PROSTHETIC VALVE AND DEPLOYMENT SYSTEM

• US 20180085215A1
• Filed: 12/14/2015
• Published: 03/29/2018
• Est. Priority Date: 12/14/2014
• Status: Active Grant

• Current Assignee: Trisol Medical Ltd.
• Original Assignee: Trisol Medical Ltd.
• Inventors: VATURI, Mordehay, GOLLAN, Tal
• Granted Patent: US 11,045,311 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped

Abstract

A prosthetic heart valve, for example a tricuspid valve, may include a flexible membrane and a frame. The frame may be attached to the periphery of the tricuspid orifice. The diaphragm may be attached to the frame around a part of the perimeter of the orifice. Optionally the frame may be flexible. For example the frame may elastically flex between a substantially circular shape and/of an elliptical and/or crescent shape. Optionally there may not be a stiff cross piece crossing a central region of the orifice and connected on opposing sides of frame. In some embodiments, the diaphragm may take a dome shape during systole.

Claims

1. A prosthetic valve, comprising:

a frame sized and shaped to fit in an orifice, the frame having a minimum external perimeter and a minimum cross section;

a flexible diaphragm including an edge at least as large as the minimum external perimeter of the frame and a side of the diaphragm having a surface area greater than the minimum cross section of the frame;

the flexible diaphragm is connected to the frame along a length ranging between 1% and 25% of a length of the edge such that a portion of the diaphragm is held partially expanded along the length.

2. The prosthetic valve of claim 1, wherein the length of connection of the diaphragm to the frame is along a peripheral portion of the orifice.

3. The prosthetic valve of claim 1, wherein the flexible diaphragm forms a dome with an apex in an upstream direction.

4. The prosthetic valve of claim 1, wherein the frame has a downstream border and wherein the edge of the flexible diaphragm is at least as large as a perimeter of the frame at the downstream border.

5. The prosthetic valve of claim 1, wherein the frame surrounds a simply connected space and the diaphragm divides the simply connected space into at least two disconnected channels.

6. The prosthetic valve of claim 1, wherein the frame has an axial length of between 20 to 30% of the perimeter of the orifice.

7. The prosthetic valve of claim 1, wherein the length of connection of the diaphragm to the frame ranges includes between 2% and 7% of the perimeter of the orifice.

9. The prosthetic valve of claim 1, wherein the diaphragm has a collapsed position allowing flow from an upstream direction to a downstream direction between the diaphragm and the perimeter of the orifice and an expanded position inhibiting the flow.

10. The prosthetic valve of claim 9, wherein the diaphragm includes a free region including an apex of the diaphragm.

11. The prosthetic valve of claim 10, wherein in the expanded position, the apex is upstream of the frame.

12. The prosthetic valve of claim 1 wherein the frame flexes such that a ratio of length of an axis of the frame during diastole with respect to a length of the axis during systole is at least 1.3 to 1.

13. The prosthetic valve of claim 1 wherein there is no stiff element connected on two sides to the frame and crossing a free area including a projection of at least 40% of a cross section of the orifice including a center of the orifice.

14. The prosthetic valve of claim 1, further comprising:

a delivery system for a prosthetic heart valve including;

an extender including;

a first portion with a proximal end located proximal to the prosthetic heart valve, the first portion extending through a flow channel of the prosthetic heart valve; and

a second portion located distal to the prosthetic heart valve;

a delivery knurl mounted on the second portion of the extender; and

a guide wire channel extending through the delivery knurl.

15. The prosthetic valve of claim 14, further comprising;

a guide wire extending from a proximal side of the prosthetic valve through a second flow channel of the prosthetic valve and further extending through the guide wire channel.

22. The prosthetic valve of claim 9, wherein said valve is configured to switch from said collapsed position to said expanded position in response to a back flow from a downstream chamber, said back flow occurring between a beginning of a systolic phase until said diaphragm reaches said expanded position and wherein said valve is further configured to permit a back flow volume of between 1 to 40% of a volume of said downstream chamber to flow from said downstream chamber into at least one of a volume of said diaphragm and an upstream chamber.

8. (canceled)

16. (canceled)

17. A method of controlling flow through an orifice comprising:

suspending a diaphragm on a periphery of the orifice;

collapsing the diaphragm by means of a pressure gradient in a first direction through the orifice the pressure gradient in the first direction driving flow passing between the periphery and the diaphragm on at least on two sides of the diaphragm;

filling the diaphragm with regurgitated fluid driven by a second pressure gradient in a second direction opposite the first direction, and

pressing the diaphragm against a periphery of the orifice by fluid pressure from the second gradient.

18. The method of controlling of claim 17, further including:

fitting a frame into orifice and wherein the suspending is from a frame fit into the orifice.

19. The method of controlling of claim 18, further comprising:

repeatedly elastically flexing the frame between two geometries having respective aspect ratios of greater than 1.3 to 1 and

retaining an apex of the diaphragm upstream of the frame during the repeated flexing.

20. The method of controlling of claim 17, further comprising:

resuming the pressure gradient in the first direction after the filling and

returning at least 80% of the regurgitated fluid back through the orifice during the resuming.

21. The method of controlling of claim 17, further comprising:

permitting back flow from a downstream chamber of between 1 to 40% of a volume of said downstream chamber driven into said orifice by said second pressure gradient; and

closing said orifice to further back flow as a result of said pressing;

said closing subsequent to said permitting.