Cover device for a surgical site, cartridge for a surgical stapler, and related surgical methods
A cartridge configured to be connected to a surgical stapler includes an anvil leg having an inwardly facing surface and a staple leg pivotally connected to the anvil leg. The staple leg includes a plurality of staples and an inwardly facing surface configured to move towards the inwardly facing surface of the anvil leg. The inwardly facing surface of the staple leg includes a plurality of openings positioned for the plurality of staples to pass through the plurality of openings to tissue positioned between the anvil leg and the staple leg. The cartridge also includes a cover device having at least one sheet of amnion attached to the inner surface of at least one of the anvil leg or the staple leg configured to attach to the tissue positioned between the inwardly facing surface of the anvil leg and the inwardly facing surface of the staple leg.
1 . A cartridge configured to be connected to a surgical stapler, comprising
an anvil leg comprising an inwardly facing surface;
a staple leg pivotally connected to the anvil leg comprising a plurality of staples positioned in an interior of the staple leg and an inwardly facing surface configured to move towards the inwardly facing surface of the anvil leg, the inwardly facing surface comprising a plurality of openings positioned for the plurality of staples to pass through the plurality of openings to tissue positioned between the inwardly facing surface of the anvil leg and the inwardly facing surface of the staple leg, and
a cover device comprising at least one sleeve comprising at least two layers with an inner-most layer of the at least two layers that is configured to contact wetted patient tissue comprising dried and chorion-free amnion attached to the inwardly facing surface of at least one of the anvil leg or the staple leg, the at least one sleeve comprising a proximal end, a distal end, and a curved surface extending therebetween,
wherein the at least one sleeve is configured to separate from the inwardly facing surface of at least one of the anvil leg or the staple leg due to forces exerted on the at least one sleeve by the plurality of staples and is configured to adhere and/or remain connected to the wetted patient tissue, such that the at least one sleeve attaches to the tissue positioned between the inwardly facing surface of the anvil leg and the inwardly facing surface of the staple leg with the plurality of staples securing the at least one sleeve to the tissue.
2 . The cartridge of claim 1 , wherein the at least one sleeve comprises a sheet having a thickness of about 50 μm to about 100 μm.
3 . The cartridge of claim 1 , wherein the at least one sleeve has a width of about 3 cm to 5 cm and a length of about 5 cm to 7 cm.
4 . The cartridge of claim 1 , wherein the plurality of openings of the inwardly facing surface of the staple leg is arranged in a substantially linear pattern producing a stapled region that is from 1 to 3 staples in width and from 3 to 10 staples in length.
5 . The cartridge of claim 1 , wherein the cartridge is configured to simultaneously release the plurality of staples through the plurality of openings upon triggering of the surgical stapler creating at least one staple line through the tissue.
6 . The cartridge of claim 1 , wherein the cartridge comprises a connector extending from a proximal end of the anvil leg or the staple leg, the connector being configured to engage a corresponding port of a handle of the surgical stapler for connecting the cartridge to the handle.
7 . The cartridge of claim 1 , wherein the surgical stapler is a gastrointestinal stapler.
8 . A cover device configured to be positioned on a leg of a surgical stapler and to transfer from the leg of the surgical stapler to tissue at a surgical site during a stapling procedure, the cover device comprising
at least one sleeve comprising at least two layers with an inner-most layer of the at least two layers that is configured to contact wetted patient tissue comprising dried and chorion-free amnion configured to be attached to an inwardly facing surface of the leg of the surgical stapler, the at least one sleeve comprising a proximal end, a distal end, and a curved surface extending therebetween,
wherein the at least one sleeve is configured to separate from the inwardly facing surface of the leg of the surgical stapler due to forces exerted on the at least one sleeve by a plurality of staples released by the surgical stapler and is configured to adhere and/or remain connected to the wetted patient tissue, such that the at least one sleeve attaches to the tissue at the surgical site with the plurality of staples securing the at least one sleeve to the tissue.
9 . A method for performing a surgical procedure, comprising:
preparing a surgical stapler comprising a cartridge for the surgical procedure, wherein the cartridge comprises:
an anvil leg comprising an inwardly facing surface;
a staple leg pivotally connected to the anvil leg comprising a plurality of staples positioned in an interior of the staple leg and an inwardly facing surface configured to move towards the inwardly facing surface of the anvil leg, the inwardly facing surface comprising a plurality of openings positioned for the plurality of staples to pass through the plurality of openings, and
a cover device comprising at least one sleeve comprising at least two layers with an inner-most layer of the at least two layers that is configured to contact wetted patient tissue comprising dried and chorion-free amnion attached to the inwardly facing surface of at least one of the anvil leg or the staple leg, the at least one sleeve comprising a proximal end, a distal end, and a curved surface extending therebetween;
positioning patient tissue of a surgical site between the anvil leg and the staple leg of the cartridge;
tightening the cartridge causing the staple leg to move toward the anvil leg and causing at least a portion of the curved surface of the at least one sleeve to press against the patient tissue, such that the at least one sleeve adheres and/or remains connected to the wetted patient tissue; and
activating the surgical stapler causing the plurality of staples to pass from the staple leg through the patient tissue and the at least one sleeve, thereby causing the at least one sleeve to separate from the inwardly facing surface of at least one of the anvil leg or the staple leg due to forces exerted on the at least one sleeve by the plurality of staples and forming at least one staple line in the patient tissue that secures the at least one sleeve to the patient tissue.
10 . The cartridge of claim 1 , wherein the at least one sleeve further comprises a perforated line extending longitudinally through the at least one sleeve between the proximal end and the distal end of the at least one sleeve, and wherein the forces exerted on the at least one sleeve by the plurality of staples cause the at least one sleeve to separate along the perforated line, thereby separating the at least one sleeve from the inwardly facing surface of at least one of the anvil leg or the staple leg.
11 . The cartridge of claim 1 , wherein the at least one sleeve is formed from a 5 cm by 7 cm rectangular sheet of amnion or 4 cm by 6 cm rectangular sheet of amnion.
12 . The method of claim 9 , wherein the at least one sleeve further comprises a perforated line extending longitudinally through the at least one sleeve between the proximal end and the distal end of the at least one sleeve, and wherein the forces exerted on the at least one sleeve by the plurality of staples cause the at least one sleeve to separate along the perforated line, thereby separating the at least one sleeve from the inwardly facing surface of at least one of the anvil leg or the staple leg so that the at least one sleeve is secured to the patient tissue by the plurality of staples.
13 . The method of claim 9 , wherein activating the surgical stapler releases the plurality of staples producing at least two parallel lines of staples.
14 . The method of claim 9 , wherein the surgical procedure comprises a side-to-side anastomosis, and wherein positioning patient tissue between the anvil leg and the staple leg of the cartridge comprises inserting the anvil leg and the staple leg through open ends of tubular structures of the gastrointestinal tract of the patient that are to be joined together.