Devices and methods for vascular recanalization

• US 9,931,495 B2
• Filed: 03/23/2015
• Issued: 04/03/2018
• Est. Priority Date: 02/23/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Aboytes, Maria
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US14/666,054
• Publication Number:
  US 20150196744A1
• Time in Patent Office: 1,107 Days
• Field of Search: 606191, 606194, 606200, 604104
• 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 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

In some embodiments, a medical device for recanalizing a vessel having a blockage and restoring blood flow through an obstructed blood vessel includes an expandable member coupled to a core wire and a hypotube that are movable relative to each other to manipulate the expandable member between various configurations. The expandable member having a capture structure in an expanded configuration. The expandable member can include multiple interstices formed by woven mesh filaments or braided strands through which the material blocking the vessel can pass. The capture structure can include a shape on its external surface that facilitates dislodgement and capture of the material within capture spaces created by the expandable member. Some embodiments include a capture sack or cap for capturing material and preventing material from migrating down stream of the blockage. Superoxygenated blood can be infused distal to the blockage to minimize loss of function during an ischemic event.

Claims

1. A method of treating an embolism comprising:

delivering an embolectomy device to an embolism that at least, partially restricts blood flow through a blood vessel, wherein the embolectomy device comprises an expandable member having a first expandable portion, a second expandable portion, and a third expandable portion, each of the first expandable portion, the second expandable portion, and the third expandable portion comprising a mesh, the meshes of the first expandable portion and the third expandable portion having a first mesh density, the mesh of the second expandable portion having a second mesh density, the second mesh density being less than the first mesh density when the first expandable portion, the second expandable portion, and the third expandable portion are expanded to the same extent, wherein at least a portion of the expandable member is configured to expand outwardly to engage at least a portion of the embolism or blood vessel wall;

deploying the embolectomy device within the embolism so as to restore blood flow through the embolism and, form a flow channel through the embolism while the expandable member of the embolectomy device is expanded, wherein the embolectomy device in a deployed configuration comprises first and third portions expanded to a greater extent than the second portion, the second expandable portion being disposed between the first and third expandable portions, and wherein the first and third expandable portions project radially outward beyond the second portion;

moving the embolectomy device and at east a portion of the embolism along the blood vessel; and

withdrawing the embolectomy device and at least a portion of the embolism from the blood vessel.

2. The method of claim 1, further comprising accessing the blood vessel of a patient, wherein delivering comprises inserting a delivery catheter containing the embolectomy device into the blood vessel to a clot of the embolism and positioning the delivery catheter through the clot.

3. The method of claim 2, further comprising deploying the embolectomy device from the delivery catheter, wherein at least a portion of the expandable member is positioned and expanded beyond the clot of the embolism.

4. The method of claim 3, wherein the expandable member is self-expanding when unconstrained from the delivery catheter within the blood vessel.

5. The method of claim 1, further comprising cutting into a material of the embolism with the embolectomy device.

6. The method of claim 1, wherein the expandable member defines at least one capture region on an external surface of the expandable member in the deployed configuration, the at least one capture region defined in part by the first and third portions which are expanded to a greater extent than the second portion in the deployed configuration.

7. The method of claim 6, further comprising disrupting and receiving at least a portion of the embolism with the at least one capture region.

8. The method of claim 6, wherein the expandable member defines a plurality of annular capture regions configured to disrupt and receive at least a portion of the embolus.

9. The method of claim 1, wherein the first expandable portion has a first outer perimeter, the second expandable portion has a second perimeter, and the third expandable portion has a third outer perimeter, wherein in the deployed configuration the second outer perimeter is smaller than the first and third outer perimeters such that the expandable member defines at least one capture region between the first and third outer perimeters.

10. The method of claim 9, further comprising disrupting and receiving at least a portion of the embolism with the at least one capture region.

11. The method of claim 1, wherein deploying the expandable member generates an outwardly expanding radial force such that the expandable member can expand through a material of the embolism and displace or masticate the material in the blood vessel.

12. The method of claim 1, wherein deploying the embolectomy device within the embolism comprises expanding the embolectomy device so that the expandable member is biased to a predetermined shape.

13. The method of claim 1, wherein the expandable member comprises woven or braided filaments or strands of metal or polymer that form a mesh configuration.

14. The method of claim 13, wherein the embolectomy device comprises a continuous mesh and the first expandable portion, the second expandable portion, and the third expandable portion are integrally formed of the mesh, wherein in the deployed configuration the mesh is expanded to a greater extent at the first and third portions than at the second portion.

15. A method of treating an embolism comprising:

accessing a vessel of a patient;

delivering a clot treatment device to a clot of an embolism that at least partially restricts blood flow through a blood vessel with a delivery catheter, wherein the clot treatment device comprises an expandable member having a first portion with a first outer perimeter, a second portion with a second outer perimeter, and a third portion with a third outer perimeter, each of the first portion, the second portion, and the third portion comprising a mesh, the meshes of the first portion and the third portion having a first mesh density, the mesh of the second portion having a second mesh density, the second mesh density being less than the first mesh density when the first portion, the second portion, and the third portion are expanded to the same extent, wherein the second portion is disposed between the first and third portions, and wherein at least a portion of the expandable member is configured to expand outwardly to engage at least a portion of the embolism or blood vessel wall;

positioning the clot treatment device within the embolism;

radially expanding the expandable member against the clot so as to restore blood flow through the clot in the blood vessel while the expandable member of the clot treatment device is expanded, wherein the clot treatment device in a deployed configuration comprises first and third portions expanded to a greater extent than the second portion, and wherein the second outer perimeter is smaller than the first and third outer perimeters such that the expandable member defines at least one capture region between the first and third outer perimeters;

disrupting at least a portion of the clot with the at least one capture region of expandable member;

retrieving at least a portion of the clot with the at least one capture region of the expandable member; and

withdrawing the clot treatment device and at least a portion of the clot from the blood vessel.

16. The method of claim 15, wherein the expandable member is self-expanding when unconstrained from the delivery catheter within the blood vessel.

17. The method of claim 15, wherein the expandable member defines a plurality of annular capture regions on an external surface of the expandable member in the deployed configuration to disrupt and retrieve at least the portion of the clot.