Support structures and methods of using the same

• US 8,225,799 B2
• Filed: 11/04/2010
• Issued: 07/24/2012
• 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.
• Primary Examiner(s): LOW, LINDSAY M
• Application Number:
  US12/939,459
• Publication Number:
  US 20110057016A1
• Time in Patent Office: 628 Days
• Field of Search: 2271751-1821, 227/19
• US Class Current: 128/898
• 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 or resorptive
• 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. 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 including a body and having at least one layer of expandable material comprising a first and a second membrane extending radially outward from the body;

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 by deploying each of the first and second membranes from a rolled-up condition to an expanded condition.

2. The method according to claim 1, 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.

3. The method according to claim 2, 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.

4. The method according to claim 3, 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.

5. The method according to claim 1, wherein each of the first and second membranes of the support structure is made from a polymeric film.

6. The method according to claim 1, wherein each of the first and second membranes of the support structure is made from polyethylene.

7. The method according to claim 1, 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.

8. The method according to claim 7, further comprising the step of pulling on at least one rip-cord to expand the first and second membranes.

9. 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 including a body having at least one layer of expandable material comprising a first and a second membrane extending radially outward from the body, wherein each membrane includes a first inner layer and a second outer layer;

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, wherein the second outer layer is expanded at a greater rate than the first inner layer.

10. The method according to claim 9, wherein the second outer layer of each membrane of the support structure swells at a rate greater than the first inner layer.

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

12. The method according to claim 11, 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.

13. The method 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.

14. 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, and the support structure having 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;

disposing the 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 such that the support structure is pre-mounted onto the shaft of the anvil assembly prior to positioning the anvil assembly in the first intestinal section;

hydrating the support structure to expand the body from the first diameter and the first thickness to a second diameter and a second thickness, the body being constructed from a first part of a two-part wound treatment material, and fluid applied thereto being a second part of the two-part wound treatment material;

approximating the anvil assembly and the tubular body portion subsequent to hydrating the support structure 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.