Seal element for anastomosis

• US 20060085030A1
• Filed: 09/28/2005
• Published: 04/20/2006
• Est. Priority Date: 10/15/2004
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Fowler, David, Kennedy, John, Criscuolo, Christopher J., Bettuchi, Michael J., Hadba, Ahmad Robert
• Granted Patent: US 8,372,094 B2
• Time in Patent Office: Days
• US Class Current: 606/214
• 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 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1152 applying the staples on the outside of the lumen
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/07214 Stapler heads

Abstract

A seal element for sealing between tissue lumens includes a first material for allowing tissue ingrowth and a second sealant material.

Claims

1. A seal element for positioning between tubular sections of tissue to be joined, the seal element comprising:

a first material that promotes tissue ingrowth; and

a second material comprising a sealant at least partially surrounding the first material.

2. The seal element of claim 1 wherein the first material is a porous material.

3. The seal element of claim 1 wherein the first material is selected from the group consisting of a foam, a mesh, a non-woven structure, a perforated sheet and combinations thereof.

4. The seal element of claim 1 wherein the first material is selected from the group consisting of glycolide, lactide, caprolactone, trimethylene carbonate, dioxanone, polyalkylene oxides, and combinations thereof

5. The seal element of claim 1 wherein the first material comprises a porous material having pores ranging in size from about 50 μ

m to about 200 μ

m.

6. The seal element of claim 1 wherein the first material has a thickness ranging from about 0.010 inches to about 0.020 inches.

7. The seal element of claim 1 wherein the second material is compressible.

8. The seal element of claim 1 wherein the second material is expandable.

9. The seal element of claim 1 wherein the second material is a hydrophilic material.

10. The seal element of claim 1 wherein the second material is derived from a monomer selected from the group consisting of methacrylic acid, acrylic acid, n-vinyl pyrrolidone, potassium sulfopropyl acrylate, potassium sulfopropyl methacrylate, acrylamide, dimethylacrylamide, 2-methacryloyloxyethyl phosphorylcholine, hydroxethylmethacrylate, 2-hydroxyethyl methacrylate and combinations thereof.

11. The seal element of claim 1 wherein the second material is poly(2-hydroxyethyl methacrylate).

12. The seal element of claim 1 wherein the second material comprises a surface having a pattern formed thereon.

13. The seal element of claim 1 wherein at least one of the first or second materials further comprises at least one medically useful substance.

14. The seal element of claim 13 wherein the at least one medically useful substance is selected from the group consisting of drugs, enzymes, growth factors, peptides, proteins, dyes, diagnostic agents, hemostasis agents, antimicrobials, antibiotics, anti-fungals, anti-virals, monoclonal antibodies, polyclonal antibodies, antimicrobial proteins/peptides, enzymes, gene therapy, viral particles, chemotherapeutics, anti-inflammatories, NSAIDS, steroids, telomerase inhibitors, growth factors, extracellular matrix molecules, cell adhesion molecules, polysaccharides and combinations thereof.

15. The seal element of claim 1 further comprising a generally centrally located aperture.

16. An assembly for disposing a seal element between tissue lumens comprising:

a circular surgical stapling device comprising an anvil assembly and a tubular body portion wherein the anvil assembly comprises an anvil member and a first shaft and the tubular body portion comprises a plurality of surgical staples in a circular configuration and a second shaft disposed inwardly of the surgical staples, the first shaft being attachable to the second shaft; and

a seal element comprising a first material and a second material wherein the first material promotes tissue ingrowth and the second material comprises a sealant.

17. The assembly of claim 16 wherein the first material is a porous material.

18. The assembly of claim 17 wherein the first material is selected from the group consisting of a foam, a mesh, a non-woven structure, a perforated sheet and combinations thereof.

19. The assembly of claim 17 wherein the first material is selected from the group consisting of glycolide, lactide, caprolactone, trimethylene carbonate, dioxanone, polyalkylene oxides, and combinations thereof

20. The assembly of claim 17 wherein the first material comprises a porous material having pores ranging in size from about 50 μ

m to about 200 μ

m.

21. The assembly of claim 17 wherein the first material has a thickness ranging from about 0.010 inches to about 0.020 inches.

22. The assembly of claim 17 wherein the second material is compressible.

23. The assembly of claim 17 wherein the second material is expandable.

24. The assembly of claim 17 wherein the second material is a hydrophilic material.

25. The assembly of claim 17 wherein the second material is derived from a monomer selected from the group consisting of methacrylic acid, acrylic acid, n-vinyl pyrrolidone, potassium sulfopropyl acrylate, potassium sulfopropyl methacrylate, acrylamide, dimethylacrylamide, 2-methacryloyloxyethyl phosphorylcholine, hydroxethylmethacrylate, 2-hydroxyethyl methacrylate and combinations thereof.

26. The assembly of claim 17 wherein the second material is poly(2-hydroxyethyl methacrylate)

27. The assembly of claim 17 wherein the second material comprises a surface having a pattern formed thereon.

28. The assembly of claim 17 wherein at least one of the first or second materials further comprises at least one medically useful substance.

29. The assembly of claim 28 wherein the at least one medically useful substance is selected from the group consisting of drugs, enzymes, growth factors, peptides, proteins, dyes, diagnostic agents, hemostasis agents, antimicrobials, antibiotics, anti-fungals, anti-virals, monoclonal antibodies, polyclonal antibodies, antimicrobial proteins/peptides, enzymes, gene therapy, viral particles, chemotherapeutics, anti-inflammatories, NSAIDS, steroids, telomerase inhibitors, growth factors, extracellular matrix molecules, cell adhesion molecules, polysaccharides and combinations thereof.

30. The assembly of claim 17 further comprising a generally centrally located aperture.

31. A method of disposing a seal element between adjacent tubular tissues to be joined, the method comprising:

providing a circular surgical anastomosis device, the circular surgical anastomosis device including;

an anvil assembly having an anvil member and a first shaft; and

a tubular body portion having an annular knife operatively disposed therein and a second shaft disposed radially inward of the annular knife, the first shaft of the anvil assembly being selectively attachable to the second shaft of the tubular body;

inserting the anvil assembly into a first tubular tissue;

inserting the tubular body portion into a second tubular tissue;

disposing a support structure between the first tubular tissue and the second tubular tissue, the seal element comprising a first material and a second material wherein the first material promotes tissue ingrowth and the second material comprises a sealant;

approximating the anvil assembly and tubular body portion with one another so that an end portion of the first tubular tissue, the support structure, and an end portion of the second tubular tissue are disposed between the anvil member and the tubular body portion, the seal element being disposed between the first tubular tissue and the second tubular tissue;

firing the surgical anastomosis device to sever the portions of the first and second tubular tissues disposed radially inward of the annular knife, and to touch the portions of the first and second tubular tissues radially outward of the annular knife against the structure to thereby secure the seal element between the first and second tubular tissues.