Mechanically tuned buttress material to assist with proper formation of surgical element in diseased tissue

• US 20070179528A1
• Filed: 04/21/2006
• Published: 08/02/2007
• Est. Priority Date: 02/02/2006
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Stopek, Joshua, Prommersberger, Megan, Soltz, Michael
• Granted Patent: US 9,629,626 B2
• Time in Patent Office: Days
• US Class Current: 606/219
• 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 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/0807 Indication means

Abstract

An apparatus for supporting tissue during compression prior to the insertion of a surgical element into the tissue has a substrate. The substrate is made from a predetermined material. The predetermined material has a thickness and a predetermined stress strain profile. The predetermined stress strain profile is complementary to a stress strain profile of the tissue and permits the substrate to support the tissue when the surgical element is delivered into the tissue. The substrate provides hemostasis control of the tissue when the surgical element is delivered into the tissue.

Claims

1. A surgical indicator to indicate the proper formation of a surgical element comprising:

a member having a modulating property, wherein the member modulates from a first condition when no stress is applied to another second condition when a stress is applied; and

wherein the modulating property is configured to provide an indication when compressed to a predetermined compression stress level, wherein the predetermined compression stress level indicates an optimal tissue compression of the tissue type, the indication being a tissue state that is optimal for the formation of the surgical element for the predetermined tissue type.

2. The indicator of claim 1, wherein the member is a substrate, and wherein the modulating property is a compartment having a dye, the compartment being made with a tensile strength that is configured to rupture at the predetermined compression stress level to release the dye to provide the indication.

3. The indicator of claim 1, wherein the indication is visual.

4. The indicator of claim 2, wherein the compartment bursts and the indication is audible.

5. The indicator of claim 1, wherein the member is a pressure sensitive film having a color when no stress is applied to the film, and wherein the pressure sensitive film is configured to indicate when compressed to the predetermined compression stress level to indicate the optimal tissue compression of the tissue type.

6. The indicator of claim 1, wherein the surgical element is a staple.

7. The indicator of claim 1, wherein the surgical element is a suture.

8. The indicator of claim 2, wherein the dye is non-toxic, and colors the tissue to another color.

9. The indicator of claim 2, wherein the substrate has the compartment that bursts to release the dye upon being compressed to the predetermined compression stress level, and wherein the dye is contained in the member and is not released on the tissue.

10. The indicator of claim 2, wherein the member has the compartment forming a lumen with a gas in the lumen, the lumen bursting open to release the dye and the gas in the inner lumen upon being compressed to the predetermined compression stress level.

11. An apparatus for determining an optimal amount of tissue compression prior to the insertion of a surgical element into the tissue, comprising:

a substrate being made from a predetermined material, wherein the predetermined material has an initial color when no stress is applied to the substrate, and wherein the predetermined material has second color when a predetermined compression stress is applied to the substrate, the second color indicating the proper time in order to fire a surgical element into tissue.

12. The apparatus of claim 11, wherein the predetermined material is a pressure sensitive film.

13. The apparatus of claim 11, wherein the predetermined material is a pressure sensitive film, and wherein the pressure sensitive film changes color to indicate an area for a staple formation.

14. An apparatus for supporting tissue during compression prior to the insertion of a surgical element into the tissue, comprising:

a substrate being made from a predetermined material, wherein the predetermined material has a thickness and a predetermined modulus of elasticity for a stress strain profile, the predetermined modulus of elasticity being complementary to a modulus of elasticity of the tissue to permit the substrate to support the tissue when the surgical element is delivered into the tissue, the substrate providing hemostasis control of the tissue when the surgical element is delivered into the tissue.

15. The apparatus of claim 14, wherein the predetermined material has a modulus that is more elastic than the tissue.

16. The apparatus of claim 14, wherein the predetermined material has a modular that is less elastic than the tissue.

17. The apparatus of claim 14, wherein the surgical element is a surgical stapler.

18. The apparatus of claim 14, wherein the surgical element is a suture.

19. The apparatus of claim 14, wherein the surgical element is a stapler, and wherein the substrate further comprises a pressure sensitive film, and wherein the pressure sensitive film visually indicates an area for a staple formation.

20. The apparatus of claim 14, wherein the substrate is a polymer.

21. The apparatus of claim 14, wherein the substrate is a modified polymer having a fibers with a degree of cross-linking, the degree being modified to determine the predetermined stress strain profile.

26. The apparatus of claim 14, wherein the substrate has a plurality of layers.

27. The apparatus of claim 14, wherein the substrate is a composite material.

28. The apparatus of claim 14, wherein the substrate is a composite having a first layer with the first layer being a collagen supported by a webbing.

22. A method of determining an optimal amount of compression of tissue to provide an indication to the surgeon of the optimal compression and a time to fire a surgical element into tissue, the method comprising:

applying a pressure sensitive film to tissue, the pressure sensitive film configured to provide an indication when compressed to a predetermined compression stress level, wherein the film is tuned such that the predetermined compression stress level indicates the optimal tissue compression of the tissue type;

compressing the pressure sensitive film and the tissue; and

firing the instrument when the pressure sensitive film provides a visual indication.

23. A method of determining an optimal amount of compression of tissue to provide an indication to the surgeon of the optimal compression and a time to fire a surgical element into tissue, the method comprising:

applying a substrate having a dye filled sac, the sac configured to burst when compressed to a predetermined compression stress level, wherein the sac is configured to yield when the predetermined stress level is the optimal tissue compression of the tissue type;

compressing the substrate together with the tissue; and

firing the instrument when the dye is released from the sac.

24. An apparatus for determining an optimal amount of tissue compression prior to the insertion of a surgical element into the tissue, comprising:

a substrate being made from a predetermined material having a plurality of sacs with each of the plurality of sacs having a reactant, wherein the predetermined material has an initial color when no stress is applied to the substrate, and wherein when a predetermined compression stress is applied to the substrate the sacs rupture to release the reactant, the reactant reacting with the predetermined material to modulate the predetermined material from the initial color to a second color, the second color indicating the proper time in order to fire a surgical element into tissue.

25. An apparatus for determining an optimal amount of tissue compression prior to the insertion of a surgical element into the tissue, comprising:

a substrate being made from a predetermined material having a plurality of crystals, wherein the predetermined material has an initial color when no stress is applied to the substrate, and wherein the predetermined material has second color when a predetermined compression stress is applied to the substrate, the predetermined stress breaking at least one of the plurality of crystals, the broken crystals modulating an optical property of the predetermined material to indicate the proper time in order to fire a surgical element into tissue.