Atherectomy devices and methods

• US 8,361,094 B2
• Filed: 12/06/2006
• Issued: 01/29/2013
• Est. Priority Date: 06/30/2006
• Status: Expired due to Fees

• Current Assignee: Atheromed, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Atheromed, Inc. (Koninklijke Philips N.V.)
• Inventors: To, John, Danek, Christopher James
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US11/567,715
• Publication Number:
  US 20080004647A1
• Time in Patent Office: 2,246 Days
• Field of Search: 606/158, 606/159, 606/167, 606/170, 606/171, 606/180, 606/198, 128/898, 604/22
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22041 outside the catheter
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/3784 : both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments

Abstract

The devices and methods generally relate to treatment of occluded body lumens. In particular, the present devices and methods relate to removal of the occluding material from the blood vessels as well as other body lumens. In some variations, the methods include providing a vascular device comprising a catheter body, a cutter assembly, a drive mechanism, a torque shaft, a conveyor mechanism, and a deflecting mechanism. The methods may further include operating the drive mechanism to cut occlusive material, operating the deflecting mechanism to deflect the distal end of the catheter body, and rotating the distal end of the catheter body to sweep the cutter assembly.

Claims

1. A method for cutting and removing occlusive material from a body lumen, the method comprising:

providing a vascular device comprising

a catheter body sized and configured for 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,

a cutter assembly having an outside diameter located at the distal end of the catheter body, the cutter assembly comprising a spinning turbine coring cutter including a housing rotatably coupled to the distal end of the catheter body and at least one helical cutting blade inside the housing configured to rotate about the central axis 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 body and coupled to the cutter to rotate the helical cutting blade about the center axis relative to the housing,

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

a deflecting mechanism slideable within the catheter body in response to a force applied at the proximal end of the catheter body for deflecting the distal end of the catheter body 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,

manipulating the proximal end of the catheter body to insert the distal end of the catheter body within the body lumen,

manipulating the proximal end of the catheter body to advance the distal end of the catheter body within the body lumen toward the occlusive material,

operating the drive mechanism to rotate the helical cutting blade about the central axis to cut occlusive material at the distal end of the catheter body, to convey the occlusive material from the body lumen proximally into the housing, and to convey the occlusive material conveyed into the housing by the helical cutting blade further proximally along the catheter body by the conveyor mechanism for discharge without supplement of a vacuum pump,

operating the deflecting mechanism at the proximal end of the catheter body to deflect the distal end of the catheter body 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 cutter body in the body lumen, and

rotating the distal end of the catheter body when the distal end 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 rotating the distal end of the catheter body comprises operating a torque control device separate from the deflecting mechanism to manually or automatically control the sweep of the cutter assembly.

2. A method according to claim 1

wherein manipulating the proximal end of the catheter body to advance the distal end of the catheter body within the body lumen toward the occlusive material includes advancing the distal end of the catheter body within a body lumen having a bifurcation.

3. A method according to claim 1

wherein manipulating the proximal end of the catheter body to advance the distal end of the catheter body within the body lumen toward the occlusive material includes advancing the distal end of the catheter body within a tortuous body lumen.

4. A method according to claim 1

wherein manipulating the proximal end of the catheter body to advance the distal end of the catheter body within the body lumen toward the occlusive material includes advancing the distal end of the catheter body within a body lumen subject to biomechanical stresses.

5. A method according to claim 1

wherein operating the drive mechanism to rotate the helical cutting blade about the central axis to cut and convey the occlusive material from the body lumen includes restoring patency to a lesion in the body lumen.

6. A method according to claim 1

wherein operating the drive mechanism to rotate the helical cutting blade about the central axis to cut and convey the occlusive material from the body lumen comprises debulking a lesion in the body lumen.