Intralumenal material removal using an expandable cutting device

• US 6,565,588 B1
• Filed: 11/28/2000
• Issued: 05/20/2003
• Est. Priority Date: 04/05/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Pathway Medical Technologies, Inc. (Bayer AG)
• Inventors: Lawson, Craig E., Wulfman, Edward I., Clement, Thomas J.
• Primary Examiner(s): Dawson, Glenn K.
• Assistant Examiner(s): Mendoza, Michael G.
• Application Number:
  US09/724,914
• Time in Patent Office: 903 Days
• Field of Search: 606/1, 606/108, 606/159, 606/170, 606/171, 606/180, 604/22
• US Class Current: 606/180
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002

Abstract

Intralumenal material removal systems are provided using an advanceable, rotatable and expandable cutter assembly. The intralumenal material removal system includes a cutter assembly positionable in the lumen of a mammalian subject and operably connected to system controls. The cutter assembly comprises a distal cutting head and an adjustable cutting assembly that is axially advanceable by translating the drive shaft and rotatable by rotating the drive shaft. The adjustable cutting assembly is adjustable between a smaller diameter condition and a larger diameter condition. The cutter may thus be introduced to and withdrawn from the material removal site in a retracted, smaller diameter condition that facilitates translation and navigation of the device through various lumens. The adjustable cutting assembly may be selectively expanded at the material removal site to facilitate cutting, removal and aspiration of the occlusive material.

Claims

1. An intralumenal material removal system comprising:

a drive shaft that is rotatable and translatable;

a drive system operably coupled to the drive shaft in proximity to its proximal end for rotating the drive shaft at rotational speeds in excess of 500 rpm;

a hollow sheath having a diameter larger than a drive shaft diameter and forming a lumen between an inner surface of the sheath and an outer surface of the drive shaft; and

a cutter assembly mounted at a distal end of the drive shaft, the cutter assembly comprising a plurality of material removal ports in communication with the lumen, a distal fixed diameter cutter having a plurality of cutting blades, and a proximal, expandable diameter cutter.

2. The system of claim 1, wherein the drive system operably coupled to the drive shaft in proximity to its proximal end is selectively bi-directional and is capable of selectively rotating the drive shaft in opposite directions.

3. The system of claim 1, wherein the proximal cutter has a first diameter when rotated in a first direction and a second diameter, larger than the first diameter, when rotated in a second direction opposite the first direction.

4. The system of claim 1, wherein the drive shaft is flexible and hollow, and comprises a first longitudinal section having a predominantly left-lay helical configuration, and a second longitudinal section adjoining the first section and having a predominantly right-lay helical configuration.

5. The system of claim 1, additionally comprising an advancer system for axially displacing the drive shaft and cutter assembly.

6. The system of claim 1, additionally comprising a flexible guidewire.

7. The system of claim 1, additionally comprising a magnetic coupler for operably coupling the drive system to the drive shaft.

8. The system of claim 1, additionally comprising a retainer assembly associated with the drive shaft and hollow sheath.

9. The system of claim 1, additionally comprising a retainer assembly associated with the drive shaft and hollow sheath located an operable distance from the cutter assembly.

22. An intraluminal material removal system according to claim 2, additionally comprising material removal ports in communication with the lumen and in proximity to the cutting blades.

10. An intralumenal material removal system comprising:

a drive shaft that is rotatable and translatable;

a drive system operably coupled to the drive shaft in proximity to its proximal end for rotating the drive shaft at rotational speeds in excess of 500 rpm; and

a cutter assembly mounted at a distal end of the drive shaft, the cutter assembly comprising a plurality of cutting blades and a plurality of ports in communication with the lumen, wherein the drive shaft is flexible and hollow and comprises adjoining sections along a longitudinal axis having differently oriented helical configurations, at least one section having a predominantly left-lay helical configuration and at least one section having a predominantly right-lay helical configuration.

11. The system of claim 10, wherein the drive shaft comprises adjoining sections of left-lay and right-lay helical configurations of substantially equivalent length.

12. An intralumenal material removal system comprising:

a drive shaft that is rotatable and translatable;

a selectively bi-directional drive system operably coupled to the drive shaft in proximity to its proximal end for rotating the drive shaft at rotational speeds in excess of 500 rpm; and

an expandable cutter assembly mounted at a distal end of the drive shaft, the expandable cutter assembly comprising a plurality of cutting blades, wherein the expandable cutter assembly has a first diameter when rotated in a first direction and a second diameter, larger than the first diameter, when rotated in a second direction opposite the first direction.

13. The system of claim 12, wherein the material removal system additionally comprises a plurality of material removal ports in communication with the lumen.

14. The system of claim 12, wherein the material removal system comprises a plurality of cutter blades that are configured to operate using the principle of differential cutting.

15. The system of claim 12, wherein the material removal system comprises a plurality of cutting blades pivotable on axes parallel to a central longitudinal axis of the cutter assembly.

16. The system of claim 12, additionally comprising a hollow sheath having a diameter larger than a drive shaft diameter and forming a lumen between an inner surface of the sheath and an outer surface of the drive shaft, and an aspiration source in communication with the lumen.

17. The system of claim 12, additionally comprising an advancer system for axially displacing the drive shaft and cutter assembly.

18. The system of claim 12, additionally comprising a flexible guidewire.

19. The system of claim 12, additionally comprising a magnetic coupler for operably coupling the drive system to the drive shaft.

20. A method for removing material from the interior of a lumen using a material removal system having a fixed diameter material removal device and an adjustable diameter material removal device, comprising:

rotating the material removal system in a first direction while advancing it through material to be removed in a first pass in which the fixed diameter material removal device is the primary material remover, translating the material removal system in an antegrade direction for a subsequent pass, and rotating the material removal system in a second direction, opposite the first direction, while advancing it through the material to be removed in a subsequent pass in which the adjustable diameter material removal device is in an expanded condition and is the primary material remover.

21. An intralumenal material removal system comprising:

a drive shaft that is rotatable and translatable;

a drive system operably coupled to the drive shaft in proximity to its proximal end for rotating the drive shaft at rotational speeds in excess of 500;

a hollow sheath having a diameter larger than a drive shaft diameter and forming a lumen between an inner surface of the sheath and an outer surface of the drive shaft; and

a cutter assembly mounted at a distal end of the drive shaft, the cutter assembly comprising a plurality of cutting blades pivotable on axes parallel to a central longitudinal axis of the cutter assembly.

23. An intraluminal material removal system according to claim 21, wherein the drive system is selectively bi-directional.

24. An intraluminal material removal system according to claim 21, wherein the cutting blades have beveled edges.

25. An intraluminal material removal system according to claim 21, wherein the cutting blades operate according to the principle of differential cutting.

26. The system of claim 21, comprising eight or fewer cutting blades.

27. The system of claim 21, wherein the cutter assembly is adjustable to different diameters by positioning the pivotable cutting blades in a first smaller diameter condition and a second larger diameter condition, and additionally comprises raised spines having a stop face to contact and to support the pivotable cutting blades when in the first diameter condition.

28. The system of claim 27, wherein the raised spines additionally include a support face to contact the blades when in the second diameter condition.