Device and method for internal ligation of tubular structures

• US 6,736,822 B2
• Filed: 02/20/2002
• Issued: 05/18/2004
• Est. Priority Date: 02/20/2002
• Status: Expired due to Fees

• Current Assignee: Hologic Incorporated
• Original Assignee: Biomedical Engineering Solutions, Inc.
• Inventors: McClellan, Scott B., McClellan, Annette M. L., Moulis, Patricia M.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Pantuck, Bradford C
• Application Number:
  US10/079,015
• Publication Number:
  US 20030158563A1
• Time in Patent Office: 818 Days
• Field of Search: 606/140, 606/141, 606/139, 606/148, 128/831
• US Class Current: 606/139
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/12018 Elastic band ligators
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/303 with four or more legs
• CPC Class Codes: A61F 6/202 Means specially adapted for ligaturing, compressing or clamping of oviduct or vas deferens of tubular organs in general A61B17/12
• CPC Class Codes: A61F 6/208 Implements for ligaturing
• CPC Class Codes: A61F 6/225 transcervical

Abstract

A surgical device for performing internal ligation of a fallopian tube or other tubular anatomical structure, by application of one or more ligating bands to a folded portion of the wall of the tubular structure. A method of using the device is also disclosed. The inventive method and device may be used for sterilization to prevent undesired pregnancies, or for other medical applications. One embodiment of the device includes an elongated tubular element that is inserted into the fallopian tube, a grasper that extends out of the tubular element, grasps the interior of the fallopian tube and retracts into the tubular element in a folded bundle of the fallopian tube tissue; and a pusher balloon for pushing a ligating band from the tip of the tubular element onto the tissue bundle. A fold assist mechanism may be included to help evert a section of a fallopian, or other, tube.

Claims

1. A method for blocking a passageway through a tubular anatomical structure, comprising the steps of:

grasping tissue on the interior of said tubular anatomical structure with a grasper, said grasper being carried at a distal end of an elongate member;

proximally retracting said grasper with respect to a fold mechanism operable to increase a diameter of said tubular anatomical structure at a location proximal to said grasper;

activating said fold mechanism to assist in formation of a tissue bundle comprising tissue from around the entire circumference of said tubular anatomical structure; and

applying a ligating structure to said tissue bundle to block said passageway.

2. The method according to claim 1, wherein said fold mechanism comprises a toggling leg having a knee adapted for radial translation to expand a first cross-section of said tubular anatomical structure, to a diameter larger than a diameter of a second cross-section of said tubular anatomical structure at a location being grasped by said grasper, so as to assist in forming a circumferential fold in said tubular anatomical structure when said grasper is proximally retracted with respect to said fold mechanism.

3. The method according to claim 2, wherein said grasper and said fold mechanism are cooperatively structured such that proximal retraction of said grasper simultaneously activates said fold mechanism.

4. The method according to claim 3, said fold mechanism being configured and arranged to assist in everting a first tubular section of said tubular anatomical structure, located adjacent and proximal to a second tubular section being grasped by said grasper, such that a vector, originating at one end and following a centerline of said tubular anatomical structure, is substantially coaxial, but reversed in direction, between said first and second tubular sections.

5. The method according to claim 1, said grasper comprising an inflatable section, the method further comprising the step of inflating said inflatable section whereby to adhere a portion of said inflatable section, carrying an adhesive, to a section of said tubular anatomical structure to perform said grasping.

6. The method according to claim 1, further comprising the step of detaching said grasper from said distal end of said elongate member, and removing said elongate member from inside said tubular anatomical structure.

7. A device for everting a first tubular section of a tubular anatomical structure to form a tissue bundle and applying at least one ligating structure to said tissue bundle, comprising:

an elongated conduit comprising a distal end, a proximal end, and a lumen therebetween, wherein said distal end is adapted for insertion into said tubular anatomical structure;

a grasper carried at a distal end of an elongate member, said elongate member being slidably disposed within said lumen, said grasper being capable of extending distally from said conduit, grasping grasped tissue on the interior of said tubular anatomical structure, and retracting proximally with said grasped tissue;

an active fold mechanism configured and arranged to assist said grasper in everting said first tubular section;

a ligating structure releasably carried near a distal end of said device; and

application structure disposed near said distal end of said conduit and adapted for applying said ligating structure to said tissue bundle.

8. The device of claim 7, wherein said grasper comprises a balloon structure disposable for inflation distal to said fold mechanism.

9. The device of claim 8, wherein said grasper further comprises an adhesive substance being released, by inflation of said balloon, to form an adhesive layer between said balloon and said grasped tissue.

10. The device of claim 9, wherein said balloon comprises a dual walled inflation structure having outer and inner walls with an adhesive substance disposed between said outer and inner walls, said outer wall of said inflation structure having pores being expandable on inflation of said balloon to permit passage through said expanded pores by said adhesive substance.

11. The device of claim 7, said fold mechanism comprising:

a leg having a knee adapted for radial translation to expand a first cross-section of said tubular anatomical structure, to a diameter larger than a diameter of a second cross-section of said tubular anatomical structure at a location being grasped by said grasper, whereby to assist in forming a circumferential fold in said tubular anatomical structure when said grasper is retracted proximally with respect to said fold mechanism.

12. The device of claim 11, wherein said leg comprises a shin portion distal to said knee;

and a thigh portion proximal to said knee.

13. The device of claim 12, wherein said shin portion and said thigh portion are approximately of the same length.

14. The device of claim 12, wherein said shin portion having a length shorter than a length of a thigh portion, whereby to cause a first, outward, radial displacement of said knee, and a second, inward, radial translation of said knee as said grasper is moved proximally from a grasp engaging position to a folded position.

15. The device of claim 11, comprising a plurality of toggling legs, each leg having a knee, said legs being arranged to provide a plurality of knees spaced apart around a centerline and arranged in harmony for common action of said plurality of knees to expand said first cross-section.

16. The device of claim 7, said application structure comprising a portion of said distal end of said conduit.

17. The device of claim 7, wherein said ligating structure comprises a resilient O-ring.

18. A device for blocking a passageway of a flexible tube, at an internal and intermediate location between ends of the tube, comprising:

a conduit comprising a distal end, a proximal end, and a lumen therebetween, said distal end being adapted for insertion into one open end of said tube;

a balloon comprising a dual walled inflation structure having outer and inner walls with an adhesive substance disposed between said outer and inner walls, said outer wall of said inflation structure having pores being expandable on inflation of said balloon to permit passage through expanded said pores by said adhesive substance;

an elongate member with a distal end adapted to carry said balloon, said elongate member being slidably disposed within said lumen, said balloon being capable of extending distally from said conduit, inflating to create an adhesive grasp on a first tube section of the interior of said tube, and retracting proximally with said first tube section;

a ligating structure releasably carried near a distal end of said device; and

application structure disposed near said distal end of said conduit and adapted for applying said ligating structure to block said passageway.

19. The device of claim 18, further comprising:

a fold assisting structure located, configured, and arranged to assist said balloon in everting a section of said tube.

20. The device of claim 19, said fold assisting structure comprising a mechanism operable to increase a diameter of a second tube section at a location proximal to said first tube section, thereby permitting said first tube section to be retracted proximally to a concentric position within said second tube section to create a circumferential fold in said tube and a resulting tissue peduncle.

21. The device according to claim 20, said mechanism comprising:

a plurality of legs, each leg having a knee, said legs being arranged to provide a plurality of knees spaced apart around a centerline and arranged in harmony for radial translation of said plurality of knees to increase a diameter of said second tube section.

22. A method for blocking a passageway in a tubular anatomical structure, said method comprising:

grasping the tubular anatomical structure'"'"'s interior tissue with a grasper, said grasper being carried at a distal end of an elongate member;

proximally retracting said grasper with respect to a toggling leg having a knee adapted for radial translation to expand a first cross-section of the tubular anatomical structure, to a diameter larger than a diameter of a second cross-section of the tubular anatomical structure at a location being grasped by said grasper, so as to assist in forming a circumferential fold in the tubular anatomical structure;

activating said toggling leg to assist in formation of a tissue bundle; and

applying a ligating structure to the tissue bundle to block the passageway.

23. The method according to claim 22, wherein said grasper and said toggling leg are cooperatively structured such that proximal retraction of said grasper simultaneously activates said toggling leg.

24. The method according to claim 23, wherein said toggling leg is configured and arranged to assist in everting a first tubular section of the tubular anatomical structure, located adjacent and proximal to a second tubular section being grasped by said grasper, such that a vector, originating at one end and following a centerline of the tubular anatomical structure, is substantially coaxial, but reversed in direction, between said first and second tubular sections.

25. A method for blocking a passageway in a tubular anatomical structure, said method comprising:

inflating an inflatable grasper to adhere a portion of said inflatable grasper, carrying an adhesive, to a section of the tubular anatomical structure to grasp tissue on the interior of the tubular anatomical structure, said inflatable grasper being carried at a distal end of an elongate member;

proximally retracting said inflatable grasper with respect to a fold mechanism operable to increase a diameter of the tubular anatomical structure at a location proximal to said inflatable grasper;

activating said fold mechanism to assist in formation of a tissue bundle comprising tissue from around the entire circumference of the tubular anatomical structure; and

applying a ligating structure to the tissue bundle to block the passageway.

26. A method for blocking a passageway in a tubular anatomical structure, said method comprising:

grasping tissue on the interior of the tubular anatomical structure with a grasper, said grasper being carried at a distal end of an elongate member;

proximally retracting said grasper with respect to a fold mechanism operable to increase a diameter of the tubular anatomical structure at a location proximal to said grasper;

activating said fold mechanism to assist in formation of a tissue bundle comprising tissue from around the entire circumference of the tubular anatomical structure;

applying a ligating structure to the tissue bundle to block the passageway; and

detaching said grasper from said distal end of said elongate member.