Oscillation-aided implant insertion system and device

Inventors

Bagwell, Roger BAlsubhi, Alanoud SClement, Ryan SGreaser, Jenna KSteffan, Eric MTirko, Natasha N

Assignees

Actuated Medical Inc

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Publication Number

US-12415080-B2

Patent

Publication Date

2025-09-16

Expiration Date


Abstract

An implant insertion device includes a vibrational actuator generating axial vibrations, a coupler interconnected to the actuator and selectively retaining an implant with penetrating electrodes. The coupler has a distal end cavity at one end dimensioned to receive and retain at least a portion of the implant. Vibrations are transferred to the electrodes during insertion. A vacuum assembly connects to the coupler and provides a negative pressure, or suction force, when a vacuum source is attached and activated. This suction force is sufficient to hold the implant to the distal end of the coupler. Deactivation of the vacuum source removes the suction force, causing the implant to detach from the coupler without perturbation of position. The insertion device may then be removed. A system to coordinate the operation of the actuator and movement of the device and/or tissue relative to one another for delivery of the implant is also provided.

Core Innovation

The invention provides a device for inserting an implant into target tissue that uses a vibrational actuator and a coupler with a coupler lumen. The vibrational actuator generates vibrations when activated, and the coupler distal end selectively retains the implant while the device transmits vibrations from the actuator to the implant. The coupler lumen extends between a proximal end mechanically interconnected with the vibrational actuator and the distal end configured to selectively retain the implant.

A vacuum assembly mechanically interconnects the vibrational actuator and the coupler and transmits vibrations from the vibrational actuator to the coupler. The vacuum assembly includes a vacuum connection body with a body lumen that is connected to the coupler lumen in fluid flow communication, thereby collectively defining a vacuum path between a vacuum source and the distal end of the coupler. Upon activation to create air flow in negative pressure from the distal end through the coupler lumen and the body lumen to the vacuum source, the negative pressure selectively retains the implant at the distal end and selectively releases the implant from the distal end by deactivation of the vacuum source.

The coupler simultaneously transmits the vibrations to the implant and facilitates air flow in a negative pressure at the implant sufficient to retain the implant at the distal end of the coupler. In the method aspect, a device is aligned with a coupler to target tissue, an implant having a base and at least one electrode is brought within proximity to the distal end, and negative pressure retains the implant while the electrode is oscillated by activating the vibrational actuator. The device is advanced along an insertion axis toward the target tissue until the electrode penetrates to a desired depth, the vibrational actuator is deactivated, and the implant is selectively released by deactivating the vacuum source.

Claims Coverage

The document includes two independent claims: one device claim and one method claim. Together, they specify a system that couples a vibrational actuator to a coupler while applying a vacuum path to selectively retain and release an implant, and they further define oscillation during advancement and release by vacuum deactivation.

Vibrational actuator and coupler with selective implant retention lumen and distal end

A device for inserting an implant into target tissue comprising a vibrational actuator configured to generate vibrations when activated, and a coupler having a proximal end mechanically interconnected with the vibrational actuator, a distal end configured to selectively retain the implant, and a coupler lumen extending between the proximal and distal ends.

Vacuum assembly defining a vacuum path for selective retention and release via negative pressure

A vacuum assembly mechanically interconnecting the vibrational actuator and the coupler and transmitting the vibrations from the vibrational actuator to the coupler, the vacuum assembly including a vacuum connection body with a body lumen connected in fluid flow communication with the coupler lumen to collectively define a vacuum path between the vacuum source and the distal end of the coupler, where the vacuum path is dimensioned to permit air flow in negative pressure to selectively retain the implant upon activation and to selectively release the implant by deactivation of the vacuum source.

Simultaneous vibration transmission and vacuum air flow at the implant during retention

The coupler simultaneously transmits the vibrations to the implant and facilitates said air flow in a negative pressure at said implant sufficient to retain said implant at said distal end of said coupler.

Aligning and advancing with oscillating electrode while retaining implant by negative pressure

A method of inserting an implant into tissue comprising aligning a device comprising a vibrational actuator, a vacuum connection body, and a coupler with target tissue; bringing an implant having a base and at least one electrode within proximity to a distal end of the coupler; activating a vacuum source interconnected to the vacuum connection body to create air flow in a negative pressure between the implant and the distal end and thereby selectively retain the implant; oscillating the at least one electrode by activating the vibrational actuator and transmitting vibrations through the vacuum connection body and the coupler to the implant at the distal end; advancing the device with the implant along an insertion axis until the at least one electrode penetrates to a desired depth; deactivating the vibrational actuator; and selectively releasing the implant by deactivating the vacuum source.

Across the independent claims, the invention centers on coordinating vibrations with a coupler that both transmits vibrations to the implant and supports a vacuum path that creates negative pressure for selective retention during oscillation and advancement, followed by selective release when the vacuum source is deactivated.

Stated Advantages

Reducing insertion force and tissue dimpling by transmitting axial micro-vibrations to the penetrating electrodes during insertion.

Potentially reducing foreign body response (FBR).

Documented Applications

Inserting a penetrating electrode implant into target tissue using a device with an oscillation-aided implant insertion system and a vacuum path for retaining and releasing the implant.

Method use of aligning an implant insertion device and oscillating an electrode while advancing along an insertion axis until a desired penetration depth, then releasing the implant by deactivating the vacuum source.

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