Apparatus and method for treating cardiovascular diseases

• US 8,652,201 B2
• Filed: 01/22/2009
• Issued: 02/18/2014
• Est. Priority Date: 04/26/2006
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Oberti, Carlos, Navia, Jose L., Krasuski, Richard
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/357,520
• Publication Number:
  US 20090177262A1
• Time in Patent Office: 1,853 Days
• Field of Search: 623/1.12, 623/1.15, 623/1.18, 623/1.25, 623/1.36, 623 142- 143, 623/1.46, 623/2.36, 623/1.44, 623/1.3, 623/1.31, 623/2.17, 623/2.18
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A method is provided for treating a cardiovascular disease, such as pulmonary arterial hypertension, an arrhythmia, or heart failure. One step of the method includes providing an apparatus. The apparatus includes an expandable support member having oppositely disposed proximal and distal end portions and a main body portion extending between the end portions. The proximal end portion includes a plurality of wing members extending from the main body portion. At least a portion of the expandable support member is treated with at least one therapeutic agent for eluting into a blood vessel. The expandable support member is inserted into the pulmonary vasculature and then advanced to a bifurcation in the pulmonary vasculature. The bifurcation includes the intersection of a first pulmonary vessel, a second pulmonary vessel, and a third pulmonary vessel. The expandable support member is secured at the bifurcation to treat pulmonary arterial hypertension, for example.

Claims

1. A method for treating a cardiovascular disease, said method comprising the steps of:

providing an apparatus comprising an expandable support member having oppositely disposed proximal and distal end portions and a main body portion extending between the end portions, the proximal end portion comprising a plurality of wing members extending from the main body portion, at least a portion of the expandable support member being treated with at least one therapeutic agent for eluting into a blood vessel;

inserting the expandable support member into the pulmonary vasculature;

advancing the expandable support member to a bifurcation in the pulmonary vasculature, the bifurcation comprising the intersection of a first pulmonary blood vessel, a second pulmonary blood vessel, and third pulmonary blood vessel; and

securing the expandable support member within the bifurcation so that the wing members engage a portion of the vessel wall in both the second and third pulmonary blood vessels;

wherein the at least one therapeutic agent elutes into the pulmonary vasculature to treat the cardiovascular disease;

wherein the cardiovascular disease is selected from the group consisting of arrhythmias, heart failure, acute and chronic heart transplant rejection, and pulmonary arterial hypertension.

2. The method of claim 1, where said step of securing the expandable support member at the bifurcation further includes expanding the expandable support member so that the at least one wing member and the main body portion engage a portion of the arterial wall at the bifurcation.

3. The method of claim 2 wherein said step of expanding the expandable support member further includes the steps of:

positioning the at least one wing member at the bifurcation so that the at least one wing member engages a portion of the left pulmonary artery;

positioning a second wing member at the bifurcation so that the second wing member engages a portion of the right pulmonary artery; and

positioning the main body portion at the bifurcation so that the main body portion engages a portion of the pulmonary artery.

4. The method of claim 2, wherein said step of expanding the expandable support member further includes the steps of:

positioning the main body portion at the bifurcation so that the main body portion engages a portion of the left pulmonary artery; and

positioning the at least one wing member at the bifurcation so that the at least one wing member engages a portion of the pulmonary artery.

5. The method of claim 3 further including the steps of:

providing a second apparatus comprising a second expandable support member having oppositely disposed proximal and distal end portions and a second main body portion extending between the end portions, the proximal end portion comprising a plurality of wing members extending from the second main body portion, at least a portion of the second expandable support member being treated with at least one therapeutic agent for eluting into a blood vessel;

inserting the second expandable support member into the pulmonary vasculature;

advancing the second expandable support member to a second bifurcation in the pulmonary vasculature; and

securing the second expandable support member at the second bifurcation;

wherein the at least one therapeutic agent elutes into the pulmonary vasculature to treat the cardiovascular disease.

6. The method of claim 5, wherein said step of securing the second expandable support member at the second bifurcation further includes the steps of:

positioning the second main body portion so that the second main body portion engages a portion of an upper branch of the left pulmonary artery; and

positioning at least one wing member of the second expandable support member so that the at least one wing member engages a portion of the left pulmonary artery.

7. The method of claim 5, wherein said step of securing the second expandable support member at the second bifurcation further includes the steps of:

positioning the second main body portion so that the second main body portion engages a portion of an upper branch of the right pulmonary artery; and

positioning at least one wing member of the second expandable support member so that the at least one wing member engages a portion of the right pulmonary artery.

8. The method of claim 1, wherein said step of inserting the expandable support member into the pulmonary vasculature is done percutaneously via an intravascular catheter.

9. The method of claim 8 further comprising expanding the expandable support member with an expandable balloon.

10. The method of claim 8 further comprising the steps of:

delivering the expandable support member to the bifurcation via the catheter in a collapsed configuration; and

removing the catheter so that the expandable support member self-expands into the bifurcation.

11. The method of claim 1, wherein the cardiovascular disease is pulmonary arterial hypertension.

12. The method of claim 1, wherein at least a portion of the expandable support member is made from a bioabsorbable material.

23. The method of claim 1, wherein said step of providing an apparatus further includes providing an expandable support member having each of the wing members separately spaced apart from one another.

24. The method of claim 1, wherein said step of providing an apparatus further includes providing an expandable support member having each of the wing members radially spaced apart from one another.

25. The method of claim 23, wherein each of the wing members resembles an arch.

13. A method for treating a cardiovascular disease, said method comprising the steps of:

providing an apparatus comprising an expandable support member having oppositely disposed proximal and distal end portions and a main body portion extending between the end portions, the proximal end portion comprising a plurality of wing members extending from the main body portion, at least a portion of the expandable support member being treated with at least one therapeutic agent for eluting into an atrial chamber and/or cardiac tissue;

inserting the expandable support member into an atrial appendage, the atrial appendage having an ostium surrounded by an antrum of the atrial chamber, the atrial appendage being structurally and physiologically distinct from the atrial chamber; and

securing the expandable support member in the atrial appendage.

14. The method of claim 13, wherein said step of securing the expandable support member in the atrial appendage further comprises expanding the expandable support member so that a portion of the main body portion engages the ostium and at least one wing member engages a portion of the antrum surrounding the ostium.

15. The method of claim 14, wherein said step of inserting the expandable support member into the atrial appendage is done percutaneously via an intravascular catheter.

16. The method of claim 15 further comprising expanding the expandable support member with an expandable balloon.

17. The method of claim 15 further comprising the steps of:

delivering the expandable support member to the atrial appendage via the catheter in a collapsed configuration; and

removing the catheter so that the expandable support member self-expands into the atrial appendage.

18. The method of claim 13, wherein the atrial appendage is a left atrial appendage.

19. The method of claim 13, wherein the cardiovascular disease is an arrhythmia.

20. The method of claim 13, wherein at least a portion of the expandable support member is made from a bioabsorbable material.

21. A method for treating a cardiovascular disease, said method comprising the steps of:

providing an apparatus comprising an expandable support member and an electrical mechanism coupled to the expandable support member, the expandable support member having oppositely disposed proximal and distal end portions and a main body portion extending between the end portions, the proximal end portion comprising a plurality of wing members extending from the main body portion, at least a portion of the expandable support member being treated with at least one therapeutic agent for eluting into a blood vessel, the electrical mechanism for delivering electrical energy to at least a portion of the ostium of a pulmonary blood vessel to ablate tissue;

inserting the expandable support member into the pulmonary vasculature;

advancing the expandable support member to a bifurcation in the pulmonary vasculature, the bifurcation comprising the intersection of a first pulmonary blood vessel, a second pulmonary blood vessel, and third pulmonary blood vessel; and

securing the expandable support member within the bifurcation so that the wing members engage a portion of the vessel wall in both the second and third pulmonary blood vessels;

wherein the at least one therapeutic agent elutes into the pulmonary vasculature to treat the cardiovascular disease;

wherein the cardiovascular disease is selected from the group consisting of arrhythmias, heart failure, acute and chronic heart transplant rejection, and pulmonary arterial hypertension.

22. The method of claim 21, further comprising activating the electrical mechanism to deliver electrical energy to the at least a portion of the ostium of the pulmonary blood vessel to ablate tissue.