Methods and devices for treating stroke

• US 10,531,882 B2
• Filed: 01/04/2017
• Issued: 01/14/2020
• Est. Priority Date: 01/04/2016
• Status: Active Grant

• Current Assignee: Alcyone Therapeutics, Inc.
• Original Assignee: Alcyone Lifesciences, Inc.
• Inventors: Anand, P J, Ekholm, John, Singh, Deep Arjun
• Primary Examiner(s): Stigell, Theodore J
• Application Number:
  US15/397,947
• Publication Number:
  US 20170189040A1
• Time in Patent Office: 1,105 Days
• 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 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/22088 ultrasound absorbing, drug activated by ultrasound
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/10 for stereotaxic surgery, e.g. frame-based stereotaxis
• 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 1/85 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 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod

Abstract

Methods and devices are disclosed herein that allow for infusion and aspiration through a single device. The device can be used to treat a stroke by delivering the device to the site of a blood clot and simultaneously or sequentially infusing a thrombolytic or other drug into the clot and aspirating the dissolving clot from the patient. The methods and devices can advantageously permit more efficient thrombolytic infusion and clot aspiration. Modular systems are also disclosed, as are methods of treating subdural hematoma or other conditions.

Claims

1. A method of treating a patient, comprising:

advancing a catheter system to a treatment site within the patient, wherein the catheter system comprises an infusion catheter slidably disposed within an aspiration catheter;

delivering at least one of a drug and an irrigation fluid to the treatment site through an infusion lumen of the infusion catheter of the catheter system;

advancing the aspiration catheter of the catheter system distally over the infusion catheter towards the treatment site after delivering the at least one of the drug and the irrigation fluid through the infusion catheter, the aspiration catheter being advanced distally over the infusion catheter such that a distal portion of the aspiration catheter is positioned at a distal portion of the infusion catheter; and

aspirating any material from the treatment site through an aspiration lumen of the aspiration catheter after advancing the aspiration catheter distally over the infusion catheter.

2. The method of claim 1, wherein the treatment site comprises a clot in a brain of the patient.

3. The method of claim 1, wherein the drug comprises a thrombolytic.

4. The method of claim 1, wherein the aspirated material comprises clot material.

5. The method of claim 1, wherein aspirating the material comprises steering the aspiration catheter within the treatment site.

6. The method of claim 1, wherein delivering the drug comprises enhancing diffusion rate of the drug by applying acoustic energy to the treatment site.

7. The method of claim 1, wherein delivering the drug comprises controlling the direction in which the drug is distributed using acoustic energy.

8. The method of claim 6, wherein the acoustic energy is emitted from a time reversal acoustic (TRA) system, wherein the TRA system comprises a hydrophone or microphone disposed in a distal end of the infusion catheter, one or more leads extending from the hydrophone or microphone to a proximal end of the infusion catheter, and a reverberator configured to time-reverse a signal detected by the hydrophone or microphone and emit acoustic waves based on the time-reversed signal.

9. The method of claim 1, wherein the infusion catheter has at least one outlet port for delivering at least one of the drug and the irrigation fluid to the treatment site and the aspiration catheter has at least one aspiration port for aspirating the material from the treatment site.

10. A method of treating a patient, comprising:

advancing a catheter system to a treatment site within the patient, wherein the catheter system comprises an infusion catheter slidably disposed within an aspiration catheter, wherein the infusion catheter includes at least one outlet port disposed in a lateral sidewall of a distal portion of the infusion catheter and adapted to deliver at least one of a drug and an irrigation fluid to the treatment site, and wherein the aspiration catheter is at least initially disposed relative to the infusion catheter such that the at least one outlet port is exposed for such delivery;

delivering at least one of the drug and the irrigation fluid to the treatment site through the at least one outlet port of the infusion catheter of the catheter system;

advancing the aspiration catheter of the catheter system distally over the infusion catheter towards the treatment site after delivering the at least one of the drug and the irrigation fluid through the infusion catheter, the aspiration catheter being advanced distally over the infusion catheter to cover the at least one outlet port of the infusion catheter; and

aspirating any material from the treatment site through an aspiration lumen of the aspiration catheter after advancing the aspiration catheter distally over the infusion catheter.

11. The method of claim 10, wherein the treatment site comprises a clot in a brain of the patient.

12. The method of claim 10, wherein the drug comprises a thrombolytic.

13. The method of claim 10, wherein the aspirated material comprises clot material.

14. The method of claim 10, wherein aspirating the material comprises steering the aspiration catheter within the treatment site.

15. The method of claim 10, wherein delivering the drug comprises enhancing diffusion rate of the drug by applying acoustic energy to the treatment site.

16. The method of claim 10, wherein delivering the drug comprises controlling the direction in which the drug is distributed using acoustic energy.

17. The method of claim 16, wherein the acoustic energy is emitted from a time reversal acoustic (TRA) system, wherein the TRA system comprises a hydrophone or microphone disposed in a distal end of the infusion catheter, one or more leads extending from the hydrophone or microphone to a proximal end of the infusion catheter, and a reverberator configured to time-reverse a signal detected by the hydrophone or microphone and emit acoustic waves based on the time-reversed signal.

18. The method of claim 10, wherein the aspiration catheter has at least one aspiration port for aspirating the material from the treatment site.