Medical device for repairing a fistula

• US 9,585,647 B2
• Filed: 11/12/2014
• Issued: 03/07/2017
• Est. Priority Date: 08/26/2009
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Clark, Ian J.
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US14/539,830
• Publication Number:
  US 20150073471A1
• Time in Patent Office: 846 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple

Abstract

A closure element applying medical device for repairing a fistula is described. The closure element applying medical device can be configured for repairing any type of fistula that provides an abnormal channel from one body part to another body part (e.g., organ to organ, organ to vessel, and/or vessel to vessel). Examples of fistulas that can be repaired with the present invention include anorectal fistulas, enteroenteral fistulas, enterocutaneous fistulas, vesicovaginal fistulas, arteriovenous fistulas, perilymph fistulas, rectovaginal fistulas, ureterocolon fistulas, and the like. The medical device can include a closure element, a shaft, a carrier assembly, and controller systems. The medical device can also include a locator assembly. Additionally, the closure element applying medical device can include endoscope components so as to function also as an endoscope.

Claims

1. A tissue closure system for engaging with tissue within or adjacent to a fistula to close and repair the fistula, the tissue closure system comprising:

a tissue closure element comprising;

an elongate body portion, the elongate body portion including an inflection portion;

a first tissue-grabbing member joined to the elongate body portion;

a second tissue-grabbing member joined to the elongate body portion and disposed opposite the first tissue-grabbing member; and

wherein the first and second tissue-grabbing members move about the inflection portion as the tissue closure element moves from an expanded configuration toward a closed configuration, wherein at least a portion of the first tissue-grabbing member overlaps a portion of the elongate body portion when the tissue closure element moves from the expanded configuration toward the closed configuration, wherein the tissue closure element is substantially “

S”

-shaped in the expanded configuration and moves toward an “

8”

-shape as it moves toward the closed configuration, such that the first and second tissue-grabbing members move toward the elongate body as the tissue closure element moves from the expanded configuration toward the closed configuration;

a carrier assembly having a garage for retaining the tissue closure element, said carrier assembly having a flexible portion being selectively controlled to bend to direct the tissue closure element toward tissue within or near the fistula, the flexible portion selectively controllable to bend to an angle of at least about 45 degrees;

a carrier assembly controller system operatively coupled to the flexible portion of the carrier assembly for controlling the delivery of the carrier assembly to the fistula; and

a closure element deployment controller system operatively coupled to the carrier assembly for deploying the tissue closure element to the tissue to repair the fistula, the tissue closure element disposed within the garage and oriented such that both the first and second tissue grabbing members are both oriented toward the tissue.

2. The tissue closure system of claim 1, wherein at least a portion of the first tissue-grabbing member is adjacent to at least a portion of the second tissue-grabbing member in the closed configuration.

3. The tissue closure system of claim 1, wherein an arcuate path of the first tissue-grabbing member while passing from the expanded configuration toward the closed configuration is in the same rotational direction as an arcuate path of the second tissue-grabbing member while passing from the expanded configuration toward the closed configuration.

4. The tissue closure system of claim 1, wherein an arcuate path of the first tissue-grabbing member while passing from the expanded configuration toward the closed configuration is in the opposite rotational direction as an arcuate path of the second tissue-grabbing member while passing from the expanded configuration toward the closed configuration.

5. The tissue closure system of claim 1, wherein the tissue closure element is prepared from a biodegradable material.

6. The tissue closure system of claim 1, wherein the tissue closure element is treated with an active pharmaceutical ingredient.

7. The tissue closure system of claim 1, wherein the tissue closure element is configured with greater flexibility or decreased mechanical strength when in a deployed configuration relative to the flexibility or mechanical strength of a blood vessel incision closure device configured to resist blood pressure when in a deployed configuration in a blood pressurized blood vessel environment.

8. The tissue closure system of claim 1, further comprising a locator assembly operably coupled to the carrier assembly, the locator assembly being slidable around or through the tissue closure element.

9. The tissue closure system of claim 8, wherein the locator assembly includes a locator, the locator including at least two locator wings.

10. The tissue closure system of claim 8, wherein the locator assembly is configured to collapse and withdraw from the fistula simultaneously as the tissue closure element is deployed.

11. The tissue closure system of claim 1, wherein the carrier assembly includes a carrier member that is bendable from a predeployment configuration to a deployment configuration.

12. The tissue closure system of claim 1, further comprising endoscope components configured such that the medical device is capable of functioning as an endoscope.

16. The tissue closure system of claim 1, wherein the first tissue-grabbing member and the second tissue-grabbing member are tines.

17. The tissue closure system of claim 1, wherein the first tissue-grabbing tine and the second tissue-grabbing tine taper to their distal end.

13. A method for closing and repairing a fistula, the method comprising:

positioning a tissue closure element near tissue within or adjacent to the fistula with a carrier assembly having a garage for retaining the closure element, the carrier assembly having a flexible portion being selectively controlled to bend to direct the closure element toward tissue within or near the fistula, the tissue closure element disposed within the garage, the tissue closure element comprising;

an elongate body portion, the body portion including an inflection portion;

a first tissue-grabbing member having a tine joined to the elongate body portion;

a second tissue-grabbing member having a tine joined to the elongate body portion and disposed opposite the first tissue-grabbing member;

wherein the first and second tissue grabbing-members are both oriented toward the tissue in the garage, the first and second tissue-grabbing members move about the inflection portion as the tissue closure element moves from an expanded configuration toward a closed configuration, wherein at least a portion of the first tissue-grabbing member overlaps a portion of the elongate body portion when the tissue closure element moves from the expanded configuration toward the closed configuration, wherein the tissue closure element is substantially “

S”

-shaped in the expanded configuration and moves toward an “

8”

-shape as it moves toward the closed configuration, such that the first and second tissue-grabbing members move toward the elongate body as the tissue closure element moves from the expanded configuration toward the closed configuration;

moving the tissue closure element from the predeployed configuration into an expanded configuration; and

deploying the tissue closure element into tissue within or adjacent to the fistula, the tissue closure element moving toward the closed configuration upon deployment into the tissue to close and repair the fistula.

14. The method of claim 13, wherein at least a portion of the first tissue-grabbing member is adjacent to at least a portion of the second tissue-grabbing member in the closed configuration.

15. The method of claim 13, wherein at least a portion of the first tissue-grabbing member overlaps a portion of the elongate body portion when the tissue closure element moves from the expanded configuration toward the closed configuration.