Embolization device and a method of using the same

• US 10,383,636 B2
• Filed: 03/12/2018
• Issued: 08/20/2019
• Est. Priority Date: 11/12/2002
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Thomas J. Fogarty
• Inventors: Fogarty, Thomas J., Drews, Michael J., Modesitt, D. Bruce, Holmgren, Neil D., Willis, David B.
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/918,869
• Publication Number:
  US 20180199946A1
• Time in Patent Office: 526 Days
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• 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 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve

Abstract

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

Claims

1. A system for treating an aneurysm comprising:

a catheter having a distal exit having a deployed configuration and an undeployed configuration; and

a self-fusing material,

wherein when the self-fusing material is in the undeployed configuration, the distal exit is placed between an outer surface of a prosthesis and a wall of the aneurysm, and the self-fusing material is in the catheter,

wherein when the self-fusing material is in a deployed configuration, the self-fusing material is in the space between the outer surface of the prosthesis and the wall of the aneurysm, and the self-fusing material has fused to itself, promoting a thrombogenic response within the aneurysm to stabilize the self-fusing material and the prosthesis,

wherein the self-fusing material is configured to promote fusing or other coagulative effect, and

wherein the self-fusing material is radiopaque such that in the deployed configuration, the visualization of the prosthesis is unobstructed by the radiopaque nature of the self-fusing material.

2. The system of claim 1, wherein the self-fusing material comprises a polymer formulation.

3. The system of claim 1, wherein at the distal exit of the catheter, the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.

4. The system of claim 1, further comprising a visualization tool for visualizing the self-fusing material before, during, and after the self-fusing material has been deployed.

5. The system of claim 1, wherein the self-fusing material comprises a coating, wherein the coating is an agent, and wherein the agent is at least one of a therapeutic agent and a diagnostic agent.

6. A system for treating an aneurysm comprising:

a catheter having a distal exit having a deployed configuration and an undeployed configuration; and

a self-fusing material,

wherein when the self-fusing material is in an undeployed configuration, the distal exit is placed between an outer surface of a prosthesis and a wall of the aneurysm, and the self-fusing material is in the catheter,

wherein when the self-fusing material is in a deployed configuration, the self-fusing material is in the space of the aneurysm, and the self-fusing material has fused to itself, promoting a thrombogenic response within the aneurysm to stabilize the self-fusing material,

wherein the self-fusing material is configured to promote fusing or other coagulative effect, and

wherein at the distal exit of the catheter, the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.

7. The system of claim 6, wherein the self-fusing material comprises a polymer formulation.

8. The system of claim 6, wherein at the distal exit of the catheter, the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.

9. The system of claim 6, further comprising a visualization tool that can visualize the self-fusing material before, during, and after the self-fusing material has been deployed.

10. A method for treating an aneurysm comprising:

placing a distal exit of a catheter between an outer surface of a prosthesis and a wall of the aneurysm; and

deploying a self-fusing material through the distal exit of the catheter;

wherein after the self-fusing material is fully deployed from the catheter, the self-fusing material fuses with itself, promoting a thrombogenic response within the aneurysm to stabilize the self-fusing material,

wherein the self-fusing material is configured to promote fusing or other coagulative effect, and

wherein the self-fusing material is radiopaque such that in the deployed configuration, the visualization of the prosthesis is unobstructed by the radiopaque nature of the self-fusing material.

11. The method of claim 10, wherein the self-fusing material comprises a polymer formulation.

12. The method of claim 10, wherein the self-fusing material is deployed within the space of the aneurysm using a trans-graft, trans-collateral, trans-sac, or endoluminal procedure.

13. The method of claim 10, further comprising visualizing an initial placement and nesting of the self-fusing material prior to and during deployment with a visualization tool.

14. The method of claim 10, wherein at the distal exit of the catheter, the catheter comprises a valve to minimize or completely prevent backflow of body fluids or other leakage.

15. The method of claim 10, wherein placing the distal exit of the catheter between the outer surface of the prosthesis and the wall of the aneurysm comprises placing the distal exit of the catheter within a space of the aneurysm, wherein the space of the aneurysm is between the outer surface of the prosthesis and the wall of the aneurysm.

16. The method of claim 15, wherein the self-fusing material is radiopaque such that after the self-fusing material has been deployed, the visualization of the prosthesis is unobstructed by the radiopaque nature of the self-fusing material.

17. The method of claim 15, further comprising selecting the self-fusing material having a proper volume so that the self-fusing material is large enough to substantially fill a void in the aneurysm, yet small enough to prevent substantial alteration of a natural fluid flow through the prosthesis.

18. The method of claim 15, wherein the self-fusing material is deployed between the outer surface of the prosthesis and the wall of the aneurysm using a trans-graft, trans-collateral, trans-sac, or endoluminal procedure.

19. The method of claim 15, wherein the self-fusing material comprises a polymer formulation.

20. The method of claim 10, further comprising visualizing the self-fusing material before, during, and after the self-fusing material has been deployed.