TISSUE THICKNESS COMPENSATOR COMPRISING CONTROLLED RELEASE AND EXPANSION

• US 20120241493A1
• Filed: 03/28/2012
• Published: 09/27/2012
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Baxter, Chester O. III, Shelton, Frederick E. IV, Scheib, Charles J., Widenhouse, Christopher W., Weisenburgh, William B. II, Stammen, John L., Ransick, Mark H., Mutchler, Stephanie A., Knight, Gary W., Cropper, Michael S., Conlon, Sean P., Swayze, Jeffrey S.
• Granted Patent: US 10,123,798 B2
• Time in Patent Office: Days
• US Class Current: 227/175.1
• 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 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• 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 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00889 : antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00893 : pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 : expandable upon contact with fluid
• 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 2017/2919 : 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 2017/2946 : Locking means
• CPC Class Codes: A61B 2017/320052 : Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61L 31/00 : Materials for other surgical articles , e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices shape or structure of stent-grafts A61F2/07, of stents A61F2/82, of surgical gloves A61B42/00, of surgical drapes A61B46/00, of occluding devices A61B17/12022
• CPC Class Codes: A61L 31/04 : Macromolecular materials
• CPC Class Codes: A61L 31/145 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: F04C 2270/0421 : Controlled or regulated
• CPC Class Codes: H05K 999/99 : dummy group

Abstract

A tissue thickness compensator may generally comprise a first layer comprising a first biocompatible material sealingly enclosed in a water impermeable material and a second layer comprising a second biocompatible material comprising at least one encapsulation, wherein the first biocompatible material expands when contacted with a fluid. The tissue thickness compensator may comprise a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a medicament, and/or pharmaceutically active agent. The encapsulation may comprise a biodegradable material to degrade in vivo and/or in situ. The tissue thickness compensator may comprise a hydrogel. The reaction product may comprise a fluid-swellable composition. 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 biocompatible material sealingly enclosed in a water impermeable material; and

a second layer comprising a second biocompatible material comprising at least one encapsulation;

wherein the first biocompatible material expands when contacted with a fluid.

2. The tissue thickness compensator of claim 1 comprising a third layer comprising a third biocompatible material, wherein the first layer is intermediate the second layer and third layer.

3. The tissue thickness compensator of claim 2, wherein each of the first layer and second layer comprise a tissue-contacting surface.

4. The tissue thickness compensator of claim 2, wherein the first biocompatible material, second biocompatible material, and third biocompatible material are independently selected from albumin, alginate, carbohydrate, casein, cellulose, chitin, chitosan, collagen, blood, dextran, elastin, fibrin, fibrinogen, gelatin, heparin, hyaluronic acid, keratin, protein, serum, starch, poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phosphazine), polyesters, polyethylene glycols, polyalkyleneoxides, polyacrylamides, polycarbonates, polyhydroxyethylmethylacrylate, poly(vinylpyrrolidone), polyvinyl alcohols, poly(caprolactone), poly(dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerols, poly(amino acids), copoly(ether-esters), polyalkylene oxalates, polyamides, poly(iminocarbonates), polyoxaesters, polyorthoesters, polyphosphazenes and combinations thereof.

5. The tissue thickness compensator of claim 1, wherein the first biocompatible material comprises a dry hydrogel.

6. The tissue thickness compensator of claim 5, wherein the hydrogel comprises polyalkylene oxides, polysaccharides, esters, aliphatic esters, orthoesters, phosphoesters, carbonates, urethanes, ethers, amides, phenolics, and combinations thereof.

7. The tissue thickness compensator of claim 1, wherein the first biocompatible material is a water-swellable composition.

8. The tissue thickness compensator of claim 1, wherein the fluid comprises water, saline, and a bodily fluid.

9. The tissue thickness compensator of claim 1, wherein the first biocompatible material contacts the fluid when the water impermeable material is ruptured.

10. The tissue thickness compensator of claim 1, wherein the water impermeable material comprises poly(lactic acid), poly(glycolic acid), poly(hydroxybutyrate), poly(phosphazine), polyesters, polyethylene glycols, polyalkyleneoxides, polyacrylamides, polycarbonates, polyhydroxyethylmethylacrylate, poly(vinylpyrrolidone), polyvinyl alcohols, poly(caprolactone), poly(dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerols, poly(amino acids), copoly(ether-esters), polyalkylene oxalates, polyamides, poly(iminocarbonates), polyoxaesters, polyorthoesters, polyphosphazenes and combinations thereof.

11. The tissue thickness compensator of claim 1, wherein the at least one encapsulation comprises at least one encapsulated component comprising a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a medicament, pharmaceutically active agent, and combinations thereof.

12. The tissue thickness compensator of claim 11, wherein the anti-microbial agent comprises triclosan, chlorhexidine and its salts, silver and its salts, ammonium and its salts, copper and its salts, iron and its salts, and zinc and its salts and combinations thereof.

13. The tissue thickness compensator of claim 1, wherein the at least one encapsulation comprises a tube comprising polyglycolic acid, polylactic acid, polydioxanone, polyhydroxyalkanoate, poliglecaprone, polycaprolactone, and combinations thereof.

14. The tissue thickness compensator of claim 1, wherein the at least one encapsulation degrades in vivo.

15. An article selected from an anvil of a stapling apparatus and a staple cartridge for a stapling apparatus, the article comprising the tissue thickness compensator of claim 1.

16. A tissue thickness compensator comprising:

an inner layer comprising a hydrogel impregnated with at least one of a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a medicament, and a pharmaceutically active agent; and

an outer layer comprising a water impermeable material sealingly enclosing the inner layer;

wherein the hydrogel expands when contacted with at least one of water, saline, and a bodily fluid.

17. The tissue thickness compensator of claim 16, wherein the hydrogel contacts the at least one of water, saline, and a bodily fluid when the water impermeable material is ruptured, and wherein the at least one of a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a medicament, and a pharmaceutically active agent is released when the water impermeable material is ruptured.

18. A method of making a tissue thickness compensator, the method comprising:

providing a tissue thickness compensator comprising;

an inner layer comprising a biocompatible material; and

an outer layer comprising a water impermeable material sealingly enclosing the inner layer; and

impregnating the inner layer with at least one of a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a medicament, and a pharmaceutically active agent;

wherein the biocompatible material expands when contacted with at least one of water, saline, and a bodily fluid.

19. The method of claim 18 further comprising:

rupturing the water impermeable material;

contacting the biocompatible material and the at least one of water, saline, and a bodily fluid to expand the tissue thickness compensator.