Diversion device to increase cerebral blood flow
View Patent ↗Methods and devices provide for temporary partial aortic occlusion to achieve diversion of blood flow to the brain in patients suffering from cerebral ischemia. The device can include an expandable frame with a membrane mounted on a first portion of the frame. The membrane can have at least one opening. In some embodiments, the membrane has an outer region and an inner region, and an opening in the inner region. In use, the frame can expand to conform to the inner walls of the aorta and the membrane can at least partially occlude the aorta thereby increasing cerebral perfusion. The frame can include one or more anchors to aid in maintaining the device in position against the arterial blood flow pressure.
1. A partial aortic occlusion device, comprising:
an expandable frame having an upstream portion and a downstream portion, the frame defining a circular mouth in the upstream portion configured to expand when positioned substantially perpendicular to the direction of blood flow in an aorta having an aortic lumen defined by an aortic wall, such that the upstream portion substantially conforms to the aortic wall to thereby at least partially occlude the aorta and increase cerebral profusion, wherein the downstream portion is substantially smaller in cross section than the expanded upstream portion, and the frame comprises a tapered transition between the upstream and downstream portions, such that the downstream portion is positioned in a central area of the aortic lumen without contacting the aortic wall when the circular mouth of the upstream portion is positioned in the aorta generally transverse to a line joining the upstream and downstream portions;
a membrane mounted across at least a part of the circular mouth, the membrane having a continuous outer annular region adjacent the frame, said continuous outer region defining an opening, wherein the membrane is impermeable to blood and is biodegradable; and
a permeable filtering material disposed on the downstream portion of the expandable frame, the filtering material configured to capture emboli and fragments of the biodegradable membrane entering the downstream portion through the circular mouth in the upstream portion.
2. The partial aortic occlusion device of claim 1 , wherein the frame includes one or more anchors configured to removably attach the device to a wall of the aorta.
3. The partial aortic occlusion device of claim 1 , wherein the expandable frame is made of super elastic material.
4. The partial aortic occlusion device of claim 1 , wherein the expandable frame includes at least two struts, the struts spaced apart in the upstream portion of the frame and connected in the downstream portion of the frame.
5. The partial aortic occlusion device of claim 4 , wherein at least two struts include one or more anchors configured to removably attach the device to a wall of the aorta.
6. The partial aortic occlusion device of claim 1 , wherein the frame defines a distal end opening in the downstream portion, and wherein the distal end opening in the downstream portion and the opening defined by the membrane are sized to receive a catheter therethrough.
7. The partial aortic occlusion device of claim 1 , wherein the membrane has two or more openings.
8. A method for temporarily increasing cerebral blood flow in a patient, comprising the steps of:
inserting an expandable filter device into the aorta, said filter device comprising an upstream portion having a circular mouth and a biodegradable membrane extending across the circular mouth, said filter device further comprising a downstream portion with a permeable filtering material disposed on the downstream portion,
wherein the circular mouth of the upstream portion is generally transverse to a line joining the upstream and downstream portions and the membrane extending across the circular mouth is impermeable to blood and further defines a central opening, and
expanding the filter device to partially occlude the aorta and increase cerebral blood flow wherein the biodegradable membrane degrades to allow aortic blood flow to gradually increase, and wherein the permeable filtering material disposed on the downstream portion is configured to capture fragments of the biodegradable membrane.
9. The method of claim 8 , wherein the membrane biodegrades upon contact with an enzymatic agent, the method further comprising a step of injecting an enzymatic agent to degrade the membrane after the patient's cerebral blood flow returns to a substantially normal level.
10. The method of claim 8 , wherein the membrane biodegrades when irradiated; the method further comprising a step of irradiating the membrane after the patient's cerebral blood flow returns to a substantially normal level.
11. The method of claim 8 , wherein the filter device is inserted in the aorta above the renal arteries.
12. The method of claim 8 , wherein the filter device is inserted below the common carotid artery and brachiocephalic trunk.
13. The method of claim 8 , further comprising a step of removing the filter device after the membrane biodegrades.
14. The method of claim 8 , wherein the opening in the membrane is sized to receive a catheter and the downstream portion of the device has one or more openings sized to receive a catheter; such that a catheter can traverse the filter device to provide access to arteries and organs upstream of the filter device.
15. The method of claim 8 , wherein the filter device is coated with a non-thrombogenic agent.
16. The method of claim 8 , further comprising a step of administering a CO 2 /O 2 mixture to the patient.
17. A method for temporarily increasing cerebral blood flow in a patient, comprising the steps of:
inserting an expandable filter device into the aorta, the filter device including a first portion having a circular mouth and an occlusive membrane that biodegrades in the presence of radiation extending across the circular mouth, and the filter device including a second portion with a permeable filtering material disposed on the second portion;
expanding the filter device to partially occlude the celiac trunk and increase cerebral blood flow;
wherein the second portion is configured to capture emboli and fragments of the biodegradable membrane, and
irradiating the membrane after the patient's cerebral blood flow returns to a substantially normal level to allow aortic blood flow to gradually increase.
18. A partial aortic occlusion device, comprising:
an expandable frame having an upstream portion and a downstream portion, the frame defining a circular mouth in the upstream portion configured to expand when positioned substantially perpendicular to the direction of blood flow in an aorta having an aortic lumen defined by an aortic wall, such that the upstream portion substantially conforms to the aortic wall to thereby at least partially occlude the aorta and increase cerebral profusion;
wherein the circular mouth of the upstream portion is generally transverse to the downstream portion;
an occlusive membrane mounted across at least a part of the circular mouth, the membrane having an outer annular region defining an opening in the occlusive membrane, wherein the membrane is biodegradable in the presence of an enzymatic agent; and
a permeable filtering material disposed on the downstream portion of the expandable frame; the filtering material configured to capture emboli and fragments of the biodegradable membrane entering the downstream portion through the circular mouth of the upstream portion
wherein the downstream portion of the expandable frame has at least one longitudinal region of smaller diameter than the upstream portion of the expandable frame wherein the expandable frame tapers to form a generally conical shape, and
wherein blood, exclusive of emboli and other debris, which enters the circular mouth, passes through the permeable filtering material.
19. The partial aortic occlusion device of claim 18 , wherein the occlusive membrane includes a region that is partially permeable.
20. The partial aortic occlusion device of claim 18 , wherein the frame includes one or more anchors configured to removably attach the device to the aortic wall.
21. The partial aortic occlusion device of claim 18 , wherein the expandable frame is made of super elastic material.
22. The partial aortic occlusion device of claim 18 , wherein the expandable frame includes at least two struts, the struts spaced apart in the upstream portion of the frame and connected in the downstream portion of the frame.
23. The partial aortic occlusion device of claim 18 , wherein the frame has at least one opening in the downstream portion, and the opening in the downstream portion and the opening in the membrane are sized to receive a catheter therethrough.