Venous valve cutter

• US 5,601,580 A
• Filed: 01/09/1995
• Issued: 02/11/1997
• Est. Priority Date: 04/09/1992
• Status: Expired due to Term

• Current Assignee: URESIL, LLC
• Original Assignee: Uresil Corporation
• Inventors: Goldberg, Mark C., Poloyko, Alexander
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): RASCHE, PATRICK WILLIAM
• Application Number:
  US08/313,229
• Time in Patent Office: 764 Days
• Field of Search: 606/159, 606/167, 606/170, 606/179, 606/194, 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. Fiber optics provided for viewing the valves as they are penetrated by the sharp cutting edges.

Claims

1. A method of in-situ removal of venous valve leaflets from a saphenous vein having a proximal end and a distal end and a lumen tapering from its distal end to its proximal end comprising:

a) introducing at the proximal end of the vein a valve cutter assembly with a blunt-tipped head and an irrigation channel at its distal tip;

b) introducing fluid through the distal tip of the blunt-tipped head to dilate the vein and, with the vein distended, advancing the valve cutter assembly distally;

c) removing the blunt-tipped head when the assembly reaches the sapheno-femoral junction or an adequate distal tributary of the saphenous vein and replacing it with an appropriately sized valve cutter head also having an irrigation channel at its distal tip and clamping the saphenous vein at its open fossa ovalis or distal to the distal saphenous valve;

d) positioning the valve cutter head at the distal end of the vein, injecting fluid through the channel in the cutter head thereby closing the valve;

e) pulling back on the valve cutter assembly to engage and cut the most distal valve and then maintaining hydrostatic pressure while the valve cutter assembly is pulled down to engage and cut each sequential valve until all valves have been rendered incompetent; and

f) repeating steps d) and e) with a plurality of appropriately sized valve cutter heads to match the heads to the vein'"'"'s tapering lumen.

2. 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; and

fiber optic means directed distally and positioned proximally to the circular cutting edge for viewing the cutting of the venous valve leaflets as the cutting edge of the valve cutter advances through the vessel and assessing the cut.

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;

a leader having a diameter generally equal to that of said cutter head and a stem connecting said cutter head and said leader; and

fiber optic means mounted in the leader proximal to the circular cutting edge for viewing the cutting of the venous valve leaflets by the cutting edge as the valve cutter advances through the vein and assessing the cut.

4. 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; and

fiber optic means mounted in the leader proximal to the circular cutting edge for viewing the cutting of the venous valve leaflets by the cutting edge as the valve cutter advances through the vein and assessing the cut.

5. A method of in-situ removal of venous valve leaflets from a vein having an inner wall comprising:

a) introducing at the proximal end of the vein a valve cutter with a cutter head having a proximal end, a distal tip, and 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 fiber optic means directed distally and positioned proximally to the circular cutting edge;

b) advancing the cutter head up through the vein from the proximal end to the distal end;

c) reversing the direction of movement of the valve cutter;

d) engaging the leaflets with the cutter head while viewing the cutting of the venous valve leaflets by the cutting edge as the valve cutter advances through the vessel and assessing the cut; and

e) rendering successive valves incompetent.