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

Patent metadata

Field	Value
Publication number	US-11298506-B2
Application number	US-201816132861-A
Country	US
Kind code	B2
Filing date	Sep 17, 2018
Priority date	Sep 17, 2018
Publication date	Apr 12, 2022
Grant date	Apr 12, 2022

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).

First claim

What is claimed is:

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/aspirat

Assignees

• Stryker Corp
• Stryker European Operations Holdings Llc

Inventors

• Porter Stephen
• Schabert Jon

Classifications

• A61M25/0068 Primary

  Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure · CPC title

• A61M1/86

  Connectors between drainage tube and handpiece, e.g. drainage tubes detachable from handpiece · CPC title

• A61M1/85 Primary

  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 title

• A61M1/772

  operating alternately · CPC title

• A61M1/77

  Suction-irrigation systems (aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463) · CPC title