IMPLANTABLE ADJUNCT COMPRISING BONDED LAYERS

• US 20170086838A1
• Filed: 09/30/2015
• Published: 03/30/2017
• Est. Priority Date: 09/30/2015
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Harris, Jason L., Shelton, Frederick E. IV, Vendely, Michael J., Morgan, Jerome R., Jamiolkowski, Dennis D., Zeiner, Mark S.
• Granted Patent: US 10,980,539 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00955 thermoplastic
• CPC Class Codes: A61B 2017/00964 composite
• CPC Class Codes: A61B 2017/07235 containing different staples, e.g. staples of different shapes, sizes or materials
• CPC Class Codes: A61B 2017/07242 achieving different staple heights during the same shot, e.g. using an anvil anvil having different heights or staples of different sizes
• CPC Class Codes: A61B 2017/07271 characterised by its cartridge
• CPC Class Codes: A61B 2017/07278 characterised by its sled or its staple holder

Abstract

A staple cartridge assembly comprising an implantable adjunct or layer assembly is disclosed. The implantable adjunct comprises a plurality of layers, wherein at least one of the layers has been melted to bond with one or more of the other layers of the implantable adjunct.

Claims

1. A staple cartridge assembly, comprising:

a cartridge body comprising a deck;

staples removably stored in said cartridge body; and

an implantable adjunct positioned over said deck, comprising;

a first outer layer comprised of interwoven fibers;

a second outer layer comprised of interwoven fibers; and

a bonding layer positioned intermediate said first outer layer and said second outer layer, wherein said bonding layer is comprised of a meltable material having a threshold melt temperature, and wherein said adjunct has previously been exposed to a temperature in excess of said threshold melt temperature such that said bonding layer is bonded with said first outer layer and said second outer layer.

2. The staple cartridge assembly of claim 1, wherein said interwoven fibers of said first outer layer are comprised of a first material having a first melt temperature which is greater than said threshold melt temperature, and wherein said interwoven fibers of said first outer layer have not been melted.

3. The staple cartridge assembly of claim 2, wherein said interwoven fibers of said second outer layer are comprised of a second material having a second melt temperature which is different than said first melt temperature and greater than said threshold melt temperature, and wherein said interwoven fibers of said second outer layer have not been melted.

4. The staple cartridge assembly of claim 1, wherein said bonding layer comprises a first bonding layer, and wherein said adjunct further comprises:

a spacer layer comprised of a material having a melt temperature which is greater than said threshold melt temperature; and

a second bonding layer comprised of said meltable material, wherein said first bonding layer is positioned intermediate said first outer layer and said spacer layer, and wherein said second bonding layer is positioned intermediate said second outer layer and said spacer layer.

5. The staple cartridge assembly of claim 4, wherein said spacer layer comprises a plurality of openings defined therein which are configured to receive melted portions of said first bonding layer and said second bonding layer when said adjunct is exposed to a temperature in excess of said threshold melt temperature.

6. The staple cartridge assembly of claim 5, wherein melted portions of said first bonding layer has penetrated said first outside layer, and wherein melted portions of said second bonding layer has penetrated said second outside layer.

7. The staple cartridge assembly of claim 5, wherein said plurality of openings are arranged in a first density in a first portion of said spacer layer and a second density in a second portion of said spacer layer, wherein said first density is greater than said second density, and wherein the bond between said first portion and said bonding layers is stronger than the bond between said second portion and said bonding layers.

8. The staple cartridge assembly of claim 4, wherein said spacer layer comprises a lofted weave.

9. The staple cartridge assembly of claim 1, wherein said bonding layer comprises a PDS film.

10. The staple cartridge assembly of claim 1, wherein said bonding layer comprises apertures defined therein.

11. The staple cartridge assembly of claim 1, wherein said bonding layer has penetrated said first outside layer and said second outside layer.

12. The staple cartridge assembly of claim 1, wherein said first outside layer and said second outside layer include meltable portions which are comprised of said meltable material, and wherein said meltable portions of said first outside layer and said second outside layer are merged with said bonding layer after said adjunct is exposed to a temperature in excess of said threshold melt temperature.

13. A staple cartridge assembly, comprising:

a cartridge body comprising a deck;

staples removably stored in said cartridge body; and

an implantable layer assembly positioned over said deck, comprising;

a first layer;

a second layer; and

a bonding layer positioned intermediate said first layer and said second layer, wherein said bonding layer is comprised of a meltable material having a threshold melt temperature, and wherein said implantable layer assembly has been previously exposed to a temperature at least equaling said threshold melt temperature such that said bonding layer is bonded with at least one of said first layer and said second layer.

14. The staple cartridge assembly of claim 13, wherein said bonding layer is mechanically bonded to said first layer and said second layer.

15. The staple cartridge assembly of claim 13, wherein said interwoven fibers of said first layer are comprised of a first material having a first melt temperature which is greater than said threshold melt temperature, and wherein said interwoven fibers of said first layer have not been melted.

16. The staple cartridge assembly of claim 15, wherein said interwoven fibers of said second layer are comprised of a second material having a second melt temperature which is different than said first melt temperature and greater than said threshold melt temperature, and wherein said interwoven fibers of said second layer have not been melted.

17. The staple cartridge assembly of claim 13, wherein said bonding layer comprises a first bonding layer, and wherein said implantable layer assembly further comprises:

a spacer layer comprised of a material having a melt temperature which is greater than said threshold melt temperature; and

a second bonding layer comprised of said meltable material, wherein said first bonding layer is positioned intermediate said first layer and said spacer layer, and wherein said second bonding layer is positioned intermediate said second layer and said spacer layer.

18. The staple cartridge assembly of claim 17, wherein said spacer layer comprises a plurality of openings defined therein which are configured to receive melted portions of said first bonding layer and said second bonding layer when said adjunct is exposed to a temperature that at least equals said threshold melt temperature.

19. The staple cartridge assembly of claim 18, wherein said plurality of openings are arranged in a first density in a first portion of said spacer layer and a second density in a second portion of said spacer layer, wherein said first density is greater than said second density, and wherein a bond between said first portion and said bonding layers is stronger than a bond between said second portion and said bonding layers.

20. The staple cartridge assembly of claim 17, wherein melted portions of said first bonding layer has penetrated said first layer, and wherein melted portions of said second bonding layer has penetrated said second layer.

21. A method of manufacturing a staple cartridge assembly, comprising the steps of:

obtaining a first layer, a second layer, and a bonding layer;

positioning said bonding layer intermediate said first layer and said second layer;

heating said bonding layer to a temperature which at least partially melts said bonding layer;

obtaining a cartridge body;

positioning staples in the cartridge body; and

attaching the first layer, the second layer, and the bonding layer to the cartridge body.

22. The method of claim 21, wherein said heating step does not melt said first layer and said second layer.