Systems and methods of removing challenging clots and restoring perfusion to a vessel

Patent metadata

Field	Value
Publication number	US-2024065713-A1
Application number	US-202318237048-A
Country	US
Kind code	A1
Filing date	Aug 23, 2023
Priority date	Aug 23, 2022
Publication date	Feb 29, 2024
Grant date	—

Abstract

A method and/or use of restoring blood flow in neurovasculature by removing thrombus in a plurality of human patients experiencing ischemic stroke using a revascularization device as either a first-line device or a second-line device.

First claim

What is claimed is:

1 . A method of restoring blood flow in neurovasculature of a human patient experiencing ischemic stroke, the method comprising:
identifying a respective human patient within a plurality of human patients at risk of comprising a thrombus; passing a revascularization device as a first-line device to a blood vessel of the respective human patient of the plurality of human patients for retrieving a thrombus,
wherein the revascularization device comprises:
a collapsed delivery configuration and an expanded deployed configuration,
a proximal pinch section having a spiral shape comprising a spiral pitch and
a distal section comprising a barrel shape;
removing the revascularization device to restore perfusion to the blood vessel and achieve approximately 80% revascularization rate after last pass of the revascularization device under a modified treatment in cerebral infarction score of equal to or greater than grade 2b (mTICI>2b) for the plurality of human patients comprising a thrombus within a predetermined time period of natural stroke symptom onset.

2 . The method of claim 1 , further comprising detecting, prior to the step of passing the revascularization device as the first-line device, an initial revascularization rate of the respective human patient of the plurality of human patients less than a grade 2b (mTICI<2b).

3 . The method of claim 1 , wherein removing the revascularization device to restore perfusion to the blood vessel and achieve approximately 80% revascularization rate for the plurality of human patients under the modified treatment in cerebral infarction score of equal to or greater than grade 2b (mTICI≥2b) comprises less than three passes of the revascularization device as the first-line device.

4 . The method of claim 1 , wherein removing the revascularization device to restore perfusion to the blood vessel and achieve approximately 80% revascularization rate for the plurality of human patients under the modified treatment in cerebral infarction score of equal to or greater than grade 2b (mTICI≥2b) comprises an average of approximately 2.4 passes of the revascularization device as the first-line device.

5 . The method of claim 1 , further comprising reducing, by the step of passing the revascularization device as the first-line device, post-procedural clinical complications selected from at least one of vessel dissection, vessel perforation, hematoma, emboli in new territory, infarction in new territory, or hemorrhagic transformation.

6 . The method of claim 1 , the method being performed within at least 11 hours of stroke symptom onset.

7 . The method of claim 1 , the thrombus being positioned in an internal carotid artery, a M1 segment and/or a M2 segment of a middle cerebral artery, a vertebral artery, or a basilar artery of the human patient.

8 . The method of claim 1 , wherein prior to passing the revascularization device by, through, or about the thrombus in the blood vessel of each of the plurality of human patients, the method comprises passing a stent retriever device by, through, or about the thrombus in the blood vessel of each of the plurality of human patients.

9 . The method of claim 1 , the revascularization device configured to position the thrombus against a wall of the blood vessel and then pinch at least a portion of the thrombus with the proximal pinch section.

10 . The method of claim 1 wherein, in the expanded deployed configuration, the revascularization device comprises peaks of the proximal pinch section are laterally spaced-apart and when under tension, pinching the thrombus between the peaks.

11 . The method of claim 1 , the proximal pinch section comprising a plurality of cells defined by struts and crowns connected to corresponding struts and crowns, and wherein at least some of the struts or the crowns of the proximal pinch section are aligned with a wave-like form to enhance embedding of clot.

12 . The method of claim 1 , the proximal pinch section comprises one or more clot gripping features.

13 . A method of restoring blood flow in neurovasculature by removing thrombus in a plurality of human patients experiencing ischemic stroke, the method comprising:
passing a revascularization device by, through, or about a thrombus in a blood vessel of each of the plurality of human patients to restore perfusion to the blood vessel and achieve at least approximately 68.8% revascularization rate after an average of less than two passes of the revascularization device as a second-line device for the plurality of human patients under a modified treatment in cerebral infarction score of equal to or greater than a grade of 2b (mTICI≥2b), the thrombus being fibrin-rich.

14 . The method of claim 13 , wherein prior to passing the revascularization device by, through, or about the thrombus in the blood vessel of each of the plurality of human patients, the method comprises passing a stent retriever device by, through, or about the thrombus in the blood vessel of each of the plurality of human patients.

15 . The method of claim 14 , further comprising:
wherein after the step of passing the stent retriever device by, through, or about the thrombus in the blood vessel of each of the plurality of human patients, and wherein prior to passing the revascularization device by, through, or about the thrombus in the blood vessel of each of the plurality of human patients, the method comprises detecting a revascularization rate of a respective human patient of the plurality of human patients less than a grade 2b (mTICI<2b).

16 . The method of claim 15 , wherein prior to passing the revascularization device by, through, or about the thrombus in the blood vessel of each of the plurality of human patients, the method further comprises:
switching to the revascularization device as the second-line device to restore perfusion to the blood vessel by passing the revascularization device by, through, or about the thrombus to achieve at least approximately 68.8% revascularization rate after an average of approximately 1.7 passes of the revascularization device for the plurality of human patients under the modified treatment in cerebral infarction score of equal to or greater than a grade of 2b (mTICI≥2b).

17 . The method of claim 13 , the revascularization device comprising:
a collapsed delivery configuration and an expanded deployed configuration; a proximal pinch section comprising a spiral shape comprising a spiral pitch; and a distal section comprising a barrel shape,
wherein the revascularization device is configured to position the thrombus against a wall of the blood vessel and then pinch at least a portion of the thrombus with the proximal pinch section.

18 . The method of claim 13 , wherein the step of passing the revascularization device comprises retracting the revascularization device, after being passed by, through or about the thrombus, while pinching the thrombus.

19 . The method of claim 14 , wherein the revascularization device is configured to remove the thrombus or portions thereof that remain after passing the stent retriever device as a first-line device.

20 . The method of claim 13 , wherein the thrombus or portion thereof comprises more fibrin than red blood cells.

Assignees

• Neuravi Ltd

Inventors

• Kokoszka Malgorzata Alicja
• Vale David
• Casey Brendan
• Gilvarry Michael
• O'Gorman Jacqueline
• King Daniel
• Mcardle Kevin
• Fahy Brian

Classifications

• A61B17/221 Primary

  Gripping devices in the form of loops or baskets {for gripping calculi or similar types of obstructions (surgical snare instruments A61B17/32056)} · CPC title

• A61F2002/9528

  for retrieval of stents · CPC title

• A61B2017/2215

  having an open distal end · CPC title