Medical devices and methods useful for applying bolster material
Described are medical devices useful for applying a bolster material to a surgical fastening device such as a stapler, and related methods of manufacture and use. The devices include an applicator element for receipt between arms of the stapler, and a bolster material, desirably a remodelable extracellular matrix material, coupled to the applicator element. In certain embodiments, the bolster material is held by the applicator element, for example having at least a portion looped around or received through or over a portion of the applicator element. Also described are unique implantable materials including coatings of dried, reversible adhesive.
1. A medical device useful for applying a bolster material to a surgical fastening device having a first arm and a second arm presenting respective first arm and second arm surfaces, the medical device comprising:
an applicator element which is receivable between the first and second arms, said applicator element having a first side and a second side;
a first piece of bolster material coupled to the applicator element and presented at said first side of said applicator element for contact with at least said first arm surface;
a first adhesive coating layer comprising a dried adhesive material carried on a surface of said first piece of bolster material and configured to temporarily adhere said first piece of bolster material to said first arm surface;
a second piece of bolster material coupled to the applicator element and presented at said second side of said applicator element for contact with said second arm surface;
a second adhesive coating layer comprising a dried adhesive material carried on a surface of said second piece of bolster material and configured to temporarily adhere said second piece of bolster material to said second arm surface;
wherein said first and second pieces of bolster material each have a plurality of tucked portions comprising outwardly facing surface portions tucked under corresponding overlying portions of said applicator element, said surface portions of said first and second pieces of bolster material held against surfaces of said overlying portions, and wherein said first and second pieces of bolster material each have a plurality of untucked portions extending between said tucked portions, said untucked portions comprising outwardly facing surface portions including a longitudinal lateral edge of each of the first and second pieces of bolster material which are not covered by the applicator element; and
a sterile package, wherein said medical device is contained within said sterile package.
2. The medical device of claim 1 , wherein said first piece of bolster material and said second piece of bolster material comprise a bioresorbable synthetic polymer.
3. The medical device of claim 2 , wherein said first piece bolster material and said second piece of bolster material each comprise a multilaminate bolster material.
4. The medical device of claim 1 , wherein the first piece of bolster material and the second piece of bolster material each comprises collagen.
5. The medical device of claim 4 , wherein the first piece of bolster material and the second piece of bolster material each comprises an extracellular matrix material.
6. The medical device of claim 1 , wherein the first piece of bolster material includes at least one weakened area adapted for creating a separation in the first piece of bolster material.
7. The medical device of claim 6 , wherein said second piece of bolster material includes at least one weakened area adapted for creating a separation in the second piece of bolster material.
8. The medical device of claim 1 , wherein the applicator element includes at least one weakened area adapted for creating a separation in the applicator element.
9. The medical device of claim 1 , wherein the applicator element is made of a material susceptible to manual tearing.
10. The medical device of any of claim 1 , wherein the applicator element comprises a compressible material.
11. The medical device of claim 10 , wherein the compressible material is a polymer foam.
12. The medical device of claim 1 , wherein, said overlying portions of said applicator element configured with a sufficiently low coefficient of friction so as be slidable in relation to said tucked portions.
13. The medical device of claim 1 , wherein said first piece of bolster material and said second piece of bolster material each have a thickness of 50 to 1000 microns.
14. The medical device of claim 1 , wherein said adhesive is covered by a release paper.