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Infusion Pumps

Veerendra Balchand

Alazare T. Bati

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Abstract

Over 29.1 million or 9.3 % of the U.S population suffers from diabetes mellitus. [10] The most prominent treatment of diabetes mellitus is insulin injection. However, studies have shown it is inefficient. Recent developments of automated delivery system, which utilize infusion pumps have allowed for a continuous and extremely precise release of fluids/drugs.[6] Thus reducing medication error and opening doors for further advancement in drug delivery.

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Background

  • Before 1950’s
    • Drugs were made into pill or capsule formulation [6]
      • Released upon water contact
      • Uncontrollable release of drug kinetics
  • In 1952
    • Smith Klein Beecham introduced the Spansule Technology
      • Allowed for a sustained release formulation that was able to control the drug release kinetics and achieve 12-h efficacy. [12]

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Evolution of Infusion Pumps

  • First Generation (1950-1980)
    • oral and transdermal controlled release

formulations for clinical applications [6]

    • Barriers
      • Physicochemical properties
  • Second Generation (1980 -2010)
    • Smart Delivery System [12]
    • Barriers
      • Biological
  • Third Generation (2010 - 2040)
    • Modulated Delivery System [6]
    • Barriers
      • Biological and Physicochemical properties

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Topic Description

  • Infusion Pumps help deliver fluids into a patient's body in controlled amounts. [6]
  • Types of Infusion pumps
      • Stationary pumps
        • Help deliver fluids at patient's bedside
      • Ambulatory pump
        • Function as wearable devices
    • Benefits of Infusion pumps over conventional methods
      • delivery in miniature amounts
      • automated delivery intervals
    • Examples of conditions Infusion pumps act as a method of transport
      • Nutrients
      • Medication
      • Insulin
      • chemotherapy drugs
      • Antibiotics

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Clinical Relevance

  • Infusion pumps are capable of delivering fluids in large or small amounts. Such as… [3]
    • nutrients
    • medications
    • anticoagulants
    • antibiotics
  • Different types of infusion pumps:
    • Replacement pumps [11]
    • Pre-blood pumps (PBPs)
    • Effluent pumps
    • Passive/active-drug-infusion pumps

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Clinical Relevance (cont.)

  • Use of infusion pumps for insulin delivery:
    • Fully automated measurement of blood glucose levels and the delivery of insulin and glucagon [4]
  • Benefits of using an infusion pump for insulin delivery:
    • a fully automated closed-loop dual sensor bi-hormonal artificial pancreas system that does not require human interaction [4]
    • algorithm called the FMPD which was designed to deliver insulin based on the normal physiology of the B-cells
      • implementation of the FMPD algorithm to control both insulin and glucagon based on sensed glucose readings [4]

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Effect of Insulin Pumps on Patients

  • The graphs to the left the impact of a using an insulin infusion pump. The x-axis of these graphs represent time of the day, while the y-axis represents blood glucose level. It is clear that the patient’s blood glucose levels are much more controlled when the insulin infusion pump was used. [13]

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How insulin infusion pumps determine dose:

  • The image to the left shows two graphs. The top graph shows a normal blood glucose levels, while the bottom graph shows how an algorithm created at the University of Perugia to match normal blood glucose levels. The algorithm would be used for insulin infusion pumps to determine how much insulin to release into the body for the patient to acquire normal blood glucose levels. [14]

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Technical Analysis

  • Technical analysis of flow-adjustable elastic drug infusion pump
    • conventional passive-type infusion pumps have fixed flowrate and monotonic flow pattern [8]
      • Flow rate (volumetric) formula: V= v*A, where v is velocity and A is cross sectional area [8]
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  • Flow rate regulation:
    • the flowrate of the drug depends on the internal pressure of the drug chamber and flow resistance of the outlet catheter [2]
    • To prevent this flow variance and guarantee accurate flow maintenance during the overall operational period:
      • the internal pressure of the drug chamber must be constant in all states [2]
      • actual flow rate of the drug must be regulated around the target flow rate during the entire period of operation [2]

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Technical Analysis

  • Mathematical model of flow of a hollow microneedle array driven by a micro-pump
    • the drug solution diffuses into the skin due to its concentration gradient and natural flow between soft tissues [7]
      • The flow volume of drug solution into the skin during a time period of dt can be expressed as:[7]

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Dosage Analysis

  • The formula below shows how to calculate flow rate in ml/h. These are the units commonly used in the clinical setting. [11]

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Current Technology

  • Here you can see one of the latest models of the insulin infusion pump.

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Bioethics

  • Evaluation of Biomaterials [5]
    • Compliance with MDR (Medical Device Reporting)
  • Animal Research
    • Cost efficient and less regulation
  • Human Experimentation
    • Moral dilemma to disclose failure clinical trials [9]
  • Cost
    • Manufacturing costs
      • Use of cheap materials
        • Defective products
        • Carcinogenic effects
        • Metabolic effects
        • Immunologic effects
    • Cost of product
      • Cost of final product greater than implant material
      • Financial burden on public and healthcare [9]

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Future Prospects

  • Delivery of poorly water-soluble drugs [12]
    • Cancer drugs
  • Targeted drug delivery using nanoparticles
    • Cancer drugs
    • siRNA to tumors
  • Long-term drug delivery
    • Peptide
    • Nucleic acid
    • Protein
  • Self-regulated drug delivery [1]
    • Insulin Systems
    • Artificial Kidney System
    • Artificial Pancreas System

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References

  1. Guenego, A., Bouzillé, G., Breitel, S., Esvant, A., Poirier, J., Bonnet, F., & Guilhem, I. (2016). Insulin Pump Failures: Has There Been an Improvement? Update of a Prospective Observational Study. Diabetes Technology & Therapeutics. doi:10.1089/dia.2016.0265
  2. Choi, S., Kang, S., Kim, H., & Nam, K. (2011). Development and in vitro evaluation of a flow-adjustable elastic drug infusion pump. Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, 225(11), 1070-1077. doi:10.1177/0954411911419008
  3. Armignacco, P., Garzotto, F., Bellini, C., Neri, M., Lorenzin, A., Sartori, M., & Ronco, C. (2015). Pumps in Wearable Ultrafiltration Devices: Pumps in Wuf Devices. Blood Purification, 39(1-3), 115-124. doi:10.1159/000368943
  4. P. G. Jacobs et al., "Development of a fully automated closed loop artificial pancreas control system with dual pump delivery of insulin and glucagon," 2011 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Boston, MA, 2011, pp. 397-400.
  5. Blauw, H., Keith-Hynes, P., Koops, R., & Devries, J. H. (2016). A Review of Safety and Design Requirements of the Artificial Pancreas. Annals of Biomedical Engineering, 44(11), 3158-3172. doi:10.1007/s10439-016-1679-2
  6. Park, K. (2014). The Controlled Drug Delivery Systems: Past Forward and Future Back. Journal of Controlled Release : Official Journal of the Controlled Release Society, 190, 3–8. http://doi.org/10.1016/j.jconrel.2014.03.054
  7. Yang, F., Chen, K., & Feng, Z. (2011). Analytical model of initial fluid infusion by a microneedle drug delivery system. 2011 4th International Conference on Biomedical Engineering and Informatics (BMEI). doi:10.1109/bmei.2011.6098420
  8. Cebeiro, J., Musacchio, A., & Sardá, E. F. (2011). Low flow measurement for infusion pumps: Implementation and uncertainty determination of the normalized method. Journal of Physics: Conference Series, 332, 012005. doi:10.1088/1742-6596/332/1/012005
  9. Rodbard, D. (2016). Continuous Glucose Monitoring: A Review of Successes, Challenges, and Opportunities. Diabetes Technology & Therapeutics, 18(Suppl 2), S2–3–S2–13. http://doi.org/10.1089/dia.2015.0417
  10. 2014 National Diabetes Statistics Report. (2015). Retrieved December 06, 2016, from http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html
  11. Matthew B. Weinger and Andrew Kline (2016) Reflections on the Current State of Infusion Therapy. Biomedical Instrumentation & Technology: July/August 2016, Vol. 50, No. 4, pp. 253-262.
  12. Yun, Y. H., Lee, B. K., & Park, K. (2015, October 9). Controlled Drug Delivery: Historical perspective for the next generation. Journal of Controlled Release, 219, 2-7. doi:10.1016/j.jconrel.2015.10.005
  13. Alaris™ Pump module. (n.d.). Retrieved December 07, 2016, from http://www.carefusion.com/our-products/infusion/infusion-system-devices/alaris-pump-module

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1b.http://www.gsk.com/en-gb/about-us/our-history/

2b.http://www.summitbiomedical.com/Infusion-Pumps.html

3b. http://www.diabetestone.com/pumping.html

6b.http://www.medspares.co.nz/equipment/infusionsyringe-pumps

4b.S. R. Dikondwar, "Design and development of insulin delivery system prototype," 2011 IEEE 3rd International Conference on Communication Software and Networks, Xi'an, 2011, pp. 575-579.

doi: 10.1109/ICCSN.2011.6014636

6b.http://www.carefusion.com/our-products/infusion/infusion-system-devices/alaris-pump-module

5b. R. Dudde and T. Vering, "Advanced insulin infusion using a control loop (ADICOL) concept and realization of a control-loop application for the automated delivery of insulin," 4th International IEEE EMBS Special Topic Conference on Information Technology Applications in Biomedicine, 2003., 2003, pp. 280-282.

doi: 10.1109/ITAB.2003.1222532

7b.https://ww2.kqed.org/futureofyou/2015/08/03/millions-of-americans-use-medical-devices-that-are-vulnerable-to-hacking

8b. http://stmedia.startribune.com/images/ows_146560598462864.jpg

9b.http://image.slidesharecdn.com/1-prismaflexcrrtintro-seg12007-110326040426-phpapp02/95/1-prismaflex-crrt-intro-seg-1-2007-30-728.jpg?cb=1301112387

10b. http://main.diabetes.org/dforg/pdfs/2016/2016-cg-insulin-pumps-chart.pdf

Citations for images:

13. S. R. Dikondwar, "Design and development of insulin delivery system prototype," 2011 IEEE 3rd International Conference on Communication Software and Networks, Xi'an, 2011, pp. 575-579.

14. R. Dudde and T. Vering, "Advanced insulin infusion using a control loop (ADICOL) concept and realization of a control-loop application for the automated delivery of insulin," 4th International IEEE EMBS Special Topic Conference on Information Technology Applications in Biomedicine, 2003.,

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