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New Method CMR-Guided Endomyocardial Biopsy in Suspicion Context of Isolated Cardiac Sarcoidosis

Sun, 01 Sep 2024 00:00:00 +0000

Segmentation of cardiac infarction in delayed-enhancement MRI using probability map and transformers-based neural networks

Fri, 01 Dec 2023 00:00:00 +0000

Transformers-Based Neural Network for Cardiac Infarction Segmentation in Delayed-Enhancement MRI

Mon, 16 Oct 2023 00:00:00 +0000

Connector for cables

Thu, 31 Mar 2022 00:00:00 +0000

LPR: from a lab idea to a clinical prototype

Mon, 01 Jun 2020 00:00:00 +0000

Taking a medical robot from concept to first-in-human trials: TRL maturation, quality assurance, risk analysis and industrial spin-off.

The clinical gesture

Inserting a needle under image guidance is a common interventional-radiology procedure: for a biopsy or tumour ablation, the clinician acquires a volume image, plans a trajectory on one slice, then inserts the needle. The gesture is delicate — at the moment of insertion the radiologist has very few guidance tools and relies mostly on experience and on memorising the chosen slice. Under CT, checking the trajectory means repeated control images, hence radiation and back-and-forth; under MRI, the gesture becomes almost impossible to perform by hand inside the bore.

The LPR (Light Puncture Robot) addresses this: a lightweight robot placed directly on the patient to follow its motion as closely as possible, able to hold, position and insert the needle under the clinician’s control. It is compatible with both X-ray CT and MRI — therefore built entirely from non-ferromagnetic materials — and registers itself automatically in the image. The video below sums it up, from registration to needle positioning:

Climbing the TRLs

The real challenge with a medical device isn’t having the idea: it’s pushing it up the technology-readiness levels (TRL) until it can be tested on humans. Here is the path the LPR travelled, from concept (TRL 1) to clinical prototype (TRL 6):

The first steps were quick: observing the clinical procedure, the first design, the first prototype (the α prototype, already there when I joined the team). The real work started afterwards. Moving from TRL 4 to TRL 5 — from a lab-validated robot to one cleared for testing on humans — took far more than research: a redesign of the code under quality assurance, a full risk analysis, and outside expertise. We worked with our partner Axe Systems to manufacture the mechanical part under quality assurance, and with the clinical investigation centre (CIC-IT) of Grenoble Alpes University Hospital and the company SQI for risk analysis and quality-controlled development. This file secured clearance from the French medicines agency (ANSM) and let us build a protocol guaranteeing the robot’s safety for preclinical trials on healthy subjects in MRI, without needle insertion.

These trials mobilised, over two years, a ten-person team that I coordinated (3 from the CIC-IT, 3 from TIMC, 2 from Axe Systems, 2 from SQI).

Moving from TRL 4 to TRL 5 means rewriting the code under quality assurance, running a risk analysis, and making research, clinical and industry teams work together. That is exactly the work a company expects when it wants to turn a promising prototype into a credible device.

The next step — industrialisation — could no longer happen in the lab. So I led a start-up project built on the robot, supported by Grenoble’s tech-transfer office (SATT Linksium), first in maturation (2017) then in incubation (2018–2019). This phase produced two patents and two applications to the national BPI i-Lab innovation contest (2018 and 2019). The feedback was excellent — 17/20 on the technology dimension, 14.6/20 on the financial dimension, 14.8/20 overall — but the project was ultimately not funded. I recruited and supervised an engineer (Jérémy Lenfant) and then two successive co-founders for the business side (Bertrand Perrin, then Antoine Bourrier).

Project management: the funding

Beyond the technical side, the LPR was a long exercise in coordination at the research / clinical / industry interface, backed by a series of grants I secured and ran:

Project	Role	Funder / type	Partners	Period
Robacus	Coordinator	ANR TecSan — ANR-11-TECS-020-01	TIMC, LIRMM, Grenoble Alpes Univ. Hospital (CIC-IT, radiology), Axe Systems	2012–2015
LPROP	Coordinator	Carnot LSI Institute — pre-maturation	TIMC	2015–2016
Emergence (×2)	Coordinator	TIMC — internal (equipment & interns)	TIMC	2016–2017
LPR maturation	Coordinator	SATT Linksium	TIMC, Linksium	2017
LPR incubation	Coordinator	SATT Linksium	Linksium, co-founders	2018–2019

Behind the scenes: remote control of the robot

In collaboration with the LIRMM team (Montpellier), a partner in the Robacus project, we demonstrated real-time remote control of the robot through a force-feedback teleoperation interface — a step toward a gesture where the radiologist would drive insertion from the control room, without radiation exposure. This feasibility demo was not taken further, but it nicely illustrates the flexibility of the guidance software’s architecture, built on , the medical-application prototyping framework I co-develop: its modularity made it possible to reuse code from one prototype version to the next, rather than rewriting everything.

Skills brought to bear

Multi-partner project coordination (research · clinical · industry) · quality-assured and risk-analysed development of a medical device · running regulated preclinical trials on healthy subjects · TRL maturation of a software component, from concept to clinical prototype · industrial maturation and incubation (patent drafting, business plan, team recruitment) · modular, reusable software architecture for medical prototyping.

2022. Fouard Céline, Lenfant Jérémy, Ganesaratnam Gokularajah, Hungr Nikolaï — Connector for cables. US Patent
2018. Ghelfi Julien, Moreau-Gaudry Alexandre, Hungr Nikolaï, Fourd Céline, Veron Baptiste, Medici Maud, Chipon Émilie, Cinquin Philippe, Bricault Ivan — Evaluation of the needle positioning accuracy of a light puncture robot under MRI guidance: results of a clinical trial on healthy volunteers. Cardiovascular and interventional radiology, vol 41 no 9
2016. Hungr Nikolaï, Bricault Ivan, Cinquin Philippe, Fouard Céline — Design and validation of a CT-and MRI-guided robot for percutaneous needle procedures. IEEE transactions on robotics, vol 32 Issue 4
2014. Dorileo Ederson, Hungr Nikolaï, Zemiti Nabil, Fouard Céline, Poignet Philippe — A modular CT/MRI-guided teleoperation platform for robot assisted punctures planning. CARS 2014-28th International Congress and Exhibition on Computer Assisted Radiology and Surgery
2014. Dorileo Ederson, Zemiti Nabil, Poignet Philippe, Hungr Nikolaï, Bricault Ivan, Fouard Céline — Observations of Lightly Flexible Needle Deflection in 3D CT/MRI. Proceedings of Surgetica 2014
2011. Hungr Nikolaï, Fouard Céline, Robert Adeline, Bricault Ivan, Cinquin Philippe — Interventional radiology robot for CT and MRI guided percutaneous interventions. Proceedings of the 14th international conference on Medical image Ccomputing and Computer-Assisted Intervention (MICCAI)
2008. Zemiti Nabil, Bricault Ivan, Fouard Céline, Sanche Bénédicte, Cinquin Philippe — LPR: A CT and MR-compatible puncture robot to enhance accuracy and safety of image-guided interventions. IEEE/ASME Transactions on Mechatronics
2008. Bricault Ivan, Zemiti Nabil, Jouniaux Émilie, Fouard Céline, Taillant Élise, Dorandeu Frédéric, Cinquin Philippe — Light Puncture Robot for CT and MRI Interventions. IEEE Engineering in Medicine and Biology Magazine

Design and validation of a CT-and MRI-guided robot for percutaneous needle procedures

Tue, 02 Aug 2016 00:00:00 +0000

A modular CT/MRI-guided teleoperation platform for robot assisted punctures planning

Sat, 28 Jun 2014 00:00:00 +0000

Observations of Lightly Flexible Needle Deflection in 3D CT/MRI

Wed, 01 Jan 2014 00:00:00 +0000

Interventional radiology robot for CT and MRI guided percutaneous interventions

Sun, 18 Sep 2011 00:00:00 +0000

LPR: A CT and MR-compatible puncture robot to enhance accuracy and safety of image-guided interventions

Fri, 13 Jun 2008 00:00:00 +0000

Light Puncture Robot for CT and MRI Interventions

Fri, 23 May 2008 00:00:00 +0000

Interventional cardiology

Mon, 01 Jan 0001 00:00:00 +0000

From clinical need to prototype: guiding the gesture at the heart of the cath lab.

Interventional cardiology is performed under imaging, yet the clinician must often act without directly seeing the target: the lesion to treat or to biopsy does not appear on the real-time image in the room. Carried out with Prof. Gilles Barone-Rochette (Grenoble Alpes University Hospital) and the LTSI laboratory in Rennes, this project pursues a single goal expressed through two clinical questions: to give the cardiologist reliable guidance, built from preoperative imaging and usable directly in the room.

The common thread: bouncing back when the data runs short

The project started with the guidance of cell therapy. The first clinical trial enrolled fewer patients than expected: the data needed for the next steps were not there. Rather than abandoning it, we redeployed the technical building blocks already developed (image segmentation, navigation) toward a related clinical need with more immediate value and a better-identified bottleneck: endomyocardial biopsy.

This pivot is, in itself, a deliverable: it illustrates the ability to de-risk a project, preserve the assets already built, and refocus the effort where the clinical value is highest — exactly the kind of trade-off a company expects when an R&D programme does not go as planned.

Sub-project 1 — Guiding post-infarction cell therapy

After a heart attack, some therapies consist in re-injecting cells into the myocardium. The whole challenge is precision: reaching the right areas, relying on information (the extent of fibrosis, the viable regions) that is only visible on preoperative imaging, not on the real-time image in the room.

Our approach: fuse multimodal imaging to transfer, during the intervention, the targets identified preoperatively. The core building block is the automatic segmentation of the myocardium and fibrosis on late gadolinium enhancement MRI (LGE-MRI), developed using deep learning as part of Erwan Lecesne’s PhD (co-supervised with the LTSI in Rennes), then integrated into to be presented to the clinician in the room.

Re-injecting cells in the right place: the precision of the gesture determines the therapy’s effectiveness.

CamiTK is a prototyping toolkit: it makes it possible to move quickly from concept to evaluated prototype, but its output is not meant to be a CE-marked medical device. This building block is therefore a proof of concept; its industrial transfer is currently under discussion with partners in the field.

Sub-project 2 — A map for endomyocardial biopsy

Three conditions — cardiac sarcoidosis, chronic myocarditis and arrhythmogenic cardiomyopathy — can present a similar clinical picture yet call for opposite treatments. To decide, a biopsy is needed… provided the sample is taken in the right place.

Endomyocardial biopsy: sampling a piece of cardiac tissue, where the lesion is located.

The state of the art leaves a real gap:

“blind” biopsy is poorly specific, because the fibrosis to target stays invisible during the gesture;
electro-anatomical guidance is long and, likewise, blind to fibrosis.

Our solution acts as a “GPS” for the biopsy catheter: it transfers the target identified on preoperative imaging onto the real-time image, to guide the sampling. Two design choices make it a solution built for adoption: it is hardware-independent (compatible with an existing room) and works on real-time fluoroscopy, with no complex fusion step. It directly reuses the segmentation building block from the first sub-project.

Diagram of the proposed guidance system for endomyocardial biopsy (published).

Current status: we are preparing the first clinical trials in the laboratory; industrial transfer will follow.

What this project demonstrates

Designing from a real clinical need, in close dialogue with practitioners, rather than around a technical feat.
Mastering medical image processing and AI, and putting them at the service of a precise, useful target.
Taking a prototype from the laboratory toward the clinic, with a clear awareness of maturity stages (TRL), the trial framework and CE marking.
Architecting for adoption: hardware independence, integration into a prototyping toolkit, reuse of building blocks.
Refocusing a project to preserve its value: agility and de-risking in the face of the unexpected.
Leading a multi-site collaboration (Grenoble–Rennes) and co-supervising a PhD.

Funding obtained

Funding	Amount	Purpose
Famtastic project (France Life Imaging)	€20,000	Kick-starting the collaboration with the LTSI (Rennes)
PUI (UGA)	€60,000	Maturing the prototype toward the first clinical trials
PhD funding (LabeX CAMI)	€170,000	Co-supervision of Erwan Lecesne’s PhD
Post-doctorate (LabeX CAMI)	€56,000	One year of post-doctoral engineering
Total	€306,000

Collaborations and supervision

Prof. Gilles Barone-Rochette — interventional cardiologist, Grenoble Alpes University Hospital: clinical partner of the project.
LTSI laboratory (Rennes) — Professor Mireille Garreau and Antoine Simon (associate professor): collaboration on cardiac image processing.
Erwan Lecesne’s PhD (2020–2024), co-supervised at 50% with Mireille Garreau (LTSI): multimodal image processing to improve post-infarction cell therapy.
Théophile Tiffet’s PhD — medical resident: echocardiography / SPECT calibration for interventional cardiology.

2024. Barone-Rochette Gilles, MD,, Erwan Lecesne, MSc,, Antoine Simon, PhD, Mireille Garreau, PhD,, Celine Fouard, PhD — New Method CMR-Guided Endomyocardial Biopsy in Suspicion Context of Isolated Cardiac Sarcoidosis. Circulation: Cardiovascular Imaging, vol 17, no 4
2023. Erwan Lecesne, Antoine Simon, Mireille Garreau, Barone-Rochette Gilles, Celine Fouard — Segmentation of cardiac infarction in delayed-enhancement MRI using probability map and transformers-based neural networks. Computer Methods and Programs in Biomedicine, vol 242
2023. Lecesne Erwan, Simon Antoine, Garreau Mireille, Barone-Rochette Gilles, Fouard Céline — Transformers-Based Neural Network for Cardiac Infarction Segmentation in Delayed-Enhancement MRI. 2023 IEEE Twelfth International Conference on Image Processing Theory, Tools and Applications (IPTA)