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Composite self-cohered web materials

a self-cohered, web technology, applied in the field of implantable medical materials and devices, to achieve the effects of high porosity, high degree of loft, conformability, and tissue complian

Inactive Publication Date: 2007-02-01
WL GORE & ASSOC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0014] The present invention is directed to synthetic bioabsorbable, non-woven, self-cohered polymeric web materials having a high degree of porosity. The highly porous web materials are mechanically strong and have a high degree of loft, suppleness, drapability, conformability, and tissue compliance. In some embodiments, the present invention exhibits elastic properties. The invention is suitable for use as an implantable medical device or a component of a medical device. The invention is also suitable for use in many instances as a thrombogenic agent at a site of bleeding or aneurysm formation.

Problems solved by technology

Nor do they disclose such an un-self-cohered material can be stretched in an unannealed state to either reduce component fiber diameter or to induce, or increase, porosity in the finished material.

Method used

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  • Composite self-cohered web materials

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0077] This example describes formation of an article of the present invention. Initially, an unannealed, non-woven, self-cohered polymeric precursor web was formed. The precursor web material was heated slightly and subjected to stretching in a single, or uniaxial, direction to increase the porosity of the web material. The highly porous self-cohered web material was then set with heat.

[0078] The precursor web material was formed from a 67% poly(glycolide) and 33% poly(trimethylenecarbonate) (w / w) segmented triblock copolymer (67% PGA:33% TMC). The copolymer is available in resin form from United States Surgical (Norwalk, Conn. US), a unit of Tyco Healthcare Group LP. This polymer is commonly referred to as polyglyconate and has historically been available through the former Davis & Geck (Danbury, Conn.). A typical 67% PGA:33% TMC resin lot was characterized previously by Hayes in U.S. Pat. No. 6,165,217, which is incorporated herein by reference. The process of characterizing the...

example 2

[0098] In this example, precursor webs produced using the various belt speeds and transverse expansion ratios described in Example 1 were obtained for a variety of web densities and stretch, or draw, ratios. Following processing, scanning electron micrographs (SEM) were generated of representative areas of this embodiment of the present invention. Some characteristics of the stretched web of the present invention and the filaments comprising the web were quantified as follows.

[0099] The cross-sectional diameter of the stretched filaments in each web material of the present invention was determined by visually examining the SEMs. In each SEM, fifty (50) stretched filaments were randomly chosen and the diameter of a cross-section of each filament was measured. The cumulative results of these filament cross-sectional diameters is contained in Table 3 and summarized in FIGS. 6 and 7. The stretch ratios are expressed as multiples of “X.” For example, “0X” refers to unstretched precursor...

example 3

[0105] As a result of stretching the material described in Example 1, both the amount of polymeric material per unit area (area density) and amount of polymeric material per unit volume (volume density) were reduced. A precursor web (produced at a belt speed of 0.67 feet / minute (20.4 cm / minute)) was further processed in an oven set at 100° C. for 25 minutes to completely anneal, or “heat-set,” the web material.

[0106] The unannealed, unstretched, self-cohered precursor web material was substantially similar to the web material disclosed in the '217 Patent. A heat-set version of the precursor web material was determined to have an area density of approximate 23 mg / cm2 and a volume density of approximately 0.16 g / cc. Commercially forms of this type of web are available from W.L. Gore & Associates, Inc., Flagstaff, Ariz., under the tradenames GORE Bioabsorbable SeamGuard and GORE Resolut Adapt LT. Each of these unstretched web materials has an area density of 9.7 mg / cm2 and 8.4 mg / cm2,...

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Abstract

The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof.

Description

FIELD OF THE INVENTION [0001] The present invention relates to implantable medical materials and devices. More particularly, the present invention is directed to implantable medical materials and devices made with bioabsorbable polymeric materials in the form of non-woven, self-cohered, filamentous webs having a high degree of porosity. BACKGROUND OF THE INVENTION [0002] A variety of bioabsorbable polymeric compounds have been developed for use in medical applications. Materials made from these compounds can be used to construct implantable devices that do not remain permanently in the body of an implant recipient. Bioabsorbable materials are removed from the body of an implant recipient by inherent physiological process of the implant recipient. These processes can include simple dissolution of all or part of the bioabsorbable compound, hydrolysis of labile chemical bonds in the bioabsorbable compound, enzymatic action, and / or surface erosion of the material. The breakdown products...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F2/04
CPCA61L31/146A61L31/148Y10T428/1317Y10T428/1376A61B17/07292Y10T442/681
Inventor FARNSWORTH, TED R.FLYNN, CHARLESWHITE, CHARLES F.
Owner WL GORE & ASSOC INC
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