Manually rotatable thrombus engagement tool

Inventors

Buck, MichaelFox, JuliaJacobs, James

Assignees

Imperative Care Inc

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Publication Number

US-11633272-B2

Patent

Publication Date

2023-04-25

Expiration Date


Abstract

A thrombus engagement tool having a flexible shaft, a clot engagement tip, and a handle. The engagement tip may include one or more radially outwardly extending structures such as a helical thread. The helical thread can be advanced through a catheter to engage a clot. The handle may be configured to be rotated by hand. When the handle is rotated, the helical thread of the engagement tip can rotate in the same direction thereby allowing the helical threat to engage the clot. The helical thread can wrap around the flexible shaft at least about one, two, or four or more full revolutions, but in some cases no more than about ten or no more than about six revolutions.

Core Innovation

The invention relates to a thrombus engagement tool configured to be advanced through a catheter and to engage thrombus. The thrombus engagement tool includes a rotatable core having a proximal end and a distal end, and a thrombus engagement tip on the distal end of the rotatable core. The thrombus engagement tip comprises a helical thread.

The thrombus engagement tip further comprises an advance segment on a distal side of the helical thread and a trailing segment on a proximal side of the helical thread. The advance segment includes an atraumatic tip, where the atraumatic tip comprises a soft polymer. In the described structural concepts, the thrombus engagement tip is formed with the advance segment and trailing segment that are molded onto the core.

The tool is described with additional structural features intended to control the relationship between the tip and the catheter lumen and to indicate distal tip projection. An annular aspiration flow path is formed around the helical-thread engagement tip, where the helical thread outer diameter is constrained relative to the catheter lumen inside diameter. Optional radiopaque markers are arranged under portions of the tip, and a position indicator is provided using a limit-bearing surface and/or a position indicator formed by a distal end of a tube surrounding the rotatable core.

Claims Coverage

The independent claims cover two aspects of the same thrombus engagement tool: the distal tip construction with a helical thread plus an atraumatic soft-polymer advance segment and a proximal trailing segment, and the proximal handle for manual rotation with an indicium of rotational direction. Across the independent claims, the coverage emphasizes at least four key inventive features: rotatable core for catheter advancement, helical-thread engagement tip architecture, an atraumatic soft-polymer advance segment, and proximal rotational-direction indicium on a handle. Dependent refinements further add interference-fit projections, radiopaque markers placement, a limit-bearing surface to control distal projection relative to an aspiration catheter, and dimensional compatibility constraints linking thread outside diameter to catheter inside diameter.

Rotatable core advanced through a catheter

A thrombus engagement tool configured to be advanced through a catheter and to engage thrombus, comprising a rotatable core having a proximal end and a distal end.

Helical-thread thrombus engagement tip with advance and trailing segments

A thrombus engagement tip on the distal end of the rotatable core, the thrombus engagement tip comprising a helical thread with an advance segment on a distal side of the helical thread and a trailing segment on a proximal side of the helical thread.

Atraumatic soft-polymer advance segment

The advance segment on a distal side of the helical thread includes an atraumatic tip, where the atraumatic tip comprises a soft polymer.

Handle with indicium of rotational direction

A handle on the proximal end of the rotatable core, the handle comprising an indicium of rotational direction.

Interference-fit projection beneath tip segments

A projection on the rotatable core positioned beneath at least one of an advance segment or a trailing segment to create an interference fit with the thrombus engagement tip.

Radiopaque markers under advance and trailing segments

A thrombus engagement tool including a first radiopaque marker positioned under the advancing segment and a second radiopaque marker positioned under the trailing segment.

Limit-bearing surface restricting distal projection relative to aspiration catheter

A handle having a limit bearing surface configured to restrict how far the thrombus engagement tip can project distally relative to the distal end of an aspiration catheter.

Thread outer diameter constrained relative to catheter inside diameter

A thrombus engagement tool combined with a catheter such that the helical thread outside diameter is no more than about 60% of the catheter inside diameter.

Overall, the claims cover a catheter-advanced thrombus engagement tool with a rotatable core and a helical-thread distal tip that includes an atraumatic soft-polymer advance segment and a proximal trailing segment. The independent claims also require a proximal handle with an indicium of rotational direction, while dependent claim coverage further adds interference-fit projection features, radiopaque markers under tip segments, a limit-bearing surface to control distal tip projection, and dimensional constraints linking thread outside diameter to catheter inside diameter.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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