Closure device and methods for making and using them

• US 8,236,026 B2
• Filed: 03/27/2006
• Issued: 08/07/2012
• Est. Priority Date: 12/07/2000
• Status: Active Grant

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Carley, Michael T., Ginn, Richard S., Sagastegui, Javier, Jabba, Ronald J., Aldrich, William N., Belef, W. Martin
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US11/390,586
• Publication Number:
  US 20060167484A1
• Time in Patent Office: 2,325 Days
• Field of Search: 606/142, 606/213, 606139-141, 606143-158, 606/185, 606215-221, 227/175.1, 227/179.1
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: H03K 3/356139 with synchronous operation
• CPC Class Codes: H03K 3/356156 with synchronous operation

Abstract

A clip for engaging tissue includes a generally annular-shaped body defining a plane and disposed about a central axis extending normal to the plane. The body includes alternating inner and outer curved regions, defining a zigzag pattern about a periphery of the clip. The body is biased towards a planar configuration lying in the plane and deflectable towards a transverse configuration extending out of the plane. Tines extend from the inner curved regions, the tines being oriented towards the central axis in the planar configuration, and parallel to the central axis in the transverse configuration. The tines may include primary tines and secondary tines that are shorter than the primary tines. The primary tines may be disposed on opposing inner curved regions and oriented towards one another such that they overlap in the planar configuration.

Claims

1. A method for facilitating closure of an opening in a body luminal wall, comprising:

positioning an expandable locator having at least one expandable element through the opening to engage the at least one expandable element with an internal surface of the body luminal wall when the at least one expandable element is in an expanded orientation;

positioning a clip relative to the expandable locator, the clip comprising a body and one or more tines having free distal ends extending from the body, the body being movable by a force from a planar, first configuration where the tines generally extend toward a central axis into a transverse, pre-deployment second configuration in which the tines are spread open and generally extend in the direction of the central axis;

deploying the clip in the transverse, pre-deployment configuration so that the free distal ends penetrate tissue adjacent the opening in the body luminal wall, the clip automatically returning toward the first planar configuration after engaging the tissue to draw the tissue around the opening to facilitate closure thereof; and

removing the expandable locator through the opening in the body luminal wall.

2. The method as in claim 1, wherein a sheath having a lumen is disposed through the opening in the body luminal wall to facilitate the positioning of the expandable locator against the internal surface, the method further comprising:

extending the expandable locator from a distal end of the lumen of the sheath into the body lumen;

expanding the at least one expandable element into the expanded orientation; and

withdrawing the sheath to position the expandable locator against the internal surface.

3. The method as in claim 2, further comprising:

advancing a carrier assembly carrying the clip toward the distal end of the sheath and the tissue; and

engaging the clip with the tissue.

4. The method as in claim 3, further comprising:

collapsing the at least one expandable element;

withdrawing the at least one expandable element into the lumen of the sheath; and

releasing the clip from the carrier assembly.

5. The method as in claim 4, further comprising collapsing the at least one expandable element immediately before or after the clip is released from the carrier assembly.

6. The method as in claim 4, further comprising collapsing the expandable at least one element when the carrier assembly reaches the distal end of the sheath.

7. The method as in claim 6, further comprising releasing the clip when the carrier assembly reaches the distal end of the sheath.

8. A method for facilitating closure of an opening in a body luminal wall, comprising:

positioning an expandable locator against an internal surface of the body luminal wall to engage at least one expandable element of the locator with the body luminal wall;

positioning an annular clip relative to the expandable locator, the annular clip comprising a body and one or more tines having free distal ends extending from the body, the body being moveable by a force from the planar, first configuration where the tines generally extend toward a central axis into a transverse, pre-deployment second configuration in which the tines are spread open and generally extend in the direction of the central axis;

slidably deploying the annular clip in the transverse, pre-deployment configuration so that the free distal ends penetrate an external surface of the body luminal wall adjacent the opening in the body luminal wall, the annular clip automatically returning toward the first planar configuration after engaging the external surface as the locator is removed to draw the external surface adjacent the opening toward the opening to facilitate closure thereof; and

removing the expandable locator, after deploying the annular clip, through the opening in the body luminal wall so as to close the opening.

9. The method as in claim 8, wherein a sheath having a lumen is disposed through the opening in the body luminal wall to facilitate the positioning of the expandable locator against the internal surface, the method further comprising:

extending the expandable locator from a distal end of the lumen of the sheath into the body lumen;

expanding the at least one expandable element into the expanded orientation; and

withdrawing the sheath to position the expandable locator against the internal surface.

10. The method as in claim 9, further comprising:

advancing a carrier assembly carrying the annular clip toward the distal end of the sheath and the external surface adjacent the opening in the body luminal wall; and

engaging the annular clip into the external surface adjacent the opening in the body luminal wall.

11. The method as in claim 10, further comprising:

collapsing the at least one expandable element;

withdrawing the at least one expandable element into the lumen of the sheath; and

releasing the annular clip from the carrier assembly to close the opening.

12. The method as in claim 11, further comprising collapsing the at least one expandable element immediately after the clip is deployed.

13. The method as in claim 12, further comprising collapsing the at least one expandable element after the carrier assembly reaches the proximal end of the sheath.

14. The method as in claim 13, further comprising releasing the clip when the carrier assembly reaches the distal end of the sheath.

15. A method for facilitating closure of an opening in a body luminal wall, comprising:

positioning an expandable locator against an internal surface of the body luminal wall such that at least one expandable element of the locator in an expanded orientation contacts the internal surface adjacent the opening in the body luminal wall;

positioning an annular clip relative to the expandable locator, the annular clip comprising a body and one or more tines having free distal ends extending from the body, the body being moveable by a force from the planar, first configuration where the tine extend toward a central axis into a transverse, pre-deployment second configuration in which the tines are spread open and generally extend in the direction of the central axis and proximate to an external surface adjacent the opening in the body luminal wall;

removing the expandable locator through the opening in the body luminal wall; and

deploying the annular clip in the transverse, pre-deployment configuration so that the free distal ends penetrate tissue adjacent the opening in the body luminal wall, the clip automatically returning toward the first planar configuration after engaging the tissue and after removing the expanded locator to draw the tissue around the opening to facilitate closure thereof.

16. The method as in claim 15, wherein a sheath having a lumen is disposed through the opening in the body luminal wall to facilitate the positioning of the expandable locator against the internal surface, the method further comprising:

extending the expandable locator from a distal end of the lumen of the sheath into the body lumen;

expanding the at least one expandable element into the expanded orientation; and

withdrawing the sheath to position the expandable locator against the internal surface adjacent the opening in the body luminal wall.

17. The method as in claim 16, further comprising:

advancing a carrier assembly carrying the annular clip toward the distal end of the sheath and the external surface adjacent the opening in the body luminal wall; and

engaging the annular clip into the external surface adjacent the opening in the body luminal wall so as to be capable of closing said opening.

18. The method as in claim 17, further comprising:

collapsing the at least one expandable element;

withdrawing the at least one expandable element into the lumen of the sheath; and

releasing the annular clip from the carrier assembly.

19. The method as in claim 18, further comprising collapsing the at least one expandable element before the annular clip is released from the carrier assembly or before the carrier assembly reaches the distal end of the sheath.

20. The method as in claim 19, further comprising retracting the at least one expandable element in a collapsed orientation into the sheath before the clip is released from the carrier assembly.

21. The method as in claim 15, further comprising:

puncturing the body luminal wall with tines of the clip until tips of the tines enter the body luminal wall after the clip is proximate to the external surface adjacent the opening in the body luminal wall;

collapsing the expanded elements after the tines puncture the external surface adjacent the opening in the body luminal wall; and

withdrawing the collapsed expandable elements into the lumen of a sheath before deploying the clip so as to close the opening.