MEDICAL CLOT TREATMENT DEVICE WITH DISTAL FILTER

• US 20110082493A1
• Filed: 12/13/2010
• Published: 04/07/2011
• Est. Priority Date: 09/30/1997
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Samson, Gene, Carrison, Harold F.
• Granted Patent: US 8,486,104 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22045 fixed to the catheter; guiding tip
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical

Abstract

This is a surgical device usually delivered through an intravascular catheter. It may be used in several ways. It may, for instance, be used to open a clear passageway adjacent thrombus to allow both blood and medication to bypass the clot. It may be used to pierce and to remove thrombus. These thrombus are often found in tortuous vasculature. The device includes several sections. The device has a core element, typically a core wire. Placed around the distal end of the core element is a collapsible but preferably self expanding proximal cage assembly and a distal filter, preferably a self-expanding cage assembly or other filter component. The various portions of those components are preferably radio-opaque. The proximal end of the proximal cage is typically is affixed to an actuator in such a way as to allow expansion of the cage after deployment. The proximal cage assembly may be used for collecting emboli or for displacing them to allow blood flow to resume, either with or without concurrent clot-dissolving drug treatment. The distal sector, whether a self-expanding cage or fan, is placed distally of the thrombus to collect portions of the thrombus which may loosen during the treatment or removal procedure.

Claims

1. (canceled)

2. An embolism treatment device, comprising:

an elongated core wire having a proximal section, a distal section, and a distal coil tip;

a proximal cage assembly rotatably disposed on the distal section of the elongated core wire;

a distal cage assembly rotatably disposed on the distal section of the elongated core wire distal the proximal cage assembly;

a separation member disposed between the proximal cage assembly and the distal cage assembly; and

an actuator element located proximal of the proximal cage assembly, the actuator element axially movable along the elongated core wire such that when the actuator element is in a first position, the proximal and distal cage assemblies are each in a collapsed configuration, and when the actuator element is in a second position, the proximal and distal cage assemblies are each in an expanded configuration;

wherein the proximal cage assembly and the distal cage assembly are each self-collapsing.

3. The embolism treatment device of claim 2, wherein the proximal cage assembly has a substantially open interior in the expanded configuration.

4. The embolism treatment device of claim 2, wherein the distal cage assembly has a substantially open interior in the expanded configuration.

5. The embolism treatment device of claim 2, wherein the distal cage assembly includes a tubular liner.

6. The embolism treatment device of claim 5, wherein the tubular liner moves independently of the actuator element.

7. The embolism treatment device of claim 5, wherein a distal-most end of the distal cage assembly is fixed to the tubular liner.

8. The embolism treatment device of claim 2, wherein the elongated core wire includes a braid member disposed on and adhered to the elongated core wire.

9. The embolism treatment device of claim 2, wherein at least one of the proximal cage assembly and the distal cage assembly comprises a woven braid of wires that are each tightly wrapped with radiopaque wire.

10. A method of treating an embolism, the method comprising:

obtaining an embolism treatment device comprising;

an elongated core wire;

a proximal cage assembly rotatably disposed on the elongated core wire;

a distal cage assembly rotatably disposed on the elongated core wire distal the proximal cage assembly;

a separation member disposed between the proximal cage assembly and the distal cage assembly; and

an actuator element located proximal of the proximal cage assembly, the actuator element axially movable along the elongated core wire such that when the actuator element is in a first position, the proximal and distal cage assemblies are each in a collapsed configuration, and when the actuator element is in a second position, the proximal and distal cage assemblies are each in an expanded configuration;

inserting the embolism treatment device in the collapsed configuration into a blood vessel containing a clot having a proximal end and a distal end;

positioning the embolism treatment device within the vessel such that the distal cage assembly is disposed distal the clot distal end and the proximal cage assembly overlaps the clot proximal end and the clot distal end;

expanding the proximal cage assembly and the distal cage assembly such that the proximal cage assembly displaces at least a portion of the clot and blood flows through a lumen of the proximal cage assembly;

capturing fragments of the clot that break loose when the clot is displaced by the proximal cage assembly with the distal cage assembly; and

removing the fragments captured by the distal cage assembly from the blood vessel.

11. The method of claim 10, wherein the step of removing the fragments captured by the distal cage assembly further comprises introducing thrombolytics into the blood vessel to dissolve the fragments while the embolic treatment device prevents downstream movement of the clot.

12. The method of claim 10, wherein the step of removing the fragments captured by the distal cage assembly further comprises:

collapsing the proximal cage assembly and the distal cage assembly; and

removing the embolism treatment device and the captured fragments from the blood vessel.

13. The method of claim 10, wherein the elongated core wire includes a braid member disposed on and adhered to the elongated core wire.

14. The method of claim 10, wherein at least one of the proximal cage assembly and the distal cage assembly comprises a woven braid of wires that are each tightly wrapped with radiopaque wire.

15. The method of claim 10, wherein the proximal cage assembly and the distal cage assembly are each self-collapsing.