Surgical staples comprising hardness variations for improved fastening of tissue

• US 10,357,251 B2
• Filed: 08/26/2015
• Issued: 07/23/2019
• Est. Priority Date: 08/26/2015
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Shelton, IV, Frederick E., Swayze, Jeffrey S., Baxter, III, Chester O.
• Primary Examiner(s): Smith, Scott A.
• Application Number:
  US14/836,411
• Publication Number:
  US 20170056008A1
• Time in Patent Office: 1,427 Days
• Field of Search: 227 19, 2271751, 2271752, 2271761, 2271801, 227902, 606 75, 606139, 606153, 606213, 606219, 606220, 606223, 606329, 606151
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00964 composite
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06042 : located close to needle tip
• CPC Class Codes: A61B 2017/0645 : being elastically deformed for insertion
• 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 2017/07264 : 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 2017/1142 : Purse-string sutures
• CPC Class Codes: A61B 2017/2929 : with a head rotatable about the longitudinal axis of the shaft
• CPC Class Codes: A61B 2017/320052 : Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2090/037 : with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/038 : during shipment
• CPC Class Codes: A61B 2090/08021 : of the patient or his organs
• CPC Class Codes: A61L 31/022 : Metals or alloys
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body

Abstract

A surgical staple cartridge is disclosed comprising a plurality of staples removably stored within the surgical staple cartridge. The staples comprise staple legs which extend from a staple base portion. The staple legs comprise staple tips configured to pierce tissue and contact a corresponding forming pocket of an anvil of surgical stapling instrument. The staples further comprise zones having different hardnesses.

Claims

1. A surgical staple cartridge for use with a surgical stapling instrument, said surgical staple cartridge comprising:

a cartridge body;

a plurality of staple cavities; and

a plurality of staples removably stored within said staple cavities, wherein each said staple comprises;

a staple base;

a pair of staple legs extending from said staple base;

a first zone comprising a material having a first hardness; and

a second zone comprising said material having a second hardness which is different than said first hardness.

2. The surgical staple cartridge of claim 1, wherein said first zone is hardened using a first method and said second zone is hardened using a second method different than said first method.

3. The surgical staple cartridge of claim 1, wherein only one of said first zone and said second zone is hardened by a hardening method.

4. The surgical staple cartridge of claim 1, wherein each said staple further comprises bend portions intermediate said staple legs and said staple base, and wherein said bend portions comprise said first zone and said staple base comprises said second zone.

5. The surgical staple cartridge of claim 1, wherein said staple base comprises said first zone and said staple legs comprise said second zone.

6. The surgical staple cartridge of claim 5, wherein said staple legs are not hardened and said staple base is hardened such that said staple legs are encouraged to assume a formed configuration and such that said staple base is configured to avoid plastic deformation.

7. A surgical staple configured to be removably stored within a surgical staple cartridge in an unfired configuration, said surgical staple comprising a non-uniform hardness profile, wherein said surgical staple further comprises a first zone comprised of a material having a first hardness and a second zone comprised of said material having a second hardness, wherein said first zone is hardened to said first hardness when said surgical staple is in a pre-load configuration, and wherein said second zone is hardened to said second hardness when said surgical staple is in the pre-load configuration.

8. A surgical fastener cartridge for use with a surgical fastening instrument, said surgical fastener cartridge comprising:

a cartridge body;

a plurality of fastener cavities; and

a plurality of fasteners removably stored within said fastener cavities, wherein each said fastener comprises;

a fastener base;

a first fastener leg extending from said fastener base;

a second fastener leg extending from said fastener base;

a first region comprising a material comprising a first hardness; and

a second region comprising said material comprising a second hardness which is different than said first hardness.

9. The surgical fastener cartridge of claim 8, wherein said first region is hardened using a first method and said second region is hardened using a second method different than said first method.

10. The surgical fastener cartridge of claim 8, wherein only one of said first region and said second region is hardened by a hardening method.

11. The surgical fastener cartridge of claim 8, wherein each said fastener further comprises bend portions intermediate said fastener legs and said fastener base, and wherein said bend portions comprise said first region and said fastener base comprises said second region.

12. The surgical fastener cartridge of claim 8, wherein said fastener base comprises said first region and said fastener legs comprise said second region.

13. The surgical fastener cartridge of claim 12, wherein said fastener legs are not hardened and said fastener base is hardened such that said fastener legs are encouraged to assume a formed configuration and such that said fastener base is configured to avoid plastic deformation.

14. A surgical staple for use with a surgical stapling instrument, wherein said surgical staple is configured to be ejected from a staple cartridge of the surgical stapling instrument, wherein said surgical staple comprises:

a staple base configured to be engaged by a firing member of the surgical stapling instrument;

a pair of staple legs extending from said staple base;

a first zone comprising a material, wherein said material of said first zone comprises a first hardness; and

a second zone comprising said material, wherein said material of said second zone comprises a second hardness which is different than said first hardness.

15. The surgical staple of claim 14, wherein said first zone is hardened using a first method and said second zone is hardened using a second method different than said first method.

16. The surgical staple of claim 14, wherein only one of said first zone and said second zone is hardened by a hardening method.

17. The surgical staple of claim 14, wherein said surgical staple further comprises bend portions intermediate said staple legs and said staple base, and wherein said bend portions comprise said first zone and said staple base comprises said second zone.

18. The surgical staple of claim 14, wherein said staple base comprises said first zone and said staple legs comprise said second zone.

19. The surgical staple of claim 18, wherein said staple legs are not hardened and said staple base is hardened such that said staple legs are encouraged to assume a formed configuration and such that said staple base is configured to avoid plastic deformation.