Tissue thickness compensators

• US 9,833,242 B2
• Filed: 12/28/2015
• Issued: 12/05/2017
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Baxter, III, Chester O., Shelton, IV, Frederick E., Schmid, Katherine J., Aronhalt, Taylor W., Johnson, Gregory W., Stammen, John L., Knight, Gary W., Widenhouse, Christopher W., Weisenburgh, II, William B., Mutchler, Stephanie A., Bedard, Timothy S.
• Primary Examiner(s): Smith, Scott A.
• Application Number:
  US14/980,239
• Publication Number:
  US 20160220254A1
• Time in Patent Office: 708 Days
• Field of Search: 227 19, 2271751, 2271761, 2271781, 2271801, 606139, 606153, 606151, 606219
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• 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 17/0686 having a forming anvil staying below the tissue during stapling
• 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 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00951 adhesive
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0688 Packages or dispensers for surgical staplers
• CPC Class Codes: A61B 2017/07228 Arrangement of the staples
• 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 2017/07264 : characterised by its staple forming cavities, e.g. geometry or material
• CPC Class Codes: A61B 2017/07271 : characterised by its cartridge
• CPC Class Codes: A61B 2017/07278 : characterised by its sled or its staple holder
• CPC Class Codes: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2919 : details of linkages or pivot points
• CPC Class Codes: A61B 2017/2923 : Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2933 : camming or guiding means
• CPC Class Codes: A61B 2017/2936 : Pins in guiding slots
• CPC Class Codes: A61B 2017/320052 : Guides for cutting instruments

Abstract

A two-part tissue thickness compensator assembly can include a first tissue thickness compensator configured to be positioned relative to an anvil of a surgical stapler, a second tissue thickness compensator configured to be positioned relative to a staple cartridge of the surgical stapler, and a hinge connecting the first tissue thickness compensator to the second tissue thickness compensator. The first and/or second tissue thickness compensators may include additional engagement features, such as a raised ridge that engages a slot in the anvil and/or the staple cartridge. In certain embodiments, the first and/or second tissue thickness compensators may include an encasement that contains a suitable biologic agent. An end effector assembly may be provided for attachment to a surgical instrument that includes, for example, a staple cartridge, an anvil, a first tissue thickness compensator positioned on the anvil, and a second tissue thickness compensator positioned on the staple cartridge.

Claims

1. A surgical stapler, comprising:

a staple cartridge comprising a cartridge body comprising a plurality of staple cavities, a plurality of staples positioned within said staple cavities, and a stepped deck surface, wherein said staple cavities are defined in said stepped deck surface;

an anvil configured for a facing relationship with said cartridge body, said anvil comprising at least one staple forming surface;

a first tissue thickness compensator removably attached to said cartridge body over said stepped deck surface, wherein said first tissue thickness compensator comprises a stepped bottom surface that substantially matches said stepped deck surface, and wherein said first tissue thickness compensator comprises a first thickness; and

a second tissue thickness compensator removably attached to said anvil, wherein said second tissue thickness compensator comprises a second thickness, wherein said first and second tissue thickness compensators are configured to be captured within said staples and assume different compressed heights within different said staples, and wherein the sum of said first thickness and said second thickness is at least equal to a minimum thickness which provides adequate tissue thickness compensation within said staples.

2. The surgical stapler of claim 1, wherein said first tissue thickness compensator defines a first uncompressed height and said second tissue thickness compensator defines a second uncompressed height, and wherein said first uncompressed height is equal to said second uncompressed height.

3. The surgical stapler of claim 1, wherein said first tissue thickness compensator defines a first uncompressed height and said second tissue thickness compensator defines a second uncompressed height, and wherein said first uncompressed height is greater than said second uncompressed height.

4. The surgical stapler of claim 1, wherein said first tissue thickness compensator defines a first uncompressed height and said second tissue thickness compensator defines a second uncompressed height, and wherein said second uncompressed height is greater than said first uncompressed height.

5. The surgical stapler of claim 1, wherein said anvil comprises a first engagement feature, wherein said second tissue thickness compensator further comprises a second engagement feature, and wherein said first engagement feature and said second engagement feature are configured to releasably engage with each other.

6. The surgical stapler of claim 5, wherein said first engagement feature comprises a protrusion, wherein said second engagement feature comprises a recess, and wherein said protrusion is configured to engage said recess.

7. The surgical stapler of claim 6, wherein said protrusion comprises at least one lip, wherein said recess comprises at least one slot, and wherein said lip is configured to engage said slot.

8. The surgical stapler of claim 1, wherein said first tissue thickness compensator comprises wings extending from a surface, wherein said anvil defines sides, and wherein said wings are configured to engage said sides of said anvil.

9. The surgical stapler of claim 1, further comprising an adhesive configured to removably adhere said second tissue thickness compensator to said anvil.

10. The surgical stapler of claim 1, wherein said first tissue thickness compensator comprises a foam encased by a film, wherein said foam comprises at least one of an anti-microbial gel and a biologic liquid.

11. The surgical stapler of claim 1, wherein said second tissue thickness compensator comprises a foam encased by a film, wherein the foam comprises at least one of an anti-microbial gel and a biologic liquid.

12. The surgical stapler of claim 1, wherein said second tissue thickness compensator is hingedly attached to said first tissue thickness compensator.

13. A staple cartridge for a surgical stapler wherein said surgical stapler includes an anvil, said staple cartridge comprising:

a cartridge body comprising a plurality of staple cavities, a plurality of staples positioned within said staple cavities, and a stepped deck surface, wherein said staple cavities are defined in said stepped deck surface, and wherein said cartridge body is configured to be positioned in a surgical stapler in a facing relationship with the anvil of the surgical stapler, and wherein each said staple defines a tissue compression area; and

a first tissue thickness compensator positioned relative to said cartridge body over said stepped deck surface, wherein said first tissue thickness compensator comprises a stepped bottom surface that substantially matches said stepped deck surface; and

a second tissue thickness compensator configured to be positioned relative to the anvil, wherein said first and second tissue thickness compensators are configured to be captured within said staples and to assume different compressed heights within different said staples, wherein said first tissue thickness compensator is configured to apply a first biasing force to tissue captured within said staples in a first direction, and wherein said second tissue thickness compensator is configured to apply a second biasing force to the tissue captured within said staples in a second direction.

14. The staple cartridge of claim 13, wherein said second tissue thickness compensator is hingedly attached to said first tissue thickness compensator.

15. The staple cartridge of claim 13, wherein said first tissue thickness compensator defines a first uncompressed height and said second tissue thickness compensator defines a second uncompressed height, and wherein said first uncompressed height is equal to said second uncompressed height.

16. The staple cartridge of claim 13, wherein said first tissue thickness compensator defines a first uncompressed height and said second tissue thickness compensator defines a second uncompressed height, and wherein said first uncompressed height is different than said second uncompressed height.

17. The staple cartridge of claim 13, wherein said second tissue thickness compensator further comprises an engagement feature configured to engage an engagement feature on the anvil.

18. The staple cartridge of claim 13, wherein said first tissue thickness compensator comprises wings extending from a surface, and wherein said wings are configured to engage sides of the anvil.

19. The staple cartridge of claim 13, further comprising an adhesive configured to removably adhere said second tissue thickness compensator to said anvil.

20. The staple cartridge of claim 13, wherein said first tissue thickness compensator comprises a foam encased by a film, wherein said foam comprises at least one of an anti-microbial gel and a biologic liquid.

21. The staple cartridge of claim 13, wherein said second direction of said second biasing force is opposite said first direction of said first biasing force.

22. A surgical stapler, comprising:

clamping means for clamping tissue within a body cavity of a patient;

stapling means for stapling the tissue clamped by the clamping means, the stapling means comprising a stepped deck surface; and

tissue thickness compensation means for compressing the tissue clamped by the clamping means such that a combined thickness of the clamped tissue and the tissue thickness compensation means is substantially constant, wherein the tissue thickness compensation means is disposed intermediate the tissue and said clamping means.