SYSTEMS AND METHODS FOR REMOVAL OF BLOOD AND THROMBOTIC MATERIAL

• US 20150327875A1
• Filed: 05/18/2015
• Published: 11/19/2015
• Est. Priority Date: 05/19/2014
• Status: Active Grant

• Current Assignee: Walk Vascular, LLC
• Original Assignee: Walk Vascular, LLC
• Inventors: Look, David M., Mallaby, Mark
• Granted Patent: US 9,883,877 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 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00212 using remote controls
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 1/72 Cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/743 by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/81 Piston pumps, e.g. syringes
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2209/10 Equipment for cleaning
• CPC Class Codes: A61M 5/14216 : Reciprocating piston type
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons

Abstract

A system for aspirating thrombus includes a catheter having a supply lumen having a distal end and an aspiration lumen configured to couple to a vacuum source and having an interior wall surface and an open distal end, an orifice at or near the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen, the orifice located proximally of the open distal end of the aspiration lumen, wherein the orifice is configured to create a spray pattern that impinges on the interior wall surface of the aspiration lumen when a distal end of the aspiration catheter is immersed within an aqueous environment, and a disposable tubing set having a first conduit configured to couple the supply lumen of the aspiration catheter to a fluid source, and a pump component associated with the first conduit and configured to detachably couple to a drive unit.

Claims

1. A system for aspirating thrombus comprising:

an aspiration catheter having a supply lumen and an aspiration lumen, the supply lumen having a wall and a closed distal end, the aspiration lumen configured to couple to a vacuum source and having an interior wall surface, and an open distal end;

an orifice in the wall of the supply lumen, in fluid communication with the interior of the aspiration lumen, the orifice located proximally of the open distal end of the aspiration lumen and adjacent the closed distal end of the supply lumen, wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen such that the spray pattern impinges on the interior wall surface of the aspiration lumen when a distal end of the aspiration catheter is immersed within an aqueous environment; and

a tubing set having a first conduit configured to couple to the supply lumen of the aspiration catheter to a fluid source, and a pump component associated with the first conduit and configured to detachably couple to a drive unit, such that motion from the drive unit is transferred to the pump component such that resultant motion of the pump component causes fluid from the fluid source to be injected through the supply lumen of the aspiration catheter, and through the orifice into the aspiration lumen.

2. The system of claim 1, wherein the aqueous environment has a temperature of between about 36°

C. and 38°

C.

3. The system of claim 1, wherein the pump component comprises a piston.

4. The system of claim 3, wherein the piston is slidably contained within a supply cylinder and an injection cylinder, the piston configured to actuate into the supply cylinder while actuating out of the injection cylinder, thus causing the injection cylinder to increase its volume of fluid supplied from the fluid source, and wherein the piston is further configured to actuate into the injection cylinder while actuating out of the supply cylinder, thus causing the injection cylinder to decrease its volume by injecting fluid supplied from the fluid source into the supply lumen of the aspiration catheter.

5. The system of claim 4, wherein the piston includes an inner bore having a one-way valve.

6. The system of claim 1, wherein the spray pattern is defined by an angle of between about 1°

to about 45°

in each direction of the vertical midline of the aspiration lumen.

7. The system of claim 6, wherein the spray pattern is defined by an angle of between about 20°

to about 35°

in each direction of the vertical midline of the aspiration lumen.

8. The system of claim 1, wherein a usable volume ratio R_U between the supply cylinder and the injection cylinder is between about 1.15 and about 2.00.

9. The system of claim 8, wherein the usable volume ratio R_U between the supply cylinder and the injection cylinder is between about 1.25 and about 1.85.

10. The system of claim 1, wherein the open distal end of the aspiration lumen has a most distal portion and a most proximal portion, and wherein an axial center of the orifice is about 0.3302 mm to about 0.4826 mm proximal to the most proximal portion of the open distal end of the aspiration lumen.

11. The system of claim 1, further comprising a vacuum-activated interface configured to cause the drive unit to start to operate or to remain in an operating condition when a vacuum pressure at the vacuum-activated interface is less than a threshold value, and configured to cause the drive unit to stop or to remain in a non-operating condition when the vacuum pressure at the vacuum-activated interface is greater than the threshold value.

12. The system of claim 11, wherein the vacuum-activated interface comprises a vacuum switch valve.

13. The system of claim 11, wherein the vacuum-activated interface comprises a pressure transducer.

14. The system of claim 1, wherein the open distal end of the aspiration lumen is angled in relation to the longitudinal axis of the aspiration lumen.

15. A system for aspirating thrombus comprising:

an aspiration catheter having a supply lumen and an aspiration lumen, the supply lumen having a distal end, the aspiration lumen configured to couple to a vacuum source and having an interior wall surface, and an open distal end;

an orifice at or near the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen, the orifice located proximally of the open distal end of the aspiration lumen, wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen such that the spray pattern impinges on the interior wall surface of the aspiration lumen when a distal end of the aspiration catheter is immersed within an aqueous environment; and

a tubing set having a first conduit configured to couple the supply lumen of the aspiration catheter to a fluid source, and a pump component associated with the first conduit and configured to detachably couple to a drive unit, such that motion from the drive unit is transferred to the pump component such that resultant motion of the pump component causes fluid from the fluid source to be injected through the supply lumen of the aspiration catheter, and through the orifice into the aspiration lumen.

16. The system of claim 15, wherein the supply lumen of the aspiration catheter extends generally parallel to the aspiration lumen, and wherein the distal end of the supply lumen curves towards the interior wall surface of the aspiration lumen.

17. The system of claim 16, wherein the distal end of the supply lumen has an internal diameter that is less than about 0.203 mm.

18. The system of claim 17, wherein the distal end of the supply lumen has an internal diameter that is between about 0.076 mm and about 0.102 mm.

19. The system of claim 16, wherein the open distal end of the aspiration lumen has a most distal portion and a most proximal portion, and wherein an axial center of the orifice is about 0.3302 mm to about 0.4826 mm proximal to the most proximal portion of the open distal end of the aspiration lumen.

20. The system of claim 16, wherein the aqueous environment has a temperature of between about 36°

C. and 38°

C.

21. A method for delivery of a drug comprising:

providing a catheter comprising;

a supply lumen and an aspiration lumen, the supply lumen having a distal end, the aspiration lumen configured to couple to a vacuum source and having an interior wall surface, and an open distal end;

an orifice at or near the distal end of the supply lumen, in fluid communication with the interior of the aspiration lumen, the orifice located proximally of the open distal end of the aspiration lumen, wherein the orifice is configured to create a spray pattern when pressurized fluid is pumped through the supply lumen such that the spray pattern impinges on the interior wall surface of the aspiration lumen when a distal end of the aspiration catheter is immersed within an aqueous environment;

providing a tubing set having a first conduit configured to couple the supply lumen of the catheter to a fluid source, and a pump component associated with the first conduit and configured to detachably couple to a drive unit, such that motion from the drive unit is transferred to the pump component such that resultant motion of the pump component causes fluid from the fluid source to be injected through the supply lumen of the catheter, and through the orifice into the aspiration lumen;

coupling the supply lumen of the catheter to a fluid source, wherein the fluid source contains at least a first drug for intravascular delivery;

inserting the catheter within a blood vessel of a patient and advancing the catheter to a target site;

coupling the pump component to a drive unit; and

operating the drive unit to cause the pump component to inject at least some of the first drug in the region of the target site.