Implantable arterio-venous shunt devices and methods for their use

• US 20070299384A1
• Filed: 04/24/2007
• Published: 12/27/2007
• Est. Priority Date: 04/08/2003
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Nishimura, Toshihiko, Pearl, Ronald, Kao, Peter, Faul, John
• Granted Patent: US 7,967,769 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/202 partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A long-term implantable arterio-venous shunt device or creation of a fistula is provided that can be used as a therapeutic method for treating chronic obstructive pulmonary disease (COPD). The shunt device is implanted between an artery and a vein, preferably between a peripheral artery and the inferior vena cava. The shunt device and method of creating a fistula increases cardiac output and decreases the systemic vascular resistance and allows a blood flow rate through the shunt device of at least 5 ml/min after the implantation. Based on the effects of the method and device to the respiratory, cardiac and circulatory system, the method and device are beneficial as a therapy to patients with problems or conditions related to these systems.

Claims

1. A therapeutic method for treating chronic obstructive pulmonary disease in a subject, the method increasing cardiac output in the subject, the method comprising:

creating a fistula between a systemic artery and a systemic vein of said subject, said fistula adapted to allow blood flow rate therethrough of at least 5 ml/min, wherein said blood flow through the fistula bypasses the peripheral microcirculation, and wherein creation of said fistula results in an increase in the cardiac output in said subject.

2. The method as set forth in claim 1, wherein said artery and said vein are selected from the group consisting of iliac artery and vein, femoral artery and saphenous vein, axillary artery and vein, and subclavian artery and vein.

3. The method as set forth in claim 1, wherein said method decreases systemic vascular resistance by at least 5%.

4. The method as set forth in claim 1, wherein the creation of the fistula is between a systemic artery and a systemic vein of said subject.

5. The method as set forth in claim 4, wherein said fistula has a cross sectional area of about 19 mm² to about 750 mm².

6. The method as set forth in claim 4, wherein said fistula has a length of about 2.5 mm to about 15 mm.

7. The method as set forth in claim 4, wherein said fistula has a radius of about 2.5 mm to about 15 mm.

8. The method as set forth in claim 1, wherein the increase in the cardiac output is an increase in the mean cardiac output of at least 15% compared to mean cardiac output prior to creating the fistula.

9. The method as set forth in claim 8, wherein the increase in the mean cardiac output is at least 25%.

10. The method as set forth in claim 8, wherein the increase in the mean cardiac output is at least 35%.

11. The method as set forth in claim 8, wherein the increase in the mean cardiac output is at least 45%.

12. The method as set forth in claim 8, wherein the increase in the mean cardiac output is at least 55%.

13. The method as set forth in claim 8, wherein the increase in the mean cardiac output is at least 65%.

14. The method as set forth in claim 1, wherein said fistula is created via an open surgical procedure, a minimally invasive surgical procedure, or an intravascular procedure.

15. An apparatus for increasing cardiac output in a subject having chronic obstructive pulmonary disease, the apparatus comprising:

an arteriovenous shunt device shaped and adapted for placement between a systemic artery and a systemic vein in said subject.

16. The apparatus as set forth in claim 15, wherein said artery and said vein are selected from the group consisting of iliac artery and vein, femoral artery and saphenous vein, axillary artery and vein, and subclavian artery and vein.

17. The apparatus as set forth in claim 15, wherein said cross sectional area is in the range of about 19 mm² to about 750 mm².

18. The apparatus as set forth in claim 15, wherein said length is in the range of about 2.5 mm to about 15 mm.

19. The apparatus as set forth in claim 15, wherein the cross sectional area of the shunt device has a radius in the range of about 2.5 mm to about 15 mm.

20. The apparatus as set forth in claim 15, further comprising a control means to control said blood flow rate through said shunt at a blood flow rate level or range.

21. The apparatus as set forth in claim 20, wherein said control means comprises one or more sensors to sense said blood flow rate or the pressure difference across said shunt device.

22. The apparatus as set forth in claim 20, wherein said control means comprises one or more flow control elements.

23. The apparatus as set forth in claim 15, wherein said shunt device is a self-adjustable shunt device to self-adjust its cross sectional area or its length, or both, as a function of the pressure difference across said shunt device to automatically control said blood flow rate through said shunt at a predetermined blood flow rate level or range.

24. The apparatus as set forth in claim 15, wherein the inner wall of said shunt device has a coating to prevent clot formation or atheroma formation.

25. The apparatus as set forth in claim 15 wherein said shunt is shaped and adapted for placement between said systemic artery and said systemic vein proximal of the renal arteries.

26. The apparatus as set forth in claim 15 wherein said shunt is shaped and adapted for placement between said systemic artery and said systemic vein distal of the renal arteries.

27. The apparatus as set forth in claim 15, wherein the increase in the cardiac output is an increase in the mean cardiac output of at least 15% compared to mean cardiac output prior to placement of the shunt device between systemic artery and a systemic vein of said subject.

28. The apparatus as set forth in claim 27, wherein the increase in the mean cardiac output is at least 25%.

29. The apparatus as set forth in claim 27, wherein the increase in the mean cardiac output is at least 35%.

30. The apparatus as set forth in claim 27, wherein the increase in the mean cardiac output is at least 45%.

31. The apparatus as set forth in claim 27, wherein the increase in the mean cardiac output is at least 55%.

32. The apparatus as set forth in claim 27, wherein the increase in the mean cardiac output is at least 65%.

33. A therapeutic method for increasing cardiac output in a subject having chronic obstructive pulmonary disease, the method comprising:

creating an arterio-venous fistula between a systemic artery and a systemic vein of said subject, wherein said fistula allows blood flow rate therethrough of at least 5 ml/min, wherein said blood flow through the fistula bypasses the peripheral microcirculation, and wherein creation of said fistula results in an increase in the cardiac output in said subject.

34. The therapeutic method as set forth in claim 33, wherein the flow rate is in the range from 5 ml/min to 5000 ml/min.

35. The therapeutic method as set forth in claim 33, wherein said fistula has a cross-sectional area in the range from 3 mm² to 3000 mm².

36. The therapeutic method as set forth in claim 33, wherein the fistula has a size selected to provide a flow which will maintain said subject'"'"'s heart rate below 170 beats per minute.

37. The therapeutic method as set forth in claim 33, wherein the blood flow increases PaO₂ by at least 10% compared to PaO₂ prior to the fistula creation.

38. The therapeutic method as set forth in claim 33, wherein said artery and said vein are selected from the group consisting of, iliac artery and vein, femoral artery and saphenous vein, axillary artery and vein, and subclavian artery and vein.

39. The therapeutic method as set forth in claim 33 wherein said systemic artery and said systemic vein are proximal of the renal arteries.

40. The therapeutic method as set forth in claim 33 wherein said systemic artery and said systemic vein are distal of the renal arteries.

41. The method as set forth in claim 33, wherein said method decreases systemic vascular resistance by at least 5%.

42. The therapeutic method as set forth in claim 33, wherein the increase in the cardiac output is an increase in the mean cardiac output of at least 15% compared to mean cardiac output prior to creating the fistula.

43. The method as set forth in claim 42, wherein the increase in the mean cardiac output is at least 25%.

44. The method as set forth in claim 42, wherein the increase in the mean cardiac output is at least 35%.

45. The method as set forth in claim 42, wherein the increase in the mean cardiac output is at least 45%.

46. The method as set forth in claim 42, wherein the increase in the mean cardiac output is at least 55%.

47. The method as set forth in claim 42, wherein the increase in the mean cardiac output is at least 65%.

48. A therapeutic method for treating a disease or disorder in a subject, the method increasing cardiac output in the subject, the method comprising:

creating a fistula between a systemic artery and a systemic vein of said subject, said fistula adapted to allow blood flow rate therethrough of at least 5 ml/min, wherein said blood flow through the fistula bypasses the peripheral microcirculation, and wherein creation of said fistula results in an increase in the cardiac output in said subject.

49. The method of claim 48, wherein the disease or disorder is selected from the group consisting of chronic obstructive pulmonary disease, congestive heart failure, heart failure, chronic hypertension, and coronary artery disease;

systemic arterial hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis, adult respiratory distress syndrome, chronic bronchitis emphysema, emphysema, cystic fibrosis, cystic lung disease, and chronic asthma.

50. The method as set forth in claim 48, wherein said method decreases systemic vascular resistance by at least 5%.

51. An apparatus for increasing cardiac output in a subject having a disease or disorder, the apparatus comprising:

an arteriovenous shunt device shaped and adapted for placement between a systemic artery and a systemic vein in said subject.

52. The apparatus of claim 51, wherein the disease or disorder is selected from the group consisting of chronic obstructive pulmonary disease, congestive heart failure, heart failure, chronic hypertension, and coronary artery disease;

systemic arterial hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis, adult respiratory distress syndrome, chronic bronchitis emphysema, emphysema, cystic fibrosis, cystic lung disease, and chronic asthma.

53. A therapeutic method for increasing cardiac output in a subject having disease or disorder, the method comprising:

creating an arterio-venous fistula between a systemic artery and a systemic vein of said subject, wherein said fistula allows blood flow rate therethrough of at least 5 ml/min, wherein said blood flow through the fistula bypasses the peripheral microcirculation, and wherein creation of said fistula results in an increase in the cardiac output in said subject.

54. The method of claim 53, wherein the disease or disorder is selected from the group consisting of chronic obstructive pulmonary disease, congestive heart failure, heart failure, chronic hypertension, and coronary artery disease;

systemic arterial hypertension, hypotension, respiratory failure, pulmonary arterial hypertension, lung fibrosis, adult respiratory distress syndrome, chronic bronchitis emphysema, emphysema, cystic fibrosis, cystic lung disease, and chronic asthma.

55. The method as set forth in claim 53, wherein said method decreases systemic vascular resistance by at least 5%.