Prosthetic renal valve

• US 9,597,205 B2
• Filed: 06/06/2013
• Issued: 03/21/2017
• Est. Priority Date: 06/06/2012
• Status: Active Grant

• Current Assignee: Magenta Medical Ltd.
• Original Assignee: Magenta Medical Ltd.
• Inventors: Tuval, Yosi
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): BARIA, DINAH N
• Application Number:
  US14/405,144
• Publication Number:
  US 20150164662A1
• Time in Patent Office: 1,384 Days
• US Class Current: 1/1
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/006 modular

Abstract

Apparatus and methods are described including a valve (34) that includes valve leaflets (33) and a non-branched valve frame (31) configured to support the valve leaflets, the frame defining a single longitudinal axis thereof, the longitudinal axis being a generally straight line along a full length of the frame. The valve (34) is placed at least partially within a renal vein of a subject. The valve defines an open state thereof in which the valve leaflets (33) allow generally unimpeded antegrade blood flow therethrough, and a closed state thereof in which the valve leaflets (33), in a passive manner, reduce venous pressure within the renal vein relative to central venous pressure of the subject. Other applications are also described.

Claims

1. A method comprising:

identifying a subject as suffering from a condition that causes the subject to have elevated renal venous pressure even in an absence of a condition that causes renal venous pressure of the subject to be elevated due to pressure being exerted on the subject'"'"'s renal vein through walls of the subject'"'"'s renal vein from a location outside the renal vein; and

in response thereto, reducing blood pressure within a renal vein of the subject relative to the subject'"'"'s central venous pressure, by placing a device at least partially within the subject'"'"'s renal vein, the device being configured, in a passive manner, to reduce venous pressure within the subject'"'"'s renal vein relative to central venous pressure of the subject.

2. A method comprising:

identifying a subject as suffering from a condition that causes the subject to have elevated central venous pressure; and

in response thereto, reducing blood pressure within renal veins of the subject relative to the subject'"'"'s central venous pressure, by placing a first device at least partially in a left renal vein of the subject and placing a second device at least partially in a right renal vein of the subject, the devices being configured, in a passive manner, to reduce venous pressure within the subject'"'"'s renal veins relative to central venous pressure of the subject.

3. A method comprising:

identifying a subject as suffering from a condition that causes the subject to have elevated central venous pressure, the condition being selected from the group consisting of;

cardiac dysfunction, congestive heart failure, and kidney dysfunction; and

in response thereto, reducing blood pressure within a renal vein of the subject relative to the subject'"'"'s central venous pressure, by placing a device at least partially within the subject'"'"'s renal vein, the device being configured, in a passive manner, to reduce venous pressure within the subject'"'"'s renal vein relative to central venous pressure of the subject.

4. The method according to claim 3, wherein reducing pressure within the renal vein comprises reducing pressure within the renal vein by placing the device at least partially within the renal vein in an absence of any device being placed at a location that is within an abdomen of the subject and outside a venous system of the subject.

5. The method according to claim 3, wherein identifying the subject as suffering from the condition that causes the subject to have elevated central venous pressure comprises identifying the subject as suffering from elevated renal venous pressure.

6. The method according to claim 3, wherein identifying the subject as suffering from the condition that causes the subject to have elevated central venous pressure comprises identifying the subject as suffering from elevated central venous pressure even in an absence of the subject suffering from tricuspid valve regurgitation.

7. The method according to claim 3, wherein reducing the blood pressure within the renal vein comprises reducing the blood pressure within the subject'"'"'s renal vein relative to central venous pressure of the subject, even during lower body exercise that is performed by the subject.

8. The method according to claim 3, wherein identifying the subject as suffering from the condition comprises identifying the subject as suffering from a condition selected from the group consisting of:

cardiac dysfunction, and congestive heart failure.

9. A method comprising:

identifying a subject as suffering from a condition that causes the subject to have elevated central venous pressure; and

in response thereto, reducing blood pressure within a renal vein of the subject relative to the subject'"'"'s central venous pressure, by placing a valve at least partially within the subject'"'"'s renal vein, the valve being configured, in a passive manner, to reduce venous pressure within the subject'"'"'s renal vein relative to central venous pressure of the subject.

10. The method according to claim 9, wherein placing the valve at least partially within the subject'"'"'s renal vein, comprises placing at least partially within the subject'"'"'s renal vein a valve that includes valve leaflets, such that in an open state of the valve, the valve leaflets allow generally unimpeded antegrade blood flow therethrough.

11. The method according to claim 9, wherein placing the valve at least partially within the subject'"'"'s renal vein comprises reducing compression of the renal vein resulting from intra-abdominal pressure that is exerted on the renal vein, relative to a level of compression of the renal vein resulting from intra-abdominal pressure that is exerted on the renal vein in an absence of the valve.

12. The method according to claim 9, wherein placing the valve at least partially within the renal vein comprises forming a bulged portion within the subject'"'"'s renal vein by placing at least partially within the renal vein a valve that includes:

a narrow portion thereof to which the valve leaflets are coupled, and

a bulging portion that is bulged with respect to the narrow portion, and that is configured to cause the renal vein to form a bulged portion in a vicinity of the valve leaflets.

13. The method according to claim 9, wherein placing the valve at least partially within the renal vein comprises forming a bulged portion within the subject'"'"'s renal vein by placing at least partially within the renal vein a valve that includes:

valve leaflets; and

a frame configured to support the valve leaflets, the frame defining;

a cylindrical portion thereof that defines an outer surface thereof, and

at least one protruding portion thereof, the protruding portion being shaped such as to form the bulged portion by diverging radially from the outer surface of the cylindrical portion, such that a separation between the protruding portion and the outer surface of the cylindrical portion is greater at a downstream end of the protruding portion than at an upstream end of the protruding portion.

14. The method according to claim 13, wherein placing the valve at least partially within the renal vein comprises placing at least partially within the renal vein a valve, the protruding portion of the valve being shaped to be disposed outside of radial projections of downstream edges of the valve leaflets, such that even when the valve leaflets are in open states thereof, the valve leaflets do not contact the protruding portion.

15. The method according to claim 13, wherein placing the valve at least partially within the renal vein comprises placing the valve at least partially within the renal vein, the valve leaflets of the valve being coupled to the frame downstream of the protruding portion, such that an upstream end of each of the valve leaflets is longitudinally spaced from a downstream end of the protruding portion.

16. The method according to claim 13, wherein placing the valve at least partially within the renal vein comprises placing at least partially within the renal vein a valve, the protruding portion of the valve diverging from the outer surface of the cylindrical portion of the valve at an angle of greater than 40 degrees with respect to the outer surface of a downstream portion of the cylindrical portion.

17. The method according to claim 13, wherein placing the valve at least partially within the renal vein comprises placing the valve at least partially within the renal vein such that the valve leaflets are disposed within the bulged portion.

18. The method according to claim 17, wherein placing the valve at least partially within the renal vein such that the valve leaflets are disposed within the bulged portion comprises generating fluid flow dynamics in a vicinity of the leaflets that are such as to reduce stagnation of blood in the vicinity of the leaflets.

19. The method according to claim 17, wherein placing the valve at least partially within the renal vein such that the valve leaflets are disposed within the bulged portion comprises generating fluid flow dynamics in a vicinity of the leaflets that are such as to cause the leaflets to open in response to antegrade blood flow in the vicinity of the leaflets.

20. The method according to claim 9, wherein placing the valve at least partially within the renal vein comprises deforming at least a portion of a junction between the renal vein and a vena cava of the subject, by placing the valve at least partially within the renal vein such that a portion of the valve is disposed in a vicinity of the junction, the portion of the valve being shaped such as to deform the portion of the junction.

21. The method according to claim 20, wherein the valve includes valve leaflets, and wherein placing the valve at least partially within the renal vein comprises placing the valve at least partially within the renal vein such that the valve leaflets are disposed within the cavity at the portion of the junction.

22. The method according to claim 21, wherein placing the valve at least partially within the renal vein such that the valve leaflets are disposed within the cavity at the portion of the junction comprises generating fluid flow dynamics in a vicinity of the leaflets that are such as to cause the leaflets to open in response to antegrade blood flow in the vicinity of the leaflets.

23. The method according to claim 21, wherein placing the valve at least partially within the renal vein such that the valve leaflets are disposed within the cavity at the portion of the junction comprises generating fluid flow dynamics in a vicinity of the leaflets that are such as to reduce stagnation of blood in the vicinity of the leaflets.

24. The method according to claim 20,

wherein the valve includes:

valve leaflets; and

a frame configured to support the valve leaflets, the frame defining;

a cylindrical portion thereof that defines an outer surface thereof, the valve leaflets being coupled to a downstream portion of the cylindrical portion, and

at least one protruding portion thereof, the protruding portion being shaped such as to protrude radially from the outer surface of the cylindrical portion, and

wherein deforming at least the portion of the junction comprises deforming the portion of the junction with the at least one protruding portion.

25. A method for use with renal veins and a vena cava of a subject, the method comprising:

identifying a subject as suffering from a condition that causes the subject to have elevated central venous pressure; and

in response thereto, reducing blood pressure within the subject'"'"'s renal veins relative to the subject'"'"'s central venous pressure, by placing a valve frame at least partially inside the subject'"'"'s vena cava, such that valve leaflets that are coupled to the valve frame are disposed in vicinities of ostia of junctions between the vena cava and the renal veins, and such that the valve leaflets are configured to;

open in response to antegrade blood flow from the renal vein into the vena cava, and

close in response to retrograde blood flow from the vena cava into the renal vein, such that, even when the valve leaflets are closed, blood flow through the vena cava is not occluded by the valve leaflets.

26. The method according to claim 25,

wherein the valve frame includes a central portion and side branches that branch from the central portion, the valve leaflets being coupled to the side branches, and

wherein placing the valve frame at least partially inside the subject'"'"'s vena cava comprises placing the central portion of the valve frame inside the vena cava and placing the side branches of the valve frame at least partially inside respective renal veins.

27. The method according to claim 25, wherein placing the valve frame at least partially inside the subject'"'"'s vena cava comprises placing the valve frame at least partially inside the subject'"'"'s vena cava such that the valve leaflets are disposed inside the vena cava in the vicinities of the ostia of the junctions between the vena cava and the renal veins.

28. The method according to claim 25, wherein placing the valve frame at least partially inside the subject'"'"'s vena cava comprises placing the valve frame at least partially inside the subject'"'"'s vena cava such that the valve leaflets are disposed inside the renal veins in the vicinities of the ostia of the junctions between the vena cava and the renal veins.