Valve with delayed leaflet deployment

• US 8,414,641 B2
• Filed: 03/02/2012
• Issued: 04/09/2013
• 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: Stocker, Patrick J., Walker, Joseph C.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/411,049
• Publication Number:
  US 20120165927A1
• Time in Patent Office: 403 Days
• Field of Search: 623/1.24, 623/2.11, 623/2.14
• US Class Current: 623/1.24
• 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 has an open state and a closed state, and movement of the valve leaflet between the open state and the closed state provides for unidirectional flow of a liquid through the valve; and

a biodegradable adhesive at one or more attachment points between the valve leaflet and the valve frame, the biodegradable adhesive holding the valve leaflet in the open state for a predetermined time of no less than one week after implantation into a lumen of a body.

2. The valve of claim 1, the valve further including a first treatment in regions other than the one or more attachment points, said treatment promoting tissue in-growth after implantation into a lumen of a body.

3. The valve of claim 2, the valve further including a second treatment at the one or more attachment points to prevent tissue in-growth at least for the predetermined time after implantation into a lumen of a body.

4. The valve of claim 1, the biological adhesive comprising a porous first portion for tissue in-growth after implantation into a lumen of a body.

5. The valve of claim 1, the biological adhesive having a layered structure.

6. The valve of claim 5, wherein said layered structure promotes tissue in-growth after implantation into a lumen of a body.

7. The valve of claim 6, the biodegradable adhesive being different types of biodegradable adhesive, the layered structure formed of the different types of biodegradable adhesives.

8. 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.

9. The valve of claim 1, where the valve leaflet includes a commissure that can reversibly seal for unidirectional flow of a liquid through the valve after the predetermined time, 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.

10. 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;

a valve leaflet coupled to the valve frame, where the valve leaflet has an open state and a closed state, and movement of the valve leaflet between the open state and the closed state provides for unidirectional flow of a liquid through the valve; and

a biodegradable adhesive at one or more discrete attachment points between the valve leaflet and the valve frame, the biodegradable adhesive holding the valve leaflet in the open state for a predetermined time of no less than one week after implantation into a lumen of a body.

11. The system of claim 10, 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.

12. The system of claim 10, 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.

13. The system of claim 10, 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. The valve of claim 10, the valve further including a first treatment in regions of the valve other than the one or more attachment points, said treatment promoting tissue in-growth after implantation into a lumen of a body.

15. The valve of claim 14, the valve further including a second treatment at the one or more attachment points to prevent tissue in-growth at least for the predetermined time after implantation into a lumen of a body.

16. The valve of claim 10, the biological adhesive comprising a porous first portion for tissue in-growth after implantation into a lumen of a body.

17. The valve of claim 10, the biological adhesive having a layered structure.

18. The valve of claim 17, wherein said layered structure promotes tissue in-growth after implantation into a lumen of a body.

19. The valve of claim 18, the biodegradable adhesive being different types of biodegradable adhesive, the layered structure formed of the different types of biodegradable adhesives.

20. A valve, comprising:

a valve frame;

a valve leaflet coupled to the valve frame, where the valve leaflet has an open state and a closed state, and movement of the valve leaflet between the open state and the closed state provides for unidirectional flow of a liquid through the valve; and

a biodegradable adhesive at one or more attachment points between the valve leaflet and the valve frame, the biological adhesive comprising a porous first portion for tissue in-growth after implantation into a lumen of a body, the biodegradable adhesive holding the valve leaflet in the open state for a predetermined time of no less than one week after implantation into a lumen of a body.