VASCULAR REMODELING DEVICE

• US 20110184452A1
• 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: Tran, Quang, Huynh, Andy, Molaei, Masoud, Shrivastava, Sanjay, Slee, Earl, Schuman, Victoria
• Granted Patent: US 9,468,442 B2
• Time in Patent Office: Days
• US Class Current: 606/195
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes
• CPC Class Codes: A61F 2230/0071 spherical

Abstract

An intraluminal apparatus including a catheter and device is positionable at a junction of afferent and efferent vessels of a bifurcation having an aneurysm. After positioning the device 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 the device permits perfusion to the efferent vessels. Positioning the device may include deployment and optional release from a catheter. Embolic material may be inserted in the aneurysm before or after positioning the device. The device may have a proximal end, a distal end, and a plurality of filaments extending between and coupled at the proximal end and the distal end. The device may include a central filament configured to reshape the device. The distal end of the device may include a covering. The device may be football shaped, pumpkin shaped, or acorn shaped.

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 device in a compressed state, the device comprising a plurality of filaments extending between the proximal end and the distal end and coupled at the proximal end and at the distal end;

deploying the device from at least partially inside the catheter to outside the catheter at the junction of the bifurcation, wherein, during deployment, the device self-expands to conform in an expanded state to the junction of the bifurcation and wherein, after deployment and while the proximal end of the device is connected to the catheter, the device acts as a scaffolding to inhibit herniation of objects out of the neck of the aneurysm and permits perfusion of fluid to the efferent vessels;

retracting the device at least partially back inside the catheter; and

withdrawing the catheter and the device.

2. The method of claim 1, further comprising inserting embolic material into the aneurysm.

3. The method of claim 1, wherein deploying the device comprises locking the device into place across ostia of the afferent and efferent vessels and the neck of the aneurysm.

4. The method of claim 1, wherein deploying the device further comprises:

retracting the device into the catheter; and

re-deploying the device in at least one of a second orientation and a second position, wherein, during re-deployment, the device self-expands to conform to the junction of the bifurcation.

5. An intraluminal apparatus comprising:

a catheter; and

a device having a distal end and a proximal end, the device comprising a plurality of filaments extending between the proximal end and the distal end and coupled at the proximal end and at the distal end, wherein the device is configured to self-expand from a compressed state upon deployment from at least partially inside the catheter to outside the catheter to conform in an expanded state to a junction of a bifurcation having an afferent vessel, efferent vessels, and an aneurysm having a neck and a fundus, wherein the device is configured 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 while the proximal end of the device is connected to the catheter, wherein the device is retractable from the expanded state at least partially back inside the catheter.

6. The apparatus of claim 5, wherein the device comprises between about 4 filaments and about 12 filaments.

7. The apparatus of claim 5, wherein the device comprises a covering on at least a portion of the device.

8. The apparatus of claim 5, wherein the device is optionally releasable from the catheter by electrolytic, chemical, or mechanical detachment.

9. The apparatus of claim 5, wherein distal ends of the filaments comprise a coating configured to preferentially repel certain material.

10. The apparatus of claim 5, wherein the device is generally acorn-shaped in the expanded state, the device comprising a distal portion proximal of the distal end and a proximal portion between the distal portion and the proximal end, and wherein a diameter of the distal portion is greater than a diameter of the proximal portion.

11. The apparatus of claim 10, wherein the distal portion comprises a distal section, at least some of the plurality of filaments comprising a feature configured to increase the surface area of the distal section.

12. The apparatus of claim 11, wherein the feature is leaf-shaped.

13. The apparatus of claim 10, wherein the distal portion comprises a distal section, the plurality of filaments in the distal section spiraling towards the distal end.

14. An intraluminal apparatus comprising:

a catheter; and

a device having a distal end and a proximal end, wherein the device is configured to self-expand upon deployment from at least partially inside the catheter to outside the catheter to conform in an expanded state to a junction of a bifurcation having an afferent vessel, efferent vessels, and an aneurysm having a neck and a fundus, the distal end of the device comprising a covering configured to act as a scaffolding to inhibit herniation of embolic material out of the neck of the aneurysm, the device configured to permit perfusion of fluid to the efferent vessels.

15. The apparatus of claim 14, wherein the covering comprises polyester, nylon, or polytetrafluoroethylene.

16. The apparatus of claim 14, wherein the covering comprises polylactic acid or polyglycolic acid.

17. The apparatus of claim 14, wherein the covering is highly porous or semi-porous.

18. 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 device in a compressed state, wherein the device comprises a plurality of filaments and a central filament;

deploying the device from at least partially inside the catheter to outside the catheter at the junction of the bifurcation, wherein, during deployment, the device self-expands to conform to the junction of the bifurcation;

reshaping the deployed device by using the central filament to adjust a distance between a proximal end of the device and a distal end of the device, wherein, after deployment, the device acts as a scaffolding to inhibit herniation of objects out of the neck of the aneurysm and permits perfusion of fluid to the efferent vessels;

retracting the device at least partially back inside the catheter; and

withdrawing the catheter and the device.

19. The method of claim 18, further comprising locking into shape the reshaped deployed device.

20. An intraluminal apparatus comprising:

a catheter;

a device having a proximal end connected to the catheter and a distal end, the device comprising;

a plurality of filaments extending between the proximal end and the distal end and coupled at the proximal end and at the distal end, the filaments configured to self-expand upon deployment from inside the catheter to outside the catheter to conform to a junction having an afferent vessel, efferent vessels, and an aneurysm having a neck and a fundus in an expanded state; and

a central filament extending between the proximal end and the distal end, the central filament configured to reshape the device in the expanded state by adjusting a distance between the distal end and the proximal end, wherein the device is configured 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 while the proximal end of the device is connected to the catheter.

21. The apparatus of claim 20, wherein the device comprises prongs and a ring proximate to the proximal end of the device, the prongs and the ring configured to lock into shape the reshaped deployed device.

22. The apparatus of claim 20, wherein the central filament comprises a plurality of outwardly-biased arms, the catheter comprises a bulbous portion, and the proximal end of the device comprises a sleeve, the central filament slidable within the sleeve, wherein the sleeve is configured to contain the plurality of arms around the bulbous portion when the central filament is in a first position relative to the sleeve, and wherein the plurality of arms are each configured to outwardly expand to lock into shape the reshaped deployed device and to release the bulbous portion when the central filament is in a second position relative to the sleeve, the second position proximal to the first position.