# US 11,304,673 B2 · Diagnostic method, method for validation of diagnostic method, and treatment method

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- Number: US 11,304,673 B2
- Document ID: US11304673B2
- Status: Granted
- Kind: B2
- Application number: 16/176,938
- Filed: 2018-10-31
- Published: 2019-05-02
- Granted: 2022-04-19
- Earliest claimed: 2017-10-31
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Yoshitaka Itou; Yoshiyuki Saito; Shota Ishii; Tetsuya Fukuoka
- Web page: https://patentgrep.com/patent/US11304673B2

## CPC

- A61B 6/504: {for diagnosis of blood vessels, e.g. by angiography}
- A61B 5/0086: {using infrared radiation}
- A61B 5/02007: {Evaluating blood vessel condition, e.g. elasticity, compliance}
- A61B 5/489: {Blood vessels}
- A61B 6/503: {for diagnosis of the heart}
- A61B 6/5217: {extracting a diagnostic or physiological parameter from medical diagnostic data}
- G06F 18/24133: {Distances to prototypes}
- G06T 7/0012: {Biomedical image inspection}
- G06V 10/764: using classification, e.g. of video objects
- G06V 10/82: using neural networks
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/7267: {involving training the classification device}
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/5223: {generating planar views from image data, e.g. extracting a coronal view from a 3D image}
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61M 25/0169: {Exchanging a catheter while keeping the guidewire in place}
- A61M 2025/0059: {having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking}
- G06T 2207/10081: Computed x-ray tomography [CT]
- G06T 2207/20081: Training; Learning
- G06T 2207/20084: Artificial neural networks [ANN]
- G06T 2207/30096: Tumor; Lesion
- G06T 2207/30101: Blood vessel; Artery; Vein; Vascular
- G06V 2201/03: Recognition of patterns in medical or anatomical images
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
- G06V: IMAGE OR VIDEO RECOGNITION OR UNDERSTANDING
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

In a method for diagnosing and treating a patient having lesions in both arteries of left and right lower limbs. By determining that a larger lesion curvature to be treated first, catheters and an operation time can be reduced is to be treated first on a priority basis based on diagnostic data, deciding that a smaller lesion curvature is to be treated next, then treating the lesions substantially continuously.

## Claims

### Claim 1

A method for diagnosing multiple lesions in a plurality of bifurcated lumens for treatment by catheter intervention, the plurality of bifurcated lumens being connected to a biological lumen via a bifurcation from a main lumen, the method comprising:
training a machine-learning algorithm with lesion curvature information, types of guide wires, types of catheters, types of treatment catheters, and operation times for completed treatments;
detecting electromagnetic waves obtained through a patient by irradiating the patient with electromagnetic waves, and obtaining electromagnetic wave information on the patient based on a changed electromagnetic wave;
using the machine-learning algorithm to identify a plurality of lesions from the electromagnetic wave information, acquire lesion curvature information on each of the plurality of lesions from the electromagnetic wave information, and determine a lesion to be treated first among the plurality of lesions based on the lesion curvature information and a lesion to be treated subsequently among the plurality of lesions, the plurality of lesions including one or more lesions in each of the plurality of bifurcated lumens;
determining the lesion to be treated first among the plurality of lesions based on the lesion curvature information of each of the one or more lesion in each of the plurality of bifurcated lumens, the lesion to be treated first being in one of the plurality of bifurcated lumens; and
determining the lesion to be treated subsequently among the plurality of lesions based on the lesion curvature information of each of the one or more lesions in each of the plurality of bifurcated lumens, the lesion to be treated subsequently being in another of the plurality of bifurcated lumens.

### Claim 2 (depends on 1)

The diagnostic method according to claim 1, comprising:
determining the lesion to be treated first among the plurality of lesions to be a lesion having a larger lesion curvature based on the lesion curvature information.

### Claim 3

A method for diagnosing multiple lesions by artificial intelligence in a plurality of bifurcated lumens for treatment by catheter intervention, the plurality of bifurcated lumens being connected to a biological lumen via a bifurcation from a main lumen, the main lumen being an aorta, the bifurcation being an aortailiac bifurcation, and the plurality of bifurcated lumens being left and right lower limb arteries, and the left and right lower limb arteries each have lesions, the method comprising:
detecting electromagnetic waves obtained through a patient by irradiating the patient with electromagnetic waves, and obtaining electromagnetic wave information on the patient based on a changed electromagnetic wave;
identifying a plurality of lesions from the electromagnetic wave information, the plurality of lesions including one or more lesions in each of the plurality of bifurcated lumens;
acquiring lesion curvature information from the electromagnetic wave information on each of the plurality of lesions;
determining a lesion to be treated first among the plurality of lesions based on the lesion curvature information of each of the one or more lesion in each of the plurality of bifurcated lumens, the lesion to be treated first being in one of the plurality of bifurcated lumens, and wherein the lesion having a larger lesion curvature of the plurality of lesions is to be treated first based on the lesion curvature information;
determining a lesion to be treated subsequently among the plurality of lesions based on the lesion curvature information of each of the one or more lesions in each of the plurality of bifurcated lumens, the lesion to be treated subsequently being in another of the plurality of bifurcated lumens, and wherein the treatment of the plurality of lesions is with a guide wire and/or a guiding catheter, and a treatment catheter;
obtaining the lesion curvature information from the bifurcation for each of the plurality of lesions;
selecting the guide wire and/or the guiding catheter, and the treatment catheter based on the lesion curvature information of each of the one or more lesions in each of the plurality of bifurcated lumens; and
inserting the guide wire and/or the guiding catheter, and the treatment catheter from a radial artery of an arm.

### Claim 4 (depends on 1)

The diagnostic method according to claim 1, comprising:
determining the lesion to be treated first among the plurality of lesions to be a lesion having a larger lesion curvature; and
determining a lesion having a smaller lesion curvature to be the lesion to be treated subsequently.

### Claim 5 (depends on 1)

The diagnostic method according to claim 1, comprising:
selecting the electromagnetic waves from one or more of X-rays, magnetic field lines, ultrasound waves, infrared rays, and visible light.

### Claim 6 (depends on 1)

The diagnostic method according to claim 1, wherein based on the lesion curvature information, the method comprising:
determining the lesion to be treated first among the plurality of lesions by deep learning.

### Claim 7 (depends on 1)

The diagnostic method according to claim 1, comprising:
performing the diagnosis by reinforcement-learning using a result of treatment.

### Claim 8

A validation method for diagnosing multiple lesions by in a biological lumen by catheter intervention in which a plurality of bifurcated lumens are connected via a bifurcation from a main lumen, the validation method comprising:
training a machine-learning algorithm with lesion curvature information, types of guide wires, types of catheters, types of treatment catheters, and operation times for completed treatments;
detecting electromagnetic waves obtained through a patient by irradiating the patient with electromagnetic waves, and obtaining electromagnetic wave information on the patient based on a changed electromagnetic wave;
using the machine-learning algorithm to identify a plurality of lesions from the electromagnetic wave information, acquire lesion curvature information on each of the plurality of lesions from the electromagnetic wave information, and determine a lesion to be treated first among the plurality of lesions based on the lesion curvature information and a lesion to be treated subsequently among the plurality of lesions, the plurality of lesions including one or more lesions in each of the plurality of bifurcated lumens;
determining the lesion to be treated first among the plurality of lesions based on the lesion curvature information of each of the one or more lesion in each of the plurality of bifurcated lumens, the lesion to be treated first being in one of the plurality of bifurcated lumens;
determining the lesion to be treated subsequently among the plurality of lesions based on the lesion curvature information of each of the one or more lesions in each of the plurality of bifurcated lumens, the lesion to be treated subsequently being in another of the plurality of bifurcated lumens; and
validating a diagnosis using the lesion curvature information.

### Claim 9 (depends on 8)

The validation method according to claim 8, comprising:
using information that the lesion having a larger lesion curvature is to be treated first.

### Claim 10 (depends on 8)

The validation method according to claim 8, comprising:
using patient information after treatment in the validation method.

### Claim 11 (depends on 8)

The validation method according to claim 8, comprising:
performing the validation method by reinforcement-learning using patient information after treatment as remuneration.

### Claim 12

A treatment method for treating a patient having a lesion in each of left and right lower limb arteries connected via an aortailiac bifurcation to the aorta with a machine-learning algorithm, the method comprising:
training a machine-learning algorithm with lesion curvature information, types of guide wires, types of catheters, types of treatment catheters, and operation times for completed treatments;
detecting electromagnetic waves obtained through a patient by irradiating the patient with electromagnetic waves, and obtaining electromagnetic wave information on the patient based on a changed electromagnetic wave;
using the machine-learning algorithm to identify a plurality of lesions from the electromagnetic wave information, acquire lesion curvature information on each of the plurality of lesions from the electromagnetic wave information, and determine a lesion to be treated first among the plurality of lesions based on the lesion curvature information and a lesion to be treated subsequently among the plurality of lesions, the plurality of lesions including one or more lesions in each of the plurality of bifurcated lumens;
determining a lesion having a larger lesion curvature to be the lesion to be treated first among the plurality of lesions based on the lesion curvature information of each of the one or more lesion in each of the plurality of bifurcated lumens, the lesion to be treated first being in one of the plurality of bifurcated lumens;
determining a lesion having a smaller lesion curvature to be the lesion to be treated subsequently among the plurality of lesions based on the lesion curvature information of each of the one or more lesions in each of the plurality of bifurcated lumens, the lesion to be treated subsequently being in another of the plurality of bifurcated lumens;
selecting a catheter and a therapeutic catheter based on the lesion curvature information of each of the one or more lesions in each of the plurality of bifurcated lumens;
introducing the catheter from an artery of an arm of the patient, advancing and placing a catheter tip of the catheter to at least the aortailiac bifurcation of the patient;
inserting the therapeutic catheter into a lumen of the catheter positioned, projecting a therapeutic catheter tip of the therapeutic catheter from the catheter tip; and
treating the lesion having the larger lesion curvature first, and then projecting the therapeutic catheter tip of the therapeutic catheter from the catheter tip to treat the lesion having the smaller lesion curvature.

### Claim 13 (depends on 12)

The treatment method according to claim 12, further comprising:
using the catheter in treating the lesion having the smaller lesion curvature.

### Claim 14 (depends on 12)

The treatment method according to claim 12, further comprising:
using the therapeutic catheter in treating the lesion having the smaller lesion curvature.

### Claim 15 (depends on 12)

The treatment method according to claim 12, wherein after treating the larger lesion curvature, the method comprising:
removing the therapeutic catheter from the catheter; and
using a second therapeutic catheter in the treating of the lesion having the smaller lesion curvature.

### Claim 16 (depends on 12)

The treatment method according to claim 12, wherein the catheter is a guiding catheter, the method comprising:
using a catheter assembly including an inner catheter inserted in a lumen of the guiding catheter in the placing of the catheter tip of the catheter to at least the aortailiac bifurcation of the patient.
