Medicant eluting adjuncts and methods of using medicant eluting adjuncts

• US 10,569,071 B2
• Filed: 08/31/2015
• Issued: 02/25/2020
• Est. Priority Date: 08/31/2015
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Harris, Jason L., Shelton, IV, Frederick E., Vendely, Michael J., Widenhouse, Tamara S.
• Primary Examiner(s): Holwerda, Kathleen S
• Assistant Examiner(s): Labranche, Brooke
• Application Number:
  US14/840,613
• Publication Number:
  US 20170055986A1
• Time in Patent Office: 1,639 Days
• Field of Search: 2271751, 606 75, 606219
• 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 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

Various exemplary devices and methods are provided for performing surgical procedures. In general, one or more adjuncts can be used in conjunction with surgical instruments. The adjunct(s) can have medicant(s) thereon and/or therein. The medicant(s) can vary depending on the desired effect of the medicant(s) on surrounding tissue. As a non-limiting example, medicant(s) can be provided to influence hemostasis, inflammation, macrophages, and/or fibroblasts. When used in conjunction with a surgical stapler, the adjunct(s) can be disposed between and/or on jaws of the stapler, incorporated into a staple cartridge disposed in the jaws, or otherwise placed in proximity to the staples. When staples are deployed, the adjunct(s) can remain at the treatment site with the staples.

Claims

1. A surgical method, comprising:

positioning an end effector of a surgical stapler adjacent tissue of a patient, the end effector having disposed therein a cartridge body including a plurality of staples, and the end effector having releasably disposed thereon a biocompatible adjunct material, the adjunct material having an effective amount of at least one medicant disposed within and releasable from the adjunct material, the adjunct material having at least a first layer and a second layer, the first layer including at least first and second distinct portions disposed along at least an outer surface of the first layer, each of the first and second distinct portions of the first layer having a distinct degradation rate from each of the other first and second distinct portion of the first layer, each of the first and second distinct portions being arranged on the outer surface such that a degradation rate of the first layer varies along at least one of a total length and a total width of the outer surface, the first distinct portion being disposed along only a first side of the outer surface of the first layer, the second distinct portion being disposed along only a second side of the outer surface of the first layer, the second layer being disposed entirely within the first layer; and

actuating the stapler to eject the staples out of openings in the cartridge body, thereby stapling the adjunct material to the tissue and releasing the adjunct material from the cartridge body, the at least one medicant being releasable from the adjunct material to the tissue according to at least a predetermined temporal pattern that is defined by the degradation rates of the at least first and second distinct portions of the first layer and a different degradation rate of the second layer;

wherein the first distinct portion has thin fibers configured to encourage regrowth, and the second distinct portion has thicker fibers relative to the thin fibers of the first distinct portion configured to discourage regrowth.

2. The method of claim 1, wherein the at least one medicant is releasable from the adjunct material to the tissue according to at least the predetermined temporal pattern, and the predetermined temporal pattern includes a substantially immediate release of the at least one medicant upon the stapling of the adjunct material.

3. The method of claim 1, wherein the at least one medicant is releasable from the adjunct material to the tissue according to at least the predetermined temporal pattern, and the predetermined temporal pattern includes the at least one medicant not being released from the adjunct material until a predetermined amount of time after the stapling of the adjunct material.

4. The method of claim 1, wherein the at least one medicant is releasable from the adjunct material to the tissue according to at least the predetermined temporal pattern, and the predetermined temporal pattern is defined by at least one of a degradation rate of a region within the adjunct material from which the at least one medicant is being released, a degradation rate of one or more coatings retaining the at least one medicant within the adjunct material, and an environmental condition at the tissue.

5. The method of claim 1, wherein the at least one medicant is releasable from the adjunct material to the tissue according to at least a predetermined spatial pattern, the adjunct material including a plurality of distinct regions each releasably retaining therein the at least one medicant, the at least one medicant being releasable from each of the regions in a different spatial pattern.

6. The method of claim 1, further comprising, prior to positioning the end effector adjacent the tissue of the patient, removably disposing the cartridge body into the end effector.

7. The method of claim 1, further comprising removing the surgical stapler from the patient, the staples and the adjunct material remaining within the patient.

8. The method of claim 1, wherein the at least one medicant includes at least one of an antimicrobial agent, an antifungal agent, an antiviral agent, an anti-inflammatory agent, a growth factor, an analgesic, an anesthetic, a tissue matrix degradation inhibitor, an anti-cancer agent, and a hemostatic agent.

9. The method of claim 1, wherein the at least one medicant includes a first medicant and a second medicant that is different than the first medicant, the first layer has only the first medicant disposed therein, and the second layer has only the second medicant disposed therein.

10. The method of claim 1, wherein the at least one medicant includes only a first medicant, and the first and second layer each have the first medicant disposed therein.

11. The method of claim 1, wherein the first and second sides of the outer surface of the first layer are disposed opposite to each other relative to only one of the total length and the total width of the outer surface such that the degradation rate of the first layer is configured to release the at least one medicant in a first elution profile along the total length and a second elution profile along the total width, the first and second elution profiles being different from each other.

12. The method of claim 1, wherein each of the first and second distinct portions are arranged such that the degradation rate of the first layer varies continuously across one of the total length or the total width of the outer surface.

13. A surgical method, comprising:

positioning an end effector of a surgical stapler adjacent an organ of a patient, the end effector having disposed therein a cartridge body including a plurality of staples, and the end effector having a biocompatible adjunct material releasably disposed on a first external surface thereof, the adjunct material having a plurality of distinct regions each having an effective amount of at least one medicant disposed within and releasable therefrom;

actuating the stapler to deploy the staples from the cartridge body, thereby stapling the adjunct material to the organ and releasing the adjunct material from the end effector, the plurality of distinct regions releasing the medicant in a predetermined spatial pattern, the adjunct material having a predetermined spatial structure, and the spatial pattern of the plurality of distinct regions and the spatial structure of the adjunct material encouraging regrowth of tissue of the organ in at least a first location on the organ and discourage regrowth of tissue in at least a second location of the organ, the plurality of distinct regions including a first fiber lattice section having a first plurality of fibers configured to encourage the regrowth and a second fiber lattice section having a second plurality of fibers being less tightly spaced relative to the fibers of the first plurality of fibers and configured to discourage the regrowth, the first and second fiber lattice sections being disposed together along a second external surface of the adjunct material, each fiber of the first plurality of fibers extending substantially parallel to each other fiber of the first plurality of fibers along the second external surface, and each fiber of the second plurality of fibers extending substantially parallel to each other fiber of the second plurality of fibers along the second external surface; and

after the actuation, removing the end effector with the cartridge body disposed therein from the patient;

wherein the first fiber lattice section has thin fibers configured to encourage regrowth, and the second fiber lattice section has thicker fibers relative to the thin fibers of the first fiber lattice section configured to discourage regrowth.

14. The method of claim 13, wherein the predetermined treatment includes at least one of an antimicrobial effect, an antifungal effect, an antiviral effect, an anti-inflammatory effect, a growth factor effect, an analgesic effect, an anesthetic effect, tissue matrix degradation inhibition, an anti-cancer effect, and a hemostatic effect.

15. The method of claim 13, wherein encouraging regrowth of tissue of the organ includes causing the tissue to regrow in a direction that mimics a natural direction of tissue fibers of the organ.

16. The method of claim 13, wherein the adjunct material is stapled to an exterior surface of the organ.

17. The method of claim 13, wherein the adjunct material is stapled to an interior surface of the organ.

18. The method of claim 13, wherein the organ includes one of a stomach, an intestine, a liver, and a lung.

19. The method of claim 13, further comprising removably and replaceably disposing the cartridge body with the staples therein into the end effector.

20. The method of claim 13, wherein the second external surface of the adjunct material extends parallel to the first external surface of the end effector.

21. A surgical method, comprising:

positioning an end effector of a surgical stapler adjacent an organ of a patient, the end effector having disposed therein a cartridge body including a plurality of staples, and the end effector having a biocompatible adjunct material releasably disposed on a first external surface thereof, the adjunct material having a plurality of distinct regions each having an effective amount of at least one medicant disposed within and releasable therefrom;

actuating the stapler to deploy the staples from the cartridge body, thereby stapling the adjunct material to the organ and releasing the adjunct material from the end effector, the plurality of distinct regions releasing the medicant in a predetermined spatial pattern, the adjunct material having a predetermined spatial structure, and the spatial pattern of the plurality of distinct regions and the spatial structure of the adjunct material encouraging regrowth of tissue of the organ in at least a first location on the organ and discourage regrowth of tissue in at least a second location of the organ, the plurality of distinct regions including a first fiber lattice section having a first plurality of fibers configured to encourage the regrowth and a second fiber lattice section having a second plurality of fibers being less tightly spaced relative to the fibers of the first plurality of fibers and configured to discourage the regrowth, the first and second fiber lattice sections being disposed together along a second external surface of the adjunct material, each fiber of the first plurality of fibers extending substantially parallel to each other fiber of the first plurality of fibers along the second external surface, and each fiber of the second plurality of fibers extending substantially parallel to each other fiber of the second plurality of fibers along the second external surface; and

after the actuation, removing the end effector with the cartridge body disposed therein from the patient;

wherein the first fiber lattice section has positively charged fibers configured to encourage regrowth, and the second fiber lattice section has negatively charged fibers configured to discourage regrowth.