Prosthetic venous valves

• US 6,315,793 B1
• Filed: 09/08/1999
• Issued: 11/13/2001
• Est. Priority Date: 09/08/1999
• Status: Expired due to Term

• Current Assignee: Valve Special Purpose Co. LLC (Cryolife Incorporated)
• Original Assignee: On-X Life Technologies, Inc. (Cryolife Incorporated)
• Inventors: Stupka, Jonathan C., More, Robert B., Bokros, Jack C.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): BARRETT, THOMAS C
• Application Number:
  US09/392,234
• Time in Patent Office: 797 Days
• Field of Search: 623/1.24, 623/1.16, 623/2.26, 623/2.35, 623/2.34, 137/541, 137/329.03, 251/82
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2/2475 Venous valves

Abstract

A prosthetic venous valve having a two-piece housing which includes upstream and downstream sections. The upstream section contains a circular seat against which an occluder comes in sealing contact when the valve is in its closed position. The downstream housing section is shaped so as to prevent escape of the occluder downstream and to halt the reciprocating motion of the occluder in the open position where there is an open pathway past the occluder. A plurality of fins on the interior of the downstream housing section or on the surface of the occluder assure there is a blood flow path downstream past the occluder in the open position. The two-piece construction allows the housing sections to be axially spaced apart so that blood comes in contact with the interior surface of the patient'"'"'s vein immediately downstream of the upstream section of the housing. Such arrangement is biologically advantageous and permits momentary deflections of either of the housing sections from its normal coaxial orientation without harm to the valve or disruption of its functioning.

Claims

1. A prosthetic venous valve which comprises

a generally tubular housing including an upstream section made of rigid material and a separate downstream section,

said upstream section comprising a rigid tubular body which provides a flow path for blood having an open entrance passageway and enclosing a first central region,

said downstream section comprising a rigid tubular body which provides a flow path for blood having an open discharge passageway and enclosing a second central region,

a separate occluder proportioned to move between said central regions,

said upstream section being formed with a seat in its interior surface in said first central region for sealing contact with said occluder to prevent blood flow upstream therepast and through said entrance region,

said occluder reciprocating between an open position adjacent said second central region and a closed position in contact with said seat in said first central region, and

said second central region of said downstream section having an inner surface formed to prevent the escape of said occluder downstream therethrough, said occluder and said inner surface being shaped so that when said occluder is in said open position a path remains open to said discharge passageway,

whereby this separate construction allows said upstream and downstream sections to be operatively implanted in a patient spaced apart from each other.

2. The venous valve according to claim 1 wherein each of said upstream and downstream sections carries, on the exterior surface thereof, means for positioning said sections at a desired spaced-apart location within a patient'"'"'s vein whereby said sections and said occluder can be separately inserted through a longitudinally extending slit in a patient'"'"'s vein and said separate sections individually secured in operable orientation in the desired location.

3. The venous valve according to claim 1 wherein said inner surface of said downstream section contains at least one detent extending generally radially inward from the remainder of said inner surface which prevents said occluder from moving therepast.

4. The venous valve according to claim 3 wherein said occluder is spheroidal in shape.

5. The venous valve according to claim 3 wherein said occluder is elongated in the direction of the axis along which said occluder reciprocates.

6. The venous valve according to claim 1 wherein said occluder is elongated in the axial direction along which it reciprocates and carries a plurality of radially outwardly extending fins which, in the open position, locate said occluder centrally with respect to said second central region by engagement with said rigid tubular downstream housing section in the open position and assure an open blood flow path downstream through said valve.

7. The venous valve according to claim 1 wherein a surrounding retainer is connected to exterior surfaces of said upstream and downstream sections and maintains said sections in desired spaced apart relation to each other with said occluder located therebetween.

8. The venous valve according to claim 7 wherein said occluder is a spheroid and wherein said upstream and downstream sections are spaced apart a distance equal to between about 40% and about 80% of the diameter of said spheroid.

9. The venous valve according to claim 7 wherein said surrounding retainer is a wire cage constructed of radioopaque wire material having sufficient stiffness to resist inadvertent bending and maintain said desired spacing in vivo within a patient.

10. The venous valve according to claim 7 wherein said surrounding retainer includes flexible barbs which in operative position extend diagonally outward from exterior surfaces of said upstream and downstream sections, but which can be resiliently positioned adjacent said exterior surfaces for installation.

11. The venous valve according to claim 10 wherein a plurality of said barbs are associated with said upstream section and extend diagonally in a downstream direction and wherein said barbs are associated with said downstream section and extend diagonally in an upstream direction.

12. A prosthetic venous valve which comprises

a generally tubular housing including an upstream section made of rigid material and a separate downstream section,

said upstream section having an open entrance passageway and a central region,

said downstream section having a central region which is designed to face said central region of said upstream section and having an open discharge region of reduced diameter,

a separate occluder proportioned to move back and forth between said central regions between an open position and a closed position when said valve is implanted within the vein of a patient,

said upstream section being formed with a seat in its interior surface in said first central region surrounding said open entrance passageway for sealing contact with said occluder in said closed position to prevent blood flow upstream therepast,

said discharge region of reduced diameter being of such size so as to prevent the downstream escape of said occluder therethrough, and

said occluder being shaped so that, when it resides in said open position, a downstream blood flow path remains leading to and through said open discharge passageway, whereby said upstream and downstream housing sections can be separately implanted in a patient, spaced from each other in coaxial alignment, so they are capable of slight movement out of coaxial alignment independent of each other.

13. The venous valve according to claim 12 wherein said occluder is elongated and generally circular in cross-section, having an axial length at least about twice its diameter.

14. The venous valve according to claim 13 wherein said upstream end of said occluder is a portion of a spheroidal surface and said downstream end is formed with at least two equally spaced-apart fins.

15. The venous valve according to claim 14 wherein said upstream section and said occluder are designed for implantation within the vein of a patient and wherein said downstream housing section is designed as a collar for attachment exterior of the vein of the patient at a location appropriately downstream from said central region of said upstream housing section.

16. The venous valve according to claim 15 wherein said fins are of relatively uniform thickness except near their downstream ends where enlarged pads are provided for contact over an extended surface with the inner surface of the vein adjacent the upstream end of said collar-shaped housing section.

17. The venous valve according to claim 14 wherein said fins are obliquely oriented and thereby impart an axial rotation to said occluder when it reciprocates between said open position and said closed position.

18. A prosthetic venous valve which comprises

a two-piece generally tubular housing including an upstream section made of rigid material proportioned for implantation within a patient'"'"'s vein and a separate downstream collar section proportioned for implantation exterior of the patient'"'"'s vein,

said upstream section having an open entrance passageway and a first central region,

said downstream section having an open discharge passageway and a second central region, and

a separate occluder proportioned to move between said central regions,

said upstream section being formed with an interior surface having a seat in said first central region for sealing contact with said occluder to prevent blood flow upstream therepast and through said entrance passageway,

said occluder being designed to reciprocate between an open position in association with said second central region and a closed position in contact with said seat in said first central region, and

said second central region of said downstream section having an inner surface formed to prevent the escape of said occluder downstream therepast, and

said occluder and said inner surface being shaped so that when said occluder is in said open position a pathway remains open to said discharge passageway,

whereby this two-piece construction allows said upstream and downstream sections to be separately operatively implanted in a patient.

19. The venous valve according to claim 18 wherein said occluder has a plurality of obliquely oriented fins which causes it to rotate about an axis as it reciprocates between said open and closed positions.