Prosthetic device for sustaining a blood-vessel or hollow organ

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent structure

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606194, 623 12, A61F 206

Patent

active

056433395

DESCRIPTION:

BRIEF SUMMARY
The invention pertains to the field of medical equipment, and to be more exact to a prosthetic device for sustaining a vessel or hollow organ lumen, having a wire frame in form of a flexible tubular shaped body which in development is formed by many rows of interconnected cells, each of which cells comprises two U-shaped wire sections formning together approximately an elongated oval with a larger axis and a smaller axis, wherein adjacent cells in neighbouring rows are shifted by half of the larger axis of the oval with respect to each other in the direction of the larger axis and are shifted by the smaller axis of the oval with respect to each other in the direction of the smaller axis.
Various diseases of blood-vessels or hollow organs cause a stenosis or complete obturation (occlusion) of their lumen, which results in a decrease or complete loss of their functional attributes.
The wide spread of diseases of this kind demands an elaboration of quite new methods of medical treatment.
The device for sustaining of the blood-vessel or hollow organ lumen has a tubular shaped frame body, which is introduced in the vessel or hollow organ, fixed in the necessary place and sustains its lumen.
The problem of designing such devices has already a twenty year history.
Nevertheless, a universal reliable device satisfying all necessary requirements has as yet not been created.
The device for sustaining of the vessel or hollow organ lumen should satisfy the following requirements:
effectively fulfil the function of recovery and sustaining of the vessel or hollow organ lumen;
have a reliable and simple in control delivery system;
possibility of use within a wide range of sizes from 3 to 50 mm and more;
have biological compatibility with the organism tissues;
posibility of use in different anatomical areas of vessels and hollow organs;
minimum traumatism during and after operation;
stiffness of the construction to provide counteraction to in situ external compression forces.
An attempt to create a device compatible with the organism tissues was undertaken in the USSR patent No. 1237201, dated Feb. 15, 1986.
This known device for sustaining the vessel or hollow organ lumen represents a wire frame having a tubular shaped body. The frame is formed by a wire element, having round or square cross-section and arranged in a cylindrical helical line. The frame has a shape of a helical cylindrical spring and it is furnished with fixing elements to keep it on the device for delivery into the vessel or hollow organ. Each fixing element is made in form of a loop, one of which is formed at the initial section of the wire element, and the other at its final section. The facility for delivery of the above device to the vessel or hollow organ comprises an introducer in form of a X-ray contrast tube and another X-ray contrast tube of a lesser diameter, on whose surface the device is secured by means of a connecting element. The material of the frame wire is an alloy of the titanium-nickel system, which is biologically compatible with the organism tissues.
The device known from the USSR patent is reliable in use. However, it is expedient to use the known device in vessels or hollow organs having a diameter of not more than 8 mm, which is conditioned by the value of the ultimate strain of the frame material limited by 8% (the so-called strain limit of the shape memory effect), as well as by the demand of minimizing the puncture hole (hole in vessel through which the device is introduced into the organism). The device may only to a limited extent withstand external compression forces.
The use of the known device in vessels and hollow organs with a diameter exceeding 8 mm, and at preservation of the condition of not exceeding the ultimate strain of the frame material, would demand a decrease of the thickness of the wire frame elements, which would result in a further loss of stiffness of the frame, or in a necessity to increase the diameter of the puncture hole, which in turn would cause an intolerable traumatism of the vascular or hollow org

REFERENCES:
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patent: 5102417 (1992-04-01), Palmaz
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patent: 5370683 (1994-12-01), Fontaine
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patent: 5405377 (1995-04-01), Cragg
Rosch, J., et al., "Modified Gianturco Expandable Wire Stents in Experimental and Clinical Use," Ann. Radiol., 1988, vol. 31, No. 2, pp. 100-103.

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