Method and apparatus for implanting an occlusive structure

• US 8,333,786 B2
• Filed: 10/18/2010
• Issued: 12/18/2012
• Est. Priority Date: 01/25/2005
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Mirizzi, Michael S., Prestezog, Anna G., Karabey, Halil I., Rodriguez, John W.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): MASHACK, MARK F
• Application Number:
  US12/906,961
• Publication Number:
  US 20110172695A1
• Time in Patent Office: 792 Days
• Field of Search: 606/200, 606/213, 606/139, 606/108, 606/151, 606157-159, 424422-426, 623 2372- 2375, 623/1.11, 623/1.1, 623 1311- 1314, 623 1318- 132, 604 11- 18, 604/385.18, 128830-831
• US Class Current: 606/200
• 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

A method of treating a vein comprises accessing a vein at an access point spaced from a sapheno-femoral junction. A bioabsorbable fibrous body is implanted into the vein through the access point. The body is moved in the vein toward the sapheno-femoral junction.

Claims

1. A method of treating a hollow anatomical structure (HAS) of a patient, the method comprising:

percutaneously accessing the HAS;

advancing a bioabsorbable fibrous body into the HAS in a downstream direction from the percutaneous access site, the body comprising;

a plurality of loose, non-knit and non-woven fibers, each fiber being bulked in a generally radial direction, extending in a generally longitudinal direction, having a number of bends along the length thereof such that in a first state each fiber has a shorter length and a greater width than in a second state, each fiber also being formed from one or more bioabsorbable materials, the fibers having a first bioabsorption rate; and

a bioabsorbable tether coupled to the fibrous body at a distal portion of the fibrous body, the tether extending longitudinally from the distal portion and along and substantially parallel to the fibrous body, the tether having a second bioabsorption rate that is different from the first bioabsorption rate;

implanting the bioabsorbable fibrous body in the HAS such that a proximal portion of it, including a proximal portion of the tether, extends through and out of the HAS and the percutaneous access site to terminate outside the patient'"'"'s body;

uncompressing and expanding the bioabsorbable fibrous body through self-expansion of individual fibers by moving individual fibers to the first state from the second state in which individual fibers have a shorter length and a greater width than in the second state on account of each fiber having a number of bends along the length thereof; and

occluding the HAS.

2. The method of claim 1, further comprising securing the tether near the percutaneous access site and outside of the HAS so that the tether limits migration of the body within the HAS.

3. The method of claim 1, further comprising trimming an end portion of the body so that it is substantially flush with the skin but the tether extends beyond the body through the access site.

4. The method of claim 1, wherein occluding the HAS comprises creating a scaffold within the HAS with the fibrous body and allowing infiltration of bodily fluids into voids within the scaffold to stimulate tissue in-growth within the HAS.

5. The method of claim 1, further comprising tying a knot in the tether outside a wall of the HAS but below the skin.

6. The method of claim 1, further comprising deploying a tab coupled to the tether in the patient'"'"'s subcutaneous tissue.

7. The method of claim 1, further comprising thermally shrinking the HAS near a location of the fibrous body.

8. The method of claim 1, wherein the HAS comprises a blood vessel.

9. The method of claim 1, wherein the tether and the proximal portion of the fibrous body are not coupled to one another, and thereby configured for relative motion.

10. The method of claim 1, wherein the tether has a larger cross-section than any individual fiber in the fibrous body.

11. A method of treating a hollow anatomical structure (HAS) of a patient, the method comprising:

implanting a bioabsorbable fibrous body in the HAS through an access site on the patient'"'"'s skin, the body comprising;

a plurality of loose, non-knit and non-woven fibers, each fiber being bulked in a generally radial direction, and extending in a generally longitudinal direction, having a number of bends along the length thereof such that, in an at-rest state, each fiber has a shorter length and a greater width than in a compressed state, each fiber also being formed from one or more bioabsorbable materials;

a bioabsorbable tether coupled to the fibrous body at a distal portion of the fibrous body, the tether extending longitudinally from the distal portion and along and substantially parallel to the fibrous body within the HAS after implantation;

the plurality of fibers being formed into an elongate bundle of fibers, the bundle being folded back along its longitudinal axis to form the fibrous body; and

positioning the fibrous body so that a proximal portion of it, including a proximal portion of the tether extends through and out of the HAS and the access site to terminate outside the patient'"'"'s body;

uncompressing and expanding the bioabsorbable fibrous body through self-expansion of individual fibers by moving individual fibers to the at-rest state from the compressed state such that the individual fibers have a shorter length and a greater width in the at-rest state than in the compressed state on account of each fiber having a number of bends along the length thereof;

occluding the HAS.

12. The method of claim 11, wherein self-expansion of the individual fibers within the fibrous body creates a high void content scaffold for tissue in-growth within the HAS, the scaffold substantially filling a section of the HAS and allowing bodily fluid infiltration into the voids.

13. The method of claim 11, further comprising securing the tether near the access site.

14. The method of claim 13, further comprising trimming an end portion of the body so that it is substantially flush with the skin but the tether extends beyond the body through the access site.

15. The method of claim 11, further comprising tying a knot in the tether outside a wall of the HAS but below the skin.

16. The method of claim 11, further comprising deploying a tab coupled to the tether in the patient'"'"'s subcutaneous tissue.

17. The method of claim 11, further comprising thermally shrinking the HAS near a location of the fibrous body.

18. The method of claim 11, wherein the HAS comprises a blood vessel.

19. The method of claim 11, wherein the tether and the proximal portion of the fibrous body are not coupled to one another, and thereby configured for relative motion.

20. The method of claim 11, wherein the tether has a larger cross-section than any individual fiber in the fibrous body.

21. A method of treating a hollow anatomical structure (HAS) of a patient, the method comprising:

implanting a bioabsorbable fibrous body in the HAS through an access site on the patient'"'"'s skin, the body comprising;

a plurality of loose, non-knit and non-woven fibers, each fiber being bulked in a generally radial direction, and extending in a generally longitudinal direction, having a number of bends along the length thereof such that, in an at-rest state, each fiber has a shorter length and a greater width than in a compressed state, each fiber also being formed from one or more bioabsorbable materials;

a bioabsorbable tether coupled to the fibrous body at a distal portion of the fibrous body, the tether extending longitudinally from the distal portion and along and substantially parallel to the fibrous body within the HAS after implantation;

the plurality of fibers being formed into an elongate bundle of fibers, the bundle being folded back along its longitudinal axis to form the fibrous body; and

positioning the fibrous body so that a proximal portion of it, including a proximal portion of the tether extends through and out of the HAS and the access site to terminate outside the patient'"'"'s body;

uncompressing and expanding the bioabsorbable fibrous body through self-expansion of individual fibers by moving individual fibers to the at-rest state from the compressed state such that the individual fibers have a shorter length and a greater width in the at-rest state than in the compressed state on account of each fiber having a number of bends along the length thereof;

wherein the fibers include abrasive outer surfaces to enhance frictional contact between the fibers and the patient'"'"'s tissue;

occluding the HAS.

22. The method of claim 21, wherein self-expansion of the individual fibers within the fibrous body creates a high void content scaffold for tissue in-growth within the HAS, the scaffold substantially filling a section of the HAS and allowing bodily fluid infiltration into the voids.

23. The method of claim 21, further comprising securing the tether near the access site.

24. The method of claim 23, further comprising trimming an end portion of the body so that it is substantially flush with the skin but the tether extends beyond the body through the access site.

25. The method of claim 21, further comprising tying a knot in the tether outside a wall of the HAS but below the skin.

26. The method of claim 21, further comprising deploying a tab coupled to the tether in the patient'"'"'s subcutaneous tissue.

27. The method of claim 21, further comprising thermally shrinking the HAS near a location of the fibrous body.

28. The method of claim 21, wherein the HAS comprises a blood vessel.

29. The method of claim 21, wherein the tether and the proximal portion of the fibrous body are not coupled to one another, and thereby configured for relative motion.

30. The method of claim 21, wherein the tether has a larger cross-section than any individual fiber in the fibrous body.