Methods for manufacturing a clip and clip

• US 8,585,836 B2
• Filed: 06/18/2012
• Issued: 11/19/2013
• Est. Priority Date: 12/31/2002
• 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.
• Primary Examiner(s): Kastler, Scott
• Assistant Examiner(s): LUK, VANESSA TIBAY
• Application Number:
  US13/525,839
• Publication Number:
  US 20120255655A1
• Time in Patent Office: 519 Days
• Field of Search: 148/559, 148/563
• US Class Current: 148/563
• 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 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: C22C 19/007 with a light metal (alkali metal Li, Na, K, Rb, Cs; earth alkali metal Be, Mg, Ca, Sr, Ba, Al Ga, Ge, Ti) or B, Si, Zr, Hf, Sc, Y, lanthanides, actinides, as the next major constituent
• CPC Class Codes: C22F 1/00 Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working apparatus for mechanical working of metal B21, B23, B24
• CPC Class Codes: C22F 1/10 of nickel or cobalt or alloys based thereon
• CPC Class Codes: C22F 1/16 of other metals or alloys based thereon

Abstract

The present disclosure relates to a clip manufactured according to a method which can be used to engage body tissue for the purpose of closing wounds. Such clips are generally annular in shape and have radially inwardly extending tines. The present disclosure first forms a precursor which, in one embodiment, has the tines extending radially outwardly from the annular body and then forms the clip by inverting the precursor such that the tines extend radially inwardly. In an alternate embodiment, the precursor is formed with an over-sized lateral dimension and then compressed inwardly to bring the tines closer together and to reduce the lateral dimension of the precursor. Such clips may be manufactured from a superelastic alloy such as nickel-titanium, in which case the inverted or compressed precursor must be heated and quenched to heat set the clip in its final shape.

Claims

1. A method of manufacturing a clip comprising:

forming the precursor of a clip from a material comprising a superelastic alloy which has an austenitic state and a martensitic state, said precursor having a substantially annular body which is substantially planar and having a plurality of tines which extend radially outwardly from said body;

inverting said precursor such that said tines extend radially inwardly and said precursor is in a generally planar configuration, a first tine of the plurality of tines extending toward a central axis of said body when in the substantially planar configuration and a second tine is in contact with the first tine, the central axis of the clip being perpendicular to a plane formed by the clip in the substantially planar configuration;

heating said precursor in its inverted configuration to cause said alloy to become substantially austenitic; and

quenching said heated precursor to form a clip which is substantially austenitic in the substantially planar configuration with at least two tines of the plurality of tines being in over-and-under, overlapping relationship in the substantially planar configuration.

2. The method of claim 1, wherein said alloy is nickel-titanium.

3. The method of claim 1, wherein said body comprises a plurality of looped elements.

4. The method of claim 1, wherein after inversion, at least two tines are in side-by-side relationship.

5. The method of claim 1, wherein after inversion, at least two tines are in over-and-under relationship.

6. The method of claim 1, wherein the first tine is longer than the second tine or the second tine is longer than the first tine.

7. The method of claim 1, wherein said forming step comprises cutting said precursor from a sheet of material comprising a superelastic alloy.

8. A method of manufacturing a clip comprising:

forming the precursor of a clip from a material comprising a superelastic alloy which has an austenitic state and a martensitic state, said precursor having a substantially annular body which is substantially planar and having a plurality of tines which extend radially outwardly from said body;

inverting said precursor such that the plurality of tines extend out of a plane formed by said body when in the substantially planar configuration, the central axis of the clip being perpendicular to the plane formed by said body in the substantially planar configuration;

heating said precursor in its rotated configuration to cause said alloy to become substantially austenitic; and

quenching said heated precursor to form a clip which is substantially austenitic in the substantially planar configuration with at least two tines of the plurality of tines being in over-and-under, overlapping relationship in the substantially planar configuration.

9. The method of claim 8, wherein said alloy is nickel-titanium.

10. The method of claim 8, wherein said body comprises a plurality of looped elements.

11. The method of claim 8, wherein after inversion, at least two tines are in side-by-side relationship.

12. The method of claim 8, wherein after inverting, at least two tines are in over-and-under relationship.

13. The method of claim 8, wherein at least two tines of the plurality of tines are in contact with each other.

14. The method of claim 13, wherein a first tine of the at least two tines is longer than a second tine of the at least two tines or the second tine is longer than the first tine.

15. The method of claim 8, wherein the plurality of tines that extend out of the plane formed by said body each form an acute angle with the plane formed by said body.

16. The method of claim 8, wherein said forming step comprises cutting said precursor from a sheet of material comprising a superelastic alloy.

17. A method of manufacturing a clip comprising:

forming a precursor of a clip from a material comprising a superelastic alloy which has an austenitic state and a martensitic state, said precursor having an annular body forming a plane in a precursor configuration and having a plurality of tines which extend radially outwardly from said body;

inverting said precursor such that said tines extend transverse to said plane in the precursor configuration, wherein the superelastic alloy has a grain orientation and one or more tines of the plurality of tines have a longitudinal dimension transverse to the grain orientation;

heating said precursor in its inverted configuration to cause said alloy to become austenitic; and

quenching said heated precursor to form a clip which is austenitic.

18. The method of claim 17 wherein the superelastic alloy is nickel-titanium.

19. The method of claim 17 wherein said body comprises a plurality of looped elements.

20. The method of claim 17 wherein after inverting, at least two tines of the plurality of tines are in side-by-side relationship.

21. The method of claim 17 wherein after inverting, at least two tines of the plurality of tines are in over-and-under relationship.

22. The method of claim 17 wherein at least one tine of the plurality of tines is longer than a radially opposed tine.

23. The method of claim 17 wherein said forming step comprises cutting said precursor from a sheet of material comprising a superelastic alloy.

24. A method of manufacturing a clip comprising:

forming the precursor of a clip from a material comprising a superelastic alloy which has an austenitic state and a martensitic state, said precursor having a substantially annular body which is substantially planar and having a plurality of tines which extend radially inwardly from said body, said precursor having a lateral dimension which is substantially larger than that of the clip;

compressing said precursor in a substantially planar configuration in a radially inward direction to bring at least two tines of the plurality of tines into contact with each other with at least one tine of the at least two tines of the plurality of tines extending beyond a central axis of the clip while in the substantially planar configuration, the central axis of the clip being perpendicular to a plane formed by the clip in the substantially planar configuration;

heating said precursor in its compressed and substantially planar configuration to cause said alloy to become substantially austenitic; and

quenching said heated precursor to form a clip which is substantially austenitic.

25. The method of claim 24, wherein said alloy is nickel-titanium.

26. The method of claim 24, wherein said body comprises a plurality of looped elements.

27. The method of claim 24, wherein said forming step comprises cutting said precursor from a sheet of material comprising a superelastic alloy.

28. The method of claim 24, wherein a first tine of the at least two tines is longer than a second tine of the at least two tines or the second tine of the at least two tines is longer than the first tine of the at least two tines.

29. The method of claim 24, wherein after compression, at least two tines are in side-by-side relationship.

30. The method of claim 24, wherein after compression, at least two tines are in over-and-under relationship.

31. A method of manufacturing a clip comprising:

forming the precursor of a clip from a material comprising a superelastic alloy which has an austenitic state and a martensitic state, said precursor having a substantially annular body which is substantially planar and having a plurality of tines which extend radially inwardly from said body, said precursor having a lateral dimension which is substantially larger than that of the clip;

compressing said precursor in a substantially planar configuration in a radially inward direction to bring said tines toward a central axis of said body when in the substantially planar configuration and said precursor is in a generally planar configuration, the central axis of the clip being perpendicular to a plane formed by said body in the substantially planar configuration, wherein at least one tine of the plurality of tines extends out of the plane formed by said body;

heating said precursor in its compressed and substantially planar configuration to cause said alloy to become substantially austenitic; and

quenching said heated precursor to form a clip which is substantially austenitic.

32. The method of claim 31, wherein said alloy is nickel-titanium.

33. The method of claim 31, wherein said body comprises a plurality of looped elements.

34. The method of claim 31, wherein after compression, at least two tines are in side-by-side relationship.

35. The method of claim 31, wherein after compression, at least two tines are in over-and-under relationship.

36. The method of claim 31, wherein at least two tines of the plurality of tines are in contact with each other.

37. The method of claim 36, wherein a first tine of the at least two tines is longer than a second tine of the at least two tines or the second tine of the at least two tines is longer than the first tine of the at least two tines.

38. The method of claim 31, wherein the at least one tine that extends out of the plane formed by said body forms an acute angle with the plane formed by said body.

39. The method of claim 31, wherein said forming step comprises cutting said precursor from a sheet of material comprising a superelastic alloy.