IP Library Granted Patent US 10,052,107
Granted Patent B2
US 10,052,107 · App. 14/212,930 · Granted Aug 21, 2018

Systems and methods for the treatment of aneurysms

Inventors: Rany Busold (Medford, MA); John Marini (Weymouth, MA); Upma Sharma (Somerville, MA); Adam Rago (Falmouth, MA); Jennifer Mortensen (Somerville, MA); Joseph Lomakin (Cambridge, MA); Gregory T. Zugates (Chelmsford, MA); Janet Komatsu (Cambridge, MA); Jeffrey Groom, III (Medford, MA)
Assignee: ARSENAL MEDICAL, INC.
A61B17/12118A61B17/1219A61B17/12186A61B17/12195A61F2/07A61B2017/1205A61B2217/005A61F2002/077
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Quick Facts
Patent No.
US 10,052,107
App. No.
14/212,930
Granted
Aug 21, 2018
Kind
B2
Abstract

Systems and method for treating aneurysms are provided which utilize formulations that form polymer foams in situ. The formulations generally have a buoyancy greater than or less than blood, and either float to the top of the aneurysm and foam from the top down or sink to the bottom and foam from the bottom up.

Claims (32)

1. A system for treating a patient, comprising:

an endoprosthesis configured to span an aneurysm characterized by a top and a bottom; and

a formulation adapted to form a polymer foam when exposed to blood,

wherein the formulation is configured to flow outward from a catheter tip and form an expanding mass in a space between the endoprosthesis and a wall of the aneurysm and wherein the formulation is a siloxane formulation that reacts with the blood in situ and expands no more than 1.3 times the original volume of the formulation: and

wherein the formulation is configured to have a density greater than the density of blood, sinks toward the bottom of the aneurysm when disposed therein and generates a foam that expands upward in the aneurysm; or

the formulation is configured to have a density less than that of blood, floats toward the top of the aneurysm when disposed therein and generates a foam that expands downward in the aneurysm.

2. The system of claim 1 , wherein the formulation is configured to float in blood and the formulation, when disposed within the aneurysm, floats to the top and generates a foam that expands to occupy at least a portion of the volume of the aneurysm from the top down.

3. The system of claim 2 , further comprising a catheter having a tip that is positionable at the bottom of the aneurysm, wherein the catheter is configured to permit at least one of the discharge of the formulation into the aneurysm and the inflow of blood displaced by a downward expansion of the foam.

4. The system of claim 3 , wherein the catheter includes a first lumen configured to discharge the formulation into the aneurysm and a second lumen configured to permit the inflow of blood displaced by the downward expansion of the foam.

5. The system of claim 3 , wherein the tip of the catheter is sized to fit within a lumbar artery.

6. The system of claim 3 , wherein the tip of the catheter is sized to fit through one of a fenestration within the endoprosthesis and a space between the endoprosthesis and a blood vessel fluidly connected to the aneurysm.

7. The system of claim 3 , wherein the tip of the catheter includes a retractable shield adapted to inhibit the migration of the formulation from the top of the aneurysm toward the bottom.

8. The system of claim 1 , wherein the endoprosthesis is a stent graft.

9. The system of claim 1 , wherein the endoprosthesis is a catheter balloon and is configured to be removed after a foam has been formed between an outer surface of the catheter balloon and an inner surface of the aneurysm.

10. The system of claim 1 , wherein the formulation has a density greater than that of blood and the formulation, when disposed within the aneurysm, sinks to the bottom and generates a foam that expands to occupy at least a portion of the volume of the aneurysm from the bottom up.

11. The system of claim 10 , further comprising a catheter having a tip that is positionable at the top of the aneurysm, wherein the catheter is configured to permit at least one of the discharge of the formulation into the aneurysm and the inflow of blood displaced by an upward expansion of the foam.

12. The system of claim 11 , wherein the catheter includes a first lumen configured to discharge the formulation into the aneurysm and a second lumen configured to permit the inflow of blood displaced by the upward expansion of the foam.

13. The system of claim 11 , wherein the tip of the catheter is sized to fit within an inferior mesenteric artery.

14. The system of claim 11 , wherein the tip of the catheter is sized to fit through one of a fenestration within the endoprosthesis and a space between the endoprosthesis and a blood vessel fluidly connected to the aneurysm.

15. The system of claim 11 , wherein the tip of the catheter includes a retractable shield adapted to inhibit the migration of the formulation from the bottom of the aneurysm toward the top.

16. The system of claim 10 , wherein the endoprosthesis is a catheter balloon and is configured to be removed after a foam has been formed between an outer surface of the catheter balloon and an inner surface of the aneurysm.

17. The system of claim 1 , wherein the endoprosthesis is a stent graft.

18. A system for treating a patient, comprising:

an endoprosthesis configured to span an abdominal aortic aneurysm;

a formulation configured to form a polymer foam within the abdominal aortic aneurysm, wherein the formulation is a siloxane formulation that reacts with the blood in situ; and

wherein the formulation is formulated to have a density greater than the density of blood, sinks toward the bottom of the abdominal aortic aneurysm when disposed therein and generates a foam that expands upward in the aneurysm,

or is formulated to have a density less than that of blood, and when disposed within the abdominal aortic aneurysm, floats toward the top of the abdominal aortic aneurysm and expands downward in the aneurysm; and

a delivery catheter having a tip and insertable through one of an inferior mesenteric artery, a lumbar artery, a fenestration within the endoprosthesis and a space between the endoprosthesis and a wall of a blood vessel adjoining the abdominal aortic aneurysm,

wherein the formulation is configured to flow outward from the catheter tip and to occupy a predetermined location within the aortic aneurysm prior to expansion and form an expanding mass that expands in a predetermined direction therefrom in the space between the endoprosthesis and the wall of the blood vessel and expands no more than 1.3 times the original volume of the formulation.

19. The system of claim 18 ,

wherein the formulation has a density less than that of blood.

20. The system of claim 18 , wherein the formulation has a density that is greater than that of blood.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 16, 2021
From: ARSENAL AAA, LLC
To: MEDTRONIC VASCULAR, INC.
Reel/Frame 057503/0059 →
NUNC PRO TUNC ASSIGNMENT Recorded Jan 29, 2019
From: ARSENAL MEDICAL, INC.
To: ARSENAL AAA, LLC.
Reel/Frame 048165/0932 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 16, 2017
From: GROOM, JEFFREY, II; BUSOLD, RANY; MARINI, JOHN; SHARMA, UPMA; RAGO, ADAM; MORTENSEN, JENNIFER; LOMAKIN, JOSEPH; ZUGATES, GREGORY T; KOMATSU, JANET
To: ARSENAL MEDICAL, INC.
Reel/Frame 042729/0176 →
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING AND THE NATURE OF CONVEYANCE PREVIOUSLY RECORDED AT REEL: 035855 FRAME: 0083. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Jan 22, 2016
From: ARSENAL AAA
To: MEDTRONIC, INC.
Reel/Frame 037629/0132 →
SECURITY INTEREST Recorded Nov 15, 2015
From: ARSENAL AAA, LLC
To: MEDTRONIC, INC.
Reel/Frame 037041/0955 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 17, 2015
From: ARSENAL AAA, LLC
To: MEDTRONIC, INC.
Reel/Frame 035855/0083 →
Continuity (5)
Continuation In Part 13532013 · Jun 25, 2012
Provisional Application 61852422 · Mar 15, 2013
Provisional Application 61852315 · Mar 15, 2013
Related Publication 20160256170A1 · Sep 8, 2016
Related Publication 20180177507A9 · Jun 28, 2018