Valvulotome

• US 20080255595A1
• Filed: 04/11/2007
• Published: 10/16/2008
• Est. Priority Date: 03/04/2005
• Status: Active Grant

• Current Assignee: Koven Technology Canada, Inc.
• Original Assignee: Koven Technology Canada, Inc.
• Inventors: Koven, Paul, Koven, Joan, Buchbinder, Dale
• Granted Patent: US 8,372,097 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22097 Valve removal in veins

Abstract

A valvulotome device for cutting valves inside a lumen of a vein having a deployable assembly with deployable cutting blades and guide fins which permit continual centralizing, self-alignment of the cutting blades within the lumen of the vein as the valves are being excised is disclosed. The valvulotome device further includes a handle operatively associated with the deployable assembly through a catheter by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position.

Claims

1. A valvulotome device (10) comprising:

a handle (12) having a thumb wheel (30), the thumb wheel (30) being operatively associated with a catheter (18) that encloses a catheter wire (16), and a deployable assembly (14) operatively engaged to the thumb wheel (30) through the catheter (18) and catheter wire (16), the deployable assembly (14) including a blade assembly (24) having a plurality of cutting blades (26) and a guide fin assembly (22) having a plurality of guide fins (27) with a connection tube (36) interposed between the blade assembly (14) and the guide fin assembly (22);

wherein the deployable assembly (14) is deployable from a closed position to one or more deployment positions upon actuation of the catheter (18) by the handle (12) such that the blade assembly (24) and the guide fin assembly (22) incrementally and simultaneously deploy to the one or more deployment positions by deployment of the plurality of cutting blades (26) and plurality of guide fins (27) to a respective outer diameter for each of said one or more deployment positions.

2. The valvulotome device (10) according to claim 1, wherein said respective outer diameter of said guide fins (27) is larger than said respective outer diameter of said cutting blades (26) at each of said one or more deployment positions.

3. The valvulotome device (10) according to claim 1, wherein said guide fins (27) and said cutting blades (26) have no out diameter in said closed position.

4. The valvulotome device (10) according to claim 1, wherein said handle (12) includes a first casing (32) engaged to a second casing (34), said first casing (32) and said second casing (34) collectively defining a chamber (35) in communication with a slot (88) and an opening (115).

5. The valvulotome device (10) according to claim 4, wherein said thumb wheel (30) is rotatable disposed within said slot (88).

6. The valvulotome device (10) according to claim 4, further including a strain relief (40) engaged to said opening (115) of said handle (12), said strain relief (40) having a neck (84) defining an aperture (86) adapted to permit said catheter (18) to be inserted therethrough.

7. The valvulotome device (10) according to claim 1, wherein said catheter (18) defines a proximal end (122) operatively associated with said thumb wheel (30) and a distal end (120) that communicates with a hollow catheter sheath (38), said catheter sheath (38) being engaged to a hollow bullet (20) for collectively containing said deployable assembly (14) in said closed position.

8. The valvulotome device (10) according to claim 7, wherein said hollow catheter sheath (38) becomes disengaged from said hollow bullet (20) when said deployable assembly (14) deploys to said one or more deployment positions.

9. The valvulotome device (10) according to claim 7, wherein said hollow catheter sheath (38) becomes disengaged or engaged to said hollow bullet (20) when said catheter (18) is actuated by said handle (12).

10. The valvulotome device (10) according to claim 8, wherein said hollow catheter sheath (38) becomes engaged to said hollow bullet (20) when said catheter (18) moved away from said handle (12), while the catheter sheath (38) becomes disengaged from said hollow bullet (20) when said catheter (18) is moved toward said handle (12).

11. The valvulotome device (10) according to claim 4, wherein said slot (88) defines a pointed indicator (105) and said thumb wheel (30) includes a visual indicator (39) having a series of numbers (103) corresponding to the outer diameter for a particular deployment position taken by said guide fin assembly (22), wherein said pointed indicator (105) points to one of said series of numbers (103) to indicate said particular deployment position of said deployable assembly (14).

12. The valvulotome device (10) according to claim 1, wherein each of said plurality of guide fins (27) includes a long portion (53) and a short portion (55) with a bendable portion (57) interposed between said long portion (53) and said short portion (55) for permitting each of said plurality of guide fins (27) to expand to said one or more deployment positions.

13. The valvulotome device (10) according to claim 1, wherein each of said plurality of guide fins (27) has the same outer diameter and each of said plurality of cutting blades (26) has the same outer diameter.

14. The valvulotome device (10) according to claim 1, wherein said catheter wire (16) maintains a fixed spatial relationship between said handle (12) and said deployable assembly (14).

15. The valvulotome device (10) according to claim 4, wherein said first casing (32) defining a first track (91A) and said second casing (34) defining a second track (91B), said first casing (32) defining a pair of arcuate tracks (64) wherein said handle (12) further includes a linear rack (58), said linear rack (58) being adapted for linear movement along said track, said linear rack (58) defining a first rack body (59A) having a channel (94A) and a second rack body (59B) having a channel (94B) that collectively define a conduit and an anchor portion (87) adapted to engage said catheter (18), said first rack body (59A) defining a plurality of linear gear teeth (60).

17. The valvulotome device (10) according to claim 15, wherein said catheter (18) includes a flange (69) adapted to be disposed inside said anchor portion (87) of said linear rack, wherein linear movement of said linear rack (58) causes movement of said catheter (18) is either a distal direction (B) or proximal direction (A) such that movement in the distal direction (B) causes the deployable assembly (14) to deploy from said closed position to said one or more sequential deployment positions wherein said thumb wheel (30) includes a wheel gear (43) and a wheel body (45), said wheel body (45) defining a rounded peripheral edge (108) having a plurality of openings (116) in communication with a cavity (73), said wheel gear (43) having a pinion gear portion (82) defining a plurality of pinion gear teeth (83) adapted to engage said linear gear teeth (60) of said linear rack (58), said wheel gear (43) further including an arm portion (68) defining a pair of opposing teeth (70), said opposing teeth (70) being adapted to incrementally engage said pair of arcuate tracks (64) when said thumb wheel (30) is rotated.

20. The valvulotome device (10) according to claim 17, wherein said handle includes raised protrusions, each of said raised protrusions (78) includes a respective marker (101), each respective marker (101) providing a visual indication as to the rotational direction of said thumb wheel (30) wherein rotation of said thumb wheel (30) in one direction causes the linear rack (58) to move said catheter (18) in said proximal direction (A) and rotation of said thumb wheel (30) in an opposite direction causes the liner track (58) to move said catheter (18) in said distal direction (B).

16. (canceled)

18. (canceled)

19. (canceled)

21-22. -22. (canceled)

23. A valvulotome device (10) comprising:

a handle (12) having a thumb wheel (30), the thumb wheel (30) being operatively associated with a catheter wire (16);

a catheter (18) defining a lumen adapted to enclose the catheter wire (16) and in communication with a catheter sheath (38); and

a deployable assembly (14) operatively engaged to the thumb wheel (30) through the catheter (18), the deployable assembly (14) including a blade assembly (24) having a plurality of deployable cutting blades (26) and a guide fin assembly (22) having a plurality of expandable guide fins (27), the deployable assembly (14) further including a hollow bullet (20) operatively engaged to the catheter sheath (38) such that the deployable assembly (14) is fully disposed within the bullet (20) and the catheter sheath (38) when the deployable assembly (14) is in a closed position;

wherein the deployable assembly (14) is deployable to one or more deployment positions from the closed position upon actuation of the catheter (18) by a one-handed operation of the thumb wheel (30) such that the catheter sheath (38) becomes disengaged or engaged relative to the bullet (20) upon the one-handed operation of the thumb wheel (30).

24. The valvulotome device (10) according to claim 23, wherein said guide fin assembly (22) is interposed between said blade assembly (24) and said handle (12).

25. The valvulotome device (10) according to claim 23, wherein the one-handed operation of the thumb wheel (30) causes said catheter (18) to move in a proximal direction (A) or a distal direction (B) such that movement of said catheter in the proximal direction (A) causes said deployable assembly (14) to move from said closed position to one or more deployment positions while movement of said catheter in the distal direction (B) causes said deployable assembly (14) to move from said one or more deployment positions to said closed position.

26. The valvulotome device (10) according to claim 25, wherein the one-handed operation of the thumb wheel (30) in one direction causes the catheter to move in a proximal direction (A) such that said catheter sheath (38) moves away and disengages said bullet (20) while the one-handed operation of the thumb wheel (30) in an opposite direction causes the catheter to move in the distal direction (B) such that the catheter sheath (38) moves towards said bullet (20).

27. A method of excising venous valves comprising:

a) providing a valvulotome device (10) having a handle (12), the handle (12) being operatively associated with a catheter (18) through a thumb wheel (30);

the catheter (18) defining a lumen adapted to enclose a catheter wire (16) and including a catheter sheath (38); and

a deployable assembly (14) operatively engaged to the thumb wheel (30) through the catheter (18), the deployable assembly (14) including a blade assembly (24) having a plurality of deployable cutting blades (26) and a guide fin assembly (22) having a plurality of deployable guide fins (27) with a connection tube (36) interposed between the deployable assembly (14) further including a hollow bullet (20) operatively engaged to the catheter sheath (38) such that the deployable assembly (14) is fully disposed within the bullet (20) and the catheter sheath (38) when the deployable assembly (14) is in a closed position with the bullet (20) engaged to the catheter sheath (38);

wherein the deployable assembly (14) is deployable to one or more deployment positions upon actuation of the catheter (18) by the thumb wheel (30);

b) inserting the deployable assembly (14) within the lumen of a vein and extending the deployable assembly (14) through at least one or more valves of the vein;

c) rotating the thumb wheel (30) in one direction such that the catheter sheath (38) disengages from the bullet (20) and the deployable assembly (14) assumes one of the one or more deployment positions attained by simultaneous deployment of the blade assembly (24) and the guide fin assembly (22) by the deployable assembly (14) from the closed position, each of the one or more deployment positions by the deployable assembly (14) causing the plurality of cutting blades (26) and the plurality of guide fins (27) to attain a respective outer diameter; and

d) withdrawing the deployable assembly (14) back through the lumen of the vein such that guide fin assembly (22) and the cutting blade assembly (24) are in a particular deployment position when the cutting blades (26) excise the valves of the vein.

28. The method according to claim 27, further comprising rotating the thumb wheel (30) in an opposite direction such that the catheter sheath (38) moves toward the bullet (20).

29. The method according to claim 27, wherein said outer diameter of said plurality of guide fins (27) is larger than the outer diameter of said plurality of cutting blades (26) at any of said one or more deployment positions by said deployable assembly (14).

30. The method according to claim 27, wherein withdrawing the deployable assembly (14) back through the lumen of the vein allows for closure of the valve around the connection tube (36) prior to being excised by the cutting blades (26).