Inducing tissue adhesions using surgical adjuncts and medicants

• US 10,245,034 B2
• Filed: 08/31/2015
• Issued: 04/02/2019
• Est. Priority Date: 08/31/2015
• Status: Active Grant

• Current Assignee: Ethicon, LLC (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Shelton, IV, Frederick E., Harris, Jason L., Vendely, Michael J., Scheib, Charles J.
• Primary Examiner(s): Long, Robert
• Application Number:
  US14/841,147
• Publication Number:
  US 20170055989A1
• Time in Patent Office: 1,310 Days
• Field of Search: 2271751-1821
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/22 for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Tissue adhesions using surgical adjuncts and medicants are provided. In general, an implantable adjunct can have one or more medicants releasably retained therein that are configured to induce tissue adhesions. The adjunct can be configured to be applied to lung tissue in conjunction with surgical staples using a surgical stapler. Pleurodesis can be encouraged through delivery of the adjunct to the lung tissue.

Claims

1. A staple cartridge assembly for use with a surgical stapler, comprising:

a cartridge body having a plurality of staple cavities, each staple cavity having a surgical staple disposed therein;

a biocompatible adjunct material releasably retained on the cartridge body and configured to be delivered to lung tissue by deployment of the staples in the cartridge body to form at least one line of deployed staples, the adjunct material having a conformable layer, a reinforcing layer, and a barrier layer disposed between the conformable layer and the reinforcing layer, the conformable layer being configured to conform to an irregular surface of lung tissue such that the conformable layer is configured to conform to expansion and extension of lung tissue; and

an effective amount of at least one medicant, the at least one medicant being disposed within and releasable from the conformable layer, the at least one medicant being effective to induce tissue adhesions adjacent the at least one line of deployed staples, the barrier layer preventing release of the medicant from the conformable layer into the reinforcing layer,

wherein the adjunct material includes a carrier configured to undergo a phase change from a solid state to a liquid state, the at least one medicant being configured to be released from the adjunct material with the carrier in the liquid state but not in the solid state, the at least one medicant being encapsulated in microcapsules dispersed in the carrier, the microcapsules being configured to adhere to soft tissue by having a coating thereon of an adhesive tissue adherent agent.

2. The assembly of claim 1, wherein the adjunct material is configured to release the at least one medicant therefrom as a single released dose.

3. The assembly of claim 1, wherein the at least one medicant includes a growth factor.

4. The assembly of claim 1, wherein the at least one medicant includes at least one of interleukin (IL) beta, Tissue Growth Factor Beta (TGF-B), and platelet rich plasma.

5. A method of using the staple cartridge assembly of claim 1, the method comprising:

removably attaching the cartridge body to a surgical stapler;

positioning the stapler at a target location adjacent lung tissue; and

with the stapler positioned at the target location, actuating the stapler to deploy the staples from the cartridge body and into the lung tissue, thereby delivering the adjunct material to the lung tissue.

6. The method of claim 5, wherein the at least one medicant is effective to induce tissue adhesions between pleural surfaces of the lung tissue having the adjunct material delivered thereto.

13. The assembly of claim 1, further comprising a marker attached to the adjunct material, the marker being configured to mark a location on lung tissue.

14. The method of claim 5, wherein the reinforcing layer of the delivered adjunct material abuts against the lung tissue.

17. The assembly of claim 1, wherein the carrier is configured to change state due to exposure to light.

7. An end effector for a surgical instrument, comprising:

a first jaw having a cartridge body removably attached thereto, the cartridge body having on a tissue-facing surface thereof a plurality of staple cavities configured to seat staples therein;

a second jaw having an anvil with a plurality of staple forming cavities formed on a tissue-facing surface thereof, wherein at least one of the first and second jaws is movable relative to the other;

a biocompatible adjunct material releasably retained on at least one of the tissue-facing surfaces of the first and second jaws and configured to be delivered to lung tissue by deployment of the staples in the cartridge body to form at least one line of deployed staples, the adjunct material having a conformable layer, a reinforcing layer, and a barrier layer disposed between the conformable layer and the reinforcing layer, the conformable layer being configured to conform to an irregular surface of lung tissue such that the conformable layer is configured to conform to expansion and extension of lung tissue; and

an effective amount of at least one medicant, the at least one medicant being disposed within and releasable from the conformable layer, the at least one medicant being effective to induce tissue adhesions adjacent the at least one line of deployed staples, the barrier layer preventing release of the medicant from the conformable layer into the reinforcing layer,

wherein the adjunct material includes a carrier configured to undergo a phase change from a solid state to a liquid state, the at least one medicant being configured to be released from the adjunct material with the carrier in the liquid state but not in the solid state, the at least one medicant being encapsulated in microcapsules dispersed in the carrier, the microcapsules being configured to adhere to soft tissue by having a coating thereon of an adhesive tissue adherent agent.

8. The end effector of claim 7, wherein the adjunct material is configured to release the at least one medicant therefrom as a single released dose.

9. The end effector of claim 7, wherein the at least one medicant includes a growth factor.

10. The end effector of claim 7, wherein the at least one medicant includes at least one of interleukin (IL) beta, Tissue Growth Factor Beta (TGF-B), and platelet rich plasma.

11. A method of using the end effector of claim 7, the method comprising:

positioning a surgical stapler at a target location within a patient adjacent lung tissue, the stapler having the end effector at a distal end thereof; and

with the stapler positioned at the target location, actuating the stapler to deploy the staples from the cartridge body and into the tissue, thereby delivering the adjunct material to the lung tissue.

12. The method of claim 11, wherein the at least one medicant is effective to induce tissue adhesions between pleural surfaces of the lung tissue having the adjunct material delivered thereto.

15. The end effector of claim 7, further comprising a marker attached to the adjunct material, the marker being configured to mark a location on lung tissue.

16. The method of claim 11, wherein the reinforcing layer of the delivered adjunct material abuts against the lung tissue.

18. The end effector of claim 7, wherein the carrier is configured to change state due to exposure to light.