# US 2021/0330438 A1 · Kits for surgical repair of soft tissue defects and components, packaging, and methods of use thereof

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- Number: US 2021/0330438 A1
- Document ID: US20210330438A1
- Status: Published application
- Kind: A1
- Application number: 17/202,162
- Filed: 2021-03-15
- Published: 2021-10-28
- Earliest claimed: 2020-04-23
- Assignees: Sofradim Production
- Applicants: Sofradim Production
- Inventors: Pierre Bailly; Thierry Brune; Guy Jouvray
- Web page: https://patentgrep.com/patent/US20210330438A1

## CPC

- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)}
- A61F 2002/0072: {Delivery tools therefor}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2250/0031: made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
- A61F 2250/006: modular
- 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)

## Abstract

The present disclosure describes kits for surgical repair of soft tissue defects, including hernias. The kits include any combination of components selected from an implantable sheet, a central tie, a delivery tool, a delivery tool insert configured to be received within the delivery tool, a rolling device, and an insertion member. Packaging for the kits and/or components and methods of using the kits and/or components are also provided.

## Claims

### Claim 1

A two-piece implantable sheet delivery device comprising:
a delivery tool including an elongate body extending between a proximal end portion and a distal end portion, the elongate body including a lumen extending therethrough and a pair of windows defined in a sidewall of the elongate body, the pair of windows configured to allow access to the lumen from outside of the elongate body, and,
a delivery tool insert configured to be received within the lumen of the elongate body, the delivery tool insert including a proximal end portion, a distal end portion, and a pair of resilient arms extending therebetween, the pair of resilient arms configured to extend through the pair of windows when aligned therewith, wherein the two-piece implantable sheet delivery device is configured to transition between a restrained configuration and an expanded configuration.

### Claim 2 (depends on 1)

The two-piece implantable sheet delivery device of claim 1, wherein the proximal end portion and the distal end portion of the delivery tool insert define a longitudinal axis therebetween and the pair of resilient arms display a natural bias to extend away from each other and the longitudinal axis.

### Claim 3 (depends on 1)

The two-piece implantable sheet delivery device of claim 1, wherein the pair of resilient arms of the delivery tool insert naturally form a generally circular shaped opening therebetween.

### Claim 4 (depends on 1)

The two-piece implantable sheet delivery device of claim 1, wherein the distal end portion of the delivery tool insert further comprises at least one locking member extending therefrom and the distal end portion of the delivery tool further comprises at least one locking recess defined therein, the locking member configured to be secured in the at least one locking recess when aligned therewith, to lock the delivery tool insert within the lumen of the delivery tool.

### Claim 5 (depends on 1)

The two-piece implantable sheet delivery device of claim 1, wherein the distal end portion of the delivery tool further comprises a slot separating the distal end portion of the delivery tool into an upper and lower jaw member, the slot configured to secure a distal end portion of an implantable sheet between the upper and lower jaw members.

### Claim 6 (depends on 1)

The two-piece implantable sheet delivery device of claim 1, further comprising a pair of tie holes defined through a central portion of the elongate body of the delivery tool.

### Claim 7 (depends on 1)

The two-piece implantable sheet delivery device of claim 1, wherein the distal end portion of the delivery tool further comprises a suture aperture defined therethrough, the suture aperture configured to receive a looped suture suitable for grasping when withdrawing the delivery tool from the patient.

### Claim 8 (depends on 1)

The two-piece implantable sheet delivery device of claim 1, wherein the distal end portion of the delivery tool further comprises at least one crenulation extending outwardly from an outer surface of the distal end portion, the crenulation configured to engage openings in the implantable sheet when rolled thereon.

### Claim 9

A surgical kit for hemia repair comprising:
a mesh delivery too including an elongate body extending between a proximal end portion and distal end portion, the elongate body including a lumen extending therethrough and at least one window defined in a sidewall of the elongate body, the window configured to allow access to the lumen from a side of the elongate body,
a delivery tool insert configured to be received within the lumen of the elongate body, the delivery tool insert including a proximal end portion, a distal end portion, and at least one resilient arm extending therebetween, the at least one resilient arm configured to extend through the at least one window when aligned therewith, and an implantable sheet including a first and second opposite face.

### Claim 10 (depends on 9)

The surgical kit of claim 9, further comprising a central tie configured to connect the implantable sheet to the delivery tool, wherein the central tie is configured to pass through a pair of tie holes defined through the central portion of the elongate body of the delivery tool forming a loop inside the lumen of the delivery tool and extending away from the delivery tool through the second face of the sheet and forming a handle extending away from the opposite first face of the sheet.

### Claim 11 (depends on 9)

The surgical kit of claim 9, further comprising a rolling device configured to roll the implantable sheet around the outer surface of the delivery tool.

### Claim 12 (depends on 9)

The surgical kit of claim 9, further comprising an insertion member including an elongate body extending between a proximal end portion including a handle and a distal end portion including a socket, the socket configured to matingly engage the proximal end of the delivery tool.

### Claim 13

A method of preparing a rolled sheet-tool-insert assembly comprising:
combining an implantable sheet, a central stitch, and a delivery tool to form a sheet-tool assembly, the delivery tool including an elongate body extending between a proximal end portion and a distal end portion, the elongate body including a lumen extending therethrough and at least one window defined in a sidewall of the elongate body, the window configured to allow access to the lumen from a side of the elongate body,
preparing a rolled sheet-tool assembly from the sheet-tool assembly by using a rolling device,
inserting a delivery tool insert into the lumen of the delivery tool to form a rolled sheet-tool-insert assembly, the delivery tool insert including a proximal end portion, a distal end portion, and at least one resilient arm extending therebetween, the at least one resilient arm configured to extend through the at least one window when aligned therewith.
