Occlusive implant and methods for hollow anatomical structure

• US 9,017,361 B2
• Filed: 04/20/2006
• Issued: 04/28/2015
• Est. Priority Date: 04/20/2006
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Karabey, Halil Ibrahim, Mirizzi, Michael S., Prestezog, Anna Grace
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US11/407,858
• Publication Number:
  US 20070248640A1
• Time in Patent Office: 3,295 Days
• Field of Search: 606/200, 606/213, 606/151, 606/157, 606/158
• US Class Current: 606/200
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• 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 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

Apparatus and methods for treating a hollow anatomical structure comprises an implant sized for insertion into a hollow anatomical structure. The implant comprises a plurality of loose, bulked fibers. The fibers are formed from one or more bioabsorbable materials. Upon implantation, the apparatus causes a partial occlusion of the hollow anatomical structure, followed by a complete or substantially complete occlusion.

Claims

1. A method of treating a hollow anatomical structure having a lumen, the method comprising:

inserting an implant into the lumen, the implant comprising a radially-compressible fibrous mass and a tether extending axially through the fibrous mass to a distal tether end coupled to a distal end of the fibrous mass, wherein the fibrous mass predominantly comprises a plurality of loose bioabsorbable fibers that are in substantial alignment with each other along their lengths, wherein the fibers are radially-bulked, such that when the fibrous mass is in a radially compressed configuration, each of the fibers has a greater length and defines a smaller radial thickness than when the fibrous mass is in a radially uncompressed configuration, wherein inserting the implant comprises inserting the implant into the lumen with the fibrous mass in its compressed configuration, and so that the tether has a proximal end extending outside of the hollow anatomical structure, and wherein the hollow anatomical structure comprises a blood vessel;

securing the proximal end of the tether to tissue outside of the hollow anatomical structure;

allowing the fibrous mass to expand within the lumen from its radially compressed configuration toward its radially uncompressed configuration as the fibers of the fibrous mass decrease in length and thereby define a greater radial thickness, thereby creating a high void-content scaffold spanning a section of the lumen of the hollow anatomical structure and causing a partial occlusion of the lumen, wherein causing the partial occlusion comprises reducing blood flow through the lumen by 10%-90%; and

gradually creating a substantially complete occlusion of the lumen by allowing blood to infiltrate the voids of the scaffold.

2. The method of claim 1, wherein said hollow anatomical structure comprises a varicose vein.

3. The method of claim 1, wherein causing a partial occlusion of said hollow anatomical structure comprises reducing blood flow through the lumen by 20%-80%.

4. The method of claim 1, wherein causing a partial occlusion of said hollow anatomical structure comprises reducing blood flow through the lumen by 25%-75%.

5. The method of claim 1, wherein, creating a substantially complete occlusion further comprises causing complete occlusion as a result of tissue in-growth within the scaffold.

6. A method of reducing the patency of a blood vessel having a lumen, the method comprising:

inserting an implant into the lumen, the implant comprising a radially-compressible fibrous mass and a tether extending axially through the fibrous mass to a distal tether end coupled to a distal end of the fibrous mass, wherein the fibrous mass predominantly comprises a plurality of loose bioabsorbable fibers that are in substantial alignment with each other along their lengths, wherein, when the fibrous mass is in a radially compressed configuration, each of the fibers assumes a first state with a first length and defining a first amount of tortuosity, and when the fibrous mass is in a radially uncompressed configuration, each of the fibers assumes a second state with a second length less than the first length and defining a second amount of tortuosity greater than the first amount of tortuosity, wherein inserting the implant comprises inserting the implant into the lumen with the fibrous mass in its compressed configuration, and so that the tether has a proximal end extending outside of the hollow anatomical structure;

allowing the fibrous mass to expand within the lumen from its radially compressed configuration toward its radially uncompressed configuration, so that the fibers of the fibrous mass change from the first state to the second state, thereby creating a high void-content scaffold that partially occludes the lumen and reduces blood flow through the lumen by 10%-90%; and

securing the proximal end of the tether to tissue outside of the blood vessel; and

gradually creating a substantially complete occlusion of the lumen by allowing blood to infiltrate the voids of the scaffold.

7. The method of claim 6, wherein said fibers of said fibrous mass are crimped.

8. The method of claim 6, wherein said fibers of said fibrous mass are textured.

9. The method of claim 6, wherein inserting said implant comprises substantially spanning the lumen of said blood vessel with said fibers.

10. The method of claim 6, wherein the blood vessel comprises a varicose vein.

11. A method of inhibiting migration of a bioabsorbable fibrous scaffold implanted within a lumen of a hollow anatomical structure, said method comprising:

implanting a high void-content scaffold into the lumen of the hollow anatomical structure, the scaffold being resiliently compressible from an uncompressed configuration to a compressed configuration, the scaffold having a proximal portion and a distal portion and predominantly comprising a plurality of loose bioabsorbable fibers extending in a generally longitudinal direction, each of the fibers having a number of bends along its length such that, when the scaffold is in the uncompressed configuration, each of the fibers assumes a first configuration having a first length and defining a first radial width, and when the scaffold is in the compressed configuration, each of the fibers assumes a second configuration having a second length longer than the first length and defining a second radial width less than the first radial width, wherein implanting the scaffold into the lumen comprises implanting the scaffold in the compressed configuration with the fibers in the second configuration, and wherein the hollow anatomical structure comprises a blood vessel;

securing a proximal end of a tension member to tissue outside of the hollow anatomical structure, the tension member having a distal end that is coupled to the distal portion of the scaffold, the tension member extending proximally along the scaffold;

allowing the scaffold to return to the uncompressed configuration within the lumen through self-expansion of the fibers, whereby the fibers are returned from the second configuration to the first configuration, thereby creating a partial occlusion of the lumen that reduces blood flow through the lumen by 10%-90%, whereby the scaffold, in its uncompressed configuration, is substantially inhibited from migration within the lumen; and

gradually creating a substantially complete occlusion of the lumen by permitting blood flowing through the lumen to infiltrate the high void content scaffold.

12. The method of claim 11, wherein permitting blood to infiltrate said scaffold comprises permitting antegrade blood flow to infiltrate said scaffold.

13. The method of claim 11, wherein said fibers span the lumen of said hollow anatomical structure, and permitting fluid to infiltrate said scaffold comprises permitting fluid flow between said fibers.

14. The method of claim 11, wherein gradually creating a substantially complete occlusion comprises causing tissue ingrowth into said scaffold.

15. The method of claim 11, wherein the hollow anatomical structure comprises a varicose vein.

16. A method of treating a hollow anatomical structure having a lumen, said method comprising:

inserting into the lumen of the hollow anatomical structure an implant and an anchor device passing longitudinally through the implant and having a distal end coupled to a distal portion of the implant, wherein the implant predominantly comprises a plurality of loose bioabsorbable fibers in substantial longitudinal alignment, each of the fibers being configured to have a greater length and a less tortuous configuration when the implant is compressed in a transverse direction, and to return to a lesser length and a more tortuous configuration when the implant is relieved of transverse compression, the implant being transversely compressed when inserted into the lumen, wherein the hollow anatomical structure comprises a blood vessel;

relieving the implant of transverse compression while it is in the lumen, whereby the implant is brought into engagement with the hollow anatomical structure as the fibers return to the more tortuous configuration, the implant thereby forming a high void-content scaffold that partially occludes the lumen and reduces blood flow through the lumen by 10%-90%;

positioning the implant such that said anchor device extends proximally substantially parallel along the fibers to a location upstream from the distal portion;

securing said anchor device to tissue outside of the hollow anatomical structure; and

gradually creating a substantially complete occlusion of the lumen by allowing blood to infiltrate the voids of the scaffold.

17. The method of claim 16, wherein said hollow anatomical structure comprises a varicose vein.

18. The method of claim 16, wherein said fibers comprise a plurality of loose, bulked fibers.

19. The method of claim 16, wherein said anchor device comprises a tether.

20. The method of claim 16, wherein forming the high void-content scaffold comprises forming the high void-content scaffold that partially occludes the lumen and reduces blood flow through the lumen by 20%-80%.