Systems for aneurysm treatment
Disclosed herein is a method of producing high purity pentagalloyl glucose (PGG), analogues or derivatives thereof, at least 99.9% pure, by washing with dimethyl ether. The PGG may be provided in a kit, including a hydrolyzer for dissolving the PGG and a saline solution. Also disclosed herein is a device for delivery of a therapeutic solution to a blood vessel. The device may be a catheter having an upstream balloon and a downstream balloon. The upstream balloon may be expanded to anchor the catheter and occlude antegrade blood flow. The downstream balloon may be expanded to occlude retrograde blood flow, creating a sealed volume within the blood vessel. The downstream balloon may have pores configured to deliver the therapeutic solution into the sealed volume or a portion of the sealed volume. The downstream balloon may be expanded by an expansion of a balloon disposed inside the downstream balloon.
1. A device for treating an aneurysm, the device comprising:
a shaft;
a first balloon attached to a distal end of the shaft,
wherein the first balloon is configured to anchor the device and to occlude downstream blood flow upon expansion of the first balloon; and
a second balloon attached proximal of the first balloon,
wherein the second balloon is configured to be substantially aligned with the aneurysm,
wherein the second balloon is configured to displace blood from a sac of the aneurysm when the second balloon is expanded,
wherein the second balloon is formed of a material that is sufficiently compliant and conformable to assume a shape of the sac of the aneurysm,
wherein a maximum expanded diameter of the second balloon is greater than a maximum expanded diameter of the first balloon,
wherein the second balloon comprises a plurality of pores for delivering a therapeutic agent to the aneurysm,
wherein the plurality of pores of the second balloon are configured to place an interior volume of the second balloon in fluid communication with an intravascular environment of the aneurysm,
wherein the plurality of pores comprises between 30 and 200 pores and wherein a diameter of each of the plurality of pores is between 0.05 mm and 0.2 mm so as to deliver a fluid from the plurality of pores at a volumetric flow rate between 0.05 mL/min and 20 mL/min, and
wherein the volumetric flow rate is constant or substantially constant.
2. A kit for treating aneurysms, the kit comprising:
the device of claim 1 ;
purified pentagalloyl glucose (PGG); and
a hydrolyzer.
3. The device of claim 1 , wherein the first balloon comprises a generally spherical shape and the second balloon comprises a generally prolate spheroid shape.
4. The device of claim 1 , further comprising a handle, wherein the handle comprises a first port and a second port, wherein the first port is configured to allow a first fluid to be introduced to cause the expansion of the first balloon, wherein the second port is configured to allow a second fluid to be introduced to cause the expansion of the second balloon, and wherein the second port is configured to allow the therapeutic agent to be introduced and delivered through the plurality of pores of the second balloon.
5. The device of claim 4 , wherein the maximum expanded diameter of the second balloon is between 125% and 175% of the maximum expanded diameter of the first balloon, wherein a length of the second balloon is greater than a length of the first balloon, and wherein, upon a maximum expansion of the second balloon, the length of the second balloon is greater than the maximum expanded diameter of the second balloon.
6. The device of claim 1 , wherein the plurality of pores comprises 40 pores.
7. The device of claim 1 , wherein the volumetric flow rate is 8 mL/min.
8. A catheter for treating an aneurysm, the catheter comprising:
an elongate body configured to be introduced into a blood vessel, the elongate body having a proximal end, a distal end, and a main shaft having a lumen extending therethrough;
a first inflatable balloon coupled to the distal end of the elongate body, the first inflatable balloon having an interior volume in fluid communication with a first inflation lumen and being configured to occlude downstream blood flow upon expansion; and
a second inflatable balloon coupled to the elongate body proximally to the first inflatable balloon, the second inflatable balloon having an interior volume in fluid communication with a second inflation lumen,
wherein the second inflatable balloon is configured to be substantially aligned with the aneurysm,
wherein the second inflatable balloon is formed of a material that is sufficiently compliant and conformable to assume a shape of a sac of the aneurysm when the second inflatable balloon is expanded,
wherein a maximum expanded diameter of the second inflatable balloon is greater than a maximum expanded diameter of the first inflatable balloon,
wherein the second inflatable balloon circumferentially surrounds the elongate body,
wherein the second inflatable balloon comprises a plurality of pores disposed on a surface of the second inflatable balloon configured to place the interior volume of the second inflatable balloon in fluid communication with an intravascular environment of the blood vessel,
wherein the plurality of pores comprises between 30 and 200 pores and wherein a diameter of each of the plurality of pores is between 0.05 mm and 0.2 mm so as to deliver a fluid from the plurality of pores at a volumetric flow rate between 0.05 mL/min and 20 mL/min.
9. The catheter of claim 8 , wherein the main shaft extends through the second inflatable balloon and a distal end of the main shaft forms the distal end of the elongate body.
10. The catheter of claim 9 , wherein the first inflation lumen and the second inflation lumen are formed within the main shaft.
11. The catheter of claim 8 , wherein the elongate body further comprises a second shaft having a lumen extending therethrough, the second shaft being disposed within the lumen of the main shaft, the first inflatable balloon being coupled to a distal end of the second shaft and the second inflatable balloon being coupled to a distal end of the main shaft.
12. The catheter of claim 11 , wherein the lumen of the main shaft is the second inflation lumen.
13. The catheter of claim 11 , wherein the lumen of the second shaft is the first inflation lumen.
14. The catheter of claim 11 , wherein the second inflatable balloon is generally a prolate spheroid shape forming an annular interior volume that surrounds the elongate body.
15. The catheter of claim 11 , wherein the maximum expanded diameter of the second inflatable balloon is approximately 175% of the maximum expanded diameter of the first inflatable balloon, wherein, upon the expansion of the second inflatable balloon, a length of the second inflatable balloon is greater than a length of the first inflatable balloon, and wherein, upon the expansion of the second inflatable balloon expanded second inflatable balloon.
16. The catheter of claim 11 , further comprising a third inflatable balloon disposed within the interior volume of the second inflatable balloon, the third inflatable balloon having an interior volume in fluid communication with a third inflation lumen, wherein an expansion of the third inflatable balloon is configured to at least partially expand the second inflatable balloon, and wherein the expansion of the third inflatable balloon is configured to facilitate expulsion of at least a partial volume of inflation fluid disposed within the interior volume of the second inflatable balloon through the plurality of pores into the intravascular environment.
17. The catheter of claim 8 , wherein the second inflatable balloon comprises a membrane that is less compliant than a membrane of the first inflatable balloon.
18. The catheter of claim 8 , wherein the first inflatable balloon comprises a generally spherical shape and the second inflatable balloon comprises a generally prolate spheroid shape.
19. The catheter of claim 8 , wherein a separation distance between the first inflatable balloon and the second inflatable balloon is fixed.
20. The catheter of claim 8 , further comprising a handle, wherein the handle comprises a first port and a second port, wherein the first port is configured to allow a first fluid to be introduced into the first inflation lumen to cause the expansion of the first inflatable balloon, wherein the second port is configured to allow a second fluid to be introduced into the second inflation lumen to cause an expansion of the second inflatable balloon, and wherein the second port is configured to allow a therapeutic agent to be introduced into the second inflation lumen to be delivered through the plurality of pores of the second inflatable balloon.
21. The catheter of claim 20 , wherein the maximum expanded diameter of the second inflatable balloon is between 125% and 175% of the maximum expanded diameter of the first inflatable balloon, wherein a length of the second inflatable balloon is greater than a length of the first inflatable balloon, and wherein, upon a maximum expansion of the second inflatable balloon, the length of the second inflatable balloon is greater than the maximum expanded diameter of the second inflatable balloon.
22. The catheter of claim 8 , wherein the diameter of each of the plurality of pores is the same when the second inflatable balloon is in a maximum expanded configuration as when the second inflatable balloon is not expanded.
23. The catheter of claim 8 , wherein the volumetric flow rate is constant or substantially constant.
24. The catheter of claim 23 , wherein the volumetric flow rate is 8 mL/min.
25. The catheter of claim 8 , wherein the plurality of pores comprises 40 pores.