# US 12,108,960 B1 · Apparatus and methods for controlled clot aspiration

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- Number: US 12,108,960 B1
- Document ID: US12108960B1
- Status: Granted
- Kind: B1
- Application number: 18/532,982
- Filed: 2023-12-07
- Granted: 2024-10-08
- Earliest claimed: 2018-07-24
- Assignees: Penumbra, Inc.
- Applicants: Penumbra, Inc.
- Inventors: Scott Teigen; Steven Loisel; Stephen Pons; Ben Tompkins
- Web page: https://patentgrep.com/patent/US12108960B1

## CPC

- A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61M 1/75: {Intermittent or pulsating suction (A61M1/63, A61M1/772 take precedence)}
- A61M 1/76: {Handpieces (specially for suction-irrigation A61M1/774, aspiration tips A61M1/84)}
- 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)}
- A61M 1/774: {Handpieces specially adapted for providing suction as well as irrigation, either simultaneously or independently}
- A61B 17/00: Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20)
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00561: {creating a vacuum}
- A61B 17/32037: {for removing obstructions from inner organs or blood vessels, e.g. for atherectomy}
- A61B 17/3498: {Valves therefor, e.g. flapper valves, slide valves (haemostasis valves A61M39/06; check valves A61M39/24)}
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2217/005: with suction drainage system
- A61M 39/105: {Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes (multi-channel connectors in general F16L37/56)}
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

An aspiration thrombectomy system including an aspiration catheter having a proximal end and a distal end, the aspiration catheter having a lumen to accommodate fluid, a vacuum source including a controllable vacuum valve, a tubing connected to the aspiration catheter, and a controller configured to detect a change in a catheter diameter corresponding to a change in the connection between the aspiration catheter and the tubing. The controller is configured to change a pulsation protocol associated with the aspiration catheter responsive to the change in the catheter diameter, and the pulsation protocol specifies pressure variations and pressure patterns to modulate the vacuum valve to change a level of vacuum at the distal end of the aspiration catheter.

## Claims

### Claim 1

An aspiration system for removing a clot via aspiration thrombectomy, the aspiration system having a plurality of components comprising:
a plurality of aspiration catheters, each aspiration catheter having a proximal end and a distal end, wherein the distal end of each aspiration catheter is configured to be introduced through a vasculature of a patient to interface with a clot in the vasculature, wherein the proximal end of each aspiration catheter comprises a lumen configured to accommodate fluid, wherein each aspiration catheter comprises a catheter hub associated with the proximal end of the aspiration catheter, wherein each aspiration catheter is associated with one or more catheter parameters corresponding to the aspiration catheter, wherein one or more of the catheter parameters associated with each aspiration catheter is a catheter size or a catheter diameter of the respective aspiration catheter, and wherein the plurality of aspiration catheters comprise aspiration catheters corresponding to a plurality of different catheter sizes or catheter diameters;
a console of the aspiration system, wherein the console comprises a physical frame configured to support one or more of the aspiration system components, wherein the physical frame comprises one or more apertures accessible to one or more of the components of the aspiration system;
a vacuum canister configured to collect material extracted by the aspiration system, wherein the vacuum canister is physically coupled to the physical frame of the console, wherein a physical frame of the vacuum canister comprises substantially transparent material configured for the collected material in the vacuum canister to be externally visible;
a vacuum source configured to deliver vacuum to the aspiration catheter, wherein the vacuum source comprises a vacuum pump, wherein the vacuum pump is housed in the console of the aspiration system, and wherein the vacuum source is fluidically connected to the aspiration catheter and the vacuum canister;
a fluid source configured to deliver pressure to the aspiration catheter, wherein the fluid source is external to the console of the aspiration system, and wherein the fluid source is fluidically connected to the aspiration catheter;
a plurality of controllable actuators of the aspiration system, wherein the plurality of controllable actuators comprise one or more first actuators associated with the vacuum source, wherein the one or more first actuators are configured to be operated to deliver specific amounts of vacuum to the aspiration catheter, wherein the plurality of controllable actuators further comprise one or more second actuators associated with the fluid source, and wherein the one or more second actuators are configured to be operated to deliver specific amounts of pressure to the aspiration catheter;
a set of tubing comprising one or more portions of connection tubing, wherein the tubing set is configured to fluidically connect the vacuum source, the vacuum canister, the fluid source, and the aspiration catheter, and wherein an endpoint of the tubing set is configured to interface with the catheter hub associated with the proximal end of the aspiration catheter; and
a controller of the aspiration system configured to:
determine that a first aspiration catheter of the plurality of aspiration catheters is connected to the tubing set based on one or more catheter parameters associated with the first aspiration catheter; and
operate the plurality of controllable actuators, based on one or more of the catheter parameters associated with the first aspiration catheter, by utilizing an algorithm associated with the aspiration system to adjust one or more operating parameters associated with the controllable actuators, to deliver an amount of aspiration power at the distal end of the first aspiration catheter, wherein the amount of aspiration power comprises one or more levels of vacuum or pressure applied at the distal end of the first aspiration catheter, and wherein the amount of aspiration power is determined based on the algorithm.

### Claim 2 (depends on 1)

The aspiration system of claim 1, wherein determining that the first aspiration catheter is connected to the tubing set is based at least in part on the one or more catheter parameters associated with the first aspiration catheter corresponding to the catheter size or catheter diameter of the first aspiration catheter.

### Claim 3 (depends on 1)

The aspiration system of claim 1, wherein determining that the first aspiration catheter is connected to the tubing set is based at least in part on sensor data associated with the proximal end of the aspiration catheter.

### Claim 4 (depends on 1)

The aspiration system of claim 1, wherein operating the plurality of controllable actuators is based at least in part on the one or more catheter parameters associated with the first aspiration catheter corresponding to the catheter size or catheter diameter of the first aspiration catheter.

### Claim 5 (depends on 1)

The aspiration system of claim 1, wherein operating the plurality of controllable actuators to deliver an amount of aspiration power is based on one or more extraction cycles, wherein each extraction cycle comprises one or more of the levels of vacuum or pressure applied at the distal end of the aspiration catheter.

### Claim 6 (depends on 5)

The aspiration system of claim 5, wherein the controller is configured to adjust one or more amplitudes or frequencies of one or more of the extraction cycles to optimize a minimum number of extraction cycles for extracting a clot with the first catheter.

### Claim 7 (depends on 1)

The aspiration system of claim 1, wherein one or more of the extraction cycles are configured to cycle between a full level of vacuum and zero vacuum at least 8 times per second.

### Claim 8 (depends on 1)

The aspiration system of claim 1, wherein the aspiration system comprises one or more enclosures having an interior cavity, and wherein each of the enclosures comprise one or more of the controllable actuators of the aspiration system.

### Claim 9 (depends on 8)

The aspiration system of claim 8, wherein at least one of the enclosures is an external unit enclosure separate from the console of the aspiration system, wherein the external unit enclosure is positioned between the console and the aspiration catheter, and wherein the external unit enclosure is fluidically connected to the console via one or more portions of the connection tubing.

### Claim 10 (depends on 8)

The aspiration system of claim 8, wherein at least one of the enclosures is physically coupled to the physical frame of the console.

### Claim 11 (depends on 10)

The aspiration system of claim 10, wherein the enclosure physically coupled to the physical frame of the console is a base unit enclosure coupled to an exterior portion of the physical frame of the console, and wherein the base unit enclosure further comprises the controller of the aspiration system.

### Claim 12 (depends on 10)

The aspiration system of claim 10, wherein the enclosure physically coupled to the physical frame of the console is positioned within the physical frame of the console.

### Claim 13 (depends on 8)

The aspiration system of claim 8, wherein at least one of the enclosures is a base unit enclosure coupled to an exterior portion of the physical frame of the console, wherein at least one of the enclosures is an external unit enclosure separate from the base unit enclosure and console of the aspiration system, wherein the external unit enclosure is positioned between the base unit enclosure and the aspiration catheter, and wherein the external unit enclosure is fluidically connected to the console via one or more portions of the connection tubing connected to the base unit enclosure.

### Claim 14 (depends on 13)

The aspiration system of claim 13, wherein the base unit enclosure further comprises the controller of the aspiration system, and wherein the external unit enclosure comprises a controller associated with the external unit enclosure.

### Claim 15 (depends on 1)

The aspiration system of claim 1, wherein the pressure delivered to the aspiration catheter by the fluid source is induced via a gravity-based configuration of the fluid source.

### Claim 16 (depends on 1)

The aspiration system of claim 1, wherein the vacuum canister comprises a filter plate.

### Claim 17 (depends on 1)

The aspiration system of claim 1, wherein the filter plate is positioned in a mid-section of the interior of the vacuum canister.

### Claim 18 (depends on 1)

The aspiration system of claim 1, wherein the vacuum canister is physically coupled to a physical frame of the console via a base portion of the physical frame of the vacuum canister positioned on a bottom portion of the physical frame of the console.