Pressure mapping of medical compression bandages used for venous leg ulcer treatment

Chronic leg ulcers affect 1% of the adult population in the developed countries. The majority of leg ulcers are due to venous disease. The impact of venous ulcers on the quality of life is significant, and it costs the NHS £300 − 600m annually. Medical compression bandages (MCBs) are the cornerstone in the treatment of chronic venous ulcers. MCBs should be applied with a pressure gradient reducing from the ankle to the knee. Visual inspection of bandages in situ for the amount of extension and overlap in the MCBs is normally what nurses use in day by day clinical practice to control the pressure they apply to patients’ legs. Interface pressure produced by a bandage is proportional to the tension which, in turn, is proportional to the extension of the bandage, and pressure is inversely proportional to the limb radius. Experts in the field believe that applying MCBs with a constant extension will enable users to achieve the required gradient pressure profile, as the circumference of the leg increases from the ankle towards the mid-calf. Despite the many studies published investigating the effectiveness of different MCBs, very little work has been done to understand the underpinning physics of how MCBs apply pressure to the leg. In addition, although many types of pressure measurement systems have been developed and used by various researchers, most of these devices have not been systematically tested for their performance and measurement reliability. In this thesis, the physics behind compression therapy is investigated and modeled using mathematical equations, some of which are validated experimentally. Analytical results suggest that ignoring MCBs thickness when computing the interface pressure will have a negligible effect on the accuracy of the pressure calculation produced by singlelayer MCBs. However, MCBs thickness should be considered in computing the interface pressure produced by multi-layer MCBs. Moreover, a model developed by other researchers to explain the impact of the pressure sensor’s physical dimensions on the interface pressure is tested experimentally. Results suggest that the model is not sufficient to estimate the amount of perturbation in the pressure, and a better model is needed. Furthermore, the thesis outlines experiments conducted to study MCBs and obtain polynomial expressions to describe the MCBs tension-elongation curves. The polynomial expressions are used in conjunction with mathematical models to compute the interface pressure induced by MCBs. In addition, the thesis demonstrates how the information obtained from these experiments is used in line with a mathematical model to classify compression bandages and simulate the impact of limb shape change secondary to calf muscle activity on the interface pressure. Moreover, the thesis reports on the evaluation of various types of resistive-based flexible pressure sensors. It illustrates that FlexiForce outperforms other resistive-based flexible sensors in static evaluation for sensitivity to low pressures, nonlinearity, repeatability, hysteresis and drift. However, the typical accuracy of FlexiForce sensor is found to be ±12% full scale, where full scale in this case is 120mmHg. The accuracy error is further reduced to approximately ±6% full scale by arranging the sensors in arrays and using averaging techniques. Arrays of FlexiForce sensors are used then to map the interface pressure under MCBs applied to different mediums. The pressure maps obtained by FlexiForce sensors are compared with the maps obtained using microelectromechanical systems (MEMS) force sensors and PicoPress transducer, a commercial medical pressure transducer used currently to study the pressure induced under MCBs. Furthermore, the measured pressures in all these cases are compared with the pressures computed theoretically from the bandage extension. Results show low levels of agreement or, in some cases, no agreement between the measured and computed pressures, which lead to question the reliability of using extension as a feedback method to control the interface pressure applied by MCBs. Additionally, in spite of some deficiencies in the performance of FlexiForce sensors, the thesis demonstrates that they could be used to obtain pressure maps for qualitative purposes. This, in some cases, is found to provide more reliable pressure readings than commercial sensors like PicoPress. Generally, current medical pressure transducers are thick; thus, they tend to overestimate the pressure applied by compression bandages significantly. The thesis details the assessment of pressure-mapping bandage prototypes and the associated tests carried out to evaluate their performance. Preliminary results suggest that the pressure-mapping bandage prototypes cannot be used to have accurate measurements. Nevertheless, they can provide the user with qualitative information about the pressure profile in terms of pressure levels and gradient. Finally, the thesis presents the usage of a pressure-mapping leg for training purposes for student nurses. This involved studying student nurses’ bandaging techniques and pinpointing their main bandaging technique pitfalls. Compared with experienced nurses, fewer of the student nurses applied MCBs with reverse pressure gradient.

[1]  P. Gregg,et al.  In vivo pressure profiles of thigh‐length graduated compression stockings , 1998, The British journal of surgery.

[2]  J C Barbenel,et al.  Device for measuring soft tissue interface pressures. , 1990, Journal of biomedical engineering.

[3]  John P Bentley,et al.  Principles of measurement systems , 1983 .

[4]  H. Partsch,et al.  Inelastic compression increases venous ejection fraction more than elastic bandages in patients with superficial venous reflux , 2008, Phlebology.

[5]  P. Carpentier,et al.  Superimposed Elastic Stockings: Pressure Measurements , 2007, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[6]  B. Tank,et al.  Calculating the Pressure and the Stiffness in Three Different Categories of Class II Medical Elastic Compression Stockings , 2006, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[7]  D. Wilson,et al.  Accuracy and repeatability of a pressure measurement system in the patellofemoral joint. , 2003, Journal of biomechanics.

[8]  F. Wood,et al.  Direct measurement of cutaneous pressures generated by pressure garments. , 1997, Burns : journal of the International Society for Burn Injuries.

[9]  H Partsch,et al.  The use of pressure change on standing as a surrogate measure of the stiffness of a compression bandage. , 2005, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[10]  W. Boeckx,et al.  Reproducibility of repeated measurements with the Kikuhime pressure sensor under pressure garments in burn scar treatment. , 2007, Burns : journal of the International Society for Burn Injuries.

[11]  C. Ruckley,et al.  Socioeconomic Impact of Chronic Venous Insufficiency and Leg Ulcers , 1997, Angiology.

[12]  L. Vinckx,et al.  Analysis of the pressure perturbation due to the introduction of a measuring probe under an elastic garment , 2006, Medical and Biological Engineering and Computing.

[13]  H. Partsch,et al.  Thigh compression , 2008, Phlebology.

[14]  R. Prescott,et al.  Multi-layer compression: comparison of four different four-layer bandage systems applied to the leg. , 2004, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[15]  A. Nicolaides,et al.  A pressure profile for elastic stockings. , 1980, British medical journal.

[16]  Elaine Nicpon Marieb,et al.  Human anatomy & physiology / Elaine N. Marieb, Katja Hoehn , 2007 .

[17]  G B Mosti,et al.  Simultaneous changes of leg circumference and interface pressure under different compression bandages. , 2007, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[18]  I. Gaied,et al.  Identification strategy for orthotropic knitted elastomeric fabrics under large biaxial deformations , 2007 .

[19]  Steve Thomas,et al.  Laboratory-based evaluation of a compression-bandaging system. , 2003, Nursing times.

[20]  J M Melhuish,et al.  The physics of sub-bandage pressure measurement. , 2000, Journal of wound care.

[21]  Pablo González de Santos,et al.  Accurate modeling of low-cost piezoresistive force sensors for haptic interfaces , 2010, 2010 IEEE International Conference on Robotics and Automation.

[22]  R. Langer,et al.  Epidemiology of Chronic Peripheral Venous Disease , 2007 .

[23]  E. A. Nelson,et al.  Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. , 2006, Journal of vascular surgery.

[24]  Rong Liu,et al.  Objective Evaluation of Skin Pressure Distribution of Graduated Elastic Compression Stockings , 2005, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[25]  Elizabeth Andrea Nelson A study of patient and nurse factors influencing sub-bandage pressure , 2001 .

[26]  I Gaied,et al.  Experimental assessment and analytical 2D predictions of the stocking pressures induced on a model leg by Medical Compressive Stockings. , 2006, Journal of biomechanics.

[27]  D. Tolson,et al.  Class-3c compression bandaging for venous ulcers: comparison of spiral and figure-of-eight techniques. , 2006, Journal of advanced nursing.

[28]  H. Partsch,et al.  Controlled, Comparative Study of Relation between Volume Changes and Interface Pressure under Short‐Stretch Bandages in Leg Lymphedema Patients , 2008, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[29]  Yong-Ku Kong,et al.  An investigation of hand forces and postures for using selected mechanical pipettes , 2008 .

[30]  S. Anand,et al.  Design and development of novel bandages for compression therapy. , 2003, British journal of nursing.

[31]  C. Moffatt Four-Layer Bandaging: From Concept to Practice , 2002, The international journal of lower extremity wounds.

[32]  A Cliquet,et al.  A low-cost instrumented glove for monitoring forces during object manipulation. , 1997, IEEE transactions on rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society.

[33]  R. Martini,et al.  Quality of life in chronic venous insufficiency , 2005 .

[34]  Xin Zhang,et al.  Skin pressure profiles and variations with body postural changes beneath medical elastic compression stockings , 2007, International journal of dermatology.

[35]  K. L. Moore,et al.  Clinically Oriented Anatomy , 1985 .

[36]  J Melhuish,et al.  How compression therapy works. , 1999, Journal of wound care.

[37]  A. Górkiewicz-Petkow,et al.  Compression therapy in the treatment of chronic venous insufficiency - theory and practice , 2007 .

[38]  A. Satpathy,et al.  Measuring sub-bandage pressure: comparing the use of pressure monitors and pulse oximeters. , 2006, Journal of wound care.

[39]  Theodore E Milner,et al.  A technique for conditioning and calibrating force-sensing resistors for repeatable and reliable measurement of compressive force. , 2008, Journal of biomechanics.

[40]  J. Lottin,et al.  Measurement System for Gesture Characterization During Chest Physiotherapy Act on Newborn Babies Suffering from Bronchiolitis , 2007, 2007 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[41]  C. Ruckley,et al.  Hazards of compression treatment of the leg: an estimate from Scottish surgeons. , 1987, British medical journal.

[42]  H. Schumann,et al.  Bandage pressure measurement and training: simple interventions to improve efficacy in compression bandaging , 2009, International wound journal.

[43]  B. P. Saville,et al.  Physical Testing of Textiles , 1999 .

[44]  R. Kamm,et al.  The effects of external compression on venous blood flow and tissue deformation in the lower leg. , 1999, Journal of biomechanical engineering.

[45]  A D Chant,et al.  Sustained compression and healing of chronic venous ulcers. , 1989, BMJ.

[46]  Steve Rothberg,et al.  Evaluation of thin, flexible sensors for time-resolved grip force measurement , 2007 .

[47]  Lisa Macintyre,et al.  The Study of Pressure Delivery for Hypertrophic Scar Treatment , 2006 .

[48]  C. Moffatt Variability of pressure provided by sustained compression , 2008, International wound journal.

[49]  Gregorio Obieta,et al.  All-plastic distributed pressure sensors: taylor-made performance by electroactive materials design , 2008 .

[50]  H. Partsch,et al.  Influence of Different Materials in Multicomponent Bandages on Pressure and Stiffness of the Final Bandage , 2008, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[51]  A. Satpathy,et al.  Is compression bandaging accurate? The routine use of interface pressure measurements in compression bandaging of venous leg ulcers , 2006 .

[52]  Russell Cork,et al.  XSENSOR technology: a pressure imaging overview , 2007 .

[53]  A. Kalamdani,et al.  Tactile sensing by the sole of the foot: part i: apparatus and initial experiments toward obtaining dynamic pressure maps useful for stabilizing standing, walking, and running of humanoid robots , 2006, 2006 IEEE International Workshop on Haptic Audio Visual Environments and their Applications (HAVE 2006).

[54]  M. Kosiak,et al.  Etiology and pathology of ischemic ulcers. , 1959, Archives of physical medicine and rehabilitation.

[55]  G.W. John,et al.  Influence of intermittent compression cuff design on calf deformation: computational results , 2007, 2007 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

[56]  R. Williams,et al.  Measurement of forces associated with compression therapy , 2006, Medical & Biological Engineering & Computing.

[57]  M. Clark,et al.  Classification of Compression Bandages: Practical Aspects , 2008, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[58]  M D Stinson,et al.  Pressure mapping systems: reliability of pressure map interpretation , 2003, Clinical rehabilitation.

[59]  Peter A. Wieringa,et al.  Forces Applied to the Maxillary Incisors During Video-Assisted Intubation , 2009, Anesthesia and analgesia.

[60]  Thomas R Oxland,et al.  Accuracy and repeatability of a new method for measuring facet loads in the lumbar spine. , 2006, Journal of biomechanics.

[61]  P. Allan,et al.  Chronic venous insufficiency: clinical and duplex correlations. The Edinburgh Vein Study of venous disorders in the general population. , 2002, Journal of vascular surgery.

[62]  H. Ishibashi,et al.  Interface Pressure and Stiffness of Various Elastic Stockings during Posture Changes and Exercise , 2008, Vascular.

[63]  Joan M. Stevenson,et al.  Development of a Dynamic Biomechanical Model for Load Carriage: Phase 4, Part C2: Assessment of Pressure Measurement Systems on Curved Surfaces for the Dynamic Biomechanical Model of Human Load Carriage , 2005 .

[64]  Xin Zhang,et al.  Quantitative assessment of relationship between pressure performances and material mechanical properties of medical graduated compression stockings , 2007 .

[65]  A. Kalamdani,et al.  Development and characterization of a high-spatial-temporal-resolution foot-sole-pressure measurement system , 2006 .

[66]  W. Joyce,et al.  A reduction in serum cytokine levels parallels healing of venous ulcers in patients undergoing compression therapy. , 2002, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[67]  M. Clark,et al.  Measurement of Lower Leg Compression In Vivo: Recommendations for the Performance of Measurements of Interface Pressure and Stiffness , 2006, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[68]  Jeffrey R Basford,et al.  The Law of Laplace and its relevance to contemporary medicine and rehabilitation. , 2002, Archives of physical medicine and rehabilitation.

[69]  C.M.A. Ashruf,et al.  Thin flexible pressure sensors , 2002 .

[70]  A. Hughes,et al.  Role of MRI in investigating the effects of elastic compression stockings on the deformation of the superficial and deep veins in the lower leg , 2007, Journal of magnetic resonance imaging : JMRI.

[71]  T. Nijsten,et al.  Changes in the pressure and the dynamic stiffness index of medical elastic compression stockings after having been worn for eight hours: a pilot study , 2009, Phlebology.

[72]  Christine Barthod,et al.  Instrumentation and Labview Based Continuous Processing for Chest Physiotherapy , 2008, BIODEVICES.

[73]  T. Raj,et al.  How long do compression bandages maintain their pressure during ambulatory treatment of varicose veins? , 1980, The British journal of surgery.

[74]  R. Prescott,et al.  Compression therapy: effects of posture and application techniques on initial pressures delivered by bandages of different physical properties. , 2006, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[75]  T. Phillips,et al.  Venous ulcers. , 2007, Clinics in dermatology.

[76]  S. Anand,et al.  New single-layer compression bandage system for chronic venous leg ulcers. , 2009, British journal of nursing.

[77]  Steve Rothberg,et al.  Measurement and analysis of grip force during a golf shot , 2008 .

[78]  Kent N Bachus,et al.  Measuring contact area, force, and pressure for bioengineering applications: using Fuji Film and TekScan systems. , 2006, Medical engineering & physics.

[79]  Jorge Barrio,et al.  Sensorized thimble for haptics applications , 2009, 2009 IEEE International Conference on Mechatronics.

[80]  B. Eklöf Classifying Venous Disease , 2007 .

[81]  P. Gloviczki,et al.  Venous Embryology and Anatomy , 2007 .

[82]  J. Fraden,et al.  Handbook of Modern Sensors: Physics, Designs, and Applications, 2nd ed. , 1998 .

[83]  T. Mittlmeier,et al.  Intra-articular pressure measurement in the radioulnocarpal joint using a novel sensor: in vitro and in vivo results. , 2007, The Journal of hand surgery.

[84]  Hugo Partsch,et al.  Calf compression pressure required to achieve venous closure from supine to standing positions. , 2005, Journal of vascular surgery.

[85]  A Nikonovas,et al.  The application of force-sensing resistor sensors for measuring forces developed by the human hand , 2004, Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine.

[86]  V Allen,et al.  Accuracy of interface pressure measurement systems. , 1993, Journal of biomedical engineering.

[87]  P. Bachoo Interventions for uncomplicated varicose veins , 2009, Phlebology.

[88]  H. Ishibashi,et al.  A comparison of interface pressure and stiffness between elastic stockings and bandages , 2009, Phlebology.

[89]  M. Ferguson-Pell,et al.  Evaluation of a sensor for low interface pressure applications. , 2000, Medical engineering & physics.

[90]  J. Woodburn,et al.  Observations on the F-Scan in-shoe pressure measuring system. , 1996, Clinical biomechanics.

[91]  Gregorio Obieta,et al.  Design of all-plastic distributed pressure sensors based on electroactive materials , 2007, SPIE Microtechnologies.

[92]  J. Bergan Risk Factors, Manifestations, and Clinical Examination of the Patient with Primary Venous Insufficiency , 2007 .

[93]  Alison King,et al.  Flexible tactile sensor technology: bringing haptics to life , 2004 .

[94]  David Wertheim,et al.  An integrated instrumentation approach to the study of wound healing , 1998, Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society. Vol.20 Biomedical Engineering Towards the Year 2000 and Beyond (Cat. No.98CH36286).

[95]  Patrick F. Dunn,et al.  Measurement and Data Analysis for Engineering and Science , 2017 .

[96]  T T Choy,et al.  Pressure therapy in the treatment of post-burn hypertrophic scar--a critical look into its usefulness and fallacies by pressure monitoring. , 1984, Burns, including thermal injury.

[97]  E. A. Nelson,et al.  Compression for venous leg ulcers. , 2009, The Cochrane database of systematic reviews.

[98]  Hugo Partsch,et al.  Interface pressure and stiffness of ready made compression stockings: comparison of in vivo and in vitro measurements. , 2006, Journal of vascular surgery.

[99]  M. Courtney,et al.  Factors associated with recurrence of venous leg ulcers: a survey and retrospective chart review. , 2009, International journal of nursing studies.

[100]  A Finnie Interface pressure measurements in leg ulcer management. , 2000, British journal of nursing.

[101]  D Bergqvist,et al.  Chronic leg ulcers: the impact of venous disease. , 1999, Journal of vascular surgery.

[102]  C. H. Lai,et al.  Validation of the Pliance X System in measuring interface pressure generated by pressure garment. , 2009, Burns : journal of the International Society for Burn Injuries.

[103]  Hugo Partsch,et al.  Mechanism and Effects of Compression Therapy , 2007 .

[104]  G. Moneta,et al.  The hemodynamics and diagnosis of venous disease. , 2007, Journal of vascular surgery.

[105]  J. Beebe-Dimmer,et al.  The epidemiology of chronic venous insufficiency and varicose veins. , 2005, Annals of epidemiology.

[106]  S Ghosh,et al.  Pressure mapping and performance of the compression bandage/garment for venous leg ulcer treatment. , 2008, Journal of tissue viability.

[107]  B. Golomb,et al.  Chronic venous disease in an ethnically diverse population: the San Diego Population Study. , 2003, American journal of epidemiology.

[108]  Yong-Ku Kong,et al.  Optimal cylindrical handle diameter for grip force tasks , 2005 .

[109]  P. Mulder,et al.  Variation in the dynamic stiffness index of different types of medical elastic compression stockings , 2008, Phlebology.

[110]  Bernard Bayle,et al.  Nonlinear modeling of low cost force sensors , 2008, 2008 IEEE International Conference on Robotics and Automation.

[111]  S. Thomas Bandages and bandaging. , 1990, Nursing standard (Royal College of Nursing (Great Britain) : 1987). Special supplement.

[112]  R. STOLK,et al.  A Method for Measuring the Dynamic Behavior of Medical Compression Hosiery during Walking , 2004, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[113]  P. Coleridge-Smith,et al.  Leg ulcer treatment. , 2009, Journal of vascular surgery.

[114]  K. Burnand,et al.  Graduated elastic stockings. , 1986, British medical journal.

[115]  H. Partsch,et al.  Does thigh compression improve venous hemodynamics in chronic venous insufficiency? , 2002, Journal of vascular surgery.

[116]  G. Schmid-Schönbein,et al.  Chronic venous disease. , 2006, Minerva cardioangiologica.

[117]  E. A. Nelson,et al.  Compression for preventing recurrence of venous ulcers. , 2014, The Cochrane database of systematic reviews.

[118]  Hugo Partsch,et al.  The Static Stiffness Index: A Simple Method to Assess the Elastic Property of Compression Material In Vivo , 2005, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[119]  N. Cullum,et al.  Four layer bandage compared with short stretch bandage for venous leg ulcers: systematic review and meta-analysis of randomised controlled trials with data from individual patients , 2009, BMJ : British Medical Journal.

[120]  Bertrand Lun,et al.  Comparison of low-strength compression stockings with bandages for the treatment of recalcitrant venous ulcers. , 2010, Journal of vascular surgery.

[121]  Fedor Lurie,et al.  On the mechanism of action of pneumatic compression devices: Combined magnetic resonance imaging and duplex ultrasound investigation. , 2008, Journal of vascular surgery.

[122]  A W Buis,et al.  Calibration problems encountered while monitoring stump/socket interface pressures with force sensing resistors: Techniques adopted to minimise inaccuracies , 1997, Prosthetics and orthotics international.

[123]  R. Lord,et al.  Graduated compression stockings (20−30 mmHG) do not compress leg veins in the standing position , 2004, ANZ journal of surgery.

[124]  S. Anand,et al.  EVALUATION OF PRESSURE PROFILE OF BANDAGES USING MANNEQUIN LEG , 2006 .

[125]  Holger Hänssle,et al.  Instruction of Compression Therapy by Means of Interface Pressure Measurement , 2000, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[126]  D. Bogdanović,et al.  The influence of different sub-bandage pressure values on venous leg ulcers healing when treated with compression therapy. , 2010, Journal of vascular surgery.

[127]  J. Almeida,et al.  Role of Physiologic Testing in Venous Disorders , 2007 .

[128]  A A Polliack,et al.  Scientific validation of two commercial pressure sensor systems for prosthetic socket fit , 2000, Prosthetics and orthotics international.

[129]  David N Firmin,et al.  Effects of elastic compression stockings on wall shear stress in deep and superficial veins of the calf. , 2008, American journal of physiology. Heart and circulatory physiology.

[130]  A. Bradbury,et al.  Clinical presentation and assessment of patients with venous disease , 2008, Handbook of Venous Disorders : Guidelines of the American Venous Forum.

[131]  R. Williams,et al.  Movement-related variation in forces under compression stockings. , 1999, European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery.

[132]  M W Ferguson-Pell,et al.  Design Criteria for the Measurement of Pressure at Body/Support Interfaces: , 1980 .

[133]  R. Taylor,et al.  Using a bandage pressure monitor as an aid in improving bandaging skills. , 1998, Journal of wound care.

[134]  H. Partsch Do we still need compression bandages? Haemodynamic effects of compression stockings and bandages , 2006 .

[135]  R. H. Fox,et al.  The return of blood to the heart , 1993 .