# US 11,028,509 B2 · Method for forming a base knit suitable for manufacturing hernia prostheses and hernia prostheses obtained therefrom

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- Number: US 11,028,509 B2
- Document ID: US11028509B2
- Status: Granted
- Kind: B2
- Application number: 15/965,842
- Filed: 2018-04-28
- Published: 2018-11-08
- Granted: 2021-06-08
- Earliest claimed: 2017-05-02
- Assignees: Sofradim Production
- Applicants: Sofradim Production
- Inventors: Xavier Couderc; Jeremy Miralles; Camille Noorman
- Web page: https://patentgrep.com/patent/US11028509B2

## CPC

- D04B 21/12: characterised by thread material
- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- D04B 21/16: incorporating synthetic threads
- D04B 27/24: Thread guide bar assemblies
- A61F 2002/0068: {having a special mesh pattern}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2230/0039: H-shaped
- A61F 2240/001: Designing or manufacturing processes
- A61F 2250/0017: differing in yarn density
- A61F 2250/0031: made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
- D10B 2321/022: polypropylene
- D10B 2403/0213: with apertures, e.g. with one or more mesh fabric plies
- D10B 2509/08: Hernia repair mesh
- D04B: KNITTING
- 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)
- D10B: INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES

## Abstract

The invention relates to a method for forming a prosthetic base knit (1) made of two parallel sheets of porous knits, namely a first sheet (2) of porous knit and a second sheet of porous knit, said two parallel sheets being joined together in a discrete manner by a plurality of connecting porous knits (4) spaced apart from each other. The invention further relates to a method for manufacturing H-shaped prostheses for hernia repair from said base knit thus obtained and to the prostheses obtained therefrom.

## Claims

### Claim 1

A method for forming a prosthetic base knit made of two parallel sheets of porous knits including a first sheet of porous knit and a second sheet of porous knit, said two parallel sheets being joined together in a discrete manner by a plurality of connecting porous knits spaced apart from each other, said method comprising knitting on a warp knitting machine comprising two needle-beds, a first needle-bed comprising a first guide bar B1, a second guide bar B2 and a third guide bar B3, and a second needle-bed comprising a fourth guide bar B4, a fifth guide bar B5 and a sixth guide bar B6, yarns of a biocompatible material threaded in said first, second, third, fifth and sixth guide bars, according to a defined knitting pattern unit along a warp direction of the warp knitting machine, said pattern unit corresponding to a total number of N courses ranging from 1 to N completed along said warp direction on each needle-bed, and according to a defined threading-in unit repeated along a width of the warp knitting machine, said threading-in unit corresponding to a total number T of needles along said width of the warp knitting machine, N and T being each an integer equal or greater than 5, wherein
i) for needles ranging from 1 to T and courses ranging from 1 to N, patterns followed by the first and second guide bars produce on the first needle-bed said first sheet of porous knit under a form of a first bidimensional porous knit, and patterns followed by the fifth and sixth guide bars produce on the second needle-bed said second sheet of porous knit under a form of a second bidimensional porous knit, and
ii) for needles ranging from w to z, where 1≤w<z≤T and courses ranging from x to y, where 1≤x<y=N, where w, x, y, and z are integers, the pattern followed by the third guide bar B3 produces a connecting porous knit joining said first sheet of porous knit to said second sheet of porous knit, under a form of a three-dimensional porous knit, made of yarns threaded in said third guide bar B3 crossing from the first needle-bed to the second needle-bed and vice-versa.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said fourth guide bar B4 being threaded with yarns of a biocompatible material, for needles ranging from r to s, where 1≤r<s<w<z≤T or 1≤w≤z<r<s≤T, and courses ranging from 1 to N, a knitting pattern of the fourth guide bar B4 produces a pillar knit joining said first sheet of porous knit to said second sheet of porous knit, under the form of a three-dimensional knit made of yarns threaded in said fourth guide bar B4 crossing from the first needle-bed to the second needle-bed and vice-versa.

### Claim 3 (depends on 1)

The method according to claim 1, wherein N being equal to 264, knitting patterns followed by said first, second, third, fifth and sixth guide bars is as follows, according to the ISO 11676 standard (publication year 2014):
B1: (3-2-2-2/2-1-1-1/0-1-2-2)×88//
B2: (2-3-3-3/3-4-4-4/5-4-3-3)×88//
B3: (2-3-3-3/3-4-4-4/5-4-3-3)×36/ (2-3-3-2/3-4-3-2/5-4-4-5)×3/ (2-3-3-3/3-4-4-4/5-4-3-3)×49//
B5: (2-2-1-0/1-1-1-2/1-1-1-0/1-1-1-2/4-4-6-7/6-6-6-5/6-6-6-7/6-6-6-5)×33//
B6: (5-5-6-7/6-6-6-5/6-6-6-7/6-6-6-5/3-3-1-0/1-1-1-2/1-1-1-0/1-1-1-2)×33//.

### Claim 4 (depends on 2)

The method according to claim 2, wherein the knitting pattern of the fourth guide bar B4 is as follows, according to the ISO 11676 standard (publication year 2014):
B4: (2-3-3-2/3-4-3-2/5-4-4-5)×75/1-1-1-2/1-1-1-0/1-1-1-2/4-4-6-7/6-6-6-5/6-6-6-7/6-6-6-5/(2-2-1-0/1-1-1-2/1-1-1-0/1-1-1-2/4-4-6-7/6-6-6-5/6-5-6-7/6-6-6-5)×4//.

### Claim 5 (depends on 1)

The method according to claim 1, wherein T being equal to 156, the threading-in of said first, second, third, fourth, fifth and sixth guide bars is the following:
B1: (D.)78
B2: (S.)2(D.)31(S.)4(D.)31(S.)10
B3: (S.)2.62(S.)4.62(S.)2.16
B4: 0.140(S.)8
B5: (S.)78
B6: (S.)78.

### Claim 6 (depends on 1)

The method according to claim 1, wherein a distance between the first needle-bed and the second needle-bed is set at a value ranging from about 1 mm to about 15 mm.

### Claim 7 (depends on 1)

The method according to claim 1, wherein a distance between the first needle-bed and the second needle-bed is set at a value of about 10 mm.

### Claim 8 (depends on 1)

The method according to claim 1, wherein said yarns are monofilaments.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the biocompatible material is polypropylene.

### Claim 10 (depends on 1)

The method according to claim 1, further comprising a heat-setting step during which the base knit is submitted to a heat-setting treatment.

### Claim 11 (depends on 10)

The method according to claim 10, wherein the heat-setting treatment is performed at a temperature ranging from about 90° C. to about 250° C.

### Claim 12 (depends on 11)

The method according to claim 11, wherein the temperature ranges from about 110° C. to about 240° C.

### Claim 13 (depends on 11)

The method according to claim 11, wherein the temperature ranges from about 130° C. to about 145° C.

### Claim 14 (depends on 11)

The method according to claim 11, wherein the temperature is about 140° C.

### Claim 15 (depends on 1)

The method according claim 1, wherein the knitting pattern followed by the third guide-bar B3 allows producing the connecting porous knit showing a tensile breaking strength ranging from about 30 N to 200 N in the warp direction and ranging from about 30 N to 200 N in the weft direction.

### Claim 16 (depends on 15)

The method according claim 15, wherein the tensile breaking strength ranges from about 80 N to about 180 N in the warp direction.

### Claim 17 (depends on 15)

The method according claim 15, wherein the tensile breaking strength ranges from about 110 N to about 160 N in the warp direction.

### Claim 18 (depends on 15)

The method according claim 15, wherein the tensile breaking strength is from about 139 N in the warp direction.

### Claim 19 (depends on 15)

The method according claim 15, wherein the tensile breaking strength ranges from about 80 N to about 180 N in the weft direction.

### Claim 20 (depends on 15)

The method according claim 15, wherein the tensile breaking strength ranges from about 110 N to about 160 N in the weft direction.

### Claim 21 (depends on 15)

The method according claim 15, wherein the tensile breaking strength is from about 143 N in the weft direction.

### Claim 22 (depends on 1)

The method according to claim 1, wherein the knitting pattern followed by the third guide-bar B3 allows producing the connecting porous knit showing a tensile elongation under 50N ranging from about 20% to 100% in the warp direction and ranging from about 20% to 100% in the weft direction.

### Claim 23 (depends on 22)

The method according claim 22, wherein the tensile elongation under 50N is about 36% in the warp direction and about 54% in the weft direction.

### Claim 24 (depends on 1)

The method according to claim 1, wherein the knitting pattern followed by the third guide-bar B3 allows producing the connecting porous knit showing a tensile elongation at break ranging from about 60% to about 200% in the warp direction and ranging from about 60% to about 200% in the weft direction.

### Claim 25 (depends on 24)

The method according claim 24, wherein the tensile elongation at break is about 72% in the warp direction and about 112% in the weft direction.

### Claim 26 (depends on 1)

A method for manufacturing a H-shaped prosthesis suitable for hernia repair, said H-shaped prosthesis comprising an underlay layer, an onlay layer, and a connector, said method comprising the following steps:
isolating an adequate portion of a base knit obtained according to claim 1, said portion including one connecting knit,
cutting the first sheet of porous knit of said portion to a shape and dimension desired for forming said underlay layer,
cutting the second sheet of porous knit of said portion to a shape and dimension desired for forming said onlay layer, said connecting knit forming said connector.

### Claim 27

A method for manufacturing a H-shaped prosthesis suitable for hernia repair, said H-shaped prosthesis comprising an underlay layer, an onlay layer and a connector, said method comprising the following steps:
Aº) producing a prosthetic base knit made of two parallel sheets of porous knits including a first sheet of porous knit and a second sheet of porous knit, said two parallel sheets being joined together by a connecting porous knit, said method comprising knitting on a warp knitting machine comprising two needle-beds, a first needle-bed comprising a first guide bar B1, a second guide bar B2 and a third guide bar B3, and a second needle-bed comprising a fourth guide bar B4, a fifth guide bar B5 and a sixth guide bar B6, yarns of a biocompatible material threaded in said first, second, third, fifth and sixth guide bars, according to a defined pattern unit corresponding to a total number of N courses ranging from 1 to N completed along said warp direction on each needle-bed, and according to a defined threading-in unit corresponding to a total number T of needles along said width of the machine, N and T being each an integer equal or greater than 5, wherein
i) for needles ranging from 1 to T and courses ranging from 1 to N, knitting patterns followed by the first and second guide bars produce on the first needle-bed said first sheet of porous knit under the form of a first bidimensional porous knit, and knitting patterns followed by the fifth and sixth guide bars produce on the second needle-bed said second sheet of porous knit under the form of a second bidimensional porous knit, and
ii) ii) for needles ranging from w to z, where 1≤w<z≤T and courses ranging from x to y, where 1≤x<y≤N, where w, x, y, and z are integers, a knitting pattern followed by the third guide bar B3 produces a connecting porous knit joining said first sheet of porous knit to said second sheet of porous knit, under the form of a three-dimensional porous knit, made of yarns threaded in said third guide bar B3 crossing from the first needle-bed to the second needle-bed and vice-versa,
Bº) cutting the first sheet of porous knit to a shape and dimension desired for forming said underlay layer,
Cº) cutting the second sheet of porous knit to a shape and dimension desired for forming said onlay layer, said connecting knit forming said connector.
