VASCULAR REMODELING DEVICE

• US 20110184453A1
• Filed: 01/28/2011
• Published: 07/28/2011
• Est. Priority Date: 01/28/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Schuman, Victoria, Levy, Elad Israel, Shrivastava, Sanjay, Slee, Earl
• Granted Patent: US 8,926,681 B2
• Time in Patent Office: Days
• US Class Current: 606/195
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices artificial blood vessels A61L27/507
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• 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: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A generally spherical vascular remodeling device is permanently positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device at the junction to substantially conform the device to the shape of the junction, the device acts as a scaffolding to inhibit herniation of objects out of the aneurysm and permits perfusion to the efferent vessels. Positioning the device may include deployment and mechanical or electrolytic release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a first end, a second end substantially opposite to the first end, and a plurality of polymer filaments extending between and coupled at the first end and the second end. Such devices may be football shaped, pumpkin shaped, or twisted. The device may include a plurality of polymer loops forming a generally spherical shape.

Claims

1. A method of treating an aneurysm at a junction of a bifurcation having an afferent vessel and efferent vessels, the aneurysm having a neck and a fundus, the method comprising:

advancing a catheter proximate to the junction of the bifurcation, the catheter at least partially containing a generally spherical vascular remodeling device in a compressed state, wherein the device comprises a plurality of polymer filaments;

positioning the device at the junction of the bifurcation; and

withdrawing the catheter and leaving the device at the junction of the bifurcation, wherein the device acts as a scaffolding to inhibit herniation of objects out of the neck of the aneurysm and wherein the device permits perfusion of fluid to the efferent vessels.

2. The method of claim 1, wherein at least some of the polymer filaments comprise polyglycolic acid, polylactic acid, poly(lactic-co-glycolic acid), poly-epsilon-caprolactone, or naturally-derived bioabsorbable polymers.

3. The method of claim 1, wherein a first group of the polymer filaments comprise a first polymer having a first rate of bioabsorption and wherein a second group of the polymer filaments comprise a second polymer different than the first polymer, the second polymer having a second rate of bioabsorption different that the first rate of bioabsorption.

4. The method of claim 1, wherein the bifurcation is a neurovascular bifurcation.

5. The method of claim 1, wherein the device substantially conforms to a shape of the junction.

6. The method of claim 1, wherein positioning the device comprises:

deploying the device from the catheter; and

expanding the device.

7. The method of claim 6, wherein expanding the device comprises allowing the device to expand towards an uncompressed state.

8. The method of claim 6, wherein positioning the device further comprises, after expanding the device, releasing the device from the catheter.

9. The method of claim 8, wherein releasing the device comprises mechanically releasing or electrolytically releasing the device from the catheter.

10. The method of claim 8, further comprising:

after expanding the device, retracting the device into the catheter;

redeploying the device from the catheter; and

re-expanding the device.

11. The method of claim 1, further comprising inserting embolic material in the fundus of the aneurysm, the objects comprising the embolic material.

12. A generally spherical remodeling device comprising:

a first end;

a second end substantially opposite to the first end; and

a plurality of polymer filaments extending between the first end and the second end and coupled at the first end and the second end,

wherein the device is configured

to be positioned at a junction of a bifurcation comprising at least one afferent vessel, efferent vessels, and an aneurysm having a neck after withdrawal of a delivery catheter,

to act as a scaffolding to inhibit herniation of objects out of the neck of the aneurysm, and

to permit perfusion of fluid to the efferent vessels

13. The device of claim 12, wherein at least some of the polymer filaments comprise polyglycolic acid, polylactic acid, poly(lactic-co-glycolic acid), poly-epsilon-caprolactone, or naturally-derived bioabsorbable polymers.

14. The device of claim 12, wherein a first group of the polymer filaments comprise a first polymer having a first rate of bioabsorption and a second group of the polymer filaments comprise a second polymer different than the first polymer, the second polymer having a second rate of bioabsorption different that the first rate of bioabsorption.

15. The device of claim 12, wherein the device is generally football-shaped, the first end extending outwardly and the second end extending outwardly.

16. The device of claim 12, wherein the device is generally pumpkin-shaped, the first end extending outwardly and the second end extending inwardly.

17. The device of claim 12, wherein porosity distally increases between the second end and an approximate midpoint and wherein porosity distally decreases between the midpoint and the first end.

18. The device of claim 12, wherein the filaments are longitudinally angled at the second end.

19. The device of claim 12, wherein the plurality of filaments comprises between about 6 filaments and about 12 filaments.

20. The device of claim 12, wherein a proximal end of the device comprises a bioabsorbable coupling.

21. The device of claim 20, wherein the coupling is configured to bioabsorb more quickly than the plurality of polymer filaments.

22. The device of claim 21, wherein the plurality of polymer filaments are configured to extend towards the afferent vessel after bioabsorption of the coupling.

23. A remodeling device comprising a plurality of polymer arcuate loops forming a generally spherical shape, wherein the device is configured to be positioned at a junction of a bifurcation having an aneurysm after withdrawal of a delivery catheter, wherein the device is configured to act as a scaffolding to inhibit matter from herniating out of the aneurysm, and wherein the device is configured to permit perfusion of blood to efferent vessels of the bifurcation.

24. The device of claim 23, wherein at least some of the polymer loops comprise polyglycolic acid, polylactic acid, poly(lactic-co-glycolic acid), poly-epsilon-caprolactone, or naturally-derived bioabsorbable polymers.

25. The device of claim 23, wherein a first group of the polymer loops comprise a first polymer having a first rate of bioabsorption and a second group of the polymer loops comprise a second polymer different than the first polymer, the second polymer having a second rate of bioabsorption different that the first rate of bioabsorption.