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Vascular grafts and method for preserving patency of the same

Inactive Publication Date: 2015-08-27
HEALIONICS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent describes a vascular graft that reduces the growth of scar tissue around it. The graft has three layers: a layer that contacts blood, a layer that contacts host tissue, and a layer that interfaces with tissue. The layer that interfaces with tissue has tiny bumps and holes that make it easy for cells to grow in and around it. This helps to prevent the formation of a fibrous barrier around the graft, which can help to keep it open and allow blood to flow through it.

Problems solved by technology

The occlusive failure of the grafts can be especially severe for replacements of small caliber vessels (less than 6 mm internal diameter), limiting the use of prosthetic grafts in these cases.
Stenosis also presents a major medical problem in dialysis care.
However, occlusive failure could limit the average lifespan of a dialysis graft to less than two years.

Method used

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  • Vascular grafts and method for preserving patency of the same
  • Vascular grafts and method for preserving patency of the same
  • Vascular grafts and method for preserving patency of the same

Examples

Experimental program
Comparison scheme
Effect test

example 1

Microporous Silicone Vascular Grafts as AV Shunt

Materials:

[0078]Control grafts (N=4) were ePTFE vascular grafts (from Impra) with regular wall thickness of 6 mm and spiral wrapped ribs for radial reinforcement.

[0079]Test grafts (N=6) were 100% silicone grafts as shown in FIG. 2.

[0080]Some of the control grafts and test grafts were fitted with mid-graft percutaneous ports.

[0081]Sheep were 35-40 kg at time of implant. The animals were heparinized.

Methods

[0082]The vascular grafts were implanted in an ovine arteriovenous (AV) shunt model. The control grafts were soaked in heparinized saline prior to implant according to standard clinical practice. The test grafts were prehydrated by immersing in heparinized saline and cycling vacuum until bubbles were no longer visible. The prehydration step ensured that all the air in the pores was displaced.

[0083]The grafts were implanted bilaterally in a straight ipsilateral configuration (distal carotid artery to proximal jugular vein). The animals ...

example 2

Surface-Modified EPTFE Vascular Grafts in AV Shunt Model

Materials:

[0093]Control grafts (N=2) were ePTFE grafts (by Vascutek) with regular wall of 6 mm with no radial reinforcement.

[0094]Test grafts (N=4) were surface-modified ePTFE grafts as shown in FIGS. 3 and 4. In particular, an ePTFE graft was modified with STAR Biomaterial by dip-coating the outer surface with an adhesive (NuSil MED-2214 silicone), and then adhering a monolayer of granules of sphere-templated microporous silicone. These STAR-treated ePTFE grafts had a surface topography formed by ˜300-micron size microporous granules having 35-micron spherical pores, which were interconnected by about 15-micron interpore openings.

[0095]Sheep were 65-80 kg at time of implant. The animals were placed on antiplatelet therapy (salicylic acid and clopidogrel) for the duration of the study.

Methods

[0096]Vascular grafts were implanted in an ovine arteriovenous (AV) shunt model. As in Example 1, the control grafts were soaked in hepari...

example 3

Surface-Modified EPTFE Vascular Grafts in Arterial Bypass Model

Methods:

[0106]Control grafts (N=2) were ePTFE grafts (by Vascutek) with regular wall of 5 mm with no radial reinforcement.

[0107]Test grafts (N=2) were surface-modified ePTFE grafts as shown in FIGS. 3 and 4. In particular, an ePTFE graft was modified with STAR Biomaterial by dip-coating the outer surface with an adhesive (NuSil MED-2214 silicone), and then adhering a monolayer of granules of sphere-templated microporous silicone. These STAR-treated ePTFE grafts had a surface topography formed by ˜300-micron size microporous granules having 35-micron spherical pores, which are interconnected by about 15-micron interpore openings.

[0108]Sheep were 35-40 kg at time of implant. The animals were placed on antiplatelet therapy (salicylic acid and clopidogrel) for the duration of the study.

Methods

[0109]The vascular grafts were implanted in a small caliber arterial bypass model. The control grafts were soaked in heparinized salin...

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Abstract

This disclosure provides vascular grafts having a textured microporous surface capable of reducing perigraft fibrotic capsular formation, and a method of maintaining the patency of the vascular grafts.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS[0001]This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Nos. 61 / 943,178, filed Feb. 21, 2014, and 61 / 984,537, filed Apr. 25, 2014, which applications are incorporated herein by reference in their entireties.BACKGROUND[0002]1. Technical Field[0003]This invention relates to vascular grafts, such as artificial blood vessels.[0004]2. Description of the Related Art[0005]Prosthetic vascular grafts are artificial tubular blood conduits or patches. They are commonly used to replace or repair diseased segments of natural arteries or veins. They are also routinely used as arteriovenous shunts to present a suitable vascular access site for dialysis treatment.[0006]To form an anastomosis with a native blood vessel, a vascular graft is directly connected (e.g., by suturing) at the ends of the graft to the cut edges of a native vessel (“end-to-end”) or to the side of the native vessel (“end-to-side”).[0007]Th...

Claims

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Application Information

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IPC IPC(8): A61F2/06A61F2/00
CPCA61F2/06A61F2002/0081A61F2210/0076A61F2/0077A61L31/04A61L31/146
Inventor MARSHALL, ANDREW J.MAGINNESS, MAXODA, ADRIENNESCANLAN, BRANDT
Owner HEALIONICS CORP
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