Closure device and methods for making and using them

• US 8,128,644 B2
• Filed: 09/19/2003
• Issued: 03/06/2012
• Est. Priority Date: 12/07/2000
• Status: Expired due to Fees

• 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:
  US10/667,144
• Publication Number:
  US 20040073236A1
• Time in Patent Office: 3,091 Days
• Field of Search: 606/151, 606/157, 606/153, 606/213, 606/152, 606/155, 606215-221, 606/75, 606/76, 606/154, 606/158, 411/531, 411/533, 245/45, 24/305.S, 245/63, 245/70, 132/156, 132/157, 132/273, 132/282, 132/283, 132/284, 227/179.1
• US Class Current: 606/151
• 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 device for engaging tissue at a puncture site and facilitating closure of the puncture site, comprising:

an annular-shaped body defining a plane and disposed about a central axis extending substantially normal to the plane, the body comprising a plurality of looped elements extending about a periphery of the body to form an endless sinusoidal pattern;

a plurality of tines having free distal ends extending from the looped elements through the central axis of the annular-shaped body; and

the body and tines comprising a resilient material so that the body and tines normally lie in a planar, deployed first configuration, the material of the body and tines being sufficiently resilient so that when a force is applied to the tines they are forced from the planar, deployed first configuration into a transverse, pre-deployment second configuration in which the tines and free distal ends are spread open for insertion of the free distal ends into the tissue around the puncture site, and thereafter the body and tines will automatically return toward the first configuration so as to engage the puncture site and facilitate closure thereof after the force is removed.

2. The device of claim 1, wherein the plurality of tines comprises primary tines having a first length and the device further comprises secondary tines having a second length.

3. The device of claim 2, wherein the first lengths of the primary tines are substantially longer than the second lengths of the secondary tines.

4. The device of claim 2, wherein the one or more secondary tines comprise tines disposed on either side of a primary tine.

5. The device of claim 1, wherein the body is biased towards the planar configuration for biasing the plurality of tines generally towards the central axis.

6. The device of claim 1, wherein the plurality of tines and the body are formed from a single sheet of material.

7. The device of claim 6, wherein the sheet of material comprises a superelastic alloy.

8. The device of claim 1, wherein the looped elements are expandable between expanded and compressed states for increasing and reducing, respectively, a periphery of the body in the transverse orientation.

9. The device of claim 8, wherein looped elements are biased towards the compressed state.

10. A device for engaging tissue at a puncture site and facilitating closure of the puncture site, comprising:

an annular-shaped body defining a plane and disposed about a central axis extending substantially normal to the plane, the body comprising a plurality of looped elements extending about a periphery of the body to form an endless sinusoidal pattern;

a plurality of arcuate tines having free distal ends extending from the looped elements through the central axis of the generally annular-shaped body; and

the body and arcuate tines comprising a resilient material so that the body and arcuate tines normally lie in a planar, deployed first configuration, the material of the body and arcuate tines being sufficiently resilient so that when a force is applied to the arcuate tines they are forced from the planar, deployed first configuration into a transverse, pre-deployment second configuration in which the arcuate tines and free distal ends are spread open for insertion of the free distal ends into the tissue around the puncture site, and thereafter the body and arcuate tines will automatically return toward the first configuration so as to engage the puncture site and facilitate closure thereof after the force is removed.

11. A device for engaging tissue at a puncture site and facilitating closure of the puncture site, comprising:

an annular-shaped body defining a plane and disposed about a central axis extending substantially normal to the plane, the body comprising a plurality of looped elements extending about a periphery of the body to form an endless sinusoidal pattern;

a plurality of substantially straight tines having free distal ends extending from the looped elements through the central axis of the generally annular-shaped body ; and

the body and tines comprising a resilient material so that the body and tines normally lie in a planar, deployed first configuration, the material of the body and tines being sufficiently resilient so that when a force is applied to the tines they are forced from the planar, deployed first configuration into a transverse, pre-deployment second configuration in which the tines and free distal ends are spread open for insertion of the free distal ends into the tissue around the puncture site, and thereafter the body and tines will automatically return toward the first configuration so as to engage the puncture site and facilitate closure thereof after the force is removed.

12. The device of claim 11, wherein the plurality of substantially straight tines comprises primary tines having a first length and the device further comprises secondary tines having a second length.

13. The device of claim 12, wherein the first lengths of the primary tines are substantially longer than the second lengths of the secondary tines.

14. The device of claim 12, wherein the one or more secondary tines comprise tines disposed on either side of a primary tine.

15. The device of claim 11, wherein the body is biased towards the planar configuration for biasing the plurality of tines generally towards the central axis.

16. The device of claim 11, wherein the plurality of tines, the plurality of looped elements, and the body are formed from a single sheet of material.

17. The device of claim 16, wherein the sheet of material comprises a superelastic alloy.

18. The device of claim 11, wherein the plurality of looped elements are expandable between expanded and compressed states for increasing and reducing, respectively, a periphery of the body in the transverse orientation.

19. The device of claim 18, wherein the plurality of looped elements are biased towards the compressed state.