A METHOD OF MAPPING IMAGES OF HUMAN DISEASE AND OF DESIGNING OR SELECTING A MEDICAL DEVICE USING A SURROGATE MODEL

• US 20170076014A1
• Filed: 02/13/2015
• Published: 03/16/2017
• Est. Priority Date: 02/14/2014
• Status: Active Grant

• Current Assignee: Carena Healthcare Ltd.
• Original Assignee: University of Southampton
• Inventors: Bressloff, Neil W.
• Granted Patent: US 10,642,942 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61B 6/5211 involving processing of medical diagnostic data
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/483 involving the acquisition of a 3D volume of data
• CPC Class Codes: A61B 8/5215 involving processing of medical diagnostic data
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: G06F 17/11 for solving equations , e.g. nonlinear equations, general mathematical optimization problems optimization specially adapted for a specific administrative, business or logistic context G06Q10/04
• CPC Class Codes: G06F 30/00 Computer-aided design [CAD]
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A method of designing or selecting an implantable medical device comprises the steps of: i) obtaining a plurality of measured data points of a characteristic of an anatomical feature of an individual; ii) using said data points to construct a surrogate model of said characteristic, the surrogate model being constructed by interpolating or regressing measured data points of the characteristic, and using said surrogate model to obtain predicted values of said characteristic at a plurality of locations; iii) using said predicted values to determine or select at least one value of a design parameter of the implantable medical device. There is further disclosed a method of monitoring or diagnosing a disease or disorder.

Claims

1. A method of designing or selecting an implantable medical device, comprising the steps of:

i) obtaining a plurality of measured data points of a characteristic of an anatomical feature of an individual;

ii) constructing a surrogate model of said characteristic by interpolating or regressing measured data points of the characteristic, and using said surrogate model to obtain predicted values of said characteristic at a plurality of locations; and

iii) using said predicted values to determine or select at least one value of a design parameter of the implantable medical device.

2. A method according to claim 1, wherein the surrogate model is a response surface model.

3. A method according to claim 1, wherein step iii) comprises using said predicted values to determine values of the design parameter of the implantable medical device at locations on the device that correspond, when the device is implanted, to the locations of the predicted values.

4. A method according to claim 1, wherein step i) comprises obtaining the plurality of measured data points from anatomical images.

5. A method according to claim 1, wherein step ii) comprises constructing said surrogate model using the method of Kriging.

7. A method according to claim 5, further comprising the step of

using an expected improvement calculation to determine further locations at which to obtain measured data points in order to improve the surrogate model.

9. A method according to claim 1, wherein step (i) further comprises the step of:

obtaining a plurality of measured data points for each of a plurality of characteristics of an anatomical feature of an individual; and

step (ii) further comprises the step of;

constructing a surrogate model of said characteristic, by interpolating or regressing measured data points of the characteristic, and using said surrogate models to obtain predicted values of said characteristics at a plurality of locations.

11. A method according to claim 1, wherein the implantable medical device is a mesh arterial stent, and the design parameter is the strut width of said mesh arterial stent.

12. A method according to claim 11, wherein the characteristic is the diseased tissue thickness in an artery.

13. A method according to claim 1, wherein the characteristic is the degree of calcification of the diseased tissue in an artery.

14. A method according to claim 12, wherein step i) comprises obtaining the plurality of measured data points from a plurality of intravascular ultrasound images of sections of the artery at locations along the diseased section of the artery.

16. A method according to claim 11, further comprising the steps of

numerically searching to obtain the position and the value of the maximum of the characteristic from the surrogate model;

orientating the stent such that the position of the maximum of the characteristic from the surrogate model corresponds to the location on said arterial stent where the strut width is a maximum.

17. A method according to claim 12, wherein the strut width at locations on the stent that correspond, when the device is implanted, to the locations of the predicted values of the diseased tissue thickness is calculated with reference to the predicted values of the diseased tissue thickness at said locations.

20. A non-transitory computer program product stored on a computer-readable medium comprising instructions operative to cause a processor to execute a method according to claim 1.

21. A method of manufacturing an implantable medical device, comprising the method of designing an implantable medical device of claim 1, and further comprising the step of manufacturing an implantable medical device according to the design parameter.

22. An implantable medical device, manufactured according to the method of claim 21.

23. A method of selecting an implantable medical device from a range of existing implantable medical devices, comprising the method of selecting an implantable medical device of claim 1.

24. A method according to claim 23, wherein step iii) comprises generating an image from the predicted values, wherein the at least one value of a design parameter is selected based on the image.

6. (canceled)

8. (canceled)

10. (canceled)

19. A method according to claim 10, wherein the measured data points are obtained from X-ray angiography data.

15. (canceled)

18. (canceled)

25. A method of monitoring or diagnosing a disease or disorder, comprising the steps of:

i) obtaining a plurality of measured data points of a characteristic of an anatomical feature of an individual;

ii) constructing a surrogate model of said characteristic by interpolating or regressing measured data points of the characteristic;

iii) using said surrogate model to obtain a first metric of said characteristic;

iv) comparing the first metric with a second metric of said characteristic.