Devices and methods for reducing venous pressure

• US 9,277,995 B2
• Filed: 01/28/2011
• Issued: 03/08/2016
• Est. Priority Date: 01/29/2010
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: Celermajer, David, Sutherland, Michael W., McNamara, Edward
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US13/016,290
• Publication Number:
  US 20110190874A1
• Time in Patent Office: 1,866 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219
• US Class Current: 1/1
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

Devices and method are disclosed for reducing pressure in a patient'"'"'s vena cava and in the right atrium of a patient'"'"'s heart. A valve is implanted in the inferior vena cava (IFC) between the patient'"'"'s renal veins and hepatic veins. When pressure in a patient'"'"'s IFC reaches high levels, i.e., the pressure differential across the valve reaches high levels, the valve automatically closes or begins to close. The closing is caused by the pressure of the patient'"'"'s blood moving one or more flaps in the valve to a closed or near-closed position. This prevents excessive pressure in the upper or superior vena cava and the right atrium of the patient'"'"'s heart. The device also includes a pressure relief feature that opens and allows retrograde flow of blood if the pressure differential exceeds a yet higher pressure.

Claims

1. A device for treating heart failure of a patient, comprising:

a stent for implantation in an inferior vena cava of the patient;

at least one pressure control feature configured to prevent elevated blood pressure from damaging an organ or vessel, wherein the at least one pressure control feature is configured to allow blood flow in a first direction and to resist flow in a second direction opposite to the first direction blood flow in the first direction is allowed when a pressure on a first side of the device exceeds a pressure on a second side of the device by a first value; and

at least one connector joining the at least one pressure control feature to said stent,

wherein the stent comprises a pressure relief feature comprising a reversibly collapsible portion of the stent configured to reversibly collapse to permit blood to flow in the second direction and reduce pressure differential across the device when the pressure on the second side of the device exceeds the pressure on the first side of the device by a second value, the second value greater than the first value, and wherein the stent, not including the reversibly collapsible portion, is configured to maintain substantial circumferential contact with the inferior vena cava when the reversibly collapsible portion collapses.

2. The device of claim 1, wherein the at least one pressure control feature comprises a plurality of flaps which are open to allow blood flow in the first direction and which are designed to begin to close when a pressure drop across the device is at least 10mm Hg.

3. The device of claim 1, wherein the at least one connector is selected from the group consisting of a suture and a crimping member.

4. A device for treating heart failure, comprising:

an elongate tubular member;

at least one pressure control feature;

and

a connector joining said at least one pressure control feature to said elongate tubular member,

wherein the at least one pressure control feature is configured for implantation in a blood vessel to prevent elevated blood pressure from damaging an organ or a vessel by allowing blood flow in a first direction and resisting blood flow in a second direction opposite to the first direction blood flow in the first direction is allowed when pressure on a first side of the device exceeds pressure on a second side of the device by a first value, and

wherein the elongate tubular member comprises a reversibly collapsible portion as a pressure relief feature configured to reversibly activate and reduce pressure differential across the device when the pressure on the second side of the device exceeds pressure on the first side of the device by a second value by allowing blood flow in the second direction, the second value greater than the first value, and wherein the elongate tubular member is configured to maintain substantial circumferential contact with the blood vessel into which said elongate tubular member is implanted when the reversibly collapsible portion collapses.

5. The device of claim 4, wherein the at least one pressure control feature comprises at least one flexible flap and wherein the reversibly collapsible portion comprises at least one flexible portion of a circumferential wall of the elongate tubular member.

6. The device of claim 4, wherein the at least one pressure control feature comprises a portion of a flexible flap attached to a circumferential wall of the elongate tubular member.

7. The device of claim 4, wherein the reversibly collapsible portion comprises at least one portion of a circumferential wall of the elongate tubular member having a reduced cross section or thickness.

8. A device to reduce venous pressure comprising:

a stent adapted to exert an outward radial force upon a lumen of an inferior vena cava, wherein the stent comprises an emergency pressure relief feature comprising a reversibly collapsible portion of the stent, and wherein the stent, not including the emergency pressure relief feature, is configured to maintain substantial circumferential contact with the inferior vena cava when the reversibly collapsible portion collapses;

at least one anchor integral with said stent adapted to contact a surface of said lumen; and

a valve having a first side and a second side and is configured to allow blood to flow in a first direction, wherein said first direction is a normal direction of blood flow and wherein said normal direction of blood flow is from said first side of the valve to said second side of the valve and wherein said valve is configured to close when a venous pressure on the second side of the valve exceeds a venous pressure on the first side of the valve by a first predetermined amount, and

wherein the emergency pressure release feature is configured to allow blood to flow retrograde in a direction opposite to the normal direction while said valve is at least partially closed and when the venous pressure on the second side of the valve exceeds a venous pressure on the first side of the valve by a second predetermined amount, the second predetermined amount greater than the first predetermined amount.

9. The device of claim 8, wherein the valve comprises a plurality of flexible flaps connected to the stent.

10. The device of claim 8, wherein the reversibly collapsible portion comprises a circumferential portion of the stent.

11. A device to reduce venous pressure comprising:

a stent adapted to exert an outward radial force upon a lumen of an inferior vena cava, wherein the stent comprises an emergency pressure relief feature comprising a reversibly collapsible portion of the stent, and wherein the stent, not including the emergency pressure relief feature, is configured to maintain substantial circumferential contact with the inferior vena cava when the reversibly collapsible portion collapses;

at least one anchor integral with said stent adapted to contact a surface of said lumen; and

a valve having a first side and a second side and is configured to allow blood to flow in a first direction, wherein said first direction is a normal direction of blood flow and wherein said normal direction of blood flow is from said first side of the valve to said second side of the valve and wherein said valve is configured to close when a venous pressure on the second side of the valve exceeds a venous pressure on the first side of the valve by a first value,

wherein the emergency pressure relief feature is configured to open to allow blood to flow retrograde in a direction opposite to the normal direction while said valve is at least partially closed and when the venous pressure on the second side of the valve exceeds a venous pressure on the first side of the valve by a second value, the second value greater than the first value.