IP Library Granted Patent US 11,298,506
Granted Patent B2
US 11,298,506 · App. 16/132,861 · Granted Apr 12, 2022

Intra-ventricular infusion and evacuation catheter for treatment of intracerebral hemorrhage (ICH)

Inventors: Stephen Porter (Piedmont, CA); Jon Schabert (Dublin, CA)
Assignees: STRYKER CORPORATION; STRYKER EUROPEAN OPERATIONS HOLDINGS LLC
A61M25/0068A61B17/22004A61M1/0058A61B2017/22079A61B2017/22084A61B2018/00267A61B2217/005A61B2217/007A61M25/003A61M25/0074A61M2025/0036A61M2025/0063A61M2210/0693
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Quick Facts
Patent No.
US 11,298,506
App. No.
16/132,861
Granted
Apr 12, 2022
Kind
B2
Abstract

A method of treating an anatomical cavity of a patient comprises introducing an infusion/aspiration catheter into the patient, such that a plurality of arms of the catheter reside within the anatomical cavity, delivering a fluid into the at least one of a connector, such that fluid exits the at least one fluid port of at least one of the arms, thereby infusing the anatomical cavity with the fluid, and aspirating the fluid into the at least one fluid port of at least one of the arms, such that the fluid exits the connector(s).

Claims (28)

1. A method of treating an anatomical cavity within a brain of a patient using an infusion/aspiration catheter, wherein the patient has clot residing within the anatomical cavity as a result of a hemorrhagic stroke suffered by the patient, the infusion/aspiration catheter comprising an elongate catheter body having a proximal end, a distal end, and a plurality of independent lumens extending between the proximal end and the distal end, a plurality of arms respectively having proximal ends affixed together at the distal end of elongate catheter body, each of the arms having a lumen in fluid communication with a respective one of the independent lumens of the elongate catheter body, each of the arms having at least one fluid port in fluid communication with the lumen of the respective arm, and at least one connector affixed to the proximal end of the elongate catheter body in fluid communication with the independent lumens of the elongate catheter body, the method comprising:

introducing the infusion/aspiration catheter into the patient, such that the plurality of arms reside within the anatomical cavity;

delivering a fluid comprising recombinant tissue plasminogen activator (rt-PA) into the at least one of the connector, such that fluid exits the at least one fluid port of at least one of the arms, thereby infusing the anatomical cavity with the fluid, and the infused rt-PA dissolves the clot; and

aspirating the fluid, along with dissolved clot, into the at least one fluid port of at least one of the arms, such that the fluid, along with the dissolved clot, exits the at least one connector.

2. The method of claim 1 , wherein the at least one connector comprises a plurality of connectors in fluid communication with the independent lumens of the elongate catheter body, and wherein the fluid is simultaneously infused into and aspirated from the anatomical cavity via different ones of the connectors.

3. The method of claim 1 , wherein the fluid is sequentially infused into and aspirated from the anatomical cavity via the same ones of the at least one connector.

4. The method of claim 1 , wherein the anatomical cavity is a ventricle within the brain of the patient or a region where clot has displaced brain tissue of the patient.

5. The method of claim 4 , wherein the infusion/aspiration catheter is introduced into the anatomical cavity through a burr hole in a cranium of the patient.

6. The method of claim 1 , further comprising expanding the arms outward within the anatomical cavity.

7. The method of claim 6 , further comprising placing an introducer sheath within the anatomical cavity, wherein the plurality of arms is pre-shaped to expand outward in the absence of an external force, and wherein introducing the infusion/aspiration catheter into the patient comprises introducing the infusion/aspiration catheter through the introducer sheath, such that the introducer sheath applies an external force to the plurality of arms to straighten the arms, and deploying plurality of arms from the introducer sheath, such that the external force is released from the plurality of arms, thereby allowing the arms to expand outward.

8. The method of claim 6 , wherein an actuation wire is affixed to a distal hub of the infusion/aspiration catheter, the method further comprising displacing the actuation wire distally relative to the infusion/aspiration catheter to straighten the arms while introducing the infusion/aspiration catheter into the anatomical cavity, and displacing the actuation wire proximally relative to the infusion/aspiration catheter to expand the arms outward within the anatomical cavity.

9. The method of claim 1 , wherein the elongate catheter body further has a central lumen extending between the proximal end and distal end of the elongate catheter body, wherein introducing the infusion/aspiration catheter into the anatomical cavity comprises disposing a rigid stylet within the central lumen of the elongate catheter body.

10. A method of treating an anatomical cavity within a brain of a patient using an infusion/aspiration catheter, wherein the patient has clot residing within the anatomical cavity as a result of a hemorrhagic stroke suffered by the patient, the infusion/aspiration catheter comprising an elongate catheter body having a proximal end, a distal end, at least one infusion lumen, and an aspiration lumen extending between the proximal end and the distal end, the aspiration lumen terminating in a distal fluid port at the distal end of the elongate catheter body, a plurality of arms respectively having proximal ends affixed together at the distal end of elongate catheter body, the distal fluid port of the elongate catheter body being between the proximal ends of the plurality of arms, the arms having lumens in fluid communication with the at least one infusion lumen, each of the arms having at least one fluid port in fluid communication with the lumen of the respective arm, at least one infusion connector affixed to the proximal end of the elongate catheter body in fluid communication with the at least one infusion lumen, and an aspiration connector affixed to the proximal end of the elongate catheter body in fluid communication with the at least one aspiration lumen, the method comprising:

introducing the infusion/aspiration catheter into the patient, such that the plurality of arms reside within the anatomical cavity;

delivering a fluid comprising recombinant tissue plasminogen activator (rt-PA) into the at least one of the infusion connector, such that fluid exits the at least one fluid port of each of the plurality of arms, thereby infusing the anatomical cavity with the fluid and the infused rt-PA dissolves the clot; and

aspirating the fluid, along with dissolved clot, into the distal fluid port of the elongate catheter body, such that the fluid, along with dissolved clot, exits the aspiration connector.

11. The method of claim 10 , wherein the fluid is simultaneously infused into and aspirated from the anatomical cavity.

12. The method of claim 10 , wherein the fluid is sequentially infused into and aspirated from the anatomical cavity.

13. The method of claim 10 , wherein the anatomical cavity is a ventricle within the brain of the patient or a region where clot has displaced brain tissue of the patient, and wherein the infusion/aspiration catheter is introduced into the anatomical cavity through a burr hole in a cranium of the patient.

14. The method of claim 10 , further comprising

expanding the arms outward within the anatomical cavity, and

placing an introducer sheath within the anatomical cavity, wherein the plurality of arms is pre-shaped to expand outward in the absence of an external force, and wherein introducing the infusion/aspiration catheter into the patient comprises introducing the infusion/aspiration catheter through the introducer sheath, such that the introducer sheath applies an external force to the plurality of arms to straighten the arms, and deploying plurality of arms from the introducer sheath, such that the external force is released from the plurality of arms, thereby allowing the arms to expand outward.

15. The method of claim 10 , wherein an actuation wire is affixed to a distal hub of the infusion/aspiration catheter, the method further comprising

expanding the arms outward within the anatomical cavity, and

displacing the actuation wire distally relative to the infusion/aspiration catheter to straighten the arms while introducing the infusion/aspiration catheter into the anatomical cavity, and displacing the actuation wire proximally relative to the infusion/aspiration catheter to expand the arms outward within the anatomical cavity.

16. The method of claim 10 , wherein introducing the infusion/aspiration catheter into the anatomical cavity comprises disposing a rigid stylet within the central lumen of the elongate catheter body.

17. The method of claim 1 , wherein the arms are electrodeless, and the clot is removed from the brain without performing an ablation procedure within the anatomical cavity.

18. The method of claim 10 , wherein the arms are electrodeless, and the clot is removed from the brain without performing an ablation procedure within the anatomical cavity.

Assignments (4)
CHANGE OF ADDRESS Recorded Dec 18, 2024
From: STRYKER EUROPEAN OPERATIONS HOLDINGS LLC
To: STRYKER EUROPEAN OPERATIONS HOLDINGS LLC
Reel/Frame 069730/0754 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 28, 2023
From: STRYKER EUROPEAN HOLDINGS I, LLC
To: STRYKER EUROPEAN OPERATIONS HOLDINGS LLC
Reel/Frame 064415/0620 →
CHANGE OF NAME Recorded Jul 22, 2021
From: STRYKER EUROPEAN HOLDINGS III, LLC
To: STRYKER EUROPEAN OPERATIONS HOLDINGS LLC
Reel/Frame 056963/0810 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 20, 2018
From: PORTER, STEPHEN; SCHABERT, JON
To: STRYKER CORPORATION; STRYKER EUROPEAN HOLDINGS I, LLC
Reel/Frame 046932/0511 →
Cited By (1)
US 12,280,195