Infusion catheter and methods of use

Patent metadata

Field	Value
Publication number	US-12097345-B2
Application number	US-202017031511-A
Country	US
Kind code	B2
Filing date	Sep 24, 2020
Priority date	Jun 1, 2018
Publication date	Sep 24, 2024
Grant date	Sep 24, 2024

Abstract

Venous infusion catheter assemblies and methods of use are described herein. A catheter assembly may comprise an elongated body having a proximal end and a distal end, with an expandable occlusion element disposed on the elongated catheter body. A catheter may include a first infusion lumen extending to a proximal infusion port positioned on the catheter body proximally of the occlusion element and a second infusion lumen extending to a distal infusion port. Some embodiments may use a suction lumen extending to at least one suction port. When the catheter is introduced into vasculature of a patient, the suction port may be positioned in the patient's superior vena cava or right atrium to draw blood, the distal infusion port is positioned to direct normothermic or hyperthermic fluid toward the patient's heart, and the proximal infusion port is positioned to create a flow of hypothermic fluid in the patient's cerebral vasculature.

First claim

We claim:

1. A venous infusion catheter assembly comprising:
an elongated catheter body having a proximal end and a distal end;
a hemicylindrical occluder disposed on the elongated catheter body for fluid delivery;
at least one infusion lumen, wherein:
the at least one infusion lumen extends from the proximal end of the catheter body to a proximal infusion port positioned on the catheter body proximally of the hemicylindrical occluder,
the at least one infusion lumen extends from the proximal end of the catheter body to a distal infusion port positioned on the catheter body distally of the hemicylindrical occluder, and
the fluid delivery is through the proximal infusion port or through the distal infusion port based on an orientation of the hemicylindrical occluder;

a suction lumen extending from the proximal end of the catheter body to at least one suction port positioned on the catheter body; and
wherein the proximal infusion port and the distal infusion port are spaced relative to the hemicylindrical occluder such that when the catheter is introduced into vasculature of a patient, the suction port is positioned in the patient's superior vena cava or right atrium to draw blood flowing through the patient's vena cava, the distal infusion port is positioned in the patient's superior vena cava or right atrium to direct normothermic or hyperthermic fluid toward the patient's heart, and the proximal infusion port is positioned in the patient's internal jugular vein to create a retrograde flow of hypothermic fluid in the patient's cerebral vasculature.

2. The venous infusion catheter assembly of claim 1 further comprising an inflation lumen extending from the proximal end of the catheter body to the hemicylindrical occluder.

3. The venous infusion catheter assembly of claim 1 further comprising a positional marker positioned on the catheter body at or proximally adjacent to at least one of the at least one suction port, the proximal infusion port, the distal infusion port.

4. The venous infusion catheter assembly of claim 3 , wherein the positional marker is a radiopaque marker or an ultrasonically opaque marker.

5. The venous infusion catheter assembly of claim 1 further comprising a positional marker on the distal end of the catheter body, the positional marker comprising a radiopaque marker or an ultrasonically opaque marker.

6. The venous infusion catheter assembly of claim 1 further comprising a heat exchange assembly fluidly connected with the suction lumen and the at least one infusion lumen.

7. The venous infusion catheter assembly of claim 6 further comprising a controller communicatively connected to the heat exchange assembly.

8. The venous infusion catheter assembly of claim 7 , wherein the heat exchange assembly further comprises a pump with adjustable flow rate connected to the controller.

9. The venous infusion catheter assembly of claim 8 , wherein the controller is configured to adjust at least one of flow rate of the pump or temperature of the heat exchange assembly.

10. The venous infusion catheter assembly of claim 8 , wherein the controller is further configured to:
receive a brain temperature and a heart temperature; and
adjust at least one of flow rate of the pump or temperature of the heat exchange assembly based on the brain temperature and the heart temperature.

11. The venous infusion catheter assembly of claim 7 , wherein the controller controls the heat exchange assembly to output hypothermic fluid to the infusion controller controls the heat exchange assembly to output hypothermic fluid to the at least one infusion lumen through the proximal infusion port.

12. The venous infusion catheter assembly of claim 7 , wherein the controller controls the heat exchange assembly to output normothermic or hyperthermic fluid to the at least one infusion lumen through the distal infusion port.

13. The venous infusion catheter assembly of claim 7 , wherein the heat exchange assembly and the controller are integrated in a housing.

14. The venous infusion catheter assembly of claim 1 further comprising a temperature sensor positioned on or in the catheter body distally of the hemicylindrical occluder or in suction tubing.

15. The venous infusion catheter assembly of claim 1 further comprising a guidewire extending from the proximal end of the catheter body to the distal end of the catheter body.

16. The venous infusion catheter assembly of claim 1 further comprising an expandable element disposed on the elongated catheter body and positioned on the catheter body distally of the hemicylindrical occluder between the hemicylindrical occluder and the at least one suction port such that the at least one suction port is not occluded by the patient's vein wall.

17. The venous infusion catheter assembly of claim 16 , wherein the expandable element is nonocclusive.

18. The venous infusion catheter assembly of claim 1 , wherein the normothermic or hyperthermic fluid comprises blood of temperature between 36 degrees Celsius and 42 degrees Celsius.

19. The venous infusion catheter assembly of claim 1 , wherein the hypothermic fluid comprises blood of temperature between 0 degrees Celsius and 36 degrees Celsius.

20. The venous infusion catheter assembly of claim 1 , wherein the at least one infusion lumen comprises a layer of insulation.

21. The venous infusion catheter assembly of claim 1 , wherein the normothermic or hyperthermic fluid comprises suctioned blood.

22. The venous infusion catheter assembly of claim 1 , wherein the hypothermic fluid comprises cooled suctioned blood.

23. The venous infusion catheter assembly of claim 1 , wherein one or more of the at least one infusion lumen, the suction lumen, or a pressure lumen extending through the catheter body comprises a reinforcement coil or hypotube.

24. The venous infusion catheter assembly of claim 1 further comprising a pressure lumen extending from the proximal end of the catheter body to a port positioned proximally of the hemicylindrical occluder.

25. The venous infusion catheter assembly of claim 1 further comprising a mounting fixture.

26. The venous infusion catheter assembly of claim 1 further comprising a tapered tip positioned at the distal end of the catheter body.

27. The venous infusion catheter assembly of claim 26 wherein the tapered tip is constructed of a material of lower durometer than the catheter body.

28. The venous infusion catheter assembly of claim 1 further comprising a second suction port, different from the at least one suction port, that is fluidly connected to the suction lumen and positioned on the catheter body distally of the hemicylindrical occluder between the hemicylindrical occluder and the distal infusion port.

29. The venous infusion catheter assembly of claim 1 further comprising a second suction port, different from the at least one suction port, that is fluidly connected to the suction lumen and positioned on the catheter body distally of the distal infusion port.

30. The venous infusion catheter assembly of claim 1 , wherein the elongated catheter body is introduced into vasculature of the patient in a first direction to deliver a flow of fluid through the catheter and directed in a direction opposite of the first direction.

Assignees

• Penumbra Inc

Inventors

• Schultz Robert D
• Olshavsky Justin M
• Vaughan Bridget C
• Teigen Corey
• Teigen Scott
• Salamy Michael E
• Chellappa Nitika S
• Yeluru Akhilesh R R
• Quraishi Annam K
• Jones Melissa E R
• Shaw Aurko J
• Sprinkel Matthew W L
• Lee Anderson S
• Koretsky Evan T
• Loisel Steve
• Shaffer Robyn

Classifications

• A61M2025/1056

  having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon · CPC title

• A61M2205/3368

  Temperature · CPC title

• A61M2205/3334

  Measuring or controlling the flow rate · CPC title

• A61M2230/50

  Temperature · CPC title

• A61M2025/105

  having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes · CPC title