Three dimensional, low friction vasoocclusive coil, and method of manufacture

• US 6,638,291 B1
• Filed: 06/08/2000
• Issued: 10/28/2003
• Est. Priority Date: 04/20/1995
• Status: Expired due to Fees

• Current Assignee: Micrus Corporation (Johnson & Johnson)
• Original Assignee: Micrus Corporation (Johnson & Johnson)
• Inventors: Kurz, Daniel, Sein-Lwyn, Crystal K., Horton, Joseph A., Wilson, Peter, Ferrera, David A., Lei, Lok A.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/590,794
• Time in Patent Office: 1,237 Days
• Field of Search: 606/200, 606/151, 606/191, 623/1.1, 623/1.18, 623/1.19, 623/1.2, 623/1.21, 128/898
• US Class Current: 606/191
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: B29C 53/76 about more than one axis , e.g. T-pieces, balls
• CPC Class Codes: B29C 53/821 Mandrels especially adapted for winding and joining
• CPC Class Codes: B29C 61/00 Shaping by liberation of internal stresses; Making preforms having internal stresses; Apparatus therefor for surface shaping B29C59/18; for lining articles B29C63/38; for joining preformed parts B29C65/66 ; for packaging B65B53/00; connecting arrangements or other fittings for plastics pipes using shrink-down material F16L47/22, electrical connections insulated using heat shrinking insulating sleeves H01R4/72; cable junctions protected by sleeves H02G15/18
• CPC Class Codes: B29K 2029/00 Use of polyvinylalcohols, polyvinylethers, polyvinylaldehydes, polyvinylketones or polyvinylketals or derivatives thereof as moulding material
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7734 Spherical balls B29L2031/54; globes B29L2022/002
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 67/00 Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 77/00 Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08L79/06; of polyamideimides or polyamide acids C08L79/08; Compositions of derivatives of such polymers

Abstract

The three dimensional, low friction vasoocclusive coil has a portion that is three dimensionally box or cubed shaped. The three dimensional box or cubed shaped portion will form a basket for filling the anatomical cavity at the site in the vasculature to be treated. The vasoocclusive device is formed from at least one strand of a flexible material formed to have a first inoperable, substantially linear configuration for insertion into and through a catheter or cannula to a desired portion of the vasculature to be treated, and a second operable, three dimensional configuration for occluding the desired portion of the vasculature to be treated. The vasoocclusive coil may optionally include a portion that is substantially J-shaped or helically shaped, for filling and reinforcing the three dimensional portion.

Claims

1. A vasoocclusive device that is adapted to be inserted into a portion of a vasculature for occluding a portion of the vasculature for use in interventional therapy and vascular surgery, comprising:

at least one strand of a flexible material formed to have a first portion with a first inoperable, substantially linear configuration for insertion into and through a catheter to a desired portion of the vasculature to be treated, and a second operable, three dimensional substantially box shaped orthogonal configuration for occluding the desired part of the vasculature to be treated; and

a

a second portion extending outwardly from the first portion in its second configuration and having a first inoperable, substantially linear configuration for insertion into and through a catheter to a desired portion of the vasculature to be treated, and a second operable, substantially J-shape for filling and reinforcing the three dimensional shaped portion when the vasoocclusive device is implanted at the site in the vasculature to be treated.

2. The vasoocclusive device of claim 1, wherein said vasoocclusive device is formed from at least one flexible strand of a resilient radiopaque material to provide a radiopaque marker of the deployed configuration of a device made of the strand during vascular surgery.

3. The vasoocclusive device of claim 2, wherein said radiopaque strand comprises at least one centrally, axially disposed radiopaque wire.

4. The vasoocclusive device of claim 2, wherein said radiopaque strand is made of platinum.

5. The vasoocclusive device of claim 2, wherein said radiopaque strand is made of tungsten.

6. The vasoocclusive device of claim 2, wherein said radiopaque strand is made of gold.

7. The vasoocclusive device of claim 1, wherein said at least one strand comprises a super-elastic material.

8. The vasoocclusive device of claim 7, wherein said super-elastic material comprises a nickel titanium alloy.

9. The vasoocclusive device of claim 1, wherein said at least one strand comprises a shape memory material.

10. The vasoocclusive device of claim 9, wherein said shape memory material comprises a nickel-titanium alloy.

11. The vasoocclusive device of claim 10, wherein said shape memory nickel-titanium alloy is heat treated such that the alloy is highly flexible at a temperature appropriate for introduction into the body via a catheter, and after placement, the device will take on the operable configuration.

12. The vasoocclusive device of claim 1, wherein said strand of flexible material is further formed into a helical shape which is the form of the first, inoperable, substantially linear configuration of the strand.

13. A method of making a vasoocclusive device that is adapted to be inserted into a portion of a vasculature for occluding the portion of the vasculature for use in interventional therapy and vascular surgery, said vasoocclusive device being formed from at least one strand of a flexible material formed to have a first inoperable, substantially linear configuration for insertion into and through a catheter to a desired portion of the vasculature to be treated, and having a second operable, three dimensional configuration for occluding the desired portion of the vasculature to be treated, the method comprising the steps of:

winding at least one strand of a flexible material about an orthogonally shaped mandrel in a three dimensional configuration of the vasoocclusive device,

said orthogonally shaped mandrel including a handle, and helically winding a portion of said at least one strand of flexible material about the handle;

heating said at least one strand of a flexible material for a sufficient period of time to impart the form to the material included in the device to form a first operable, three dimensional portion of the vasoocclusive device and a second operable, substantially J-shape portion of the vasoocclusive device extending outwardly from the three dimensional portion and configured filling and reinforcing the distal, three dimensional portion when the vasoocclusive device is implanted at the portion of the vasculature to be treated;

removing the vasoocclusive device from the mandrel; and

cold working the vasoocclusive device into a desired elongated configuration for placement into a catheter or cannula for use.

14. The method of claim 13, wherein the mandrel about which said at least one flexible strand forming the vasoocclusive device is wound has a substantially orthogonally shaped main body with plurality of posts disposed on the body, said posts being at least as large in diameter as the radius of said body.

15. The method of claim 14, wherein said main body is substantially cubical.

16. The method of claim 14, wherein six posts are disposed on the body aligned with three orthogonal x, y and z axes through the body of the mandrel, for aligning and shaping the distal portion of the vasoocclusive device as it is wound on the mandrel.

17. A vasoocclusive device that is adapted to be inserted into a portion of a vasculature for occluding a portion of the vasculature for use in interventional therapy and vascular surgery, comprising:

at least one strand of a flexible material formed to have a first portion with a first inoperable, substantially linear configuration for insertion into and through a catheter to a desired portion of the vasculature to be treated, and a second operable, three dimensional substantially cube-shaped orthogonal configuration for occluding the desired part of the vasculature to be treated; and

a second portion extending outwardly from the first portion in its second configuration and having a first inoperable, substantially linear configuration for insertion into and through a catheter to a desired portion of the vasculature to be treated, and a second operable, substantially J-shape for filling and reinforcing the distal, three dimensional shaped portion when the vasoocclusive device is implanted at the site in the vasculature to be treated.

18. A method of making a vasoocclusive device that is adapted to be inserted into a portion of a vasculature for occluding the portion of the vasculature for use in interventional therapy and vascular surgery, said vasoocclusive device being formed from at least one strand of a flexible material formed to have a first inoperable, substantially linear configuration for insertion into and through a catheter to a desired portion of the vasculature to be treated, and a portion having a second operable, three dimensional configuration for occluding the desired portion of the vasculature to be treated, the method comprising the steps of:

winding at least one strand of a flexible material about an orthogonally shaped mandrel in a three dimensional configuration of the vasoocclusive device,

said orthogonally shaped mandrel including a handle, and helically portion of said at least one strand of flexible material about the handle;

heating said at least one strand of a flexible material for a sufficient period of time to impart the form to the material included in the device to form a first operable, three dimensional portion of the vasoocclusive device and a second operable, substantially J-shape portion extending outwardly from the three dimensional portion and configured for filling and reinforcing the three dimensional portion when the vasoocclusive device is implanted at the portion of the vasculature to be treated;

removing the vasoocclusive coil from the mandrel; and

cold working the vasoocclusive coil into a desired elongated configuration for placement into a catheter or cannula for use.