Elastomerically impregnated ePTFE to enhance stretch and recovery properties for vascular grafts and coverings

• US 7,789,908 B2
• Filed: 06/25/2002
• Issued: 09/07/2010
• Est. Priority Date: 06/25/2002
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Sowinski, Krzysztof, Rakos, Ronald
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/179,484
• Publication Number:
  US 20040024442A1
• Time in Patent Office: 2,996 Days
• Field of Search: 623/1.1, 623/1.13, 623/1.25, 623/1.32, 623/1.39, 623/1.4, 623 146- 148, 623/11.11, 623/12, 623 2364- 2368, 623/23.7, 623/23.71, 623/1.45, 606/151, 606191-200, 600/37, 427 224- 226
• US Class Current: 623/1.45
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10T 428/249933 Fiber embedded in or on the surface of a natural or synthetic rubber matrix

Abstract

An elastomerically recoverable PTFE material is provided including a longitudinally compressed fibrils of ePTFE material penetrated by elastomeric material within the pores defining the elastomeric matrix. The elastomeric matrix and the compressed fibrils cooperatively expand and recover without plastic deformation of the ePTFE material. The material may be used for various prosthesis, such as a vascular a prosthesis like a patch, a graft and an implantable tubular stent. Further, a method of producing the elastomerically recoverable PTFE material is provided herein.

Claims

1. An elastomerically recoverable PTFE material, consisting essentially of:

(a) an ePTFE material defined by nodes and fibrils, said fibrils being in a longitudinally compressed state and defining pores of a size sufficient to permit penetration of an elastomeric material wherein said eslatomeric material impregnates said pores throughout the ePTFE material without creating an exterior coating on said ePTFE material, wherein said ePTFE material is a tube, having an internal diameter, an external diameter, and a longitudinal axis, the ePTFE material having been expanded in the longitudinal direction; and

(b) an elastomeric material having a solids content of about 7.5% to about 15% by weight within said pores;

said compressed fibrils and elastomeric material cooperatively permitting longitudinal expansion between about 90% and about 300% of said longitudinally compressed state and elastomeric recovery without plastic deformation of said ePTFE material, wherein said elastomeric material is a polycarbonate urethane material having a shore hardness rating between 70A and 75D, said elastomeric material being absent from an outer surface of said tube.

7. The method according to claim 1 wherein said applying step includes the step of spray coating at least a portion of the ePTFE material with the elastomeric material.

2. An elastomerically recoverable PTFE material, consisting essentially of:

(a) an ePTFE material in the form of a tube having an internal diameter and an external diameter and characterized by a longitudinal axis, the ePTFE material defined by nodes and fibrils, said fibrils being compressed in a direction parallel to the longitudinal axis and defining pores of a size sufficient to permit penetration of an elastomeric material wherein said elastomeric material impregnates said pores throughout the ePTFE material without creating an exterior coating on said ePFTE material; and

p1 (b) an elastomeric material having a solids content of about 7.5% to about 15% by weight within said pores;

said compressed fibrils and elastomeric material cooperatively permitting longitudinal expansion between about 90% and about 300% of said longitudinally compressed state and elastomeric recovery without plastic deformation of said ePFTE material, wherein said elastomeric material is a polycarbonate urethane material having a shore hardness rating between 70A and 75 D, said elastomeric material being absent from an outer surface of said tube material.

3. A method of producing an elastomerically recoverable PTFE structure consisting essentially of the steps of:

(a) providing an ePTFE material defined by nodes, fibrils and pores, wherein said pores have a pore size, said pore size is a space defined by a distance between said nodes and distance between said fibrils wherein said ePTFE material is a tube, having an internal diameter and an external diameter;

(b) subsequently compressing said fibrils of the ePTFE tube longitudinally wherein said pore size is sufficient to permit penetration of an elastomeric material within said pores;

(c) applying an elastomeric material to said compressed fibrils in a sufficient amount to impregnate said pores of said ePTFE material wherein said elastomeric material impregnates said pores without creating an exterior coating on said ePTFE material;

(d) partially drying said elastomeric material within said pores; and

(e) subsequently applying at least one additional application of said elastomeric material to said pores in a sufficient amount to impregnate said pores of said ePTFE material to provide a structurally integral elasomerically recoverable ePTFE material wherein said elastomeric material impregnates said pores without creating an exterior coating on said ePTFE material; and

(f) drying at least an additional application of said elastomeric material within said pores;

wherein, subsequent to a final application of said elastomeric material, the elastomeric material is impregnated in said pores without the presence of an exterior coating on said ePTFE material.

4. The method according to claim 3 further comprising the step of permitting the elastomeric material to dry within said pores while said fibrils are still longitudinally compressed defining an elastomeric matrix.

5. The method according to claim 3 wherein said compressing step includes the steps of:

(a) pulling said ePTFE tube over a mandrel having an external diameter of approximately the same dimensions as said internal diameter of the ePTFE tube; and

(b) compressing at least a portion of the ePTFE tube along a longitudinal axis of the tube while the tube is supported by the mandrel.

6. The method according to claim 3 wherein said applying step includes the step of dip coating at least a portion of the ePTFE material with the elastomeric material.

8. The method according to claim 3 wherein said applying step includes the step of brushing the elastomeric material onto at least a portion of the ePTFE material.

9. The method according to claim 3 wherein said applying step comprises the step of applying elastomeric material over the entire ePTFE material, and wherein the compressing step comprises the step of compressing the ePTFE material uniformly along its entire length.

10. The method according to claim 3 wherein said elastomeric material is polyurethane.