Electrospinning process for making a textile suitable for use as a medical article

Inventors

Phaneuf, Matthew D. • Brown, Philip J. • Bide, Martin J.

Assignees

BioScurfaces Inc • Rhode Island Board of Education • Clemson University • Biosurfaces Inc

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Publication Number

US-8771582-B2

Patent

Publication Date

2014-07-08

Expiration Date


Abstract

The present invention is a bioactive, nanofibrous material construct which is manufactured using a unique electrospinning perfusion methodology. One embodiment provides a nanofibrous biocomposite material formed as a discrete textile fabric from a prepared liquid admixture of (i) a non-biodegradable durable synthetic polymer; (ii) a biologically active agent; and (iii) a liquid organic carrier. These biologically-active agents are chemical compounds which retain their recognized biological activity both before and after becoming non-permanently bound to the formed textile material; and will become subsequently released in-situ as discrete freely mobile agents from the fabric upon uptake of water from the ambient environment.

Core Innovation

The invention provides an electrospinning perfusion method for forming a fabricated textile suitable for use as a medical article. A non-biodegradable polymer and a pre-chosen biologically-active agent are dissolved in an organic solvent, with the dissolving step occurring at an ice-cold temperature, and the admixture is then permitted to warm to about 20°C to about 50°C.

The admixture is loaded into an electrospinning perfusion assembly comprising at least one perfusion instrument that can be set at a specified flow rate. The admixture is perfused onto a target surface at the specified flow rate and at a temperature between about 20°C and about 50°C, and the perfused material is removed from the target surface to form a nanofibrous fabricated textile.

In another embodiment, a non-biodegradable polyester or polyurethane and a pre-chosen biologically-active agent are dissolved in hexafluoroisopropanol at an ice-cold temperature. The admixture is loaded into an electrospinning perfusion assembly having a spinneret sized to produce nanofibers with a diameter of less than about 2 micrometers, and is perfused through the spinneret onto a target surface at a temperature between 15°C and 30°C.

In a further embodiment, dissolving occurs at about 4°C, the admixture is permitted to warm to between about 20°C and about 25°C, and perfusing occurs at between about 20°C and about 25°C. The resulting nanofibrous fabricated textile consists essentially of the non-degradable polyester or polyurethane, with the biologically active agent releasably entrapped within the non-degradable polyester or polyurethane.

Claims Coverage

The independent claims are clm-00001, clm-00006, and clm-00010, covering three electrospinning perfusion process variants for producing nanofibrous fabricated textiles suitable for medical articles. The claims include temperature-controlled dissolving and perfusing, specified flow rate, hexafluoroisopropanol, a spinneret sized to produce nanofibers with diameter less than about 2 micrometers, and releasable entrapment of biologically active agent.

Ice-cold dissolving and controlled warming for medical-article textile formation

Dissolving a non-biodegradable polymer and a pre-chosen biologically-active agent in an organic solvent to provide an admixture, the dissolving step occurring at an ice-cold temperature; permitting the admixture to warm to a temperature between about 20°C and about 50°C.

Electrospinning perfusion at specified flow rate onto a target at controlled temperature

Loading the admixture into an electrospinning perfusion assembly comprised of at least one perfusion instrument which can be set at a specified flow rate; perfusing said admixture onto a target surface at the specified flow rate, the step of perfusing occurring at a temperature between about 20°C and about 50°C to provide a perfused material.

Forming a nanofibrous fabricated textile by removing perfused material

Removing the perfused material from the target surface to form a nanofibrous fabricated textile.

Hexafluoroisopropanol admixture with non-biodegradable polyester or polyurethane and releasably entrapped biologically active agent

Dissolving a non-biodegradable polyester or polyurethane and a pre-chosen biologically-active agent in hexafluoroisopropanol to provide an admixture, the dissolving step occurring at an ice-cold temperature; removing the perfused admixture from the target surface to form a nanofibrous fabricated textile which consists essentially of the non-degradable polyester or polyurethane and the pre-chosen biologically-active agent, the biologically active agent being releasably entrapped within the non-degradable polyester or polyurethane.

Spinneret producing nanofibers with diameter less than about 2 micrometers

Loading the admixture into an electrospinning perfusion assembly comprised of at least one perfusion instrument which can be set at a specified flow rate, the perfusion instrument having a spinneret sized to produce nanofibers with a diameter of less than about 2 micrometers; perfusing said admixture through the spinneret and onto a target surface at the specified flow rate, the step of perfusing occurring at a temperature between 15°C and 30°C to provide a perfused admixture comprising polymeric fibers with a diameter of less than about 2 micrometers.

About 4°C dissolving and 20–25°C warming and perfusing

Dissolving a non-biodegradable polymer and a pre-chosen biologically-active agent in an organic solvent to provide an admixture, the dissolving step occurring at temperature of about 4°C; permitting the admixture to warm to a temperature between about 20°C and about 25°C; perfusing said admixture onto a target surface at the specified flow rate, the step of perfusing occurring at a temperature between about 20°C and about 25°C to provide a perfused material.

Across clm-00001, clm-00006, and clm-00010, the claims focus on an electrospinning perfusion process where an admixture prepared by ice-cold dissolving is warmed to a controlled range and perfused onto a target surface at a specified flow rate and controlled temperature to form a nanofibrous fabricated textile for a medical article. In clm-00006, the claims further specify hexafluoroisopropanol, a spinneret sized to produce nanofibers with diameter less than about 2 micrometers, and a textile consisting essentially of non-degradable polyester or polyurethane with a biologically active agent releasably entrapped within it.

Stated Advantages

Provides advantages over immersion/dipping methods.

Provides advantages over high-heat incorporation.

Documented Applications

A fabricated textile suitable for use as a medical article.

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