Closure device and methods for making and using them

• US 8,690,910 B2
• Filed: 03/31/2006
• Issued: 04/08/2014
• Est. Priority Date: 12/07/2000
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Inventors: Carley, Michael T., Sagastegui, Javier, Ginn, Richard S., Aldrich, William N., Belef, W. Martin, Roe, Steven N., Jabba, Ronald J.
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US11/396,141
• Publication Number:
  US 20070282352A1
• Time in Patent Office: 2,930 Days
• Field of Search: 606131-143, 606150-157, 606/213, 606219-221
• US Class Current: 606/213
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A method for closing an opening in a wall of a body lumen using a clip can include advancing a distal end of an elongate member within the body lumen, the elongate member having a distal portion that assists in presenting the wall for receiving a clip having a plurality of tissue engaging portions having tips that point generally toward a central axis of the clip. The clip can be advanced relative to the elongate member and the wall of the body lumen until the plurality of tissue engaging portions penetrate the wall of the body lumen. Once the clip penetrates the wall, the elongate member can be withdrawn from the body lumen, leaving the clip to substantially close the opening in the wall of the body lumen.

Claims

1. A method for closing an opening in a wall of a body lumen, comprising:

advancing a distal end of a first elongate member within the body lumen, the first elongate member extending through a lumen of a second elongate member, the first elongate member having a distal portion that assists in both locating the wall and presenting the wall for receiving a clip, the clip having a plurality of tissue engaging portions having tips that point generally toward a central axis of the clip;

partially withdrawing the first elongate member, together with the second elongate member, proximally from the body lumen to withdraw the distal portion of the first elongate member and locate the wall and present the wall for receiving the clip;

advancing the clip relative to the first elongate member and the second elongate member and the wall of the body lumen until the plurality of tissue engaging portions penetrate the presented wall of the body lumen; and

withdrawing the first elongate member and the second elongate member from the body lumen, leaving the clip to substantially close the opening in the wall of the body lumen.

2. The method of claim 1 wherein when the first elongate member and the second elongate member are withdrawn, the plurality of tissue engaging portions automatically at least partially move towards a planar configuration to substantially close the opening.

3. The method of claim 1, further comprising providing a carrier assembly movable relative to the second elongate member, the carrier assembly carrying the clip.

4. The method of claim 1, wherein each of the plurality of tissue engaging portions comprise primary tissue engaging portions and secondary tissue engaging portions, and wherein advancing the clip comprises:

puncturing the wall of the body lumen with the primary tissue engaging portions until tips of the primary tissue engaging portions enter the body lumen; and

puncturing the wall of the body lumen with the secondary tissue engaging portions, wherein the primary tissue engaging portions and the secondary tissue engaging portions puncture the wall without contacting the distal portion of the first elongate member.

5. The method of claim 1, wherein advancing the clip relative to the first elongate member further comprises advancing the clip until a distal end of the plurality of tissue engagement portions penetrate the wall and stopping advancement before the distal end of the plurality of tissue engagement portions enter the body lumen.

6. The method of claim 1, wherein the clip is fabricated from a shape memory material.

7. A method for closing an opening in a wall of a body lumen, comprising:

advancing a distal end of a first elongate member within the body lumen, the first elongate member slidably extending through a lumen of a second elongate member, the first elongate member having a distal portion, the distal portion assisting in both locating and presenting the wall for receiving a clip, the clip having a plurality of tissue engaging portions symmetrically disposed about the clip;

partially withdrawing the first elongate member, together with the second elongate member, proximally from the body lumen to withdraw the distal portion of the first elongate member to locate the wall and present the wall for receiving the clip;

advancing the clip relative to the first elongate member and the second elongate member and the wall of the body lumen, as the distal portion of the first elongate member assists with both locating and presenting the wall for receiving the clip, until the plurality of tissue engaging portions penetrate an outer surface of the presented wall of the body lumen, the tissue engaging portions and the distal portion of the first elongate member being angularly offset from one another, the clip being annularly disposed around a portion of the second elongate member supporting the distal portion of the first elongate member that assists in both locating and presenting the wall for receiving the clip; and

withdrawing the first elongate member and the second elongate member from the body lumen, leaving the clip to substantially close the opening in the wall of the body lumen.

8. The method of claim 7, wherein the clip expands upon the clip being advanced to penetrate the wall of the body lumen surrounding the opening.

9. The method of claim 7, further comprising advancing the clip within a carrier assembly that moves relative to the second elongate member.

10. The method of claim 9, where advancing the clip comprises moving the clip within the carrier assembly toward the distal portion of the first elongate member until the clip deploys from within the carrier assembly.

11. The method of claim 7, further comprising retracting the distal portion of the first elongate member upon the plurality of tissue engaging portions penetrating the wall of the body lumen.

12. A method for closing an opening in a wall of a body lumen, comprising:

advancing a distal end of a first elongate member within the body lumen using a guide wire, the first elongate member slidably extending through a lumen of a second elongate member, the first elongate member being an obturator, the obturator assisting in both locating and proximally presenting the wall for receiving a clip, the clip having a plurality of tissue engaging portions symmetrically disposed about the clip, the obturator extending from a distal end of the second elongate member;

locating an inner surface of the wall using the obturator;

withdrawing the obturator proximally to present an outer surface of the wall for receiving the clip;

positioning a distal end of the second elongate member relative to the first elongate member, the second elongate member comprising a carrier assembly that receives the clip with the clip being annularly disposed around a portion of the second elongate member supporting the distal portion of the first elongate member that assists in both locating and presenting the wall for receiving the clip and outside of the lumen of the second elongate member;

advancing the clip distally, toward the wall of the body lumen, as the distal portion of the first elongate member assists with presenting the wall for receiving the clip, until the plurality of tissue engaging portions penetrate the outer surface of the presented wall of the body lumen; and

withdrawing the first elongate member and the second elongate member from the body lumen, leaving the clip to substantially close the opening in the wall of the body lumen.

13. The method of claim 12, further comprising radially deflecting the plurality of tissue engaging portions as the clip is advanced relative to the first elongate member and the wall of the body lumen.

14. The method of claim 13 wherein the clip further comprises a plurality of spring elements.

15. The method of claim 12, wherein each of the plurality of tissue engaging portions further comprise a tip, the tip of each of the plurality of tissue engaging portions moving toward a central axis of the clip upon the plurality of tissue engaging portions penetrating the wall of the body lumen.

16. The method of claim 12, wherein each of the plurality of tissue engaging portions comprises primary tissue engaging portions and secondary tissue engaging portions, and wherein advancing the clip comprises:

puncturing the wall of the body lumen with the primary tissue engaging portions until tips of the primary tissue engaging portions enter the body lumen; and

puncturing the wall of the body lumen with the secondary tissue engaging portions, wherein the primary tissue engaging portions and the secondary tissue engaging portions puncture the walls without contacting the distal portion of the elongate member.

17. The method of claim 12, wherein the clip is fabricated from a shape memory material.