Surgical stapler buttress assembly with humidity tolerant adhesive
View Patent ↗A buttress assembly is configured to temporarily adhere to a wet surgical stapler end effector. The buttress assembly includes a buttress body and a humidity tolerant adhesive. The adhesive includes a bioabsorbable polymer having a block configuration selected from the group consisting of A-B-A and A-B-C. The A block is a bioabsorbable homopolymer characterized by a glass transition temperature of at least about 0° C., a crystallinity as measured by X-ray diffraction of at least about 30%, and a melting temperature of at least about 50° C. The B block is a bioabsorbable homopolymer or co-polymer that is characterized by a glass transition temperature of at least about −40° C., a crystallinity as measured by X-ray diffraction of at most about 25%, and 2 a molecular weight of from about 20 to about 80 kDa. The C block is a bioabsorbable hydrophilic homopolymer or co-polymer that is miscible with water at 37° C.
1. A buttress assembly that is configured to temporarily adhere to a wet surgical stapler end effector, the buttress assembly comprising:
(a) a buttress body; and
(b) a humidity tolerant adhesive applied to at least one side of the buttress body, the humidity tolerant adhesive comprising a bioabsorbable polymer having a block configuration selected from the group consisting of:
(i) A-B-A, and
(ii) A-B-C,
wherein the A block is a bioabsorbable homopolymer characterized by a glass transition temperature of at least about 0° C., a crystallinity as measured by X-ray diffraction of at least about 30%, and a melting temperature of at least about 50° C.;
wherein the B block is a bioabsorbable homopolymer or co-polymer that is characterized by a glass transition temperature of at least about −40° C., a crystallinity as measured by X-ray diffraction of at most about 25%, and a molecular weight of from about 20 to about 80 kDa; and
wherein the C block is a bioabsorbable hydrophilic homopolymer or co-polymer that is miscible with water at 37° C.
2. The buttress assembly according to claim 1 , wherein the A block is a homopolymer selected from the group consisting of: poly(L-lactide) (PLLA); poly(caprolactone) (PCL); polyglycolide (PGA); poly(3-hydroxybutyrate) (PH 3 B); poly(3-hydroxyvalerate) (PHV); and poly(p-dioxanone) (PPDO).
3. The buttress assembly according to claim 1 , wherein the B block is a homopolymer or co-polymer comprising monomer(s) selected from the group consisting of: caprolactone (CL), L-Lactide (LLA), D,L-Lactide ((D,L)LA), Glycolide (GA), Polydioxanone (PDO), Trimethylene carbonate (TMC), sebacic acid (SA), 1,6-bis(carboxyphenoxy)hexane (CPH), and combinations thereof.
4. The buttress assembly according to claim 1 , wherein the C block is a hydrophilic homopolymer or co-polymer selected from the group consisting of: polyethylene oxide (PEO); polyethylene oxide-co-polypropylene oxide (PEO-co-PPO); polyethylene oxide-co-polysulfone (PEO-co-PSO); polyvinylpyrrolidine (PVP); polyacrylic acid (PAA); polyvinyl alcohol (PVOH).
5. The buttress assembly according to claim 1 , wherein the humidity tolerant adhesive comprises a bioabsorbable polymer having an A-B-A block configuration and a tackifying agent, wherein the humidity tolerant adhesive is extruded onto the at least one side of the buttress body.
6. The buttress assembly according to claim 5 , wherein the tackifying agent is a poly(L-lactide)-co-polyglycolide (PLGA) random heteropolymer having a molecular weight of from about 1 to about 8 kDA.
7. The buttress assembly according to claim 1 , wherein the humidity tolerant adhesive comprises a bioabsorbable polymer having an A-B-A block configuration and further comprising a tackifying agent, wherein the humidity tolerant adhesive is extruded to form a flexible film that is applied to at least one side of the buttress body.
8. The buttress assembly according to claim 1 , wherein the humidity tolerant adhesive comprises a bioabsorbable polymer having an A-B-C block configuration, wherein A is glycolide (GLY), B is a co-polymer of caprolactone-glycolide (CAP-co-GLY) and C is polyethylene oxide (PEO).
9. The buttress assembly according to claim 1 , wherein the buttress body comprises polyglactin 910.
10. The buttress assembly according to claim 9 , wherein the polyglactin 910 is in the form of a woven mesh.
11. A method of applying a buttress assembly to a wet surgical stapler end effector, wherein the end effector comprises an anvil and staple cartridge, the method comprising the steps of:
(a) positioning the buttress assembly between the anvil and the staple cartridge, wherein the buttress assembly comprises a buttress body and a humidity tolerant adhesive material, wherein the humidity tolerant adhesive material comprises a bioabsorbable polymer having a block configuration selected from the group of:
(i) A-B-A, and
(ii) A-B-C,
wherein the A block is a bioabsorbable homopolymer characterized by a glass transition temperature of at least about 0° C., and a crystallinity as measured by X-ray diffraction of at least about 30%,
wherein the B block is a bioabsorbable homopolymer or co-polymer that is characterized by a glass transition temperature of at least about −40° C., a crystallinity as measured by X-ray diffraction of at most about 25%, and a molecular weight of from about 20 to about 80 kDa,
wherein the C block is a bioabsorbable hydrophilic homopolymer or co-polymer that is miscible with water at 37° C.,
wherein the humidity tolerant adhesive material faces either an underside of the anvil or a deck of the staple cartridge, wherein the anvil is in an open position relative to the staple cartridge during the act of positioning the buttress assembly between the anvil and the staple cartridge;
(b) moving the anvil toward the staple cartridge to press the humidity tolerant adhesive material against the anvil or the staple cartridge; and
(c) moving the anvil back to the open position, wherein the buttress assembly is adhered to the anvil or the deck of the staple cartridge via the humidity tolerant adhesive material with the anvil moved back to the open position.
12. The method according to claim 11 , wherein the A block is a homopolymer selected from the group consisting of: poly(L-lactide) (PLLA); poly(caprolactone) (PCL); polyglycolide (PGA); poly(3-hydroxybutyrate) (PH 3 B); poly(3-hydroxyvalerate) (PHV); and poly(p-dioxanone) (PPDO).
13. The method according to claim 11 , wherein the B block is a homopolymer or co-polymer comprising monomer(s) selected from the group consisting of: caprolactone (CL), L-Lactide (LLA), D,L-Lactide ((D,L)LA), Glycolide (GA), Polydioxanone (PDO), Trimethylene carbonate (TMC), sebacic acid (SA), 1,6-bis(carboxyphenoxy)hexane (CPH), and combinations thereof.
14. The method according to claim 11 , wherein the C block is a hydrophilic homopolymer or co-polymer selected from the group consisting of: polyethylene oxide (PEO); polyethylene oxide-co-polypropylene oxide (PEO-co-PPO); polyethylene oxide-co-polysulfone (PEO-co-PSO); polyvinylpyrrolidine (PVP); polyacrylic acid (PAA); polyvinyl alcohol (PVOH).
15. The method according to claim 11 , wherein the humidity tolerant adhesive comprises a bioabsorbable polymer having an A-B-A block configuration and further comprising a tackifying agent, wherein the humidity tolerant adhesive is extruded onto the at least one side of the buttress body.
16. The method according to claim 15 , wherein the tackifying agent is a poly(L-lactide)-co-polyglycolide (PLGA) random heteropolymer having a molecular weight of from about 1 to about 8 kDA.
17. The method according to claim 15 , wherein the tackifying agent is a poly(L-lactide)-co-polyglycolide (PLGA) random heteropolymer having a molecular weight of from about 1 to about 8 kDA.
18. The method according to claim 11 , wherein the humidity tolerant adhesive comprises a bioabsorbable polymer having an A-B-A block configuration and further comprising a tackifying agent, wherein the humidity tolerant adhesive is extruded to form a flexible film that is applied to at least one side of the buttress body.
19. The method according to claim 11 , further comprising:
(a) removing the buttress assembly from the wet surgical stapler end effector; and
(b) re-applying the buttress assembly to the wet surgical stapler end effector.
20. A buttress assembly that is configured to temporarily adhere to a wet surgical stapler end effector, the buttress assembly comprising:
(a) a buttress body; and
(b) a humidity tolerant adhesive applied to at least one side of the buttress body, the humidity tolerant adhesive comprising a bioabsorbable polymer having a block configuration selected from the group of:
(i) A-B-A, and
(iii) A-B-C,
wherein the A block is bioabsorbable homopolymer selected from the group consisting of: poly(L-lactide) (PLLA); poly(caprolactone) (PCL); polyglycolide (PGA); poly(3-hydroxybutyrate) (PH 3 B); poly(3-hydroxyvalerate) (PHV); and poly(p-dioxanone) (PPDO),
wherein the B block is a homopolymer or co-polymer comprising monomer(s) selected from the group consisting of: caprolactone (CL), L-Lactide (LLA), D,L-Lactide ((D,L)LA), Glycolide (GA), Polydioxanone (PDO), sebacic acid (SA), 1,6-bis(carboxyphenoxy)hexane (CPH), and combinations thereof, and
wherein the C block is a hydrophilic homopolymer or co-polymer selected from the group consisting of: polyethylene oxide (PEO); polyethylene oxide-co-polypropylene oxide (PEO-co-PPO); polyethylene oxide-co-polysulfone (PEO-co-PSO); polyvinylpyrrolidine (PVP); polyacrylic acid (PAA); polyvinyl alcohol (PVOH).