# US 12,004,942 B2 · Mesh or membrane covering based on biological or biosynthetic material for prosthesis, provided with fixing system for fixing to the same prosthesis, and corresponding manufacturing process thereof

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- Number: US 12,004,942 B2
- Document ID: US12004942B2
- Status: Granted
- Kind: B2
- Application number: 17/019,424
- Filed: 2020-09-14
- Published: 2020-12-31
- Granted: 2024-06-11
- Earliest claimed: 2019-03-13
- Assignees: Flavio Nanni; Nello Cara; Federia Gulizia; Valter Varano
- Applicants: Flavio Nanni; Nello Cara; Federica Gulizia; Valter Varano
- Inventors: Flavio Nanni
- Web page: https://patentgrep.com/patent/US12004942B2

## CPC

- A61F 2/12: Mammary prostheses
- A61L 2/04: Heat (radiation A61L2/08)
- A61L 2/081: Gamma radiation
- A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation
- A61L 2/20: Gaseous substances, e.g. vapours
- A61L 27/362: {Skin, e.g. dermal papillae}
- A61L 27/3625: {Vascular tissue, e.g. heart valves}
- B33Y 80/00: Products made by additive manufacturing
- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2220/005: using adhesives
- A61F 2220/0058: soldered or brazed or welded
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0006: circular
- A61F 2230/0008: elliptical or oval
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2240/004: Using a positive or negative model, e.g. moulds
- A61L 27/24: Collagen
- A61L 2101/44: Heterocyclic compounds
- A61L 2103/05: Living organisms or biological materials
- B29C 64/118: using filamentary material being melted, e.g. fused deposition modelling [FDM]
- B33Y 10/00: Processes of additive manufacturing
- 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)
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)

## Abstract

The present invention relates to a mesh or membrane covering (2) based on biological material, for example collagen, or biosynthetic material for prostheses (1), in particular for a breast prosthesis (1), said prosthesis (1) having a rear surface that, when applied, is faced towards the person on whom (1) is applied, said covering (2) being characterized in that it provides a fixing system (4; 3) for fixing to said prosthesis (1), said fixing system providing a plurality of teeth or petals (4) or outer perimeter edge foldable on said rear surface of the prosthesis (1) by means (5). The invention further relates to a method for fixing said covering to a prosthesis, a prosthesis comprising said covering and a process for making said covering.

## Claims

### Claim 1

A covering (2) for a prosthesis (1), said prosthesis (1) having a rear surface which, when applied, is faced towards the person on whom the prosthesis (1) is applied, said covering (2) having a fixing system (4; 3) to said prosthesis (1), said fixing system providing a plurality of teeth or petals (4), realized on said covering (2), said teeth or petals (4) being so configured as to be foldable, so that when the covering (2) is arranged on said prosthesis (1) said teeth or petals (4) are coupled with said rear surface of the prosthesis (1), by securing means (5) for securing the teeth or petals (4) folded over said prosthesis (2), wherein on at least two or on each tooth or petal (4) a through hole (18) or at least one slot-shaped incision, for example single or double, is obtained, said through hole (18) or at least one slot-shaped incision being adapted to the passage of at least one thread, in particular at least one suture thread.

### Claim 2 (depends on 1)

The covering (2) according to claim 1, wherein said plurality of teeth or petals (4) are between two and forty-eight.

### Claim 3 (depends on 1)

The covering (2) according to claim 1, wherein said plurality of teeth or petals (4) are arranged in spoke fashion on the outer perimeter of said covering (2).

### Claim 4 (depends on 1)

The covering (2) according to claim 1, wherein said plurality of teeth or petals (4) have a length comprised between 5 mm and 50 mm.

### Claim 5 (depends on 1)

The covering (2) according to claim 1, wherein each through hole (18) or incision is arranged in the upper third of the height of the respective tooth or petal (4).

### Claim 6 (depends on 1)

The covering (2) according to claim 1, wherein the diameter of each hole (18) is comprised between 0.5 mm and 3.0 mm.

### Claim 7 (depends on 1)

The covering (2) according to claim 1, wherein the covering (2) has a mesh portion (13), in particular at a central part of said covering (2).

### Claim 8 (depends on 7)

The covering (2) according to claim 7, wherein said mesh portion (13) has a centrifugal expansion.

### Claim 9 (depends on 1)

The covering (2) according to claim 1, wherein the outer perimeter of said covering (2) has a circular or elliptic or polygonal shape or polygonal shape adapted to be inscribed or circumscribed in a circle or an ellipse.

### Claim 10 (depends on 9)

The covering (2) according to claim 9, wherein when the outer perimeter of the covering (2) has an elliptic or circle shape, the proportional ratio between the axes of the ellipse is comprised between 1:1 to 3:1.

### Claim 11 (depends on 1)

The covering (2) according claim 1, wherein covering (2) is made exclusively from one or more biopolymers or from a mixture of one or more biopolymers and further ingredients, such as for example elastin.

### Claim 12 (depends on 1)

The covering (2) according to claim 1, wherein covering (2) is made of resorbable and biocompatible material.

### Claim 13 (depends on 1)

The kit for covering a prosthesis (1), said kit comprising a covering (2) according to claim 1, wherein the kit comprises one or more threads for fixing said covering (2) to said prosthesis (1), wherein said one or more threads are adapted to pass through said holes (18) or incisions obtained on said teeth or petals (4) or on said perimeter edge (19) of said covering (2).

### Claim 14 (depends on 13)

The kit according to claim 13, wherein said one or more threads (20) are inserted through said holes (18) or incisions.

### Claim 15 (depends on 14)

The kit according to claim 14, wherein said one or more threads (20) are inserted through said holes (18) or incisions so that, when said covering (2) is in use for covering a prosthesis (1), and said one or more threads (20) are subjected to manual traction, said teeth or petals (4) are synchronously pulled towards the centre of the rear face of the prosthesis (1), consequently causing the wrapping of the prosthesis (1) by the covering (2).

### Claim 16 (depends on 14)

The kit according to claim 14, wherein the kit comprises a pair of threads (20) inserted through said holes (18) in an opposite direction to one another, so that their respective ends are coupled on opposite sides of the covering (2).

### Claim 17 (depends on 1)

The kit for covering a prosthesis (1), wherein said kit comprising a covering according to claim 1, and a breast prosthesis (1) having a rear surface, said covering (2) being applied on said breast prosthesis (1) with said plurality of teeth or petals (4) folded and fixed at said rear surface.

### Claim 18

A covering (2) for a prosthesis (1), said prosthesis (1) having a rear surface which, when applied, is faced towards the person on whom the prosthesis (1) is applied, said coveting (2) having a fixing system (4; 3) to said prosthesis (1), said fixing system providing a plurality of teeth or petals (4), realized on said covering (2) said teeth or petals (4) being so configured as to be foldable, so that when the covering (2) is arranged on said prosthesis (1) said teeth or petals (4) are coupled with said rear surface of the prosthesis (1), by securing means (5) for securing the teeth or petals (4) folded over said prosthesis (2), wherein the covering (2) has a mesh portion (13), in particular at a central part of said covering (2), wherein the mesh portion (13) has a plurality of notches (14, 15).

### Claim 19 (depends on 18)

The covering (2) according to claim 18, wherein said notches (14) have a centrifugal expansion with respect to the centre of said covering (2).

### Claim 20 (depends on 18)

The covering (2) according to claim 18, wherein said notches (15) are radial notches (15), arranged on closed concentric or spiral lines.

### Claim 21 (depends on 20)

The covering according to claim 20, wherein said closed lines have a polygonal shape.

### Claim 22 (depends on 18)

The covering (2) according to claim 18, wherein said notches (5) are so arranged as to form a plurality of adjacent and contiguous triangular sections.

### Claim 23 (depends on 18)

The covering (2) according to claim 18, wherein said notches (15) are so arranged as to form a plurality of adjacent triangular sections separated by a uniform area (21), wherein each uniform area (21) is devoid of notches or cuts or incisions or slits, and connects a central portion (17) to a peripheral portion (16) of the covering (2).

### Claim 24 (depends on 23)

The covering (2) according to claim 23, wherein said triangular sections are between three and six triangular sections.

### Claim 25 (depends on 18)

The covering (2) according to claim 18, wherein the length of each of said notches (14, 15) is comprised between 2 mm and 2 cm.

### Claim 26 (depends on 20)

The covering (2) according to claim 20, wherein the distance between several closed lines is comprised between 2 mm and 2 cm.

### Claim 27 (depends on 18)

A kit for covering a prosthesis (1), said kit comprising a covering (2) according to claim 18, wherein the kit comprises a disk (5) for fixing said covering (2) to said prosthesis (1), wherein said disk (5), said disk (5) being so configured that when said covering (2) is arranged on said prosthesis (1), said disk (5) is able to cover an area of the teeth or petals (4).

### Claim 28 (depends on 27)

The kit for covering a prosthesis (1) according to claim 27, wherein said disk (5) is made of smooth or corrugated elastomeric material, covered with polyurethane, or of collagen or of another medical grade biopolymer.

### Claim 29

A covering (2) for a prosthesis (1), said prosthesis (1) having a rear surface which, when applied, is faced towards the person on whom the prosthesis (1) is applied, said covering (2) having a fixing system (4; 3) to said prosthesis (1), said fixing system providing a plurality of teeth or petals (4), realized on said covering (2), said teeth or petals (4) being so configured as to be foldable, so that when the covering (2) is arranged on said prosthesis (1) said teeth or petals (4) are coupled with said rear surface of the prosthesis (1), by securing means (5) for securing the teeth or petals (4) folded over said prosthesis (2), wherein the covering (2) has a mesh portion (13), in particular at a central part of said covering (2), wherein said covering (2) has a peripheral portion or band (16) made of a full non uniform surface that surrounds peripherally the mesh portion (13), said peripheral band (16) being devoid of notches or incisions or slits.

### Claim 30 (depends on 29)

The covering (2) according to claim 29, wherein said peripheral band (16) has a thickness comprised between 6 mm and 3 cm.

### Claim 31

A covering (2) for a prosthesis (1), said prosthesis (1) having a rear surface which, when applied, is faced towards the person on whom the prosthesis (1) is applied, said covering (2) having a fixing system (4; 3) to said prosthesis (1), said fixing system providing a plurality of teeth or petals (4), realized on said covering (2), said teeth or petals (4) being: so configured as to be foldable, so that when the covering (2) is arranged on said prosthesis (1) said teeth or petals (4) are coupled with said rear surface of the prosthesis (1), by securing means (5) for securing the teeth or petals (4) folded over said prosthesis (2), wherein the covering (2) has a mesh portion (13), in particular at a central part of said covering (2), wherein the covering (2) provides a central portion (17) surrounded by said mesh portion (13), said central portion (17) having a uniform surface devoid of cuts or incisions or slits.

### Claim 32 (depends on 31)

The covering (2) according to claim 31, wherein the diameter of said central portion (17) varies between 2 cm and 5 cm.