Expandable occlusive structure

• US 9,017,350 B2
• Filed: 01/25/2006
• Issued: 04/28/2015
• Est. Priority Date: 01/25/2005
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Karabey, Halil I., Prestezog, Anna G., Mirizzi, Michael S.
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US11/339,927
• Publication Number:
  US 20060212055A1
• Time in Patent Office: 3,380 Days
• Field of Search: 606/151, 606/213
• US Class Current: 606/158
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• 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 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• 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 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

An apparatus for treating a hollow anatomical structure comprises an implant comprising a plurality of bioabsorbable fibers. The implant has a compressed state in which the implant can fit within a cylindrical tube having an inside diameter of 8 French or less. The implant is expandable from the compressed state to an expanded state in which the implant has sufficient size to span the inside diameter of a cylindrical tube having an inside diameter of 12 French or greater.

Claims

1. An apparatus for treating a hollow anatomical structure, said apparatus comprising:

an implant comprising a plurality of loose, non-knit, non-woven, bioabsorbable fibers arranged generally parallel to each other and extending along a longitudinal axis of said implant, each of said fibers having a number of bends along the length of the fiber, the bends providing the fiber with a greater transverse width than a fiber without bends, the bends also providing resilience to the fiber such that in a first state the fiber has a shorter length and a greater transverse width than in a second state where the fiber has a longer length and a smaller transverse width, each fiber configured for self-expansion, independent of the other fibers of the implant, in a lateral dimension transverse to the longitudinal axis through a change in shape from the second state to the first state, where the bends along the length are more pronounced in the first state compared to the second state, each of said fibers having a denier of about 0.1 to about 10;

said implant configured to have a compressed state in which said implant can fit within a cylindrical tube having an inside diameter of 8 French or less;

said plurality of fibers being formed into an elongate bundle of fibers comprising at least about 500 fibers and configured to be laterally expandable, due to the aggregate, unassisted self-expandability of the individual fibers, from said second state to said first state in which said implant is configured to span and conform to the inside diameter of a hollow anatomical structure having an inside diameter of 12 French or greater;

said implant configured to provide a high void content scaffold within the hollow anatomical structure and to allow blood infiltration into the voids.

2. The apparatus of claim 1, wherein said implant has sufficient size, when in said expanded state, to span and conform to the inside diameter of a hollow anatomical structure having an inside diameter of 12-60 French.

3. The apparatus of claim 2, wherein said implant can pass through a cylindrical tube having an inside diameter of 6-8 French when in said compressed state.

4. The apparatus of claim 2, wherein said implant comprises a fixation element configured to limit migration of said implant when in said hollow anatomical structure.

5. The apparatus of claim 1, wherein said implant can fit within a cylindrical tube having an inside diameter of 6-8 French when in said compressed state.

6. The apparatus of claim 1, wherein said implant comprises a fixation element configured to limit migration of said implant when in said hollow anatomical structure.

7. The apparatus of claim 1, wherein said implant is laterally expandable by a factor of at least 50% of its original cross-sectional size due to the aggregate, unassisted self-expandability of the fibers.

8. The apparatus of claim 1, wherein said fibers form a vessel wall engagement surface of said implant.

9. The apparatus of claim 8, wherein said surface comprises a radially outermost portion of said implant.

10. The apparatus of claim 1, wherein the bends along the length of each of the fibers are present in both the first state and the second state.

11. An apparatus for treating a hollow anatomical structure, said apparatus comprising:

an implant comprising a plurality of loose, non-knit, non-woven, bioabsorbable fibers extending generally along a longitudinal axis of said implant, each of said fibers configured for individual radial self-expansion and having an undulating configuration such that each fiber is resilient and can expand in a dimension transverse to the longitudinal axis of the implant, but under radial compression the width of the fiber decreases and the length of the fiber increases, the length extending along the longitudinal axis, the fiber having a denier of about 0.1 to about 10;

said implant configured to have a compressed state in which said implant can pass through a cylindrical tube having an inside diameter of 8 French or less;

said implant configured to be radially expandable, due to the aggregate, unassisted self-expandability of the individual fibers, from said compressed state to a treatment state in which said implant has a transverse size which is sufficiently large to occupy an adult human greater saphenous vein of average size while forming a high void content scaffold;

said implant further configured to extend along a longitudinal axis of said greater saphenous vein to acutely slow the flow of blood through said greater saphenous vein; and

said individual fibers configured to self-expand by assuming an increased width and a decreased length when compression is decreased on the undulating configuration of the individual fibers.

12. The apparatus of claim 11, wherein said fibers form a vessel wall engagement surface of said implant.

13. The apparatus of claim 12, wherein said surface comprises a radially outermost portion of said implant.

14. The apparatus of claim 11, wherein the undulating configuration of the fibers is present in both the compressed state and the treatment state.

15. An apparatus for occluding a hollow anatomical structure, said apparatus comprising:

an implant comprising a loosely arranged, non-knit, non-woven, scaffold of fibers, said fibers being configured to be bioabsorbable and individually self-expandable, said fibers being crimped such that they have a succession of waves along the length thereof and such that they have a greater width and a shorter length in a compressed state compared to an expanded state because of the crimp retention of the individual fibers, said scaffold formed into an elongate bundle of fibers comprising at least about 500 fibers;

wherein said implant in the compressed state can fit within a cylindrical tube having an inside diameter of 8 French or less; and

said implant being laterally expandable, due to the aggregate, unassisted self-expandability of the individual fibers, from said compressed state to said expanded state in which said implant has a transverse size which is sufficiently large to span the inside diameter of a cylindrical tube having an inside diameter of 12 French or greater while forming said scaffold, said scaffold configured to have a high void content to allow blood to flow into the voids;

wherein the fibers are crimped in both the compressed state and the expanded state.

16. The apparatus of claim 15, wherein said implant comprises a fixation element configured to limit migration of said implant when in said hollow anatomical structure.

17. The apparatus of claim 15, wherein said implant is laterally expandable by a factor of at least 50% of its original cross-sectional size due to the aggregate, unassisted self-expandability of the fibers.

18. The apparatus of claim 15, wherein said implant has sufficient size, when in said expanded state, to span and conform to the inside diameter of a hollow anatomical structure having an inside diameter of 24-36 French.

19. The apparatus of claim 15, wherein said fibers form a vessel wall engagement surface of said implant.

20. The apparatus of claim 19, wherein said surface comprises a radially outermost portion of said implant.