Support structures and methods of using the same

• US 20060085034A1
• Filed: 09/30/2005
• Published: 04/20/2006
• Est. Priority Date: 10/18/2004
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Bettuchi, Michael J.
• Granted Patent: US 7,938,307 B2
• Time in Patent Office: Days
• US Class Current: 606/219
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1152 applying the staples on the outside of the lumen
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00853 low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/1157 applying the staples radially

Abstract

According to an aspect of the present disclosure, an apparatus for forming an anastomosis between adjacent intestinal sections of tissue is provided. The apparatus includes an anastomosis device having an anvil and a tubular body portion, wherein the anvil is selectively attachable to the tubular body portion by a shaft; and a support structure for deposition between the intestinal sections of tissue. The support structure includes a body defining an aperture therein for receiving the shaft. The body has an outer terminal edge. The support structure includes at least one layer of expandable material disposed at the outer terminal edge of the body.

Claims

1. An apparatus for forming an anastomosis between adjacent intestinal sections of tissue, comprising:

a) an anastomosis device having an anvil and a tubular body portion, the anvil being selectively attachable to the tubular body portion by a shaft; and

b) a support structure for deposition between the intestinal sections of tissue, the support structure including a body defining an aperture therein for receiving the shaft, the body having an outer terminal edge, the support structure including at least one layer of expandable material disposed at the outer terminal edge of the body.

2. The apparatus according to claim 1, wherein the at least one layer of expandable material comprises a first and a second membrane extending radially outward from the outer terminal edge of the body portion.

3. The apparatus according to claim 1, wherein the aperture is defined by an inner terminal edge of the body, the inner terminal edge being disposed radially inward of staple receiving slots of a staple cartridge assembly disposed in the tubular body portion.

4. The apparatus according to claim 2, wherein each of the first and second membranes is made from a polymeric film.

5. The apparatus according to claim 2, wherein each of the first and second membranes is made from polyethylene.

6. The apparatus according to claim 2, wherein the support structure has an undeployed condition wherein the first and second membranes are rolled-up towards the body, and a deployed condition wherein the first membrane extends in a substantially distal direction from the body and the second membrane extends in a substantially proximal direction from the body.

7. The apparatus according to claim 6, further comprising a rip-cord for expanding the first and second membranes, the rip-cord being rolled-up into each of the first and second membranes when the support structure is in the undeployed condition.

8. The apparatus according to claim 2, wherein each membrane includes a first inner layer and a second outer layer.

9. The apparatus according to claim 8, wherein the second outer layer of each membrane swells at a rate greater than the first inner layer.

10. The apparatus according to claim 9, wherein the second outer layers of the first and second membranes are made from a hydrogel.

11. The apparatus according to claim 8, wherein the first inner layer of each of the first and second membranes is constructed from a substantially non-absorbable material.

12. The apparatus according to claim 11, wherein the first inner layer of each of the first and second membranes is fabricated from a bio-absorbable material selected from the group consisting of mesh, knit, woven and non-woven materials.

13. The apparatus according to claim 1, wherein the body is perforated.

14. The apparatus according to claim 1, wherein the body is porous.

15. The apparatus according to claim 1, wherein the at least one layer of expandable material expands upon fluid absorption.

16. The apparatus according to claim 1, wherein the body is fabricated from at least one of a polyglactic material, a glycolide homopolymer, and a synthetic absorbable lactomer 9-1 material.

17. The apparatus according to claim 1, wherein the body is selected from the group consisting of a mesh, knit, woven and non-woven material.

18. The apparatus according to claim 1, wherein the body is a fabric.

19. The apparatus according to claim 1, wherein the body includes a wound treatment material.

20. The apparatus according to claim 19, wherein the wound treatment material is at least one of an adhesive, a sealant, a hemostat, and a medicament.

21. The apparatus of claim 1, wherein the body is compressible so that the outer terminal edge of the body extends beyond the outer radial surface of the anvil and tubular body portion.

22. The apparatus according to claim 21, wherein the body is fabricated from foam.

23. The apparatus according to claim 21, wherein the body has a first thickness greater than one quarter of a diameter of the body.

24. The apparatus according to claim 21, wherein the support structure has an unhydrated condition wherein the body has a first diameter and a first thickness, and a hydrated condition wherein the body has a second diameter greater than the first diameter and a second thickness greater than the first thickness.

25. The apparatus according to claim 21, wherein the body expands from the first diameter and the first thickness to a second diameter and a second thickness upon application of a fluid thereto.

26. The apparatus according to claim 25, wherein the body is constructed from a first part of a two-part wound treatment material, and the fluid applied thereto is a second part of the two-part wound treatment material.

27. A method of disposing a support structure between adjacent intestinal sections, comprising the steps of:

providing a circular surgical anastomosis device, the circular surgical anastomosis device including;

an anvil assembly having an anvil member and a first shaft; and

a tubular body portion having an annular knife operatively disposed therein and a second shaft disposed radially inward of the annular knife, the first shaft of the anvil assembly being selectively attachable to the second shaft of the tubular body;

inserting the anvil assembly into a first intestinal section;

inserting the tubular body portion into a second intestinal section;

disposing a support structure between the first intestinal section and the second intestinal section, the support structure having at least one layer of expandable material;

approximating the anvil assembly and tubular body portion with one another so that an end portion of the first intestinal section, the support structure, and an end portion of the second intestinal section are disposed between the anvil member and the tubular body portion, the support structure being disposed between the first intestinal section and the second intestinal section;

firing the surgical anastomosis device to sever the portions of the first and second intestinal sections disposed radially inward of the annular knife, and to touch the portions of the first and second intestinal sections radially outward of the annular knife against the structure; and

expanding the at least one layer of expandable material

28. The method according to claim 27, wherein:

the anvil assembly includes a first shaft and the tubular body portion includes a second shaft disposed radially inward of the annular knife, the first shaft of the anvil member being attachable to the second shaft of the tubular body portion; and

further including the step of attaching the first shaft of the anvil assembly to the second shaft of the tubular body portion prior to the step of approximating the anvil assembly to the tubular body portion.

29. The method according to claim 28, wherein:

the support structure includes an aperture formed therein; and

further including the step of inserting one of the first shaft of the anvil assembly and the second shaft of the tubular body portion into the aperture of the support structure prior to the step of attaching the first shaft of the anvil assembly to the second shaft of the tubular body portion.

30. The method according to claim 29, wherein the tubular body portion carries a plurality of surgical staples, the surgical staples being disposed radially outward of the annular knife, and wherein in firing the surgical anastomosis device includes deploying the plurality of staples so that the staples penetrate a first interstitial section, the support structure and then a second interstitial section.

31. The method according to claim 27, wherein the support structure includes:

a body and a first and a second membrane extending radially outward from the body.

32. The method according to claim 31, wherein each of the first and second membranes of the support structure is made from a polymeric film.

33. The method according to claim 31, wherein each of the first and second membranes of the support structure is made from polyethylene.

34. The method according to claim 31, wherein expanding the at least one layer of expandable material includes deploying the first and second membranes from a rolled-up condition to an expanded condition.

35. The method according to claim 34, wherein, in the expanded condition, the first membrane extends in a substantially distal direction from the body portion of the support structure and the second membrane extends in a substantially proximal direction from the body portion of the support structure.

36. The method according to claim 35, further comprising the step of pulling on at least one rip-cord to expand the first and second membranes.

37. The method according to claim 31, wherein each membrane of the support structure includes a first inner layer and a second outer layer.

38. The method according to claim 37, wherein expanding the at least one layer includes expanding the second outer layer at a greater rate than the first inner layer.

39. The method according to claim 38, wherein the second outer layer of each membrane of the support structure swells at a rate greater than the first inner layer.

40. The method according to claim 39, wherein the second outer layers of the first and second membranes are made from a hydrogel.

41. The method according to claim 40, wherein the first inner layer of each of the first and second membranes of the support structure is constructed from a substantially non-absorbable material.

42. The method according to claim 41, wherein the first inner layer of each of the first and second membranes is fabricated from a bio-absorbable material selected from the group consisting of mesh knit, woven and non-woven materials.

43. A method of performing a surgical anastomosis procedure, comprising the steps of:

providing an anastomosis apparatus having an anvil assembly movably mounted with respect to a tubular body portion;

providing a support structure including a body having an outer terminal edge, and an aperture therethrough, the body being compressible;

disposing an anvil assembly into a first intestinal section;

disposing a distal end portion of the surgical stapling apparatus in a second intestinal section;

positioning the support structure on a shaft of the anvil assembly;

approximating the anvil assembly and the tubular body portion to capture the body of the support structure between the first intestinal section and the second intestinal section and to compress the body portion therebetween so that the body extends radially beyond the anvil member and the tubular body portion to seal the perimeter of the anastomosis site; and

firing the anastomosis apparatus to join the first intestinal section, support structure, and second intestinal section.

44. The method according to claim 43, wherein the support structure has an unhydrated condition wherein the body has a first diameter and a first thickness, and a hydrated condition wherein the body has a second diameter greater than the first diameter and a second thickness greater than the first thickness.

45. The method according to claim 44, wherein the support structure is pre-mounted onto the shaft of the anvil assembly prior to positioning of the anvil assembly in the first intestinal section, wherein prior to approximating the anvil assembly and the tubular body portion, the method further includes the step of hydrating the support structure to expand the body from the first diameter and the first thickness to a second diameter and a second thickness.

46. The method according to claim 45, wherein the body is constructed from a first part of a multiple-part wound treatment material, and the fluid applied thereto is a second part of the multiple-part wound treatment material.