IP Library Granted Patent US 10,293,089
Granted Patent B2
US 10,293,089 · App. 14/881,046 · Granted May 21, 2019

System and method to increase the overall diameter of veins

Inventor: F. Nicholas Franano (Olathe, KS)
Assignee: Flow Forward Medical, Inc.
A61M1/101A61M1/10A61M1/12A61M1/125A61M1/367A61M1/3655A61M1/1008A61M1/1086A61M1/122A61M2205/0205A61M2205/3334A61M2206/10
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Quick Facts
Patent No.
US 10,293,089
App. No.
14/881,046
Granted
May 21, 2019
Kind
B2
Abstract

A system and method for increasing the speed of blood and wall shear stress (WSS) in a peripheral vein for a sufficient period of time to result in a persistent increase in the overall diameter and lumen diameter of the vein is provided. The method includes pumping blood at a desired rate and pulsatility. The pumping is monitored and adjusted, as necessary, to maintain the desired blood speed, WSS and pulsatility in the peripheral vein in order to optimize the rate and extent of dilation of the peripheral vein.

Claims (28)

1. A method for creating an arteriovenous fistula or an arteriovenous graft in a human patient, the method comprising:

fluidly connecting one end of a pump-conduit assembly to a donating vein;

fluidly connecting another end of the pump-conduit assembly to an accepting vein;

pumping deoxygenated blood from the donating vein into the accepting vein;

pumping deoxygenated blood from the donating vein into the accepting vein for a period of time sufficient to result in a persistent increase in an overall diameter of the accepting vein, wherein a mean pulse pressure in a conduit fluidly connected to the accepting vein is less than 20 mmHg; and,

creating the arteriovenous fistula or arteriovenous graft in the patient using at least a portion of the accepting vein with the overall diameter that is persistently increased.

2. The method of claim 1 , wherein the arteriovenous fistula or the arteriovenous graft provides hemodialysis access.

3. The method of claim 1 , wherein the pump-conduit assembly pumps blood at a rate between 50 ml/min and 1500 ml/min.

4. The method of claim 1 , wherein the pump-conduit assembly pumps blood at a rate between 100 ml/min and 1000 ml/min.

5. The method of claim 1 , wherein a wall shear stress in the accepting vein is greater than or equal to 0.76 Pa when the pump-conduit assembly is in operation.

6. The method of claim 1 , wherein a wall shear stress in the accepting vein is between 0.76 Pa and 23 Pa when the pump-conduit assembly is in operation.

7. The method of claim 1 , wherein a wall shear stress in the accepting vein is between 2.5 Pa and 10 Pa when the pump-conduit assembly is in operation.

8. The method of claim 1 , wherein a speed of the blood in the accepting vein is between 15 cm/s and 100 cm/s when the pump-conduit assembly is in operation.

9. The method of claim 1 , wherein blood is pumped through the pump-conduit assembly for between 7 days and 42 days.

10. The method of claim 1 further comprising:

determining the overall diameter of the accepting vein and blood flow through the accepting vein after pumping the blood; and,

changing a speed of a pump portion of the pump-conduit assembly in order to maintain a desired wall shear stress or blood speed in the accepting vein.

11. The method of claim 1 , wherein a pulse pressure of the blood in the accepting vein adjacent to a connection between the accepting vein and the pump-conduit assembly is less than 10 mmHg when the pump-conduit assembly is in operation.

12. The method of claim 1 , wherein the mean pulse pressure in the conduit fluidly connected to the accepting vein is less than 10 mmHg.

13. The method of claim 1 , wherein the mean pulse pressure in the conduit fluidly connected to the accepting vein is less than 5 mmHg.

14. The method of claim 1 , wherein a pulse pressure of the blood in the accepting vein adjacent to a connection between the accepting vein and the pump-conduit assembly is less than 5 mmHg when the pump-conduit assembly is in operation.

15. The method of claim 1 , wherein the blood is pumped through the pump-conduit assembly for a distance of between 20 cm and 200 cm.

16. The method of claim 1 , wherein the donating vein is selected from a group consisting of a right atrium, a superior vena cava, an inferior vena cava, a brachiocephalic vein, a jugular vein, a subclavian vein, an axillary vein, a common iliac vein, an external iliac vein, or a femoral vein.

17. The method of claim 1 , wherein the accepting vein is selected from a group consisting of a cephalic vein, an ulnar vein, an antecubital vein, a basilic vein, a brachial vein, a lesser saphenous vein, a greater saphenous vein, or a femoral vein.

18. The method of claim 1 , wherein a pump portion of the pump-conduit assembly is implanted in the patient.

19. The method of claim 1 , wherein a pump portion of the pump-conduit assembly remains extracorporeal to the patient.

20. The method of claim 1 , wherein the overall diameter of the accepting vein that is persistently increased is at least 2.5 mm.

21. The method of claim 1 , wherein the overall diameter of the accepting vein that is persistently increased is at least 4.0 mm.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 11, 2024
From: ARTIO MEDICAL, INC.
To: AMPLIFI VASCULAR, INC.
Reel/Frame 069203/0709 →
MERGER AND CHANGE OF NAME Recorded Jul 28, 2022
From: FLOW FORWARD MEDICAL, INC.; ARTIO MEDICAL, INC.
To: ARTIO MEDICAL, INC.
Reel/Frame 061003/0478 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2018
From: FRANANO, F. NICHOLAS
To: NOVITA THERAPEUTICS, LLC
Reel/Frame 047457/0381 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2018
From: NOVITA THERAPEUTICS, LLC
To: FLOW FORWARD MEDICAL, INC.
Reel/Frame 047457/0391 →
Continuity (3)
Division 13030054 · Feb 17, 2011
Provisional Application 61305508 · Feb 17, 2010
Related Publication 20160030647A1 · Feb 4, 2016