Reduced force device for intravascular access and guidewire placement

Inventors

Bagwell, Roger B • Clement, Ryan S • Mulvihill, Maureen L • Scruggs, Casey A • Snook, Kevin A

Assignees

Actuated Medical Inc

Abstract

A device for penetrating tissue with reduced force and placing a guidewire is provided. The device includes a driving actuator generating reciprocating motion. A penetrating member having a lumen dimensioned to accommodate a guidewire is provided. A coupler mechanically connects the driving actuator and the penetrating member to transfer the reciprocating motion to the penetrating member. The penetrating member may be coaxial or axially offset from the driving actuator. At least one frictional member facilitates the movement of the guidewire through the lumen for placement at the target tissue. The frictional member(s) may be operated manually or by a guidewire actuator. A housing may also be provided including a channel also dimensioned to accommodate the guidewire, and may further include the frictional member(s) for facilitating movement of the guidewire. The channel and lumen are aligned to permit placement of the guidewire at the target site.

Core Innovation

The invention provides a device for guidewire placement that uses an electrically activated driving actuator to generate repetitive reciprocating motion in an axial direction at a frequency in a range of 50 to 500 Hz sufficient to reduce the force needed to penetrate living being tissue when the driving actuator is activated. The device includes a penetrating member having an open distal end and an opposite open proximal end, and a lumen extending between the open distal and proximal ends dimensioned to accommodate a guidewire. The repetitive reciprocating motion is transmitted to the penetrating member through a coupler so that the penetrating member moves with the repetitive reciprocating motion at the stated frequency in the axial direction during penetration.

The device further includes at least one frictional member configured to selectively engage and facilitate movement of the guidewire through the lumen. In one configuration, the system includes a housing and a guidewire channel sized for and aligned to accommodate the guidewire with the lumen of the penetrating member, including a continuous bore. In another configuration, the penetrating member and lumen extend axially along a penetrating axis that is spaced apart from the driving axis, with the coupler transmitting the repetitive reciprocating motion from the driving axis to the penetrating member along the penetrating axis.

The disclosed actuator implementations include a voice coil motor with LVDT feedback, and additionally include solenoid/DC motor, piezoelectric/Langevin, and flextensional transducers as options for the electrically activated driving actuator. The coupling and penetrating-member configurations include a detachable penetrating component and couplers that enable coaxial or axially offset (parallel axes) relationships between the driving axis and the penetrating axis. The document also discusses control/feedback concepts including frequency and current control to maintain oscillation and mitigate damping during tissue loading, together with performance-related experimental data showing reduced penetration force and reduced tissue deformation in the penetration context.

Claims Coverage

The independent claims cover two closely related device architectures for guidewire placement: an axial reciprocating penetration device where the actuator drives a penetrating member and includes a lumen and frictional guidewire facilitation, and a similar device where the penetration axis is spaced apart from the driving axis and the coupler transfers motion between axes. Each independent claim includes multiple structural and functional inventive features.

Across the independent claims, the core claimed elements are an electrically activated driving actuator that generates repetitive reciprocating motion sufficient to reduce tissue penetration force, a penetrating member with an open-ended guidewire lumen, a coupler that mechanically transmits the actuator motion to move the penetrating member during penetration, and at least one frictional member that selectively engages to facilitate guidewire movement through the lumen. The second independent claim additionally specifies that the penetrating axis is spaced apart from the driving axis and that the coupler transfers motion between those axes.

Stated Advantages

Documented Applications