# US 2016/0250048 A1 · Layered medical appliances and methods

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- Number: US 2016/0250048 A1
- Document ID: US20160250048A1
- Status: Published application
- Kind: A1
- Application number: 15/053,232
- Filed: 2016-02-25
- Published: 2016-09-01
- Earliest claimed: 2015-02-26
- Assignees: Merit Medical Systems, Inc.
- Applicants: Merit Medical Systems, Inc.
- Inventors: John Hall; Wayne Mower; Rachel Simmons; Bart Dolmatch
- Web page: https://patentgrep.com/patent/US20160250048A1

## CPC

- A61F 2/07: Stent-grafts
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- A61F 2/945: hardenable, e.g. stents formed in situ
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/507: {for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062)}
- A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)}
- B32B 27/08: of synthetic resin
- B32B 27/322: {comprising halogenated polyolefins, e.g. PTFE}
- C08L 27/18: Homopolymers or copolymers or tetrafluoroethene
- A61F 2002/072: {Encapsulated stents, e.g. wire or whole stent embedded in lining}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2220/005: using adhesives
- A61F 2240/001: Designing or manufacturing processes
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0023: differing in porosity
- A61F 2250/0028: differing in fibre orientations
- A61F 2250/0051: differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61F 2250/0069: Sealing means
- B32B 2307/7265: Non-permeable
- B32B 2535/00: Medical equipment, e.g. bandage, prostheses or catheter
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## 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.

## Claims

### 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 2)

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

### Claim 5 (depends on 2)

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

### Claim 6 (depends on 5)

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.

### Claim 7 (depends on 5)

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.

### Claim 8 (depends on 5)

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

### Claim 9 (depends on 5)

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

### Claim 10 (depends on 9)

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

### Claim 11 (depends on 1)

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.

### Claim 12 (depends on 1)

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

### Claim 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.

### Claim 14 (depends on 13)

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.

### Claim 15 (depends on 14)

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

### Claim 16 (depends on 15)

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

### Claim 17 (depends on 15)

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.

### Claim 18 (depends on 16)

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

### Claim 19 (depends on 13)

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

### Claim 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.

### Claim 21 (depends on 20)

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.

### Claim 22 (depends on 21)

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

### Claim 23 (depends on 22)

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.

### Claim 24 (depends on 20)

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