Implantable layers and methods for modifying the shape of the implantable layers for use with a surgical fastening instrument

• US 9,839,423 B2
• Filed: 02/24/2014
• Issued: 12/12/2017
• Est. Priority Date: 02/24/2014
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Vendely, Michael J., Timmer, Mark D., Donners, Jackie J., Reynolds, II, Donald L., Aronhalt, Taylor W., Barton, Trevor J.
• Primary Examiner(s): Long, Robert
• Application Number:
  US14/187,390
• Publication Number:
  US 20150238188A1
• Time in Patent Office: 1,387 Days
• Field of Search: 2271751-1821
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0688 Packages or dispensers for surgical staplers
• 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 2017/07257 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: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: B29C 43/00 Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor by liberation of internal stresses B29C61/006
• CPC Class Codes: B29C 43/52 : Heating or cooling
• CPC Class Codes: B29C 55/00 : Shaping by stretching, e.g. drawing through a die; Apparatus therefor B29C61/08 takes precedence
• CPC Class Codes: B29C 67/20 : for porous or cellular articles, e.g. of foam plastics, coarse-pored chemical aspects of working up macro-molecular substances to porous or cellular articles C08J9/00
• CPC Class Codes: B29K 2105/04 : cellular or porous
• CPC Class Codes: B29K 2995/0056 : Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/7546 : Surgical equipment

Abstract

A method is disclosed for altering an implantable layer for use with a surgical instrument which includes the steps of obtaining an implantable layer comprised at least partially from a material including a glass transition temperature and a melting temperature, wherein the implantable layer includes a first shape, heating the material to a temperature higher than the glass transition temperature and lower than the melting temperature, manipulating the implantable layer to a second shape different than the first shape, allowing the material to cool below the glass transition temperature, and releasing the implantable layer.

Claims

1. A method for altering a tissue thickness compensator for use with a surgical instrument, said method comprising the steps of:

obtaining a tissue thickness compensator comprised at least partially from a material including a glass transition temperature and a melting temperature, wherein said tissue thickness compensator comprises a first shape;

heating said material to a temperature higher than said glass transition temperature and lower than said melting temperature;

applying a modifying member to a tissue-facing side of said tissue thickness compensator;

manipulating said tissue thickness compensator with said modifying member to a second shape different than said first shape by inducing a localized change in a portion of said tissue thickness compensator in contact with said modifying member;

allowing said material to cool below said glass transition temperature; and

releasing said modifying member from said portion of said tissue thickness compensator.

2. The method of claim 1, wherein said step of obtaining said tissue thickness compensator comprises the steps of:

obtaining a biocompatible polymer comprising a glass transition temperature and a melting temperature;

dissolving said biocompatible polymer in a solvent to produce a solution; and

lyophilizing said solution.

3. The method of claim 1, wherein said step of manipulating said tissue thickness compensator comprises applying at least one compressive force to said tissue thickness compensator.

4. The method of claim 1, wherein said step of manipulating said tissue thickness compensator comprises applying at least one tensile force to said tissue thickness compensator.

5. The method of claim 1, further comprising the step of actively cooling said manipulated tissue thickness compensator below said glass transition temperature.

12. The method of claim 1, wherein said second shape has a greater density than said first shape.

6. A customized tissue thickness compensator for use with a surgical stapler, wherein said customized tissue thickness compensator is prepared by a process comprising the steps of:

obtaining a tissue thickness compensator comprising a first shape;

transitioning at least a portion of said tissue thickness compensator from an original state to a glassy state;

applying a modifying member to a tissue-facing side of said tissue thickness compensator;

manipulating said at least a portion of said tissue thickness compensator with said modifying member to a second shape by inducing a localized change in a portion of said tissue thickness compensator in contact with said modifying member;

allowing said at least a portion of said tissue thickness compensator to return from said glassy state to a non-glassy state; and

releasing said modifying member from said at least a portion of said tissue thickness compensator.

7. The customized tissue thickness compensator of claim 6, wherein said step of obtaining said tissue thickness compensator comprises the steps of:

obtaining a biocompatible polymer comprising a glass transition temperature and a melting temperature;

dissolving said biocompatible polymer in a solvent to produce a solution; and

lyophilizing said solution.

8. The customized tissue thickness compensator of claim 6, wherein said step of manipulating said at least a portion of said tissue thickness compensator comprises applying at least one compressive force to said at least a portion of said tissue thickness compensator.

9. The customized tissue thickness compensator of claim 6, wherein said step of manipulating said at least a portion of said tissue thickness compensator comprises applying at least one tensile force to said at least a portion of said tissue thickness compensator.

10. The customized tissue thickness compensator of claim 6, wherein said process comprises the step of actively cooling said at least a portion of said tissue thickness compensator to remove said at least a portion of said tissue thickness compensator from said glassy state to said non-glassy state.

11. The customized tissue thickness compensator of claim 6, wherein said process comprises the step of maintaining said manipulation of said at least a portion of said tissue thickness compensator for a period of time sufficient to permit said at least a portion of said tissue thickness compensator to maintain said manipulation.

13. The customized tissue thickness compensator of claim 6, wherein the density of said second shape of said tissue thickness compensator is greater than the density of the first shape of said tissue thickness compensator.