Implantable adjunct systems for determining adjunct skew

• US 10,299,878 B2
• Filed: 09/25/2015
• Issued: 05/28/2019
• Est. Priority Date: 09/25/2015
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Shelton, IV, Frederick E., Nagy, Jennifer M.
• Primary Examiner(s): Smith, Scott A
• Application Number:
  US14/865,306
• Publication Number:
  US 20170086936A1
• Time in Patent Office: 1,341 Days
• Field of Search: 227 19, 2271761, 2271752, 2271801, 606139, 606153, 606219
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/07228 Arrangement of the staples
• CPC Class Codes: A61B 2017/07271 characterised by its cartridge
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for

Abstract

An implantable adjunct for use with a surgical stapling instrument is provided. The implantable adjunct comprises a mechanism for allowing a clinician to determine the degree of skew, if any, that the adjunct may experience when implanted into a subject with a surgical stapling instrument. The implantable adjunct comprises one or more reference systems configured to be compared to the staples, the edges of the adjunct, and/or any other adjunct elements by a clinician once the adjunct has been implanted into the subject. The one or more reference systems comprise references that define one or more zones of the adjunct. A clinician can visually determine what zone, or zones, of the adjunct the staples have satisfactorily, and/or unsatisfactorily, purchased the adjunct.

Claims

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

a cartridge body, comprising;

a longitudinal slot configured to receive a cutting member;

a deck; and

a plurality of staple cavities, comprising;

an outer row of staple cavities; and

an inner row of staple cavities positioned adjacent said longitudinal slot; and

a plurality of staples removably stored within said staple cavities, wherein said staples are configured to be ejected from said staple cavities from an unfired position to a fired position; and

an implantable adjunct positioned adjacent said deck, wherein said implantable adjunct is configured to be implanted into a subject when said staples are ejected from said staple cavities into said fired position, wherein said implantable adjunct comprises a reference system that defines a first zone and a second zone, wherein said first zone comprises a first perimeter demarcation within the perimeter of said first zone, wherein said second zone comprises a second perimeter demarcation within the perimeter of said second zone, wherein said reference system is configured to assist a clinician in determining the position of said staples relative to said first zone and said second zone when said staples are in said fired position, wherein the positioning of said staples in said first zone provides a low-risk indication in terms of tissue ligation and the positioning of said staples in said second zone provides a high-risk indication in terms of tissue ligation, and wherein said first perimeter demarcation and said second perimeter demarcation are present after said implantable adjunct has been compressed against tissue.

2. The staple cartridge system of claim 1, wherein said reference system comprises a longitudinal reference positioned such that the clinician can determine an amount of longitudinal skew of said implantable adjunct by comparing said staples to said longitudinal reference when said staples are in said fired position.

3. The staple cartridge system of claim 1, wherein said reference system comprises a lateral reference positioned such that a clinician can determine an amount of lateral skew of said implantable adjunct by comparing said staples to said lateral reference when said staples are in said fired position.

4. The staple cartridge system of claim 3, wherein said cartridge body comprises an outer edge, wherein said outer row of staple cavities is positioned adjacent said outer edge, and wherein said lateral reference comprises a first reference positioned between said outer edge and said outer row of staple cavities.

5. The staple cartridge system of claim 4, wherein said reference system further comprises a second reference positioned between said inner row of staple cavities and said longitudinal slot.

6. The staple cartridge system of claim 1, wherein said implantable adjunct comprises a woven material.

7. The staple cartridge system of claim 6, wherein said reference system comprises a colored strand woven into said woven material.

8. The staple cartridge system of claim 1, wherein said implantable adjunct comprises a non-woven material.

9. The staple cartridge system of claim 1, wherein said first zone comprises a first color and a second color, wherein said first color and said second color are divided by an intended cut-line, and wherein said cutting member is configured to incise said implantable adjunct along the intended cut-line.

10. The staple cartridge system of claim 1, wherein said reference system comprises two inner lateral references, wherein the area between the two inner lateral references defines said second zone, and wherein said cutting member is configured to incise said implantable adjunct in said second zone.

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

a cartridge body, comprising;

a longitudinal slot configured to receive a cutting member;

a deck; and

a plurality of staple cavities, comprising;

an outer row of staple cavities; and

an inner row of staple cavities positioned adjacent said longitudinal slot; and

a plurality of staples removably stored within said staple cavities, wherein said staples are configured to be ejected from said staple cavities from an unfired position to a fired position; and

an implantable adjunct positioned adjacent said deck, wherein said implantable adjunct is configured to be implanted into a subject when said staples are ejected from said staple cavities into said fired position, wherein said implantable adjunct comprises a reference system that defines a first zone and a second zone, wherein said reference system is configured to assist a clinician in determining the position of said staples relative to said first zone and said second zone when said staples are in said fired position, wherein said reference system comprises a longitudinal reference positioned such that the clinician can determine an amount of longitudinal skew of said implantable adjunct by comparing said staples to said longitudinal reference when said staples are in said fired position, wherein said plurality of staple cavities further comprises at least one distal-most cavity and at least one proximal-most cavity, wherein said at least one distal-most cavity defines a distal purchase datum and said at least one proximal-most cavity defines a proximal purchase datum, and wherein said distal purchase datum and said proximal purchase datum are positioned in said first zone when said staples are in said unfired position.

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

a cartridge body, comprising;

a longitudinal slot configured to receive a cutting member;

a deck; and

a plurality of staple cavities, comprising;

an outer row of staple cavities; and

an inner row of staple cavities positioned adjacent said longitudinal slot; and

a plurality of staples removably stored within said staple cavities, wherein said staples are configured to be ejected from said staple cavities from an unfired position to a fired position; and

an implantable adjunct positioned adjacent said deck, wherein said implantable adjunct is configured to be implanted into a subject when said staples are ejected from said staple cavities into said fired position, wherein said implantable adjunct comprises a reference system that defines a first zone and a second zone, wherein said reference system is configured to assist a clinician in determining the position of said staples relative to said first zone and said second zone when said staples are in said fired position, wherein the positioning of said staples in said first zone provides a low-risk indication in terms of tissue ligation and the positioning of said staples in said second zone provides a high-risk indication in terms of tissue ligation, wherein said reference system comprises dye applied on said implantable adjunct, and wherein said first zone comprises a first color and said second zone comprises a second color.

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

a cartridge body, comprising;

a longitudinal slot configured to receive a cutting member;

a deck; and

a plurality of staple cavities arranged in a plurality of longitudinal rows;

a plurality of staples removably stored within said staple cavities, wherein said staples are configured to be ejected from said staple cavities into a fired position; and

an implantable adjunct positioned above said deck, wherein said implantable adjunct is configured to be implanted into a subject when said staples are ejected from said staple cavities into said fired position, wherein said implantable adjunct comprises a reference for determining the alignment of said staples relative to said implantable adjunct once said staples are in said fired position, and wherein said reference is defined on said implantable adjunct at a location which allows a clinician to assess whether said staples are too close to an edge of said implantable adjunct.

14. The staple cartridge system of claim 13, wherein said plurality of staple cavities comprises an outer row of staple cavities and an inner row of staple cavities, wherein said inner row of staple cavities is adjacent said longitudinal slot, and wherein said reference comprises a first reference corresponding to said inner row of staple cavities and a second reference corresponding to said outer row of staple cavities.

15. The staple cartridge system of claim 13, wherein said implantable adjunct comprises a woven material.

16. The staple cartridge system of claim 13, wherein said implantable adjunct comprises a non-woven material.

17. A surgical end effector system, comprising:

a cutting member;

a first jaw;

a second jaw, wherein said first jaw is moveable relative to said second jaw;

an anvil;

a staple cartridge, comprising;

an outer edge portion;

a plurality of staple cavities arranged in a plurality of rows;

a plurality of staples configured to be ejected from said staple cavities, wherein said staples are arranged in an inner row of staples and an outer row of staples; and

a slot, wherein said inner row of staples is positioned laterally outward with respect to said slot, and wherein said outer row of staples is positioned laterally outward with respect to said inner row of staples and laterally inward with respect to said outer edge portion;

an implantable adjunct, comprising a reference system defining a first zone and a second zone,

wherein said first zone corresponds to said inner row of staples and said outer row of staples such that before said staples are ejected from said staple cavities, said first zone is above said inner row of staples and said outer row of staples;

wherein said second zone corresponds to said slot and said outer edge portion such that, before said staples are ejected from said staple cavities, said second zone is above said outer edge portion and said slot; and

wherein said first zone comprises a perimeter, wherein said implantable adjunct comprises a perimeter demarcation around said perimeter of said first zone, and wherein said perimeter demarcation is present after said implantable adjunct has been stretched by tissue.

18. The surgical end effector system of claim 17, wherein said first zone comprises a first color and said second zone comprises a second color which is different than said first color.

19. The surgical end effector system of claim 17, wherein said implantable adjunct comprises a non-woven material.

20. The surgical end effector system of claim 17, wherein said implantable adjunct comprises a woven material.