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Science of Skin: Challenges of Long Wear Adhesives

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Presentation by Del R. Lawson, Ph.D., R&D Manager – 3M Medical Materials and Technologies, 3M Critical & Chronic Care Solutions Division at the Smart Health Conference 2018, held at Bally's Las Vegas on the 26-27th of April, 2018.

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Science of Skin: Challenges of Long Wear Adhesives

  1. 1. Science of Skin: Challenges of Long Wear Adhesives Del R. Lawson, Ph.D. R&D Manager – 3M Medical Materials and Technologies 3M Critical & Chronic Care Solutions Division
  2. 2. 2. All Rights Reserved.19 April 2018© 3M 3M at a glance ▪ Sales in ~200 countries ▪ $31.7 billion in sales ▪ Five business groups ▪ 90,000 3M employees globally *2016 figures ▪ $1.7 billion invested in R&D ▪ 113,000 patents ▪ 101 straight years of dividends ▪ One of 30 companies on the Dow Jones Industrial Index The 3M Carlton Science Center
  3. 3. 3. All Rights Reserved.19 April 2018© 3M
  4. 4. State of Science Index
  5. 5. 5© 3M 2018. All Rights Reserved. Science needs a champion 5 By 2050, the world population is expected to surpass 9 billion people. Science will be more important than ever to address the challenges we face our world continues to grow.
  6. 6. 6© 3M 2018. All Rights Reserved. Supply and demand of natural resources, including fossil fuels, minerals, renewables, water, and food will experience a powerful transformation A gradual but powerful shift in the composition, location, and sheer size of the Earth’s population is at the core of nearly all observable global trends Digitization is fundamentally changing how businesses and individuals interact, make decisions, and conduct daily operations The center of world economic influence is transitioning from dominance of developed countries towards an increasingly multipolar environment We are facing EPIC opportunities and problems… Reimagining natural resources Shifting demographics Digital transformation Evolving economic landscape
  7. 7. 7. All Rights Reserved.19 April 2018© 3M
  8. 8. 8. All Rights Reserved.19 April 2018© 3M + + Our people and collaborative culture Insights from customers and the market 46 technology platforms How do we apply science to solve problems and improve lives?
  9. 9. 9. All Rights Reserved.19 April 2018© 3M Electronics & Energy Health Care Consumer Helping hold planes and cars together Medical tapes and dressings Post-it® notes, Scotch® tapes, Command™ strips Industrial Safety & Graphics Scotchlite™ reflective material and car wraps Securing films and other parts of electronic devices Ad Adhesives We apply individual technologies across our businesses…
  10. 10. 10. All Rights Reserved.19 April 2018© 3M High-performance window film Medical dressings Ad Adhesives Fi Films FcFlexible Converting and Packaging Pm Polymer Processing Nw Nonwoven Materials Sm Specialty Materials Su Surface Modification Wo Wound Management Ad Adhesives Fi Films Nt Nano- technology Lm Light Management Filtek™ Dental Adhesives, Restoratives and Crowns Am Advanced Materials Ce Ceramics NtNano- technology Co Advanced Composites Do Dental and Ortho Materials PdParticle and Dispersion Processing Su Surface Modification Bi Biotech …and combine them in unique and creative ways Ad Adhesives
  11. 11. s The Science of Skin
  12. 12. 12. All Rights Reserved.25 April 2018© 3M 3M Confidential. Chronic disease and pain management require consistent day-to-day actions, rather than visits to the doctor to shape outcomes. There is a growing need for wearable devices which can remind, warn, encourage, and perhaps most importantly, supply the patient with innovative strategies to comply with treatment regimens (and in some cases, provide that treatment). Wearables have a unique value proposition for manufacturers, patients, and society as a whole in healthcare. Devices have already found their way into incentivized wellness programs. Pilots are underway in hospital systems to replace traditional vital monitoring with wearable devices.
  13. 13. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 13 Market Need - Increased Wear Time for Medical Devices • The essential nature of medical devices is increasing the value associated with extended wear. • Extended wear is possible, but the “do no harm” rule still applies. • How do we insure wear time does not come at the expense of skin injuries? • How can you select the best options to trial for your medical device applications? • Best practice – involve your adhesive partner early • How do we extend our understanding of adhesive performance from the lab to predict performance in the field? • Future – what can be done to improve the appearance of devices to reduce the potential social stigma of wearables?
  14. 14. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 14 What do you think about when you think about Skin? Mostly, we take it for granted • It should be thought of as the elastic “organ” that covers our body • It is our interface to the world • Physical, chemical, and microbial barrier • It protects us from the Sun • The sense of touch relies on the nerves embedded in our skin • Receptor for Heat, Cold, Pressure and Pain sensations • It can repair itself when damaged • It supports regulation of our body temperature and phosphate/calcium levels
  15. 15. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 15 Skin structure – layers upon layers with important jobs to do Stratum Corneum Epidermis Papillary Dermis Reticular Dermis Hair follicles Hypodermis
  16. 16. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 16 Microbiology of the Skin
  17. 17. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 17 15% water 70% water Water (moisture) management is critical to epidermal function
  18. 18. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 18 Factors Affecting Skin Adhesion and Wear Time Key Characteristics of Skin Human Skin Breathing, Sensitive Surface Cell Renewal Cycle Elastic Surface Low Surface Energy Rough Texture Stratum corneum: 14 days Epidermis: 28 days Reversible Stretch up to 50% 25 dynes/cm (Skin) 31 dynes/cm (Polypropylene) >500 dynes/cm (Stainless) Hair & Growth Pores Skin Wrinkles Dead Skin Cells Sweat Salt Lotions & Powders Contaminated Surface
  19. 19. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 19 What is a Medical Adhesive Tape? In the USA, “medical” adhesives, and the tape components created with them, should be produced under FDA current guidelines for Good Manufacturing Practices [cGMP] According to written operating standards that adhere to ISO:13485 Quality Management System guidelines In a clean facility that has dedicated validated equipment, supply chain traceability and is regularly audited for compliance To produce an adhesive tape that has been tested per ISO:10993 for biocompatibility and is shown to be safe for use on skin.
  20. 20. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 20 The Evolution of Adhesives Used in Medical Products 1900s 1960s 1990s Natural Rubber Latex Adhesives Introduced Acrylate Adhesives Introduced Silicone Adhesives Introduced Synthetic Rubber Adhesives X
  21. 21. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 21 How Can Medical Adhesives Cause Skin Injury? A skin injury can occur when the skin-to-adhesive attachment is stronger than the skin-to-skin attachment (Skin Stripping). skin adhesive backing The unintentional removal of skin layers is one aspect of Medical Adhesive Related Skin Injuries (MARSI)
  22. 22. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 22 Avoiding skin injuries requires a trade off of adhesive performance and properties Skin cell removal visualization Acrylate Adhesives Silicone Adhesive
  23. 23. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 23 MARSI Examples – Potential Patient Safety Concern MacerationIrritant Contact Dermatitis Allergic Dermatitis Folliculitis Tension Injury or BlisterSkin Tear Skin Stripping
  24. 24. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 24 Risk Factors for MARSI Immuno- suppression Extremes of age Skin changes with sun exposure Underlying illness Choice of Adhesive
  25. 25. 25. All Rights Reserved.19 April 2018© 3M 3M Confidential. Adhering medical devices can be a difficult task. Using the wrong adhesive could result in unforeseen added costs and device development delays. Our goal with Find My Adhesive is to leverage our more than 50 years of adhesive research and development expertise to provide a useful tool to design engineers that helps streamline the adhesive selection process and improve the device’s overall probability of success. The interactive, intuitive and efficient tool can assist design engineers in an oftentimes unexpectedly challenging and critical part of the medical device design process FindMyAdhesive.com can help with adhesive selection
  26. 26. s 3M MedTech Adhesive Evaluations of Wear Time* *Wear time results may vary, not a guarantee of performance
  27. 27. 3M Confidential.27 19 April 2018. All Rights Reserved.© 3M In order to develop extended wear solutions, we started with the products at hand > 60 Years Experience in Medical Tapes
  28. 28. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 28 • In-house wear studies and analysis • Select 3M MedTech portfolio and experimental samples • Intended to screen wear time performance and skin health • 3M employees • Healthy Volunteers • Wash to prep skin • Clip Excess Hair • 3 replicates typical • Record activity 3M Internal Wear Time Studies
  29. 29. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 29 • Target: >80% survival • Showered, no hot tubs • Active Adults • Recorded Activity Wear Time Performance over 8 Days
  30. 30. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 30 Extended Wear Study – 21 days • Select 3M MedTech tapes based on best performers in the 8 day study • Included experimental Gentle to Skin and long wear samples • 3M employees • Healthy Volunteers • Wash to prep skin • 3 replicates • Record activity • Tape only, no device
  31. 31. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 31 Wear Time Performance over 21 Days
  32. 32. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 32 Evaluation of Skin Irritation at 10 and 21 days The skin was graded following these guidelines: 0=No redness (of the skin) 1=Slight redness, barely perceptible 2=Definite redness 3=Severe redness (well defined) with edema 4=Extreme response with edema (swelling)
  33. 33. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 33 Pain Response upon Removal of Tapes at 10 and 21 days 4.6 4.3 4.3 5.2 6.7 3.3 3.3 4.5 3.3 4.1 0 10 20 30 40 50 60 70 80 90 100 [03] 1776 [04] 9834 [05] 9873H [06] 9841 [10] 1533L Pain Score (0-100mm) Pain Upon Removal (mean ± standard error) Day 21 Day 10 No pain zone: May have tugging or pulling sensation Very Painful
  34. 34. s Extended Wear Tape – Interesting… But what about medical devices?
  35. 35. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 35 Wear time study with Occlusive Device • Purpose to understand performance and skin health with device • Device locations – Abdomen and Chest • Experimental adhesives with Polyurethane backing • Samples with and without skirt (extended edge) Antenna Top Protective Layer Adhesive Tape Assembly DCT EMI Shielding Tape Assembly DCT Stick-to-Skin Adhesive
  36. 36. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 36 Images of Occlusive Plate Study Lift score of “1” 15 day - chest15 day - abdomen
  37. 37. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 37 Effect of “Skirt” on Wear Time Hypothesis: Skirt transforms failure from peel to shear
  38. 38. 3MTM 4076 Extended Wear Medical Tape • Polycarbonate “Device” Footprint: 30mm x 46mm Thickness: 3mm Weight: 4 grams • 3MTM 9889 device attachment • 16 - 3M Healthy volunteers, 8 devices/subject • Average miles walked: 70 miles • Activity tracked - only restriction hot tubs • # 5,6 & 11 were most active with highest recorded intensity minutes • #4,6 & 7 swam • #5 trained for and ran a 1/2 marathon • #11 ran daily • #12 harvested corn *Wear time results may vary, not a guarantee of performance * Day 14 0 10 20 30 40 50 60 70 80 90 100 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 PercentAttached Subject Number Percent of Devices Attached - Day 14 (3MTM 4076, Mock Device)
  39. 39. Science of Skin: Challenges of Long Wear Adhesives . All Rights Reserved.19 April 2018© 3M 3M.com/MedTech 39 Summary • Skin is a dynamic interface and highly individualized • Adhesive use can be a patient safety concern; important to prevent MARSI • Lab tests, combined with predictive models of wear time remain elusive • Clinical studies remain the most reliable predictor of performance on skin • Think about TAPE/ADHESIVES earlier in the design process • Example: An extended edge/skirt can improve wear time • 3M MedTech Tape Constructions have demonstrated extended wear time* • Improved Tape Constructions and trials are under development *Wear time results may vary, not a guarantee of performance
  40. 40. Science of Skin: Challenges of Long Wear Adhesives Special thanks to Dr. Pat Parks (3M Medical Officer), Diana Eitzman and Marcia Cartier for their pioneering work on the 3M Science of Skin and clinical trials, along with the entire 3M MedTech R&D team.
  41. 41. 41© 3M 2016. All Rights Reserved. www.3M.com/MedTech www.Findmyadhesive.com 3M Medical Materials & Technologies
  42. 42. 42. All Rights Reserved.25 April 2018© 3M 3M Confidential. Adhesion is a property of the system. Skin is a part of that system. IV Securements Tapes and Adhesives Biomedical Electrodes

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