Capsule Camera

CAPSULE CAMERA

A PILL WIT H A VIE W

What is capsule endoscopy? •Capsule endoscopy is a novel noninvasive technology designed primarily to provide diagnostic imaging .

HISTORY

This Miniature Ingestible Camera was conceived by Tarun Mullick developed in late 1980's with the help of gastroenterologist, Dr. Sudhir Dutta.

The Camera Pill Swallowable Camera Capsule, from Given Imaging, including Zarlink’s ULP RF Transmitter

Specifications § Diameter of 10 mm and a Length of 20 mm. § § Bullet shape - This shape and its diameter are critical for mapping the small intestine. § Uses Silver oxide button batteries - high energy density & disposable. § Made up of biocompatible material.

Features of the Capsule •Capsule takes two images per second •On average, 50,000 images are obtained during an 8 hour exam •Magnification: 8x •Capsule coating: non-adherant •Disposable

CONSTRUCTION OF CAPSULE CAMERA - HAS 8 PARTS

CAPSULE CAMERA(Internal view) Capsule Electronics 1.Optical dome 2. Lens holder 3. Lens 4.Illuminating

LEDs 5. CMOS imager 6 .Battery 7. ASIC transmitter 8. Antenna

1.Optical Dome

Front part of capsule

Bullet shaped

Easy orientation

Easy propelling

2.Lens Holder

Lens Holder holds lens tightly & avoids its dislocation.

3.Lens

Arranged behind Light Receiving Window Focuses light on the CMOS Image Sensor behind it.

4.CMOS Image Sensor

PIXEL ARRAY

READ CIRCUIT

OSCILLATI NG CIRCUIT

CODING CIRCUIT

CONTROL CIRCUIT

SWITCHING CIRCUIT

CURRENT LIMITING CIRCUIT

5.Battery

Button shaped & two in number Made of Zinc/Alkaline Electrolyte/Silver Oxide Has discharge voltage, disposable and doesn’t cause harm to the body.

6.ASIC Transmitter

The ASIC (Application Specific Integrated Circuit) Transmitter Two Transmitting Electrodes are connected to the outlines of the ASIC Transmitter. These electrodes are electrically isolated from each other.

7.Antennae

The dome containing the Antennae is made of non conducting material which is harmless to the human body. Parylene coated onto polyethylene or polypropylene is used. As shown, the Antennae is arranged at the end of the capsule. It is enclosed in a dome shaped chamber.

The Antennae receives the data from the ASIC Transmitter and sends it to the Data Recorder tied to the patient’s waist.

PillCam Platform Components • PillCam ESO or SB • Data Recorder • Given Workstation • RAPID Software

Data Recorder with pick up antennae & a Computer.

A view of Data Recorder being mounted on a belt pack tied to the patient’s waist.

SB 2 with RAPID 4

SB 2 with RAPID 5

Improved Diagnostic Confidence: RAPID Atlas • All images reviewed and labeled by physician advisory panel. • Enables side-by-side comparison of case image to known pathology. • Searchable by Capsule Endoscopy Structured Terminology (CEST), findings, and diseases.

TYPES AND APPLICATION

-4 TYPES

PillcamSB •Approved by FDA in 2001 •Size-11mm x 26 mm •Weight-3.7 grams •One-sided imaging •Two pictures per second •1:8 magnification •140 degree field of view •Over 50,000 images in 8 hours •PillcamSB 2-cleared by FDA May 2007-offers wider field of view and improved optics

PillcamESO •Approved by the FDA in 2004 •Size 11mm x 26mm •Weight-3.7 grams •Two sided photography •14 images per second •2,600 pictures in 20 minutes •PillcamESO 2-cleared by FDA May 2007-offers wider field of view and 18 images per second

Agile Patency Capsule

•Same size as actual video capsule •Composed of lactose •Contains a timer, radiofrequency identification tag, and radio-opaque material •Can be seen by plain abdominal film or by special handheld radiofrequency detector •Designed to progressively dissolve after 40 hours of contact with digestive secretions •Disintegrates completely between 80 and 100 hours •Allows localization of site of stenosis before video capsule •Not considered standard of practice

Uses

PillCam™ SB- Crohn's Disease, Small bowel tumors, Small bowel injury, Celiac Disease, MalAbsorption Disorders, Vascular Disorders, Ulcerative Colitis PillCam™ ESO -esophageal diseases, gastro esophageal reflux disease, Barrett's esophagus PillCam™ COLONcolon Agile™ patency capsule- intestinal patency

EXISTING PRODUCTS 1.OMOM 3.PILLCAM

2.M2A 4.NORIKA3 5.MTSI

Preparation §Patient fasts overnight or for at least 12 hours §No iron pills for 5 days or olestra §Colyte prep: clear liquid diet at noon, 2/3 gallon colyteat 6 PM, 4 hours prior to capsule take 1/3 gallon colyteand 2 simethicone tablets §Magnesium Citrate prep: clear liquid diet at noon, 1 bottle of magnesium citrate followed by 1 bottle of gatoradeat 6 PM, 8 PM and 4 hours prior to capsule with 2 simethicone tablets 4 hours prior

Procedure for PillcamSB Ø•Patient comes to endoscopy center Ø•8-lead antenna placed on patient and battery pack placed on patient Ø•Patient swallows pill and leaves unit Ø•Can ingest liquids 2 hours after capsule taken Ø•Can eat food 4 hours after capsule taken Ø•Patient brings back recorder approximately 8 hours after ingestion Ø•Patient does NOT recover capsule Ø•Recorder then downloaded onto computer which can take 2.5 to 3 hours Ø•Capsule then read on computer

Procedure for PillcamESO Ø•Patient swallows the pill while lying down with little or no water Ø•The patient is then slowly elevated Ø•This allows for the capsule to spend a longer time in the esophagus and therefore allow for better visualization of the esophagus

Endoscopy Procedure Ø Capsule is swallowed by the patient like a conventional pill. Ø It takes images as it is propelled forward by peristalsis. Ø A wireless recorder, worn on a belt, receives the images transmitted by the pill. Ø A computer workstation processes the data and produces a short video clip or still images.

The Diagnostic Procedure

Capsule Imaging • Moved by peristalsis • 2Hz, 576 X576 color image • Typical studies are around 6-8 hours. • 10,000s of images from each study • Somewhat cumbersome to

In approximately eight hours, the patient will return to the clinic for removal of equipment.

9:00 am

5:00 pm

Advantages § Painless, no side affects or complications.

§Miniature size, so can move easily through the digestive system. § Accurate, precise & low power consumption. §Images taken are of very high quality which are sent almost instantaneously to the data recorder for storage. § §Made of bio compatible material, doesn’t cause any harm to the body. § §The procedure is simple.

§Use of Suspected Blood Indicator (SBI)which add no cost. § §AdvanCE (Advance CE) for patients unable to swallow § §High sensitivity and specificity for detecting lesions. § §CE avoids the risks associated with sedation and radiation. § §It is noninvasive and may not require the patient to miss work. §Reducing physician reading times and improving cost-effectiveness. § §More efficient than normal endoscopy,the X ray or the CT scan. §Remote interpretation for rural settings

Image Spectrum: PillCam Capsule Endoscopy

Bleeding

Suspected Crohn’s

Celiac Disease Tumors

Capsule Endoscopy Versus Other Imaging Modalities Study

Yield

Capsule vs Ileoscopy 61% vs 46% Capsule vsPush enterosc 51% vs 7% Capsule vs CT enterography 75% vs 37% Capsule vs Small bowel MRI 60% vs 40%

Disadvantages Gastrointestinal obstructions and swallowing disorders prevent free flow of capsule through the digestive system. Patients with pacemakers, pregnant women and all pediatrics have to be monitored continuously while taking the capsule. The M2A procedure is not a replacement for Colonoscopy. It is not reusable. Capsule obstruction which necessitate surgical removal More expensive than the other procedures Batteries may not last long Presence of cardiac pacemakers and cardiac defibrillators could corruption and loss of the transmitted data. MRI not possible while the capsule inside the patient's body v

lead to

CAPSULE ENDOSCOPY RETENTION • Capsule retained proximal to an intestinal narrowing for at least TWO WEEKS. • Untreated, may be permanent. • Capsule removal requires medical endoscopic or surgical intervention

Future Improvements §Equipping the capsule with a LASER. § Adding additional features like Zooming & Auto Focus. § Can be used in Restorative Surgery & Pharmacological Intervention. § Further reduction in size using Nano Technology. §Making it cost effective. §

§SB2 with new features mm §RAPID® REAL TIME VIEWER §Labeling the bowel wall, sample luminal contents, biopsy the mucosa, provide therapeutic ablation of lesions, or control the movement of the device. §Evaluation of celiac sprue and chronic abdominal pain. §Longer battery half-life §Humanoid robot §Capsule camera with telemetric capacities §Making it cost effective.

RAPID® REAL TIME VIEWER � Remote Patient Check-in � Real-time viewing � Data Transfer to GDS � PillCam ESO Viewing

Conclusion

The Endoscopy capsule is a pioneering concept for Medical Technology of the 21st century. The endoscopy system is the first of its kind to be able to provide noninvasive imaging of the entire small intestine. It has revolutionized the field of diagnostic imaging to a great extent and has proved to be of great help to physicians all over the world.

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