Systems and methods for clot disruption and retrieval

• US 6,454,775 B1
• Filed: 12/06/1999
• Issued: 09/24/2002
• Est. Priority Date: 12/06/1999
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Bacchus Vascular Incorporated (Medtronic Plc)
• Inventors: Demarais, Denise, Leeflang, Stephen A., Evans, Michael A., Eversull, Christian S.
• Primary Examiner(s): O'Connor, Cary E.
• Application Number:
  US09/454,517
• Time in Patent Office: 1,023 Days
• Field of Search: 606/159, 606/113, 606/114, 606/127, 606/128, 606/115
• US Class Current: 606/128
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Thrombectomy and other treatments are achieved using a catheter having a positioning cage and a macerator within the positioning cage. The catheter is introduced to a target body lumen, typically a blood vessel, and a positioning cage deployed at a treatment site. The macerator is then operated to disrupt thrombus, clot, or other occlusive materials at the treatment site, and the catheter is used to collect and remove the disruptive materials from the body lumen. In particular examples, the macerator may be radially expansible and optionally rotated and/or axially translated within the positioning cage to effect disruption of the occlusive material.

Claims

1. A macerator comprising:

a tubular shaft having a proximal end, a distal end, and at least one lumen therethrough;

a wire having a distal section terminating in a distal tip and proximal shank;

wherein the distal tip of the wire is attached to an exterior location near the distal end of the tubular shaft and wherein the proximal shank is slidably received in the lumen of the shaft so that the distal section of the wire can be radially expanded and contracted by axially translating the shank within the shaft.

2. A macerator as in claim 1, wherein the tubular shaft includes only a single lumen which extends the entire length of the shaft and wherein the wire passes into the lumen through a port in a side of the shaft.

3. A macerator as in claim 2, wherein the lumen has an internal diameter of at least 0.25 mm to accommodate both the wire and a guidewire.

4. A macerator as in claim 3, wherein the wire has a maximum diameter in the range from 0.05 mm to 1.3 mm.

5. A macerator as in claim 1, wherein the tubular shaft has at least two lumens, wherein the wire is received in a proximal portion of one lumen and the other lumen is configured to receive a guidewire.

6. A macerator as in claim 5, wherein the lumen which receives the wire terminates proximally of the distal end of the tubular shaft and wherein the lumen which receives the guidewire extends to the distal end of the shaft.

7. A macerator as in claim 6, wherein the lumen which receives the guidewire extends the entire length of the shaft.

8. A macerator as in claim 1, further comprising a helical rotor disposed over at least a portion of the tubular shaft, wherein said rotor is configured to act as a mechanical pump when the macerator is rotated about its axis.

9. A macerator comprising:

a tubular shaft assembly including;

(a) an outer tube having a proximal end, a distal end, and a lumen therethrough; and

(b) an inner tube having a proximal end, a distal end, and a lumen therethrough, wherein the outer tube is slidably and/or rotatably received over the inner tube;

a wire capture coil having one end attached to the proximal end of the inner tube and another end attached to the proximal end of the outer tube, wherein the coil can be radially expanded and collapsed by rotating and/or axially translating the inner tube relative to the outer tube; and

a helical rotor disposed over at least a portion of the tubular shaft, wherein said rotor is configured to act as a mechanical pump when the macerator is rotated about its axis.

10. A method for removing occlusive material from a body lumen, said method comprising:

positioning a macerator so that it is spaced inwardly from the occlusive material over a surrounding wall of the body lumen;

rotating and adjusting a width of the macerator to draw in and disrupt the occlusive material without significant shearing; and

withdrawing the disrupted material from the body lumen.

11. A method as in claim 10, further comprising adjusting a width of the macerator.

12. A method as in claim 10, wherein the macerator is a shaped wire.

13. A method as in claim 12, wherein the width is adjusted by relative rotation of a pair of spaced-apart points on the wire.

14. A method as in claim 12, wherein the width is adjusted by relative axial adjustment of a pair of spaced-apart points on the wire.

15. A method as in claim 10, wherein positioning comprises expanding a positioning cage with the body lumen, wherein the macerator is located within the positioning cage.

16. A method as in claim 15, further comprising axially translating the rotating macerator within the positioning cage.

17. A method as in claim 15, wherein the macerator is rotated without axial movement.

18. A kit comprising:

a catheter having a rotatable macerator near a distal end thereof; and

instructions for use setting forth a method comprising;

positioning the macerator within a body lumen so that the macerator is spaced inwardly from occlusive material covering a luminal wall;

rotating and adjusting the width of the macerator to draw in and disrupt the occlusive material without significant shearing; and

withdrawing the disrupted material from the body lumen.