Ultrasound-Guided Robotic Central Line Placement

Last updated: 5/10/2023

Summary

The project aims to improve the accuracy and safety of central line placement, specifically for non-tunnelled central line catheter placement through the subclavian. This will be achieved through the development of a lightweight, patient-mountable robotic system for needle, guidewire, and catheter insertion. The accuracy and safety of the system will be tested, and workflow documentation will be provided for easy integration into clinical practice. Ultimately, the goal of the project is to improve patient safety and outcomes.

  • Students: Kesi Liang, Pranathi Golla, Xuanning Liu
  • Mentor(s): Dr. Axel Krieger, Lidia Al-Zogbi, Dr. Vinciya Pandian, Dr. Mathias Unberath, Wenhao Gu

Introduction

Background

  • Centrally Inserted Central line Catheters (CICCs) are inserted into a central vein to administer medication, nutrition etc. into bloodstream.
  • The procedure has 4 standard access points: jugular, subclavian, femoral and arm veins.

  • There are different kinds of CICCs: Non-tunnelled CICC, Tunnelled CICC, Peripherally Inserted Central line Catheter (PICC), Implanted port.
  • The choice of CICC depends on the individual patient’s needs and medical condition.

Motivation

  • Central lines can introduce microorganisms that can cause infections:
    • result in increased healthcare costs, and even death.
    • Therefore, a robotic system can minimise the risk of infection and reduce healthcare costs.
  • The procedure of central line placement can be physically and mentally demanding for clinicians:
    • requires a steady hand, precise movements and focus.
    • Hence, a robotic system can assist clinicians with these tasks.

Objectives

The objective of this project is to design and develop a robotic system for ultrasound-guided central line placement that can enhance the accuracy and safety of the operation. The goals of this project are as follows:

  • Develop a prototype of a light-weight and patient-mountable robotic system for non-tunneled central line catheter placement through the subclavian vein. The system would automate the following procedures:
    • Needle insertion
    • Guidewire insertion
    • Catheter insertion
  • Provide documentation of the work, including high-level and low-level design specifications, and design documents.

Deliverables

  • Minimum: (Expected April 10th)
    1. Design document with the high-level and low-level specifications of the robotic central line placement system, which can perform needle insertion, guidewire advancement, and catheter advancement through the subclavian.
    2. CAD model of the robotic system.
  • Expected: (Expected May 10th)
    1. Prototype and functionality demonstration of the system, which can perform central line placement automatically with image guidance.
    2. Documentation of the functioning of the system.
  • Maximum: (Summer Semester)
    1. GUI for insertion site selection from the ultrasound images.
    2. Experimental evaluation of the accuracy and safety of the system on phantoms.
    3. Submission of the work to a peer-reviewed venue.

Technical Approach

Design Assumptions

  1. Clinician’s role: The clinician will scan the region using ultrasound and decide on the insertion site and angle, ensuring the robot’s focus is on the insertion process.
  2. Guidewire type: The guidewire used will be straight without a J-tip, simplifying the design requirements for the guidewire advancement mechanism.
  3. No dilators: Dilators will not be used in the insertion process, reducing the complexity of the robotic system.
  4. Manual retraction: The clinician will manually retract the needle and guidewire, allowing the robot to concentrate on insertion tasks.
  5. Detachable syringe: The syringe will be detachable from the needle without the need for a twisting motion, easing the robot’s needle insertion mechanism design.
  6. Clinician’s assistance: The clinician will load the guidewire and catheter onto the robot system, simplifying the design requirements for object handling.

Design Specifications

  1. Angular workspace: The robot should have an angular workspace of around 10 degrees to 45 degrees relative to the skin, ensuring a suitable range of insertion angles.
  2. Degrees of freedom: The robot should have 2 rotational degrees of freedom and 2 translational degrees of freedom, enabling precise positioning and movement during the procedure.
  3. Precision and accuracy: The robot should have a precision of at least 1mm in all movements with an accuracy of 90%, ensuring reliable and consistent performance.
  4. Needle insertion parameters: The robot should be able to insert an 18-gauge needle at an angle of 30-40 degrees (see [16]) and a depth of 2-6 cm (refer to [17]), conforming to standard central line placement guidelines.
  5. Guidewire advancement: The robot should be able to advance about 10-15 cm of a 50 cm guidewire (see [18]), ensuring proper placement within the target vessel.
  6. Guidewire compatibility: The robot should be able to insert a guidewire with a diameter of 0.035 inches (see [16]) through the needle, accommodating standard guidewire sizes.
  7. Catheter compatibility: The robot should be able to insert a catheter with a size 8.0 French (refer to [16]), conforming to standard central line catheter sizes.
  8. Remote center of motion indication: The robot should be able to indicate the remote center of motion, providing guidance and ensuring proper alignment during the procedure.

Robot Design

The robotic system consists of five parts: the base, the arc, and the carriage, the needle insertion actuator, and the guidewire & catheter advancement actuator. It has 2 rotational degrees of freedom (DoF) and 2 translational DoF. The angular workspace of insertion is 13 degrees to 50 degrees relative to the skin, and the depth workspace is 19.8 mm to 67.4 mm. The mechanical remote center of motion (RCM) is 8.5 mm above the skin.

The base includes a GelPort and a rigid base.

  1. GelPort, a sticky soft material generally used in laparoscopic surgery, holds the robot on the patient.
  2. The rigid base sticks on the GelPort, which connects the GelPort and supports the arc.

The arc is connected to the rigid base and is driven by a step motor attached to the rigid base to provide one rotational DoF along the y-axis. The teeth on the arc are matched with the gear on the carriage, providing restrictions on the motion of the carriage.

The carriage uses a circular rack and pinion gear mechanism to slide over the arc. There is a small gear on the carriage driven by a step motor on the back to provide one rotational DoF along the x-axis. There is a laser pointer bucket at the bottom of the carriage, holding the laser pointer to indicate the RCM when rotating. There is a motor on each side of the carriage, driving the needle insertion actuator and the guidewire & catheter advancement actuator separately to provide two translational DoF. As both actuators use a rack and pinion gear mechanism to move along the carriage, there are pinions attached to the shaft of the motors and sliders matched with the racks on the actuators to provide restrictions on the motion.

The needle insertion actuator is a holder of the needle syringe. There is a rack on the back of the holder, which is coordinated with the pinion on the carriage. There is a guide rail on the rack, which is coordinated with the slider on the carriage.

The guidewire & catheter advancement actuator is as shown. Similar to the structure of the needle insertion actuator, there is a rack on the back of the actuator, which is coordinated with the pinion on the carriage. There is a guide rail on the rack, which is coordinated with the slider on the carriage. A detachable guidewire & catheter feeder is held on the actuator, allowing the guidewire and catheter to go through and restricting the direction of their movements. The feeder is coordinated with a roller driven by a step motor to advance the guidewire and catheter.

Image Guidance and User Interface

  • Feedback based solely on ultrasound image
  • User-friendly software showing real-time ultrasound images
  • Clinician determines and confirm target point and insertion angle in image coordinate
  • Coordinates transformed from image coordinate to actuator coordinates
  • Actuator precisely controls needle movement to desired location
  • Clinician can stop the insertion if needed

Testing Plan

  • Design validation:
    • Validate the design using computer simulations
    • Ensure that the robot’s kinematic designs are correct
  • Functional testing:
    • Conduct functional testing of prototype
    • Ensure robot can accurately and reliably perform the necessary movements and actions
  • Performance testing:
    • Test the robot in a laboratory or simulated clinical environment
    • Ensure that it can perform central line placement accurately and consistently
  • Involve measuring the robot performance metrics, such as accuracy, precision, and speed
  • Issue identification and resolution:
    • Identify and address any issues or problems that arise during testing

Dependencies

Milestones and Status

  1. Milestone name: Preliminary Research
    • Planned Date: February 24th
    • Expected Date: March 5th
    • Status: Completed
  2. Milestone name: Design Specifications
    • Planned Date: March 6th
    • Expected Date: March 10th
    • Status: Completed
  3. Milestone name: Mechanical design and enhancement
    • Planned Date: March 10th
    • Expected Date: April 25th
    • Status: Completed
  4. Milestone name: Prototyping
    • Planned Date: April 25th
    • Expected Date: May 5th
    • Status: Completed
  5. Milestone name: Documentation
    • Planned Date: May 5th
    • Expected Date: May 10th
    • Status: Completed

}

Reports and presentations

Project Bibliography

  1. A. Tse and M. A. Schick, “Central line placement,” in StatPearls, StatPearls Publishing, 2022.
  2. Y. Haddadin, P. Annamaraju, and H. Regunath, “Central line associated blood stream infections,” in StatPearls, StatPearls Publishing, 2017.
  3. V. Chopra and I. Davidson, “Central venous access: Device and site selection in adults,” in UpToDate, UpToDate Publishing, 2022.
  4. E. Cheung, M. O. Baerlocher, M. Asch, and A. Myers, “Venous access: a practical review for 2009,” Canadian Family Physician, vol. 55, no. 5, pp. 494–496, 2009.
  5. J. R. Roberts and J. R. Hedges, Roberts and Hedges’ clinical procedures in emergency medicine E-book. Elsevier Health Sciences, 2013.
  6. N. Zevallos, E. Harber, K. Patel, Y. Gu, K. Sladick, F. Guyette, L. Weiss, M. R. Pinsky, H. Gomez, J. Galeotti, et al., “Toward robotically automated femoral vascular access,” in 2021 International Symposium on Medical Robotics (ISMR), pp. 1–7, IEEE, 2021.
  7. R. D. Brewer and J. K. Salisbury, “Visual vein-finding for robotic iv insertion,” in 2010 IEEE International Conference on Robotics and Automation, pp. 4597–4602, 2010.
  8. A. I. Chen, M. L. Balter, T. J. Maguire, and M. L. Yarmush, “Deep learning robotic guidance for autonomous vascular access,” Nature Machine Intelligence, vol. 2, no. 2, pp. 104–115, 2020.
  9. Brattain LJ, Pierce TT, Gjesteby LA, Johnson MR, DeLosa ND, Werblin JS, Gupta JF, Ozturk A, Wang X, Li Q, Telfer BA, Samir AE, “AI-Enabled, Ultrasound-Guided Handheld Robotic Device for Femoral Vascular Access,” Biosensors, vol. 11, no. 12, 2021.
  10. R. D. Brewer, “Improving peripheral iv catheterization through robotics: From simple assistive devices to a fully-autonomous system,” 2015.
  11. L. J. Brattain, T. T. Pierce, L. A. Gjesteby, M. R. Johnson, N. D. DeLosa, J. S. Werblin, J. F. Gupta, A. Ozturk, X. Wang, Q. Li, et al., “AI-enabled, ultrasound-guided handheld robotic device for femoral vascular access,” Biosensors, vol. 11, no. 12, p. 522, 2021.
  12. N. Patel, J. Yan, G. Li, R. Monfaredi, L. Priba, H. Donald-Simpson, J. Joy, A. Dennison, A. Melzer, K. Sharma, et al., “Body-mounted robotic system for MRI-guided shoulder arthrography: Cadaver and clinical workflow studies,” Frontiers in Robotics and AI, p. 125, 2021.
  13. F. Y. Wu, M. Torabi, A. Yamada, A. Golden, G. S. Fischer, K. Tuncali, D. Frey, and C. Walsh, “An MRI Coil-Mounted Multi-Probe Robotic Positioner for Cryoablation,” Proceedings of the ASME 2013 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference IDETC/CIE 2013, 08 2013.
  14. Z. He, Z. Dong, G. Fang, J. D.-L. Ho, C.-L. Cheung, H.-C. Chang, C. C.-N. Chong, J. Y.-K. Chan, D. T. M. Chan, and K.-W. Kwok, “Design of a Percutaneous MRI-Guided Needle Robot With Soft Fluid-Driven Actuator,” IEEE Robotics and Automation Letters, vol. 5, no. 2, pp. 2100–2107, 2020.
  15. Suzuki, T., Masahiro Kanazawa, Yoshio Kinefuchi, Haruo Fukuyama, Mamoru Takiguchi, Michio Yamamoto, Kazuhiro Abe, and Yosuke Okuda. “A pilot/introducer needle for central vein cannulation.” The Tokai Journal of Experimental and Clinical Medicine 20, no. 4-6 (1995): 223-226.
  16. Wang, Henry E., and Thomas A. Sweeney. “Subclavian central venous catheterization complicated by guidewire looping and entrapment.” The Journal of emergency medicine 17, no. 4 (1999): 721-724.
  17. Tse, Audrey, and Michael A. Schick. “Central line placement.” In StatPearls [Internet]. StatPearls Publishing, 2022.
  18. Heffner, Alan C., and Amalia Cochran. “Overview of acute and emergency central venous access in adults” in UpToDate, UpToDate Publishing, 2022.

Other Resources and Project Files

Here give list of other project files (e.g., source code) associated with the project. If these are online give a link to an appropriate external repository or to uploaded media files under this name space (2023-22).

courses/456/2023/projects/456-2023-22/project-22.txt · Last modified: by xliu226




ERC CISST    LCSR    WSE    JHU