Devices and methods for protecting against distal embolisms

• US 7,534,221 B2
• Filed: 05/24/2004
• Issued: 05/19/2009
• Est. Priority Date: 05/24/2004
• Status: Expired due to Fees

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Pile-Spellman, John
• Primary Examiner(s): Deak; Leslie R
• Assistant Examiner(s): WIEST, PHILIP R
• Application Number:
  US10/852,044
• Publication Number:
  US 20050261726A1
• Time in Patent Office: 1,821 Days
• Field of Search: 604/4.01, 604/6.08, 604 601- 604, 604/6.09, 604/6.11, 604/6.13, 604/6.14, 604/6.16, 604/7, 604/19, 604/27, 604/28, 604/48, 604/500, 604/522, 604506-510, 604/113, 604/114, 604/96.01, 604/907, 604/915, 422 44- 48, 128/898, 600466-469, 514/832, 514/833, 424/1.1, 424/1.2, 424/1.3, 424/2, 424/325, 424/372, 424/374, 424/377, 424/383, 424/283.1, 424/284.1, 424/93, 424/73, 424/93.1, 424/93.3, 424/93.7, 606/1, 606/2, 606/7, 606/8, 606/10, 606/13, 606/14, 606/27, 606/108, 606/191, 606/192, 606/194, 606/200
• US Class Current: 604/5.01
• 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 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 2202/0429 Red blood cells; Erythrocytes

Abstract

Endovascular intervention methods entail creating a temporary capillary block in the vasculature of at least a portion of a patient'"'"'s organ, such as a hemisphere of the patient'"'"'s brain, the capillary block essentially blocking blood flow through capillaries in the portion of the patient'"'"'s organ, and performing the endovascular intervention. Distal embolism protection devices include a blood pump and at least one of a centrifuge element, a dialysis element, a cooling element, and a filtration element. The blood pump is generally capable of drawing blood from a patient'"'"'s vein, circulating the blood through each of the elements so that a characteristic of a blood component may be manipulated therewith, and perfusing the modified blood into a patient'"'"'s artery. A capillary block is thereby created in the vasculature of at least a portion of a patient'"'"'s organ with manipulated blood components.

Claims

1. An endovascular intervention method comprising:

creating a temporary capillary block in vasculature of at least a portion of a patient'"'"'s organ downstream from a site for an endovascular intervention, the capillary block essentially blocking blood flow through capillaries in the portion of the patient'"'"'s organ; and

performing the endovascular intervention;

wherein creating the temporary capillary block comprises manipulating at least one characteristic of a blood component that affects an ability of blood to circulate though the organ'"'"'s vasculature, the capillary block created by virtue of manipulated suspended component.

2. The method of claim 1, comprising performing an endovascular intervention selected from the group consisting of endovascular embolization, angioplasty, and stenting.

3. The method of claim 1, comprising creating a temporary block in the vasculature of a patient'"'"'s brain.

4. An endovascular intervention method comprising:

creating a temporary capillary block in vasculature of at least a portion of a patient'"'"'s organ downstream from a site for an endovascular intervention, the capillary block essentially blocking blood flow through capillaries in the portion of the patient'"'"'s organ; and

performing the endovascular intervention;

wherein creating the temporary capillary block comprises manipulating at least one characteristic of erythrocytes suspended in the patient'"'"'s blood that affects the ability of blood to circulate through the organ'"'"'s vasculature, the capillary block created with the manipulated erythrocytes.

5. An endovascular intervention method comprising:

creating a temporary capillary block in vasculature of at least a portion of a patient'"'"'s organ downstream from a site for an endovascular intervention, the capillary block essentially blocking blood flow through capillaries in the portion of the patient'"'"'s organ;

performing the endovascular intervention; and

creating the temporary capillary block in the vasculature of at least a portion of a patient'"'"'s brain by increasing hematocrit of the blood in the patient'"'"'s organ.

6. The method of claim 5, comprising increasing the hematocrit of the patient'"'"'s blood to about 60%.

7. An endovascular intervention method comprising:

creating a temporary capillary block in vasculature of at least a portion of a patient'"'"'s organ downstream from a site for an endovascular intervention, the capillary block essentially blocking blood flow through capillaries in the portion of the patient'"'"'s organ; and

performing the endovascular intervention;

wherein creating the temporary capillary block in the vasculature of at least a portion of the patient'"'"'s organ comprises increasing the size of at least one suspended component in the patient'"'"'s blood, the capillary block created with the suspended component having the increased size.

8. An endovascular intervention method comprising:

creating a temporary capillary block in vasculature of at least a portion of a patient'"'"'s organ downstream from a site for an endovascular intervention, the capillary block essentially blocking blood flow through capillaries in the portion of the patient'"'"'s organ; and

performing the endovascular intervention;

wherein creating the temporary capillary block in the vasculature of at least a portion of the patient'"'"'s organ comprises increasing the size of erythrocytes suspended in a patient'"'"'s blood, the capillary block created with the erythrocytes having the increased size.

9. The method of claim 8, comprising increasing the size of erythrocytes suspended in the patient'"'"'s blood to about 12 μ

m.

10. The method of claim 8, wherein increasing the size of erythrocytes suspended in the patient'"'"'s blood comprises exposing at least a portion of the patient'"'"'s blood to a hypotonic fluid.

11. An endovascular intervention method comprising:

creating a temporary capillary block in vasculature of at least a portion of a patient'"'"'s organ downstream from a site for an endovascular intervention, the capillary block essentially blocking blood flow through capillaries in the portion of the patient'"'"'s organ; and

performing the endovascular intervention;

wherein creating the temporary capillary block in the vasculature of at least a portion of the patient'"'"'s organ comprises stabilizing a cell membrane of erythrocytes suspended in the patient'"'"'s blood, the capillary block created with the stabilized-membrane erythrocytes.

12. The method of claim 11, wherein stabilizing a cell membrane of erythrocytes suspended in the patient'"'"'s blood comprises at least one of decreasing cell membrane permeability and increasing cell membrane stiffness.

13. An endovascular intervention method comprising:

creating a temporary capillary block in vasculature of at least a portion of a patient'"'"'s organ downstream from a site for an endovascular intervention, the capillary block essentially blocking blood flow through capillaries in the portion of the patient'"'"'s organ; and

performing the endovascular intervention;

wherein creating the temporary capillary block in the vasculature of the patient'"'"'s organ comprises;

drawing blood from the patient;

manipulating at least one characteristic of a suspended component in the drawn blood that affects the ability of blood to circulate through the organ'"'"'s vasculature; and

perfusing the blood having the manipulated suspended component into the patient at an artery upstream from the portion of the patient'"'"'s organ targeted for the capillary block, the capillary block created with the manipulated suspended component.

14. The method of claim 13 comprising introducing a therapeutic agent into the blood drawn from the patient.

15. An endovascular intervention method comprising:

creating a temporary capillary block in vasculature of a hemisphere of a patient'"'"'s brain with erythrocytes having modified characteristics, erythrocyte characteristics modified by at least one of increasing erythrocyte size and decreasing erythrocyte cell membrane permeability; and

performing the endovascular intervention.

16. An endovascular intervention method comprising,

drawing blood from a patient;

manipulating at least one characteristic of erythrocytes suspended in the drawn blood that affects the ability of blood to circulate through vasculature of a patient'"'"'s brain; and

perfusing the blood having the manipulated suspended component into the patient at a carotid artery upstream of a hemisphere of the patient'"'"'s brain targeted for a temporary capillary block,

creating the temporary capillary block with the manipulated erythrocytes.

17. A distal embolism protection device comprising a blood pump and at least one element connected to the pump, the element selected from the group of elements consisting of:

a centrifuge element;

a dialysis element;

a cooling element; and

a filtration element, the blood pump capable of drawing blood from a patient'"'"'s vein, circulating the blood through each of the elements therewith manipulating at least one characteristic of a blood component that affects an ability of blood to circulate through a patient'"'"'s vasculature, and perfusing the modified blood into a patient'"'"'s artery, a capillary block created in vasculature of at least a portion of a patient'"'"'s organ with the manipulated blood components; and

a dialysis element configured to stabilize a size of erythrocytes suspended in blood drawn from the patient, the capillary block created with erythrocytes increased in size.

18. The device of claim 17, comprising a cooling element capable of cooling drawn blood to about 20degrees C. thereby increasing cell membrane stiffness of erythrocytes suspended in the patient'"'"'s blood, the capillary block created with the erythrocytes with the stiffened cell membranes.

19. The device of claim 17, comprising a centrifuge element adapted to increase hematocrit of blood drawn from a patient to about 60%, the capillary block may be created with erythrocytes.

20. A distal embolism protection device comprising a blood pump and at least one element connected to the pump, the element selected from the group of elements consisting of:

a centrifuge element;

a dialysis element;

a cooling element; and

a filtration element, the blood pump capable of drawing blood from a patient'"'"'s vein, circulating the blood through each of the elements therewith manipulating at least one characteristic of a blood component that affects an ability of blood to circulate through a patient'"'"'s vasculature, and perfusing the modified blood into a patient'"'"'s artery, a capillary block created in vasculature of at least a portion of a patient'"'"'s organ with the manipulated blood components; and

a dialysis element configured to stabilize erythrocytes suspended in blood drawn from the patient, the capillary block created with stabilized erythrocytes.