Tapered implantable device and methods for making such devices

• US 9,814,560 B2
• Filed: 12/02/2014
• Issued: 11/14/2017
• Est. Priority Date: 12/05/2013
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Duncan, Jeffrey B., Schlaud, Marc A., Studley, IV, Arthur R.
• Primary Examiner(s): Pellegrino, Brian
• Application Number:
  US14/557,927
• Publication Number:
  US 20150157444A1
• Time in Patent Office: 1,078 Days
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2240/00 Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0058 Additional features; Implant or prostheses properties not otherwise provided for
• CPC Class Codes: B29C 53/083 bending longitudinally, i.e. modifying the curvature of the tube axis
• CPC Class Codes: B29C 53/086 bending radially, i.e. deformig the cross-section of the tube
• CPC Class Codes: B29C 55/005 characterised by the choice of materials
• CPC Class Codes: B29C 55/22 of tubes B29C61/08 takes precedence
• CPC Class Codes: B29C 55/24 radial
• CPC Class Codes: B29C 55/30 Drawing through a die pultrusion B29C70/52
• CPC Class Codes: B29C 57/04 using mechanical means B29C57/025 takes precedence
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29L 2031/7534 Cardiovascular protheses

Abstract

A tapered implantable device includes an ePTFE tubular member having a tapered length portion. The tapered length portion provides rapid recovery properties. The tapered length portion can feature a microstructure that includes a multiplicity of bent fibrils.

Claims

1. A method of forming a tapered implantable article with a longitudinally compressed tapered portion, the method comprising:

forming a tapered portion having a first longer length in an ePTFE tubular member using a first mandrel having a first, longer tapered length segment;

removing the ePTFE tubular member from the first mandrel;

longitudinally compressing the tapered portion having a first longer length of the ePTFE tubular member on a second mandrel having a second, shorter tapered length segment into a tapered portion having a second shorter length, wherein the second shorter length is at least 15% shorter than the first longer length; and

removing the ePTFE tubular member from the second mandrel, the longitudinally compressed tapered portion maintaining the second shorter length following removal from the second mandel.

2. The method of claim 1, wherein a compression ratio comprises the ratio of the tapered portion having a first longer length to the tapered portion having a second shorter length and a mandrel ratio comprises a ratio of a length of the first, longer tapered length segment to a length of the second, shorter tapered length segment, wherein the mandrel ratio is within 33% of the compression ratio.

3. The method of claim 2, wherein the mandrel ratio is within 10% of the compression ratio.

4. The method of claim 2, wherein the compression ratio and the mandrel ratios are substantially the same.

5. The method of claim 1, wherein the step of forming a tapered portion having a first longer length in an ePTFE tubular member comprises pulling an extruded ePTFE tube over the first mandrel.

6. The method of claim 1, wherein the ePTFE tubular member comprises a multiplicity of fibrils, wherein a majority of the fibrils are bent.

7. The method of claim 1, wherein the tapered portion having a first longer length and the tapered portion having a second shorter length comprise transverse cross sectional shapes of equal diameter.

8. The method of claim 1, wherein the tapered portion having a second shorter length comprises a uniform, frustoconical shape.

9. The method of claim 1, wherein the tapered portion having a second shorter length having a non-linear taper.

10. The method of claim 1, further comprising the step of heating the ePTFE tubular member after longitudinally compressing the tapered portion of the ePTFE tubular member on the second mandrel.

11. The method of claim 1, wherein the step of longitudinally compressing the tapered portion having a first longer length on a second mandrel further comprises compressing the ePTFE tubular member with a female die having a complimentary shape to a shape of the second, shorter tapered length segment.

12. The method of claim 1, further comprising the step of wrapping a film around at least a portion of an abluminal surface of the ePTFE tubular member when the ePTFE tubular member is in the first longer length.

13. The method of claim 1, wherein the ePTFE tubular member has a first smaller diameter portion having a constant diameter, a second larger diameter portion having a constant diameter that is larger than the constant diameter of the smaller diameter portion, and further wherein the tapered portion is located between the first smaller diameter portion and the second larger diameter portion.