Valve with delayed leaflet deployment

• US 20090164029A1
• Filed: 12/21/2007
• Published: 06/25/2009
• Est. Priority Date: 12/21/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Walker, Joseph C., Stocker, Patrick J.
• Granted Patent: US 7,892,276 B2
• Time in Patent Office: Days
• US Class Current: 623/23.680
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

A valve for use in a body lumen, where the valve includes a valve leaflet with delayed leaflet deployment relative an in vivo implant time. The valve includes a valve frame, a valve leaflet coupled to the valve frame. The valve leaflet includes a commissure that can reversibly seal for unidirectional flow of a liquid through the valve, and a biodegradable adhesive between the valve leaflet and the valve frame to hold at least the commissure of the valve leaflet in a static relationship relative the valve frame for a predetermined time once implanted in vivo.

Claims

1. A valve, comprising:

a valve frame;

a valve leaflet coupled to the valve frame, where the valve leaflet includes a commissure that can reversibly seal for unidirectional flow of a liquid through the valve; and

a biodegradable adhesive between the valve leaflet and the valve frame to hold at least the commissure of the valve leaflet in a static relationship relative the valve frame.

2. The valve of claim 1, where the biodegradable adhesive holds the valve leaflet at one or more discrete attachment points to hold each valve leaflet in the static relationship relative the valve frame.

3. The valve of claim 1, where the valve frame includes a distal end and where the biodegradable adhesive holds the valve leaflet completely along the distal end of the valve frame.

4. The valve of claim 1, where the biodegradable adhesive holds at least the commissure of the valve leaflet in the static relationship relative the valve frame for a predetermined time after implantation into a lumen of a body.

5. The valve of claim 1, further including allowing at least a portion of the commissure of the valve leaflet to gather toward the longitudinal axis when the valve frame is in a radially compressed state.

6. The valve of claim 1, where the valve leaflet includes an anti-thromobogenic coating.

7. The valve of claim 1, where the biodegradable adhesive holds at least a portion of the valve leaflet static relative the valve frame once in vivo for a predetermined time of no less than one week.

8. A valve, comprising:

a valve frame;

a valve leaflet coupled to the valve frame, where the valve leaflet includes a commissure that can reversibly seal for unidirectional flow of a liquid through the valve and an anti-thromobogenic coating; and

a biodegradable adhesive between the valve leaflet and the valve frame to hold at least the commissure of the valve leaflet in a static relationship relative the valve frame for a predetermined time of no less than one week after implantation into a lumen of a body.

9. A system, comprising:

an elongate delivery catheter; and

a valve positioned at least partially over the elongate delivery catheter, where the valve includes;

a valve frame having frame members defining a lumen;

a valve leaflet attached to a portion of the valve frame, the valve leaflet having a commissure; and

a biodegradable adhesive between the valve leaflet and the valve frame to hold at least the commissure of the valve leaflet in a static relationship relative the valve frame.

10. The system of claim 9, where the elongate delivery catheter includes an expandable balloon positioned around at least a portion of the elongate delivery catheter, and where the valve is positioned at least partially over the expandable balloon.

11. The system of claim 9, where the elongate delivery catheter includes a retractable sheath positioned over at least a portion of the valve, where the retractable sheath can be retracted to release the valve from the elongate delivery catheter.

12. The system of claim 9, where the biodegradable adhesive holds the valve leaflet at one or more discrete attachment points to the valve frame.

13. The system of claim 9, where the valve frame includes a distal end and where the biodegradable adhesive holds the valve leaflet completely along the distal end of the valve frame.

14. A method, comprising:

forming a valve with a valve frame and a valve leaflet having a commissure; and

releasably joining at least a portion of the valve leaflet to the valve frame with a biodegradable adhesive so the commissure does not help to prevent retrograde flow for at least a predetermined time after the valve has been implanted in a vessel of a body.

15. The method of claim 14, where releasably joining at least a portion of the valve leaflet to the valve frame includes releasably joining at least a portion of a peripheral edge of the valve leaflet to the valve frame.

16. The method of claim 15, where the releasably joining the portion of the peripheral edge of the valve leaflet to the valve frame includes releasably joining the peripheral edge and the valve frame at attachment points spaced equidistant from a longitudinally axis of the valve frame.

17. The method of claim 16, further including allowing at least a portion of the peripheral edge of the valve leaflet to gather toward the longitudinal axis when the valve frame is in a radially compressed state.

18. The method of claim 14, where the releasably joining the portion of the peripheral edge of the valve leaflet to the valve frame includes releasably joining the peripheral edge in its entirety to the valve frame.

19. The method of claim 14, including at least partially coating the valve frame with a coating that promotes at least tissue in-growth;

and

at least partially coating the valve leaflet with an anti-thromobogenic coating.

20. A method, comprising:

positioning a valve at a predetermined location with a delivery catheter, the valve including a valve leaflet having a proximal end portion and a distal end portion relative the proximal end portion, and a valve frame;

deploying the valve with the delivery catheter at the predetermined location;

removing the delivery catheter from the predetermined location;

retaining the proximal end portion and the distal end portion of the valve leaflet in a static relationship relative the valve frame after removal of the delivery catheter to allow for uncontrolled blood flow through the valve; and

allowing the valve leaflet to release from its static relationship after a predetermined time.

21. The method of claim 20, where positioning the valve at the predetermined location includes positioning the valve in a pulmonary vein.

22. The method of claim 20, where retaining the valve leaflet includes keeping a biodegradable adhesive at least partially between the valve leaflet and the valve frame for a time interval of no less than one week.

23. The method of claim 20, where allowing the valve leaflet to release from its static relationship includes exposing the biodegradable adhesive to body fluids that cause the biodegradation of the biodegradable adhesive.

24. The method of claim 20, where retaining the valve leaflet includes minimizing longitudinal shear stresses on the valve frame during the predetermined time.

25. The method of claim 20, including promoting tissue in-growth around the valve frame during the predetermined time.