Soft tissue repair prosthesis, expandable device, and method of soft tissue repair

• US 10,548,703 B2
• Filed: 10/21/2016
• Issued: 02/04/2020
• Est. Priority Date: 11/21/2008
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Darois, Roger E., Groetelaars, John Peter, Jacene, Michael F., Colesanti, Anthony, Lee, Michael J., Longo, Richard V., Smith, Tara, Brann, James M.
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US15/299,578
• Publication Number:
  US 20170100229A1
• Time in Patent Office: 1,201 Days
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A hernia repair device is provided which may include a soft tissue repair prosthesis and an expandable device configured to be removably connected with the soft tissue repair prosthesis. When expanded, the expandable device may be configured to position the soft tissue repair prosthesis adjacent a hernia defect. The soft tissue repair prosthesis may include at least one loop or slit configured to receive a portion of the expandable device. The prosthesis may include a tether to hoist, locate or position the soft tissue repair prosthesis. The expandable device may include indicia for positioning the prosthesis relative to the edge of the hernia defect.

Claims

1. A hernia repair device, comprising:

an expandable device;

an implantable soft tissue repair prosthesis comprising a mesh fabric configured to be attached to soft tissue by a fixation device and having a plurality of slits therethrough, wherein each of the plurality of slits has a predetermined size configured to receive a portion of the expandable device to removably connect the prosthesis with the expandable device and to position the prosthesis adjacent a hernia defect; and

a tether coupled to the prosthesis at a location separate and distinct from a plurality of slits, wherein manipulation of the tether allows hoisting, locating or positioning of the soft tissue repair prosthesis,

wherein the expandable device is configured to expand from a reduced profile to an expanded configuration to expand the prosthesis, and

wherein the expandable device is removably engaged in each of the plurality of slits.

2. The hernia repair device of claim 1, wherein the expandable device includes at least one arm and at least one slit of the plurality of slits is configured to receive at least a portion of the arm to removably connect the prosthesis with the expandable device.

3. The hernia repair device of claim 2, wherein an end portion of the at least one arm is non-expandable, and wherein the non-expandable end portion is configured to be passed through the at least one slit.

4. The hernia repair device of claim 1

wherein the expandable device includes numeric indicia at an edge of the expandable device for referencing a predetermined location for positioning an edge of a hernia defect relative to the prosthesis such that the prosthesis overlaps the edge of the defect a predetermined distance.

5. The hernia repair device of claim 4, wherein the indicia includes a ruler with a plurality of markings to position the prosthesis relative to the defect.

6. The hernia repair device of claim 4, wherein the indicia is visible.

7. The hernia repair device of claim 4, wherein the indicia is visible with imaging.

8. The hernia repair device of claim 4, wherein the indicia is tactile.

9. The hernia repair device of claim 4, wherein the soft tissue repair prosthesis is formed from a mesh fabric.

10. The hernia repair device of claim 1, wherein the expandable device being configured to expand the prosthesis comprises the expandable device being configured to unroll the prosthesis.

11. The hernia repair device of claim 1, wherein the fixation device includes one or more selected from the group consisting of sutures, fasteners, adhesives, and tacks.

12. A hernia repair device, comprising:

an expandable device;

an implantable soft tissue repair prosthesis comprising a mesh fabric and having at least one slit therethrough, wherein the mesh fabric has a first portion and a second portion, wherein the second portion has different tissue ingrowth properties than the first portion, and wherein the at least one slit has a predetermined size configured to receive a portion of the expandable device to removably connect the prosthesis with the expandable device; and

a tether coupled to the prosthesis at a location separate and distinct from the at least one slit, wherein manipulation of the tether allows hoisting, locating or positioning of the soft tissue repair prosthesis,

wherein the expandable device is configured to expand from a reduced profile to an expanded configuration to expand the prosthesis, and

wherein the expandable device is removably engaged in the at least one slit.

13. The hernia repair device of claim 12, wherein the at least one slit includes a plurality of slits, wherein the plurality of slits each have a predetermined size configured to receive a portion of the expandable device to removably connect the prosthesis with the expandable device to position the prosthesis adjacent a hernia defect.

14. The hernia repair device of claim 13, wherein the expandable device includes at least one arm and the at least one slit is configured to receive at least a portion of the arm to removably connect the prosthesis with the expandable device.

15. The hernia repair device of claim 14, wherein an end portion of the at least one arm is non-expandable, and wherein the non-expandable end portion is configured to be passed through the at least one slit.

16. A method of delivering a soft tissue repair prosthesis, comprising:

providing a soft tissue repair prosthesis comprising a mesh fabric configured to be attached to soft tissue by a fixation device and having a plurality of slits therethrough;

removably connecting the soft tissue repair prosthesis with a portion of an expandable device by inserting the portion of the expandable device through at least one slit of the plurality of slits of the soft tissue repair prosthesis;

expanding the expandable device from a reduced profile to an expanded configuration to expand the prosthesis; and

manipulating a tether coupled to the prosthesis at a location separate and distinct from the plurality of slits, wherein manipulation of the tether allows hoisting, locating or positioning of the soft tissue repair prosthesis,

wherein the expandable device is removable from the at least one slit such that the prosthesis is removable from the expandable device without cutting or removing the at least one slit.

17. The method of claim 16, further comprising inserting the prosthesis and the expandable device into an abdominal space.

18. The method of claim 17, further comprising:

positioning the prosthesis around a hernia defect in an abdominal wall;

securing the prosthesis to the abdominal wall; and

detaching the prosthesis and the expandable device.

19. The method of claim 16, further comprising using numeric indicia at an edge of the expandable device for referencing a predetermined location for positioning an edge of a hernia defect relative to the prosthesis such that the prosthesis overlaps the edge of the defect a predetermined distance.