Vascular occlusion devices and methods

• US 10,376,267 B2
• Filed: 02/23/2018
• Issued: 08/13/2019
• 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:
  US15/904,126
• Publication Number:
  US 20180242980A1
• Time in Patent Office: 536 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 the steps of:

(a) providing a catheter dimensioned to be introduced intravascularly to a target vascular site in the vascular lumen of the blood vessel, the catheter having a catheter lumen between a distal open end and a proximal open end;

(b) providing an occlusion device having a longitudinal axis between a proximal device end and a distal device end, the occlusion device comprising a braided filament mesh extending between the proximal device end and the distal device end, the filaments terminating at the proximal device end in a proximal hub and at the distal device end in a distal hub, wherein the occlusion device has a relaxed configuration in which the occlusion device has a plurality of radially-extending occlusion regions, wherein each radially-extending occlusion region has a proximal side and a distal side that meet at a peripheral edge;

(c) advancing the catheter intravascularly to position its distal open end in or near the target vascular site;

(d) advancing the occlusion device, in a radially-compressed configuration, distally through the catheter lumen until the occlusion device emerges from the open distal end of the catheter into the vascular lumen for deployment in the target vascular site;

(e) allowing the occlusion device to expand radially to a deployed configuration at the target vascular site, in which the peripheral edge of each radially-extending occlusion region engages the endoluminal wall at the target vascular site, wherein the occlusion device, when deployed in the vascular lumen, defines an occlusion zone in the vascular lumen between the peripheral edge of a most distal one of the occlusion regions and the peripheral edge of a most proximal one of the occlusion regions, the occlusion zone defining an endoluminal wall surface area within the vascular lumen, and wherein the peripheral edges of the occlusion regions contact less than about 25% of the endoluminal wall surface area defined by the occlusion zone; and

(f) maintaining the peripheral edge of each radially-extending occlusion region in engagement with the endoluminal wall at the deployed position in the target vascular site at least until the vascular lumen at the target vascular site is embolized to occlude blood flow through the vascular lumen at the target vascular site.

2. The method of claim 1, wherein the occlusion device comprises a single layer continuous braided structure.

3. The method of claim 1, wherein the braided filament mesh has a pick angle of at least 40°

.

4. The method of claim 1, wherein the occlusion device has a maximum relaxed configuration diameter that is over-sized relative to the diameter of the vascular lumen by between about 10% and 150%.

5. The method of claim 1, wherein the occlusion device defines an axial length along the longitudinal axis, and wherein the occlusion regions provide between 4 and 10 mesh layers per centimeter of the axial length.

6. The method of claim 1, wherein, when the occlusion device is in the relaxed configuration, each of the occlusion regions defines a first angle relative to the longitudinal axis, and wherein, when the occlusion device is in the deployed configuration, each of the occlusion regions defines a second angle relative to the longitudinal axis that is less than the first angle.

7. The method of claim 1, wherein, when the device is in the deployed configuration, the device is partially compressed relative to the relaxed configuration.

8. The method of claim 1, wherein, when the occlusion device is in the relaxed configuration, the plurality of radially-extending occlusion regions are of substantially equal diameter.

9. The method of claim 1, wherein, when the occlusion device is in the deployed configuration, each radially extending occlusion region defines two radial traverses of the vascular lumen for each filament, wherein the total number of radial filament traverses is between 720 and 2000.

10. The method of claim 1, wherein, in the deployed configuration, the occlusion device provides an outward force of the peripheral edges of the radially-extending occlusion regions against the endoluminal wall that is increased by the pressure of blood flow at the target vascular site, the outward force being sufficient to resist movement of the occlusion device within the blood vessel downstream from the target vascular site.

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

(a) providing a catheter dimensioned to be introduced intravascularly to a target vascular site in the vascular lumen, the catheter having a catheter lumen between a distal open end and a proximal open end;

(b) providing an occlusion device having a longitudinal axis between a proximal device end and a distal device end, the occlusion device comprising a braided filament mesh extending between the proximal device end and the distal device end, the filaments terminating at the proximal device end in a proximal hub and at the distal device end in a distal hub, wherein the occlusion device has a relaxed configuration in which the occlusion device has a plurality of radially-extending occlusion regions of substantially equal diameter, wherein each radially-extending occlusion region has a peripheral edge, and wherein, when the occlusion device is in the relaxed configuration, each of the radially extending occlusion regions defines a first angle relative to the longitudinal axis;

(c) advancing the catheter intravascularly to position its distal open end in or near the target vascular site;

(d) advancing the occlusion device, in a radially-compressed configuration, distally through the catheter lumen until the occlusion device emerges from the open distal end of the catheter to a deployed position in the vascular lumen at the target vascular site;

(e) allowing the deployed occlusion device to expand radially to a deployed configuration within the vascular lumen at the deployed position in which the peripheral edge of each radially-extending occlusion region engages the endoluminal wall at a contact region, wherein, when the occlusion device is in the deployed configuration—

each of the occlusion regions defines a second angle relative to the longitudinal axis that is less than the first angle,

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

the combined thicknesses of the peripheral edges is less than about 25% of a total length of the braided filament mesh along the longitudinal axis; and

(f) maintaining the peripheral edge of at least one of the radially-extending occlusion regions in engagement with the endoluminal wall at the target vascular site at least until the vascular lumen at the target vascular site is embolized to occlude blood flow through the vascular lumen at the target vascular site.

12. The method of claim 11, wherein, when the occlusion device is deployed, each radially extending occlusion region defines two radial traverses of the vascular lumen for each filament, wherein the total number of radial filament traverses is between 720 and 2000.

13. The method of claim 11, wherein the occlusion device comprises a single layer continuous braided structure.

14. The method of claim 11, wherein the occlusion device has a maximum relaxed configuration diameter that is over-sized relative to the diameter of the vascular lumen by between about 10% and 150%.

15. The method of claim 11, wherein the occlusion device defines an axial length along the longitudinal axis, and wherein the occlusion regions provide between 4 and 10 mesh layers per centimeter of the axial length.

16. The method of claim 11, wherein the occlusion device, when deployed in the vascular lumen, defines an occlusion zone in the vascular lumen between the peripheral edge of a most distal one of the occlusion regions and the peripheral edge of a most proximal one of the occlusion regions, the occlusion zone defining an endoluminal wall surface area within the vascular lumen, wherein the peripheral edges of the occlusion regions contact less than about 25% of the endoluminal wall surface area defined by the occlusion zone.

17. The method of claim 16, wherein, when the occlusion device is in the relaxed configuration, the plurality of radially-extending occlusion regions are of substantially equal diameter.

18. The method of claim 16, wherein, in the deployed configuration, the occlusion device provides an outward force of the peripheral edges of the radially-extending occlusion regions against the endoluminal wall that is increased by the pressure of blood flow at the target vascular site, the outward force being sufficient to resist movement of the occlusion device within the blood vessel downstream from the target vascular site.

19. The method of claim 11, wherein, when the device is in the deployed configuration, the device is partially compressed relative to the relaxed configuration.