IMPLANTABLE DEVICES USEFUL FOR REINFORCING A SURGICALLY CREATED STOMA

• US 20080167729A1
• Filed: 01/10/2008
• Published: 07/10/2008
• Est. Priority Date: 01/10/2007
• Status: Active Grant

• Current Assignee: Christopher M. Nelson, Jessica L. Rose
• Original Assignee: Christopher M. Nelson, Jessica L. Rose
• Inventors: Rose, Jessica L., Nelson, Christopher M.
• Granted Patent: US 8,795,384 B2
• Time in Patent Office: Days
• US Class Current: 623/23.72
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

An implantable tissue reinforcement device useful for treating or preventing the formation of parastomal hernias forming about a surgically created stoma. The tissue reinforcement device can comprise a synthetic or mammalian-derived sheet-like graft member, such as a resorbable material that promotes tissue ingrowth, wherein a sizing pattern is included that comprises linear indicia radiating outward from a stomal aperture. The linear indicia facilitate creation of a resized stomal opening in the graft member sufficiently large to allow passage of the resected bowel portion. A series of cuts made along the indicia create a plurality of flaps about the resized opening that are configured to abut the bowel portion and enhance reinforcement the stomal region after implantation. In one embodiment, the linear indicia comprises a series of weakened (e.g., perforated) lines that facilitate the cutting of the material by a scalpel, scissors, etc. The clinician resizes the stomal opening to a known diameter using reference indicia, such as diameter indicia and circular guide indicia. The sizing pattern can be imprinted on or etched into the material of the graft member, or it can be at least partially located on a separate template that is either laid over the graft member, preattached as a cuttable overlay, or used as a reference guide.

Claims

1. An implantable device for reinforcing tissue surrounding a surgically created stoma in a patient, the device comprising:

a graft member comprising one or more layers of a biocompatible material effective to provide reinforcement of an area generally surrounding the surgically created stoma when implanted thereabout;

wherein the graft further comprises a stomal aperture disposed within a central portion of the graft; and

wherein the tissue-reinforcement device further comprises a sizing pattern comprising visual indicia for creating a resized stomal opening of a known diameter from the stomal aperture.

2. The tissue-reinforcement device of claim 1, wherein the sizing pattern comprises a plurality of linear indicia spaced apart from one another and extending radially from the stomal aperture such that when the stomal aperture is enlarged using a cutting instrument along paths defined by the linear indicia, a plurality of flaps is created about the resized stomal opening.

3. The tissue-reinforcement device of claim 1, wherein the sizing pattern further comprises a series of diameter indicia disposed at regular intervals there along that identify the diameter of particular resized stomal opening created of the particular diameter.

4. The tissue-reinforcement device of claim 1, wherein the sizing pattern comprises a series of weakened lines configured to facilitate the creation of the sealing flaps about the stomal aperture.

5. The tissue-reinforcement device of claim 1, wherein the weakened lines comprise a series of perforation formed in the graft material, the perforations being located at regular intervals there along.

6. The tissue-reinforcement device of claim 5, wherein the sizing pattern comprises a series of concentric circular guides located a regular intervals from the stomal aperture.

7. The tissue-reinforcement device of claim 1 wherein the biocompatible material comprises one or more sheets of tissue that have been decellularized.

8. The tissue-reinforcement device of claim 1, wherein the biocompatible material comprises one or more intact sheets of tissue processed to an acellular form.

9. The tissue-reinforcement device of claim 1, wherein the graft comprises a stomal aperture access pathway extending from the stomal aperture outward to an outer edge of the graft.

10. The tissue-reinforcement device of claim 9, wherein the stomal aperture access pathway comprises one of an open channel or slit formed in the graft material.

11. The tissue-reinforcement device of claim 9, wherein the stomal aperture access pathway comprises a weakened cut line configured to facilitate creation of an open channel or slit through the graft material.

12. The tissue-reinforcement device of claim 1, wherein the sizing pattern comprises a separate template member configured to used with the graft member to provide visual guidance for resizing the stomal opening thereof.

13. The tissue-reinforcement device of claim 1, wherein the graft member material is effective to stimulate ingrowth of reinforcing tissue about the surgically created stoma.

17. A method of reinforcing a surgically created stoma, comprising the steps of:

providing a graft member comprising the tissue reinforcement device of claim 1;

determining a desired size of the resized stomal opening for the passage of a resected bowel portion therethrough;

resizing the stomal aperture to create the resized stomal opening at the desired size using a cutting instrument such that a plurality of flaps are created about the resized stomal aperture; and

implanting the graft member with the resized stomal opening about the surgically created stoma such that the plurality of flaps abut the resected bowel portion traversing the graft member.

18. The method of claim 17, wherein the graft member is implanted prophylactically prior to the creation of the surgically created stoma.

19. The method of claim 17, wherein the graft is implanted to repair a parastomal hernia by including the additional step of wrapping the graft material around the resected bowel portion such that the graft member extends therearound to reinforce the surgically created stoma.

14. An implantable device for reinforcing tissue surrounding a surgically created stoma in a patient, the device comprising:

a graft comprising one or more layers of a resorbable biocompatible material comprising a matrix effective to stimulate ingrowth of site-reinforcing tissue about the surgically created stoma when implanted therein, the graft further comprising a stomal aperture formed therein, wherein the graft further comprises a sizing pattern extending from the stomal aperture configured to guide a clinician in resizing the stomal aperture according to the diameter of the surgically created stoma; and

wherein the sizing pattern comprises plurality of linear indicia comprising weakened lines that facilitate the traversal of the biocompatible material by a cutting instrument to create a plurality of sealing flaps about the stomal aperture.

15. The tissue-reinforcement device of claim 14, wherein the graft comprises a stomal aperture access pathway extending from the stomal aperture outward to an outer edge of the graft, the stomal aperture access pathway comprising a weakened line.

16. The tissue-reinforcement device of claim 14, wherein the weakened lines comprise a plurality of perforations formed through material of the graft, the perforations being disposed at regular intervals from the stomal aperture, the perforations being aligned circumferentially such that they comprise indicia for determining the diameter of the resized stomal opening.