# US 11,026,777 B2 · Layered medical appliances and methods

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- Number: US 11,026,777 B2
- Document ID: US11026777B2
- Status: Granted
- Kind: B2
- Application number: 16/035,334
- Filed: 2018-07-13
- Published: 2019-01-10
- Granted: 2021-06-08
- 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/US11026777B2

## 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 luminal surface comprising a serially deposited fiber layer; and
an expanded polytetrafluoroethylene (ePTFE) layer coupled to the serially deposited fiber layer, wherein,
the ePTFE layer comprises one or more sublayers of ePTFE, and
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;
wherein at least one of the ePTFE sublayers is configured to be impermeable to red blood cell migration; and
wherein the one or more sublayers of ePTFE comprise different average pore sizes.

### Claim 2 (depends on 1)

The multilayered vascular prosthesis of claim 1, wherein the axis of longitudinal expansion of at least one of the ePTFE sublayers is disposed at an angle between 0 degrees and 90 degrees to the axis of longitudinal expansion of at least one adjacent ePTFE sublayer.

### Claim 3 (depends on 1)

The multilayered vascular prosthesis of claim 1, wherein the axis of longitudinal expansion of at least one of the ePTFE sublayers is perpendicular to the axis of longitudinal expansion of at least one adjacent ePTFE sublayer.

### Claim 4 (depends on 1)

The multilayered vascular prosthesis of claim 1, wherein the axis of longitudinal expansion of at least one of the ePTFE sublayers is at an angle to a longitudinal axis of the multilayered vascular prosthesis.

### Claim 5 (depends on 1)

The multilayered vascular prosthesis of claim 1, wherein an average pore size of at least one of the ePTFE sublayers is different than an average pore size of at least one adjacent ePTFE sublayer.

### Claim 6 (depends on 1)

The multilayered vascular prosthesis of claim 1, wherein pores of at least one of the ePTFE sublayers are misaligned with pores of at least one adjacent ePTFE sublayer such that a tortuous path is defined between the pores of the sublayers.

### Claim 7 (depends on 1)

The multilayered vascular prosthesis of claim 1, wherein at least one of the ePTFE sublayers is coupled to a non-porous layer.

### Claim 8

A multilayered vascular prosthesis, comprising:
a luminal surface comprising a serially deposited fiber layer; and
an expanded polytetrafluoroethylene (ePTFE) layer coupled to the serially deposited fiber layer, the ePTFE layer providing at least 65% of the tensile strength, measured in at least one direction, of a construct consisting of the serially deposited fiber layer and the ePTFE layer;
wherein the ePTFE layer comprises two or more sublayers of ePTFE,
wherein the ePTFE layer is configured to be impermeable to red blood cell migration across the ePTFE layer, and wherein pores of at least one of the ePTFE sublayers are misaligned with pores of at least one adjacent ePTFE sublayer.

### Claim 9 (depends on 8)

The multilayered vascular prosthesis of claim 8, wherein an average pore size of at least one of the ePTFE sublayers is different than an average pore size of at least one adjacent ePTFE sublayer.

### Claim 10 (depends on 8)

The multilayered vascular prosthesis of claim 8, wherein at least one of the ePTFE sublayers is coupled to a non-porous layer.

### Claim 11 (depends on 8)

The multilayered vascular prosthesis of claim 8, 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 12 (depends on 11)

The multilayered vascular prosthesis of claim 11, wherein the axis of longitudinal expansion of at least one of the ePTFE sublayers is disposed at an angle between 0 degrees and 90 degrees to the axis of longitudinal expansion of at least one adjacent ePTFE sublayer.

### Claim 13 (depends on 11)

The multilayered vascular prosthesis of claim 11, wherein the axis of longitudinal expansion of at least one of the ePTFE sublayers is disposed at an angle to a longitudinal axis of the multilayered vascular prosthesis.
