IP Library Granted Patent US 12,059,153
Granted Patent B2
US 12,059,153 · App. 17/217,578 · Granted Aug 13, 2024

Implantable adjuncts having adjustable degradation profile

Inventors: Frederick E. Shelton, IV (Hillsboro, OH); Michael J. Vendely (Lebanon, OH); Jason L. Harris (Lebanon, OH)
Assignee: Cilag GmbH International
A61B17/07292A61B2017/00004A61B2017/00893A61B2017/00938A61B2017/00942A61B2017/07257A61B2017/07271A61B2017/07278A61B2017/07285
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Quick Facts
Patent No.
US 12,059,153
App. No.
17/217,578
Granted
Aug 13, 2024
Kind
B2
Abstract

A compressible adjunct kit for use with a staple cartridge is provided and includes a biocompatible adjunct material and a pretreatment fluid. The biocompatible adjunct material is configured to be releasably retained on a staple cartridge and is configured to be delivered to tissue by deployment of staples in the staple cartridge. The adjunct material can be in the form of a porous polymer body. The pretreatment fluid is configured to be applied to the adjunct material to change the adjunct material from an untreated state to a treated state. The adjunct material in the untreated state is configured to exhibit a first degradation profile when delivered to tissue. The adjunct material in the treated state is configured to exhibit a second degradation profile, different from the first degradation profile, when delivered to tissue.

Claims (66)

1. A compressible adjunct kit for use with a staple cartridge, the compressible adjunct kit comprising:

a biocompatible adjunct material configured to be releasably retained on a staple cartridge body and configured to be delivered to tissue by deployment of staples in the staple cartridge, the adjunct material comprising a porous polymer body, and the adjunct material being configured to be selectively delivered to the tissue in either an untreated state or a treated state; and

a pretreatment fluid configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue to change the adjunct material from the untreated state that is configured to exhibit a first degradation profile after the adjunct material in the untreated state is delivered to the tissue, to the treated state that is configured to exhibit a second degradation profile, different from the first degradation profile, after the adjunct material in the treated state is delivered to the tissue;

wherein the pretreatment fluid is configured to one of (1) increase a rate of degradation of the second degradation profile with respect to the first degradation profile and (2) decrease the rate of degradation of the second degradation profile with respect to the first degradation profile;

the compressible adjunct kit further comprises a second pretreatment fluid configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue; and

the second pretreatment fluid is configured to the other one of (1) increase the rate of degradation of the second degradation profile with respect to the first degradation profile and (2) decrease the rate of degradation of the second degradation profile with respect to the first degradation profile.

2. The compressible adjunct kit of claim 1 , wherein the pretreatment fluid is configured to cause the adjunct material in the treated state to increase a pH adjacent to the adjunct material when delivered to the tissue.

3. The compressible adjunct kit of claim 1 , wherein the pretreatment fluid is configured to increase a degree of hydrophilicity of the adjunct material in the treated state.

4. The compressible adjunct kit of claim 1 , wherein the pretreatment fluid is configured to form a coating that is deposited on at least a portion of the adjunct material in the treated state.

5. The compressible adjunct kit of claim 1 , wherein the pretreatment fluid is configured to react with the adjunct material to change a terminal functional group of at least a portion of a polymer chain forming the porous polymer body in the treated state.

6. The compressible adjunct kit of claim 1 , wherein the pretreatment fluid is configured to increase a degree of hydrophobicity of the adjunct material in the treated state as compared to the untreated state.

7. The compressible adjunct kit of claim 1 , wherein the pretreatment fluid is configured to form a sealant that seals at least a portion of pores in the porous polymer body.

8. The compressible adjunct kit of claim 1 , wherein the pretreatment fluid is configured to terminate at least a portion of a plurality of polymer chains of the porous polymer body such that an average length of the plurality of polymer chains of the polymer body in the treated state is less than an average length of the plurality of polymer chains of the polymer body in the untreated state.

9. The compressible adjunct kit of claim 1 , wherein the second pretreatment fluid is configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue so as to allow a user of the adjunct material to select whether to:

apply the pretreatment fluid to the adjunct material prior to the adjunct material being delivered to the tissue,

apply the second pretreatment fluid to the adjunct material prior to the adjunct material being delivered to the tissue, or

apply neither of the pretreatment fluid and the second pretreatment fluid to the adjunct material.

10. The compressible adjunct kit of claim 1 , wherein the adjunct material with the pretreatment fluid applied thereto is configured to not begin degrading according to the second degradation profile until after the adjunct material in the treated state is delivered to the tissue; and

the adjunct material without the pretreatment fluid applied thereto is configured to not begin degrading according to the first degradation profile until after the adjunct material in the untreated state is delivered to the tissue.

11. The compressible adjunct kit of claim 1 , wherein the pretreatment fluid is configured to one of increase or decrease a rate of chemical reaction between bodily fluids containing water and the adjunct material in the treated state, as compared to the adjunct material in the untreated state.

12. A compressible adjunct kit for use with a staple cartridge, the compressible adjunct kit comprising:

a biocompatible adjunct material configured to be releasably retained on a staple cartridge body and configured to be delivered to tissue by deployment of staples in the staple cartridge, the adjunct material comprising a porous polymer body, and the adjunct material being configured to be selectively delivered to the tissue in either an untreated state or a treated state;

a pretreatment fluid configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue to change the adjunct material from the untreated state that is configured to exhibit a first degradation profile after the adjunct material in the untreated state is delivered to the tissue, to the treated state that is configured to exhibit a second degradation profile, different from the first degradation profile, after the adjunct material in the treated state is delivered to the tissue; and

a second pretreatment fluid configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue;

wherein the tissue is tissue in a body of a patient;

the pretreatment fluid is configured to increase a rate of degradation of the second degradation profile with respect to the first degradation profile by:

increasing a rate of chemical reaction between the adjunct material and water in the body of the patient,

increasing an area of contact between the adjunct material and the water in the body of the patient,

increasing hydrophilicity of surfaces of the adjunct material, or

raising a pH of material adjacent to the adjunct material after the adjunct material in the treated state is delivered to the tissue; and

the second pretreatment fluid is configured to decrease the rate of degradation of the second degradation profile with respect to the first degradation profile.

13. The compressible adjunct kit of claim 12 , wherein the second pretreatment fluid is configured to decrease the rate of degradation of the second degradation profile with respect to the first degradation profile by:

increasing hydrophobicity of the adjunct material,

sealing at least a portion of pores of the porous polymer body,

changing a terminal functional group of at least a portion of a polymer chain forming the porous polymer body, or

terminating at least a portion of a plurality of polymer chains of the porous polymer body.

14. A compressible adjunct kit for use with a staple cartridge, the compressible adjunct kit comprising:

a biocompatible adjunct material configured to be releasably retained on a staple cartridge body and configured to be delivered to tissue by deployment of staples in the staple cartridge, the adjunct material comprising a porous polymer body, and the adjunct material being configured to be selectively delivered to the tissue in either an ontreated state or a treated state; and

a pretreatment fluid configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue to change the adjunct material from the untreated state that is configured to exhibit a first degradation profile after the adjunct material in the untreated state is delivered to the tissue, to the treated state that is configured to exhibit a second degradation profile, different from the first degradation profile, after the adjunct material in the treated state is delivered to the tissue; and

a second pretreatment fluid configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue;

wherein the pretreatment fluid is configured to decrease a rate of degradation of the second degradation profile with resp ct to the first degradation profile by:

increasing hydrophobicity of the adjunct material,

sealing at least a portion of pores of the porous polymer body,

changing a terminal functional group of at least a portion of a polymer chain forming the porous polymer body, or

terminating at least a portion of a plurality of polymer chains of the porous polymer body; and

the second pretreatment fluid is configured to increase the rate of degradation of the second degradation profile with respect to the first degradation profile.

15. The compressible adjunct kit of claim 14 , wherein the second pretreatment fluid is configured to increase the rate of degradation of the second degradation profile with respect to the first degradation profile by:

increasing a rate of chemical reaction between the adjunct material and water in the body of the patient,

increasing an area of contact between the adjunct material and the water in the body of the patient,

increasing hydrophilicity of surfaces of the adjunct material, or

raising a pH of material adjacent to the adjunct material after the adjunct material in the treated state is delivered to the tissue.

16. A compressible adjunct kit for use with a staple cartridge, the compressible adjunct kit comprising:

a biocompatible adjunct material configured to be releasably retained on a staple cartridge body and configured to be delivered to tissue by deployment of staples in the staple cartridge, the adjunct material comprising a porous polymer body, and the adjunct material being configured to be selectively delivered to the tissue in either an untreated state or a treated state;

a pretreatment fluid configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue to change the adjunct material from the untreated state that is configured to exhibit a first degradation profile after the adjunct material in the untreated state is delivered to the tissue, to the treated state that is configured to exhibit a second degradation profile, different from the first degradation profile, after the adjunct material in the treated state is delivered to the tissue;

a second pretreatment fluid configured to be applied to the adjunct material prior to the adjunct material being delivered to the tissue so as to allow a user of the adjunct material to select whether to:

apply the pretreatment fluid to the adjunct material prior to the adjunct material being delivered to the tissue,

apply the second pretreatment fluid to the adjunct material prior to the adjunct material being delivered to the tissue, or

apply neither of the pretreatment fluid and the second pretreatment fluid to the adjunct material;

wherein the pretreatment fluid is configured to one of (1) increase a rate of degradation of the second degradation profile with respect to the first degradation profile and (2) decrease the rate of degradation of the second degradation profile with respect to the first degradation profile; and

the second pretreatment fluid is configured to the other one of (1) increase the rate of degradation of the second degradation profile with respect to the first degradation profile and (2) decrease the rate of degradation of the second degradation profile with respect to the first degradation profile.

17. The compressible adjunct kit of claim 16 , wherein the tissue is tissue in a body of a patient; and

the pretreatment fluid is configured to increase the rate of degradation of the second degradation profile with respect to the first degradation profile by:

increasing a rate of chemical reaction between the adjunct material and water in the body of the patient,

increasing an area of contact between the adjunct material and water in the body of the patient,

increasing hydrophilicity of surfaces of the adjunct material, or

raising a pH of material adjacent to the adjunct material after the adjunct material in the treated state is delivered to the tissue.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 15, 2022
From: SHELTON, FREDERICK E., IV; VENDELY, MICHAEL J.; HARRIS, JASON L.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 059016/0823 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2021
From: ETHICON LLC
To: CILAG GMBH INTERNATIONAL
Reel/Frame 056601/0339 →
Continuity (1)
Related Publication 20220313259A1 · Oct 6, 2022
Cited By (1)
US 12,329,377