# US 11,309,071 B2 · Devices, systems, and methods for vessel assessment and intervention recommendation

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- Number: US 11,309,071 B2
- Document ID: US11309071B2
- Status: Granted
- Kind: B2
- Application number: 14/961,505
- Filed: 2015-12-07
- Published: 2016-06-09
- Granted: 2022-04-19
- Earliest claimed: 2014-12-08
- Assignees: Philips Image Guided Therapy Corporation
- Applicants: Volcano Corporation
- Inventors: David Anderson
- Web page: https://patentgrep.com/patent/US11309071B2

## CPC

- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- A61B 5/0215: by means inserted into the body
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/4417: {related to combined acquisition of different diagnostic modalities}
- A61B 6/504: {for diagnosis of blood vessels, e.g. by angiography}
- A61B 6/5217: {extracting a diagnostic or physiological parameter from medical diagnostic data}
- A61B 8/04: Measuring blood pressure
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/104: {Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Devices, systems, and methods of evaluating risk associated with a condition of the vessel and providing an objective intervention recommendation based on the evaluated risk are disclosed. The method includes steps of obtaining physiologic measurements from a first instrument and a second instrument positioned within the vessel of the patient while the second instrument is moved longitudinally through the vessel from a first position to a second position, obtaining image data from an image of a vessel system, co-registering the physiologic measurements with the image data to produce co-registered physiologic measurements, and determining whether to perform a first surgical procedure or a second surgical procedure, wherein the determining is based on the co-registered physiologic measurements. Other associated methods, systems, and devices are also provided herein.

## Claims

### Claim 1

A method of evaluating a vessel system of a patient to recommend an intervention for the patient, the method comprising:
obtaining, at a processor, pressure measurements from a pressure-sensing instrument and a pressure-sensing guidewire positioned within a vessel of the patient while the pressure-sensing guidewire is moved longitudinally through the vessel from a first position to a second position, the pressure-sensing guidewire comprising a proximal portion, a distal portion, and a pressure sensor coupled to the distal portion;
determining, based on the pressure measurements, a plurality of pressure ratios along a length of the vessel with a lesion, wherein the length of the vessel comprises a first plurality of locations defining a first segment and a second plurality of locations defining a second segment;
obtaining, at the processor, external image data of the vessel;
co-registering, with the processor, the plurality of pressure ratios with the external image data to produce first co-registered pressure ratios having a positional relationship with the first plurality of locations and second co-registered pressure ratios having the positional relationship with the second plurality of locations;
determining, with the processor, first image-based physiologic measurements associated with the first segment and second image-based physiologic measurements associated with the second segment, from the external image data;
calculating, with the processor, a first functional disease quantification score associated with the first segment and a second functional disease quantification score associated with the second segment, wherein the calculating comprises:
determining a first image-based disease quantification score based on the first image-based physiologic measurements and a second image-based disease quantification score based on the second image-based physiologic measurements; and
modifying the first image-based disease quantification score by a first factor to generate the first functional disease quantification score and the second image-based disease quantification score by a second factor to generate the second functional disease quantification score, wherein the first factor is determined based on the first co-registered pressure ratios such that the first functional disease quantification score is attributable to the positional relationship between the first co-registered pressure ratios and the first plurality of locations, and wherein the second factor is determined based on the second co-registered pressure ratios such that the second functional disease quantification score is attributable to the positional relationship between the second co-registered pressure ratios and the second plurality of locations; and
outputting, to a display in communication with the processor, a graphical representation of the first functional disease quantification score, the second functional disease quantification score, the first image-based disease quantification score, and the second image-based disease quantification score.

### Claim 2 (depends on 1)

The method of claim 1, wherein the external image data of the vessel comprises at least one of a two-dimensional angiographic image, a three-dimensional angiographic image, or a computed tomography (CT) angiographic image.

### Claim 3 (depends on 1)

The method of claim 1, wherein co-registering the plurality of pressure ratios with the external image data comprises:
associating, in a data file, each pressure ratio with a location within the vessel;
identifying a corresponding location for each pressure ratio within the external image data; and
associating, in a co-registered pressure ratios data file, each pressure ratio with its corresponding location within the external image data of the vessel.

### Claim 4 (depends on 1)

The method of claim 1,
wherein at least one of the first functional disease quantification score or the second functional disease quantification score indicates whether to perform a first surgical procedure or a second surgical procedure, and
wherein determining whether to perform the first surgical procedure or the second surgical procedure comprises:
interpreting, by the processor, the external image data of the vessel; and
identifying one or more lesions within the vessel.

### Claim 5 (depends on 1)

The method of claim 1, wherein the first image-based physiologic measurements and the second image-based physiologic measurements comprise at least one of a dominance classification, a degree of occlusion of the lesion, a classification of the lesion, a degree of bending of the vessel, a length of the lesion, a location of the lesion, or a degree of calcification of the lesion.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first functional disease quantification score and the second functional disease quantification score is determined further based on patient history information.

### Claim 7 (depends on 1)

The method of claim 1, further comprising:
outputting, to the display, a recommendation for a procedure when at least one of the first functional disease quantification score or the second functional disease quantification score is below a threshold.

### Claim 8 (depends on 1)

The method of claim 1, wherein the first image-based disease quantification score and the second image-based disease quantification score comprise a SYNTAX score.

### Claim 9 (depends on 1)

The method of claim 1,
wherein at least one of the first functional disease quantification score or the second functional disease quantification score indicates whether to perform a first surgical procedure or a second surgical procedure, and
wherein the first surgical procedure comprises a percutaneous coronary intervention and the second surgical procedure comprises a coronary artery bypass graft.

### Claim 10

A system for generating an intervention recommendation for treating a vessel of a patient, comprising:
a pressure-sensing guidewire comprising a proximal portion, a distal portion, and a pressure sensor coupled to the distal portion; and
a processor in communication with the pressure-sensing guidewire, the processor configured to:
obtain pressure measurements from a pressure-sensing instrument and the pressure-sensing guidewire while the pressure-sensing guidewire is positioned within the vessel of the patient and moved longitudinally through the vessel from a first position to a second position;
determine, based on the pressure measurements, a plurality of pressure ratios along a length of the vessel with a lesion, wherein the length of the vessel comprises a first plurality of locations defining a first segment and a second plurality of locations defining a second segment;
obtain external image data of the vessel;
co-register the plurality of pressure ratios with the external image data to produce first co-registered pressure ratios having a positional relationship with the first plurality of locations and second co-registered pressure ratios having the positional relationship with the second plurality of locations;
determine, from the external image data, first image-based physiologic measurements associated with the first segment and second image-based physiologic measurements associated with the second segment;
calculate a first functional disease quantification score associated with the first segment and a second functional disease quantification score associated with the second segment; and
output, to a display, a graphical representation of a first image-based disease quantification score, a second image-based disease quantification score, the first functional disease quantification score, and the second functional disease quantification score,
wherein, to calculate the first functional disease quantification score and the second functional disease quantification score, the processor is configured to:
determine the first image-based disease quantification score based on the first image-based physiologic measurements and the second image-based disease quantification score based on the second image-based physiologic measurements; and
modify the first image-based disease quantification score by a first factor to generate the first functional disease quantification score and the second image-based disease quantification score by a second factor to generate the second functional disease quantification score, wherein the first factor is determined based on the first co-registered pressure ratios such that the first functional disease quantification score is attributable to the positional relationship between the first co-registered pressure ratios and the first plurality of locations, and wherein the second factor is determined based on the second co-registered pressure ratios such that the second functional disease quantification score is attributable to the positional relationship between the second co-registered pressure ratios and the second plurality of locations.

### Claim 11 (depends on 10)

The system of claim 10,
further comprising a memory in communication the processor,
wherein the external image data of the vessel comprises at least one of a two-dimensional angiographic image, a three-dimensional angiographic image, or a computed tomography angiographic (CTA) image, and
wherein the external image data is stored in the memory.

### Claim 12 (depends on 10)

The system of claim 10, wherein, to co-register the plurality of pressure ratios with the external image data, the processor is further configured to:
associate, in a data file, each pressure ratio with a location within the vessel;
identify a corresponding location for each pressure ratio within the external image data; and
associate, in a co-registered pressure ratio data file, each pressure ratio with its corresponding location within the external image data of the vessel.

### Claim 13 (depends on 10)

The system of claim 10, wherein the processor is further configured to:
identify one or more additional vessels from the external image data; and
identify one or more lesions within the one or more additional vessels.

### Claim 14 (depends on 10)

The system of claim 10, wherein the first image-based physiologic measurements and the second image-based physiologic measurements comprise at least one of a dominance classification, a degree of occlusion of the lesion, a classification of the lesion, a degree of bending of the vessel, a length of the lesion, a location of the lesion, or a degree of calcification of the lesion.

### Claim 15 (depends on 10)

The system of claim 10, wherein the processor calculates is configured to calculate the first functional disease quantification score and the second functional disease quantification score further based on patient history information.

### Claim 16 (depends on 10)

The system of claim 10, wherein the processor is further configured to:
obtain additional pressure measurements from the pressure-sensing instrument and the pressure-sensing guidewire; and
modify at least one of the first functional disease quantification score or the second functional disease quantification score based on the additional pressure measurements.

### Claim 17 (depends on 16)

The system of claim 16, wherein the first image-based disease quantification score and the second image-based disease quantification score comprise a SYNTAX score.

### Claim 18 (depends on 10)

The system of claim 10, wherein the graphical representation of the first functional disease quantification score and the second functional disease quantification score comprises a numerical value.

### Claim 19 (depends on 1)

The method of claim 1, wherein the graphical representation of the first functional disease quantification score and the second functional disease quantification score comprises a numerical value.

### Claim 20 (depends on 10)

The system of claim 10, wherein at least one of the first factor or the second factor further corresponds to a relative effect on blood flow within the vessel of a first lesion compared to a second lesion.
