Surgical staple with integral pledget for tip deflection

• US 9,289,207 B2
• Filed: 11/29/2012
• Issued: 03/22/2016
• Est. Priority Date: 11/29/2012
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Shelton, Frederick E. IV
• Primary Examiner(s): Long, Robert
• Application Number:
  US13/688,951
• Publication Number:
  US 20140144968A1
• Time in Patent Office: 1,209 Days
• Field of Search: 2271751-1821, 606142-143, 606219-221
• US Class Current: 1/1
• 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 17/07292 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 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0645 being elastically deformed for insertion
• 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 2017/07264 characterised by its staple forming cavities, e.g. geometry or material
• CPC Class Codes: A61B 2017/1132 End-to-end connections

Abstract

A circular stapler apparatus for stapling tissue includes a staple and pledget assembly and a circular staple head operable to drive staples toward an anvil. A staple of the staple and pledget assembly has a pair of legs disposed substantially perpendicular to a crown of the staple in a first position. The pair of legs is operable to advance against a pocket in the anvil to form a staple with bent legs. The staple and pledget assembly includes the staple and a pledget configured to receive the pair of legs of the staple. The pledget comprises a bioabsorbable material. The pledget is configured to advance distal ends of the pair of legs to a position in which the distal ends are laterally offset from a plane in which the crown of the staple is disposed.

Claims

1. A stapler apparatus for stapling a tissue, the apparatus comprising:

(a) an anvil having an anvil head, wherein the anvil head defines a staple-forming pocket;

(b) a stapling head assembly operable to drive a staple toward the staple-forming pocket; and

(c) a staple and pledget assembly coupled with the stapling head assembly, wherein the staple and pledget assembly comprises;

(i) a staple having a pair of legs and a crown, wherein the crown has a crown width and a crown length and is configured to apply a first pressure to the tissue along a first plane, wherein the pair of legs are disposed substantially perpendicular to the crown in a first position, wherein the pair of legs is operable to advance against the pocket in the anvil head to form a staple with bent legs, and

(ii) a pledget configured to receive the pair of legs of the staple, wherein the pledget is configured to deflect portions of the pair of legs of the staple away from a longitudinal axis of the crown such that the pledget and the staple define a formed staple configured to apply a second pressure to the tissue along a second plane transverse to the first plane, wherein the first and second planes are arranged to form a three-dimensional pressure profile.

2. The apparatus of claim 1, wherein the pledget comprises a pair of channels configured to receive distal ends of the pair of legs of the staple.

3. The apparatus of claim 1, wherein the distal ends of the pair of legs are configured to be bent by the pocket in the anvil head to form a pair of first bent portions and a pair of second bent portions, wherein each first bent portion is substantially parallel to a longitudinal axis of the crown of the staple, and wherein each second bent portion is substantially perpendicular to a respective first bent portion.

4. The apparatus of claim 3, wherein the second bent portions comprise the distal ends of the pair of legs, and wherein the distal ends of the pair of legs are configured to be disposed against an upper surface of the pledget.

5. The apparatus of claim 4, wherein the pledget is configured to tilt relative to the staple in response to the distal ends of the pair of legs bearing against an upper surface of the pledget.

6. The apparatus of claim 1, wherein the distal ends of the pair of legs are configured to be bent by the pocket in the anvil head to form a pair of first bent portions and a pair of second bent portions, wherein the distal ends of the pair of legs are configured to advance to a position disposed past a first side of the crown, and the first bent portions are configured to deflect to a position disposed past a second, opposite side of the crown.

7. The apparatus of claim 1, wherein the distal ends of the pair of legs are configured to be bent by the pocket in the anvil head to form a pair of first bent portions and a pair of second bent portions, wherein the formed staple is configured to form a width footprint measurable as a distance between the first bent portions and the distal ends of the pair of legs, wherein the width footprint is greater than the crown width.

8. The apparatus of claim 1, wherein the distal end of a first one of the legs is configured to advance in the first direction, wherein the distal end of a second one of the legs is configured to advance in a second direction, wherein the second direction is opposite the first direction.

9. The apparatus of claim 8, wherein the pledget is configured to deflect the distal end of the first one of the legs in the first direction, wherein the pledget is further configured to deflect the distal end of the second one of the legs in the second direction.

10. The apparatus of claim 1, wherein each leg of the formed staple comprises a first bent portion and a second bent portion, wherein the formed staple is configured to form a width footprint measurable as a distance between the first bent portion and the second bent portion, wherein the width footprint is greater than the crown width.

11. The apparatus of claim 1, wherein the pledget comprises a pair of end portions and an intermediate portion disposed between the pair of end portions, wherein the pair of end portions comprise channels sized and shaped to receive distal ends of the pair of legs of the staple, wherein a width of the intermediate portion is greater than a width of each of the end portions, and wherein the intermediate portion comprises at least one projection.

12. The apparatus of claim 1, wherein the pledget comprises a bioabsorbable material.

13. The apparatus of claim 1, wherein the anvil comprises a plurality of staple-forming pockets arranged in an annular array, wherein the stapling head assembly includes a plurality of staples arranged in an annular array.

14. The apparatus of claim 1, wherein a length of the pledget is greater than the crown length.

15. The apparatus of claim 1, wherein distal ends of the pair of legs of the formed staple are laterally offset from the longitudinal axis of the crown of the staple, wherein the each of the distal ends are either both disposed on a first side of the crown or respectively disposed on a first and second side of the crown.

16. A method of forming a staple with bent legs using a stapler apparatus, wherein the apparatus includes a staple and pledget assembly and a staple head operable to drive staples toward an anvil head, wherein a staple of the staple and pledget assembly has a pair of legs disposed substantially perpendicular to a crown of the staple in a first position, wherein distal ends of the pair of legs are configured for receipt within a pair of channels defined in opposing end portions of the pledget, wherein the pair of legs is operable to advance against a respective pocket in the anvil head to form the staple with bent legs, the method comprising:

(a) advancing the distal ends toward the respective pockets in the anvil head;

(b) bending the distal ends of the pair of legs via the respective pockets to form first bent portions and second bent portions, the second bent portions including the distal ends;

(d) advancing the second bent portions toward an upper surface of the pledget;

(e) tilting the pledget in a first angular direction to rotate about a longitudinal axis of the pledget while advancing the second bent portions toward the pledget; and

(f) deflecting the first bent portions while tilting the pledget in the first angular direction to create a footprint in which the distal ends are laterally spaced away from a plane passing through the pledget and the crown.

17. The method of claim 16, further comprising advancing the distal ends to a position disposed past a first side of the crown and deflecting the first bent portions to a position disposed past a second, opposite side of the crown while tilting the pledget in the first angular direction.

18. The method of claim 16, further comprising advancing one of the distal ends in a first linear direction, and advancing the other of the distal ends in a second linear direction opposite the first direction.

19. The method of claim 16, further comprising deflecting portions of each staple leg in a second angular direction, wherein the second angular direction is opposite to the first angular direction.

20. A circular stapler apparatus for stapling a tissue, the apparatus comprising:

(a) an anvil having an anvil head, wherein the anvil head defines a staple-forming pocket;

(b) a stapling head assembly operable to drive a staple toward the staple-forming pocket; and

(c) a staple and pledget assembly coupled with the stapling head assembly, wherein the staple and pledget assembly comprises;

(i) a staple having a pair of legs and a crown, wherein the crown is configured to apply a first pressure to the tissue along a first plane, wherein the pair of legs are disposed substantially perpendicular to the crown in a first position, wherein the pair of legs is operable to advance against the pocket in the anvil head to form a staple with bent legs, and

(ii) a pledget configured to receive the pair of legs of the staple, wherein the pledget is configured to deflect portions of the pair of legs of the staple in opposite directions away from a longitudinal axis of the crown such that the pledget and the staple define a formed staple configured to apply a second pressure to the tissue along a second plane transverse to the first plane, wherein the first and second planes are arranged to form a three-dimensional pressure profile.