Device and method for automated insertion of penetrating member
Inventors
Bagwell, Roger B. • Clement, Ryan S. • Mulvihill, Maureen L. • Scruggs, Casey A. • SNOOK, Kevin A. • Cohn, William E. • Herlihy, James Patrick • RENNICKS, Kenneth Wayne
Assignees
Ex Machina Medical LLC • Baylor College of Medicine • Texas Medical Center • Obvius Robotics Inc
Publication Number
US-11793543-B2
Publication Date
2023-10-24
Expiration Date
2036-09-16
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Abstract
An automatic insertion device and method of using the same is provided. A vibrator and an extender are connected to a penetrating member and are both in electrical communication with a controller. A detector identifies a subcutaneous target for insertion and the insertion angle, distance and trajectory for the penetrating member are calculated. The vibrator provides vibrations to the penetrating member and the extender advances the penetrating member for insertion. The vibrator and extender are in electrical communication with one another during the insertion process and adjustments to the insertion speed are made based on feedback of vibrational load encountered by the vibrator during insertion, and adjustments to the vibrations are made based on feedback of insertion load encountered by the extender during insertion. Iterative samples are taken to constantly adjust the operation of one motor based on the operations and feedback from the other motor.
Core Innovation
The invention provides an automated insertion device, system, and method that combines actuated positional guidance with vibration of a penetrating member, such as a needle, for penetrating skin, subcutaneous tissues, and venous walls, overcoming tissue and vessel wall deformity problems during needle insertion. The device incorporates mechanical actuators directed by a processor that calculates needle positioning and path, and actuators operate automatically according to processor instructions. Although described for needles, the system may be used to insert guidewires, catheters, and other medical devices within body cavities, vessels, or compartments.
The penetrating member is vibrated during insertion, a technique shown to reduce puncture and friction forces, decrease tissue deformation, energy absorption, penetration force, and tissue damage, and mitigate vein wall compression and rolling. The vibration increases needle velocity, reduces tissue deformation by utilizing viscoelastic properties of tissue, and enhances contrast in ultrasound imaging for user observation. Adjustments to insertion speed and vibration parameters are made automatically based on feedback of vibrational and insertion loads encountered during the insertion process, with iterative sampling enabling continuous tuning of operation modes of the vibrational and extension actuators in communication with one another to optimize insertion.
The device employs a detector, such as an ultrasound probe, to identify a subcutaneous target and calculates insertion angle, distance, and trajectory for the penetrating member toward the target. Adjustments to position and insertion are computed by a processor, and a user may interactively select or modify the target point using a display interface. The insertion speed and vibration amplitude or frequency are dynamically adjusted during insertion by monitoring loads on both the vibrator and extension actuators. The device may be handheld and ergonomically shaped, including features such as a handle, support arm, and various actuators for vertical, angular, and linear adjustments of the penetrating member.
Claims Coverage
The patent includes independent method claims describing a device and automated method for inserting a penetrating member into tissue with coordinated control of vibrational and extension actuators based on feedback loads.
Integration of imaging-based targeting with automated control
The device includes a detector to obtain imaging data of a target site, calculates targeting information including insertion distance, and provides operative instructions to vibrational and extension actuators based on this data.
Load-based bidirectional adjustment between vibrational and extension actuators
During insertion, the device detects vibrational load on the vibrational actuator and insertion load on the extension actuator, compares loads to predetermined values, and adjusts insertion speed and vibration parameters reciprocally to respond to tissue resistance.
Iterative monitoring and adjustment during insertion
The method iteratively monitors load values at frequent intervals (e.g., every 20 milliseconds) and dynamically adjusts speed and vibrational parameters during insertion minimizing tissue deformation and optimizing penetration efficiency.
The independent claims cover the automated method and device for injecting a penetrating member with coordinated vibration and extension actuators, using imaging-derived targeting information and feedback-based iterative load adjustments to control insertion speed and vibration.
Stated Advantages
Reduces tissue deformation, energy absorption, penetration force, and tissue damage during needle insertion.
Mitigates complications such as vein rolling and vessel wall compression by vibrating the penetrating member during insertion.
Improves imaging contrast for needle placement via vibration allowing better visualization by ultrasound.
Provides iterative feedback control between vibration and extension actuators to automatically optimize insertion speed and vibration parameters.
Enables automated, reliable, and faster placement of central venous catheters and other penetrating members with less complications.
Handheld ergonomic design facilitates ease of use by a wide range of medical personnel, expanding availability of vascular access.
Documented Applications
Automated insertion of central venous catheters (CVCs) in patients.
Penetration of tissues for delivery or removal of bodily fluids, tissues, nutrients, medicines, and therapies.
Obtaining percutaneous access to body compartments, including vasculature and spinal cavity.
Insertion of medical devices such as guidewires, catheters, and dilators into blood vessels and body cavities.
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