Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter

• US 10,531,883 B1
• Filed: 07/18/2019
• Issued: 01/14/2020
• Est. Priority Date: 07/20/2018
• Status: Expired due to Fees

• Current Assignee: Rapidpulse Incorporated
• Original Assignee: Syntheon 2.0, LLC
• Inventors: Deville, Derek Dee, Palmer, Matthew A., Bales, Jr., William T., McBrayer, M. Sean, Petersen, Eric, Cartledge, Richard
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US16/516,232
• Publication Number:
  US 20200022712A1
• Time in Patent Office: 180 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00154 pulsed
• 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 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/742 by changing the size of a vent A61M1/7411 takes precedence
• CPC Class Codes: A61M 1/743 by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/79 Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A thrombectomy removal system includes a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion, a vacuum source, a vent liquid source, and a vacuum and vent control system configured to cyclically connect or disconnect the vacuum source and the vent liquid source to change a level of vacuum at the distal end and substantially prevent forward flow. The vacuum source and the vent source are respectively fluidically connected to the vacuum and vent valves. A manifold connects the proximal portion to the vacuum and vent sources through the valves. Control of the valves prevents forward flow of the distal portion out from the distal end during each cycle. Each cycle can have states including vacuum-only, first double-closed, vent-only, and second double-closed. A time of the double-closed states can be no greater than 30 ms.

Claims

1. A clot removal system, comprising:

a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion;

a controllable vacuum valve;

a vacuum source fluidically connected to the vacuum valve;

a controllable vent valve having a vent liquid input;

a vent fluid source containing a vent liquid and fluidically connected to the vent valve to retain the vent liquid at the vent fluid input;

a manifold connected to the catheter, to the vacuum valve, and to the vent valve, the manifold fluidically connecting the proximal portion of the liquid column in the lumen;

to the vacuum source through the vacuum valve; and

to the vent fluid source through the vent valve;

a controller connected to the vacuum valve and the vent valve and configured to selectively open and close the vacuum valve and the vent valve such that;

responsive to opening the vacuum valve, the vacuum source is fluidically connected to the liquid column in the lumen; and

responsive to opening the vent valve, the vent fluid source is fluidically connected to the liquid column in the lumen,

the controller configured to cyclically open and close the vacuum valve and the vent valve to;

change a level of vacuum at the distal end; and

prevent forward flow of the distal portion out from the distal end during each cycle.

2. The system according to claim 1, wherein the controller is configured to cyclically open and close the vacuum valve and the vent valve in a repeated cycle comprising a double-closed state in which the vacuum valve is closed and the vent valve is closed.

3. The system according to claim 2, wherein a time of the double-closed state is no greater than 30 ms.

4. The system according to claim 1, wherein the controller is configured to cyclically open and close the vacuum valve and the vent valve in a repeated cycle comprising a vent-only state in which the vacuum valve is closed and the vent valve is open.

5. The system according to claim 4, wherein a time of the vent-only state is no greater than 50 ms.

6. The system according to claim 1, wherein the controller is configured to selectively open and close the vacuum valve and the vent valve cycle in a repeated cycle comprising:

a vacuum-only state in which the vacuum valve is open and the vent valve is closed;

a first double-closed state in which the vacuum valve is closed and the vent valve is closed;

a vent-only state in which the vacuum valve is closed and the vent valve is open; and

a second double-closed state in which the vacuum valve is closed and the vent valve is closed.

7. The system according to claim 6, wherein a time between an opening of the vent valve and a closing of the vent valve is between approximately 10 ms and approximately 50 ms.

8. The system according to claim 6, wherein a period of the cycle is between approximately 6 Hz and approximately 16 Hz.

9. The system according to claim 6, wherein a period of the cycle is between approximately 8 Hz and 12 Hz.

10. The system according to claim 1, wherein the change in the level of vacuum at the distal end is greater than approximately 15 inHg and no greater than approximately 50 ms.

11. The system according to claim 1, wherein the change in the level of vacuum at the distal end is greater than approximately 20 inHg and no greater than approximately 30 ms.

12. The system according to claim 1, wherein the change in the level of vacuum at the distal end is greater than approximately 25 inHg and no greater than approximately 20 ms.

13. The system according to claim 1, wherein:

the lumen has an internal diameter of between approximately 0.038″ and

approximately 0.106″

; and

the controller is configured to cyclically open and close the vacuum valve and the vent valve at a frequency of between 2 and 16 Hz.

14. The system according to claim 1, wherein:

the lumen has an internal diameter of between approximately 0.068″ and

approximately 0.088″

; and

the controller is configured to cyclically open and close the vacuum valve and the vent valve at a frequency of between 2 and 16 Hz.

15. The system according to claim 1, wherein the controller is configured to cyclically open and close the vacuum valve and the vent valve in a repeated cycle and prevent forward flow of the distal portion out from the distal end during each cycle by regulating timing of the vent valve.

16. The system according to claim 1, wherein the controller is configured to cyclically open and close the vacuum valve and the vent valve to retain a level of pressure at the distal end at less than physiological pressure.

17. The system according to claim 1, which further comprises a shaft and the vacuum valve and the vent valve are mounted together on the shaft.

18. A clot removal system, comprising:

a catheter having a distal end and defining a lumen filled with a liquid column having a proximal portion and a distal portion;

a controllable vacuum valve;

a vacuum source fluidically connected to the vacuum valve;

a controllable vent valve having a vent liquid input;

a vent fluid source containing a vent liquid and fluidically connected to the vent valve to retain the vent liquid at the vent fluid input;

a manifold connected to the catheter, to the vacuum valve, and to the vent valve, the manifold fluidically connecting the proximal portion of the liquid column in the lumen;

to the vacuum source through the vacuum valve; and

to the vent fluid source through the vent valve;

a controller connected to the vacuum valve and the vent valve and configured to selectively open and close the vacuum valve and the vent valve such that;

responsive to opening the vacuum valve, the vacuum source is fluidically connected to the liquid column in the lumen; and

responsive to opening the vent valve, the vent fluid source is fluidically connected to the liquid column in the lumen,

the controller configured to cyclically open and close the vacuum valve and the vent valve in a repeated cycle comprising a double-closed state in which the vacuum valve is closed and the vent valve is closed to;

change a level of vacuum at the distal end; and

prevent forward flow of the distal portion out from the distal end during each cycle, and

a time of the double-closed state is no greater than approximately 30 ms.