Expandable intravascular occlusion material removal devices and methods of use

• US 5,836,868 A
• Filed: 03/25/1996
• Issued: 11/17/1998
• Est. Priority Date: 11/13/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Kugler, Chad J., Ressemann, Thomas V., Hackett, Steven S., Vrba, Anthony C., Mische, Hans A.
• Primary Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/621,350
• Time in Patent Office: 967 Days
• Field of Search: 606/159, 606/170, 606/171, 606/180, 604/22
• 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 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
• CPC Class Codes: A61B 2017/320004 abrasive

Abstract

An improved expandable removal element (16) for an atherectomy device wherein the expandable removal element (16) is movable between an expanded position and a contracted position. In one embodiment of the present invention, a single drive shaft (92) is operatively connected to the distal end of the expandable material removal element (16) for rotating the removal element (16). A catheter (178) may surround a portion of the drive shaft (92). The catheter (178) is shiftable with respect to the drive shaft (92) for moving the material removal element between the expanded position and the contracted position. In another embodiment of the present invention, dual coaxial drive shafts are employed. The inner drive shaft (312) and the outer drive (314) are shiftable with respect to one another for moving the removal element (252) between the expanded position and the contracted position. The present invention also describes several embodiments for an improved removal element (252). One embodiment of the removal element of the present invention comprised a plurality of braided wires having an abrasive disposed thereon. Another embodiment of a removal element is to provide a plurality of individual wires within each "braid" to increase the abrasive surface area of the removal element. In this "multi-ended" configuration, a plurality of wires are bundled together to form a single multi-ended strand (330). These single multi-ended strands are then braided together and an abrasive is disposed thereon to form the removal element (252). In another embodiment or the present invention is to provide a braid pattern wherein each single primary braid wire within the braid pattern is individually radially wrapped with a second "wrapping" wire (342). The "wrapping" wire (342), which may be coated with an abrasive (344), primarily performs the removal function. Finally, a number of novel methods for removing vascular occlusion material are provided.

Claims

1. A vascular occlusion material removal device for removing vascular occlusion material in a vascular lumen, the removal device comprising:

an expandable removal element having a distal end and a proximal end insertable intravascularly into a patient;

the expandable removal element being more highly stressed when expanded and less stressed when not expanded;

a drive shaft extending to the proximal end of the removal element;

the shaft being fixedly attached to the proximal end of the removal element and conjointly rotatable therewith; and

an inner shaft disposed through the removal element and connected to the distal end of the expandable material removal element;

the inner shaft being shiftable within the material removal element and the drive shaft;

the material removal element being expandable responsive to shifting of the inner shaft with respect to the removal element and the drive shaft.

2. A vascular occlusion material removal device according to claim 1 wherein the expandable removal element further comprises a plurality of strands which are braided together to form the removal element and wherein each one of the plurality of strands comprises at least one wire.

3. An intravascular device as defined in claim 2 wherein at least one of the wires used in the plurality of strands are coated with an abrasive material.

4. An intravascular device as defined in claim 2 wherein the plurality of strands are each wrapped circumferentially with at least one wrapping wire.

5. An intravascular device as defined in claim 4 wherein said at least one wrapping wire is made of stainless steel.

6. An intravascular device as defined in claim 4 wherein an abrasive is deposited on said at least one wrapping wire.

7. An intravascular device as defined in claim 6 wherein said abrasive comprises at least one of a diamond grit and a synthetic abrasive disposed onto the wrapping wires.

8. A intravascular device as defined in claim 2 further comprising a distal tip located at the distal end of said removal element wherein an abrasive is deposited on the distal tip to create a cutting surface distally of the removal element for removing vascular occlusion material.

9. A intravascular device as defined in claim 2 wherein at least one of the wires used in the plurality of strands are made from a radiopaque material.

10. A vascular occlusion material removal device according to claim 1 wherein the inner shaft is fixedly attached to the distal end of the removal element and conjointly rotatable therewith.

11. A vascular occlusion material removal device according to claim 10 wherein said outer drive shaft includes an inner and an outer coaxial oppositely wound helices wherein the inner helix is wound in the opposite direction of the outer shafts rotation direction and the outer helix is wound in the direction of the outer shafts rotation.

12. A vascular occlusion material removal device according to claim 11 further comprising a ribbon operatively connected to the inner helix of the inner shaft.

13. A vascular occlusion material removal device according to claim 11 wherein the outer drive shaft includes an inner and an outer coaxial oppositely wound helices wherein the outer helix is wound in the opposite direction of the outer drive shafts rotation direction and the inner helix is wound in the direction of the outer drive shafts rotation.

14. A vascular occlusion material removal device according to claim 13, wherein at least one helix is prestressed.

15. A vascular occlusion material removal device according to claim 13 further comprising a ribbon helix wrapped around the inner helix of the outer drive shaft.

16. A vascular occlusion material removal device according to claim 15 further comprising a removable guide wire passable through the inner shaft and extendable distally of the removal element.