Expandable intravascular occlusion material removal devices and methods of use

• US 5,792,157 A
• Filed: 09/30/1996
• Issued: 08/11/1998
• 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: Ressemann, Thomas V., Mische, Hans A., Hoium, Scott A.
• Primary Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/723,552
• Time in Patent Office: 680 Days
• Field of Search: 606/1, 606/159, 606/170, 606/171, 606/180, 606/191.2, 604/22, 604/104, 604/105
• 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 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61B 2017/320012 Brushes
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A novel intravascular occlusion material removal device for removing vascular occlusion material in a vascular lumen comprises a prime mover and an expandable material removal element insertable intravascularly into the vascular lumen. A hollow drive shaft operatively connects the prime mover to the expandable material removal element for rotating the expandable material removal element intravascularly. A guidewire is insertable through the distal end of the expandable material removal element and the hollow drive shaft, and is shiftable within the drive shaft and the expandable material removal element. The expandable material removal element is expandable responsive to shifting of the guidewire. A material removal element movement control mechanism is operatively connected to the guidewire for positively incrementally shifting the guidewire, and a guidewire lock mechanism is operatively connected between the guidewire and the material removal element movement control mechanism for fixing the guidewire with respect to the material removal element movement control mechanism. A number of novel methods for removing vascular occlusion material are also provided. One such method comprises the steps of: providing a vascular occlusion material removal device having an expandable occlusion material removal element, the material removal element comprising a braid having a hollow interior; providing a guidewire; intravascularly navigating the guidewire to the occlusion material; inserting the guidewire into the hollow interior; intravascularly navigating the braid to the occlusion material over the guidewire; shifting the guidewire with respect to the braid to expand the braid; expanding the braid such that the braid bites into occlusion material thereby allowing occlusion material to pass into the hollow interior; and shifting the guidewire with respect to the braid to contract the braid and to capture occlusion material within the hollow interior. The expanded braid can also be rotated intravascularly to remove occlusion material.

Claims

1. A method for removing vascular occlusion material from a vascular lumen comprising the steps of:

providing a vascular occlusion material removal device having an expandable occlusion material removal element, the material removal element comprising a braid having a hollow interior;

providing a guide wire with a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

intravascularly navigating the guide wire to the occlusion material;

intravascularly navigating the braid to the occlusion material over the guide wire;

shifting the guide wire with respect to the braid to expand the braid;

expanding the braid such that the braid bites into occlusion material, thereby allowing occlusion material to pass into the hollow interior; and

shifting the guide wire with respect to the braid to contract the braid and to capture occlusion material within the hollow interior.

2. A method for removing vascular occlusion material as defined in claim 1, further comprising the step of:

withdrawing the braid from the patient to remove occlusion material captured in the hollow interior from the patient.

3. A method for removing vascular occlusion material as defined in claim 1, further comprising the step of:

rotating the braid intravascularly to remove vascular occlusion material.

4. A method for removing vascular occlusion material as defined in claim 1, further comprising the steps of:

providing a means on the removal device for positively limiting expansion of the braid; and

positively limiting expansion of the braid intravascularly by use of the means.

5. A method for removing vascular occlusion material as defined in claim 1, further comprising the steps of:

providing a catheter sheath having a distal end on the removal device insertable intravascularly into the patient, such that the distal end of the catheter sheath is located proximally of the braid;

applying a negative pressure to the catheter sheath; and

aspirating removed vascular occlusion material through the catheter sheath by means of the negative pressure.

6. A method for removing vascular occlusion material as defined in claim 5, further comprising the steps of:

applying a fluid to the catheter sheath; and

infusing the fluid into the patient through the catheter sheath.

7. A method for removing vascular occlusion material from a vascular lumen comprising the steps of:

providing a vascular occlusion material removal device having an expandable and flexible occlusion material removal element;

providing a guide wire with a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

intravascularly navigating the guide wire to the occlusion material;

inserting the guide wire into the removal element;

intravascularly navigating the removal element to the occlusion material over the guide wire;

shifting the guide wire with respect to the removal element to expand the removal element intravascularly;

energizing the removal element intravascularly to remove vascular occlusion material;

applying a fluid to the removal device; and

irrigating the vascular lumen with the fluid.

8. A method according to claim 7, wherein the material removal device includes a hollow drive shaft insertable intravascularly and operatively connected to the removal element for energizing the removal element, and further comprising the steps of:

applying a fluid to the hollow drive shaft; and

irrigating the vascular lumen with the fluid.

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

a prime mover;

an expandable material removal element insertable intravascularly into the vascular lumen, the expandable material removal element comprising a plurality of braided wires;

a hollow drive shaft operatively connecting the prime mover to the expandable material element for rotating the expandable material removal element intravascularly;

a guide wire insertable through the expandable material removal element and the hollow drive shaft;

the guide wire having a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

the guide wire being shiftable within the drive shaft and the expandable material removal element;

the expandable material removal element being expandable responsive to shifting of the guide wire;

a material removal element movement control mechanism operatively connected to the guide wire for positively shifting the guide wire; and

a guide wire lock mechanism operatively connected between the guide wire and the material removal element movement control mechanism for fixing the guide wire with respect to the material removal element movement control mechanism.

10. A vascular occlusion material removal device as defined in claim 9, further comprising at least one of 8 and 16 braided wires.

11. A vascular occlusion material removal device as defined in claim 9, wherein the wires are made of a super-elastic alloy.

12. A vascular occlusion material removal device as defined in claim 9, further comprising an abrasive disposed on the wires.

13. A vascular occlusion material removal device as defined in claim 12, wherein the abrasive comprises a diamond grit electroplated onto the wires.

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

a prime mover;

an expandable material removal element insertable intravascularly into the vascular lumen;

a hollow drive shaft operatively connecting the prime mover to the expandable material removal element for rotating the expandable material removal element intravascularly, the drive shaft comprising a cylindrical portion having a hollow interior and a coiled portion;

an aperture in the cylindrical portion for allowing fluid to flow into the hollow interior of the cylindrical portion;

a guide wire insertable through the expandable material removal element in the hollow drive shaft;

the guide wire having a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

the guide wire being shiftable within the drive shaft and the expandable material removal element;

the expandable material removal element being expandable responsive to shifting of the guide wire;

a material removal element movement control mechanism operatively connected to the guide wire for positively shifting the guide wire; and

a guide wire lock mechanism operatively connected between the guide wire and the material removal element movement control mechanism for fixing the guide wire with respect to the material removal element movement control mechanism.

15. A vascular occlusion material removal device as defined in claim 14, wherein the cylindrical portion has a proximal end;

further comprising a fluid seal located at the proximal end of the cylindrical portion for limiting fluid flow proximally of the proximal end of the cylindrical portion.

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

a prime mover;

an expandable material removal element insertable intravascularly into the vascular lumen;

a hollow drive shaft operatively connecting the prime mover to the expandable material removal element for rotating the expandable material removal element intravascularly, the hollow drive shaft comprising a coil;

a guide wire insertable through the expandable material removal element and the hollow drive shaft;

the guide wire having a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

the guide wire being shiftable within the drive shaft and the expandable material removal element;

the expandable material removal element being expandable responsive to shifting of the guide wire;

a material removal element movement control mechanism operatively connected to the guide wire for positively shifting the guide wire; and

a guide wire lock mechanism operatively connected between the guide wire and the material removal element movement control mechanism for fixing the guide wire with respect to the material removal element movement control mechanism.

17. A vascular occlusion material removal device as defined in claim 16, wherein the drive shaft further comprises a lubricous sheath overlying the coil.

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

a prime mover;

an expandable material removal element insertable intravascularly into the vascular lumen;

a hollow drive shaft operatively connecting the prime mover to the expandable material removal element for rotating the expandable material removal element intravascularly;

a guide wire insertable through the expandable material removal element in the hollow drive shaft;

the guide wire having a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

the guide wire being shiftable within the drive shaft and the expandable material removal element;

the expandable material removal element being expandable responsive to shifting of the guide wire;

a material removal element movement control mechanism operatively connected to the guide wire for positively shifting the guide wire;

a guide wire lock mechanism operatively connected between the guide wire and the material removal element movement control mechanism for fixing the guide wire with respect to the material removal element movement control mechanism; and

a dilating member on the device for performing at least one of centering the device intravascularly, stabilizing the device intravascularly, occluding flow through a vascular lumen, and angioplastically displacing occlusion material.

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

an expandable material removal element insertable intravascularly into a patient;

a guide wire insertable through the expandable material removal element;

the guide wire having a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

the guide wire being shiftable within the material removal element;

the material removal element being expandable responsive to shifting of the guide wire;

the removal element comprising a plurality of braided wires; and

an abrasive disposed on the wires for removing vascular occlusion material.

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

an expandable material removal element insertable intravascularly into a patient;

a guide wire insertable through the expandable material removal element;

the guide wire having a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

the guide wire being shiftable within the material removal element;

the material removal element being expandable responsive to shifting of the guide wire;

the removal element comprising a plurality of braided wires; and

the wires being made from a super-elastic alloy.

21. A vascular occlusion material removal device as defined in claim 20, wherein the super-elastic alloy is nitinol.

22. A method for removing vascular occlusion material from a vascular lumen comprising the steps of:

providing a vascular occlusion material removal device having an expandable occlusion material removal element, wherein the removal element comprises a plurality of braided wires, further comprising an abrasive disposed on the wires;

providing a guide wire having a bearing surface located distally thereon which operatively engages an end of the material removal element to cause longitudinal contraction thereof when the guide wire is longitudinally shifted with respect to the material removal element;

intravascularly positioning the guide wire distally of the occlusion material;

inserting the guide wire into the removal element;

intravascularly positioning the removal element over the guide wire distally of the occlusion material;

shifting the guide wire with respect to the removal element to expand the element intravascularly; and

moving the removal element proximally within the vascular lumen to remove occlusion material.

23. A method according to claim 22, further comprising the step of:

rotating the removal element intravascularly.

24. An over-the-wire vascular occlusion material removal device for removing vascular occlusion material from a vascular lumen, the removal device comprising:

a flexible vascular occlusion material removal element insertable intravascularly into the vascular lumen for removing vascular occlusion material, the removal element comprising a plurality of shape memory alloy braided wires;

a configuration defined by the removal element;

the removal element having a memory of the configuration;

the removal element being deformable; and

wherein the memory is sufficient to allow the removal element to return towards the configuration.

25. A vascular occlusion material removal device as defined in claim 24, wherein the shape memory alloy is nitinol.