Tissue thickness compensator comprising controlled release and expansion

Patent metadata

Field	Value
Publication number	US-10123798-B2
Application number	US-201213433141-A
Country	US
Kind code	B2
Filing date	Mar 28, 2012
Priority date	Sep 30, 2010
Publication date	Nov 13, 2018
Grant date	Nov 13, 2018

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.

First claim

What is claimed is:

1. A tissue thickness compensator comprising a tubular element, wherein the tubular element comprises:
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 comprises a temperature activatable precursor, wherein the temperature activatable precursor is activatable between an inactive state and an active state, and 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.

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, polyacrylam ides, 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, polyacrylam ides, polycarbonates, polyhydroxyethylmethylacrylate, poly(vinylpyrrolidone), polyvinyl alcohols, poly(caprolactone), poly(dioxanone), polyacrylic acid, polyacetate, polypropylene, glycerols, poly(amino acids), copoly(ether-esters), polyalkylene oxalates, polyam ides, 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. The tissue thickness compensator of claim 1 , wherein the temperature activatable precursor is transitioned from the inactive state to the active state prior to being implanted.

17. A tissue thickness compensator comprising a tubular element, wherein the tubular element comprises:
an inner layer comprising a temperature activatable hydrogel precursor 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 temperature activatable hydrogel precursor is activatable between an inactive state and an active state prior to being implanted, and wherein the temperature activatable hydrogel precursor expands when contacted with at least one of water, saline, and a bodily fluid.

18. The tissue thickness compensator of claim 17 , wherein the temperature activatable hydrogel precursor 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.

Assignees

• Baxter Iii Chester O
• Shelton Iv Frederick E
• Scheib Charles J
• Widenhouse Christopher W
• Weisenburgh Ii William B
• Stammen John L
• Ransick Mark H
• Mutchler Stephanie A
• Knight Gary W
• Cropper Michael S
• Conlon Sean P
• Swayze Jeffrey S
• Ethicon Llc

Inventors

• Baxter Iii Chester O
• Shelton Iv Frederick E
• Scheib Charles J
• Widenhouse Christopher W
• Weisenburgh Ii William B
• Stammen John L
• Ransick Mark H
• Mutchler Stephanie A
• Knight Gary W
• Cropper Michael S
• Conlon Sean P
• Swayze Jeffrey S

Classifications

• A61B2017/2927

  the angular position of the head being adjustable with respect to the shaft · CPC title

• A61B2017/00477

  Coupling (A61B2017/0046 takes precedence) · CPC title

• A61B2017/07264

  characterised by its staple forming cavities, e.g. geometry or material · CPC title

• A61B2017/2946

  Locking means · CPC title

• A61B17/07292

  Reinforcements for staple line, e.g. pledgets · CPC title