Ginecologia pptx

Vaginal Tactile Imager Juan Carlos Rey Rey PCG LATAM Pharma Consulting Group Right Way Right Business __________________ Dirección: Carrera 51#97a-37 Teléfono: 57-3132910715 Bogotá –Colombia Skype: juancarlos.rey@reypcglatam.com Website: www.tactile-iamging.com Introduction to Technology

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Tactile Imaging History Research highlight: Tactile imaging for quantifying vaginal elasticity in prolapse. Nature Reviews Urology 2012; 9(2): 60.

2010s

Sarvazyan A*, Egorov V*. Mechanical imaging - a technology for 3-D visualization and characterization of soft tissue abnormalities: A Review. Cur Med Imaging Reviews 2012;8(1): 64-73.

Egorov V*, van Raalte H*, Sarvazyan A*. Vaginal Tactile Imaging. IEEE Trans Biomed Eng 2010; 57(7):1736-44.

Egorov V*, Sarvazyan AP*. Mechanical Imaging of the Breast. IEEE Trans Medical Imaging 2008; 27(9):1275-87.

2000s

Egorov V* et al. Prostate Mechanical Imaging: 3-D Image Composition and Feature Calculations. IEEE Trans on Medical Imaging 2006; 25(10):1329-40.

Galea AM. Mapping tactile imaging information: parameter estimation and deformable registration. PhD thesis, Harvard University, 2004.

Wellman PS. Tactile imaging. PhD Thesis, Harvard University, 1999.

Sarvazyan AP*. Mechanical imaging: A new technology for medical diagnostics. International Journal Medical Informatics 1998: 49:195–216.

1990s

Regtien PPL explored sensors for the use in “Tactile imaging.” Sensors and Actuators A: Physical 1992; 31(1-3):83-89.

Hippocrates in The Book of Prognostics, 400 B.C., wrote: “Such swellings as are soft, free from pain, and yield to the finger, … and are less dangerous than the others. “

400 B.C.

We find in Kahun Gynecological Papyrus: ''Discernere eam quae concepit'' ... like that finger upon her menaa.“ *co-fonder of Advanced Tactile Imaging, Inc. Introduction to Technology

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Elastography and Tissue Elasticity  Elastography is a new imaging modality that maps the elastic properties of soft tissue. This modality emerged in the last decade.  Elasticity of soft tissue is the ratio of applied pressure to tissue displacement.

The “elasticity” is similar to common terms like “hardness” or “stiffness”.

Note 1: The significant dependence of the tissue elasticity from its physiological and structural changes is the basis for medical diagnosis of diseased conditions.

Note 2: Tactile Imaging is a branch of Elastography [1].

Note 3: Tissue elasticity imaging is not provided by conventional Computed Tomography, traditional Ultrasound and Magnetic Resonance Imaging.

[1]. Sarvazyan AP et al. An overview of Elastography - an emerging branch of medical imaging. Current Medical Imaging Reviews 2011; 7(4):255-282.

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Tactile Imaging: Definition ď – Tactile Imaging is a medical imaging modality that translates the sense of touch into a digital image. Tactile image is composed from pressure patterns acquired on a soft tissue surface.

Sense of touch

Computer image

Note 1: Tactile Image is rendered with the use of a pressure colormap.

Note 2: Tactile Image reveals tissue or organ anatomy and can be considered as a projection of elasticity image.

Note 3: The key element is a probe to deform the soft tissue. The probe has a pressure sensor array on the surface contacting with the soft tissue.

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Sense of Touch in Gynecology American College of Obstetricians and Gynecologists (ACOG) Guidelines recommend for women 21 years of age or older the annual health assessment which includes the pelvic examination. The bimanual examination is the part of it when two fingers are inserted into the vagina for palpation of vagina and surrounding structures.

The bimanual examination (palpation) is applied to patient who reports or exhibits symptoms suggestive of female genital problems. It is indicated before and after applied treatments including surgical interventions.

Shortcomings of the manual palpation: • Subjective technique, no universal scale, no quantification; • Low sensitivity (few physicians have the tactile ability to detect subtle variations of tissue elasticity); • Uncomfortable procedure disliked by many women.

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Unmet Clinical Need Female pelvic floor is a complex biomechanical system which was designed by the nature to meet the contradictive requirements: to support abdominal pressure, sexual function and accommodate childbirth, urination and defecation. The frequency of pelvic floor disorders is increased with age, affecting more than 40% of women from 60 to 79 years of age [1]. The pelvic floor as biomechanical system requires timely assessment and application of an optimal treatment or repair.

Note: To date, there is no standardized, noninvasive tool to accurately assess the elastic properties of the vagina and pelvic floor support structures.

[1]. Nygaard I et al. Pelvic Floor Disorders Network. Prevalence of Symptomatic Pelvic Floor Disorders in US Women. JAMA 2008; 300(11):1311-6.

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Unmet Clinical Need GYNECOLOGY • To recognize, quantify and document an abnormal deviation in vagina and pelvic floor at the earlier stage during a regular women's visit • To monitor pelvic floor changes under a heavy, repetitive strain (sports, military) OBSTETRICS • To make comparative analysis of changes in vaginal and pelvic floor conditions before and after childbirth • To monitor recovery progress after childbirth • To monitor applied treatment after childbirth UROGYNECOLOGY • To recognize, quantify and document an abnormal deviation in the pelvic floor before it has anatomical or physiological manifestation • To evaluate pelvic floor conditions before and after pelvic floor reconstructive surgery • To assess an outcome of an interventional procedure • To monitor a conservative treatment progress WOMEN HEALTH • To evaluate vaginal conditions before and after an aesthetic procedure to assess its outcome.

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Intended Use

The Vaginal Tactile Imager (VTI) obtains a mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire applied pressures and probe locations inside vagina and store the corresponding data. The device provides data visualization, analysis tools and information. The data as well the analysis information can be viewed with an intention of assisting in the diagnosis and evaluation of vaginal and pelvic floor conditions. The device is intended for use by medical personnel, general practitioners, gynecologists, obstetricians, urogynecological and plastic surgeons.

Note: This Intended Use is a combination of the Indented Use for Motility Visualization System and Perineometer.

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Operational Principles

Patient examination procedure with VTI includes four steps.

Introduction to Technology

No. 3067-0008, July 28, 2014

Patented Innovation Issued Patents: 1. Methods for assessment of improvements in pelvic organ conditions after an interventional procedure.

USA Patent No. 8,419,659; 2013.

2. Methods for assessment of pelvic organ conditions affecting the vagina. USA Patent No. 8,187,208; 2012.

3. Method of characterization and differentiation of tissue. USA Patent No. 8,142,368; 2012.

4. Tactile sensor array for soft tissue elasticity imaging. USA Patent No. 8,069,735; 2011.

5. Methods for characterizing vaginal tissue elasticity. USA Patent No. 8,052,622; 2011.

Pending Patents: 6.

Method and device for measuring tactile profile of vagina. International and US application, 2013.

7.

Methods for characterizing vaginal tissue elasticity and assessment of pelvic organ conditions affecting the vagina. International application, 2013.

Vaginal Tactile Imager, model 2S Introduction to Technology

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Vaginal Probe Every probe has carrying/storage case.

Vaginal Probe, model 2P.8

Introduction to Technology

The probe has 96 pressure (tactile) sensors on both sides, orientation sensors, microheaters, temperature sensors, memory chip to keep its calibration and history of use.

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Consumables/Accessories Probe Wipes

Probe Sheath

VTI Probe Disinfection Setup

Cleaner and Disinfectant validated to be used with VTI Stylus Germicidal Wipe

Lubricating Jelly

The VTI consumables to be used in every examination

Wireless Color Printer Introduction to Technology

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VTI: Step 1 Parameters Operator may select the regions of interest to measure the pressure.

Pressure Colormap 170 mmHg

0 mmHg

Operator can have the spatial pressure gradients directed orthogonally to vaginal channel.

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VTI: Step 2 Parameters Operator may select a region of interest to measure the pressure for anterior and posterior compartments.

Pressure Colormap 170 mmHg

0 mmHg

Operator may have the spatial pressure gradients for selected locations (red rectangular) of anterior

and posterior.

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VTI: Step 3 Parameters

Operator may select the regions of interest to measure the pressure at vaginal walls.

Pressure Colormap 170 mmHg

0 mmHg

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VTI: Step 4 Parameters

Pelvic muscle strength at selected locations

Introduction to Technology

Probe orientation during measurement

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VTI: Examination Report Examination Report is generated as PDF-file and can be directed for printing on wireless printer.

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VTI: Clinical Trials Four generations of the VTI were tested in 4 clinical trials in the United States in 20072013 within the scope of research grant from NIH/NIA. To date 221 patients were enrolled, 376 VTI examinations were completed by 5 clinical investigators.

The clinical studies demonstrate that: • Tactile imaging technology provides 94% reproducibility (tested in 8 patients, 8 scans per each patient by two operators).

• Tactile imaging can be used for quantitative anatomical and elasticity characterization of pelvic floor conditions.

• Tactile imaging might be used for comparative quantitative characterization of urogynecological surgerical outcomes.

• Tissue elasticity of the vagina and the pelvic floor support structures may be used as the marker for characterizing pelvic floor conditions.

• It seems possible to use tactile imaging for the detection of early pre-prolapse conditions not observed by widely accepted technique in medical practice.

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Competitive Technologies

Competitive technology: Elasticity Ultrasound which allows assessment of soft tissue elasticity using tissue movements induced by external or internal forces.

Advantages of VTI versus Elasticity Ultrasound: • VTI provides pelvic floor assessment under a stressed conditions (under the load).

• VTI allows measurement of pelvic floor muscle strength.

• VTI makes available imaging of the entire vagina in one frame.

• VTI has much lower price.

The VTI has no direct competition on the market.

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Key Opinion Leaders Tell About VTI Vincent Lucente, MD, MBA, Professor of Obstetrics and Gynecology at Temple University, Chief of Gynecology at St. Luke’s Health Network, Chief Medical Officer of The Institute for Female Pelvic Medicine, Allentown, PA, USA. He said about Vaginal Tactile Imaging: “It is a new technology with a future. Not only clinician will need it, but the lawyers want to see outcome of pelvic floor surgery. We do not see tissue elasticity with MRI ….”.

Harry Reich, MD, FACOG, FACS, President of International Society for Gynecological Endoscopy, Shavertown, PA, USA. He is a pioneer in the field of laparoscopic surgery having performed more than 4,000 gynecologic laparoscopy procedures including the first laparoscopic hysterectomy. He said about the Vaginal Tactile Imager: “It would be great to access the state of pelvic support before hysterectomy. … A technology that will help us make better decisions would be great.”

Jason Birnholz, MD, FACR, FRCR, FACOG, President at Diagnostic Ultrasound Consultants, Oak Brook, IL, USA. He served as Professor of Radiology at Stanford and Harvard. He is credited with introducing electronic scanning Ultrasound in 1978. He wrote us about the Tactile Imaging: “I've always thought that pressure sensing hasn't gotten its proper share of attention in simple office screening tasks.”

Hans Peter Dietz, MD, PhD, Professor in Obstetrics and Gynecology at Sydney Medical School Nepean, Penrith, Australia. He is intentionally recognized expert in diagnostic imaging in urogynaecology. He wrote us about the Vaginal Tactile Imaging: “I've read your recent paper in IUGJ with great interest. It strikes me that your instrument has great potential … I can see multiple possibilities for collaboration - in thousands of patients and research subjects ...”

Medical Imaging Panel ZRG1 SBMI-T (10) B, Center for Scientific Review, NIH, USA, gave the highest score to the Vaginal Tactile Imaging technology: “… While there are novel surgical procedures to place supportive elements and grafts, there is no quantitative measurement tool to evaluate connective tissue support failure. The proposed technology is elegant, innovative and exciting. … There is a real need for such an instrument in the gynecologic office and for pelvic reconstruction surgeons. … This work is significant and will impact the quality of life of many women.”

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Who developed this technology?

This technology is being developed by Artann Laboratories within the scope of the National Institute of Health/National Institute of Aging grant AG34714 "Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment“ (Phases I, II and IIB).

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Final Word

Thank you for your attention!

We are looking forward too work with you.

www.tactile-imaging.com

Juan Carlos Rey Rey PCG LATAM Pharma Consulting Group Right Way Right Business __________________ Dirección: Carrera 51#97a-37 Teléfono: 57-3132910715 Bogotá –Colombia Skype: juancarlos.rey@reypcglatam.com Website: www.tactile-iamging.com

Introduction to Technology

No. 3067-0008, July 28, 2014