THROMBUS REMOVAL DEVICE

• US 20080125798A1
• Filed: 11/07/2007
• Published: 05/29/2008
• Est. Priority Date: 11/08/2006
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Kuppurathanam, Shyam, Osborne, Thomas A.
• Granted Patent: US 8,246,641 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence

Abstract

A thrombus removal device includes a shaft with a distal end and a proximal end, a sheath with a distal end and a proximal end, and a helical coil attached at a proximal end to the distal end of the shaft and is disposed within the lumen of the sheath in a closed configuration. The helical coil includes a plurality of body portions with turns spaced apart longitudinally and laterally to facilitate screwing the helical coil into a thrombus and also providing an open area into which the thrombus can be captured. A distal tip of the helical coil is provided with a loop, an angle of which is about the same as the angle of at least one body portion. The helical coil assumes an open configuration when the sheath is retracted proximally from the distal tip. An aspiration device may be provided in fluid communication with the center of the helical coil.

Claims

1. A device for removing a thrombus from a body cavity, the device comprising:

a shaft including a distal end and a proximal end;

a sheath including a distal end and a proximal end and having a first lumen formed therethrough; and

a helical coil having a closed configuration and an open configuration and including a proximal portion extending to a distal tip, the proximal portion being attached to the distal end of the shaft, the distal tip being shaped as a loop, the helical coil further including a plurality of spaced apart body portions, at least one body portion having an angle relative to a longitudinal axis extending through the helical coil, the angle being substantially the same as an angle at which the loop is oriented relative to the longitudinal axis, the closed configuration of the helical coil having a first outer diameter and the open configuration having a second outer diameter, the first outer diameter being less than the second outer diameter, the helical coil being in the closed configuration when disposed inside the lumen of the sheath and being in the open configuration when disposed outside of the lumen of the sheath.

2. The device of claim 1, wherein the first outer diameter is between about 5% and 50% less than the second outer diameter.

3. The device of claim 2, wherein the first outer diameter is about 33% less than the second outer diameter.

4. The device of claim 1, wherein the angle of the plurality of spaced apart body portions in the open configuration is greater than the angle of the plurality of spaced apart body portions in the closed configuration.

5. The device of claim 1, wherein each of the spaced apart body portions are configured to expand from the closed configuration to the open configuration as the sheath proximally retracts from the distal tip of the helical coil.

6. The device of claim 1, wherein the helical coil further comprises a closed length in the closed configuration and an open length in the open configuration, the closed length being greater then the open length according to a predetermined ratio.

7. The device of claim 6, wherein the closed length is about 50 percent greater than the open length.

8. The device of claim 1 wherein the shaft further comprises a second lumen formed therethrough, the helical coil being attached to the distal end of the shaft such that the longitudinal axis of the helical coil is aligned with the second lumen.

9. The device of claim 8, further including an aspiration device, the aspiration device being attached to the proximal end of the shaft and in fluid communication with the second lumen.

10. The device of claim 1 wherein the shaft is made of shape memory alloy.

12. The device of claim 1 wherein the shaft has a diameter of about 0.014 inch.

13. The device of claim 1 wherein the helical coil is formed of at least one of the following materials:

stainless steel, platinum, Nitinol, MP35N, and palladium.

14. The device of claim 1 wherein the helical coil is formed of wire having a diameter of about 0.004 inch.

15. The device of claim 1 wherein the second outer diameter of the helical coil is at most about 0.018 inch.

16. The device of claim 6 wherein the open length of the helical coil is between about 2 and 10 cm.

17. The device of claim 16 wherein the open length of the helical coil is about 5 cm.

11. The device of claim 11 wherein the shape memory alloy is Nitinol.

18. A method for removing thrombi from a body vessel, the method comprising:

providing a thrombus removal device in the body vessel, the device including

a shaft including a distal end and a proximal end;

a sheath including a distal end and a proximal end and defining a first lumen therethrough;

a helical coil having a closed configuration and an open configuration and including a proximal portion extending to a distal tip, the proximal portion being attached to the distal end of the shaft, the distal tip being shaped as a loop, the helical coil further including a plurality of spaced apart body portions, at least one body portion having an angle relative to a longitudinal axis extending through the helical coil, the angle being substantially the same as an angle at which the loop is oriented relative to the longitudinal axis, the closed configuration of the helical coil having a first outer diameter and the open configuration having a second outer diameter, the first outer diameter being less than the second outer diameter, the helical coil being disposed within the lumen of the sheath in the closed configuration;

retracting the sheath proximally from the distal tip of the helical coil;

expanding the helical coil to the open configuration; and

rotating the shaft to screw the helical coil into a thrombus residing in the body vessel for capture of the thrombus.

19. The method of claim 18, wherein the step of rotating includes aspirating thrombi.

20. The method of claim 19, wherein the thrombi are aspirated into a second lumen formed through the shaft.

21. The method of claim 20, further comprising providing an aspiration device in fluid communication with the second lumen of the shaft;

and retracting the helical coil and the captured thrombus into the sheath.