Research Papers

Improving Maneuverability and Tactile Feedback in Medical Catheters by Optimizing the Valve Toward Minimal Friction

[+] Author and Article Information
S. K. Ravensbergen

Department of Mechanical Engineering, Eindhoven University of Technology, NL-5600-MB Eindhoven, The Netherlandss.k.ravensbergen@tue.nl

P. C. J. N. Rosielle, M. Steinbuch

Department of Mechanical Engineering, Eindhoven University of Technology, NL-5600-MB Eindhoven, The Netherlands

J. Med. Devices 3(1), 011003 (Jan 08, 2009) (4 pages) doi:10.1115/1.3054389 History: Received October 29, 2008; Revised November 14, 2008; Published January 08, 2009

A new extended hemostasis valve for sheaths is presented, with minimized stick-slip behavior to be used in (heart) catheterization procedures during long interventions (3–6 h). The invented extension to this existing sheath bypasses the silicone rubber sealing (hemostasis valve) and replaces it with a dedicated seal with the two functions separated: (1) sealing around the catheter being used and (2) closing the sheath when the catheter is removed (valve function). Measurements have been performed on the current and the invented seals, showing that the axial friction force is reduced, with a factor of 6.4, from 1.4 N to 0.22 N.

Copyright © 2009 by American Society of Mechanical Engineers
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Figure 1

Insertion of the ablation catheter in the groin area and moved toward the heart via the inferior vena cava or inserted in the neck and via the superior vena cava

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Figure 2

Cardiac ablation catheter, normally 1100–1300 mm in length and 7 French (2.33 mm) in diameter. The handle contains a knob for bending the tip and a connector for electronics and flushing. The sheath length is 500–600 mm with an 8–9 French (2.7–3.0 mm) inner and 9–10 (3.0–3.3 mm) outer diameter. Also the improved valve and seal are indicated.

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Figure 3

Normal and X-ray pictures of an existing sheath (St. Jude Medical (9)) with silicone rubber seal, flush channel, and the sheath (containing a braiding of stainless wires)

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Figure 4

Friction optimized sheath, figures from Ref. 12.

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Figure 5

The hemostasis valve setup showing the separate surrounding seal, used when the catheter tube is inserted (function (1)), and the closure valve, used when the catheter is removed (function (2)). The whole setup is inserted into an existing tight high friction hemostasis valve and locked on its housing.

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Figure 6

The improved hemostasis valve with ablation catheter

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Figure 7

Systematic view of the closing valve showing the door with torsion spring in closed (left: φ=0 deg, ϑ=36 deg, and Mdoor=2.4 N mm) and opened (right: φ=70 deg, ϑ=52 deg, and M=1.8 N mm) positions

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Figure 8

Analytical model of the closing valve: (left) the spring deflection angle ϑ(deg), and (right) the moment on the door M(N mm), caused by the spring—as function of the door aperture angle φ (deg)

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Figure 9

Exploded view of the closing valve showing the door with torsion spring in opened position

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Figure 10

Exploded view of the surrounding seal with the bayonet coupling and the 12 crescent-shaped PTFE disks. Their hole corresponds to the catheter diameter.

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Figure 11

Measurement setup, where the sheath is clamped on two places and the catheter tip is pushed with a dial gauge




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