# US 12,758,181 B2 · Ultrasound diagnostic tool for renal fibrosis assessment

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- Number: US 12,758,181 B2
- Document ID: US12758181B2
- Status: Granted
- Kind: B2
- Application number: 19/051,676
- Filed: 2025-02-12
- Published: 2025-08-21
- Granted: 2026-10-13
- Earliest claimed: 2024-02-20
- Assignees: The Hong Kong Polytechnic University
- Applicants: The Hong Kong Polytechnic University
- Inventors: Ziman Chen; Tin Cheung Ying
- Web page: https://patentgrep.com/patent/US12758181B2

## CPC

- A61B 8/08: Clinical applications (A61B8/02, A61B8/04, A61B8/06 take precedence)
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A tool for using conventional ultrasound techniques for renal fibrosis assessment, particularly in cases of chronic kidney disease. Patient parameters such as age are combined with ultrasonically determined parameters both morphological (e.g. renal length) and hemodynamic (e.g. end-diastolic velocity of circulation in the interlobal renal artery) to evaluate the risk of a patient displaying moderate-to-severe renal fibrosis over a baseline risk. Additional and/or substitute parameters are also described.

## Claims

### Claim 1

An ultrasound diagnostic tool for renal fibrosis assessment comprising:
a) a renal ultrasound system which produces renal ultrasound data related to a kidney of a patient diagnosed with chronic kidney disease and having an age;
b) an ultrasound measurement system which evaluates the renal ultrasound data to measure:
at least one morphological parameter comprising a renal length of the kidney; and
at least one hemodynamic parameter comprising an end-diastolic velocity of an interlobar renal artery;
c) a diagnostic system which performs a multivariate diagnostic calculation combining the age, the at least one morphological parameter and the at least one hemodynamic parameter to obtain a risk assessment which predicts the patient's risk of developing moderate-to-severe renal fibrosis for use by a health-care professional in determining a monitoring and/or treatment plan for the patient.

### Claim 2 (depends on 1)

The tool of claim 1, wherein the risk assessment uses an increased risk of 6 percent per additional year of the age in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 3 (depends on 2)

The tool of claim 2, wherein the risk assessment uses an increased risk of 58 percent for every one unit decrease in the renal length in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 4 (depends on 3)

The tool of claim 3, wherein the risk assessment uses an increased risk of 20 percent for every one unit decrease in the end-diastolic velocity in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 5 (depends on 1)

The tool of claim 1, wherein the risk assessment uses an increased risk of 58 percent for every one unit decrease in the renal length in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 6 (depends on 1)

The tool of claim 1, wherein the risk assessment uses an increased risk of 20 percent for every one unit decrease in the end-diastolic velocity in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 7

An ultrasound diagnostic tool for renal fibrosis assessment, comprising a processor coupled to a memory, a fixed storage system, a renal ultrasound system, and an output bus, wherein the fixed storage system and/or the memory is configured to store a computer code, and the processor is configured to execute the computer code for:
performing a series of renal ultrasound measurements on a patient diagnosed with chronic kidney disease and having an age to obtain a set of renal ultrasound data;
evaluating the renal ultrasound data to obtain:
at least one morphological parameter comprising a renal length of the kidney; and
at least one hemodynamic parameter comprising an end-diastolic velocity of an interlobar renal artery;
performing a multivariate diagnostic calculation combining the age, the at least one morphological parameter and the at least one hemodynamic parameter to obtain a risk assessment which evaluates the patient's risk of developing moderate-to-severe renal fibrosis;
outputting the risk assessment through the output bus to a display and/or a printer and/or a remote device for use by a health-care professional in determining a monitoring and/or treatment plan for the patient.

### Claim 8 (depends on 7)

The tool of claim 7, wherein the risk assessment uses an increased risk of 6 percent per additional year of the age in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 9 (depends on 8)

The tool of claim 8, wherein the risk assessment uses an increased risk of 58 percent for every one unit decrease in the renal length in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 10 (depends on 9)

The tool of claim 9, wherein the risk assessment uses an increased risk of 20 percent for every one unit decrease in the end-diastolic velocity in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 11

An ultrasound diagnostic tool for renal fibrosis assessment comprising:
a) a renal ultrasound system which produces renal ultrasound data related to a kidney of a patient having an age, wherein the patient is a person diagnosed with chronic kidney disease;
b) an ultrasound measurement system which evaluates the renal ultrasound data to measure at least one morphological parameter comprising a renal length of the kidney and at least one hemodynamic parameter comprising an end-diastolic velocity of the interlobar renal artery; and
c) a diagnostic system which performs at least one diagnostic calculation on the age, the at least one morphological parameter, and the at least one hemodynamic parameter to obtain a risk assessment which predicts the patient's risk of developing moderate-to-severe renal fibrosis, wherein the risk assessment uses an increased risk of 6 percent per additional year of the age, an increased risk of 58 percent for every one unit decrease in the renal length, and an increased risk of 20 percent for every one unit decrease in the end-diastolic velocity, in predicting the patient's risk of developing moderate-to-severe renal fibrosis.

### Claim 12 (depends on 11)

The tool of claim 11, wherein the at least one hemodynamic parameter further comprises a resistive index of the interlobar renal artery.

### Claim 13 (depends on 11)

The tool of claim 11, wherein the at least one morphological parameter further comprises at least one of a cortical thickness of the kidney and a parenchymal echogenicity of the kidney.

### Claim 14 (depends on 11)

The tool of claim 11, wherein the diagnostic system further performs the at least one diagnostic calculation on a glomerular filtration rate of the kidney as an additional clinical indicator.

### Claim 15 (depends on 11)

The tool of claim 11, wherein the renal ultrasound system further obtains contrast-enhanced ultrasound data for enhanced visualization of renal perfusion.

### Claim 16 (depends on 11)

The tool of claim 11, wherein the ultrasound measurement system further evaluates tissue stiffness of the kidney using elastography as an additional or substitute fibrosis indicator.

### Claim 17 (depends on 11)

The tool of claim 11, wherein the diagnostic system further performs the at least one diagnostic calculation on at least one biochemical marker comprising at least one of serum creatinine and albuminuria.

### Claim 18

An ultrasound diagnostic tool for renal fibrosis assessment, comprising a processor coupled to a memory, a fixed storage system, a renal ultrasound system, and an output bus, wherein the fixed storage system and/or the memory is configured to store a computer code, and the processor is configured to execute the computer code for:
a) performing a series of renal ultrasound measurements on a patient diagnosed with chronic kidney disease and having an age to obtain a set of renal ultrasound data;
b) evaluating the renal ultrasound data to obtain at least one morphological parameter comprising a renal length of the kidney and at least one hemodynamic parameter comprising an end-diastolic velocity of the interlobar renal artery;
c) performing at least one diagnostic calculation on the at least one morphological parameter and the at least one hemodynamic parameter to obtain a risk assessment which evaluates the patient's risk of developing moderate-to-severe renal fibrosis, wherein the risk assessment uses an increased risk of 6 percent per additional year of the age of the patient, an increased risk of 58 percent for every one unit decrease in the renal length, and an increased risk of 20 percent for every one unit decrease in the end-diastolic velocity; and
d) outputting the risk assessment through the output bus to a display and/or a printer and/or a remote device which can display the risk assessment to a health-care professional.

### Claim 19 (depends on 18)

The tool of claim 18, wherein the at least one hemodynamic parameter further comprises a resistive index of the interlobar renal artery.

### Claim 20 (depends on 18)

The tool of claim 18, wherein the at least one morphological parameter further comprises at least one of a cortical thickness of the kidney and a parenchymal echogenicity of the kidney.

### Claim 21 (depends on 18)

The tool of claim 18, wherein the processor is further configured to execute the computer code to perform the at least one diagnostic calculation on a glomerular filtration rate of the kidney as an additional clinical indicator.

### Claim 22 (depends on 18)

The tool of claim 18, wherein the renal ultrasound system further obtains contrast-enhanced ultrasound data for enhanced visualization of renal perfusion.

### Claim 23 (depends on 18)

The tool of claim 18, wherein the processor is further configured to execute the computer code to evaluate tissue stiffness of the kidney using elastography as an additional or substitute fibrosis indicator.

### Claim 24 (depends on 18)

The tool of claim 18, wherein the processor is further configured to execute the computer code to perform the at least one diagnostic calculation on at least one biochemical marker comprising at least one of serum creatinine and albuminuria.
