Program, information processing method, information processing device, and puncture assistance system

The system addresses the challenge of catheter position determination by using markers and light sources to generate images for precise vascular access device placement, improving puncture operation accuracy.

WO2026058468A1PCT designated stage Publication Date: 2026-03-19TERUMO KK +1
View PDF 5 Cites 0 Cited by

Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2025-02-05
Publication Date
2026-03-19

AI Technical Summary

Technical Problem

Existing systems fail to accurately determine the position of a catheter within a vascular access device during puncture procedures due to the inability to visually observe the inside of the body, making precise placement challenging.

Method used

A system that uses markers on the vascular access device, such as a vascular access device with light sources and markers, to determine the position of the catheter by acquiring and processing marker positions, generating images to guide precise catheter placement.

Benefits of technology

Enables accurate visualization of the catheter position relative to blood vessels, enhancing the precision and effectiveness of puncture operations.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure JP2025003718_19032026_PF_FP_ABST
    Figure JP2025003718_19032026_PF_FP_ABST
Patent Text Reader

Abstract

Provided is, inter alia, a program with which it is possible to present information that indicates the position of a catheter in a vascular access device. A program causes a computer to execute a process for: acquiring the positions of a first marker and a second marker in a vascular access device that is inserted into a living body; identifying the position of a catheter on the basis of the acquired positions of the first marker and the second marker and the positional relationship between the first marker and the catheter in the vascular access device; generating an image that indicates the identified position of the catheter; and outputting the generated image.
Need to check novelty before this filing date? Find Prior Art

Description

Program, Information Processing Method, Information Processing Apparatus, and Puncture Support System

[0001] The present invention relates to a program, an information processing method, an information processing apparatus, and a puncture support system.

[0002] In the medical field, for blood sampling, injection, infusion, intravascular catheter placement, etc., a puncture operation is performed on a subject using a vascular access device. The operator punctures the vascular access device from the body surface of the subject to the target location within the blood vessel. Since the inside of the living body cannot be visually observed from the outside of the body, it is not easy to properly place the vascular access device at the target position.

[0003] As a technique for supporting such a puncture operation, Patent Document 1 discloses a system that projects an image onto the skin to clarify the relative position of the needle tip with respect to the vascular structure under the skin surface using a catheter having a light source that illuminates the needle tip.

[0004] Japanese Patent No. 6054056

[0005] The technique described in Patent Document 1 has a problem in that it is for grasping the position of the tip of the needle in the vascular access device and not for grasping the position of the catheter.

[0006] An object of the present disclosure is to provide a program or the like that can present information regarding the position of a catheter in a vascular access device.

[0007] (1) A program according to an aspect of the present disclosure causes a computer to execute a process of acquiring positions of a first marker and a second marker in a vascular access device to be punctured into a living body, specifying the position of the catheter based on the acquired positions of the first marker and the second marker and the positional relationship between the catheter and the first marker in the vascular access device, generating an image showing the specified position of the catheter, and outputting the generated image.

[0008] (2) In the program of (1) above, the first marker may be formed at the tip of the needle in the vascular access device.

[0009] (3) In the program of (1) or (2) above, the positions of the first marker and the second marker may be obtained in a viewing direction different from the vertical viewing direction with respect to the axial direction of the vascular access device, the distance between the first marker and the second marker in a viewing direction different from the vertical viewing direction may be calculated based on the obtained positions of the first marker and the second marker, and the position of the catheter in a viewing direction different from the vertical viewing direction may be determined based on the calculated distance, the distance between the first marker and the second marker in the vertical viewing direction, and the distance between the first marker and the catheter.

[0010] (4) In any one of the programs described in (1) to (3) above, the position of the tip of the catheter may be determined based on the positions of the first marker and the second marker and the positional relationship between the tip of the catheter in the vascular access device and the first marker.

[0011] (5) In any one of the programs described in (1) to (4) above, the first marker and the second marker may be spaced apart in the axial direction of the vascular access device.

[0012] (6) In any one of the programs described in (1) to (5) above, if the position of the second marker moves by a predetermined amount or more after the position of the first marker is no longer detected, the output of the image showing the position of the catheter may be terminated.

[0013] (7) In any one of the programs described in (1) to (6) above, an image of the first marker and the second marker may be acquired, the position of the catheter may be determined based on the positions of the first marker and the second marker in the acquired image, and an image may be generated in which the image of the first marker is placed at the determined position of the catheter.

[0014] (8) In any one of the programs described in (1) to (7) above, an image may be acquired of the first marker and the second marker and the blood vessels of the living body, the position of the catheter may be determined based on the positions of the first marker and the second marker in the acquired image, and an image may be generated that includes an image of the first marker placed at the determined position of the catheter and an image of the blood vessels.

[0015] (9) In any one of the programs described in (1) to (8) above, the first marker may emit light from a light source.

[0016] (10) In any one of the programs described in (1) to (9) above, the first marker may emit light from a light source provided in the vascular access device.

[0017] (11) In any one of the programs described in (1) to (10) above, a plurality of the second markers may be formed so as to be spaced apart in the axial direction of the vascular access device.

[0018] (12) In any one of the programs described in (1) to (11) above, the image may be displayed on the surface of the living body in a manner corresponding to the position of the catheter in the living body.

[0019] (13) A program according to one aspect of the present disclosure detects the positions of a first marker at the tip of a needle protruding from the tip of a catheter in a vascular access device that is inserted into a living body, and a second marker in the vascular access device in a time series, and causes a computer to execute a process that outputs information indicating that the catheter has reached a blood vessel in the living body when the position of the second marker has moved by a predetermined amount or more after the position of the first marker is no longer detected.

[0020] (14) An information processing method according to one aspect of the present disclosure acquires the positions of a first marker and a second marker in a vascular access device that is inserted into a living body, identifies the position of the catheter based on the acquired positions of the first marker and the second marker and the positional relationship between the catheter and the first marker in the vascular access device, generates an image showing the identified position of the catheter, and outputs the generated image.

[0021] (15) An information processing device according to one aspect of the present disclosure includes a processing unit that acquires the positions of a first marker and a second marker in a vascular access device that is inserted into a living body, identifies the position of the catheter based on the acquired positions of the first marker and the second marker and the positional relationship between the catheter and the first marker in the vascular access device, generates an image showing the identified position of the catheter, and outputs the generated image.

[0022] (16) A puncture support system according to one aspect of the present disclosure comprises a vascular access device for puncturing a living body and a processing unit, wherein the processing unit acquires the positions of a first marker and a second marker in the vascular access device, identifies the position of the catheter based on the acquired positions of the first marker and the second marker and the positional relationship between the catheter and the first marker in the vascular access device, generates an image showing the identified position of the catheter, and outputs the generated image.

[0023] This disclosure can provide information regarding the position of a catheter in a vascular access device.

[0024] This is a diagram showing an example of the configuration of a puncture support system. This is an explanatory diagram illustrating an example of the configuration of an indwelling needle. This is a cross-sectional view illustrating an example of the configuration of an indwelling needle. This is an enlarged cross-sectional view of the tip side of the indwelling needle. This is a block diagram illustrating an example of the configuration of a processing device. This is a diagram illustrating a method for deriving the position of the catheter tip performed by the processing device. This is a diagram illustrating an example of a method for generating a display image. This is a flowchart illustrating an example of a processing procedure performed by the processing device. This is a flowchart illustrating an example of a processing procedure performed by the processing device of the second embodiment.

[0025] This disclosure will be described in detail with reference to drawings illustrating embodiments thereof.

[0026] (First Embodiment) Figure 1 shows an example of the configuration of the puncture support system 100. The puncture support system 100 comprises an indwelling needle 1 that can be inserted into a blood vessel of a living body 3, and a visualization device 2. The indwelling needle 1 is an example of a vascular access device. The puncture support system 100 is a system that supports the puncture work of a surgeon, such as a doctor, by presenting images showing the condition of the indwelling needle 1 and the blood vessel. The surgeon is an example of a user of this system. In the following, the system will be explained using the case where the target of puncture is a human and the target site of puncture is the forearm as an example. This system can also be applied to medical devices such as surgical support robots.

[0027] The indwelling needle 1 is, for example, a peripheral arteriovenous indwelling needle. The indwelling needle 1 of this embodiment comprises a first light source 161 and a first light-emitting unit 17a and a second light-emitting unit 17b that emit light when they receive light from the light source. In the following description, when it is not necessary to distinguish between the first light-emitting unit 17a and the second light-emitting unit 17b, they will simply be referred to as the light-emitting unit 17.

[0028] The visualization device 2 comprises a processing device 20, a second light source 21, a camera 22, and a display device 23, etc. The visualization device 2 is installed in a medical institution or testing facility where the puncture procedure is performed. The visualization device 2 uses the camera 22 to detect the light from the light-emitting part 17 of the indwelling needle 1 and the light irradiated onto the living body 3 from the second light source 21. The visualization device 2 generates images representing the catheter position of the indwelling needle 1 and vascular visualization images that visualize blood vessels, etc., according to the detection results, and presents them to the operator via the display device 23. Hereinafter, in order to distinguish between the light, for convenience, the light from the light-emitting part 17 will be referred to as light L1, and the light irradiated from the second light source 21 of the living body 3 and reflected by the living body 3 will be referred to as light L2, and the light from the first light-emitting part 17a will be referred to as light L1a, and the light from the second light-emitting part 17b will be referred to as light L1b.

[0029] Figure 2 is an explanatory diagram illustrating an example of the configuration of the indwelling needle 1, Figure 3 is a cross-sectional view illustrating an example of the configuration of the indwelling needle 1, and Figure 4 is an enlarged cross-sectional view of the tip side of the indwelling needle 1.

[0030] In the following description, the direction along the axis C of the indwelling needle 1 is defined as the axial direction, the side of the indwelling needle 1 that is inserted into the living body 3 in the axial direction is defined as the "tip side", and the proximal side that is operated in the axial direction is defined as the "proximal end side". Furthermore, in this specification, the tip means a certain range including the tip (extentmost point) and its surroundings, and the proximal end means a certain range including the proximal end (very proximal end) and its surroundings.

[0031] As shown in Figures 2 to 4, the indwelling needle 1 comprises a catheter 11, a catheter hub 12, an inner needle 13, an inner needle hub 14, a blood exposure prevention unit 15, a first light source unit 16 having a first light source 161, a first light-emitting unit 17a, and a second light-emitting unit 17b. The catheter hub 12 is connected to the proximal end of the catheter 11, and the inner needle hub 14 is connected to the proximal end of the inner needle 13. The blood exposure prevention unit 15 is connected to the proximal end of the inner needle hub 14, and the first light source unit 16 is connected to the proximal end of the blood exposure prevention unit 15. The indwelling needle 1 is a catheter assembly.

[0032] In the assembled state of the indwelling needle 1, the inner needle 13 is inserted into the lumen of the catheter 11 and the catheter hub 12. A portion of the tip of the inner needle 13 is positioned to protrude from the tip opening of the catheter 11, and a portion of the proximal end of the inner needle 13 is positioned to protrude towards the proximal end of the catheter hub 12. The inner needle hub 14 is located on the proximal end of the catheter hub 12. When the tip of the inner needle 13 is inserted into a blood vessel, the catheter 11 is also inserted into the same blood vessel.

[0033] The catheter 11 constitutes the outer needle and is a flexible tubular member. The catheter 11 extends to near the tip of the inner needle 13. The catheter 11 has a lumen that extends axially from the tip to the proximal end. The constituent material of the catheter 11 is not particularly limited, but transparent resin materials, especially soft resin materials, are preferred. Examples include fluororesins such as ethylene-tetrafluoroethylene copolymer (ETFE), polytetrafluoroethylene (PTFE), and perfluoroalkoxy fluororesin (PFA), olefin resins such as polyethylene and polypropylene, polyurethane resins such as polyurethane and polyurethane elastomer, or mixtures thereof.

[0034] The catheter hub 12 is formed in a hollow cylindrical shape. The constituent material of the catheter hub 12 is not particularly limited, but examples include polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer, polyurethane, acrylic resin, ABS resin, and other thermoplastic resins.

[0035] The inner needle 13 is a tubular member with rigidity capable of puncturing the living body 3. The inner needle 13 has a lumen 131 that extends axially from the tip to the base. The lumen 131 communicates with the blood exposure prevention section 15. A light guide material 18, which will be described later, is inserted into the lumen 131. The lumen 131 can function as a blood introduction path through which blood can flow, and as an optical path for light passing through the inner needle 13.

[0036] Examples of metal materials that make up the inner needle 13 include stainless steel, aluminum, aluminum alloy, titanium, and titanium alloy.

[0037] A reflective portion 132 that reflects light from the first light source 161 may be provided on the inner circumferential surface of the inner needle 13. The reflective portion 132 is formed, for example, by coating the inner circumferential surface with a light-reflecting member. Examples of light-reflecting members include silver, aluminum, chromium, or nickel. The reflective portion 132 may be provided over the entire inner circumferential surface of the inner needle 13, or it may be provided only on a part of the inner circumferential surface.

[0038] The tip of the inner needle 13 has a cutting surface 133 that is inclined with respect to the axial direction of the inner needle 13. The cutting surface 133 has a tip opening 134 that communicates with the lumen 131 of the inner needle 13.

[0039] The inner needle hub 14 is formed, for example, in a hollow, tapered shape. The internal space of the inner needle hub 14 can function as an optical path for light passing through it. Preferably, the base end of the inner needle 13 does not protrude beyond the tapered tip of the inner needle hub 14. The constituent material of the inner needle hub 14 is the same as that of the constituent material of the catheter hub 12 described above. The wall surface forming the internal space of the inner needle hub 14 may be provided with a light guide member, such as by coating, to guide light from the first light source 161.

[0040] The outer surface of the inner needle hub 14 may be provided with a first light leakage prevention section 141 that prevents light irradiated from the first light source 161 and passing through the inner needle hub 14 from leaking to the outside. As the first light leakage prevention section 141, for example, the outer surface may be colored with a light-opaque material such as carbon black, or a metal mirror, multilayer film filter, or the like as a light-opaque material may be coated on the outer surface.

[0041] The blood exposure prevention unit 15 is liquid-tightly connected to the inner needle hub 14 via a first connecting unit 142 provided at the base end of the inner needle hub 14. The blood exposure prevention unit 15 prevents blood from flowing into the first light source unit 16 and prevents blood exposure. At least a portion of the blood exposure prevention unit 15 is formed to be transparent or translucent. The transparent or translucent area can function as an optical path for light passing through the blood exposure prevention unit 15.

[0042] The outer surface of the blood exposure prevention section 15 may be provided with a second light leakage prevention section 151 that prevents light irradiated from the first light source 161 and passing through the blood exposure prevention section 15 from leaking to the outside. The second light leakage prevention section 151 can be formed in the same manner as the first light leakage prevention section 141 of the inner needle hub 14 described above. The second light leakage prevention section 151 may be formed to cover at least the transparent or translucent area of ​​the blood exposure prevention section 15.

[0043] A fitting portion 152 into which a light guide member 18 is fitted is provided at the tip of the blood exposure prevention portion 15. The light guide member 18 is inserted, for example, from the side of the inner needle hub 14 to the tip of the inner needle 13. By connecting the inner needle hub 14 and the blood exposure prevention portion 15, the light guide member 18 is fixed within the indwelling needle 1. The fitting portion 152 may be provided with a position adjuster such as a screw, and may be configured to be able to adjust the axial position of the light guide member 18 with respect to the fitting portion 152.

[0044] A second connecting portion 153 is provided at the base end portion of the blood exposure prevention portion 15. The blood exposure prevention portion 15 and the first light source portion 16 are liquid-tightly connected via the second connecting portion 153. In the blood exposure prevention portion 15, a hollow path may be formed between the base end of the light guide member 18 and the second connecting portion 153 from the viewpoint of increasing the amount of light propagating to the light guide member 18. The blood exposure prevention portion 15 may also be provided with an air vent hole(s). When an air vent hole is provided in the blood exposure prevention portion 15, it is preferable to provide a filter or the like at the air outlet. Note that the installation position of the blood exposure prevention portion 15 is not particularly limited. The blood exposure prevention portion 15 may be provided within the inner needle hub 14. Also, the blood exposure prevention portion 15 may not be provided. When the blood exposure prevention portion 15 is not provided, the first light source portion 16 may be connected to the base end portion of the inner needle hub 14.

[0045] The first light source portion 16 includes a first light source 161 and a housing 162 that houses the first light source 161. The housing 162 is formed of a material such as a light-impervious material, metal, etc., and prevents the light emitted by the first light source 161 from leaking to the outside. The housing 162 may include a light-impervious member formed by coating the outer peripheral surface or the inner peripheral surface. Examples of the light-impervious member include light-impervious dyes such as carbon black, metal mirrors, multilayer film filters, etc.

[0046] A protruding portion 163 is provided at the tip of the housing 162. By inserting the protruding portion 163 into the second connecting portion 153, the blood exposure prevention portion 15 and the first light source portion 16 are detachably connected. The method of attaching the first light source portion 16 to the blood exposure prevention portion 15 is not particularly limited, and for example, screws, fitting members, magnets, etc. may be used.

[0047] The first light source unit 16 also includes a power source (not shown) that supplies power to the first light source 161. The power source includes, for example, a battery, a wireless power supply device, a solar cell, etc. The first light source 161 includes a power cable for power supply and may be powered by wire. The power source may be separate from the first light source unit 16.

[0048] The first light source 161 includes, for example, an LED (Light Emitting Diode), a laser irradiation unit (e.g., a laser diode), a lamp (e.g., a halogen lamp), etc. The first light source 161 irradiates the light emitting unit 17 with light of a specific wavelength having biocompatibility. The light emitted by the first light source 161 preferably has high directivity. On the optical path of the light irradiated from the first light source 161, a lens, a reflector, etc. for enhancing the directivity of the light may be provided.

[0049] The wavelength of the light emitted by the first light source 161 includes, for example, the visible light region and the near-infrared light region. The emission wavelength of the first light source 161 can be, for example, 600 nm to 2500 nm, preferably 700 nm to 1400 nm, and more preferably 780 nm to 940 nm. Light of such wavelengths is easily absorbed by hemoglobin in the blood. The first light source includes a plurality of irradiation units and may be capable of irradiating light of a plurality of wavelengths, such as visible light of 600 nm and near-infrared light of 850 nm. The first light source may be capable of adjusting the luminance of the emitted light.

[0050] The indwelling needle 1 includes a first light emitting unit 17a and a second light emitting unit 17b. In this embodiment, the first light emitting unit 17a is formed at the tip portion of the inner needle 13, and the second light emitting unit 17b is formed at the base end portion of the catheter hub 12. The first light emitting unit 17a and the second light emitting unit 17b are arranged to be separated in the axial direction of the indwelling needle  1. The light emitting unit 17 is an example of a marker for recognizing a specific location on the indwelling needle 1. In this specification, the "light emitting unit" is not limited to a physically configured element and includes a portion that receives light from a light source and emits light.

[0051] The first light-emitting unit 17a emits light from the first light source 161, which propagates through the inside of the inner needle 13. By detecting the light L1a emitted from the first light-emitting unit 17a, the position of the tip 130 of the inner needle 13 in the indwelling needle 1 can be recognized.

[0052] The first light-emitting section 17a is composed of, for example, a light guide material 18 that guides light irradiated from the first light source 161 to the vicinity of the tip 130 of the inner needle 13, and a tip opening 134 at the tip of the inner needle 13. The first light-emitting section 17a radiates the light L1a led out by the light guide material 18 to the outside through the tip opening 134. Examples of the light guide material 18 include optical fibers, acrylic rods, glass rods, and light-emitting tubes.

[0053] The light guide material 18 illustrated in Figures 1 to 4 extends from the vicinity of the tip opening 134 of the inner needle 13 to the blood exposure prevention section 15. A portion of the tip side of the light guide material 18 may be located closer to the tip than the base end of the tip opening 134. The light guide material 18 may be provided continuously or intermittently in the optical path of the light from the first light source section 16. The light guide material 18 may be hollow and allow blood to flow through its interior. In this case, the hollow portion of the light guide material 18 communicates with the blood exposure prevention section 15.

[0054] When the light guide material 18 is formed in a hollow shape, it is preferable that the cross-sectional area of ​​the hollow portion of the light guide material 18 is larger than the cross-sectional area of ​​the region enclosed by the inner circumference of the inner needle 13 and the outer circumference of the light guide material 18. With the above configuration, blood preferentially flows through the hollow portion of the light guide material 18, thereby increasing the efficiency of light propagation by the light guide material 18.

[0055] The second light-emitting part 17b emits light in response to light irradiated from the first light source 161 or the second light source 21. The second light-emitting part 17b contains a near-infrared fluorescent dye that emits near-infrared fluorescence at a specific wavelength (for example, wavelength 600 nm to 2500 nm) when irradiated with excitation light. The second light-emitting part 17b is formed by coating or kneading the near-infrared fluorescent dye onto the outer circumference of the catheter hub 12. By detecting the light L1b emitted from the second light-emitting part 17b, the position of a part of the indwelling needle 1 other than the tip 130 can be recognized.

[0056] The shape of the second light-emitting part 17b is not particularly limited and may be any suitable shape, such as a circle, triangle, square, star, or cross mark. The second light-emitting part 17b is preferable to have a complex shape because it can reduce the possibility of false detection. The second light-emitting part 17b is preferably positioned in an area that is not covered by the operator's hand when the operator grasps the indwelling needle 1 for puncture. The second light-emitting part 17b may be formed in an area that similarly includes a position facing upward when the blade surface 133 is facing upward. The second light-emitting part 17b may be provided only on a part of the circumferential direction of the catheter hub 12, or it may be provided around the entire circumference. When the second light-emitting part 17b is formed in the circumferential direction, the shape of the marker 10 may be linear, such as a single line, double lines, or a wavy line. The shape of the second light-emitting part 17b may differ depending on the type of indwelling needle 1.

[0057] Preferably, the wavelengths of the light L1a emitted by the first light-emitting unit 17a and the light L1b emitted by the second light-emitting unit 17b are the same, but they may be different.

[0058] The configuration of the first light-emitting section 17a and the second light-emitting section 17b is not limited as long as they emit light upon receiving light emitted from the first light source 161 or the second light source 21. For example, the second light-emitting section 17b may be formed from a light-emitting material, phosphorescent material, upconversion (UC) fluorescent material, etc., that emits light of a specific wavelength. The second light-emitting section 17b may have a reflective structure that reflects light by applying surface treatment such as texturing or uneven processing. The second light-emitting section 17b may be composed of a light guide material 18, similar to the first light-emitting section 17a. When a light guide material 18 is used, the second light-emitting section 17b may be provided with a side hole formed midway along the axial direction of the inner needle 13, and may be configured to radiate light guided by the light guide material 18 radially outward from the inner needle 13 through the side hole and the catheter 11. When the inner needle 13 is provided with a side hole, it is preferable that the inner circumferential surface of the inner needle 13 is in contact with the outer circumferential surface of the hollow light guide material 18, and that blood can flow through the hollow portion of the light guide material 18. The second light-emitting part 17b may be provided with a transparent or translucent member capable of guiding light instead of a side hole. The second light-emitting part 17b may emit light from the light source 161. The first light-emitting part 17a may be formed from a fluorescent material or light-emitting material similar to that of the second light-emitting part 17b, either in place of or in addition to the light guide material 18.

[0059] The arrangement and number of the first light-emitting part 17a and the second light-emitting part 17b are not limited to the examples shown in Figures 1 to 4. For example, the first light-emitting part 17a may be formed in a location other than the tip of the inner needle 13. The second light-emitting part 17b may be provided at the proximal end of the catheter 11, the tip of the catheter hub 12, the tip of the inner needle hub 14, etc. Two or more second light-emitting parts 17b may be provided spaced apart in the axial direction of the indwelling needle 1.

[0060] The first and second markers are not limited to light-emitting parts; they can be any markers whose positions can be detected by an appropriate detection device. For example, a marker member of a predetermined shape using colored ink may be detected by a visible light camera.

[0061] The indwelling needle 1 is not limited to the examples described above, but may have any suitable configuration as long as it is a puncture device inserted into a blood vessel of the living body 3. The indwelling needle 1 may be a dialysis indwelling needle, a peripheral venous insertion type central venous catheter (PICC), a midline catheter, a central venous catheter (CVC), etc.

[0062] As shown in Figure 1, the visualization device 2 comprises a body that is roughly rectangular in shape. A second light source 21, a camera 22, and a display device 23 are provided on one side of the body, and the processing device 20 is housed inside the body. The second light source 21, camera 22, and display device 23 may be provided on one side of the body in a manner that allows for position and angle adjustment.

[0063] The visualization device 2 is positioned above the living body 3, with the surface on which the second light source 21, camera 22, and display device 23 are provided facing the puncture target site of the living body 3, and is used in a fixed position relative to the living body 3. The visualization device 2 may be equipped with a mounting part for fixedly attaching it to a platform on which the living body 3 is placed. Preferably, the camera 22 is positioned directly above the puncture target site, that is, facing the puncture target site, so that it can image the puncture target site from directly above. The visualization device 2 may be movable so that its position relative to the living body 3 can be changed.

[0064] The second light source 21 includes, for example, an LED, a laser irradiation unit, a lamp, etc. The second light source 21 irradiates light L2, which is near-infrared light. The emission wavelength of the second light source 21 can be, for example, 700 nm to 2500 nm, preferably 700 nm to 1400 nm, and more preferably 780 nm to 940 nm. Light in this wavelength range has high biological penetration and is easily absorbed by hemoglobin. The second light source 21 may have multiple irradiation units and be capable of irradiating light L2 of multiple wavelengths. The wavelength of light L2 from the second light source 21 and the wavelength of light L1 from the light emission unit 17 may be the same or different. It is preferable that the second light source 21 irradiates the living organism 3 uniformly. The amount of light emitted by the second light source 21 may be adjustable.

[0065] Camera 22 is an imaging device having an image sensor such as a CCD (Charge Coupled Device) sensor or a CMOS (Complementary Metal Oxide Semiconductor) sensor. Camera 22 performs imaging at a predetermined frame rate. Camera 22 receives light L1a emitted from the first light-emitting part 17a of the indwelling needle 1, light L1b emitted from the second light-emitting part 17b, and reflected or transmitted light L2 irradiated from the second light source 21 to acquire an imaging signal, and generates image data based on the acquired imaging signal. Note that light L1b may be included in the reflected or transmitted light of light L2.

[0066] The spectral sensitivity wavelength range of camera 22 is not particularly limited as long as it corresponds to the wavelengths of light L1a, light L1b, and light L2, and can be set as appropriate. The spectral sensitivity wavelength range of camera 22 can be, for example, 700 to 2500 nm. The spectral sensitivity wavelength range of camera 22 may also include the far-infrared wavelength range.

[0067] From the viewpoint of simplifying the system configuration, it is preferable that light L1 and light L2 can be detected by a single camera 22, but for example, a camera 22 for detecting light L1 and a camera 22 for detecting light L2 may be separate. If separate cameras 22 are provided, the spectral sensitivity wavelength ranges of each camera 22 may be the same or partially overlapping, or they may be different, and preferably they are different.

[0068] If the camera 22 is capable of imaging near-infrared and far-infrared light, the camera 22 that images near-infrared light and the camera 22 that images far-infrared light may be the same or separate. If the camera 22 is the same, it is preferable to equip it with, for example, a spectral filter so that near-infrared and far-infrared light can be imaged separately. If the camera 22 is separate, it is preferable that each camera 22 is coaxial, for example by using a half-mirror.

[0069] The installation positions of the second light source 21 and the camera 22 are not particularly limited. The second light source 21 and the camera 22 may be installed facing each other with the living organism 3 in between, or they may be installed on the same side as the living organism 3, or a combination of these.

[0070] The display device 23 is an output device for presenting a display image. In this embodiment, the display device 23 includes a projector and projects an image onto the body surface of the living organism 3. The display device 23 may also include a display device that can be worn by the operator, such as goggles, glasses, or a head-mounted display, or a stationary display device, such as a liquid crystal display or an organic EL (Electro-Luminescence) display. The display device 23 can be read as an output device and may also be a means of informing the user by other means, such as sound.

[0071] The configuration of the visualization device 2 is not limited to the example shown in Figure 1. The visualization device 2 may be an AR (Augmented Reality) device having, for example, a goggle shape or a head-mounted display shape.

[0072] Figure 5 is a block diagram showing an example configuration of the processing device 20. The processing device 20 is a computer that estimates the position of the tip of the catheter 11 based on the detection results of the first light-emitting unit 17a and the second light-emitting unit 17b, and performs processing to generate a display image showing the estimated position of the tip of the catheter 11 and a visualized blood vessel image.

[0073] The processing unit 20 comprises a processing unit 201, a storage unit 202, and an input / output unit 203. These units are connected by a bus. The processing unit 20 may be a single computer, or a computer system composed of multiple computers and peripheral devices. The processing unit 20 may be a virtualized virtual machine, or it may be a cloud application.

[0074] The processing unit 201 comprises one or more processors such as a CPU (Central Processing Unit), an MPU (Micro-Processing Unit), or a GPU (Graphics Processing Unit). The processing unit 201 includes memory, which is a temporary storage medium such as SRAM (Static Random Access Memory) or DRAM (Dynamic Random Access Memory). The processing unit 201 may also include functions such as a timer for measuring the elapsed time from the time a measurement start instruction is given until a measurement end instruction is given, a counter for counting numbers, and a clock for outputting date and time information. The processing unit 201 may be implemented in software, or part or all of it may be implemented in hardware such as an ASIC (Application Specific Integrated Circuit) or an FPGA (Field Programmable Gate Array).

[0075] The storage unit 202 includes, for example, a non-volatile storage device such as a hard disk or flash memory. The storage unit 202 is separate from the processing unit 20 and may be one or more externally connected storage devices. The storage unit 202 stores various computer programs and data referenced by the processing unit 201. The storage unit 202 stores a program 2P that causes the computer to execute processing related to the generation of display images.

[0076] A computer program (program product) including program 2P may be provided on a non-temporary recording medium 2A on which the computer program is recorded in a readable format. The storage unit 202 stores the computer program read from the recording medium 2A by a reading device (not shown). The recording medium 2A is, for example, a magnetic disk, an optical disk, or a semiconductor memory. The computer program may also be provided by communication. Program 2P may be a single computer program or may consist of multiple computer programs. Program 2P may also be executed on a single computer or may be executed collaboratively by multiple computers.

[0077] The input / output unit 203 is equipped with an input / output interface for connecting external devices. The input / output unit 203 is connected to the camera 22 and the display device 23. The processing unit 201 receives image data output from the camera 22 via the input / output unit 203. The processing unit 201 also outputs various signals to the display device 23 via the input / output unit 203. The input / output unit 203 is connected to the first light source 161 and the second light source 21, and may be capable of outputting various signals to the first light source 161 and the second light source 21.

[0078] The configuration of the processing unit 20 is not limited to the example described above, and may include an operation unit for receiving user input, a communication unit for communicating with external devices via a network such as the Internet, etc. The processing unit 20 may be configured as a server computer or the like located in a location separate from the facility where the puncture procedure is performed. In this case, the processing unit 20 may receive image data obtained by the camera 22 via communication, and transmit information corresponding to the received image data to the display device 23 via communication for display.

[0079] In this embodiment, a single visualization device 2 is configured to perform blood vessel detection, light emission unit 17 detection, and display image generation. However, the visualization device 2 may also include, for example, a separate device for detecting blood vessels and light emission unit 17, and a separate device for generating the display image.

[0080] The procedure for vascular puncture using the puncture support system 100 will now be described. The operator places the visualization device 2 above the living body 3 and irradiates the living body 3 and the second light source 17b with light L2 from the second light source 21. The operator inserts the indwelling needle 1 from the body surface of the living body 3 toward the blood vessel and gradually inserts the inner needle 13 toward the desired site. This causes the tip of the inner needle 13 to cut through the body tissue as it advances. After the inner needle 13 has punctured the target blood vessel, the catheter 11 and catheter hub 12 are moved to the tip and the catheter 11 is inserted into the blood vessel. After insertion, the operator removes the inner needle 13, inner needle hub 14 and first light source 16, leaving the catheter 11 and catheter hub 12 in place, thereby leaving the catheter 11 and catheter hub 12 in place in the blood vessel.

[0081] During puncture, the light L2 emitted by the second light source 21 is absorbed by hemoglobin in the blood flowing through the blood vessels of the living body 3, while being reflected by other living tissues (e.g., skin tissue and muscle tissue). The reflected light L2 is received by the camera 22. In addition, the light L1b emitted by the second light-emitting unit 17b in response to the light L2 emitted by the second light source 21 is also received by the camera 22. Furthermore, the light L1a emitted by the first light-emitting unit 17a in response to the light from the first light source 161 of the indwelling needle 1 is transmitted through the living tissue while scattering. The transmitted light L1 is received by the camera 22.

[0082] The camera 22 generates an image based on the received light L1a, light L1b, and light L2. The image includes, for example, images of blood vessels, images of the first light-emitting unit 17a, images of the second light-emitting unit 17b, images of biological tissue other than blood vessels, and images of the indwelling needle 1. Hereinafter, images of blood vessels will also be referred to as blood vessel images, images of the first light-emitting unit 17a as first light-emitting unit images, images of the second light-emitting unit 17b as second light-emitting unit images, images of biological tissue other than blood vessels as biological images, and images of the indwelling needle 1 as indwelling needle images.

[0083] In the captured image, the first and second light-emitting units are usually displayed brightest, the living body image is displayed darker than the light-emitting unit image, and the vascular image and the indwelling needle image are displayed darker than the living body image. When the tip 130 of the inner needle 13 is inserted into a blood vessel, the light L1a emitted by the first light-emitting unit 17a is absorbed by hemoglobin in the blood, so it does not reach the camera 22, or if it does reach the camera 22, its intensity is greatly reduced. As a result, the brightness of the first light-emitting unit image decreases significantly in the captured image. The change in brightness of the first light-emitting unit image allows us to understand that the tip of the inner needle 13 has been inserted into a blood vessel (vascular access).

[0084] In this embodiment, it is preferable that the light emission patterns of the first light source 161 and the second light source 21, i.e., the timing of lighting and extinguishing, are different. The first light source 161 and the second light source 21 may be controlled, for example, to light up alternately every frame in synchronization with a predetermined frame rate set in advance on the camera 22. The lighting and extinguishing of the first light source 161 and the second light source 21 are preferably controlled by the processing unit 20, but may also be controlled by a control mechanism (not shown) built into the first light source 161 and the second light source 21. When the light emission of the first light source 161 and the second light source 21 is controlled by an internal mechanism, the storage unit 202 of the processing unit 20 may store in advance the set light emission patterns (e.g., lighting interval and lighting time) for each of the first light source 161 and the second light source 21.

[0085] Furthermore, the emission timing of the first light source 161 and the second light source 21 does not need to be perfectly synchronized with the frame rate of the camera 22. As long as the illumination of either the first light source 161 or the second light source 21 is synchronized for a certain number of frames, the illumination of either light source does not necessarily need to be assigned to every frame.

[0086] By making the light emission patterns of the first light source 161 and the second light source 21 different, the content of the images captured by the camera 22 can be made different. For example, an image captured in a first state where the first light source 161 is lit (emitting light) and the second light source 21 is off (not emitting light) will be a first image including the first light-emitting part image. In the first image, the first light-emitting part image will be displayed brighter than the areas other than the first light-emitting part image. By imaging the light-emitting part 17 and the living body 3 with the second light source 21 off, only the first light-emitting part 17a can be made to emit light effectively, and the brightness difference between the first light-emitting part 17a and other areas in the light-emitting part image can be increased.

[0087] Furthermore, an image captured in the second state, where the second light source 21 is emitting light and the first light source 161 is either emitting light or not, will be a second image including at least the second light-emitting part image, a vascular image, and a living body image. In the second image, the second light-emitting part image is displayed brighter than the living body image, and the vascular image is displayed darker than the living body image. The second image may further include an indwelling needle image and a first light-emitting part image. When the second light source 21 is emitting light, the light L2 from the second light source 21 is stronger than the light L1a from the first light-emitting part 17a, so the brightness of the first light-emitting part 17a in the second image is significantly lower than the brightness of the first light-emitting part 17a in the first image.

[0088] The processing device 20 can improve the accuracy of identifying the first light-emitting unit image, the second light-emitting unit image, and the blood vessel image, etc., contained in the captured image by identifying whether the captured image acquired from the camera 22 is a first image or a second image. The method for identifying the type of captured image is not particularly limited, but for example, the type of captured image may be identified by recognizing the shape of the tip of the indwelling needle 1, the boundary of the light-emitting unit 17, the pattern light, the light-emitting unit 17, etc., in the captured image using methods such as silhouette detection, edge detection, pattern light detection, and object detection. The type of captured image may also be identified by machine learning methods, for example, by using an image classification model for identifying objects contained in the captured image. The type of captured image may also be determined based on the light emission patterns of the first light source 161 and the second light source 21, which are stored in advance, and the frame rate of the camera 22.

[0089] In this system, the first light source 161 may not be provided on the indwelling needle 1, and the system may be configured to irradiate the light-emitting unit 17 with light from a light source provided outside the indwelling needle 1. The light source that irradiates the light-emitting unit 17 with light may be the second light source 21, or it may be a light source different from the second light source 21.

[0090] As described above, the images captured by the camera 22 include at least a vascular image, a first light-emitting unit image, and a second light-emitting unit image. Based on the captured images, the positions of the tip 130 of the inner needle 13 and the proximal end of the catheter hub 12 relative to the blood vessels of the living body 3 can be determined. Here, in the puncture procedure, it is necessary to reliably insert the catheter 11 into the blood vessel together with the inner needle 13, so it is important to accurately determine the position of the tip of the catheter 11. Since the positions of the tip 130 of the inner needle 13 and the tip of the catheter 11 are different, the position of the tip of the catheter 11 cannot be determined from the captured image of the first light-emitting unit 17a at the tip 130 of the inner needle 13. In this system, the position of the tip of the catheter 11 is identified based on the detection results of the positions of the first light-emitting unit 17a and the second light-emitting unit 17b during puncture, and the identified position of the tip of the catheter 11 is visually indicated in a display image to the operator, thereby supporting the operator's puncture procedure.

[0091] Figure 6 illustrates the method used by the processing device 20 to determine the position of the tip of the catheter 11. In Figure 6, arrow A indicates a direction perpendicular to the axial direction of the indwelling needle 1, and arrow B indicates the direction captured by the camera 22, i.e., a direction different from the view perpendicular to the axial direction of the indwelling needle 1.

[0092] Let X1 be the distance between the first light-emitting part 17a and the second light-emitting part 17b when viewed in the direction of arrow A (view perpendicular to the axial direction of the indwelling needle 1), and let Y1 be the distance between the first light-emitting part 17a and the tip 110 of the catheter 11. The distance Y1 is preferably the distance between the first light-emitting part 17a and the tip of the catheter 11.

[0093] Distances X1 and Y1 can be determined, for example, by actual measurement. Distances X1 and Y1 may be stored in the storage unit 202 as known values ​​in advance, or the measured values ​​before the start of puncture may be provided to the processing unit 20. The processing unit 20 may store in the storage unit 202 in advance table data for each type of indwelling needle 1, which links the second light-emitting part information, including the shape, size, color, reaction wavelength, etc., of the second light-emitting part 17b with the distances X1 and Y1 at the indwelling needle 1. If the above table data is stored, the processing unit 20 may identify the type of indwelling needle 1 based on the shape of the second light-emitting part 17b, etc., in the image of the indwelling needle 1 that has been captured in advance, and the information stored in the table data, and derive distances X1 and Y1 corresponding to the identified indwelling needle 1.

[0094] Distances X1 and Y1 may be calculated by acquiring an image captured by the camera 22 from directly above with the indwelling needle 1 placed horizontally, and then analyzing the acquired image to determine the distance between each object. The calculation of distances X1 and Y1 may be performed automatically by the processing device 20.

[0095] Let X2 be the distance between the first light-emitting unit 17a and the second light-emitting unit 17b in the view in the direction of arrow B (view as captured by camera 22), and let Y2 be the distance between the first light-emitting unit 17a and the tip 110 of the catheter 11. Distance X2 can be calculated by analyzing the image captured at the time of puncture using camera 22. Specifically, the processing device 20 extracts the first light-emitting unit 17a and the second light-emitting unit 17b from the image captured at the time of puncture, and calculates the distance between the extracted first light-emitting unit 17a and the second light-emitting unit 17b to obtain distance X2.

[0096] As a method for detecting the first light-emitting unit 17a and the second light-emitting unit 17b from the captured image, for example, a pattern matching method may be used, or a machine learning model for object detection may be used. The processing device 20 may detect the first light-emitting unit 17a and the second light-emitting unit 17b in the image by detecting objects in the image whose brightness and size (range) are above a preset threshold. It is preferable that the light-emitting units 17 in the image are identified, including their type, such as which one is the first light-emitting unit 17a. The type of light-emitting unit 17 in the image may be determined by considering the shape of objects other than the light-emitting units 17 in the image (for example, an image of an indwelling needle).

[0097] The method for calculating the distance between the first light-emitting unit 17a and the second light-emitting unit 17b in the captured image is not particularly limited, but as an example, the length of a specific element whose size is known may be extracted from the captured image, and the ratio of the length of the extracted specific element to the actual size may be determined. The distance X2 may be calculated based on the determined ratio and the lengths of the first light-emitting unit 17a and the second light-emitting unit 17b according to their position coordinates in the captured image. A reference body for size detection may be provided in advance within the imaging area of ​​the camera 22. As the camera 22, a TOF (Time Of Flight) camera or a 3D laser sensor capable of acquiring three-dimensional position coordinates may be used to measure the distance X2.

[0098] The processing unit 20 calculates the ratio of distance X2 to the obtained distance X1 (X2 / X1). The processing unit 20 uses the calculated value as a correction coefficient and calculates distance Y2 by multiplying distance Y1 by the obtained correction coefficient. The correction coefficient may be a value that takes into account the characteristics of the camera 22 and the distance between the camera 22 and the surface of the living organism 3, in addition to the above ratio.

[0099] The processing unit 20 identifies the position of the tip 110 of the catheter 11 based on the calculated distance Y2 and the position coordinates of the first light-emitting unit 17a and the second light-emitting unit 17b in the captured image. The processing unit 20 identifies the position of the tip 110 of the catheter 11 as the position obtained by moving a distance Y2 in the direction toward the second light-emitting unit 17b along a straight line connecting the first light-emitting unit 17a and the second light-emitting unit 17b, using the first light-emitting unit 17a as a reference. Note that the light-emitting unit 17 that serves as the basis for calculating distances Y1 and Y2 is not limited to the first light-emitting unit 17a, but may also be the second light-emitting unit 17b.

[0100] The processing device 20 may also calculate the puncture angle θ of the indwelling needle 1 inserted into the living body 3 based on the position coordinates of the first light-emitting unit 17a and the second light-emitting unit 17b in the captured image. As shown in Figure 6, the puncture angle θ is shown as the angle between the straight line connecting the first light-emitting unit 17a and the second light-emitting unit 17b and the surface of the living body 3. The puncture angle θ is calculated using distances X1 and X2 by the following formula: θ = cos -1 (X2 / X1)

[0101] The processing device 20 generates a display image showing the identified position of the tip 110 of the catheter 11 by performing image processing on the captured image used to determine the position of the tip 110 of the catheter 11.

[0102] Figure 7 illustrates an example of a method for generating a display image. As shown in the upper part of Figure 7, the captured image 41 before image processing includes a first light-emitting unit image 42, a second light-emitting unit image 43, a blood vessel image 44, a biological image 45, an indwelling needle image 46, etc. As an example, the processing device 20 performs image processing on the captured image 41 to move the first light-emitting unit image 42 included in the captured image 41 to the position of the tip 110 of the identified catheter 11. As a result, as shown in the lower part of Figure 7, a display image 47 is generated that includes the first light-emitting unit image 42 positioned at the tip 110 of the catheter 11, and the second light-emitting unit image 43, blood vessel image 44, biological image 45, indwelling needle image 46, etc., shown in the same position as the original captured image 41.

[0103] The position of the tip 110 of the catheter 11 may be displayed using an object different from the first light-emitting unit image 42. The processing device 20 may generate a display image by, for example, placing a catheter tip image having a predetermined size, shape, color, etc., at the position of the identified tip 110 of the catheter 11 in the captured image 41. Furthermore, if the puncture angle θ is calculated, the display image may include text, illustrations, etc., indicating the calculated puncture angle θ.

[0104] Figure 8 is a flowchart showing an example of a processing procedure performed by the processing unit 20. The following processing is performed by the processing unit 201 according to the program 2P stored in the storage unit 202 of the processing unit 20.

[0105] The processing unit 201 of the processing device 20 obtains the distance X1 between the first light-emitting unit 17a and the second light-emitting unit 17b, and the distance Y1 between the first light-emitting unit 17a and the tip 110 of the catheter 11, when viewed perpendicular to the axial direction of the indwelling needle 1 (step S11). The processing unit 201 may obtain the distances X1 and Y1 by reading information stored in the storage unit 202, for example, or it may calculate the distances X1 and Y1 based on an image of the indwelling needle 1 that has been captured in advance.

[0106] After the start of puncture, the processing unit 201 acquires images of the living body 3 and the indwelling needle 1 (step S12). The acquired images include images of the first light-emitting unit, the second light-emitting unit, blood vessels, the living body, and the indwelling needle. The acquired images may be either a first image taken in a first state where the first light source 161 is lit and the second light source 21 is off, or a second image taken in a second state where the second light source 21 is emitting light and the first light source 161 is either lit or off. The processing unit 201 may identify the type of acquired acquired image according to a predetermined identification method.

[0107] The processing unit 201 detects the first light-emitting unit image and the second light-emitting unit image included in the acquired captured image using a predetermined object detection method, and obtains the position coordinates of the detected first light-emitting unit and the second light-emitting unit (step S13). Based on the obtained position coordinates of the first light-emitting unit and the second light-emitting unit, the processing unit 201 calculates the distance X2 between the first light-emitting unit and the second light-emitting unit in the direction view captured by the camera 22 (step S14).

[0108] The processing unit 201 calculates the distance Y2 between the first light-emitting unit 17a and the tip 110 of the catheter 11 in the direction view captured by the camera 22, based on the obtained distances X1, Y1 and distance X2 (step S15). Specifically, the processing unit 201 calculates the ratio of distance X2 to distance X1 (X2 / X1) as a correction coefficient, and calculates distance Y2 by multiplying distance Y1 by the calculated correction coefficient.

[0109] The processing unit 201 identifies the position coordinates of the tip 110 of the catheter 11 based on the calculated distance Y2 and the position coordinates of the first and second light-emitting unit images (step S16). Specifically, the processing unit 201 moves the position coordinates of the first light-emitting unit 17a by a distance Y2 in the direction of the second light-emitting unit 17b along the linear axis connecting the first light-emitting unit 17a and the second light-emitting unit 17b, thereby identifying the position coordinates after the movement as the position of the tip 110 of the catheter 11.

[0110] The processing device 20 generates a display image indicating the position of the tip 110 of the catheter 11 by performing image processing on the image acquired in step S12 to position a predetermined image at the tip 110 of the identified catheter 11 (step S17). The display image is an image that includes at least a first light-emitting unit image 42 positioned at the tip 110 of the catheter 11. The display image may also include the first light-emitting unit image 42, a second light-emitting unit image 43, a blood vessel image 44, a biological image 45, an indwelling needle image 46, or a combination thereof. Preferably, the display image includes the first light-emitting unit image 42 and the blood vessel image 44.

[0111] The processing unit 201 displays the generated display image on the surface of the living organism 3, for example, through the display device 23 (step S18). When displaying the display image on the surface of the living organism 3, it is preferable for the processing unit 201 to accurately align the first light-emitting part image 42 and the blood vessel image 44 in the display image with the living organism 3 and project the display image.

[0112] The processing unit 201 determines whether or not to terminate the process (step S19). For example, if it determines not to terminate the process because it has not received a predetermined termination operation (S19: NO), the processing unit 201 returns to step S12. For example, if it determines to terminate the process because it has received a predetermined termination operation (S19: YES), the processing unit 201 terminates the series of processes.

[0113] In the above-described process, if a first image or a second image can be acquired as the captured image, the processing unit 201 may calculate each distance by integrating the detection results of objects such as the first light-emitting unit image and the second light-emitting unit image in the most recently acquired first image and second image, respectively.

[0114] According to this embodiment, by offsetting the position of a specific light-emitting part to the catheter tip position based on the detection results of multiple light-emitting parts in the indwelling needle 1, the position of the catheter tip that does not have a light-emitting function can be visualized and presented.

[0115] By using the distances between multiple light-emitting parts acquired in advance and the distances between the light-emitting parts at the time of puncture, the offset amount between a specific light-emitting part and the catheter tip position can be easily and accurately calculated. By forming multiple light-emitting parts spaced apart in the axial direction of the indwelling needle 1, the distance between the light-emitting parts can be calculated accurately. By forming multiple light-emitting parts on the indwelling needle 1, even when the operator grasps the indwelling needle 1 at various positions, there will be light-emitting parts that are not covered by the operator's hand, and the light-emitting parts can be detected well.

[0116] By displaying the position of the catheter tip along with the vascular visualization image, the state of catheter puncture in the body can be grasped more accurately, leading to improved accuracy in the procedure. Separating the light source for vascular visualization from the light source for detecting the light-emitting part improves the detection accuracy of the light-emitting part and enhances the visibility of the displayed image. By aligning the displayed image with the body and displaying it on the body surface, the position of the catheter tip can be grasped more accurately.

[0117] (Second Embodiment) In the second embodiment, a configuration for notifying the operator that the tip 110 of the catheter 11 has entered a blood vessel will be described. In the following embodiment, the differences from the first embodiment will be mainly described, and components common to the first embodiment will be denoted by the same reference numerals and their detailed descriptions will be omitted.

[0118] When a first light-emitting unit 17a is provided at the tip 130 of the inner needle 13, the vascular access of the tip 130 of the inner needle 13 can be determined by the change in brightness of the first light-emitting unit 17a. However, even if the tip 130 of the inner needle 13 reaches the blood vessel, the tip 110 of the catheter 11 may not reach the blood vessel. The processing device 20 of this embodiment estimates the vascular access of the tip 110 of the catheter 11 based on the detection results of the first light-emitting unit 17a and the second light-emitting unit 17b, and presents information according to the estimation result.

[0119] Figure 9 is a flowchart showing an example of a processing procedure performed by the processing device 20 of the second embodiment. After the image acquisition process, for example, in step S12 of Figure 8, the processing device 20 starts the following processing.

[0120] The processing unit 201 determines whether or not the first light-emitting unit 17a has stopped emitting light based on the detection result or position acquisition result of the time-series first light-emitting unit image relative to the captured image (step S21). For example, if the first light-emitting unit image is not detected from the captured image, or if the position coordinates of the first light-emitting unit cannot be obtained because the first light-emitting unit image is not detected from the captured image, the processing unit 201 determines that the first light-emitting unit 17a has stopped emitting light. On the other hand, if the first light-emitting unit image is detected from the captured image, or if the position coordinates of the first light-emitting unit corresponding to the detected first light-emitting unit image are obtained, the processing unit 201 determines that the first light-emitting unit 17a has not stopped emitting light.

[0121] If it is determined that the first light-emitting unit 17a has not stopped emitting light (S21: NO), the processing unit 201 terminates the process. If it is determined that the first light-emitting unit 17a has not stopped emitting light, the processing unit 201 may proceed to step S13 in Figure 8.

[0122] If it is determined that the light emission of the first light-emitting unit 17a has disappeared (S21: YES), the processing unit 201 calculates the amount of movement of the second light-emitting unit 17b after the disappearance of the first light-emitting unit 17a (step S22). The amount of movement of the second light-emitting unit 17b is obtained by using the position coordinates of the second light-emitting unit 17b in the captured image at the start of detection of the disappearance of the first light-emitting unit 17a as reference coordinates, and calculating the amount of deviation between the position coordinates of the second light-emitting unit 17b in the current captured image and the reference coordinates. The start of detection of disappearance is the point in time when the image of the first light-emitting unit, which had been continuously detected since the start of puncture, is first no longer detected in the captured image, or the point in time when the position coordinates of the first light-emitting unit, which had been continuously acquired, are first no longer detected.

[0123] The processing unit 201 determines whether the calculated amount of movement of the second light-emitting unit 17b is greater than or equal to a threshold (step S23). The threshold used for this determination is the value of the distance Y2 between the first light-emitting unit 17a and the tip 110 of the catheter 11, as captured by the camera 22 in a directional view, which was calculated immediately before the start of detection of the disappearance of the first light-emitting unit 17a.

[0124] If the processing unit 201 determines that the amount of movement of the second light-emitting unit 17b is less than the threshold (S23: NO), the processing unit 201 estimates the current position coordinates of the tip 110 of the catheter 11 based on the position coordinates of the tip 110 of the catheter 11 at the time immediately preceding the start of detection of disappearance and the amount of movement of the second light-emitting unit 17b calculated in step S22 (step S24). In step S23, the processing unit 201 estimates the current position coordinates of the tip 110 of the catheter 11 by moving the position of the tip 110 of the catheter 11 at the time immediately preceding by the amount of movement calculated along the direction of movement of the second light-emitting unit 17b. Alternatively, the processing unit 201 may estimate the position of the tip 110 at the time immediately preceding as the current position of the tip 110.

[0125] The processing unit 201 generates a display image showing the estimated position of the tip 110 of the catheter 11 by performing the same processing as in steps S17 to S19 (step S25), and displays the generated display image (step S26). The processing unit 201 determines whether or not to terminate the processing (step S27). If it is determined not to terminate the processing (S27: NO), the processing unit 201 returns to step S21. If it is determined to terminate the processing (S27: YES), the processing unit 201 terminates the series of processes.

[0126] If the amount of movement of the second light-emitting unit 17b is determined to be greater than or equal to a threshold (S23: YES), the processing unit 201 outputs information indicating that the tip 110 of the catheter 11 has been inserted into the blood vessel (vascular access of the tip 110 of the catheter 11) (step S28). If the amount of movement of the second light-emitting unit 17b is greater than or equal to the distance Y2 at the previous moment, it is estimated that the tip 110 of the catheter 11 has similarly moved by a distance Y2 or more, and has moved to the position of the tip 130 of the inner needle 13 at the previous moment. Therefore, it is estimated that the tip 110 of the catheter 11 has reached the blood vessel, similar to the inner needle 13.

[0127] In step S28, the processing unit 201 may output information indicating vascular access by catheter 11 by performing processes such as ending the display of an image including an image corresponding to the tip 110 of catheter 11, displaying a display image that does not include an image corresponding to the tip 110 of catheter 11, or hiding the image corresponding to the tip 110 of catheter 11 in the display image. The information indicating vascular access is not limited to being output as an image, but may also be communicated by other means such as sound or the illumination of a lamp. The processing unit 201 then terminates the series of processes.

[0128] According to this embodiment, information indicating vascular access at the catheter tip can be presented to the operator, allowing them to grasp the vascular access achieved by the catheter and leading to further improvements in the accuracy of the procedure. Based on the luminescence state at the tip of the inner needle, vascular access at a catheter tip without a luminescence function can be simulated and reflected more accurately in the displayed image. Even after the luminescence at the tip of the inner needle disappears, the projection of an image showing the catheter tip continues until it is presumed that the catheter tip has been inserted into a blood vessel, thereby supporting reliable vascular access by the catheter.

[0129] The embodiments disclosed herein should be considered in all respects to be illustrative and not restrictive. The technical features described in each embodiment can be combined with each other, and the scope of the present invention is intended to include all modifications within the claims and equivalents thereof. The sequences shown in each embodiment are not limiting, and within a consistent scope, each processing step may be performed in a different order, and multiple processes may be performed in parallel. The processing entities for each process are not limiting, and within a consistent scope, the processing of each device may be performed by other devices.

[0130] The matters described in each embodiment can be combined with each other. Furthermore, the independent and dependent claims described in the claims can be combined with each other in any combination, regardless of the form of reference. In addition, the claims use a form in which claims referencing two or more other claims (multi-claim form), but are not limited to this. A form in which multi-claims referencing at least one multi-claim (multi-multi-claim) may also be used.

[0131] 100 Puncture support system 1 Indwelling needle 11 Catheter 13 Inner needle 130 Tip 16 First light source unit 161 First light source 17a First light-emitting unit 17b Second light-emitting unit 2 Visualization device 20 Processing unit 201 Processing unit 202 Storage unit 2P Program 2A Recording medium 21 Second light source 22 Camera 23 Display device 3 Biological

Claims

1. A program that causes a computer to perform the following processes: acquire the positions of a first marker and a second marker in a vascular access device that is inserted into a living body; identify the position of the catheter based on the acquired positions of the first and second markers and the positional relationship between the catheter and the first marker in the vascular access device; generate an image showing the identified position of the catheter; and output the generated image.

2. The program according to claim 1, wherein the first marker is formed on the tip of the needle in the vascular access device.

3. The program according to claim 1 or 2, which acquires the positions of the first marker and the second marker in a viewing direction different from the vertical viewing direction with respect to the axial direction of the vascular access device, calculates the distance between the first marker and the second marker in a viewing direction different from the vertical viewing direction based on the acquired positions of the first marker and the second marker, and identifies the position of the catheter in a viewing direction different from the vertical viewing direction based on the calculated distance, the distance between the first marker and the second marker in the vertical viewing direction, and the distance between the first marker and the catheter.

4. The program according to claim 1 or 2, which determines the position of the tip of the catheter based on the positions of the first marker and the second marker and the positional relationship between the tip of the catheter in the vascular access device and the first marker.

5. The program according to claim 1 or 2, wherein the first marker and the second marker are spaced apart in the axial direction of the vascular access device.

6. The program according to claim 1 or 2, wherein if the position of the second marker moves by a predetermined amount or more after the position of the first marker is no longer detected, the output of an image indicating the position of the catheter is terminated.

7. The program according to claim 1 or 2, which acquires an image of the first marker and the second marker, identifies the position of the catheter based on the positions of the first marker and the second marker in the acquired image, and generates an image in which the image of the first marker is placed at the identified position of the catheter.

8. The program according to claim 1 or 2, which acquires an image of the first marker and the second marker and the blood vessels of the living body, identifies the position of the catheter based on the positions of the first marker and the second marker in the acquired image, and generates an image including an image of the first marker placed at the identified position of the catheter and an image of the blood vessels.

9. The program according to claim 1 or claim 2, wherein the first marker emits light in response to light from a light source.

10. The program according to claim 1 or 2, wherein the first marker emits light from a light source provided in the vascular access device.

11. The program according to claim 1 or claim 2, wherein a plurality of the second markers are formed so as to be spaced apart in the axial direction of the vascular access device.

12. The program according to claim 1 or claim 2, which displays the image on the surface of the living body in correspondence with the position of the catheter in the living body.

13. A program that causes a computer to perform a process to detect, in chronological order, the positions of a first marker at the tip of a needle protruding from the tip of a catheter in a vascular access device inserted into a living body, and a second marker in the vascular access device, and to output information indicating that the catheter has reached a blood vessel in the living body when the position of the second marker moves by a predetermined amount or more after the position of the first marker is no longer detected.

14. An information processing method for acquiring the positions of a first marker and a second marker in a vascular access device that is inserted into a living body, identifying the position of the catheter based on the acquired positions of the first and second markers and the positional relationship between the catheter and the first marker in the vascular access device, generating an image showing the identified position of the catheter, and outputting the generated image.

15. An information processing device comprising a processing unit that acquires the positions of a first marker and a second marker in a vascular access device that is inserted into a living body, identifies the position of the catheter based on the acquired positions of the first and second markers and the positional relationship between the catheter and the first marker in the vascular access device, generates an image showing the identified position of the catheter, and outputs the generated image.

16. A puncture support system comprising a vascular access device for puncturing a living organism and a processing unit, wherein the processing unit acquires the positions of a first marker and a second marker in the vascular access device, identifies the position of the catheter based on the acquired positions of the first and second markers and the positional relationship between the catheter and the first marker in the vascular access device, generates an image showing the identified position of the catheter, and outputs the generated image.

Citation Information

Patent Citations

  • Magnetic resonance imaging device for interventional mri, and preparation method thereof

    JP2002058658A

  • Catheter discrimination and guidance system

    JP2014076355A

  • Magnetic resonance imaging apparatus, device position detection method using the same, device, and image-guided intervention support apparatus

    JP2019058461A

  • Resin composition and molded article

    WO2015022977A1

  • Medical device and identification method

    WO2019176533A1