Layered medical appliances and methods

Patent metadata

Field	Value
Publication number	US-2016250048-A1
Application number	US-201615053232-A
Country	US
Kind code	A1
Filing date	Feb 25, 2016
Priority date	Feb 26, 2015
Publication date	Sep 1, 2016
Grant date	—

Abstract

Medical appliances may be formed of multilayered constructs. The layers of the constructs may be configured with various physical properties or characteristics. The disposition and arrangement of each layer may be configured to create an overall construct with a combination of the individual properties of the layers. Constructs may be used to create vascular prostheses or other medical devices.

First claim

1 . A multilayered vascular prosthesis, comprising:
a serially deposited fiber layer disposed on a luminal surface of the prosthesis; a polytetrafluoroethylene (PTFE) layer coupled to the serially deposited fiber layer, the PTFE layer providing at least 80% of the tensile strength, measured in at least one direction, of a construct consisting of the serially deposited fiber layer and the PTFE layer.

2 . The multilayered vascular prosthesis of claim 1 , wherein the PTFE layer comprises expanded PTFE (ePTFE).

3 . The multilayered vascular prosthesis of claim 2 , wherein the ePTFE layer provides at least 90% of the tensile strength of a construct consisting of the serially deposited fiber layer and the ePTFE layer.

4 . The multilayered vascular prosthesis of claim 2 , wherein the ePTFE layer is disposed on an abluminal surface of the prosthesis.

5 . The multilayered vascular prosthesis of claim 2 , wherein the ePTFE layer comprises one or more sublayers of ePTFE.

6 . The multilayered vascular prosthesis of claim 5 , wherein an axis of longitudinal expansion of at least one of the ePTFE sublayers is disposed at an angle to an axis of longitudinal expansion of at least one adjacent ePTFE sublayer.

7 . The multilayered vascular prosthesis of claim 5 , wherein an axis of longitudinal expansion of at least one of the ePTFE sublayers is perpendicular to an axis of longitudinal expansion of at least one adjacent ePTFE sublayer.

8 . The multilayered vascular prosthesis of claim 5 , wherein each ePTFE sublayer has an average pore size of 6 microns or less.

9 . The multilayered vascular prosthesis of claim 5 , further comprising a tissue and cell impermeable layer of fluorinated ethylene propylene (FEP).

10 . The multilayered vascular prosthesis of claim 9 , wherein the FEP layer is at least partially disposed within pores of the ePTFE layer.

11 . The multilayered vascular prosthesis of claim 1 , wherein the prosthesis exerts a radial outward force of less than 2 N/mm at 20% oversizing or the point force required to fully collapse the multilayered vascular prosthesis is greater than 5 N.

12 . The multilayered vascular prosthesis of claim 1 , wherein the serially deposited fiber layer comprises rotational spun fibers.

13 . A multilayered vascular prosthesis, comprising:
a serially deposited fiber layer disposed on a luminal surface of the prosthesis; an expanded polytetrafluoroethylene (ePTFE) layer coupled to the serially deposited fiber layer, the ePTFE layer having an average pore size of less than 6 microns.

14 . The multilayered vascular prosthesis of claim 13 , wherein the ePTFE layer has greater tensile strength than the serially deposited fiber layer in at least one direction along the serially deposited fiber layer.

15 . The multilayered vascular prosthesis of claim 14 , wherein the ePTFE layer comprises one or more sublayers of ePTFE.

16 . The multilayered vascular prosthesis of claim 15 , further comprising sublayers of fluorinated ethylene propylene (FEP) disposed between one or sublayers of the ePTFE layer.

17 . The multilayered vascular prosthesis of claim 15 , wherein an axis of longitudinal expansion of at least one of the ePTFE sublayers is disposed at an angle to an axis of longitudinal expansion of at least one adjacent ePTFE sublayer.

18 . The multilayered vascular prosthesis of claim 16 , wherein the ePTFE layer is impermeable to red blood cell migration across the layer.

19 . The multilayered vascular prosthesis of claim 13 , wherein the serially deposited fiber layer comprises rotational spun fibers.

20 . A method of constructing a multilayered vascular prosthesis, the method comprising:
coupling an expanded polytetrafluoroethylene (ePTFE) layer with an internodal distance (IND) of 6 micron or less to a serially deposited layer, such that the serially deposited layer is disposed on a lumenal surface of the multilayered vascular prosthesis.

21 . The method of claim 20 , further comprising applying fluorinated ethylene propylene (FEP) to the ePTFE layer such that at least a portion of the FEP is disposed within pores of the ePTFE layer.

22 . The method of claim 21 , wherein the FEP and ePTFE layer comprise a tissue and cell impermeable boundary.

23 . The method of claim 22 , wherein the ePTFE layer is constructed by coupling a first sublayer of ePTFE to a second sublayer of ePTFE, wherein the axis of expansion of the second sublayer is disposed at an angle to the axis of expansion of the first sublayer.

24 . The method of claim 20 , further comprising rotational spinning the serially deposited layer.

Assignees

• Merit Medical Systems Inc

Inventors

• Hall John
• Mower Wayne
• Simmons Rachel
• Dolmatch Bart

Classifications

• A61F2/07 Primary

  Stent-grafts · CPC title

• A61F2/915 Primary

  with bands having a meander structure, adjacent bands being connected to each other · CPC title

• A61F2002/072

  Encapsulated stents, e.g. wire or whole stent embedded in lining · CPC title

• B32B2535/00

  Medical equipment, e.g. bandage, prostheses or catheter · CPC title

• A61F2240/001

  Designing or manufacturing processes · CPC title