# US 10,478,074 B1 · Method for determining patient suitability for a surgical procedure

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,478,074 B1
- Document ID: US10478074B1
- Status: Granted
- Kind: B1
- Application number: 16/186,965
- Filed: 2018-11-12
- Granted: 2019-11-19
- Earliest claimed: 2018-06-22
- Applicants: Dextera AS
- Inventors: Frank Dedroog; Javier Murillo-Castarlenas; Pilar Garcia-Navarro; Adrian Navas-Montilla; Jose Ramirez-Rodriguez
- Web page: https://patentgrep.com/patent/US10478074B1

## CPC

- A61B 5/02028: {Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction}
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/0816: {Measuring devices for examining respiratory frequency (measuring frequency of electric signals G01R23/00)}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- 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 system and method for determining a patient's suitability for a proposed surgical procedure is disclosed in which a simulated, procedure specific hemodynamic profile of an individual patient is obtained using a hemodynamic simulation module operating on a digital processor using a patient specific hemodynamic calculation parameter set. This is used by a trained clinician to evaluate whether the patient is a suitable candidate to undergo the proposed surgery. The patient specific hemodynamic calculation parameter set is obtained by optimizing a generic hemodynamic calculation parameter set. Optimization is done automatically by adjusting the generic hemodynamic calculation parameter set based on the comparison of simulated profiles corresponding to measured hemodynamic profiles of the patient in a non-operation situation. The automatic adjustment is guided by a Damped Least Squares Method and related algorithms.

## Claims

### Claim 1

A method for determining a patient's suitability for a proposed surgical procedure, comprising:
producing a patient specific hemodynamic calculation parameter set using the optimizing method comprising:
obtaining a generic hemodynamic calculation parameter set;
producing a measured, first situation, hemodynamic profile of said patient by measuring one or more hemodynamic parameters of said patient in a first situation;
producing a simulated, first situation, hemodynamic profile of said patient, using said generic hemodynamic calculation parameter set, and a hemodynamic simulation module;
comparing said measured, first situation, hemodynamic profile to said simulated, first situation, hemodynamic profile; and
based on said comparison, adjusting said generic hemodynamic calculation parameter set to produce an adjusted, hemodynamic calculation parameter set;
producing a further simulated, first situation, hemodynamic profile of said patient, using said adjusted hemodynamic calculation parameter set and said hemodynamic simulation module;
comparing said measured, first situation, hemodynamic profile to said further simulated, first situation, hemodynamic profile; and
repeating the previous three steps until a sufficiently good agreement is reached between said profiles, then designating the final adjusted hemodynamic calculation parameter set as the patient specific hemodynamic calculation parameter set;
using said patient specific hemodynamic calculation parameter set, and said hemodynamic simulation module, operable on a digital processor, to automatically produce a simulated, procedure specific, hemodynamic profile of said patient; and
evaluating said simulated, procedure specific, hemodynamic profile to determine if said patient is a suitable candidate for said surgical procedure.

### Claim 2 (depends on 1)

The method of claim 1 wherein, said generic hemodynamic calculation parameter set comprises data representative of a population having one or more observable characteristics in common with said patient.

### Claim 3 (depends on 2)

The method of claim 2, wherein, said observable characteristics are one of an age, a gender, an ethnicity, a weight, a height, a diet, a history of prior surgery, a history of medication use, a history of alcohol consumption, a history of smoking, a history of drug use, or some combination thereof.

### Claim 4 (depends on 1)

The method of, claim 1 wherein, said measured, first situation, hemodynamic profile comprises at least one of a systolic and a diastolic arterial blood pressures, a cardiac parameter comprising a heart rate, a systolic and a diastolic, right and left, ventricular pressure, and a respiration parameter, comprising an arterial and a venous oxygen saturation, or some combination thereof.

### Claim 5 (depends on 1)

The method of claim 1 wherein said adjusting is performed automatically by an optimization module operative on said digital computer.

### Claim 6 (depends on 5)

The method of claim 5, wherein, said optimization module utilizes an algorithm comprising a Damped Least Squares Method.

### Claim 7 (depends on 1)

The method of, claim 1 wherein said comparing further comprises:
defining a merit function representative of said measured, first situation, hemodynamic profile of said patient; and
wherein, comparing comprises, comparing a value of said merit function obtained using said simulated, first situation, hemodynamic profile to a target value of said merit function.

### Claim 8 (depends on 7)

The method of claim 7, wherein, said merit function comprises a weighted sum of two or more of said measured, first situation, hemodynamic parameters.

### Claim 9 (depends on 1)

The method of claim 1, wherein, said hemodynamic simulation module comprises a full-system, closed loop, mathematical hemodynamic model representative of the cardio-vascular circulation of the entire body of a human.

### Claim 10 (depends on 9)

The method of claim 9, wherein, said mathematical hemodynamic model comprises a lumped circuit model.

### Claim 11 (depends on 9)

The method of claim 9, wherein, said lumped circuit model is a 14-node RLE circuit model.
