Tissue thickness compensators

• US 9,220,501 B2
• Filed: 03/28/2012
• Issued: 12/29/2015
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Baxter, Chester O. III, Shelton, Frederick E. IV, Schmid, Katherine J., Aronhalt, Taylor W., Johnson, Gregory W., Stammen, John L., Knight, Gary W., Widenhouse, Christopher W., Weisenburgh, William B. II, Mutchler, Stephanie A., Bedard, Timothy S.
• Primary Examiner(s): Smith, Scott A.
• Application Number:
  US13/433,167
• Publication Number:
  US 20120241503A1
• Time in Patent Office: 1,371 Days
• Field of Search: 227/19, 227/175.1, 227/176.1, 227/178.1, 227/180.1, 606/139, 606/153, 606/219
• US Class Current: 1/1
• 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 and a plurality of staples positioned within said staple cavities;

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, wherein said first tissue thickness compensator comprises a first thickness and a first portion comprising a first uncompressed height; and

a second tissue thickness compensator removably attached to said anvil, wherein said second tissue thickness compensator comprises a second thickness and a second portion comprising a second uncompressed height, wherein said second uncompressed height is greater than said first uncompressed height, 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, wherein said first portion and said second portion are configured to be captured within the same staple, 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 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.

3. The surgical stapler of claim 2, 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.

4. The surgical stapler of claim 3, 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.

5. 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.

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

7. 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.

8. 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.

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

10. 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 and a plurality of staples positioned within said staple cavities, 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;

a first tissue thickness compensator positioned relative to said cartridge body, wherein said first tissue thickness compensator comprises a first portion comprising a first uncompressed height; and

a second tissue thickness compensator configured to be positioned relative to the anvil, wherein said second tissue thickness compensator comprises a second portion comprising a second uncompressed height, wherein said second uncompressed height is greater than said first uncompressed height, 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 portion and said second portion are configured to be captured within the same staple, 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.

11. The staple cartridge of claim 10, wherein said cartridge body further comprises a deck, wherein said staple cavities are defined in said deck, and wherein said first tissue thickness compensator is positioned over said deck.

12. The staple cartridge of claim 10, wherein said second tissue thickness compensator is hingedly attached to said first tissue thickness compensator.

13. The staple cartridge of claim 10, wherein said second tissue thickness compensator further comprises an engagement feature configured to engage an engagement feature on the anvil.

14. The staple cartridge of claim 10, wherein said first tissue thickness compensator comprises wings extending from a surface, and wherein said wings are configured to engage sides of the anvil.

15. The staple cartridge of claim 10, further comprising an adhesive configured to removably adhere said second tissue thickness compensator to said anvil.

16. The staple cartridge of claim 10, 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.

17. The staple cartridge of claim 10, wherein said second direction of said second biasing force is opposite said first direction of said first biasing force.

18. 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;

first tissue thickness compensation means for compressing a portion of the tissue clamped by the clamping means; and

second tissue thickness compensation means for compressing the portion of the tissue;

wherein an uncompressed thickness of said second tissue thickness compensation means is greater than an uncompressed thickness of said first tissue thickness compensation means, wherein a combined thickness of the clamped tissue, said first tissue thickness compensation means, and said second tissue thickness compensation means is substantially constant, and wherein said second tissue thickness compensation means is disposed intermediate the tissue and said clamping means.

19. A surgical end effector, comprising:

a plurality of staples;

a fixed jaw comprising a first layer, wherein said first layer comprises a first portion comprising a first uncompressed thickness; and

a movable jaw configured to move between an open orientation and a closed orientation relative to said fixed jaw, wherein said movable jaw comprises a second layer, wherein said second layer comprises a second portion comprising a second uncompressed thickness, wherein said second portion is aligned with said first portion when said movable jaw is in said closed orientation, and wherein said second uncompressed thickness is greater than said first uncompressed thickness;

wherein said first layer and said second layer 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.