Tissue stapler having a thickness compensator incorporating an oxygen generating agent

• US 9,320,518 B2
• Filed: 06/25/2012
• Issued: 04/26/2016
• 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: Henderson, Cortney E., Aronhalt, Taylor W., Yang, Chunlin, Scheib, Charles J., Mandakolathur Vasudevan, Venkataramanan, Yoo, Andrew C., Shelton, Frederick E. IV
• Primary Examiner(s): Chukwurah, Nathaniel
• Application Number:
  US13/531,623
• Publication Number:
  US 20120318843A1
• Time in Patent Office: 1,401 Days
• Field of Search: 227/175.1, 227/176.1, 227/179.1, 606/151, 604/304
• US Class Current: 1/1
• 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 17/072 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 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 2017/00327 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 2017/00495 for two-component glue
• 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 2017/00889 : antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00893 : pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 : expandable upon contact with fluid
• CPC Class Codes: A61B 2017/00942 : hydrophilic
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• 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 2017/07285 : characterised by its cutter
• 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 2017/2919 : 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 2017/2946 : Locking means
• CPC Class Codes: A61B 2017/320052 : Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2050/3008 : having multiple compartments
• CPC Class Codes: A61B 2050/314 : Flexible bags or pouches
• CPC Class Codes: A61B 2090/037 : with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/0801 : Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 2090/0807 : Indication means
• 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 2090/0814 : Preventing re-use
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 90/92 : coded with colour

Abstract

A staple cartridge assembly for use with a surgical stapler. The assembly has a cartridge body having a support portion with a plurality of staple cavities with openings. There is also a plurality of staples, wherein at least a portion of each the staple is removably stored within a the staple cavity. Each the staple is movable between an unfired position and a fired position, and is deformable between an unfired configuration and a fired configuration. The assembly also includes a compressible tissue thickness compensator configured to be captured within the staples. The compressible tissue thickness compensator at least partially covers the staple cavity openings. The compressed tissue thickness compensator is configured to assume different compressed heights within different the staples. The compressible tissue thickness compensator comprising a lyophilized foam having an oxygen generating agent embedded therein.

Claims

1. A staple cartridge assembly for use with a surgical stapler, wherein said staple cartridge assembly is adapted to be used with tissue having a thickness, said staple cartridge assembly comprising:

a cartridge body comprising a support portion, wherein said support portion comprises a plurality of staple cavities, and wherein each said staple cavity comprises an opening;

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

a compressible tissue thickness compensator configured to be captured within said staples, wherein said compressible tissue thickness compensator at least partially covers said staple cavity openings, wherein said support portion is configured to support said compressible tissue thickness compensator, and wherein said compressible tissue thickness compensator is configured to assume a different compressed height within different said staples, said compressible tissue thickness compensator comprising a lyophilized foam including an oxygen generating agent embedded therein,

wherein said compressible tissue thickness compensator comprises a dynamic oxygen generating agent density configured to adaptively respond to tissue having different thicknesses, wherein said dynamic oxygen generating agent comprises an uncompressed oxygen generating agent density when said compressible tissue thickness compensator is in an uncompressed state, wherein said dynamic oxygen generating agent comprises a first compressed oxygen generating agent density in a first said staple in response to tissue having a first thickness in said first staple, wherein said dynamic oxygen generating agent comprises a second compressed oxygen generating agent density in a said second staple in response to tissue having a second thickness in said second staple, wherein the first thickness is different than the second thickness, and wherein said first density is different than said second density.

2. The staple cartridge assembly of claim 1, wherein said oxygen generating agent comprises at least one of:

percarbonate and ascorbic acid phosphate.

3. The staple cartridge assembly of claim 1, wherein said compressible tissue thickness compensator comprises an uncompressed thickness which is thicker than the thickness of said tissue.

4. The staple cartridge assembly of claim 1, wherein the first thickness is greater than the second thickness, and wherein said first density is greater than said second density.

5. The staple cartridge assembly of claim 1, wherein said compressible tissue thickness compensator comprising said lyophilized foam including said oxygen generating agent embedded therein comprises a first oxygen generating agent release rate and a second oxygen generating agent release rate.

6. The staple cartridge assembly of claim 5, wherein said first rate comprises a rapid release rate, and wherein said second release rate comprises a sustained release rate.

7. A staple cartridge assembly for use with a surgical stapler, wherein said staple cartridge assembly is adapted to be used with tissue having a thickness within a range of tissue thicknesses, said staple cartridge assembly comprising:

a cartridge body comprising a support portion, wherein said support portion comprises a plurality of staple cavities, and wherein each said staple cavity comprises an opening;

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

a base; and

at least one leg extending from said base, wherein said at least one leg is deformable to capture said tissue between said at least one leg and said base when each said staple is deformed between said unfired configuration and said fired configuration; and

compressible compensation means for dynamically biasing said tissue against at least one of said leg and said base, wherein said compressible compensation means is configured to dynamically assume a different compressed height within different said staples, said compressible compensation means comprising a lyophilized foam including an oxygen generating agent embedded therein,

wherein said compressible compensation means comprises a dynamic oxygen generating agent density configured to adaptively respond to tissue having different thicknesses, wherein said dynamic oxygen generating agent density comprises an uncompressed oxygen generating agent density, wherein said dynamic oxygen generating agent density comprises a first compressed oxygen generating agent density in a first said staple in response to tissue having a first thickness in said first staple, wherein said dynamic oxygen generating agent density comprises a second compressed oxygen generating agent density in a second said staple in response to tissue having a second thickness in said second staple, wherein the first thickness is different than the second thickness, and wherein said first density is different than said second density.

8. The staple cartridge assembly of claim 7, wherein said oxygen generating agent comprises at least one of:

percarbonate and ascorbic acid phosphate.

9. The staple cartridge assembly of claim 7, wherein said compressible compensation means removably covers said staple cavity openings.

10. The staple cartridge assembly of claim 7, wherein said compressible compensation means comprises an uncompressed thickness which is thicker than the thickness of said tissue.

11. The staple cartridge assembly of claim 7, wherein the first thickness is greater than the second thickness, and wherein said first density is greater than said second density.

12. The staple cartridge assembly of claim 7, wherein said compressible compensation means comprising said lyophilized foam including said oxygen generating agent embedded therein comprises a first oxygen generating agent release rate and a second oxygen generating agent release rate.

13. The staple cartridge assembly of claim 12, wherein said first rate comprises a rapid release rate, and wherein said second release rate comprises a sustained release rate.

14. A staple cartridge assembly for use with a surgical stapler, wherein said staple cartridge assembly is adapted to be used with tissue having a thickness within a range of tissue thicknesses, said staple cartridge assembly comprising:

a cartridge body comprising a support portion, wherein said support portion comprises a plurality of staple cavities, and wherein each said staple cavity comprises an opening;

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

a base; and

at least one leg extending from said base, wherein said at least one leg is deformable to capture said tissue between said at least one leg and said base when each said staple is deformed between said unfired configuration and said fired configuration, wherein each said staple defines a deformed height in said fired configuration, and wherein said deformed height of at least some of said staples is larger than said tissue thickness whereby a gap distance is defined between said tissue and a portion of each said staple; and

tissue thickness compensation means for resiliently filling each said gap distance, wherein said tissue thickness compensation means is configured to resiliently assume different compressed heights within different said staples, said tissue thickness compensation means comprising a lyophilized foam including an oxygen generating agent embedded therein,

wherein said tissue thickness compensation means comprises a dynamic oxygen generating agent density configured to adaptively respond to tissue having different thicknesses, wherein said dynamic oxygen generating agent density comprises an initial oxygen generating agent density, wherein said dynamic oxygen generating agent density comprises a first compressed oxygen generating agent density in a first said staple in response to tissue having a first thickness in said first staple, wherein said dynamic oxygen generating agent density comprises a second compressed oxygen generating agent density in a second said staple in response to tissue having a second thickness in said second staple, wherein the first thickness is different than the second thickness, and wherein said first density is different than said second density.

15. The staple cartridge assembly of claim 14, wherein said oxygen generating agent comprises at least one of:

percarbonate and ascorbic acid phosphate.

16. The staple cartridge assembly of claim 14, wherein said tissue thickness compensation means removably covers said staple cavity openings.

17. The staple cartridge assembly of claim 14, wherein said tissue thickness compensation means comprises an uncompressed thickness which is thicker than the thickness of said tissue.

18. The staple cartridge assembly of claim 14, wherein the first thickness is greater than the second thickness, and wherein said first density is greater than said second density.

19. The staple cartridge assembly of claim 14, wherein said tissue thickness compensation means comprising said lyophilized foam including said oxygen generating agent embedded therein comprises a first oxygen generating agent release rate and a second oxygen generating agent release rate.

20. The staple cartridge assembly of claim 19, wherein said first rate comprises a rapid release rate, and wherein said second release rate comprises a sustained release rate.