Monolithic in situ forming valve system

• US 20080161909A1
• Filed: 01/29/2008
• Published: 07/03/2008
• Est. Priority Date: 02/24/2006
• Status: Active Grant

• Current Assignee: California Institute of Technology
• Original Assignee: California Institute of Technology
• Inventors: Gharib, Morteza, Kheradvar, Arash
• Granted Patent: US 7,780,724 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

Described is a monolithic in situ forming valve system. The valve system is delivered in an unformed, collapsed configuration that lacks any functional characteristics commonly associated with a valve before. However, once expanded, the system is transformed into a competent valve for use in a wide variety of applications. The valve system includes a superior expandable structure, an inferior expandable structure, and a helical pre-valve component. The helical pre-valve component comprises a first end attached with the superior expandable structure and a second end attached with the inferior expandable structure. The helical pre-valve component is formed such that expansion of the superior expandable structure and the inferior expandable structure causes the helical pre-valve structure to transform into a functional valve held between each of the expandable structures.

Claims

1. A monolithic in situ forming valve, comprising:

a superior expandable structure;

an inferior expandable structure; and

a helical pre-valve component, the helical pre-valve component comprising;

a first end attached with the superior expandable structure; and

a second end attached with the inferior expandable structure, where the helical pre-valve component is formed such that expansion of the superior expandable structure and the inferior expandable structure causes the helical pre-valve structure to transform into a functional valve held between each of the expandable structures.

2. The apparatus of claim 1, wherein the helical pre-valve component further includes a compliant sheet and at least two appendices.

3. The apparatus of claim 2, wherein the expansion of the superior expandable structure and inferior expandable structure causes vertical shrinkage of the pre-valve component, which causes a first appendix to engage with the inferior expandable structure and a second appendix to engage with the superior expandable structure, thus inducing the compliant sheet to form a valve there between.

4. The apparatus of claim 2, wherein the appendices are formed of a shape memory material and form a hook-shape when exposed to a desired temperature.

5. The apparatus of claim 2, wherein appendices are configured to secure the pre-valve component to either the superior expandable structure or the inferior expandable structure, thereby fixedly securing the compliant sheet between the superior expandable structure and the inferior expandable structure.

6. The apparatus of claim 2, wherein the compliant sheet is integrated with a plurality of leaflets made of polymeric materials.

7. The apparatus of claim 2, wherein the compliant sheet is formed of a tissue selected from a group consisting of bovine tissue, porcine tissue, and equine pericardial tissue.

8. The apparatus of claim 1, wherein the superior expandable structure and inferior expandable structure are at least partially composed of a shape memory material, such that the superior expandable structure and inferior expandable structure have a first compressed memory state shape and second expanded memory state shape, where the superior expandable structure and inferior expandable structure are deliverable in a compressed state and upon expansion, are maintained in the second expanded memory state shape. Please add the magnetic shape memory as well.

9. The apparatus of claim 1, wherein the superior expandable structure and the inferior expandable structure are in the form of a stent-like crown.

10. The apparatus of claim 1, further comprising a delivery apparatus connected with at least one of the superior expandable structure and the inferior expandable structure.

11. The apparatus of claim 10, wherein the delivery apparatus further comprises an expansion mechanism configured to selectively expand the superior expandable structure appended over the delivery apparatus and the inferior expandable structure appended over the delivery apparatus. Please add the recoil mechanism as well.

12. The apparatus of claim 11, wherein the expansion mechanism of the delivery apparatus is a balloon.

13. The apparatus of claim 1, wherein the helical pre-valve component further includes a compliant sheet and at least two appendices attached with the compliant sheet;

wherein the expansion of the superior expandable structure and inferior expandable structure causes vertical shrinkage of the pre-valve component, which causes a first appendix to engage with the inferior expandable structure and a second appendix to engage with the superior expandable structure, thus inducing the compliant sheet to form a valve there between;

wherein the appendices are formed of a shape memory material and form a hook-shape when exposed to a desired temperature;

wherein appendices are configured to secure the pre-valve component to either the superior expandable structure or the inferior expandable structure, thereby fixedly securing the compliant sheet between the superior expandable structure and the inferior expandable structure;

wherein the superior expandable structure and inferior expandable structure are at least partially composed of a shape memory material, such that the superior expandable structure and inferior expandable structure have a first compressed memory state shape and second expanded memory state shape, where the superior expandable structure and inferior expandable structure are deliverable in a compressed state and upon expansion, are maintained in the second expanded memory state shape;

wherein the superior expandable structure and the inferior expandable structure are in the form of a stent-like crown;

further comprising a delivery apparatus connected with at least one of the superior expandable structure and the inferior expandable structure; and

wherein the delivery apparatus further comprises an expansion mechanism configured to selectively expand the superior expandable structure appended over the delivery apparatus and the inferior expandable structure appended over the delivery apparatus.

14. A method for delivering and forming a valve in situ, comprising acts of:

providing an in situ forming valve, the in situ forming valve comprising;

a superior expandable structure;

an inferior expandable structure; and

a helical pre-valve component, the helical pre-valve component comprising;

a first end attached with the superior expandable structure; and

a second end attached with the inferior expandable structure,

where the helical pre-valve component is formed such that expansion of the superior expandable structure and the inferior expandable structure causes the helical pre-valve structure to transform into a functional valve held between each of the expandable structures.

15. The method of claim 14, further comprising an act of delivering the in situ forming valve to a target site using a delivery apparatus.

16. The method of claim 15, further comprising an act of expanding at least one of the superior expandable structure and the inferior expandable structure, which causes the helical pre-valve structure to vertically shrink and form the functional valve.

17. The method of claim 16, wherein in the act of providing an in situ forming valve, the helical pre-valve component further comprises a plurality of appendices, and further comprising acts of:

curling the appendices to form hook-shapes; and

hooking the appendices with at least one of the superior expandable structure and the inferior expandable structure.

18. The method of claim 17, wherein in the act of delivering the in situ forming valve, the in situ forming valve is delivering using a procedure selected from a group consisting of a percutaneous procedure, a trans-apical catheterization, an endoscopic procedure, a laparoscopic procedure, and an open-chest procedure.

19. The method of claim 14, wherein in the act of providing an in situ forming valve, the helical pre-valve component further comprises a plurality of appendices, and further comprising acts of:

curling the appendices to form hook-shapes; and

hooking the appendices with at least one of the superior expandable structure and the inferior expandable structure.

20. The method of claim 14, wherein in the act of delivering the in situ forming valve, the in situ forming valve is delivering using a procedure selected from a group consisting of a percutaneous procedure, a trans-apical catheterization, an endoscopic procedure, a laparoscopic procedure, and an open-chest procedure.