Seminar on Closed Loop Medical Devices (CSCI 7000-013, Spring 2015)

Course Format

Each week, we will read and discuss a group of related papers on a topic. For some of the weeks a student will be designated to lead the discussion. The goal for each student is to read the paper as carefully as possible before the week's lecture and contribute to its discussion in class.

Before Class

• A discussion lead for that week is assigned in advance. Each student can expect to lead a discussion at least 2-3 times during the semester.

• Students read the paper(s) before coming to class.

• Discussion lead reads the papers and works with the instructor to make up a summary of the paper.

During Class

Roughly, each class will proceed as follows:

• Discussion lead provides a summary of the paper: 10-20 minutes

• Students raise questions/comments about the paper.

After Class

Discussion lead writes a short review summarizing the discussion before sending it out to the class.

Guest Lectures

For some topics, we will have guest lectures from experts who have worked on the modeling, design and verification closed loop medical devices.

List of Papers

A list of papers to be read will be posted here. Most of the links will work if accessed on-campus or through a VPN to our campus.

Note: Preliminary list is here for your reference: mostly surveys. An updated list will be posted before the start of the semester.

Artificial Pancreas Papers

• Claudio Cobelli, Eric Renard and Boris Kovatchev, Artificial Pancreas: Past, Present, Future, Diabetes November 2011 vol. 60 no. 11 2672-2682.

• B. Kovatchev, M. Breton, C. Dalla Man and C. Cobelli, In Silico Preclinical Trials: A Proof of Concept in Closed-Loop Control of Type 1 Diabetes, J Diabetes Sci Technol. Jan 2009; 3(1): 44–55.

• Francis J. Doyle, Lauren M. Huyett, Joon Bok Lee, Howard C. Zisser and Eyal Dassau, Closed-Loop Artificial Pancreas Systems: Engineering the Algorithms, Diabetes Care, May 2014 vol. 37 no. 5 1191-1197.

• Hovorka R, Canonico V, Chassin LJ, Haueter U, Massi-Benedetti M, Orsini Federici M, Pieber TR, Schaller HC, Schaupp L, Vering T, and Wilinska ME. Nonlinear model predictive control of glucose concentration in subjects with type 1 diabetes. Physiol Meas. 2004 Aug;25(4):905-20.

Implantable Devices for Human Heart

• Michael Glikson and Paul A Friedman, The implantable cardioverter defibrillator, THE LANCET • Vol 357 • April 7, 2001.

• Zhihao Jiang, Miroslav Pajic and Rahul Mangharam, Model-Based Closed-Loop Testing of Implantable Pacemakers, ICCPS 2011, IEEE Press.

Computer Controlled Anesthesia

• T.M. Hemmerling, Automated Anesthesia, Current Opinion in Anaesthesiology Issue: Volume 22(6), December 2009, pp. 757–763.

• Anesthesia Control Group at ETH Zurich.

Other Papers/Topics of Interest

• H. Thimbleby, Is IT a dangerous prescription?, BCS Interfaces, 84, pp.5–10, 2010.

• Sandler, K., Ohrstrom, L., Moy, L., McVay, R.: Killed by Code: Software Transparency in Implantable Medical Devices. Software Freedom Law Center (2010)

• Wayne Burleson and Sandro Carrara, Security and Privacy of Implantable Medical Devices (Edited Volume by Springer-Verlag).

Schedule

The schedule of lectures shown below is subject to change. We will post papers in the private area for most topics. We will strive to post all material well in advance. Please take a look through them, and come prepared for class.

Topics

The course will focus on closed loop medical devices.

Closed-loop medical devices involve sophisticated algorithms that control critical physiological functions through sensing, computation and actuation. These devices may be completely autonomous, or enjoy a limited degree of autonomy to assist the human operator.

Examples include:

1. Artificial Pancreas: Control of insulin infusion to patients with type-1 diabetes.

2. Computer Controlled Anesthesia: Control of anesthesia delivery to surgical patients.

3. Implantable Heart Defibrillators and Pacemakers: Implanted devices that automatically control electrical signaling to the human heart, intervening to prevent dangerous heart conditions.

4. Other Closed-Loop Devices in Medicine: Feedback control in surgical robots, deep brain stimulation, closed loop mechanical ventillation, and emerging closed loop devices.

Closed-loop medical devices are safety-critical: malfunctions often result in serious injury or death to the patient.

The course will primarily focus on research around modeling, design, verification/validation and clinical issues surrounding these devices:

1. Modeling the relevant aspects of human physiology: insulin-glucose regulatory models, pharamacokinetic/pharmacodynamic models, cardiac modeling (at various scales) and other important mathematical modeling efforts in biomedical engineering.

2. Design issues surrounding these devices: sensing/actuation limitations, constraints on computation. Control algorithm design will be our main focus.

3. Verification/Validation

4. Clinical Evaluation

But these are not the only issues surrounding closed loop devices. In a broader setting, there are many other issues to focus on. The papers we read will touch upon some of these issues as well.

1. Human Factors Issues (these are often closely tied to control algorithm development).

2. Security/Privacy Issues.

3. US FDA regulations, commercialization issues, and so on.

Course Work

Grading is simply through participation. The student is expected to show up in class, prepared to discuss the paper. When asked to be a discussion lead, the student should take the time to meet with the instructor during office hours to ensure that their understanding of the paper is appropriate for leading the discussion.