be disposed within one of the conductor channels 26 of the feeding tube 12 such that the conductor is physically separated from or at least fluidly isolated from the feeding channel 14 to inhibit or reduce the contact of the feeding solution in the feeding channel. possibility. As shown in Figure 6, the inner surface defining a portion of the feeding channel 14 in the first tube section 12a has a generally circular cross-section that extends inwardly and longitudinally along one of the longitudinal dimensions of the feeding tube assembly or section. An arched portion 28. The electronic conductor 24 can be disposed within the wall of the first tube section 12a between the arcuate portion 28 of the inner surface and the outer surface of the tube section, which provides an allowable interposition between the electronic conductor 24 and the feeding channel 14 as disclosed above. The configuration of the physical separation between the intestine feeding solutions in the middle, and maximizes the area or volume of the feeding channel. A longitudinal axis A passes through the feeding channel 14. As such, this configuration promotes the flow of liquid in the feeding channel 14 and reduces the likelihood of occlusion in the feeding channel. As shown in Figure 5, a substantially uniform wall thickness around the channel 14 can reduce the amount of material retention that may occur, or at least reduce the likelihood of occlusion formation. It should be understood that the first tube section 12a can be other configurations without departing from the scope of the invention.

The feeding tube 12 (including, for example, the first tube section 12a and the second tube section 12b) may be formed of a thermoplastic polyurethane polymer such as, but not limited to, an aromatic polyether type thermoplastic polyurethane, and a radiopaque substance such as enamel. The first tube section 12a and the second tube section 12b may be formed by an extrusion method. Tube 12 can be formed from other materials and by other methods without departing from the scope of the invention. In a non-limiting example, the electronic conductor 24 or other signal transmitting component can be co-extruded with the first tube section 12a to embed the conductor in the first tube section. In another example, conductors 24 or other signal transmitting components may be fed through conductor channels 26 after formation of first tube section 12a. The introduction of the conductors can be facilitated by, for example, using a liquid internal pressurized passage 26 prior to insertion of either of the one or more conductors 24. Other forming the first tube The method of section 12a and/or tube 12 does not depart from the scope of the invention.

Referring further back to FIGS. 1 and 2, the illustrated inlet fitting 16 generally includes a first inflow port 30 and a second inflow port 32 that are in fluid communication with a single outflow port 34, respectively. The inlet joint 16 that is illustratively illustrated may be referred to as a Y interface. The first inflow port 30 can be used to connect a source of nutrient solution, such as an intestinal feeding solution. For example, a barb connector (not shown) in fluid communication with a source of intestinal feeding solution can be inserted into the first inflow port 30 and secured therein by a friction fit. Thus, one aspect of the invention may relate to the configuration of a feeding fluid in fluid communication with a feeding tube assembly. An optional cover 35 on the inlet fitting 16 can be removably received in the first inflow opening 30 to close the inflow opening when it is not in use. The second inflow port 32 can be used to connect to a source of medication. The optional first cover 36 and second cover 37 can be used separately to variably configure the second flow inlet 32 to connect or interface to one of various or different connectors typically used by various drug sources. For example, the first cover 36 can be removably received in the second flow inlet 32 to provide a central opening for engaging a catheter injector through its sized and shaped shape. The second cover 37 can be removably received in the central opening of the first cover 36, thereby providing a central opening that is sized and shaped to specifically engage one of the tips of one of the oral syringes. The inlet fitting 16 can have other shapes, sizes, and configurations, or can be omitted entirely without departing from the scope of the invention.

The inlet fitting 16 can be secured to the second end or proximal end of the tube 12 at a joint weld (indicated generally by 38) such that the outflow port 34 of the fitting 16 is in sealing fluid communication with the feeding passage 14 of the feeding tube. The joint weld 38 is typically tapered from the joint 16 to the tube 12 such that the weld has a smooth, substantially continuous decreasing diameter. It will be appreciated that the joint 16 can be secured to the tube 12 by other means without departing from the scope of the invention. For example, the inlet fitting 16 can be secured to the tube 12 by solvent bonding or other securing techniques. The joint 16 can be constructed of the same material as the feeding tube 12, or a mixed material, or a different but compatible material. In one example, the joint 16 is comprised of a mixture of polyvinyl chloride and a polyurethane elastomer. In another example, the joint 16 is constructed of an aromatic polyether thermoplastic polyurethane or a PVC that does not contain DEHP. Connector 16 can be from this hair Other types of materials are formed within the scope of the Ming.

Referring to Figures 1, 2 and 5, the imaging assembly connector 20 can have a first end edge (such as a distal end edge) secured to one of the imaging assemblies 18 and secured to the first end edge of the first tube section 12a. a second end edge (such as a proximal edge). The imaging assembly connection 20 generally defines one of the feeding outlets 40 in fluid communication with the feeding passage 14 of the tube 12. The feeding outlet 40 can include one or more openings that extend laterally through one side of the imaging assembly connector 20 (only one such lateral opening is shown). In the illustrated embodiment, the first end or distal end of the tube 12 is received and secured within the imaging assembly connector 20 at a second or proximal end of the imaging assembly connector to provide access to the feeding channel 14 And fluid communication between the feeding outlets 40. The imaging assembly connector 20 can be closed adjacent the first end or distal end to prevent the feeding solution in the feeding channel 14 from entering the imaging assembly 18. Thus, imaging assembly 18 is typically sealed from fluid passage 14 and is not in fluid communication therewith. Instead, the feeding solution typically flows laterally from the outlet 40 relative to the feeding tube 12. When it is determined that the irrigation tube assembly 10 has been properly positioned within a patient, the desired solution of the feeding solution or other feed inlet fitting 16 can be introduced through the feeding passage 14 of the tube 12 and flowed out through the outlet 40 and into the patient's digestion. Road. As shown in FIG. 5, the first end edge of the imaging assembly connector 20 can have a set shape and size to fit one of the imaging assemblies 18. The imaging assembly connector 20 can be integrally formed (or can be omitted) from the imaging assembly 18 without departing from the scope of the present invention.

The electronic conductor 24 can be embedded or otherwise received in the wall of the imaging assembly connector 20 such that the conductor is sealed from the feeding outlet 40 and the feeding channel 14 and the feeding solution is inhibited from contacting the conductor. In an embodiment, the imaging assembly connector 20 can include two different portions that are assembled together. The first portion can define a feeding outlet 40 that receives liquid from the tube 12 as described above, and a conductor passage (not shown) that is separate from and separate from the outlet of the feeding channel. The second portion can define the connecting portion 42 and one of the conductor channels extending into the first portion to facilitate connection between the imaging assembly 18 and the tube 12 or to carry the electronic conductor 24 between the imaging assembly 18 and the tube 12. The imaging assembly connector 20 can be omitted or it can have other shapes, sizes, and configurations. this In addition, imaging assembly 18 to tube 12 can be secured using other methods without departing from the scope of the invention.

In one example, imaging assembly connector 20 can be injection molded onto the end of irrigation tube 12. The direct connection of the imaging assembly connector 20 to the feeding tube provides tension relief for the electronic conductor 24 extending beyond the end of the feeding tube 12 to the imaging assembly.

Referring to FIG. 5, imaging assembly 18 can include a tubular housing 50; a flexible circuit ("flex circuit") assembly 60 disposed within the tubular housing; and a transparent or translucent cover 70 secured to tubular housing 50. A flex circuit typically includes a deformable circuit component and components mounted to the deformable circuit component. The deformable circuit component can be a flat substrate that can be bent or otherwise deformed (at least prior to deformation) and that includes an electronic conductor for establishing an electrical connection between various components mountable on the substrate. Within the scope of the present invention, the deformable circuit component can be deformable only in portions (e.g., only at discrete bend lines). In other features, the tubular outer casing 50 can provide protection for the flexible circuit assembly 60, and the outer casing can be waterproof to inhibit liquid from penetrating into the imaging assembly 18. The tubular outer casing 50 has an inner surface that defines an axial passage 52 that is shaped and dimensioned to enclose one of the flexible circuit assemblies 60 in a folded configuration. In an embodiment, the tubular outer casing 50 is formed from a generally flexible material that provides protection to the flexible circuit assembly 60 and allows the imaging assembly 18 to flex to facilitate operability of the feeding tube assembly 10. A second end of one of the tubular outer casings 50, such as a proximal end, can be configured to receive the connecting portion 42 of the imaging assembly connector 20 and can be attached to the connecting portion to secure the imaging assembly to the feeding tube 12. The tubular outer casing 50 can be substantially opaque by being formed from an opaque white material or by applying an opaque material thereon to reflect illumination from a light source (such as an internal LED 96) and from the imaging assembly. The distal end of 18 directs illumination to, for example, a field of view.

As described below, flexible circuit assembly 60 typically includes a flex circuit 80 and electronic components (not labeled) attached thereto. In a partially assembled or folded configuration exemplarily shown in Figures 5, 7 and 8, the flexible circuit assembly 60 can have a first longitudinal end (e.g., a distal end) and a second opposite longitudinal end ( For example a near end) one of the lengths. The electronic conductor 24 can be connected to a second longitudinal end (eg, a proximal end) of the flexible circuit assembly 60. Usually one phase The machine mounting portion 82 is disposed at a first longitudinal end (e.g., a distal end) of the flexible circuit assembly 60. An imaging device such as one of a digital camera (indicated generally by 84) can be mounted to the camera mounting portion 82. As shown in FIG. 8, camera 84 can have a cubic outer casing 86 having a base 86A, side 86B, side 86C, side 86D, side 86E, and an upper surface or first surface 86F. The upper surface 86F of the camera 84 can include a lens 88. Lens 88 defines a field of view that projects substantially outwardly from the distal end of imaging assembly 18. In accordance with one or more embodiments of the invention, camera 84 includes an imaging device, such as a CMOS imaging device. In a further embodiment of the invention, camera 84 may comprise a different type of solid state imaging device, such as one of a charge coupled device (CCD), or another type of imaging device. Other methods of configuring the electronics and other components of imaging assembly 18 are not departing from the scope of the invention and can be implemented as variant embodiments. For example, in another embodiment, a rigid printed circuit board (PCB) can be used in place of the flexible circuit assembly 60.

The flexible circuit assembly 60 can include a power supply mounting portion 90 (Figs. 5 and 7) and a control or data mount that typically extend from the camera mounting portion 82 toward the first longitudinal end of the flex circuit assembly 60 at a fold line. Part 92 (Figure 8). As will be described in further detail, the power supply components are typically disposed on the power supply mounting portion 90, while the camera control components are typically disposed on the data mounting portion 92.

Referring to Figures 7 and 9, a light source mounting portion 94 of the flex circuit 60 can be placed at the side 86C of the camera 84. The illustrative light source mounting portion 94 extends longitudinally from the lateral side edge of one of the flex circuits to the camera 84 at one of the fold lines of the power supply mounting portion 90. One or more light sources 96 can be disposed, for example, on the light source mounting portion 94 for illuminating an area or region adjacent the upper surface 86F of the camera housing 86. In the illustrated embodiment, the light source is a light emitting diode (LED) 96 disposed on the light source mounting portion 94 such that the LED is disposed on the side 86C of the camera housing and below or near the camera housing Surface 86F. In the illustrated embodiment, the LED 96 has a light emitting surface 98 that is substantially perpendicular to the light source mounting portion 94 to project light outward from the distal end of the imaging assembly 18. According to the illustrated embodiment (figure 9) Positioning the LED 96 and the light source mounting portion 94 relative to the camera 84 and the camera mounting portion 82 such that the light emitting surface 98 of the LED 96 is located at a relatively short distance (e.g., 0.408 mm) below the upper surface 86F of the camera housing 86. In general, LED 96 has an illumination zone that is at least partially coincident with an imaging zone or field of view of camera 84 by optional lens 88.

In another embodiment, one or more LEDs can be positioned at the end of the camera. As shown in FIG. 44, an example of a flexible circuit assembly is indicated by reference numeral 60'. As shown in a folded or at least partially assembled configuration, one of the flexible circuit assemblies 60' flex circuit 80' can include: an electronic component mounting portion 90'; and a camera mounting portion mounted with a camera 84' 82'; and one or more light sources (such as the four LEDs 96' shown) may be mounted with one of the LED mounting portions 94'. The LED mounting portion 94' is typically configured to rest on one of the upper surfaces of the camera 84' such that the LED 96' is located at or adjacent to the camera. The LED mounting portion 94' can include alignment with a camera lens (not shown) such that the LED mounting portion 94' does not block one of the fields of view 95' of the camera 84'. Figure 45 shows the flex circuit 80' in an unfolded or flat configuration. The flex circuit can have other configurations and provide an alternative location for mounting the camera and light source.

Referring to Figures 9 and 10, a camera 84 and an LED 96 disposed in the optically transparent cover 70 are shown. The cover 70 can be configured to diffuse light emitted from any one of the one or more LEDs 96 and, in some cases, filter the emitted light to a range of frequencies or a particular frequency. The cover 70 can have an outer surface that includes a cylindrical attachment portion 100 configured to couple or engage a distal end of the tubular outer casing 50; and a dome-shaped portion 102 that can extend outwardly or project from the tubular outer casing. In one example, the cylindrical attachment portion 100 can be shaped and sized to form a tight fit with the inner surface of the tubular outer casing 50. The cylindrical attachment portion 100 can be further secured to the tubular outer casing 50 using a bonding agent. The connection between the cover 70 and the outer casing 50 can be substantially waterproof to inhibit liquid from penetrating into the imaging assembly 18.

In some embodiments in accordance with one or more aspects of the present invention, the cover 70 has an inner surface defining one of the cavities extending inwardly from a proximal end of the cover. The cavity can provide or define a camera receiving portion 104 and an LED receiving portion 106. The camera storage section can be set accordingly 104 is sized and shaped to closely or securely receive side 86B, side 86C, side 86D, side 86E of camera 84, and camera receiving portion 104 may further have a depth (indicated as "D" in Figure 9), the depth Less than the camera height (indicated as "h" in Figure 9) causes the camera to extend out of the camera receiving portion 104 at the proximal end of the cover 70. The tight fit of the camera 84 in the camera receiving portion 104 can inhibit movement of the camera relative to the cover 70 and facilitate proper alignment of the cover 70 with the camera 84. The position of the cover 70 relative to the camera 84 can be adjusted or configured to at least partially reduce any effects that would adversely affect the image quality produced by the imaging assembly 18. In an exemplary embodiment, the raised portion of the camera housing that extends beyond the camera receiving portion can facilitate assembly by using a fixture for accurately positioning the camera and the cover. In other variations, the cover may utilize different configurations to interface with the housing or other components of the imaging assembly. For example, one or more variant embodiments can be directed to having a circular cylindrical volume enclosing one or more of the light sources and imaging devices.

With further reference to FIG. 9, the interior of the cover 70 can be further configured to reduce unwanted unwanted light from the LEDs 96 from entering the camera 84 and being sensed or detected by the camera. To minimize or at least partially reduce any unwanted light reflections into the camera 84, one of the inner camera facing surfaces 108 of the cover 70 (which is opposite the upper surface 86F of the camera housing 86) can be oriented or constructed substantially parallel to the camera housing. Upper surface 86F. In addition, one of the inner light opposing surfaces 110 of the cover 70 opposite the light emitting surface 98 of the LED 96 can be disposed longitudinally spaced from the surface of the cover relative to the surface 108 (i.e., distally). A relatively acute angle (e.g., a right angle) can be implemented and defined by the camera facing surface 108 of the cover 70 and the inner surface 110 connecting the inner surface 110 to the inner surface 112. This configuration should reduce any unwanted reflections from the light emitted by LED 96 into camera 84.

With further reference to FIG. 10, the dome-shaped portion 102 of the outer surface of the cover 70 includes a central distal portion 116 that can be generally flat (eg, generally planar). The side edges extending from the distal portion 116 to the base (e.g., the proximal end of the dome-shaped portion) are circular and generally smooth. In addition, the base of the cover 70 has approximately the same cross-sectional dimensions and shape as the outer casing 50 such that the cover smoothly transitions to one of the cross-sectional dimensions and shape of the outer casing. In general, the general shape of the cover 70 is referred to herein. For a truncated dome shape. The flat central distal portion 116 should minimize or at least reduce distortion of the field of view. In the illustrated embodiment, the flat central distal portion 116 has a generally circular perimeter and a dimension that is the same or larger than the field of view to further minimize the area of field of view distortion. Moreover, the portion of the inner surface portion of the cover 70 relative to the flat central portion 116 of the outer surface and the upper surface 86F of the camera 84 may also be flat and may be substantially parallel to the flat central portion of the outer surface, which should be further minimized Or at least reduce the distortion of the field of view. The rounded edge of the cover 70 facilitates insertion of the distal portion of the irrigation tube assembly 12 into the patient and enhances comfort during insertion.

11 shows an electronic block diagram of an exemplary electronic system 200 with respect to one of flexible circuit assemblies 60, in accordance with one or more embodiments of the present invention. 12 and 13 are circuit diagrams illustrating an exemplary electronic system 200. Electronic system 200 can include an electronic conductor connector 202 (such as an insulation displacement connector) for receiving electronic conductors 24 from outlet joint 20. According to the illustrated embodiment, the electronic conductor 24 includes six signal lines. The six signal lines in the illustrated embodiment include: two power supply lines, such as one power line (5V) and one ground line (GND); two serial communication lines, such as a series of clock lines (SCL) And a string of data lines (SDA); and a differential pair, such as a low voltage differential signal positive line (LVDS_P) and a low voltage differential signal negative line (LVDS_N). The power supply lines (5V and GND) are electrically connected to the LEDs 96 to energize the LEDs 96. In the illustrated circuit system 200, the power supply line provides 5 volts of power to a white LED, such as 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 thereto. Dual voltage regulator 204 produces two different voltage lines from the power provided by the power supply line. In the illustrated circuit system 200, a dual voltage regulator 204 (e.g., part number ISL9016IRUJCZ-T available from Intersil Corporation of Milpitas, California) produces a 2.8 volt power signal (e.g., analog supply voltage signal VAA) and a 1.8. Volt power signal (eg digital supply voltage signal VDD). Dual voltage regulator 204 is configured and electrically connected for supply The voltage generated therefrom is coupled to an oscillator 206, a serial communication device 208, and a camera 84. In exemplary electronic system 200, camera 84 may be part number MTV9124M01 available from Aptina Imaging Corp. of San Jose, California. However, other cameras or image sensors can be used without departing from the scope of the invention.

Oscillator 206 (such as a 22 MHz oscillator) can be electrically coupled to camera 84 and oscillator 206 configured to provide a clock signal (EXTCLK) to camera 84. A serial communication device 208 (such as one of the I ² C bus repeaters available from Philips Semiconductors or NXP BV, Germany) can be electrically connected to two serial communication lines (SDA, SCL) and camera 84 to allow Data (eg, non-image material) is communicated to camera 84 and communicated from camera 84. For example, a serial communication line (SDA, SCL) can be connected to an external computing device via console connector 22. The external computing device receives data representative of one or more camera settings, such as, but not limited to, 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 a patient anatomy image in the field of view during or after the patient is intubated and generates an imaging signal such as a series of digital video signals from the acquired image based on camera settings communicated via the serial communication device 208. The program executed by camera 84 is synchronized in accordance with the clock signal (EXTCLK) provided by oscillator 206. Camera 84 outputs a signal (eg, a serialized digital video signal) to a differential pair (LVDS_N, LVDS_P) to transmit signals to console connector 22 and to console 23. The image obtained by camera 84 can then be transported, processed, and viewed via the console.

Figure 14 illustrates the flex circuit 80 in an unfolded or flat (e.g., planar) configuration. In the unfolded configuration, camera mounting portion 82, power supply mounting portion 90, data mounting portion 92, and light source mounting portion 94 are all generally in the same plane and form a single flat surface (e.g., mounting surface). In one embodiment, all of the electronic components for the imaging assembly 18 in the electronic system (eg, electronic system 200) are attached to a single generally planar mounting surface of the flex circuit 80 when the flex circuit is in an unfolded configuration. 250. Accordingly, the electronic component can be attached to the flex circuit 80 for manufacturing in an unfolded configuration.

The relative positions of the electronic components of the exemplary electronic system 200 described above are shown in FIG. In particular, an electronic conductor connector 202 (eg, an insulation displacement connector) and a power supply 204 (eg, a dual voltage regulator) can be attached to the mounting surface 250 of the power supply mounting portion 90. A configuration such as one of the configurations shown (where power supply 204 is typically positioned relatively close to the incoming electronic conductor 24) minimizes or reduces noise on the ground line (GND). The mounting surface 250 of the oscillator 206 (e.g., clock generator) and serial communication device 208 (I ² C busbar repeater) to the data mounting portion 92 can be attached. The mounting surface 250 of the camera 84 to the camera mounting portion 82 can be attached. Since the serial communication signals (e.g., the serial data and the serial clock signals) communicated between the serial communication device 208 and the electronic conductor connector 202 have a lower video signal than the video signal transmitted from the camera 84 to the electronic conductor connector 202. One of the bandwidths, so the illustrated exemplary configuration positions the serial communication device 208 farther than the camera 84 is away from the electronic conductor connector 202. An LED 96 is attached to the light source mounting portion 94. The camera mounting portion 82 is shaped and configured such that when the flexible circuit assembly 60 is in the folded configuration described above, the light source mounting portion 94 can be placed flush with one side 86C of the camera housing.

In one embodiment, the flex circuit 80 of the flexible circuit assembly 60 is a two layer circuit. In particular, the flex circuit 80 includes a first substrate and a second substrate each having a top surface and a bottom surface. The first substrate and the second substrate may be composed of a flexible polyimide film. A conductive material (e.g., copper) selectively disposed on a top surface of the first substrate forms a first circuit pattern (e.g., a plurality of selective connection traces). 15 illustrates a first circuit pattern for an exemplary electronic system 200, in accordance with some aspects of the present disclosure. A conductive material selectively disposed on a top surface of the second substrate forms a second circuit pattern. The first substrate and the second substrate are disposed in parallel with each other (eg, stacked) such that a top surface of the first substrate is directly opposite a bottom surface of the second substrate. The first circuit pattern and the second circuit pattern are electrically connected together using, for example, a via and connected to an electronic component attached to the flexible circuit to form a two-layer circuit. The flex circuit 80 can be constructed of other materials and the flex circuit 80 can be formed in other ways without departing from the scope of the invention.

In one embodiment, the light source 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 can be joined to the conductive material on the top surface of the second substrate using, for example, vias to conduct heat from the first substrate to the second substrate. The traces formed on the second substrate of the light source mounting portion of the flexible circuit may be wider than the traces formed on the other portions of the first substrate and the second substrate. For example, a wider trace may have a width of about 0.008 inches. This configuration minimizes or reduces the likelihood of temperature rise due to heat generated by LED 96 and may allow a greater current to be provided to LED 96 to maximize or increase the illumination capability produced by LED 96 while preventing or Reduces any damage to LED 96 and the likelihood of harassment of the patient due to undesired or unacceptable high temperatures.

Referring to Figures 7, 8, and 14, in order to convert the flexible circuit assembly 60 from a flat configuration to a folded configuration, the power supply mounting portion 90 is folded toward each other at a first fold line 97 (shown in Figures 7 and 8). And the data mounting portion 92 to form a camera mounting surface 82 between the fold lines 97. The power supply mounting portion 90 and the data mounting portion 92 may be double folded at the second folding line 99 such that the two portions are substantially parallel and in relative relationship to each other. The light source mounting portion 94 may also be folded inward toward the camera mounting portion 82.

Since no components are placed on the inner or rear surface of the flexible circuit (i.e., the components are mounted on the mounting surface), alignment of the power supply mounting portion 90 and the data mounting portion 92 during assembly can be facilitated. The alignment of the power mounting portion 90 and the data mounting portion 92 also improves the alignment of the camera to a desired orientation. The pressure and force associated with fold lines 97 and 99 on either side of camera mounting surface 82 are offset against each other. Thus, equivalent or offsetting pressure or force results in positioning camera 84 to a particular orientation such that lens 88 is aligned with cover 70 and the view field of lens 88 can conform to the axis of tubular housing 50.

Figure 16 is a block diagram of an exemplary flexible circuit electronic system in accordance with an alternate embodiment of the present invention. As shown, the electronic conductor contains four cables that make up four signal lines. The four signal lines in the illustrated embodiment include: two power supply lines, such as a power line (5V) and a ground line (GND); and a differential pair, such as a low voltage differential signal line ( LVDS_P) and a low voltage differential signal negative line (LVDS_N). A microcontroller 210 cooperates with the camera 84 to allow integration into the irrigation tube assembly 10. The camera 84 includes, for example, an I ² C command/control interface and a serialized digital video output interface. Microcontroller 210 can directly transmit command and control signals to camera 84 instead of transmitting these signals across the length of the tube. Other operational parameters described herein may be implemented in this variation, such as the illustrative embodiments associated with Figures 11-13.

In Fig. 17, in accordance with one or more further embodiments of the present invention, electronic conductor 24 includes four cables that form four signal lines. The camera 84 can be customized to operate automatically and/or autonomously on a predefined operational agreement when powered or powered. In this embodiment, camera 84 does not use or rely on external, incoming command/control signals. Operating parameters of the camera 84, such as, but not limited to, exposure, white balance, may be pre-programmed, pre-set, or permanently set to customize or customize values for, for example, a particular or predefined application. For example, in one example the custom values are typically stored in a related memory structure. The camera 84 can include a sequencer (not shown), such as a microcontroller integrated into the camera module itself, the sequencer having a one-time programmable memory (OTPM) that can be programmed using custom values. (not shown). Alternatively, camera 84 may include a hardware scratchpad (not shown) having stored custom values, in which case the sequencer may be operable as appropriate. Other operational parameters described herein may be implemented in this embodiment.

18 illustrates yet another embodiment of an exemplary flexible circuit electronic system. As shown in Fig. 18, the electronic conductor 24 includes two cables constituting two signal lines. The two signal lines in the illustrated embodiment include two power supply lines for supplying power from a console to the flex circuit 60, such as a power line (5V) and a ground line (GND). The console 23 is capable of providing or providing power to the flex circuit 60 and can adjust the voltage as needed to power a radio 212A and the camera 84 and other components of the flex circuit 60. The camera 84 can then wirelessly transmit an imaging signal (such as video material) via the radio 212A to a corresponding wireless location located at the console. Electricity 212B. In an alternate embodiment, console 23 and camera 84 can communicate bi-directionally via radios 212A, 212B to exchange, for example, non-video material. Providing power to the camera 84 in this manner can eliminate the need for a limited capacity energy source, such as a battery, in the camera module itself.

Particularly when combined with a flexible circuit, reducing the number of signal lines as shown in Figures 16-18 can reduce cost and increase reliability and ease of assembly. Further, fewer conductors may reduce the likelihood of inadvertently changing lines during assembly and incorrectly connecting the lines.

Referring to Figures 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 includes an edge connector 232 that extends outwardly from the housing 228 such that one of the PCB electronic component mounting portions is disposed in the connector housing 228 and exposes the edge connector and thus can be generally easily attached thereto. In the illustrated embodiment, the connector housing 228 defines a tube connection opening 234 in which the first tube section 12a and the second tube section 12b are fixed (such as by an adhesive) to fluidly connect the first tube section and The second tube section. The tube connection opening 234 can partially define the feeding channel 14, or the feeding channel can be completely defined by the tube sections 12a, 12b. In a non-limiting example, a one-piece tube 12 (which incorporates or replaces sections 12a and 12b) extends through the tube connection opening 234 such that the feeding channel is completely defined by the tube and is not associated with any of the console connectors 22 Partially fluidly connected. The tube 12 can be secured within the tube opening 234, such as by an adhesive. The console connector can be configured in other configurations and can be secured to the tube assembly at other locations.

The electronic conductor 24 extends from the first tube section 12a into the connector housing 228 and is electrically connected to the PCB 230. An interface cable 242 or other signal transmission component is detachably coupled to the edge connector 232 to enable communication and data exchange between the console 23 and the imaging assembly 18. As explained in more detail below, an electronic memory component 243, such as an electronically erasable programmable read only memory (EEPROM), can be mounted onto the PCB 230 to allow for one of the consoles 23 (i.e., one of the consoles 23). The processor 254) or another external device accesses information (ie, data) stored and/or written therein. The PCB 230 can have additional or different electronic components mounted thereon, or the PCB can be omitted to operatively connect the electronic conductors to the PCB 230.

In another embodiment, a console connector can be formed on an inlet joint or fixed to an inlet joint. Referring to Figure 4B, in one embodiment of the invention, a housing 228' of a console connector 22' is integrally formed with an inlet connector 16'. The console connector housing 228' extends outwardly from the outflow port 34' of one of the inlet fittings 16'. As with the previous embodiment, the present console connector 22' optionally includes a PCB 230' having one of the edge connectors 232' for communicatively connecting the imaging assembly to the console. As described above and as explained in more detail below, an electronic memory component, such as an EEPROM (not shown), can be mounted onto the PCB 230'. The feeding tube assembly can include a different type of connection for connecting the imaging assembly 18 to the console 23.

Referring to FIG. 3, the interface cable 242 is shown to include a first interface connector 244 and a second interface connector 246 on opposite longitudinal ends of the cable. The first interface connector 244 can be releasably mated with the edge connector 232 and can be electrically connected to the edge connector 232, while the second interface connector 246 can be releasably mated with the console 23 and can be electrically connected to the console 23 . One or both of the interface connectors 244, 246 can be a discriminating connector (ie, a non-universal connector) that mates and connects only the respective connectors associated with the feeding tube assembly 10 and the console 23. Moreover, the edge connector 232 or other connector can be disposed within one of the sockets having one shape that selectively and differentially mates with a corresponding (e.g., complementarily configured) first interface connector 244. The socket and first interface connector 244 can include an engagement structure, such as a rib or other component that provides a friction fit between the connector and the socket to inhibit accidental disconnection. The connection between the interface cable 242 and the console connector 22 can be other configurations without departing from the scope of the present invention.

Still referring to FIG. 3, the interface cable 242 can include a control device (such as a button 248) that allows a user to record one of the instant video images (eg, a snapshot image) of the instant video displayed on the console 23. Actuation button 248 or other control device can send a signal to console 23 to instruct the console to record image information (eg, a still image) and associated time information. In an example, control device 248 can be accessed or on first interface connector 244; For example, the control device can be closer to the first interface connector than the second interface connector 246. In one or more exemplary embodiments of the invention, the control device can be provided on the first interface connector 244 or within 12 inches of the first interface connector. The console 23 can also include a snapshot control feature, such as an icon, button or other actuating device that allows the user to capture and record a snapshot image using the console, the snapshot image being optionally stored in a memory structure, and It can contain auxiliary information such as date and time. It is contemplated in some cases or embodiments that the console 23 can be positioned at a distance that is not within reach of a user (such as a medical practitioner) during insertion of the feeding tube assembly 10 into the patient. Thus, although an image (eg, video) can be viewed on the console 23, the user is unable to access the console during the insertion of the feeding tube assembly 10 to perform additional operations or features. Accordingly, by providing a control device 248 on the interface cable 242, and more specifically, by providing a control device adjacent to one of the first interface connectors 244, the user can take and record a record without touching the console 23. Snapshot image. Interface cable 242 can be other configurations without departing from the scope of the present invention.

As shown in FIG. 3, the illustrated console 23 can include: a console housing 250; a console display 252 secured to one of the housings, such as an LCD or other electronic display; and a microprocessor disposed in the housing 254. In the illustrated embodiment, microprocessor 254 is in communication with imaging assembly 18 via interface cable 242 and electronic conductor 24. The microprocessor 254 can be configured to receive an imaging signal or video signal transmitted by the imaging component 18 and display an instant image associated with the imaging signal on the display. As described in greater detail below, microprocessor 254 can be configured to display a graphical user interface on console display 252 or a different display. Console 23 may include one or more user input devices to allow a user or operator to communicate with microprocessor 254 to perform various operations using console 23. Display 252 can be a touch screen (such as a touch screen LCD or other type of display) that also functions as a user input device. In an embodiment, the touch screen allows the image scale to be reduced by touching the screen with two fingers and moving the two fingers apart to enlarge or close the two fingers. Zoom in or out of the image. In addition to (or instead of) the touch screen display 252, other user input devices such as a mouse, keyboard, joystick or other user input device may be provided. Other devices may include, but are not limited to, the ability to accept and act on voice commands or gestures to a clinician. The latter input devices have the advantage of not requiring the user to be able to touch the console. Other auxiliary components including, but not limited to, the power supply subsystem and the tandem busbars may be utilized in the console 23.

Referring to Figure 4A, the console connector 22 on the feeding tube assembly 10 as described above can include an electronic memory component 243 (such as an EEPROM) for storage and/or writing thereon via the console 23 or other Information accessed by internal or external devices (such as intestinal feeding pumps) associated with the feeding tube assembly. One or more of the following types of information may be provided or written to the electronic memory component in one or more embodiments of the invention.

In a non-limiting example, information regarding the irrigation tube assembly 10 can be written, stored, or otherwise incorporated into the electronic memory component 243. For example, data indicating the batch code and/or item code (e.g., serial number) can be written to the electronic memory component 243 and can be retrieved by the console 23 as a predefined identifier. In addition, a proprietary verification code can be included in the electronic memory component 243 to provide information that can be used to validate the console 23 to validate one of the feeding tubes of the filling tube assembly 10 series console. The console 23 can be configured to verify that the feeding tube assembly is an acceptable, correct, unexpired or compatible feeding tube assembly prior to allowing operation or additional operation, for example by executing instructions. If not properly verified, for example, if the feeding tube assembly 10 does not have valid information such as an acceptable code or an acceptable predefined identifier, the console 23 can inhibit the image from being displayed on the console. Additionally, information indicating whether the irrigation tube assembly 10 has been sterilized can be written to the electronic memory component 243. Other information regarding the irrigation tube assembly 10 can also be written or otherwise incorporated into the electronic memory component 243. The electronic memory component can thus be used as a verification component or key that can be utilized by one or more predefined identification information (e.g., a predefined identifier) before or during operation of the console.

In another non-limiting example, the time indicating the filling of the tube assembly 10 can be written (ie, The time stamp data is sent to the electronic memory component 243. For example, the date of manufacture of the feeding tube assembly 10 can be written to the electronic memory component 243. When the feeding tube assembly 10 is connected to the console 23 (such as by the interface cable 242), the console can read the information indicating the date of manufacture. In a non-limiting example, the console 23 can use the date of manufacture to determine if the feeding tube assembly 10 has exceeded its shelf life. If the filling tube assembly 10 has exceeded its predefined shelf life, the console 23 can be configured to execute stylized instructions that perform an alert, communicate a message indicating that the shelf life has expired, and prevent viewing of the image from the imaging component 18. At least one action. In another example, after the feeding tube assembly 10 is coupled to the console 23, the console can be programmed to write a service start date or first use date on the electronic memory component 243. This start date can be used as a reference for determining when the predefined lifespan of the feeding tube assembly 10 has expired or is about to expire. For example, after writing the start date to the electronic memory component 243, the console 23 can be configured to determine the time of use or the duration of use of the feeding tube assembly, and to consume the time spent with an expiration date (and time) A comparison to determine whether the remaining life or the service period of the tube assembly, the time of use, or both will expire or have expired. Other variations may involve periodically, uninterruptedly, or continuously determining whether the current date or date of use has exceeded the expiration date. If the console 23 determines that the life of the feeding tube assembly 10 has expired, the console can be programmed to perform at least one of: issuing an alert, communicating a message indicating that the period of use has expired, for any recorded The image is recorded and prevented from being viewed from imaging assembly 18. The cumulative usage time can be determined by writing a time stamp to the electronic memory component 243 to determine the number of hours actually used.

Console 23 can be configured to write other information to electronic memory component 243. For example, console 23 can be programmed to write a serial number or other identifier associated with the console such that other consoles or other devices, such as an enteral feeding pump, can read electronic memory component 243 and determine Which console is used for the selected feeding tube assembly 10. In another non-limiting example, the console can be configured to write patient-specific information to an electronic memory component 243 that includes, for example, a patient, such as a patient name, patient identification Others and other information about the patient, including but not limited to: the type of intestinal product to be injected into the patient, the patient's feeding schedule, the duration of the feeding, the associated feeding setting or other historical information. Patient information can be written to electronic memory component 243 prior to connection of irrigation tube assembly 10 to console 23, and the console can be programmed to read patient information. Alternatively, the user can use the console 23 to write patient information to the electronic memory component 243. Patient information can be encrypted to ensure patient confidentiality.

In yet another non-limiting example, a placement confirmation time stamp or some other confirmation identifier can be written to the electronic memory component 243 to indicate that the correct placement of the irrigation tube assembly 10 within the patient has been confirmed. When the user indicates that the console irrigation tube assembly has been properly positioned, the console 23 can be configured to write a timestamp to the electronic memory component 243. For example, the user can press a button or perform other operations to confirm proper placement. In addition to the timestamp or other confirmation identifier, a user name or other user identification can be written to the electronic memory component 243.

19 through 31 illustrate one or more features of an exemplary graphical user interface with respect to one of the consoles. One or more of the features described herein can be incorporated into various embodiments of the invention. Figure 19 is a flow chart showing the operation of the graphical user interface when the console 23 is first powered up, or when the console is enabled by a user after a predefined period of unused time. The predefined unused time period can be one month, six months, or even one year. Other trigger conditions that may affect a first start may involve power loss.

As shown, a user interface screen prompts a user to indicate whether it is the first user of the console 23 ("initial user"), or whether it has been associated with the console. If the user is the initial user, the console 23 grants the initial user administrator status and associated rights for accessing all or predefined features of the console. Accordingly, at 302, the initial user selection is displayed on the user interface screen to communicate with the user in one of the languages (labeled "Language"). At 304, the initial user is prompted to enter the current date and time, and a format for displaying the time (marked as "date/time") is specified as appropriate. In 306 depending on the situation The initial user input is displayed by the user interface (marked as "time display"). The initial user may select one of the following options: the console 23 tracks and displays the current day time; the amount of time consumed by the console to track and display the current program processed by the feeding tube assembly 10 (eg, starting at When entering patient data); the console tracks and displays both the current time of day and the amount of time consumed by the currently processed program. At 308, the initial user is prompted to set an administrator account by entering a username and a password.

If the user indicates that it is not the first user of the console 23, the console presents a login user interface screen to the user at 310. The user enters a username and password. If the user enters a valid username and the password associated with it, the user is logged into the user. If the console 23 determines that the username and password are invalid, the console presents the user with a login retry (ie, message) and another login opportunity. In one embodiment, console 23 may be reset after a predefined number of login attempts; all patient data, user data, and device data may be deleted, locked, or otherwise rendered inaccessible. If the user successfully logs in, a user menu interface of the main menu is presented to the user at 312. The main menu user interface screen presents the user with one or more of the following navigation options: utility function, program screen, file function and logout. The tour options can be rendered via textual and/or graphical icons. In addition, if the video data is received from the imaging component 18 when accessing the main menu user interface screen, a portion of the main menu user interface screen (eg, labeled "Preview Video" or graphically represented as a movie reel icon) Dedicated to providing video data to users. As described below, this typically occurs when the user selects the main menu user interface screen after starting a program.

In an embodiment, console 23 is configured to identify a plurality of user levels or states and to limit operations that may be performed by the console based on the level associated with each user. For example, console 23 can be configured to recognize four levels of users: operator, administrator, approver, and maintainer. Console 23 can be configured to authorize an operator level user to view video material received from imaging assembly 18. Console 23 can be configured to authorize administrator levels The user creates or creates a user account or other operator account, along with the associated data storage substructure, and views the video material received from the imaging component 18. The console 23 can be configured to authorize the user of the approver level to view the video data or imaging data received from the imaging component 18 and to label the approval data to the video material or imaging material received from the imaging component. The console 23 can be configured to authorize a user of the maintainer level to perform maintenance features such as software updates to the console. However, the console 23 authorizes the user of the maintainer level to operate the console only when the console does not store any patient data, such as having to delete patient data from the console before authorizing a maintainer user to operate the console.

If the user selects the utility function from the main menu user interface screen, the user interface image of the utility function can be presented to the user. The options presented to the user on the utility function user interface screen are typically based on the level or status associated with the user. If the user is an operator or an approver, the user function interface of the utility function can be presented to the user. The console can then provide the user with the "Language" option and the "Preview Video" feature described above. The utility function user interface screen can also provide the user with a "user administrator" option that allows the user to navigate to allow the user to change one of his/her passwords. The user administrator navigates the user interface. Picture. If the user is an administrator, the user interface of the utility function is presented to the user with the "language", "date/time", "time display" and "preview video" options described above. A "user administrator" option is also provided, which allows the user to navigate to a user administrator user interface screen. One of the administrator user user interface allows the administrator to add a user via the user interface. The utility function user interface screen presented to the administrator may also have an option labeled "Reset/Clear Console" for resetting (eg deleting patient data, user data and device data) or clearing ( For example, delete patient data and device data) console, and use to perform a software update (labeled "SW Update"). In addition to the options presented to an administrator user, the utility function user interface screen presented to a maintainer user is presented to the maintenance user. An option is provided to perform maintenance features (labeled as "maintainer characteristics"). For example, "maintainer characteristics" can include software debugging features.

Referring to the main menu user interface screen again, if the user selects the "program screen" option, a 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 one of the patients being executed. If the user enters the patient's name and identification, the program main user interface screen is displayed to the user, and as soon as the feeding tube assembly 10 is properly connected to the console, the console 23 begins the imaging assembly 18 from the feeding tube assembly 10. Receive video data. If the user does not enter the patient's name and identification (for example, leaving the patient name and patient ID field blank), the user is presented with a blank patient information user interface screen. The blank patient information user interface screen allows the user to choose to continue or enter patient information without entering patient information. If the user chooses to enter patient information, the user can be redirected to the patient information user interface screen. If the user continues to enter the patient information without entering the patient information, the user interface screen of the program is displayed to the user, and as long as the feeding tube assembly 10 is properly connected to the console, the console 23 begins the imaging assembly 18 from the feeding tube assembly. Receive video data. If the feeding tube assembly 10 is not connected or is not properly connected to the console, an error message is presented to the user.

In one embodiment, patient information can be manually entered by a user. In another embodiment, the console 23 can include a barcode scanner (not shown) for scanning a patient's barcode wristband for patient information. In yet another embodiment, patient information can be provided on electronic memory component 243. After communicatively connecting the feeding tube assembly 10 to the console 23, the console can read and record patient information from the electronic memory component 243. This embodiment can be combined with a barcode scanner embodiment and/or a manual input embodiment to provide a cross-check to the patient to ensure that the correct patient is provided with the correct medical procedure (e.g., enteral feeding).

As shown in Figures 20 and 21, the alternate program primary user interface screen can display video data received by the console 23 from the imaging component 18 or processed or processed imaging resources. material. The main user interface screen of the program can also display the current time (if selected by the user at 350), the patient's name and identification number (if entered by the user at 352 and 354 respectively), and the time consumed by the current program ( If selected by the user at 356). It takes time to start timing the current program when the user enters the patient's name and identification or chooses not to enter the patient's name and identification. The program master user interface screen 358 also includes an option for taking a snapshot (eg, a graphical or button with text). Snapshot option 358 allows a user to select the current frame in which to store the video material or the imaged imaging material collected from imaging assembly 18 by the console. The identification information about the snapshot can be automatically provided and/or entered by the user on the console for subsequent identification of the snapshot. As disclosed above, the interface cable 242 can include a control device 248 that can be provided on the console 23 in addition to (or in lieu of) the snapshot option 358. At 360, the main user interface screen of the program provides the user with a file function option (labeled as "File Function" or as a folder icon) that allows the user to access the file stored by the console. The "File Function" option can also be accessed directly from the main menu user interface screen. After selecting the "File Function" option from the main user interface screen of the program of FIG. 20 and FIG. 21 or, for example, the main menu user interface screen, the user is directed to the file function user interface screen.

The file function user interface screen presents a user with a list of directories stored in the console, and also includes the "preview video" feature described above. Each catalog represents stored video material or imaged imaging material associated with a particular tube assembly 10. In an embodiment, console 23 can read a serial number or other unique identifier from console connector 22. The serial number or other identifier can be specific to the feeding tube assembly 10 such that it can be distinguished from all other feeding tube assemblies. In the illustrated embodiment, the console connector 22 includes an electronic memory component 243 that stores an identifier for the irrigation tube assembly 10. All of the data received from the irrigation tube assembly 10 having a particular serial number or other identifier can be stored in a single directory in the console 23. Data having different serial numbers or other identifiers received from an irrigation tube assembly 10 can be stored in a different directory.

A user can 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 via the selected user interface screen (shown in an alternative embodiment of FIGS. 22 and 23). This user interface presents a list of files (eg, image files) associated with the selected directory. The image file represents the image selected by the user via the snapshot option. The user can select at least one file from the image directory and export the file via the "Export" option 380, rename the file via the "Rename" option 382, delete the file via the "Delete" option 384, and via the "Mark/View" option 386. Label or view the file.

If the user selects the "Export" option 380 from the file function user interface screen, the raw/JPEG user interface screen is displayed (shown in an alternative embodiment of FIGS. 24 and 25). This user interface presents a list of files associated with the aforementioned selected directory and allows the user to select one or more files. The user interface allows the user to specify a specific console universal serial bus (USB) at 390, through which the selected file will be exported. A suitable number of bus bars can be provided. Two stacked bus bars are provided in one embodiment. In another embodiment, the console 23 may additionally or alternatively be configured to wirelessly remit the selected file to a receiving device and/or to export the selected file to the receiving device via an Ethernet connection. Once the selected file has been exported, the option to delete the selected file from the console is also presented to the user at 392. At 394 and 396, respectively, the user is prompted to select whether to export the file as an uncompressed file (for example, a raw file) or to export the file as a compressed file (for example, 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 an embodiment, the default format of the file is DATE_SUD-SN_PT-NAME_PTID_TIME_SEQ#.img, where DATE=the current date set to the console via the "date/time" feature (eg yyymmdd); SUD-SN=single use Device serial number (eg, from console 23 from console connector 22) PT-NAME = patient name entered by the user via the patient information user interface screen; PT-ID = patient identifier entered by the user via the patient information user interface screen; TIME = via The "date/time" feature is set to the current time of the console (eg, hhmmss); SEQ# = the image number received from the imaging component, wherein the first image transmitted from the imaging component has an image number 1 and is subsequently received by each image. The image number is incremented by one.

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, the user is presented with the delete user interface screen to allow the user to delete the file. The delete user interface screen provides the user with a list of files included in the selected directory. The user can select one or more files from the directory and then select a delete option (eg delete button or icon). When the user selects the delete option from the delete user interface screen, the user interface screen is prompted to confirm the deletion of the selected file from the console via the delete confirmation user interface screen. Once the user confirms that the selected file should be deleted, the selected file is deleted from the console.

If the user selects the "Mark/View" option 386 from the file function user interface screen, one of the user interface screens shown in the alternative embodiment of FIGS. 26 and 27 is displayed. View the user interface screen to display the images stored in the selected file. Viewing the user interface screen can also provide the user with one of the "Marking" options in 400 and the "Compare with Video" option in 402. If the user selects the "Compare with Video" option at 402, the console 23 presents a comparison user interface screen to the user (shown in an alternative embodiment of FIGS. 28 and 29). The first portion 404 of the comparison user interface screen displays the images stored in the selected file. Comparing one of the user interface screens, the second portion 406 can display the view The data or the imaged imaging material currently being received by the console from the imaging assembly 18. In an embodiment, the images on the first portion 404 and the second portion 406 can be zoomed or panned. By comparing the previously captured image of the previous tube placement in the patient's body with the current video data showing the current tube placement in the patient, a user can determine if the tube has been displaced within the patient. Additionally or alternatively, a user may compare an image of a previously placed tube with current information representative of the current tube placement to facilitate evaluation of whether the tube is currently placed properly. It should be noted that the first portion 404 and the second portion 406 of the comparison user interface screen are depicted as being horizontally aligned; however, the first portion 404 and the second portion 406 may alternatively be vertically aligned with respect to each other, and may be used. The configuration is modified without departing from the scope of the invention.

The comparison user interface screen provides the user with one of the "mark" options at 408 and one of the "program screen" options at 410. If the user selects the "Program Screen" option 410, the console redirects the user to the patient information user interface screen described above. If the user selects the "Mark" option 408 from the comparison user interface screen (Figs. 28 and 29), or selects the "Mark" option 400 from the view user interface screen (Fig. 26 and Fig. 27), the console is directed to the user. One of the alternative embodiments, shown in Figures 30 and 31, is labeled with a user interface screen. The user interface screen is presented to the user with a "text" option at 420, a "dash" option at 422, an "approval" option at 424, a "reset" option at 426, and "all" at 428. Restore option.

If the user selects the "Text" option 420, the user interface screen allows the user to indicate the portion of the image that is displayed on the user interface screen by the user, for example, by touching or tapping. After receiving the user input indicating the position of the text, the user interface screen is displayed to display additional options to the user. In particular, the annotation user interface screen provides the user with the option of selecting text from a list of texts of the anatomy to name an anatomical structure. The annotation user interface also provides the user with the option to add free text to the image. If the user selects text from the text list to name an anatomical structure, then The selected text appears on the screen at the center of the text position selected by the user. If the user chooses to add free text to the image, a user interface screen is added to add a keyboard to the user interface screen and the user is allowed to input text accordingly. If the keyboard on the user interface screen is overlaid on the text position selected by the user, the text input by the user is moved up until the user finishes inputting the text. Once the text entry is completed, the entered text can be displayed across the center of the text position selected by the user on the screen.

If the user selects the "dash" option 422, the user interface screen allows the user to instruct the user to place the first end of a line segment in the image displayed on the user interface screen, for example, by touching or tapping. section. The user can then indicate, for example via a drag and drop operation, that the second end of the line segment should be located on the user interface screen. If you select the "Resume" option 426, the previously unsaved label items (such as text, line segments) are removed from the image. This operation can be repeated until no unmarked items remain in the image. If you select "Restore All" option 428, all unsaved labels 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 a user to enter his/her username and password. Once the username and password are entered, the console attempts to authenticate the user associated with the approver status. If the user has been authenticated, a new message (such as "Authorized by USERNAME on DATE") is sent to the image (for example, under the patient identification information at the top left of the image), where USERNAME=Enter the current use of the approver user interface screen. User name; DATE = current date set to the console via the "date/time" feature (eg yyymmdd); TIME = current time set to the console via the "date/time" feature (eg hhmmss).

Once an approver user indicates that he/she approves the placement of the tube, permission is allowed to pass The tube assembly 10 provides nutrition to the patient. For example, the console can be configured to provide a signal that allows the pump to operate.

The order in which the operations or implementations of the operations in the embodiments of the present invention are illustrated and described herein is not essential. That is, the operations may be performed in any order, unless otherwise stated, and embodiments of the invention may include additional operations or fewer operations than those disclosed herein. For example, it is contemplated that performing or performing a particular operation before, concurrently with, or after another operation is within the scope of the invention.

Embodiments of the invention may be implemented using computer executable instructions. Computer executable instructions can be organized into one or more computer executable components or modules. The invention may be practiced 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 specific components or modules illustrated in the drawings and described herein. Other embodiments of the invention may include different computer-executable instructions or components having more or less functionality than those illustrated and described herein.

Referring to Figures 32A-42, another embodiment of the imaging feeding tube assembly is generally indicated at 510. This embodiment is similar to the various embodiments described above, and like components are indicated by the corresponding reference numerals plus 500. Referring to Figures 32A and 32B, the imaging feeding tube assembly 510 includes: a feeding tube 512; an inlet joint adjacent one of the second longitudinal ends (i.e., a proximal end) of the tube (generally indicated as 516); An imaging assembly (shown generally as 518) of one of the longitudinal ends (ie, a distal end); and a console connector (generally indicated at 522) that is secured to the tube between the inlet fitting 516 and the imaging assembly 518. As disclosed above, imaging irrigation tube assembly 510 can be used with console 23 (or a different console or display) for displaying one or more images produced by imaging assembly 518. Inlet joint 516 is similar to inlet joint 16, and thus, various features of inlet joint 516 can be described with reference to previous inlet joints. The disclosure of the components of the aforementioned irrigation tube assembly embodiment 10 set forth herein above is also applicable to the components of the current irrigation tube assembly embodiment 512, unless otherwise stated below.

Tube 512 can be a one-piece tube. Referring to FIG. 33, an electronic conductor 524 (in general, a signal transmitting component) extends longitudinally from the imaging assembly 518 to the console connector 522 along substantially the entire length of the tube 512. In the illustrated embodiment, there are six cable lines 524 between the console (eg, console 23) and the imaging assembly for powering the imaging assembly 518 and transferring data therebetween, although without departing from the invention. There are more or fewer cables in the context of the category. Cable 524 is disposed in three separate and distinct conductor channels 526 in the illustrated embodiment. Cables 524 are provided in pairs, with each pair of cables disposed within the same conductor passage 526 in the tube wall. In one embodiment, the cable 524 and tube 512 can be coextruded such that the cable is embedded in the wall of the tube. After co-extrusion, the cable 524 can be ablated to remove the respective sheath and/or mechanically peel off the sheath to expose the lead such that the cable can be electrically connected to the imaging assembly 518 and the console connector 522.

Referring to FIGS. 34-37, the imaging assembly 518 can include an elongated housing 550, a flexible circuit assembly including a camera 584 and a light source 596 mounted thereon and housed within the housing (indicated generally as 560 in FIG. And attaching to a cover 570 on the camera at a first longitudinal end (eg, a distal end) of one of the imaging assemblies. In this embodiment, one of the flexible circuit assemblies 560, the flex circuit 580, can be a rigid circuit comprising one or more spaced apart rigid structures 561 mounted on the flex circuit. Electronic components such as those described above with respect to the previous embodiments are mounted on a rigid structure 561. The flex circuit 560 can be bent at a flexed position between the rigid structures 561 such that the flex circuit can be selectively deformed only at the bend location 581 along the length of the folded flex circuit. Light source 596 and camera 584 are mounted on the same end camera mounting portion 582 of rigid flex circuit 560 that extends generally transverse to the longitudinal axis of imaging assembly 518. In the illustrated embodiment, camera mounting portion 582 can mount one of rigid structures 561 thereto, to which camera 584 and light source 596 can be secured.

The electronic components used to operate the imaging assembly 518 can be similar or identical to the electronic components disclosed above for operating the imaging assembly 18. In addition to these electronic components, The flex circuit 560 includes a decoupling capacitor (summed indication 598) for providing a stable supply voltage with one of the low noise to the camera 84. In the illustrated embodiment, a decoupling capacitor 598 is embedded between the layers of the camera mounting portion 582 of the flex circuit 560. In this way, the decoupling capacitor 598 is directly adjacent to the camera 584.

Referring to Figures 40 and 42, the cover 570 can be similar to the cover 70 except that the cavity in the cover 570 is typically sized and shaped to accommodate only the camera 584 without the camera and light source 596 of the previous embodiment. In addition, referring to FIG. 40, the cover 570 includes a plurality of radial locking ribs 589 received in respective radial locking slots 600 (which are formed on the inner surface of the outer casing 550). Engagement between the locking rib 589 and the locking groove 600 inhibits longitudinal movement between the outer casing 550 and the cover 570. Cover 570 can be other configurations without departing from the scope of the invention.

In a non-limiting example (shown in Figure 40), the outer casing 550 can be molded and include longitudinally spaced reinforcing structures 591 (i.e., wall portions of the outer casing 550 having increased thickness) and having a greater ratio than disposed between the reinforcing structures. The structure 591 has a curved position 593 of the wall portion of the thinner outer casing 550. The stiffening structure 591 is typically disposed adjacent to the electronic component and the rigid structure on the flex circuit 580, while the flex location 593 is typically disposed adjacent the curved location on the flex circuit. With this configuration, the outer casing 550 further promotes the bending of the imaging assembly 518 along its length at selected locations and inhibits bending at the longitudinal position where the electronic components are positioned. The difference in wall thickness of the outer casing 550 relative to the structure 591 and the 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 outer casing 550 can be molded over the cover 570, the rigid flex circuit assembly 560, and the imaging assembly connector 520 to form a unitary imaging assembly 518. For example, cover 570, rigid flex circuit assembly 560, and imaging assembly connector 520 can be placed in a holder of an overmolding procedure, and then housing 550 can be molded over the component. Materials for overmolding may include urethane or other materials. In yet another embodiment, the outer casing 550 can be preformed and the cover 570 and the imaging assembly connector 520 can be secured to respective ends of the outer casing by, for example, solvent bonding or by other suitable means.

Referring to Figures 32A, 32B, 38 and 39, the current feeding tube assembly 510 includes an imaging assembly connector (generally indicated at 520) as in the aforementioned feeding tube assembly 10. Similar to the previous embodiment of the imaging assembly connector 20, the current imaging assembly connector 520 defines one of the feeding channel outlets 540 in fluid communication with the feeding channel 514 of the tube 512. In the illustrated embodiment, the first longitudinal end of the tube 512 is received and secured in the feeding channel outlet 540 of the imaging assembly connector 520 to provide fluid communication therebetween. Adjacent imaging assembly 518 encloses outlet 540 to prevent nutrient solution from entering imaging assembly 518. Accordingly, imaging assembly 518 is not in fluid communication with feeding channel 514. Instead, the feeding solution is released laterally from the outlet 540 and into the patient (only one such lateral opening is shown in Figures 32 and 38).

Referring to FIGS. 38 and 39, a first longitudinal end (eg, a distal end) of one of the imaging assembly connectors 520 defines an alignment slot 521 for receiving one of the proximal ends of the rigid flex circuit assembly 560. Aligning the slots 521 facilitates proper positioning of the rigid flex circuit assembly 560 with respect to the imaging assembly connector 520. Imaging assembly connector 520 can be other configurations without departing from the scope of the present invention.

Referring to Figure 42, the console connector 522 can be secured to the feeding tube 512 and can extend laterally outward therefrom. The currently illustrated console connector 522 includes a housing 728, a PCB 730, an inlet header connector 800, and a filler tube connector 802 secured to the housing. A connector (such as a USB port connector 532) can be mounted on the PCB 730 for communicatively connecting an interface cable to the PCB 730. In another embodiment, PCB 730 can include an edge connector as disclosed above with respect to the previous embodiments. An electronic memory component 743 can be mounted on the PCB 730. The outer casing 728 can define a receptacle 736 having a size and shape for matingly receiving one of the interface connectors (not shown) having a corresponding size and shape. A connector cover 737 can be snapped to the outer casing 728 to selectively close the receptacle 736 when it is not in use.

Housing 728 can be molded over inlet header connector 800 and fill tube connector 802 to secure the connector to the housing. Fixing the proximal end of the feeding tube 12 to one of the feeding tube connectors 802 Connected to channel 804. The inlet header connector 800 connects the inlet fitting 516 to the console connector 522 and defines a fluid connection inlet fitting 516 to one of the channels 806 of the feeding tube 512. In another embodiment (not shown), the one-piece filling tube 512 can be opened through one of the console connectors 522 and directly connected to the inlet fitting 516. The outer casing 728 can be secured to the feeding tube 512 using an adhesive or otherwise. The outer casing 728 can be secured to the inlet joint 516, and more particularly to the distal end of the inlet joint such that the outer casing abuts the inlet joint. Console connector 522 can have other configurations without departing from the scope of the present invention.

Referring to Figure 43, another embodiment of an interface cable for connecting the irrigation tube assembly 10, 510 to the console 23 is indicated at 742. Interface cable 742 is similar to interface cable 242 of the previous embodiment. As with the interface cable embodiment 242 described above, the interface cable 742 can include a first interface connector 744 and a second interface connector 746 at opposite ends of the cable. The first interface connector 744 is sized and shaped to fit (eg, selectively) into the receptacle 736 of the console connector 522 and to the USB port connector 532, or an edge connector or console Another connector associated with the connector establishes a connection. The first interface connector 744 includes an annular rib or bead 770 that engages an interior surface of one of the receptacles 736 to form a substantially fluid-tight seal therewith to prevent liquid from entering the receptacle. The second interface connector 746 is sized and shaped to mate (e.g., selectively insert) into a corresponding socket of the console 23 and establish a connection with the console. The first interface connector 744, the second interface connector 746, and the corresponding receptacle 736 can be configured such that the first interface connector 744 is incapable of mating with the receptacle on the console 23 and the second interface connector 746 is not compatible with the console connector 522 socket 736 fits. Interface cable 742 can be other configurations without departing from the scope of the present invention.

In the illustrated embodiment, the first interface connector 744 can include an imaging signal buffer component 750 that drives an imaging signal (eg, an I ² C signal) between the imaging components 18, 518 and the console (eg, I ² C buffer component). By positioning the imaging signal buffer component 750 in the first interface connector 744, the capacitance is substantially equally dispersed among the conductors 24, 524 (eg, wires in the cable) and the interface cable 742 in the irrigation tube assembly 10, 510. Between conductors (such as wires). This configuration minimizes or reduces the capacitance in any section of the system and maximizes or enhances image signal integrity. Moreover, because the console connectors 22, 522 are only mated with the first interface connector and not with the second interface connector 746, the first interface connector 744 and the imaging signal buffer component 750 will desirably be adjacent to the irrigation tube assembly 10. 510. Interface cable 742 may not include an imaging signal buffer component 750 and may be other configurations without departing from the scope of the present invention.

One or more aspects of the present invention can be directed to a catheter that can be a feeding tube having an imaging assembly that has an imaging device or sensor. The imaging assembly can generate and transmit imaging signals produced 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 be configured to selectively present a reference menu containing one of the menu items on the display. The menu item corresponds to a reference material, which includes any one or more of photos, video recordings, audio recordings, graphics, animations, and text. Materials provide information on 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 Any one or more of the information. One or more aspects of the present invention may be directed to an imaging catheter system comprising: a feeding tube having an inlet connectable to a source of a feeding liquid; at an end of the inlet and fluidly connected to the inlet through a feeding channel An exiting device; and an imaging device disposed adjacent to the outlet, the imaging device configured to generate and transmit an imaging signal corresponding to an image of a patient's anatomy; and a console including a display and a memory, The memory stores a plurality of reference materials selected from the group consisting of: audiovisual materials such as video, audio, and photos, and textual materials such as charts, animations, and texts, and combinations thereof. In some cases, each of the plurality of reference materials can provide information regarding anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter features, console preparation, console operation, console features, system operation Information on at least one of the system features and contact information. Preferably, the console is configured To receive an imaging signal, present at least a portion of the at least one image corresponding to the imaging signal on the display, and present a reference menu including one of the menu items corresponding to at least one of the reference materials on the display. At least one of the plurality of reference materials can include a photo showing one of the anatomical landmarks. The anatomical landmarks may be one of a bronchus, a larynx, a tracheal ring, a cardia, a pyloric sphincter or a pylorus, a ring cartilage, a bronchial segmentation, an esophageal junction, a gastric fold, a duodenal fold, and a pyloric hole.

One or more further aspects of the invention may be directed to one method of promoting (or providing) the use of an irrigation tube assembly. The method can include providing an irrigation tube having an imaging device connectable to an inlet of a source of feeding liquid, at an end of the inlet and connected to an outlet of the inlet through a feeding channel, and disposed adjacent to the outlet, The imaging device is configured to generate and transmit an imaging signal corresponding to an image of a patient's anatomy; and provide a console including a display and a memory, the memory storing a plurality of selected from the following Reference materials for the group: photos, video recordings, audio recordings, charts, animations, text, and combinations thereof. According to some particular embodiments, each of the reference materials may provide for anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter features, console preparation, console operation, console features, systems Information on at least one of operations, system features and contact information. In some cases, the console can be configured to receive an imaging signal, present at least a portion of the at least one image corresponding to the imaging signal on the display, and present a menu item corresponding to at least one of the reference materials on the display A reference menu. In some cases, the console can be configured to simultaneously present a photo from one of the plurality of reference materials and a video image corresponding to the image signal from the imaging component on the display, wherein the photo provides a representative anatomical or anatomical marker point. According to a further aspect of the present invention, the method may comprise at least one of: storing additional reference material in the memory; removing at least one reference material from the memory; and updating the memory using an updated memory, updated At least one updated reference material is stored in the memory. According to other further methods, the method may include: receiving from a user Receiving the console; and after receiving the console, performing at least one of: storing additional reference material in the memory, removing at least one reference material from the memory, and replacing the memory with the updated memory, updated At least one updated reference material is stored in the memory.

Referring to Figure 46, an imaging catheter system (in general, a medical system) is generally indicated by reference numeral 810. System 810 includes an imaging catheter (generally designated 812) and is operatively coupled to one of the imaging catheter consoles 814 by, for example, an interface cable 816. Imaging catheter 812 can include an imaging component 820 having one of imaging devices 822 for generating 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 a fiber optic cable. The imaging assembly can also include components (such as LEDs) for illuminating or providing light to the field of view. The imaging assembly can further include one or more components, such as a processor, a memory device that facilitates the capture of the field of view image, the conversion to an imaging signal, and the transmission of the imaging signal. The imaging device generates and transmits an imaging signal to the console 14 via cable 816 or wirelessly through any suitable communication program or protocol. Other cables may be used without departing from the scope of the invention.

The console receives and converts the imaging signal from the imaging assembly and presents the image on one of the displays 830 in one of the console housings 832. As exemplarily shown in FIG. 47, the console can also include a power switch 834 for selectively powering the console. Other consoles can be used without departing from the scope of the invention. The display preferably responds to one or more user inputs or instructions (e.g., tapping the display twice) to launch and present one or more menus providing a plurality of options for operating the console and imaging assembly. For example, one of the user inputs causes the display to present a reference menu as depicted in FIG.

Selections or items 840a, 840b, and 840c may be presented for selecting and viewing images stored using prior programs executed by the system. As shown in FIG. 47, the console can be configured to include and provide an option 842 titled "Reference Library", the call from the memory containing a database or a plurality of stored in the console memory. Reference material in the body One of the menu items is a reference menu. For example, a library of reference materials that may include one or more of the reference materials may include, for example, photos, video recordings, audio recordings, graphics, animations, and/or text. Reference materials provide information about anatomy, preparing a patient, preparing an imaging catheter for use, placing an imaging catheter in a patient, console preparation, console operation, console features, overall system operation, overall system characteristics, and/or contact information ( Any one or more items of information such as an address and/or telephone number that can be used to obtain further assistance. Other selections or information that may be provided in the menu may be viewed by manipulating proximity selection 840a to selections 840c and 842 on the display to locate one of the reels 844. In some embodiments, commands, instructions, and/or navigational icons such as a return icon 850 and an inspection view 852 can be provided along the bottom of the display.

In some embodiments (not shown), it is contemplated that display 830 presents both reference menu 842 and images generated from imaging signals provided by the imaging device. In other embodiments (not shown), it is contemplated that display 830 presents a reference menu when sensing a unique input, such as when a user touches the display twice during a pre-selection period. In still other embodiments (not shown), it is contemplated that display 830 presents an illustration (which presents a reference menu) when selected by the user. Alternatively, console 814 can include a button that can be pressed to cause display 830 to present a reference menu.

In some embodiments, the console can present both the reference material as indicated above and the image produced from the imaging signal. For example, as exemplarily illustrated in FIG. 29, a typical anatomical feature or one of the indicia photographs may be displayed on a portion of the display and live video generated from the imaging signal and transmitted by the imaging assembly may be displayed on another portion of the display. Thus, a user can identify the location of the imaging component in the patient by comparing the live video generated from the imaging signal transmitted by the imaging component with a reference photo containing one of the anatomical features or anatomical landmarks. Further, as exemplarily shown in FIG. 31, a reference material, such as a photo 864 having one or more text references or indicia 866, may be presented on the display, providing identification information such as the name of the target anatomical feature or anatomical symbol or description. Anatomical mark can be Any of the bronchus, larynx, tracheal ring, cardia, pyloric sphincter, and pyloric hole. As can be further appreciated by comparison of Figures 29 and 31, the visual reference material can be presented only on one portion of the display or on the entire display. As shown in FIG. 29, when the visual reference material is partially rendered using only one of the displays, other indicators (such as diagrams 420, 422, 424, 426, and 428) and one or more visual state identifiers 872a may be displayed on the display. , 872b and 872c. Alternatively, as shown in FIG. 31, any one or more of the illustrations 420, 422, 424, 426, and 428 and the visual state identifiers 872a, 872b may be presented over the visual reference material when the visual reference material is rendered using the entire display. And any one or more of 872c. In other cases, for example, by selecting a menu to operate the console without any identifier or token: a copy of one of the representative bronchial photographs (exemplarily shown in Figure 49A); A copy of one of the representative stomachs of one of the gastric wrinkles (exemplarily shown in Figure 49B); and a copy of one of the representative tracheal rings (exemplarily shown in Figure 49C).

Reference material can also provide instructive guidance. For example, as shown in Figure 48, the console can be configured and operated to display a graphical illustration of one of the correct and incorrect paths. Further embodiments contemplate the simultaneous presentation of the schematic illustration of Figure 48 adjacent to an instant or live video image from an imaging device to provide further guidance during use.

In some embodiments of the invention, the material may be positioned or stored in a catalog having a name corresponding to a particular reference material. For example, a portion of a system operation manual can be stored in a directory titled "System Operation Manual." In some embodiments, the reference material can be stored as a read-only file, ensuring that the content remains the same. Alternatively, dictation comments, out-of-column annotations, and other annotations may be entered into the reference material and stored as a new file with or without association with any one or more of the reference materials in the reference library or coupling.

It is further conceivable that the reference material file can be modified when the software is updated. Therefore, each software version can also be used to update and improve reference materials for the system. In other cases, Systems that have been used in the field can be sent by a user to a service, manufacturing or repair facility where any stored or existing reference material (or portions thereof) can be removed (or removed) with additional reference Information is included in the memory. In other cases, the system received at the service, manufacturing, or repair facility may be updated by replacing the memory component therein, thereby providing updated reference material.

Depending on the particular procedure in which the imaging catheter system is used, the system can also include, for example, a conventional irrigation tube assembly having an irrigation tube for delivering intestinal fluid to a patient. A large conventional irrigation tube includes a feeding passage extending between an inlet and an outlet. The imaging catheter can be positioned adjacent the outlet of the feeding tube to produce an imaging signal corresponding to a particular portion of the patient's digestive tract (eg, the stomach of a patient). In some cases, it will be desirable to seal the imaging assembly from the feeding channel of the feeding tube to inhibit intestinal feeding fluid in the feeding channel from entering the imaging assembly resulting in potential damage. In use, reference materials such as video, photos or graphics 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 can be directed to a computer readable medium accessible by a console and a plurality of data structures having reference material stored in the medium corresponding to a reference library, wherein each of the reference materials It can be: audiovisual information including, for example, photos, video files, audio files, and combinations thereof; and text or graphical information including, for example, charts, sketches, and text information. Reference material for a reference library in a computer readable medium provides: information about at least one of an anatomical reference or feature or anatomical landmark; operation instructions for at least one of an imaging catheter, a console, and a feeding tube; Contact information for at least one of the esophagus and the console. Still further aspects may be directed to providing a computer readable medium having a plurality of data structures stored on a reference material contained in a reference library on the medium; and replacing by additionally adding or using updated or revised reference materials A reference library of reference materials is updated with existing reference materials. Non-limiting examples of computer readable media include memory devices and can be optical and magnetic based media, any of which can be erasable, Programmable or permanent media.

Any reference material in the reference library may be stored in any format or file type, such as but not limited to aiff, wav, xmf, fits, tiff, avi, asf, wma, wmv, 3gp, flv, f4v, iff, jpg, bmp, mpeg , mp4, rm, ogg, pdf, rtf, and txt, either of which can be in either the original or compressed form. Any such reference material may be prevented from being modified or deleted on-site by a healthcare provider, but any such reference material may be modified, revised or deleted by a qualified technician at, for example, a repair or manufacturing facility or at a service facility.

As illustrated, the console can be configured to identify a plurality of levels (ie, states) and limit operations that can be performed by the console based on the level associated with each user. For example, the console can be configured to recognize four levels of users: operator, administrator, approver, and maintainer. Depending on the user level, the reference menu can be changed to suit the user's technology and needs. For example, the console can be configured to authorize administrator level users to create or create user accounts or other operator accounts, as well as associated data storage substructures, and to view video material. The console can be configured to authorize the user of the approver level to view the video material and label the approved data to the video material. The console can be configured to authorize a user at the maintainer level to perform maintenance functions such as software updates and time adjustments to the console. The console can be programmed to authorize the user at the maintainer level to operate the console only when no patient data is stored on the console.

Having described the aspects of the invention in detail, it is understood that modifications and variations may be made without departing from the scope of the invention as defined in the appended claims. A variety of changes can be made in the above-described constructions, products, and methods without departing from the scope of the invention, and it is intended that the subject matter described in the above description Sexual meaning. For example, simultaneous display of the reference anatomical landmarks may involve: after an operator or user has indicated that a current reference anatomical landmark has been identified by drawing and optionally labeling a photographic image from the imaging system, gradually exhibiting the next expected Or a sequence mark. When introducing the state of the invention The articles "a", "an" and "said" are intended to mean the presence of one or more elements. The terms "including", "comprising" and "having" are intended to be inclusive and include additional elements in addition to those listed.

814‧‧‧ console

830‧‧‧ display

832‧‧‧ Shell

834‧‧‧Power switch

840a‧‧‧Selection or project

840b‧‧‧Selection or project

840c‧‧‧Options or projects

842‧‧‧Selection/Reference Library

844‧‧‧ reel

850‧‧‧Return icon

852‧‧‧ inspection view

Claims (16)

A method of promoting the use of a feeding tube assembly, comprising: providing an irrigation tube having an inlet connectable to a source of feeding fluid, at the end of the inlet and through An irrigation channel fluidly coupled to an outlet of the inlet, and an imaging device disposed adjacent the outlet, the imaging device configured to generate and transmit an imaging signal corresponding to an image of one of the patient's anatomy; and provide a The console includes a display and a memory, wherein the memory stores a plurality of reference materials selected from the group consisting of a photo, a video recording, an audio recording, a chart, an animation, a text, and a combination thereof. Each of a plurality of reference materials provides information on anatomy, patient preparation, catheter preparation, imaging catheter placement, imaging catheter operation, imaging catheter features, console preparation, console operation, console features, system operation, system features And information of at least one of the contact information, wherein the console is configured to receive the imaging signals, present on the display At least a portion of at least one image of the imaged signals, and a display menu comprising one of a menu item corresponding to at least one of the reference materials, wherein at least one of the plurality of reference materials comprises A partial schematic illustration comprising a contrasting correct and incorrect path for inserting the feeding tube into the patient, each path comprising at least one separate representative anatomical image along the respective path. The method of claim 1, wherein the console is configured to simultaneously present a photo from the plurality of reference materials and a video image corresponding to the imaging signals from the imaging device on the display, wherein the photo A representative anatomical mark is provided. The method of claim 1, further comprising at least one of: storing an additional reference The material enters the memory, removes at least one reference material from the memory, and replaces the memory with an updated memory, the updated memory having an updated reference material stored therein. The method of claim 1, further comprising at least one of storing additional reference material into the memory, removing at least one reference material from the memory, and replacing the memory with an updated memory, the The updated memory stores at least one updated reference material. An imaging catheter system adjacent to an irrigation tube assembly comprising an irrigation tube for delivering an enteral feeding fluid to a patient, comprising: an imaging catheter comprising an image for generating an anatomy corresponding to a patient An imaging component of an imaging device that transmits the imaging signals generated by the imaging device; and a console adapted to receive the imaging signals transmitted by the imaging component and to a display Presenting images generated from the imaging signals, the console being adapted to selectively present a reference menu on the display comprising one of a menu item corresponding to a reference material selected from a group of reference materials, such references Materials include at least one of photographs, video recordings, audio recordings, graphics, animations, and text, each of which provides information on anatomy, patient preparation, imaging catheter preparation, imaging catheter placement, imaging catheter manipulation, imaging catheter features, control Desk preparation, console operation, console features, system operation, system features, and contact information One of the plurality of reference materials, wherein at least one of the plurality of reference materials includes a partial schematic illustration comprising a contrasting correct and incorrect path for inserting the feeding tube into the patient, each path Contains at least one separate representative anatomical image located along the respective path. The imaging catheter system of claim 5, wherein the console simultaneously presents the reference menu and the images generated from the imaging signals on the display. The imaging catheter system of claim 5, wherein the console simultaneously presents the reference material and the images generated from the imaging signals on the display. The imaging catheter system of claim 5, wherein each of the reference materials is positioned in a directory having a name corresponding to one of the respective reference materials. The imaging catheter system of claim 5, wherein the display is adapted to present the reference menu when a user touches the display twice during a pre-selection period. The imaging catheter system of claim 9, wherein the reference material is modified by updating the system software. The imaging catheter system of claim 5, wherein the feeding tube has an inlet and an outlet and a feeding passage extending between the inlet and the outlet, the imaging catheter being positioned adjacent to the outlet to generate a patient corresponding to the patient An imaging signal of one of the digestive tracts, the imaging assembly being sealed from the feeding channel to inhibit intestinal feeding fluid in the feeding channel from entering the imaging assembly. The imaging catheter system of claim 5, wherein the console is configured to present a graphical user interface on the display. The imaging catheter system of claim 12, wherein the display is a touch screen display adapted to present an illustration of control of the system by touching the display. The imaging catheter system of claim 12, wherein the console is configured to simultaneously present a reference material and a video image signal from the imaging component on the display. The imaging catheter system of claim 5, further comprising an interface cable to the imaging catheter to the console for transmitting the imaging signals generated by the imaging device to the console. The imaging catheter system of claim 5, wherein the console is configured to simultaneously display the schematic illustration for indicating and the imaging generated from the imaging signal.