Vascular occlusion devices and methods

• US 10,660,648 B2
• Filed: 06/25/2019
• Issued: 05/26/2020
• Est. Priority Date: 02/24/2017
• Status: Active Grant

• Current Assignee: Inceptus Medical, Llc
• Original Assignee: Inceptus Medical, Llc
• Inventors: Lubock, Paul, Quick, Richard, Rosenbluth, Robert, Cox, Brian J.
• Primary Examiner(s): Stransky, Katrina M
• Application Number:
  US16/452,419
• Publication Number:
  US 20190307464A1
• Time in Patent Office: 336 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• 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: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device

Abstract

A vascular occlusion device includes a braided filament mesh structure defining a longitudinal axis. The mesh structure has a relaxed configuration in which it has an axial array of radially-extending occlusion regions, each of which has a proximal side and a distal side meeting at a peripheral edge, the sides of each occlusion region forming a first angle relative to the longitudinal axis. Each occlusion region is axially separated from the adjacent occlusion region by a reduced-diameter connecting region. The mesh structure is radially compressible to a compressed state in which it is deployed intravascularly to a target site through a catheter. Upon deployment, the device radially expands to a constrained configuration in which the peripheral edges of the occlusion regions engage the vascular wall, and the sides of the occlusion regions form a second angle relative to the longitudinal axis that is smaller than the first angle.

Claims

1. A method for embolizing a blood vessel having an endoluminal wall defining a vascular lumen, the method comprising:

advancing, via a pusher, an occlusion device to a target site in the vascular lumen of the blood vessel while the occlusion device is in a compressed state;

deploying the occlusion device at the target site in the blood vessel, wherein the occlusion device includes a mesh structure defining a longitudinal axis, wherein deploying the occlusion device includes radially expanding the occlusion device from the compressed state to an expanded state, and wherein, in the expanded state—

the occlusion device includes a plurality of radially extending regions,

individual ones of the radially extending regions include an apex that contacts the endoluminal wall of the blood vessel,

each of the apices has a thickness along the longitudinal axis of the occlusion device, and

the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis;

detaching the occlusion device from the pusher; and

maintaining the occlusion device in the expanded state at the target site in the blood vessel at least until the vascular lumen at the vascular site is embolized to occlude blood flow through the vascular lumen.

2. The method of claim 1 wherein detaching the occlusion device from the pusher includes detaching the occlusion device from the pusher in less than about 1 second.

3. The method of claim 1 wherein detaching the occlusion device from the pusher includes releasing a tether connecting the occlusion device to the pusher.

4. The method of claim 1 wherein each of the apices has a thickness of less than about 1 mm, and wherein the plurality of radially extending regions includes at least three radially extending regions.

5. The method of claim 1 wherein, in the expanded state, the combined thicknesses of the apices is less than about 25% of a total length of the mesh structure along the longitudinal axis.

6. The method of claim 1 wherein the total length of the mesh structure is between about 0.5 cm and 2.5 cm.

7. The method of claim 1 wherein individual ones of the radially extending regions (a) are substantially symmetric about a plane extending through the apex and perpendicular to the longitudinal axis and (b) have a circular cross-sectional shape along the plane.

8. The method of claim 1 wherein—

the mesh structure is constrained by the blood vessel such that the expanded state is a partially-expanded state,

the mesh structure is further configured to radially expand to a fully-expanded state when the mesh structure is unconstrained by the blood vessel,

in the fully-expanded state, individual ones of the radially extending regions define a first angle relative to the longitudinal axis,

in the partially-expanded state, individual ones of the radially extending regions define a second angle relative to the longitudinal axis, and

the second angle is between about 20°

-60°

less than the first angle.

9. A method for embolizing a blood vessel having an endoluminal wall defining a vascular lumen, the method comprising:

advancing an occlusion device, in a compressed state, to a target site in the vascular lumen of the blood vessel;

deploying the occlusion device at the target site in the blood vessel, wherein the occlusion device includes a mesh structure defining a longitudinal axis, wherein deploying the occlusion device includes radially expanding the occlusion device from the compressed state to an expanded state, and wherein, in the expanded state—

the occlusion device includes a plurality of radially extending regions,

individual ones of the radially extending regions include an apex that contacts the endoluminal wall of the blood vessel,

each of the apices has a thickness along the longitudinal axis of the occlusion device, and

the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis; and

maintaining the occlusion device in the expanded state at the target site in the blood vessel at least until blood flow through the occlusion device and the vascular lumen at the vascular site is occluded.

10. The method of claim 9 wherein, in the expanded state, each of the apices has an edge radius that is between 0.10 mm and 0.40 mm.

11. The method of claim 9 wherein advancing the occlusion device includes advancing the occlusion device through a catheter via a pusher, and wherein the method further comprises detaching the occlusion device from the pusher.

12. The method of claim 9 wherein, in the expanded state, adjacent pairs of the radially extending regions are separated by a distance that inhibits laminar blood flow therebetween.

13. The method of claim 9 wherein—

individual ones of the radially extending regions (a) are substantially symmetric about a plane extending through the apex and perpendicular to the longitudinal axis and (b) have a circular cross-sectional shape along the plane,

the mesh structure is constrained by the blood vessel such that the expanded state is a partially-expanded state,

the mesh structure is further configured to radially expand to a fully-expanded state when the mesh structure is unconstrained by the blood vessel,

in the fully-expanded state, individual ones of the radially extending regions define a first angle relative to the longitudinal axis,

in the partially-expanded state, individual ones of the radially extending regions define a second angle relative to the longitudinal axis, and

the second angle is between about 20°

-60°

less than the first angle.

14. A method for embolizing a blood vessel having an endoluminal wall defining a vascular lumen, the method comprising:

advancing an occlusion device through a catheter, in a compressed state, to a target site in the vascular lumen of the blood vessel;

deploying the occlusion device at the target site in the blood vessel, wherein the occlusion device includes a mesh structure defining a longitudinal axis, wherein deploying the occlusion device includes radially expanding the occlusion device from the compressed state to an expanded state, and wherein, in the expanded state—

the occlusion device includes a plurality of radially extending regions,

individual ones of the radially extending regions include an apex that contacts the endoluminal wall of the blood vessel,

each of the apices has a thickness along the longitudinal axis of the occlusion device, and

the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis; and

maintaining the occlusion device in the expanded state at the target site in the blood vessel at least until the vascular lumen at the vascular site is embolized to occlude blood flow through the vascular lumen.

15. The method of claim 14 wherein individual ones of the radially extending regions (a) are substantially symmetric about a plane extending through the apex and perpendicular to the longitudinal axis and (b) have a circular cross-sectional shape along the plane.

16. The method of claim 14 wherein, in the expanded state, each of the apices has an edge radius that is between 0.10 mm and 0.40 mm.