Filamentary Devices For Treatment Of Vascular Defects

• US 20110208227A1
• Filed: 10/25/2010
• Published: 08/25/2011
• Est. Priority Date: 04/21/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Becking, Frank P.
• Granted Patent: US 9,039,726 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• 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 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00862 elastic or resilient
• CPC Class Codes: A61B 2017/00867 shape memory effect
• 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 2017/12068 detachable by heat
• CPC Class Codes: A61B 2018/00416 Treatment of aneurisms
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: Y10T 156/1051 by folding

Abstract

Braid-balls suitable for aneurysm occlusion and/or parent vessel occlusion/sacrifice (e.g., in treating neurovascular defects) are disclosed. Especially for aneurysm treatment, but also for either one of the aforementioned treatments, the form of the ball is very important. In particular, the density of the device is paramount in applications where braid itself is intended to moderate or stop blood flow—allowing thrombosis within a volume formed by the ball.

Claims

1-5. -5. (canceled)

6. A device for treatment of a patient'"'"'s vasculature, comprising:

a self-expanding resilient permeable shell having a proximal end, a distal end, a longitudinal axis and further comprising;

a plurality of elongate resilient filaments with a woven structure secured relative to each other at proximal ends and distal ends thereof,

a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other along a length of the filaments, and

an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end including a plurality of openings in the shell formed between the woven filaments, the largest of said openings being configured to allow blood flow through the openings at a velocity below a thrombotic threshold velocity.

7. The device of claim 6 wherein at least the distal end includes a bend in a recessed configuration such that the secured distal ends of the filaments are disposed axially within a nominal contour of the permeable shell structure in the expanded state.

8. The device of claim 7 wherein the proximal end of the shell further comprises a bend in a recessed configuration such that the secured proximal ends of the filaments are withdrawn axially within the nominal permeable shell.

9. The device of claim 6 wherein the filaments of the permeable shell are secured relative to each other in wraps or bands.

10. The device of claim 6 further comprising a distal hub secured to the distal ends of the filaments of the permeable shell.

11. The device of claim 6 further comprising a proximal hub secured to the proximal ends of the filaments of the permeable shell.

12. The device of claim 6 further comprises a band forming a cavity for a detachment tether.

13. The device of claim 12 further comprising a detachment tether secured through the cavity of the proximal hub.

14. The device of claim 6 wherein the filaments of the permeable shell have a transverse dimension of about 0.001 inch to about 0.003 inch.

15. The device of claim 6 wherein the permeable shell comprises at least about 72 filaments.

16. The device of claim 6 wherein the filaments of the permeable shell comprise a superelastic material.

17. The device of claim 16 wherein the superelastic material comprises a shape memory metal.

18. The device of claim 6 wherein the filaments of the permeable shell comprise a shape memory material that is heat set in a configuration of the relaxed expanded state.

19. The device of claim 18 wherein the shape memory metal comprises a NiTi alloy.

20. The device of claim 6 wherein the largest openings formed between adjacent filaments of a defect spanning portion of the permeable shell are about 0.017 inches to about 0.032 inches.

21. A method of treating a vascular defect of a patient, comprising:

a) providing a device for treatment of a patient'"'"'s vasculature comprising a self-expanding resilient permeable shell of woven filaments, the permeable shell having a proximal end, a distal end, a longitudinal axis, a radially constrained elongated state configured for delivery within a microcatheter with the woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other, and an expanded relaxed state with a globular and axially shortened configuration relative to the constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end and a plurality of openings in the shell formed between the woven filaments;

b) advancing a delivery system within a patient'"'"'s body such that a distal end of the delivery system is disposed at a position adjacent or within a vascular defect to be treated;

c) axially advancing the device for treatment of a patient'"'"'s vasculature within the delivery system while in a radially constrained state with an elongate delivery apparatus which has a distal end releasably secured to a proximal end of the device for treatment of the patient'"'"'s vasculature;

d) axially advancing the device until the device emerges distally from a distal end of the delivery system and deploying the device such that the woven filaments of the device radially expand from their radially constrained state and expand into a globular configuration of the permeable shell which covers and acutely occludes at least a portion of an opening or neck of the vascular defect due to the pore size of the permeable shell which slows a flow of blood therethrough to a velocity below a thrombotic threshold velocity.

22. The method of claim 21 further comprising releasing the device from the distal end of the elongate delivery apparatus.

23. The method of claim 21 wherein the device for treatment of the patient'"'"'s vasculature is positioned within the vascular defect by manipulation of a proximal end of the elongate delivery apparatus prior to release of the device.

24. The method of claim 23 further comprising withdrawing the device partially or wholly back within the delivery system by axial retraction of the elongate delivery apparatus prior to release of the device.

25. The method of claim 21 further comprising imparting elongation of the permeable shell in response to radial constraint due to constriction of the vascular defect.

26. The method of claim 21 further comprising selecting a device for treatment of a patient'"'"'s vasculature having a permeable shell in an expanded state with a transverse outer dimension which is oversize relative to a transverse dimension of the patient'"'"'s vascular defect.

27. A method of occluding a vascular defect of a patient'"'"'s vasculature comprising

providing an expandable, porous vascular occlusion device formed from a woven shell of a plurality of filamentary members that are connected to each other on at least the proximal ends of the members forming a substantially closed globular structure with a shape that approximates a size and shape of the vascular defect;

collapsing the device for delivery into the vascular system of the patient;

inserting the collapsed device through an incision in the patient'"'"'s body;

releasing and expanding the device at the vascular defect such that an outer surface contour of the device substantially fills the vascular defect;

substantially occluding the vascular defect acutely with the device that is substantially covered with clotted blood.

28. The method of claim 27 wherein the velocity of blood in the vascular defect is slowed to below a thrombotic threshold velocity after deployment of the device and thrombus forms within an interior volume of the shell of the device.

29. The method of claim 27 further comprising selecting a device with a volume that will fill at least a portion of a volume of the vascular defect.

30. The method of claim 29 wherein the selected device has approximately the same volume as the measured volume of the vascular defect.

31. A delivery system for deployment of a device for treatment of a patient'"'"'s vasculature, comprising:

a microcatheter having an inner lumen extending a length thereof;

a device for treatment of a patient'"'"'s vasculature disposed within the inner lumen of the microcatheter and comprising a self-expanding resilient permeable shell of thin filaments, the permeable shell having a proximal end, a distal end, a longitudinal axis, a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments extending longitudinally from the proximal end to the distal radially adjacent each other, and an expanded relaxed state with a globular and axially shortened configuration relative to the constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end and a plurality of openings in the shell formed between the woven filaments, the permeable shell further having a portion when in the expanded relaxed state that is configured to span an opening of a patient'"'"'s vascular defect; and

an elongate delivery apparatus having a proximal end and a distal end releasably secured to a proximal hub of the device.

32. A method of manufacturing a device for treatment of a patient'"'"'s vasculature, comprising:

braiding a plurality of elongate resilient filaments over a cylindrically shaped mandrel forming a braided tubular member;

heat setting the elongate filaments of the braided tubular member in an expanded relaxed state with a globular and axially shortened configuration relative to a constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from a longitudinal axis of the device between a proximal end and a distal end of the device with the shell having a bend at the distal end in an everted configuration such that a hub at the distal end is withdrawn axially within the permeable shell structure and a plurality of openings in the shell are formed between the woven filaments;

securing the proximal ends of the filaments together; and

securing the distal ends of the filaments together.

33. The method of claim 32 wherein the proximal end of the device further comprises a band forming a cavity for a detachment tether.

34. The method of claim 33 further comprising securing a detachment tether through the cavity.

35. The method of claim 32 further comprising securing a proximal hub to the proximal ends of the filaments, securing a distal hub to the distal ends of the filaments, wherein the hubs comprise radio-opaque bands.