Dilatation Tester for a Stent-Graft Prosthesis

Patent metadata

Field	Value
Publication number	US-2016302912-A1
Application number	US-201514691109-A
Country	US
Kind code	A1
Filing date	Apr 20, 2015
Priority date	Apr 20, 2015
Publication date	Oct 20, 2016
Grant date	—

Abstract

A dilatation or fatigue tester for a stent-graft prosthesis includes a sample holder having a compressible member that defines a chamber for receiving a stent-graft prosthesis in an expanded state, a bearing assembly disposed to contact and act on an exterior surface of the compressible member of the sample holder, and an actuation assembly operably coupled to the bearing assembly for rotating the bearing assembly relative to the sample holder. Rotation of the bearing assembly cyclically compresses the compressible member of the sample holder to thereby provide cyclical radial loading and unloading of a stent-graft prosthesis received therein for simulating physiologic loading conditions of a stent-graft prosthesis within a vasculature due to a beating heart.

First claim

What is claimed is:

1 . A dilatation tester for a stent-graft prosthesis comprising:
a sample holder having a compressible member that defines a chamber for receiving a stent-graft prosthesis in an expanded state; a bearing assembly disposed to contact an exterior surface of the compressible member of the sample holder; and an actuation assembly operably coupled to the bearing assembly for rotating the bearing assembly relative to the sample holder, wherein rotation of the bearing assembly cyclically compresses the compressible member of the sample holder to thereby provide cyclical radial compression of a stent-graft prosthesis received therein for simulating physiologic loading conditions of a stent-graft prosthesis within a vasculature due to a beating heart.

2 . The dilatation tester of claim 1 , wherein the exterior surface of the compressible member defines a plurality of longitudinally-extending protuberances evenly spaced about a circumference of the compressible member.

3 . The dilatation tester of claim 2 , wherein rotation of the bearing assembly cyclically compresses the compressible member when a plurality of needle roller bearings of the bearing assembly roll over and radially compress the plurality of longitudinally-extending protuberances.

4 . The dilatation tester of claim 3 , wherein the compressible member has an annular wall defined between the exterior surface and an interior surface thereof that includes a plurality of radially-extending slots formed therein and wherein each of the plurality of radially-extending slots aligns with a respective raised surface of the plurality of longitudinally-extending protuberances of the compressible member.

5 . The dilatation tester of claim 3 , wherein the compressible member includes a plurality of bores extending through an annular wall defined between the exterior surface and an interior surface thereof and wherein each of the plurality of bores aligns with a respective raised surface of the plurality of longitudinally-extending protuberances of the compressible member.

6 . The dilatation tester of claim 3 , wherein the interior surface of the compressible member defines the chamber of the sample holder and wherein a stent-graft prosthesis received within the chamber expands into contact with the interior surface of the compressible member.

7 . The dilatation tester of claim 1 , further comprising:
a tubular heater that is sized to be disposed within a stent-graft prosthesis received within the chamber of the sample holder.

8 . The dilatation tester of claim 7 , further comprising:
a housing within which that the sample holder and the bearing assembly are disposed; and a cover that is releasably securable to the housing, wherein the tubular heater is fixed to the cover to extend within the sample holder when the cover is secured to the housing.

9 . The dilatation tester of claim 8 , wherein the actuation assembly includes a motor and a shaft of the motor extends within the housing and is coupled to a driving gear, and wherein the driving gear meshes with a dedicated gear attached to the bearing assembly such that when the motor is operated rotation of the shaft and the driving gear drives the dedicated gear to thereby rotate the bearing assembly relative to the sample holder.

10 . The dilatation tester of claim 9 , wherein the bearing assembly is comprised of
an annular base, a plurality of dowel pins and a plurality of needle roller bearings, wherein the plurality of dowel pins are attached to the annular base to extend therefrom and to receive the plurality of needle roller bearings thereon such that a respective needle roller bearing is rotatable about a respective dowel pin.

11 . The dilatation tester of claim 10 , wherein the annular base of the bearing assembly is fixed to the dedicated gear.

12 . The dilatation tester of claim 11 , wherein the sample holder includes a cylindrical base that is fixed to the housing and wherein the dedicated gear is attached by one or more roller bearings to the cylindrical base of the sample holder.

13 . The dilatation tester of claim 10 , wherein the plurality of needle roller bearings surround and make contact with the compressible member of the sample holder.

14 . The dilatation tester of claim 9 , wherein the housing includes two or more sample holder and corresponding bearing assembly and wherein the driving gear of the actuation assembly meshes with each dedicated gear attached to the two or more bearing assembly.

15 . The dilatation tester of claim 8 , wherein the heater maintains a temperature within the housing at 37° C.

16 . A dilatation tester for a stent-graft prosthesis comprising:
a sample holder having a compressible member that defines a chamber for receiving a stent-graft prosthesis in an expanded state, wherein an exterior surface of the compressible member defines a plurality of longitudinally-extending protuberances evenly spaced about a circumference of the compressible member; a bearing assembly including a plurality of needle roller bearings that surround and make contact with the exterior surface of the compressible member of the sample holder; and an actuation assembly operably coupled to the bearing assembly for rotating the bearing assembly relative to the sample holder, wherein rotation of the bearing assembly cyclically compresses the compressible member when the plurality of needle roller bearings of the bearing assembly roll over and radially compress the plurality of longitudinally-extending protuberances of the compressible member of the sample holder to thereby provide cyclical radial loading and unloading of a stent-graft prosthesis received therein for simulating physiologic loading conditions of a stent-graft prosthesis within a vasculature due to a beating heart.

17 . The dilatation tester of claim 16 , wherein the compressible member has an annular wall defined between the exterior surface and an interior surface thereof that includes a plurality of radially-extending slots formed therein and each of the plurality of radially-extending slots of the compressible member aligns with a respective raised surface of the plurality of longitudinally-extending protuberances of the compressible member.

18 . The dilatation tester of claim 16 , wherein the compressible member includes a plurality of bores extending through an annular wall defined between the exterior surface and an interior surface thereof and wherein each of the plurality of bores aligns with a respective raised surface of the plurality of longitudinally-extending protuberances of the compressible member.

19 . A dilatation tester for a stent-graft prosthesis comprising:
a sample holder having a compressible member that defines a chamber for receiving a stent-graft prosthesis in an expanded state, wherein an exterior surface of the compressible member defines a plurality of longitudinally-extending protuberances evenly spaced about a circumference of the compressible member; a bearing assembly including a plurality of needle roller bearings that surround and make contact with the exterior surface of the compressible member of the sample holder; and an actuation assembly operably coupled to the bearing assembly for rotating the bearing assembly relative to the sample holder, wherein the compressible member and a stent-graft prosthesis received therein are radially compressed when the plurality of longitudinally-extending protuberances of the compressible member are aligned with the plurality of needle rolle

Assignees

• Medtronic Vascular Inc

Inventors

• Argentine Jeffery
• Rowe Mark

Classifications

• G01N3/34

  generated by mechanical means, e.g. hammer blows · CPC title

• G01N2203/0007

  Low frequencies up to 100 Hz · CPC title

• A61F2240/008

  Means for testing implantable prostheses · CPC title

• G01N2203/0037

  involving a rotating movement, e.g. gearing, cam, eccentric, or centrifuge effects · CPC title

• G01N2203/0073

  Fatigue · CPC title