Method of removing a thrombus from a large vein

• US 10,695,159 B2
• Filed: 12/24/2019
• Issued: 06/30/2020
• Est. Priority Date: 03/25/2004
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: David L. Hauser
• Inventors: Hauser, David L.
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US16/726,651
• Publication Number:
  US 20200129282A1
• Time in Patent Office: 189 Days
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• 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 17/225 for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
• 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 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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 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 2230/006 Y-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A method of capturing and removing a thrombus from a large vein is performed using a percutaneous thrombectomy device. The thrombectomy device includes a delivery sheath, a filter body, and an inner catheter provided with an agitation member. The sheath is advanced until a distal end is positioned proximal to the thrombus. The filter body is deployed distal to the sheath and proximal to the thrombus. The filter body preferably has a funnel shape with a tapered proximal end portion and an open distal end. The inner catheter is advanced through the sheath for contacting the thrombus with the agitation member. The agitation member is actuated to disrupt the thrombus. Thrombus particles are captured using the filter body and negative pressure is preferably applied through the sheath. The method is well-suited for treating deep vein thrombosis and does not require the use of thrombolytic drugs.

Claims

1. A method of capturing and removing a thrombus from a large vein in a patient, comprising:

identifying a large vein having an occlusive thrombus;

selecting a thrombectomy device adapted for percutaneous advancement through the vein, the thrombectomy device comprising a delivery sheath, a self-expanding filter body, and an inner catheter, wherein an agitation member is disposed along a distal end portion of the inner catheter;

inserting the sheath through a peripheral access site and into the vein;

advancing the sheath until a distal end of the sheath is positioned proximal to the thrombus;

deploying the filter body at a location distal to the sheath and proximal to the thrombus, the filter body having a tapered proximal end portion and an open distal end, the filter body having an interior volume shaped to funnel particles toward a center of the filter body, the filter body made from a nickel-titanium alloy and having an exterior surface shaped to conform to an inner wall of the vein;

longitudinally advancing the inner catheter through the sheath and through the filter body such that the agitation member is positioned distal to the filter body;

contacting the thrombus with the agitation member;

moving the agitation member to agitate and disrupt the thrombus;

capturing resulting thrombus particles with the filter body;

applying negative pressure through a central lumen of the sheath for aspirating remaining particles; and

withdrawing the thrombectomy device from the patient and restoring blood flow through the vein.

2. The method of claim 1, wherein the thrombus is captured and removed for treating deep vein thrombosis.

3. The method of claim 1, wherein the large vein is a femoral vein.

4. The method of claim 1, wherein the large vein is an inferior vena cava.

5. The method of claim 1, wherein the filter body is deployed within the vein on an upstream side of the thrombus.

6. The method of claim 1, wherein the filter body comprises a permeable mesh structure for allowing blood to pass therethrough.

7. The method of claim 1, wherein a diameter of the agitation member is controllable.

8. The method of claim 1, wherein the filter body is coupled to a distal end portion of an outer catheter, the outer catheter being sized for slidable advancement through the sheath.

9. The method of claim 1, further comprising delivering a thrombolytic drug to the thrombus to enhance dissolution of the thrombus.

10. A method of capturing and removing a thrombus for treating deep vein thrombosis, comprising:

selecting a thrombectomy device sized for percutaneous advancement through a large vein, the thrombectomy device comprising an elongate tubular delivery sheath, a self-expanding filter body formed with a permeable mesh structure, and an inner catheter having an agitation member disposed along a distal end portion thereof;

inserting the sheath through a peripheral access site and into the vein;

advancing the sheath until a distal end of the sheath is positioned proximal to a thrombus;

deploying the self-expanding filter body at a location between the sheath and the thrombus, the filter body having a tapered proximal end portion and an open distal end when in an expanded configuration, the filter body forming an interior volume shaped to funnel particles toward a center of the filter body, the filter body having an exterior surface shaped to contact an inner wall of the vein;

longitudinally advancing the inner catheter and agitation member through the sheath and through the filter body;

contacting the thrombus with the agitation member;

moving the agitation member to agitate and disrupt the thrombus;

capturing thrombus particles with the filter body;

applying negative pressure through a central lumen of the sheath; and

removing the thrombectomy device and restoring blood flow through the vein.

11. The method of claim 10, wherein the thrombus is mechanically captured and removed without using thrombolytic drugs.

12. The method of claim 11, wherein the large vein is a femoral vein.

13. The method of claim 11, wherein the large vein is an inferior vena cava.

14. The method of claim 10, wherein the filter body is made from a nickel-titanium alloy.

15. The method of claim 10, wherein a diameter of the agitation member is controllable.

16. The method of claim 10, wherein a distal end portion of an outer catheter is coupled to the filter body and wherein the outer catheter is advanced distally through the sheath for deploying the filter body.

17. The method of claim 16, wherein the filter body self-expands from a constrained configuration to the expanded configuration during deployment.

18. A method of mechanically capturing and removing a thrombus for treating deep vein thrombosis without using thrombolytic drugs, comprising:

selecting a thrombectomy device adapted for percutaneous advancement through a large vein, the thrombectomy device comprising a sheath, an outer catheter, a self-expanding filter body, and an inner catheter having an agitation member disposed along a distal end portion thereof;

inserting the sheath through a peripheral access site and through the vein until a distal end of the sheath is positioned proximal to a thrombus;

advancing the outer catheter in a distal direction for allowing the self-expanding filter body to self-expand from a constrained configuration to an expanded configuration, the filter body having a tapered proximal end portion and an open distal end when in the expanded configuration, the filter body comprising a permeable mesh structure made from a nickel-titanium alloy, the filter body having an exterior surface shaped to contact an inner wall of the vein;

advancing the inner catheter through the sheath and through the filter body for contacting the thrombus with the agitation member;

actuating the agitation member to disrupt the thrombus;

capturing resulting thrombus particles with the filter body; and

withdrawing the thrombectomy device from the patient and restoring blood flow through the vein.

19. The method of claim 18, wherein negative pressure is applied through a central lumen of the sheath.

20. The method of claim 19, wherein the large vein is a femoral vein or a jugular vein.