Layered tissue thickness compensator

• US 9,332,974 B2
• Filed: 03/28/2012
• Issued: 05/10/2016
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery LLC (Johnson & Johnson)
• Inventors: Henderson, Cortney E., Aronhalt, Taylor W., Yang, Chunlin, Scheib, Charles J., Mandakolathur Vasudevan, Venkataramanan, Timmer, Mark D., Timm, Richard W., Widenhouse, Tamara, Hall, Steven G.
• Primary Examiner(s): Chukwurah, Nathaniel
• Application Number:
  US13/433,175
• Publication Number:
  US 20120253298A1
• Time in Patent Office: 1,504 Days
• Field of Search: 227/175.1, 227/176.1, 227/180.1, 606/151, 606/219, 604/93.01, 604/288.04
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• 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 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00991 Telescopic means
• 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 2017/0725 : with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
• 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: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2916 : pins in guiding slots
• CPC Class Codes: A61B 2017/2919 : details of linkages or pivot points
• CPC Class Codes: A61B 2017/2923 : Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2933 : camming or guiding means
• CPC Class Codes: A61B 2017/2936 : Pins in guiding slots
• CPC Class Codes: A61B 2017/2937 : with flexible part
• CPC Class Codes: A61B 2017/320052 : Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61P 17/02 : for treating wounds, ulcers, burns, scars, keloids, or the like

Abstract

A tissue thickness compensator may generally comprise a first layer comprising a first medicament, a second layer comprising a second medicament, and a third layer comprising a third medicament. The tissue thickness compensator may comprise a first layer comprising a first medicament, a second layer comprising a second medicament, and a reservoir comprising a third medicament disposed within the reservoir. The medicaments may be independently selected from a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a pharmaceutically active agent, a matrix metalloproteinase inhibitor, and combinations thereof. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.

Claims

1. A tissue thickness compensator, comprising:

a first layer comprising a first medicament;

a second layer comprising a second medicament, wherein the second medicament is different than the first medicament; and

a third layer comprising a third medicament disposed between the first layer and the second layer, wherein the third medicament is different than the second medicament and the first medicament, and wherein at least one of the first layer, the second layer, and the third layer comprises an adaptive thickness for compensating for variations in tissue thickness.

2. The tissue thickness compensator of claim 1, wherein the first medicament, second medicament, and third medicament are independently selected from a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a pharmaceutically active agent, a matrix metalloproteinase inhibitor, and combinations thereof.

3. The tissue thickness compensator of claim 1, wherein the first medicament comprises a haemostatic agent, the second medicament comprises an anti-adhesion agent, and the third medicament comprises a matrix metalloproteinase inhibitor.

4. The tissue thickness compensator of claim 1, wherein the first layer comprises a first film comprising a haemostatic agent, the second layer comprises a second film comprising an anti-adhesion agent, and the third layer comprises a biocompatible foam having a matrix metalloproteinase inhibitor homogeneously distributed therein.

5. The tissue thickness compensator of claim 4, wherein the first film is mechanically bonded to the biocompatible foam.

6. The tissue thickness compensator of claim 1, wherein the first layer, second layer, and third layer are independently selected from polylactides, poly(lactic acid), polyglycolides, poly(glycolic acid), poly(trimethylene carbonate), poly(dioxanone), poly(hydroxybutyric acid), poly(hydroxyvaleric acid), poly(lactide-co-(ε

-caprolactone)), poly(glycolide-co-(ε

-caprolactone)), poly(lactic-co-glycolic acid), polycarbonates, poly(pseudo amino acids), poly(amino acids), poly(hydroxyalkanoate)s, polyalkylene oxalates, polyoxaesters, polyanhydrides, polyortho esters, and copolymers, block copolymers, homopolymers, blends, and combinations thereof.

7. The tissue thickness compensator of claim 1, wherein the first layer comprises a biodegradable polymer, and the third medicament elutes from the third layer when the first layer degrades.

8. The tissue thickness compensator of claim 1, wherein the first layer comprises at least one of the second medicament and third medicament.

9. The tissue thickness compensator of claim 1, wherein the first layer comprises collagen, gelatin, thrombin, fibrin, fibrinogen, fibronectin, elastin, albumin, hemoglobin, ovalbumin, polysaccharides, hyaluronic acid, chondroitin sulfate, hydroxyethyl starch, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitan, chitosan, agarose, maltose, maltodextrin, alginate, clotting factors, methacrylate, polyurethanes, cyanoacrylates, platelet agonists, vasoconstrictors, alum, calcium, RGD peptides, proteins, protamine sulfate,ε

-amino caproic acid, ferric sulfate, ferric subsulfates, ferric chloride, zinc, zinc chloride, aluminum chloride, aluminum sulfates, aluminum acetates, permanganates, tannins, bone wax, polyethylene glycols, fucans and combinations thereof.

10. The tissue thickness compensator of claim 1, wherein the second layer comprises poly(vinyl pyrrolidone), carboxymethyl cellulose, hyaluronic acid, polyethylene oxide, poly vinyl alcohols, doxycycline, diclofenac, aspirin, naproxen, sulindac, hydrocortisone, and combinations thereof.

11. The tissue thickness compensator of claim 1, wherein the second layer comprises one of a powder, a gel, and a fluid.

12. A tissue thickness compensator, comprising:

a plurality of layers, wherein the plurality of layers comprises;

a first layer;

a second layer; and

a third layer disposed between the first layer and the second layer;

wherein at least one of the layers comprises a film layer, wherein at least one of the layers comprises a fibrous layer, and wherein at least one of the layers comprises a medicament, and wherein at least one of the first layer, the second layer, and the third layer comprises an adaptive thickness for compensating for variations in tissue thickness.

13. The tissue thickness compensator of claim 12, wherein the medicament is selected from a group consisting of a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a pharmaceutically active agent, a matrix metalloproteinase inhibitor, and combinations thereof.

14. The tissue thickness compensator of claim 12, wherein at least two of the layers comprise a porous layer.

15. The tissue thickness compensator of claim 14, wherein the first layer comprises a first porous layer, wherein the second layer comprises a second porous layer, and wherein the third layer comprises the film layer.

16. The tissue thickness compensator of claim 15, wherein the first porous layer comprises a first density, wherein the second porous layer comprises a second density, and wherein the second density is different than the first density.

17. The tissue thickness compensator of claim 15, wherein the first porous layer comprises a woven material.

18. The tissue thickness compensator of claim 15, wherein the plurality of layers are bonded together.

19. The tissue thickness compensator of claim 15, wherein the plurality of layers are welded together.

20. A tissue thickness compensator, comprising:

a first compressible layer;

a second compressible layer, wherein the first compressible layer and the second compressible layer comprise an adaptive thickness for compensating for variations in tissue thickness; and

a film layer disposed between the first compressible layer and the second compressible layer.

21. The tissue thickness compensator of claim 20, further comprising a medicament.

22. The tissue thickness compensator of claim 21, wherein the medicament is selected from a group consisting of a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a pharmaceutically active agent, a matrix metalloproteinase inhibitor, and combinations thereof.

23. The tissue thickness compensator of claim 20, wherein the film layer is bonded to the first compressible layer and the second compressible layer.

24. The tissue thickness compensator of claim 20, wherein the first compressible layer comprises a first density, wherein the second compressible layer comprises a second density, and wherein the second density is different than the first density.

25. The tissue thickness compensator of claim 24, wherein the first compressible layer is comprised of a first porous, fibrous material, and wherein the second compressible layer is comprised of a second porous, fibrous material.