Non-invasive surgical ligation clip system and method of using

• US 7,967,831 B2
• Filed: 03/03/2008
• Issued: 06/28/2011
• Est. Priority Date: 08/08/2002
• Status: Active Grant

• Current Assignee: Interrad Medical, Inc.
• Original Assignee: Interrad Medical, Inc.
• Inventors: Rosenberg, Michael S., Claude, Timothy J.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US12/041,189
• Publication Number:
  US 20080154287A1
• Time in Patent Office: 1,212 Days
• Field of Search: 606/139, 606/142, 606/143, 606/151, 606/157, 606/158, 606/219
• US Class Current: 606/142
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect

Abstract

A surgical ligation clip capable of remote deployment through a cannula to engage an anatomical structure.

Claims

1. A clip system for application to mammalian tissue, comprising:

a needle including a bore that extends longitudinally to a distal opening of the needle, the distal opening being deliverable to a targeted internal tissue; and

a clip device that superelastically deforms to a lateral dimension smaller than an inner dimension of the needle bore so that the entire clip device advances into the needle bore for delivery out of the distal opening of the needle, the clip device including;

a first clamping arm and a second clamping arm opposing the first clamping arm and being biased toward the first clamping arm, the first and second clamping arms including proximal portions that abut against one another and distal ends that are movable away from one another, and

a flexing head coupled to proximal ends of the first and second clamping arms, the flexing head being adjustable between a first shape in which the first and second clamping arms extend generally parallel to one another and a stressed shape in which at least the distal ends of the first and second clamping arms are spaced apart while the proximal portions of the first and second clamping arms abut against one another,

wherein the needle engages the flexing head to releasably retain the flexing head in the stressed shape when the entire clip device is disposed in the needle bore and, in response to the clip device being advanced distally out of the distal opening of the needle, the flexing head adjusts toward the first shape so that the first and second clamping arms shift toward one another to provide a clamping force.

2. The clip system of claim 1 wherein the flexing head comprises a first flexing section coupled to the proximal portion of the first clamping arm and a second flexing section coupled to the proximal portion of the second clamping arm, the first flexing section of the clip device mirrors the shape of the second flexing section relative to a longitudinal axis.

3. The clip system of claim 2 wherein the first clamping arm is aligned with the second clamping arm along the longitudinal axis so that the first clamping arm contacts the second clamping arm without crossing over the longitudinal axis.

4. The clip system of claim 1 wherein the clip device comprises a single wire that defines the first jaw and the second jaw, the wire having a cross-sectional shape in a lateral plane of the clip device.

5. The clip system of claim 4 wherein the cross-sectional shape in the lateral plane is D-shaped.

6. The clip system of claim 1 wherein the clip device is configured to engage an anatomical structure when the first and second clamping arms shift toward one another.

7. The clip system of claim 1 wherein the proximal portions of the first clamping arm and the second clamping arm abut against one another when the flexing head is in the stressed shape.

8. The clip system of claim 7 wherein the distal ends of the first clamping arm and the second clamping arm comprise blunt tips.

9. The clip system of claim 1 wherein the clip device comprises a material that exhibits superelasticity characteristics at a temperature of about 37 degrees C., the flexing head exhibiting superelasticity characteristics when the flexing head returns toward the first shape after being deformed to the stressed shape while the entire clip device is disposed in the needle bore.

10. The clip system of claim 1 further comprising a push rod movably disposed in the needle bore to deliver the clip device distally from the needle bore and out of the distal opening.

11. The clip system of claim 1 wherein the first clamping arm comprises wave-shaped grips that are matable with complementary wave-shaped grips of the second clamping arm.

12. The clip system of claim 11 wherein the wave-shaped grips facilitate engagement with the targeted internal tissue between the first and second clamping arms.

13. The clip system of claim 1 wherein the first clamping arm comprises an indentation that at least partially defines a gap between the first clamping arm and the second clamping arm.

14. The clip system of claim 13 wherein the gap that is at least partially defined by the indentation provides a seat structure that retains the targeted internal tissue engaged between the first and second clamping arms.

15. The clip system of claim 1 wherein in the clip device comprises a superelastic alloy material that is mechanically processed to provide a predetermined clamping force between the first and second clamping arms.

16. The clip system of claim 15 wherein the predetermined clamping force is selected to provide a force that is sufficient to clamp the targeted internal tissue between the first and second clamping arms and that is below a threshold force to damage the targeted internal tissue.

17. A clip system for application to mammalian tissue, comprising:

a needle including a bore that extends along a longitudinal axis to a distal opening of the needle, the distal opening being deliverable to a targeted internal tissue; and

a clip device that superelastically deforms to a lateral dimension smaller than an inner dimension of the needle bore so that the entire clip device advances into the needle bore for delivery out of the distal opening of the needle, wherein the clip device is formed of a single wire having a cross-sectional shape that is D-shaped, the clip device including;

a first clamping arm and a second clamping arm opposing the first clamping arm and being biased toward the first clamping arm, the first and second clamping arms including proximal portions that abut against one another and distal ends that are movable away from one another, wherein the first clamping arm is aligned with the second clamping arm along the longitudinal axis so that the first clamping arm contacts the second clamping arm, and

a flexing head coupled to proximal ends of the first and second clamping arms, the flexing head being adjustable between a first shape in which the first and second clamping arms extend generally parallel to one another and a stressed shape in which at least the distal ends of the first and second clamping arms are spaced apart while the proximal portions of the first and second clamping arms abut against one another, wherein the needle engages and compresses the flexing head to releasably retain the flexing head in the stressed shape when the entire clip device is disposed in the needle bore.

18. The clip system of claim 17 wherein, in response to the clip device being advanced distally out of the distal opening of the needle, the flexing head shifts toward the first shape so that the first and second clamping arms shift toward one another to provide a clamping force.

19. The clip system of claim 18 wherein the clip device comprises a material that exhibits superelasticity characteristics at a temperature of about 37 degrees C., the flexing head exhibiting superelasticity characteristics when the flexing head returns toward the first shape after being deformed to the stressed shape while the entire clip device is disposed in the needle bore.

20. The clip system of claim 19 further comprising a push rod movably disposed in the needle bore to deliver the clip device distally from the needle bore and out of the distal opening.