Devices and Methods for Vascular Recanalization

• US 20150223829A1
• Filed: 04/21/2015
• Published: 08/13/2015
• Est. Priority Date: 02/23/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Medina Medical, Inc. (Medtronic Plc)
• Inventors: Aboytes, Maria
• Granted Patent: US 10,300,256 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 for prostheses A61F2210/0014
• 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 ischemic stroke comprising:

delivering a recanalization device to a neurovascular embolism that at least partially restricts blood flow through a blood vessel, the recanalization device including a tubular member, an elongate member movably disposed within the tubular member, and an expandable member constrained at a distal end to the elongate member and at a proximal end to the tubular member;

actuating the recanalization device so that the expandable member expands radially outward in a controlled manner from a collapsed configuration to an expanded configuration to engage at least a portion of the neurovascular embolism and so as to provide controlled blood flow reperfusion through the embolism and treatment of ischemic stroke, wherein the expandable member defines a plurality of openings in a wall of the expandable member and an interior region in fluid communication with the plurality of openings so that at least a portion of the neurovascular embolism enters through at least one opening and into the interior region as the expandable member engages the neurovascular embolism;

moving the recanalization device and at least a portion of the neurovascular embolism along the blood vessel; and

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

2. The method of claim 1, wherein the expandable member comprises a braid or mesh formed from a shape memory material, and wherein the expandable member has a biased predetermined shape in the expanded configuration.

3. The method of claim 2, wherein actuating the recanalization device in a controlled manner comprises applying a controlled radial force with the mesh or braid of the expandable member to expand through the neurovascular embolism and masticate or disrupt the neurovascular embolism.

4. The method of claim 1, wherein actuating the recanalization device comprises retracting the elongate member proximally relative to the tubular member so as to laterally compress the neurovascular embolism against a wall of the blood vessel along a length of the expandable member.

5. The method of claim 1, wherein actuating the recanalization device comprises axially adjusting a relative position of the tubular member constraining the expandable member at a proximal end or the elongate member constraining the expandable member at a distal end relative to one another so as to laterally compress the neurovascular embolism against a wall of the blood vessel along a length of the expandable member.

6. The method of claim 1, further comprising infusing an oxygenated or superoxygenated blood through a lumen of the elongate member and into the blood vessel distal to the neurovascular embolism.

7. The method of claim 1, further comprising accessing an arterial blood vessel by advancing a microcatheter into the arterial blood vessel and through the embolism and then inserting the recanalization device through a lumen of the delivery catheter and out of a distal end thereof to a position the expandable member adjacent to or within the embolism.

8. The method of claim 1, further comprising actuating the recanalization device to move the expandable member from the expanded configuration to a contoured, tortuous, or helical configuration to disrupt and capture at least a second portion of the neurovascular embolism with the expandable member.

9. The method of claim 8, wherein actuating the recanalization device from the expanded configuration to the contoured, tortuous, or helical configuration comprises rotating the elongate member relative to the tubular member, rotating the tubular member relative to the elongate member, or rotating both the tubular member and the elongate member in opposite directions relative to each other.

10. A method of treating a thrombus in a circulatory blood vessel, the method comprising:

delivering a clot treatment device to a thrombus that at least partially restricts blood flow through a blood vessel, the clot treatment device including a tubular member, an elongate member movably disposed within the tubular member, and an expandable member coupled at a distal end to a distal portion of the elongate member and at a proximal end to a distal portion of the tubular member;

actuating the clot treatment device so that the expandable member expands radially outward in a controlled manner from a collapsed configuration to a first expanded configuration to engage at least a portion of the thrombus so as to restore blood flow through the thrombus;

actuating the clot treatment device so that the expandable member moves from the first expanded configuration to a second expanded configuration after laterally compressing the thrombus against a wall of the blood vessel along a length of the expandable member so as to restore blood flow; and

retrieving and removing at least a portion of the thrombus with the expandable member in the second expanded configuration.

11. The method of claim 10, wherein actuating the clot treatment device from the collapsed configuration to the first expanded configuration comprises axially adjusting a relative position of the tubular member or the elongate member relative to one another so as to laterally compress the thrombus against a wall of the blood vessel along the length of the expandable member.

12. The method of claim 10, wherein actuating the clot treatment device from the first expanded configuration to the second expanded configuration comprises rotating the elongate member relative to the tubular member, rotating the tubular member relative to the elongate member, or rotating both the tubular member and the elongate member in opposite directions relative to each other so that the expandable member is twisted into the second expanded configuration having variable radial dimensions along the length of the expandable member.

13. The method of claim 10, wherein the expandable member comprises a braid or mesh formed from a shape memory material, and wherein the expandable member has a first biased predetermined shape in the first expanded configuration and a second biased predetermined shape in the second expanded configuration.

14. The method of claim 10, wherein the braid or mesh comprises sections including wires or filaments of two or more thicknesses, wherein first sections have relatively thinner wires or filaments having a greater density than second sections having relatively thicker wires or filaments, such that moving the expandable member from the first expanded configuration to the second expanded configuration causes the expandable member to form a contoured, tortuous, or helical shape in the second expanded configuration due to a variation in density between the first and second sections of the braid or mesh.

15. The method of claim 10, wherein the expandable member comprises interstices in a wall of the expandable member and an interior volume in fluid communication with the interstices, and further wherein expanding the expandable member radially outward in a controlled manner from the collapsed configuration to the first expanded configuration captures at least a portion of the thrombus within the interior volume via at least one interstice.

16. The method of claim 10, wherein the expandable member in the second expanded configuration defines a plurality of annular capture regions along an exterior surface of the expandable member, further comprising disrupting at least a portion of the thrombus with the expandable member in the second expanded configuration and capturing at least a portion of the thrombus within at least one annular capture region.

17. A method of treating a neurovascular embolism comprising:

delivering a recanalization device to a neurovascular embolism that at least partially restricts blood flow through a blood vessel, the recanalization device including a tubular member, an elongate member movably disposed within the tubular member, and an expandable member constrained at a distal end to the elongate member and at a proximal end to the tubular member;

deploying the expandable member from a collapsed configuration to a first expanded configuration in a controlled manner to engage at least a portion of the neurovascular embolism and so as to provide controlled blood flow reperfusion through the embolism;

rotating the elongate member along a longitudinal axis of the recanalization device to twist the expandable member from the first expanded configuration to a second expanded configuration, thereby forming a plurality of annular capture regions along an exterior surface of the expandable member;

dislodging at least a portion of the neurovascular embolism with the expandable member in the second expanded configuration;

capturing at least a portion of the thrombus within at least one annular capture region; and

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

18. The method of claim 17, wherein the expandable member in the second expanded configuration includes a first portion having a first outer perimeter, a second portion having a second outer perimeter, and a third portion having a third outer perimeter, wherein the second portion is disposed between the first and third portions, and wherein the second outer perimeter is smaller than both the first outer perimeter and the third outer perimeter such that the expandable member defines the at least one annular capture region between the first portion and the third portion of the expandable member.

19. The method of claim 18, wherein the expandable member of the recanalization device comprises a continuous mesh or braid and the first portion, the second portion, and the third portion are integrally formed of the mesh or braid.

20. The method of claim 17, wherein delivering the recanalization device further comprises positioning openings in a wall of the expandable member and the plurality of annular capture regions of the expandable member within an axial treatment region of the neurovascular embolism.