Implantable layers and methods for altering one or more properties of implantable layers for use with fastening instruments

• US 9,884,456 B2
• Filed: 02/24/2014
• Issued: 02/06/2018
• Est. Priority Date: 02/24/2014
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Schellin, Emily A., Vendely, Michael J., Weaner, Lauren S., Widenhouse, Christopher W., Aronhalt, Taylor W., Reynolds, II, Donald L., Miller, Michael J., Shelton, IV, Frederick E., Barton, Trevor J.
• Primary Examiner(s): Kennedy, Timothy
• Application Number:
  US14/187,386
• Publication Number:
  US 20150239180A1
• Time in Patent Office: 1,443 Days
• 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, resorptive for implantable prostheses A61F2210/0004
• 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 changing the spring rate of an implantable layer for use with a surgical instrument which includes the steps of obtaining an implantable layer having a first spring rate, wherein the implantable layer is at least partially comprised of a material having a glass transition temperature and a melting temperature, heating the implantable layer to a temperature higher than the glass transition temperature and lower than the melting temperature, deforming the implantable layer to change the first spring rate to a second spring rate, wherein the second spring rate is different than the first spring rate, allowing the implantable layer to cool below the glass transition temperature, and releasing the implantable layer.

Claims

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

obtaining a tissue thickness compensator comprising a first spring rate, wherein said tissue thickness compensator is at least partially comprised of a material having a glass transition temperature and a melting temperature;

heating said tissue thickness compensator to a temperature higher than said glass transition temperature and lower than said melting temperature;

deforming said tissue thickness compensator to induce a localized change in a tissue-facing portion of said tissue thickness compensator from said first spring rate to a second spring rate, wherein said second spring rate is different than said first spring rate;

allowing said tissue thickness compensator to cool below said glass transition temperature; and

releasing said tissue thickness compensator.

2. The method of claim 1, wherein 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 the step of deforming said tissue thickness compensator comprises holding at least a portion of said tissue thickness compensator in a constrained geometry.

4. The method of claim 1, wherein the step of deforming said tissue thickness compensator comprises holding at least a portion of said tissue thickness compensator under compression.

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

16. The method of claim 1, wherein said second spring rate is greater than said first spring rate, wherein said second spring rate corresponds to said tissue-facing portion of said tissue thickness compensator, and wherein said localized change increases the density of said tissue-facing portion of said tissue thickness compensator.

6. A method for changing the spring rate of a biocompatible foam for use with a surgical instrument, said method comprising the steps of:

obtaining a biocompatible foam comprising an original density, wherein said biocompatible foam is at least partially comprised of a material having a glass transition temperature and a melting temperature;

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

manipulating a tissue-facing portion of said biocompatible foam to provide a localized change from said original density to a modified density, wherein said biocompatible foam which is not subject to manipulation retains said original density;

allowing said biocompatible foam to cool below said glass transition temperature; and

releasing said tissue-facing portion of said biocompatible foam.

7. The method of claim 6, wherein the step of manipulating said tissue-facing portion of said biocompatible foam comprises applying at least one tensile force to said tissue-facing portion of said biocompatible foam.

8. The method of claim 6, wherein the step of manipulating said tissue-facing portion of said biocompatible foam comprises holding said tissue-facing portion of said-biocompatible foam under compression.

9. The method of claim 6, wherein the step of manipulating said tissue-facing portion of said biocompatible foam comprises holding said tissue-facing portion of said biocompatible foam in a compressed geometry.

10. The method of claim 6, further comprising actively cooling said biocompatible foam to a temperature below said glass transition temperature.

11. The method of claim 6, wherein the step of manipulating said tissue-facing portion of said biocompatible foam comprises positioning said biocompatible foam in a receiver and advancing an adjustment member against said tissue-facing portion of said biocompatible foam.

17. The method of claim 6, wherein said modified density is greater than said original density.

12. A method for changing the spring rate of a tissue thickness compensator for use with a surgical instrument, said method comprising the steps of:

obtaining a tissue thickness compensator comprising an original spring rate;

transitioning a tissue-facing portion of said tissue thickness compensator from a non-glassy state to a glassy state;

applying a force to said portion to induce a localized change from said original spring rate to a modified spring rate, wherein said tissue thickness compensator which is not subject to said force retains said original spring rate;

allowing said portion to return to said non-glassy state; and

removing said force.

13. The method of claim 12, wherein said force comprises at least one compressive force.

14. The method of claim 12, wherein said force comprises at least one tensile force.

15. The method of claim 12, further comprising actively cooling said tissue thickness compensator to a temperature below a glass transition temperature.

18. The method of claim 12, wherein said modified spring rate is greater than said original spring rate, wherein said modified spring rate corresponds to said tissue-facing portion of said tissue thickness compensator, and wherein said localized change increases the density of said tissue-facing portion of said tissue thickness compensator.