Woven and fibrous materials for reinforcing a staple line
View Patent ↗Adjunct materials and methods of using adjunct material to reinforce a staple line are provided. In general, an adjunct material can be used to maintain a seal in tissue and can prevent stapled tissue from tearing. In some embodiments, a surgical stapler can include a jaw having an adjunct material associated with the jaw. The adjunct material can be attached to tissue via staples deployed by the stapler. In some embodiments, an adjunct material can be a woven material having a single layer or multiple layers, and each layer can have different mechanical properties. In other embodiments, an adjunct material can have a single layer or multiple layers of nonwoven material, such as suture compressed into a three dimensional structure.
1. A staple cartridge for use with a surgical stapler, comprising:
a cartridge body having a plurality of staple cavities configured to seat staples therein; and
a biocompatible, compressible adjunct material releasably retained on the cartridge body and configured to be delivered to tissue by deployment of the staples in the cartridge body, the material having a compressible elastic core layer configured to compress upon application of a compressive force and expand upon removal of the compressive force, the compressible elastic core layer having woven fibers oriented such that the woven fibers are looser in a direction of the compression than in a second direction perpendicular to the direction of the compression, and at least one flexible support layer coupled to at least a first surface of the compressible elastic core layer.
2. The staple cartridge of claim 1 , wherein the flexible support layer is coupled to the first surface and to an opposed second surface of the compressible elastic core layer.
3. The staple cartridge of claim 1 , wherein the flexible support layer is coupled to the surface of the compressible elastic core by an interlocking weave.
4. The staple cartridge of claim 1 , wherein the flexible support layer is adhered to the surface of the compressible elastic core layer.
5. The staple cartridge of claim 1 , wherein the flexible support layer is comprised of woven fibers interlocked in the X and Y dimensions.
6. The staple cartridge of claim 5 , wherein the fibers of the flexible support layer are comprised of a biocompatible, absorbable suture material, selected from the group consisting of polydioxanon, Polyglycerol sebacate, Polyglycolic acid, Polycaprolactone, Polylactic acid, Polyhydroxyalkanoate, Poliglecaprone 25, polyglactin 910, polyglyconate, polyglocolide-trimethylene carbonate, polyhydroxybutyrate, poly(vinylpyrrolidone), poly(vinyl alcohol), absorbable polyurethanes, regenerated cellulose, and oxidized regenerated cellulose fibers.
7. The staple cartridge of claim 5 , wherein the fibers of the flexible support layer are comprised of suture filaments having a size in the range of about 8-0 to 4-0.
8. The staple cartridge of claim 5 , wherein the woven fibers of the flexible support layer are woven around and interlocked with the woven fibers of the compressible elastic core layer.
9. The staple cartridge of claim 1 , wherein the flexible support layer comprises a film.
10. The staple cartridge of claim 1 , wherein the woven fibers of the elastic core are non-interlocked woven fibers.
11. The staple cartridge of claim 1 , wherein a weave density of the elastic core layer is less dense than a weave density of the flexible support layers.
12. The staple cartridge of claim 1 , wherein the woven fibers of the elastic core layer have a size in the range of about 0 to 0-0.
13. The staple cartridge of claim 1 , wherein the adjunct material is selectively stiffened in certain regions.
14. The staple cartridge of claim 1 , wherein the adjunct material is comprised of a fleece, the fleece having a first density in the compressible elastic core layer and a second, different density in the flexible support layer.
15. The staple cartridge of claim 1 , wherein the woven fibers of the compressible elastic core layer oriented in the second direction are compacted to resist compression.
16. An end effector for a surgical instrument, comprising:
a first jaw having a cartridge body removably attached hereto, the cartridge body having a plurality of staple cavities configured to seat staples therein;
a second jaw having an anvil with a plurality of staples forming openings formed therein, wherein at least one of the first and second jaws is movable relative to the other; and
a tissue reinforcement comprising (i) a compressible elastic region configured to compress upon application of a compressive force and expand upon removal of the compressive force and (ii) a flexible support layer coupled to at least one surface of the compressible elastic core, wherein at least one of the compressible elastic region and the flexible support layer has a central region that is more dense than regions adjacent a perimeter of the at least one of the compressible elastic region or the flexible support layer, and wherein the tissue reinforcement is releasably retained on at least one of the tissue contacting surfaces of the cartridge body and the anvil for delivery to a tissue upon deployment of staples from the cartridge body through the compressible elastic region.
17. The end effector of claim 16 , wherein the central region is not transparent to light.
18. A method for implanting a tissue reinforcement, comprising;
engaging tissue between a cartridge assembly and an anvil of a surgical stapler at a surgical site, at least one of the cartridge assembly and anvil having a tissue reinforcement releasably retained thereon wherein,
the tissue reinforcement comprises a compressible elastic core configured to compress upon application of a compressive force and expand upon removal of the compressive force and a flexible support layer surrounding all sides of the compressible elastic core so as to envelop the elastic core; and
actuating the surgical stapler to eject staples from the cartridge assembly through the compressible elastic region and into the tissue, to maintain the tissue reinforcement at the surgical site.
19. The method of claim 18 , wherein the compressible elastic core layer is formed of a woven material that is more loosely woven than a woven material forming the flexible support layer.