# US 10,765,778 B2 · Bio-resorbable reticular prosthesis and related manufacturing method

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- Number: US 10,765,778 B2
- Document ID: US10765778B2
- Status: Granted
- Kind: B2
- Application number: 15/523,840
- Filed: 2015-11-02
- Published: 2017-11-16
- Granted: 2020-09-08
- Earliest claimed: 2014-11-03
- Applicants: Francesco Nappi
- Inventors: Francesco Nappi
- Web page: https://patentgrep.com/patent/US10765778B2

## CPC

- A61L 27/48: with macromolecular fillers
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/507: {for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062)}
- A61L 31/129: {containing macromolecular fillers}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- C08L 27/18: Homopolymers or copolymers or tetrafluoroethene
- A61F 2210/0004: bioabsorbable
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2250/0031: made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
- 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)
- 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)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

The present invention concerns a bio-resorbable prosthesis (1, 1′) for organs with lumens, as blood vessels and the like, comprising at least one bio-absorbable material layer (2), intended to be arranged in contact with said lumen organ when said prosthesis (1, 1′) is implanted, and at least one auxetic material layer (3), arranged in contact with said at least one bio-absorbable material layer (2). The present invention also concerns a method for the production of a bio-absorbable prosthesis (1, 1′).

## Claims

### Claim 1

A prosthesis (1, 1′) for organs with lumens, which prosthesis comprises:
at least one bio-absorbable material layer (2), configured to be arranged in contact with said lumen organ when said prosthesis (1, 1′) is implanted,
at least one auxetic material layer (3), arranged in contact with and within said at least one bio-absorbable material layer (2), and
a reinforcing layer, said reinforcing layer being coated by said auxetic material layer (3),
wherein said prosthesis (1′) being usable as an endovascular prosthesis, which prosthesis is a stent:
wherein said bio-absorbable material layer (2) is a mesh having a plurality of polygonally-shaped cells,
wherein said bio-absorbable material layer (2) comprises polydioxanone (PDS),
wherein said auxetic material layer (3) comprises a plurality of side longitudinal strips (31), arranged in parallel having an auxetic behavior in the longitudinal development direction,
wherein said auxetic material layer (3) comprises expanded polytetrafluoroethylene (Goretex®), and
wherein said reinforcing layer is made of metal.

### Claim 2 (depends on 1)

The prosthesis (1, 1′) according to claim 1, wherein said bio-absorbable material layer (2) further comprises polyglycolic acid and/or acid and/or poly-l-lactic acid and/or the poliglactin (Vicril®) and/or the copolymer poly-1-lactic acid co-ε-caprolactone.

### Claim 3 (depends on 1)

The prosthesis (1, 1′) according to claim 1, wherein said bio-absorbable material layer (2) is capable to release gradual release drugs and/or substances having inhibitory action on cell proliferation and/or platelet aggregation.

### Claim 4 (depends on 1)

The prosthesis (1, 1′) according to claim 1, wherein each cell of said bio-absorbable material layer (2) has a maximal transverse dimension comprised in a range 0.2-0.3 mm.

### Claim 5 (depends on 1)

The prosthesis (1, 1′) according to claim 1, wherein said auxetic material layer (3) comprises expanded polytetrafluoroethylene (expanded PTFE, Goretex®) treated with polyethylene oxide (ENP).

### Claim 6 (depends on 1)

The prosthesis (1, 1′) according to claim 1, wherein said bio-absorbable material layer (2) and/or said auxetic material layer (3) has a substantially cylindrical shape.

### Claim 7 (depends on 1)

The prosthesis (1) according to claim 1, wherein said bio-absorbable material layer (2) is arranged within said auxetic material layer (3), said prosthesis (1) being usable as extravascular prosthesis.

### Claim 8 (depends on 1)

The prosthesis (1, 1′) according to claim 1, wherein said auxetic material layer (3) comprises a plurality of transverse wires (32), which connect each of said longitudinal strips (31) with the adjacent longitudinal strips (31), such that, when said prosthesis (1, 1′) is not subject to stresses, said transverse wires are loose, following a curved pattern.

### Claim 9 (depends on 1)

The prosthesis (1) according to claim 1, wherein each longitudinal strip (31) has a bellows-like structure which makes the strip extensible in the longitudinal direction.

### Claim 10 (depends on 1)

The prosthesis (1) according to claim 1, wherein the ends of said side longitudinal strips (31) are configured to be fixed to the lateral wall of the organ with lumen in which said prosthesis (1) is applicable.

### Claim 11 (depends on 1)

A surgical method comprising a step of implanting a portion of an autologous pulmonary artery to replace an aortic root, which method provides a further step of implanting an extravascular prosthesis according to claim 1 as a support for said portion of pulmonary artery, wherein said method preferably follows a Ross procedure.

### Claim 12 (depends on 1)

A surgical method comprising a step of implanting an endoprosthesis according to claim 1.

### Claim 13 (depends on 1)

The prosthesis (1, 1′) according to claim 1, wherein said plurality of polygonally-shaped cells comprises hexagonal cells.