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Biodegradable Extravascular Stent

a biodegradable, extravascular technology, applied in the direction of prosthesis, blood vessels, surgery, etc., can solve the problems of difficult control of fibrin glue use (e.g. vein graft coating) and high failure rate of aorta-coronary and peripheral vein grafts

Inactive Publication Date: 2012-01-19
MALLINCKRODT PHARMA IP TRADING D A C
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Aorta-coronary and peripheral vein grafts are known to have a high failure rate due to occlusive complications in the graft as a result of an accelerated atherosclerosis process that is designated as vein graft disease.
A disadvantage of these fibrin glues is that they consist of two separate solutions containing fibrinogen and thrombin respectively, which have to be mixed directly on the wound, to prevent a premature reaction of the components.
The fibrinogen glue is viscous and completely homogenously mixing with the non viscous thrombin solution is often not achieved before fibrin polymer formation starts.
These features make the controlled use (e.g. even vein graft coating) of fibrin glues for extravascular support difficult.
Furthermore, the available fibrin glues use high ratios of thrombin / fibrinogen (5-20 IU thrombin / mg fibrinogen) which increases the risk of “free” active thrombin passing through the vessel wall into the blood stream (Dascombe et al.
Thrombin applied as a liquid—in particular when applied at high concentrations—poses therefore a safety risk.

Method used

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Examples

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Effect test

example 1

Testing of Fibrocaps for Extravascular Stent in a Mouse Vein Graft Model

[0023]Dry powder formulation Fibrocaps™, containing human plasma derived fibrinogen (6% w / w based on Fibrocaps) (ZLB. Marburg, Germany) and thrombin (500 IU / gram of Fibrocaps)(SNBTS, Glasgow, UK) was tested in transgenic mice that arc susceptible to cholesterol induced atherosclerosis, according to the method described by Lardenoye et al. (Circulation Res. (2002) Oct. 4, 577). In brief, the animals are fed a high-fat diet containing 0.5% cholate to improve intestinal cholesterol uptake and suppress bile-acid synthesis. This leads to increased plasma cholesterol levels.

[0024]After 4 weeks of chow or HFC 0.5%, mice are anesthetized with Hypnorm (Bayer, 25 mg / kg) and Dormicum (Roche, 25 mg / kg). The procedure used for vein grafts was similar to that described by Zou et al. (Am. J. Pathol. (1998) 153. 1301).

[0025]In brief, the right common carotid artery was dissected free from its surrounding from the bifurcation at...

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Abstract

The present invention relates to extravascular supports. In particular, to extravascular supports which are used in vein grafting. More in particular, it relates to extravascular supports which are biodegradable.

Description

FIELD OF THE INVENTION[0001]The present invention relates to extravascular supports. In particular, to extravascular supports which are used in vein grafting. More in particular, it relates to biodegradable extravascular supports.BACKGROUND OF THE INVENTION[0002]Aorta-coronary and peripheral vein grafts are known to have a high failure rate due to occlusive complications in the graft as a result of an accelerated atherosclerosis process that is designated as vein graft disease. A prominent factor promoting vein graft disease is endothelial cell damage as a result of over distention of the vein graft because of the high arterial pressure it becomes exposed to. The accelerated atherosclerosis process that eventually results in the occlusion of the graft is strongly enhanced in hypercholesterotemic patients.[0003]Extravascular supports or stents have been shown to improve the outcome of vein graft procedures because they prevent overextension and can ameliorate the arterialisation proc...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F2/82
CPCA61L27/225A61L27/34A61L27/507C08L89/00A61L31/041A61L31/042A61L31/046A61L31/14A61L31/16A61L2300/418
Inventor KOOPMAN, JACOB LAURENS
Owner MALLINCKRODT PHARMA IP TRADING D A C
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