Tissue stapler having a thickness compensator incorporating a hydrophilic agent

• US 9,314,247 B2
• Filed: 06/26/2012
• Issued: 04/19/2016
• Est. Priority Date: 03/28/2012
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Shelton, Frederick E. IV, Bezwada, Rao S., Ortiz, Mark S.
• Primary Examiner(s): Chukwurah, Nathaniel
• Application Number:
  US13/532,820
• Publication Number:
  US 20130256374A1
• Time in Patent Office: 1,393 Days
• Field of Search: 227/175.1, 227/176.1, 227/180.1, 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• 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, resorptive for implantable prostheses A61F2210/0004
• 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 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• 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 2017/00938 : hydrophobic
• 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 2017/07228 : 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 2017/07285 : characterised by its cutter
• 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 2017/2937 : with flexible part
• CPC Class Codes: A61B 2017/320052 : Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2090/0807 : Indication means

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 a hydrophillic 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, wherein said compressible tissue thickness compensator is configured to assume a different compressed height within different said staples, and wherein said compressible thickness compensator comprises a bioabsorbable hydrophilic agent embedded therein,

wherein said compressible tissue thickness compensator comprises a dynamic bioabsorbable hydrophilic agent density configured to adaptively respond to tissue having different thicknesses, wherein said dynamic bioabsorbable hydrophilic agent density comprises an uncompressed hydrophilic agent density when said tissue thickness compensator is in an uncompressed state, wherein said dynamic bioabsorbable hydrophilic agent density comprises a first compressed hydrophilic agent density in a first said staple in response to tissue having a first thickness in said first staple, wherein said dynamic bioabsorbable hydrophilic agent density comprises a second compressed hydrophilic 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 bioabsorbable hydrophilic agent comprises at least one of:

fatty acid esters, triglycerides;

cholesterol, anionic cholesterol, carboxylates, amphoteric surfactants, amino propionic acids, imido propionic acids and quaterized compounds.

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 said bioabsorbable hydrophilic agent comprises a foam comprising a surfactant.

5. The staple cartridge assembly of claim 1, wherein said bioabsorbable hydrophilic agent comprises at least one of:

fatty acid esters, triglycerides;

cholesterol, anionic cholesterol, carboxylates, amphoteric surfactants, amino propionic acids, imido propionic acids and quaterized compounds.

6. 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.

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, wherein said compressible thickness compensator comprises a bioabsorbable hydrophilic agent embedded therein,

wherein said compressible compensation means comprises a dynamic bioabsorbable hydrophilic agent density configured to adaptively respond to tissue having different thicknesses, wherein said dynamic bioabsorbable hydrophilic agent density comprises an uncompressed hydrophilic agent density, wherein said dynamic bioabsorbable hydrophilic agent density comprises a first compressed hydrophilic agent density in a first said staple in response to tissue having a first thickness in said first staple, wherein said dynamic bioabsorbable hydrophilic agent density comprises a second compressed hydrophilic 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 bioabsorbable hydrophilic agent comprises at least one of:

fatty acid esters, triglycerides;

cholesterol, anionic cholesterol, carboxylates, amphoteric surfactants, amino propionic acids, imido propionic acids and quaterized compounds.

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 said bioabsorbable hydrophilic agent comprises a foam comprising a surfactant.

12. 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.

13. 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 a different compressed height within different said staples, wherein said compressible thickness compensator comprises a bioabsorbable hydrophilic agent embedded therein,

wherein said tissue thickness compensation means comprises a dynamic bioabsorbable hydrophilic agent density configured to adaptively respond to tissue having different thicknesses, wherein said dynamic bioabsorbable hydrophilic agent density comprises an initial hydrophilic agent density, wherein said dynamic bioabsorbable hydrophilic agent density comprises a first compressed hydrophilic agent density in a first said staple in response to tissue having a first thickness in said first staple, wherein said dynamic bioabsorbable hydrophilic agent density comprises a second compressed hydrophilic 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.

14. The staple cartridge assembly of claim 13, wherein the first thickness is greater than the second thickness, and wherein said first density is greater than said second density.