Method of making a silicone composite vascular graft
First Claim
Patent Images
1. A method of fabricating a fibrous porous tubular means for use a vascular graft comprising the steps of:
- a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material;
b. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; and
,c. providing controlled heating to cure said fibers using infra-red energy means.
1 Assignment
0 Petitions
Accused Products
Abstract
A silicone/DACRON polyester composite vascular graft especially well suited as an arteriovenous (A-V) graft fistula for dialysis application. The graft has the ability to seal around needle puncture holes without externally applied pressure, excellent anti-kink, anti-crush and strength properties, and a smooth non-porous inner surface which reduces thrombus deposition and enhances the graft wall compliance or elasticity.
-
Citations
19 Claims
-
1. A method of fabricating a fibrous porous tubular means for use a vascular graft comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; and
,c. providing controlled heating to cure said fibers using infra-red energy means. - View Dependent Claims (2)
-
-
3. A method of fabricating a fibrous porous tubular means for use as a vascular graft comprising the steps of:
-
a. applying a silicone layer impermeable to blood, plasma, or cellular penetration onto a mandrel; b. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; c. spinning said mandrel and depositing said fibers onto said spinning mandrel and thereby forming a fibrous porous structure over said largely impermeable layer; and
,d. providing controlled heating with infra-red energy to cure said fibers.
-
-
4. A method of fabricating a fibrous porous tubular means for use as a vascular graft comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel and thereby forming a first layer of fibrous porous structure on said mandrel; c. providing controlled heating to cure said fibers through infra-red energy means; d. applying a silicone second layer impermeable to blood, plasma, or cellular penetration over said first layer; and
,e. applying a third layer of fibrous porous structure in a manner similar to the first layer, thereby constructing a fibrous porous structure with an intervening layer impermeable to blood, plasma, or cellular penetration.
-
-
5. A method of fabricating a tubular means for use as a vascular graft with a silicone layer impermeable to blood, plasma, or cellular penetration comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel to form a layer of said polymeric material on said mandrel; c. providing controlled heating of said fibers before said fibers contact said mandrel through infra-red energy means; d. using said controlled heating to provide controlled curing of said fibers and thereby to control the porosity of said layer of polymeric material on said mandrel; and
,e. controlling the porosity of said layer to form a layer impermeable to blood, plasma, or cellular penetration.
-
-
6. A method for fabricating a fibrous porous tubular means for use as a vascular graft comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; c. providing controlled heating of said fibers both before and after said fibers contact said mandrel through infra-red energy means; d. using said controlled heating to control the curing of said fibers before said fibers contact said mandrel; e. controlling the porosity or percent void fraction of said fibrous porous structure by controlling the amount of fiber curing which occurs prior to deposition on said mandrel; f. varying the porosity or percent void fraction in a controlled manner to form a structure with more than one layer so that different layers may have different porosity; and
,g. controlling the porosity of at least one layer to form a layer impermeable to blood, plasma, or cellular penetration, thereby forming a structure with one or more porous layer(s) and one or more impermeable layer(s) as a single integral structure.
-
-
7. A method for fabricating a kink-resistant and crush-resistant fibrous porous structure for use as a vascular graft comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; c. providing controlled heating to cure said fibers through infra-red energy means; d. controlling the porosity or percent void fraction of said fibrous porous structure by controlling the amount of fiber curing which occurs prior to deposition on said mandrel; e. subsequently applying a reinforcing bead onto said mandrel as either continuous helical bead or separate rings; and
,f. curing the structure to form a fibrous porous structure with controlled porosity and external reinforcement. - View Dependent Claims (9, 10, 11)
-
-
8. A method for fabricating a kink-resistant and crush-resistant fibrous porous structure for use as a vascular graft comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; c. providing controlled heating to cure said fibers through infra-red energy means; d. controlling the porosity or percent void fraction of said fibrous porous structure by controlling the amount of fiber curing which occurs prior to deposition on said mandrel; e. subsequently applying a reinforcing bead onto said mandrel as either continuous bead or separate rings; f. depositing additional fibers onto said mandrel over said reinforcing bead; and
,g. curing the structure to form a fibrous porous structure with controlled porosity and reinforcement within the fibrous porous structure.
-
-
12. A method for fabricating a strengthened fibrous porous structure for use as a vascular graft comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; c. providing controlled heating to cure said fibers through infra-red energy means; d. controlling the porosity or percent void fraction of said fibrous porous structure by controlling the amount of fiber curing which occurs prior to deposition on said mandrel; e. subsequently applying largely continuous strengthening fiber onto said mandrel; f. said strengthening fiber oriented with circumferential component comprising a helical winding; and
,g. curing the structure to form a fibrous porous structure with controlled porosity contained within external strengthening fibers. - View Dependent Claims (14, 15, 16)
-
-
13. A method for fabricating a strengthened fibrous porous structure for use as a vascular graft comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; c. providing controlled heating using infra-red energy to cure said fibers; d. controlling the porosity or percent void fraction of said fibrous porous structure by controlling the amount of fiber curing which occurs prior to deposition on said mandrel; e. subsequently applying largely continuous strengthening fiber onto said mandrel; f. said strengthening fiber oriented with circumferential component such as helical winding; g. depositing additional electrostatically spun polymer fibers onto said mandrel over said strengthening fiber; and
,h. curing the structure to form a fibrous porous structure with controlled porosity and strengthening fiber within the fibrous porous structure.
-
-
17. A method of fabricating a fibrous porous structure with multiple layers for use as a vascular graft comprising the steps of:
-
a. electrostatically spinning a silicone polymeric material, forming fibers of said polymeric material; b. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; c. providing controlled heating with infra-red energy of said fibers and before said fibers contact said mandrel; d. using said controlled heating to control the curing of said fibers before said fibers contact said mandrel; e. controlling the porosity or percent void fraction of said fibrous porous structure by controlling the amount of fiber curing which occurs prior to deposition on said mandrel; f. subsequently applying largely continuous strengthening fiber onto said mandrel; and
,g. applying additional layers of material comprising a reinforcing bead, strengthening fiber, coating material, or additional fibrous porous layer(s) formed by varying the porosity or percent void fraction in a controlled manner to form a structure with more than one layer so that different layers may have different porosity.
-
-
18. A method for fabricating a fibrous porous structure for use as a vascular graft comprising the steps of:
-
a. dispersing a silicone polymer in a suitable solvent which enhances the action of electrostatic forces when the dispersion is spun using electrostatic forces; b. electrostatically spinning said polymeric dispersion, forming fibers of said polymeric dispersion; c. depositing said fibers onto a spinning mandrel and thereby forming a fibrous porous structure on said mandrel; and
,d. partially curing said fibers using infra-red energy. - View Dependent Claims (19)
-
Specification