Venous valve cutter for in situ incision of venous valve leaflets

• US 5,304,189 A
• Filed: 04/09/1992
• Issued: 04/19/1994
• Est. Priority Date: 04/09/1992
• Status: Expired due to Term

• Current Assignee: URESIL, LLC
• Original Assignee: Lafeber Co.
• Inventors: Goldberg, Mark, Goldberg, Edward M., Melinyshyn, Lev, Poloyko, Alexander
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US07/865,850
• Time in Patent Office: 740 Days
• Field of Search: 606/159, 606/170, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 2017/22097 Valve removal in veins

Abstract

An improved valve cutter for in-situ incision of valve leaflets which safely, efficiently, and consistently renders venous valves incompetent while minimizing frictional forces on the endothelium of the vessel and preventing inadvertent contact between cutting surfaces and the intima of the vein wall. The valve cutter includes a plurality of proximally directed prongs presenting sharp edges, where the prongs are separated by slots similarly presenting sharp edges to pierce the valve leaflets so that the cutting head is provided with a continuous cutting surface in multiple planes running along the entire forward edge of the cutting head.

Claims

1. In a venous valve cutter for rendering venous valve leaflets incompetent having a cutter head with a forward circular cutting edge disposed in the direction of the intended movement of the cutter through the vein to render the valve leaflets incompetent, the improvement comprising:

a plurality of proximally directed prongs in the circular cutting edge presenting sharp edges, said prongs having flat leading edges and being separated by slots similarly presenting sharp edges, said cutting head having a continuous cutting surface in multiple planes running along the entire forward edge of the cutting head.

2. The valve cutter of claim 1 in which said slots are halfoval in shape.

3. An improved venous valve cutter comprising:

a cutter head having a forward circular cutting edge and means for advancing said cutter head through a vein to render valve leaflets incompetent;

said circular cutting edge having a plurality of proximally directed prongs presenting sharp leading edges, said prongs having flat leading edges and being separated by slots similarly presenting sharp cutting edges.

4. The valve cutter of claim 3 in which said slots are halfoval in shape.

5. The improved venous valve cutter of claim 3 in which said advancing means comprises a catheter.

6. The improved venous valve cutter of claim 5 in which said cutter head includes a bore at its distal tip communicating with the lumen of said catheter.

7. The improved venous valve cutter of claim 5 in which said catheter is a tightly wound coil spring covered with an inextensible sheath.

8. The improved venous valve cutter of claim 7 when said sheath is made of a highly slippery thromboresistant material.

9. The improved venous valve cutter of claim 3 in which said cutter head is made of stainless steel.

10. The improved venous valve cutter of claim 3 in which the distal end of said cutter is in the shape of a truncated cone.

11. The improved venous valve cutter of claim 3 including a leader having a diameter generally equal to that of said cutter head and a stem connecting said cutter head and said leader.

12. The improved venous valve cutter of claim 11 in which said stem is rigid.

13. The improved venous valve cutter of claim 11 in which said stem is a rigid coil spring providing additional irrigation sites through spacings in the spring coils.

14. The improved venous valve cutter of claim 3 in which the surface of said cutter head flows smoothly into a cylindrical section which is undercut along its circumference to form a second cylindrical section of slightly lesser diameter.

15. The improved venous valve cutter of claim 3 having four proximally directed prongs separated by four slots.

16. The improved venous valve cutter of claim 3 in which the inside edges of said prongs are beveled.

17. The improved venous valve cutter of claim 3 in which the leading edges of said prongs are flattened and beveled.

18. The improved venous valve cutter of claim 3 including ports in the proximal area of said cutting head to flush and lubricate said cutting edges of said cutting head.

19. The improved venous valve cutter of claim 3 including channels in the cylindrical portion of said cutter head to permit fluid flow when the cutter head encounters a tightly fitting portion of the vessel.

20. The venous valve cutter of claim 3 including a plurality of differently sized cutter heads and means for attaching the desired one of the differently sized cutter heads to the advancing means.

21. A method of in-situ removal of venous valve leaflets from a vein comprising:

a) introducing at the proximal end of the vein a valve cutter with a plurality of proximally directed prongs with sharp edges in which the prongs are separated by slots also having sharp edges, with means for advancing the cutter head through a vein to render valve leaflets incompetent, and with an irrigation channel in the distal tip of the cutter head;

b) introducing fluid through the bore in the distal tip of the cutting head while advancing the cutter head up through the vein;

c) passing a fiber optic bundle through the irrigation channel so that the cutting of the valves may be viewed as the valve cutter is advanced down the vein;

d) reversing the direction of movement of the valve cutter to advance the cutting head through the vein while maintaining fluid pressure to close the valve leaflets ahead of the cutting head;

e) engaging the leaflets with the cutter head near the vein wall to form a small penetrating incision which is gently widened by the cutting surfaces of the valve cutter slots until the valve is rendered incompetent and debris is captured in the cuter head; and

f) rendering successive valves incompetent.

22. An improved venous valve cutter comprising:

a cutter head having a forward circular cutting edge and associated therewith catheter means for advancing said cutter head through a vein to render valve leaflets incompetent;

said circular cutting edge having a plurality of proximally directed prongs presenting sharp leading edges, said prongs being separated by slots similarly presenting sharp cutting edges; and

a leader having a diameter generally equal to that of said cutter head and a rigid coil spring interconnecting the cutter head and leader and providing additional irrigation sites through spacings in the spring coils.

23. The improved venous valve cutter of claim 22 in which said catheter is a tightly wound coil spring covered with an inextensible sheath.

24. The improved venous valve cutter of claim 23 where said sheath is made of a highly slippery thromboresistant material.