Atherectomy devices and methods

• US 8,236,016 B2
• Filed: 04/10/2009
• Issued: 08/07/2012
• Est. Priority Date: 10/22/2007
• Status: Active Grant

• Current Assignee: Atheromed, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Atheromed, Inc. (Koninklijke Philips N.V.)
• Inventors: To, John T, Escudero, Paul, Danek, Christopher James
• Primary Examiner(s): Nguyen, Tuan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US12/384,970
• Publication Number:
  US 20100049225A1
• Time in Patent Office: 1,215 Days
• Field of Search: 606/159, 606/151, 606/127, 606/170, 606/180, 600/141, 600/143, 604/510, 604/528, 604/523
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2017/22048 Balloons
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes

Abstract

The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and method relate to removal of the occluding material from the blood vessels as well as other body lumens.

Claims

1. A tissue debulking device for cutting and removing material from body lumens, the device comprising:

a catheter body sized and configured for axial advancement in the body lumen, the catheter body having a center axis along which axial advancement occurs and including spaced apart proximal and distal ends and a catheter lumen extending therethrough, the distal end being sized and configured for rotation about the center axis from the proximal end of the catheter body;

a cutting assembly having an outside diameter attached at the distal end of the catheter body, the cutter assembly including a housing having at least one opening and a rotatable cutter located within the housing having at least one helical cutting surface configured to rotate about the central axis relative to the housing to cut and convey the occlusive material from the body lumen proximally into the housing;

a drive mechanism at the proximal end of the catheter body;

a torque shaft coupled to the drive mechanism and extending through the catheter lumen and coupled to the cutter to rotate the helical cutting surface about the center axis relative to the housing, a deflecting mechanism slidable within the catheter lumen in response to a force applied at the proximal end of the catheter body for deflecting the cutter assembly relative to the center axis of the catheter body to point the cutter assembly toward a side of the body lumen without necessitating axial advancement of the catheter body in the body lumen, the deflecting mechanism including a sweep frame located adjacent to the cutting assembly, the sweep frame comprising at least a weakened section defined by a serration, opening or slot on a first radial side such that compression of the sweep frame causes deflection towards the first radial side resulting in deflection of the cutter assembly, and a sweep member coupled to a proximal end of the sweep frame and slidable within the catheter lumen in response to a force applied at the proximal end of the catheter body to apply compression to the sweep frame and thereby deflect the sweep frame relative to the center axis in the direction of the radial side, the sweep frame and sweep member having one or more corresponding keys and keyways configured to allow for disengagement of the sweep member from the sweep frame, and

a torque control device separate from the deflecting mechanism to rotate the distal end of the catheter body while the cutter assembly is deflected, to sweep the cutter assembly in an arc about the center axis to cut occlusive material in a region larger than the outside diameter of the cutter assembly, wherein the torque control device manually or automatically controls the sweep of the cutter assembly.

2. The tissue debulking device of according to claim 1, wherein the weakened section on the first radial side comprises a reduced column strength.

3. The tissue debulking device of according to claim 1, wherein the catheter body further comprises a handle coupled to the proximal end, and wherein the torque control device rotates the distal end of the catheter body without rotation of the handle.

4. The tissue debulking device according to claim 1,

wherein the sweep frame comprises a tube structure being elastically deformable to deflect towards the first radial side.

5. The tissue debulking device according to claim 4,

wherein the tube structure comprises at least one semi-circumferential opening.

6. The tissue debulking device according to claim 5,

wherein the sweep frame includes a plurality of tube sections between adjacent openings that interfere when the tube structure deflects to cause the tube structure to become rigid upon deflection.

7. The tissue debulking device according to claim 5,

wherein the sweep frame includes a plurality of ribs in each opening, wherein the ribs connect adjacent sections of the tube structure to provide torsional stability and flexibility to the tube structure.

8. The tissue debulking device according to claim 5,

wherein the semi-circumferential opening is greatest at a side opposite to the first radial side.

9. The tissue debulking device according to claim 5,

wherein the semi-circumferential opening is selected to have a length to limit deflection of the cutting assembly.

10. The tissue debulking device according to claim 1,

wherein the sweep frame is radiopaque.

11. The tissue debulking device of according to claim 1,

wherein the sweep frame comprises at least one visualization mark allowing non-invasive determination of an orientation and direction of deflection of the sweep frame.

12. The tissue debulking device according to claim 1,

wherein the sweep frame comprises a material selected from a polymer, a shape memory alloy, and a metal alloy.

13. The tissue debulking device according to claim 1,

further including a conveyor mechanism helically wound about the torque shaft in a direction common with the helical cutting surface to convey the occlusive material conveyed into the housing by the helical cutting surface further proximally along the catheter body for discharge without supplement of a vacuum pump.