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Research Papers

Design and Experimental Validation of an Active Catheter for Endovascular Navigation

[+] Author and Article Information
Thibault Couture

Service de Chirurgie vasculaire,
Hôpital Pitié-Salpêtrière,
52 Boulevard Vincent-Auriol,
Paris 75013, France
e-mail: thibault.couture@gmail.com

Jérôme Szewczyk

Institut des Systèmes Intelligents et de
Robotique,
Université Pierre et Marie Curie,
Boîte courrier 173,
4 place Jussieu,
Paris 75252, France,
e-mail: szewczyk@isir.upmc.fr

1Corresponding author.

Manuscript received January 27, 2017; final manuscript received September 21, 2017; published online November 22, 2017. Assoc. Editor: Michael Eggen.

J. Med. Devices 12(1), 011003 (Nov 22, 2017) (12 pages) Paper No: MED-17-1019; doi: 10.1115/1.4038334 History: Received January 27, 2017; Revised September 21, 2017

Endovascular techniques have many advantages but rely strongly on operator skills and experience. Robotically steerable catheters have been developed but few are clinically available. We describe here the development of an active and efficient catheter based on shape memory alloys (SMA) actuators. We first established the specifications of our device considering anatomical constraints. We then present a new method for building active SMA-based catheters. The proposed method relies on the use of a core body made of three parallel metallic beams and integrates wire-shaped SMA actuators. The complete device is encapsulated into a standard 6F catheter for safety purposes. A trial-and-error campaign comparing 70 different prototypes was conducted to determine the best dimensions of the core structure and of the SMA actuators with respect to the imposed specifications. The final prototype was tested on a silicon-based arterial model and on a 23 kg pig. During these experiments, we were able to cannulate the supra-aortic trunks and the renal arteries with different angulations and without any complication. A second major contribution of this paper is the derivation of a reliable mathematical model for predicting the bending angle of our active catheters. We first use this model to state some general qualitative rules useful for an iterative dimensional optimization. We then perform a quantitative comparison between the actual and the predicted bending angles for a set of 13 different prototypes. The relative error is less than 20% for bending angles between 100 deg and 150 deg, which is the interval of interest for our applications.

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Figures

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Fig. 1

SMA actuated catheter (principle) (figure inspired from Ref. [27])

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Fig. 2

Active catheter featured with three SMA actuators (figure inspired from Ref. [27])

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Fig. 3

Radius of curvature versus number of SMA actuators

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Fig. 4

Manoeuver for entering a lateral artery: (a) general description, (b) pointing toward the ostium, (c) entering into the ostium, and (d) case of a large original artery

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Fig. 5

Description of a device comprising two active sections; (a) general description; (b) detail of an active section

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Fig. 6

Relation between the angle and the different radii of curvature

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Fig. 7

Cross-sectional views of the flexible part and of the rigid part of an active section

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Fig. 8

Axial anchoring of the SMA wire along the core structure

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Fig. 9

Radial anchoring of the SMA wire

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Fig. 10

The active device and its external covering catheter

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Fig. 11

Cross-sectional dimensions of the flexible part

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Fig. 12

Final prototype in maximal bending conditions

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Fig. 13

Test on a silicon-based anatomical phantom

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Fig. 14

Transfer function between the current intensity i and the bending angle θ

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Fig. 15

Experimental setup

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Fig. 16

Control pedal used for in vitro and in vivo experiments

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Fig. 17

Evolution of θmax with respect to the number of activations of the SMA (distal segment)

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Fig. 18

Accuracy of the theoretical model in predicting θmax

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Fig. 19

Experimental setup for in vivo validation

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Fig. 20

(a) Successful cannulations of right renal artery, left renal artery, celiac trunk, left subclavian artery, common bicarotid and right subclavian trunk; (b) angiographic control after cannulation of the right and left renal arteries, and of the celiac trunk

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Fig. 21

Expression of θmax in function of r according to the theoretical model

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