Design Innovation

Design of an Endoscopic Full-Thickness Lesion Removal Device

[+] Author and Article Information
S. McEuen, D. Tzeranis, B. Hemond, M. Dirckx, A. Slocum

Department of Mechanical Engineering,  Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA 02139

L. Lee

Gastroenterology,  Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115

J. Med. Devices 2(1), 015002 (Mar 19, 2008) (8 pages) doi:10.1115/1.2884269 History: Received September 11, 2007; Revised January 22, 2008; Published March 19, 2008

Gastroenterologists would like to remove, through endoscopy, full-thickness lesions in the stomach, but currently there are no surgical devices capable of sealing the wound left after the lesion is removed. This paper describes the design, analysis, and prototyping of a device meant to address this problem. The device is intended to be used in conjunction with currently available endoscopes and comprises five key components including spikes, a beam, a hinge, a latch, and a positioning mechanism. Trials of positioning and placing a clamp on an in vitro pig stomach tissue were successfully completed.

Copyright © 2008 by American Society of Mechanical Engineers
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Figure 1

Illustration of the proposed method for removing full-thickness stomach lesions. The tissue is tented, clamped, and excised.

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Figure 2

Picture of the final prototype system including the spiky clamp and positioning mechanism

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Figure 3

The drawing on the left is an illustration of the encirclement strategy; the lesion is clamped with radial pressure provided by a ring or a band. The drawing on the right illustrates the piercing strategy; the lesion is clamped by forcing opposing sides of the tent together with mechanical fasteners that penetrate both walls of the tissue.

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Figure 4

An early prototype spiky clamp concept, consisting of a pair of beams, hinged at one end and with a snap-fit latch at the opposite end. A row of spikes is set in one beam to provide a piercing element.

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Figure 5

The spiky clamp concept, its positioning system, stomach walls, and the geometry of the lesion during the operation

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Figure 6

A free body diagram of the forces applied to the spiky clamp beams by the stomach walls

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Figure 7

Experimental setup and results used to determine the force needed to pierce the pig stomach tissue

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Figure 8

A photograph of an endoscope highlighting the biopsy channel opening

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Figure 9

NASTRAN finite-element analysis of the final prototype beam. The maximum deflection is 2.75mm. To obtain these results the left end was fixed, the right end simply supported, and a pressure distribution of 0.319N∕mm2 was applied to the top face of the beam.

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Figure 10

Photograph of the final prototype beam deflection while clamping pig stomach tissue

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Figure 11

Zip tie acting as both the latch and hinge in final prototypes

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Figure 12

Schematic of the spiky clamp positioning system

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Figure 13

Drawing of a single sector of the flexible snake

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Figure 14

Using four cables makes it possible to induce s-shaped displacements in the flexible snake and enhance its ability to access locations inside the stomach

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Figure 15

CAD drawing of the wrist joint

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Figure 16

A photograph of a first generation spiky clamp being closed onto sheep stomach tissue

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Figure 17

A sequence of photographs showing the application of a second generation prototype to pig stomach tissue using a remote positioning mechanism




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