Staple cartridge comprising an adjustable distal portion

• US 8,978,954 B2
• Filed: 04/29/2011
• Issued: 03/17/2015
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Shelton, Frederick E. IV, Baxter, Chester O. III, Morgan, Jerome R., Aronhalt, Taylor W., Sidow, Brian R.
• Primary Examiner(s): Lopez, Michelle
• Assistant Examiner(s): CHUKWURAH, NATHANIEL C
• Application Number:
  US13/097,948
• Publication Number:
  US 20120083836A1
• Time in Patent Office: 1,418 Days
• Field of Search: 227/175.1, 227/176.1, 227/178.1, 227/180.1, 227/179.1, 227/19, 606/151, 606/153, 606/219
• US Class Current: 227/175.1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• 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 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00327 : with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00473 : Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00477 : Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00526 : Methods of manufacturing
• CPC Class Codes: A61B 2017/0053 : Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/00818 : Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00862 : elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00884 : enhancing wound closure
• CPC Class Codes: A61B 2017/00893 : pharmaceutically effective
• CPC Class Codes: A61B 2017/00951 : adhesive
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• 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 2017/07214 : Stapler heads
• CPC Class Codes: A61B 2017/07221 : curved
• 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 2017/0725 : with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
• CPC Class Codes: A61B 2017/07257 : characterised by its anvil
• 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 2017/2902 : characterized by features of the actuating rod
• CPC Class Codes: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/291 : the position of the handle being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2916 : pins in guiding slots
• CPC Class Codes: A61B 2017/2919 : details of linkages or pivot points
• CPC Class Codes: A61B 2017/292 : connection of actuating rod to handle, e.g. ball end in recess
• 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 2017/2931 : with releasable head
• CPC Class Codes: A61B 2017/2933 : camming or guiding means
• CPC Class Codes: A61B 2017/2936 : Pins in guiding slots
• CPC Class Codes: A61B 2017/2944 : Translation of jaw members
• CPC Class Codes: A61B 2017/2946 : Locking means
• CPC Class Codes: A61B 2017/320052 : Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2090/034 : abutting on parts of the device itself
• CPC Class Codes: A61B 2090/037 : with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 90/92 : coded with colour
• CPC Class Codes: B25C 5/1686 : using pre-loaded cassettes

Abstract

A fastener cartridge can comprise a support portion, a tissue thickness compensator positioned relative to the support portion, and a plurality of fasteners positioned within the support portion and/or the tissue thickness compensator which can be utilized to fasten tissue. In use, the fastener cartridge can be positioned in a first jaw of a surgical fastening device, wherein a second jaw, or anvil, can be positioned opposite the first jaw. To deploy the fasteners, a staple-deploying member is advanced through the fastener cartridge to move the fasteners toward the anvil. As the fasteners are deployed, the fasteners can capture at least a portion of the tissue thickness compensator therein along with at least a portion of the tissue being fastened.

Claims

1. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein; and

a contact member positioned at said distal end of said cartridge body, wherein said contact member extends above said deck, wherein the anvil of the surgical stapler is configured to abut said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect when subjected to a force less than a collapse threshold, and wherein said contact member is configured to collapse when subjected to a force exceeding said collapse threshold,

wherein a longitudinal axis is defined between said proximal end and said distal end, and wherein said contact member comprises a collapsible column extending in a direction which is transverse to said longitudinal axis.

2. The staple cartridge of claim 1, wherein said contact member comprises a distal tip.

3. The staple cartridge of claim 1, wherein a knife slot is defined between said proximal end and said distal end, and wherein said contact member is a least partially positioned within said knife slot.

4. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said stales and assume different compressed heights therein; and

a contact member positioned at said distal end of said cartridge body, wherein said contact member extends above said deck, wherein the anvil of the surgical stapler is configured to abut said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect when subjected to a force less than a collapse threshold, and wherein said contact member is configured to collapse when subjected to a force exceeding said collapse threshold, wherein said contact member comprises an internal cavity defined by a cavity wall, and wherein said cavity wall is configured to collapse when subjected to a force exceeding said collapse threshold.

5. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of stale cavities defined within said deck, wherein each said stale cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein; and

a contact member positioned at said distal end of said cartridge body, wherein said contact member extends above said deck, wherein the anvil of the surgical stapler is configured to abut said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect when subjected to a force less than a collapse threshold, and wherein said contact member is configured to collapse when subjected to a force exceeding said collapse threshold, wherein said contact member comprises a first internal cavity defined by a first cavity wall, wherein said first cavity wall is configured to collapse when subjected to a first force, wherein said contact member comprises a second internal cavity defined by a second cavity wall, wherein said second cavity wall is configured to collapse when subjected to a second force, and wherein said second force is greater than said first force.

6. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of stales, wherein at least a portion of each said stale is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said stales and assume different compressed heights therein; and

a contact member positioned at said distal end of said cartridge body, wherein said contact member extends above said deck, wherein the anvil of the surgical stapler is configured to abut said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect when subjected to a force less than a collapse threshold, and wherein said contact member is configured to collapse when subjected to a force exceeding said collapse threshold, wherein said contact member comprises a top contact surface and a plurality of deflectable supports, wherein said deflectable supports are positioned underneath said top contact surface, wherein said top contact surface is supported by said deflectable supports when a force below said collapse threshold is applied to said top contact surface, and wherein said deflectable supports are configured to deflect when a force above said collapse threshold is applied to said top contact surface.

7. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights within said staples; and

a contact member positioned at said distal end of said cartridge body, wherein the anvil of the surgical stapler is configured to abut said contact member, wherein said contact member is configured to deflect when subjected to a force less than a collapse threshold, and wherein said contact member is configured to collapse when subjected to a force exceeding said collapse threshold,

wherein a longitudinal axis is defined between said proximal end and said distal end, and wherein said contact member comprises a collapsible cylinder extending in a direction which is transverse to said longitudinal axis.

8. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein; and

a contact member extending above said deck, said contact member positioned at said distal end of said cartridge body, wherein the anvil of the surgical stapler is configured to abut said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect at a first rate when subjected to a force less than a threshold, and wherein said contact member is configured to deflect at a second rate when subjected to a force exceeding said threshold, wherein said second rate is larger than said first rate,

wherein a longitudinal axis is defined between said proximal end and said distal end, and wherein said contact member comprises a collapsible abutment member extending in a direction which is transverse to said longitudinal axis.

9. The staple cartridge of claim 8, wherein said contact member comprises a distal tip.

10. The staple cartridge of claim 8, wherein a knife slot is defined between said proximal end and said distal end, and wherein said contact member is a least partially positioned within said knife slot.

11. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein; and

a contact member extending above said deck, said contact member positioned at said distal end of said cartridge body, wherein the anvil of the surgical stapler is configured to abut said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect at a first rate when subjected to a force less than a threshold, and wherein said contact member is configured to deflect at a second rate when subjected to a force exceeding said threshold, wherein said second rate is larger than said first rate, wherein said contact member comprises an internal cavity defined by a cavity wall, and wherein said cavity wall is configured to collapse when subjected to a force exceeding said threshold.

12. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein; and

a contact member extending above said deck, said contact member positioned at said distal end of said cartridge body, wherein the anvil of the surgical stapler is configured to abut said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect at a first rate when subjected to a force less than a threshold, and wherein said contact member is configured to deflect at a second rate when subjected to a force exceeding said threshold, wherein said second rate is larger than said first rate, wherein said contact member comprises a first internal cavity defined by a first cavity wall, wherein said first cavity wall is configured to collapse when subjected to a first force, wherein said contact member comprises a second internal cavity defined by a second cavity wall, wherein said second cavity wall is configured to collapse when subjected to a second force, and wherein said second force is greater than said first force.

13. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein; and

a contact member extending above said deck, said contact member positioned at said distal end of said cartridge body, wherein the anvil of the surgical stapler is configured to abut said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect at a first rate when subjected to a force less than a threshold, and wherein said contact member is configured to deflect at a second rate when subjected to a force exceeding said threshold, wherein said second rate is larger than said first rate, wherein said contact member comprises a top contact surface and a plurality of deflectable supports, wherein said deflectable supports are positioned underneath said top contact surface, wherein said top contact surface is supported by said deflectable supports when a force below said threshold is applied to said top contact surface, and wherein said deflectable supports are configured to deflect when a force above said threshold is applied to said top contact surface.

14. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights within said staples; and

a contact member positioned at said distal end of said cartridge body, wherein the anvil of the surgical stapler is configured to abut said contact member, wherein said contact member is configured to deflect at a first rate when subjected to a force less than a threshold, and wherein said contact member is configured to deflect at a second rate when subjected to a force exceeding said threshold, wherein said second rate is larger than said first rate,

wherein a longitudinal axis is defined between said proximal end and said distal end, and wherein said contact member comprises a collapsible cylinder extending in a direction which is transverse to said longitudinal axis.

15. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil that clamps into a closed position, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities defined within said deck, wherein each said staple cavity comprises an opening in said deck;

a plurality of staples, wherein at least a portion of each said staple is removably stored within a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein; and

compliant means extending above said deck for limiting the downward movement of the anvil when the anvil is moved into a closed position and for collapsing downwardly when a force exceeding a limiting threshold has been applied to said compliant means by the anvil, wherein a longitudinal axis is defined between said proximal end and said distal end, and wherein said compliant means comprises a collapsible pillar extending in a direction which is transverse to said longitudinal axis.

16. A staple cartridge for treating the tissue of a patient and for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a proximal end;

a distal end;

a longitudinal axis is defined between said proximal end and said distal end;

a deck configured to support the tissue; and

a plurality of staple cavities;

a plurality of staples, wherein said each said staple is at least partially positioned in a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein; and

a cylindrical gap-setting element extending above said deck, wherein the anvil of the surgical stapler is configured to apply a compressive force to said cylindrical gap-setting element when said staples are in said unfired position, wherein said cylindrical gap-setting element is configured to deflect when subjected to a compressive force less than a collapse threshold, and wherein said cylindrical gap-setting element is configured to collapse when subjected to a compressive force exceeding said collapse threshold.

17. A staple cartridge for use with a surgical stapler, wherein the surgical stapler comprises an anvil, and wherein said staple cartridge comprises:

a cartridge body, comprising;

a deck; and

a plurality of staple cavities;

a plurality of staples, wherein each said staple is movable between an unfired position and a fired position;

a layer configured to be captured within said staples; and

a gap element extending above said deck, wherein said gap element comprises a pillar extending substantially transverse to said deck, wherein the anvil of the surgical stapler is configured to apply a compressive force to said gap element when said staples are in said unfired position, wherein said gap element is configured to control the distance between the anvil and said deck, wherein said gap element is configured to deflect when subjected to a compressive force less than a collapse threshold, and wherein said gap element is configured to collapse when subjected to a compressive force exceeding said collapse threshold.

18. An end effector for treating the tissue of a patient and for use with a surgical stapler, said end effector comprising:

a staple cartridge, comprising;

a cartridge body, comprising;

a proximal end;

a distal end;

a longitudinal axis is defined between said proximal end and said distal end;

a deck configured to support the tissue; and

a plurality of staple cavities; and

a plurality of staples removably stored in said staple cavities in an unfired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein;

an anvil configured to deform said staples; and

a contact member positioned intermediate said anvil and said deck of said cartridge body at said distal end of said cartridge body, wherein said anvil is configured to apply a compressive force to said contact member when said staples are in said unfired position, wherein said contact member is configured to deflect when subjected to a compressive force less than a collapse threshold, and wherein said contact member is configured to collapse when subjected to a compressive force exceeding said collapse threshold,

wherein said contact member comprises a collapsible pin extending in a direction which is transverse to said longitudinal axis.

19. An end effector for use with a surgical stapler, said end effector comprising:

a staple cartridge, comprising;

a cartridge body, comprising;

a proximal end;

a distal end;

a longitudinal axis is defined between said proximal end and said distal end;

a deck; and

a plurality of staple cavities; and

a plurality of staples, wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator configured to be captured within said staples;

an anvil, wherein said staples are configured to be deformed against said anvil when said staples are moved into said fired position; and

a gap-setting element disposed above said deck of said cartridge body, wherein said anvil is configured to apply a compressive force to said gap-setting element when said staples are in said unfired position, wherein said gap-setting element is configured to deflect when subjected to a compressive force from said anvil which is less than a collapse threshold, wherein said gap-setting element is configured to collapse when subjected to a compressive force from said anvil which exceeds said collapse threshold, and wherein said gap setting element comprises a collapsible arcuate member extending in a direction which is transverse to said longitudinal axis.

20. An end effector for use with a surgical stapler, said end effector comprising:

a staple cartridge, comprising;

a cartridge body, comprising;

a deck; and

a plurality of staple cavities; and

a plurality of staples, wherein each said staple is movable between an unfired position and a fired position;

a layer configured to be captured within said staples;

an anvil, wherein said staples are configured to be deformed against said anvil when said staples are moved into said fired position; and

a gap element extending above said deck, wherein said gap setting element comprises a collapsible pillar element extending in in a direction substantiall transverse to said deck, wherein said anvil is configured to apply a compressive force to said gap element when said staples are in said unfired position, wherein said gap element is configured to control the distance between said anvil and said deck, wherein said gap element is configured to deflect when subjected to a compressive force less than a collapse threshold, and wherein said gap element is configured to collapse when subjected to a compressive force exceeding said collapse threshold.

21. An end effector for treating the tissue of a patient and for use with a surgical stapler, said end effector comprising:

a staple cartridge, comprising;

a cartridge body, comprising;

a deck configured to support the tissue; and

a plurality of staple cavities; and

a plurality of staples, wherein said each said staple is at least partially positioned in a said staple cavity, and wherein each said staple is movable between an unfired position and a fired position;

a tissue thickness compensator, wherein said tissue thickness compensator is configured to be captured within said staples and assume different compressed heights therein;

an anvil configured to deform said staples; and

a columnar gap-setting element extending intermediate said anvil and said deck of said cartridge body, wherein said anvil is configured to apply a compressive force to said columnar gap-setting element, wherein said columnar gap-setting element is configured to deflect at a first rate when subjected to a compressive force less than a threshold, wherein said columnar gap-setting element is configured to deflect at a second rate when subjected to a compressive force exceeding said threshold, and wherein said second rate is larger than said first rate.

22. An end effector for use with a surgical stapler, said end effector comprising:

a staple cartridge, comprising;

a cartridge body, comprising;

a proximal end;

a distal end;

a deck; and

a plurality of staple cavities; and

a plurality of staples, wherein each said staple is movable between an unfired position and a fired position;

a layer configured to be captured within said staples;

an anvil configured to deform said staples; and

a gap element located above said deck of said staple cartridge and extending substantially transverse thereto, wherein said gap element comprises a pin member, wherein said anvil is configured to apply a compressive force to said gap element, wherein said gap element is configured to set the distance between said anvil and said deck, wherein said gap element is configured to deflect at a first rate when subjected to a compressive force less than a threshold, wherein said gap element is configured to deflect at a second rate when subjected to a compressive force exceeding said threshold, and wherein said second rate is different than said first rate.