Colonoscope System to Avoid Loop Formation

Enclosed is my report of Final Project pertaining to Design of new system proposed for a Procedure of Colonoscopy to overcome a Looping Problem.

Various factors have been discussed and some approaches have been utilized throughout this report and have found this area as full on interest, though clearly also one of the most mandatory for practical life. Working on this area has tremendously increased my knowledge.

These days Colonoscopy is a subject which is point of interest for every organization, especially for those who are having an immense research in this area related to innovation and enhancement and companies which mainly deals in Medical Equipment Technologies and various processes.

There are Designing and Electrical area which are set in Colonoscopy Equipment to the Development of Electrical System which contains a deep level of area linked to Electrical Technology. Thus, reflecting the current value of product/services among the consumers or how the value can be increased and also its scientific development

Many research firms are working globally related to development and innovation of Colonoscopy and are and also there are some companies which have the statistical data and are providing useful information for technical people so they are plan and market their business accordingly and specially those areas which are a part of Colonoscopy technology.

Influencing the ways that people act in their daily utilization lives is an anxiety for researchers in a number of disciplinary areas, including consumer Behaviour psychology, development, innovation, health research and marketing.

The particular context of the low-income consumer is one that is starting to emerge in the consumer and marketing policy literature as one of importance, particularly in terms of ensuring that these consumers get their basic needs met in their marketplace interactions.

However, there is still limited knowledge about the Colonoscopy patterns of low level of technical people mean they have less knowledge about Colonoscopy and in particular there are very few studies that have examined attempts to influence or modify lower knowledge for those technical people which don’t have sufficient knowledge for this domain.

Report is composed of different areas, for a better idea the report is organized of areas which are descried as under.

1. Necessary requirements of a report

2. Basic introduction of a Colonoscopy and its current procedure, with some concepts of its medical application are conditions which are required before any colonoscopy procedure or its application

3. Idea of a new equipment, modelling and designing methodology in order to get proper idea pertaining to new designed procedure

4. New product development procedure and approach, so once the procedure is designed a new equipment is produced what will be the activities related to costing factors, technical implementations, commercialization strategies etc.

5. Conclusion and References

This project is about the interface and a system which will help doctors and physicians to perform successful colonoscopy procedure without facing any looping problem, if any problem occurs system will help to identify problem. There are some New Product Development areas which are also discussed in this report. Various aspects of Colonoscopy and its modelling has been discussed in this report and some introduction material is also applied to apply a defining light related to various concepts

Colonoscope:
Colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a CCD camera or a fiber optic camera on a flexible tube passed through the anus. It can provide a visual diagnosis the opportunity for biopsy or removal of suspected colorectal cancer lesions. [1]

Figure 1: Gilo, Colonoscope, Image adapted from “Wikimedia.org“, 2009

Colonoscopy:
Colonoscopy is a procedure which helps doctor to examine the lining of the entire rectum and colon by using the endoscope having a camera with one of its end. Colonoscopy may be done for the following purposes:

• Blood in the Stool
• Anemia
• Abdominal Pain
• Areas of Inflammation that may indicate ulcerative colitis
• Helps to obtain biopsy tissue for examination
• Diagnose of Invasive Cancer
• Changes in Bowels Habits, such as constipation or diarrhea
• Complete removal of large polyp
• Recheck the colon following surgery for Colon Cancer

Figure 2: Colonoscopy Preparation, Image adapted from “American Gastroenterological association”, April 2013

Colonoscopy may be done for a variety of reasons, most of the time it is done to find out the cause of blood in the stool, abdominal pain, diarrhea, and change in bowel habit or an abnormality found on colonic X – rays or a Computed axial tomography scan. [2]

Individuals having previous history of polyps or colon cancer and certain individuals with a family history of some types of non-colonic cancers or colonic problems that may be associated with colonic cancer may be advised to have periodic colonoscopies because their risks are greater for polyps or colon cancer. [2]

How often should one undergo colonoscopy depends on the degree of the risks and the abnormalities found at previous colonoscopies. It has been recommended that even healthy people at normal risk for colon cancer should undergo colonoscopy at age 50 and every 10 years thereafter, for the purpose of removing colonic polyps before they become cancerous. [2]

Figure 3: Steven, Mark, Colon Cancer and Polyp Image adapted from
“Colonoscopy Preparation Process“

The process of colonoscopy includes the intubation of a Colonoscope from the anus via the colon to the cecum. Throughout a comprehensive colonoscopy procedure, the insertion shaft is inserted into the anus then pushed through the rectum, sigmoid colon, descending colon, transverse colon, and ascending colon through to the cecum. [3]

At present to perform the Colonoscopy there are two methods which are available and they are known as two – Person and One Person Colonoscopy Procedure. [3]

In the one-person colonoscopy, the physician performs the inspection alone, managing the angulation panels and valves with one hand and inserting or twisting the shaft with the other hand. In one-person colonoscopy, the physician customs the right hand to insert the scope and control the orientation of the distal end of the scope with the left hand. Thus, the one-person method typically creates a better coordination of the two operations during the procedure. [3]

In the two-person colonoscopy, a physician and an assistant perform the two-person colonoscopy, i.e., the physician controls the orientation of the scope, and the assistant pulls and pushes the Colonoscope according to the physician’s command. [3]

By contrast, in the two-person method, an assistant pushes or pulls the scope while the physicians control the scope orientation. In the latter method, good coordination often is hard to achieve. [3]

As a result, the two-person method often creates more procedure-induced abdominal pains than does the one-person method. [3]

Figure 4: Cole, Chrissie, Colonoscopy Procedure, Image adapted from
“Colonoscopy Cancer Screening Procedure“, October

Before having a colonoscopy, doctor must be aware if patient has any special medical conditions. Some of the conditions are mentioned as under: [4]

• Pregnancy
• Lung conditions
• Heart conditions
• Allergies to any medications
• Diabetes or take drugs that may affect blood clotting. Adjustments to these medications may be required before the procedure.

Some patients also needs to antibiotics before the colonoscopy. Some of the examples are described as under: [4]

• Have an artificial heart valve
• Have ever been told you need to take antibiotics before a dental or surgical procedure

 

In recent times a little amount of work has been done on colonoscopy device and little advancement has been made but still there is a problem which is common to colonoscopy device and i.e. Loop Information in colonoscopy when procedure is applied.

Figure 5: Tudor, Alex, Loop Formation in Colonoscopy, Image adapted from “Fundamentals: Diagnostic Colonoscopy“, June

Most commonly, we speak of a ‘difficult colonoscopy’ being one in which it was challenging or not possible to reach the cecum. Others might be inclined to measure difficulty based on the duration of time required, or the amount of physical exertion involved or even the discomfort the patient experiences. [5]

For the expert colonoscopies, a difficult colonoscopy might be one in which it is challenging to diligently examine each fold upon withdrawal. For the purposes of this discussion, we will confine ourselves to viewing the ‘difficult colonoscopy’ as one in which the endoscopies struggles or fails to reach the cecum. [5]

Figure 6: Steele, R.J.C, Perforation of the Bowel by Colonoscopy, United Kingdom, Image adapted from “How I do it Colonoscopy“

Research Objective:
When we analyze different colonoscopy available in the market then we realize that there are various colonoscopy procedures which has introduced in market and are adapted for medical examinations as well.

Some of the types which are introduced in medical sector are mentioned as under

• Variable Stiffness Colonoscope
• Over – tube Colonoscope
• Capsule Endoscope
• Self – Propelled Endoscope
• Virtual Colonoscopy
• Aer – O – Scope
• Neo Guide Endoscopy System
• Image Guided Colonoscopy

In this project we have mentioned new proposed equipment which is added in a Colonoscope device and will be utilized in a procedure of colonoscopy and certain small equipment has also been added with Colonoscope which helps to overcome the loop problem associated with the Colonoscopy Procedure at present.

Reason of a Loop Formation:

The actual reason of a loop formation is self-locking mechanism, it occurs when Colonoscope and Colon comes in contact two states occurs which is Stick State and Slip State.

Slip state occurs when tangential force is greater than the limit of static friction force, this friction force can be determined by the multiplication of dynamic frictional coefficient and normal applied force to the point.

Stick state is the displacement of two contact points when both of them are equal to zero. This stick state usually occurs in sigmoid colon.

Self-locking mechanism generally occurs when driving force angle is less than the friction angle and this state is known as stick state.

So far to avoid loop formation the principle has been shown up but there is no such equipment which can support this principle.

In further part of this report we will be discussing what equipment and design can help to avoid the problem and support the idea which has been generated.

Figure 13: Colon Perforation, Image adapted from

“Medical Demonstrative Evidence“, USA 1999

Idea Generation/Concept:
After analyzing various concepts and types of colonoscopy procedures available in medical field it has been observed that loop formation is a very vast and common problem available in this area which created problem for doctor to perform the procedure.

To overcome this problem equipment is suggested in this report which will be a best fit for the current principle of colonoscopy that helps to overcome the looping error and problem.

The suggested equipment here will be integrated with the Colonoscope and will help measuring the force angle and also compares it with the friction angle so if the driving force will be greater than the friction force the loop formation will be avoided.

Benefits of the new integrated equipment are described as under

• Advanced Indication of Loop formation

• Run Time Mechanism

• Forces and Parameters in an display panel so Doctors can be informed during procedure

• Smooth Procedure 

Basic Idea in a Block Diagram: (Flowchart # 1)

Modelling of a New System:

There are various stages defined below but first we will start with the Block diagram of this new model.

Block Diagram of a System: (Flowchart # 2)

Explanation of a Model/System:

Model discussed above consist of various sensors and devices which will help physicians to use a system which will give result as a Loop free Colonoscope procedure.

Colonoscopy Force Monitor:
CFM is a device that continuous measures, displays and stores the information. It is a preferred method to screen for colorectal cancer.

Figure 14: CFM Device, Image adapted from “Gastrointestinal Endoscopy”, USA 2014

It is a handheld force-measuring attachment mounted on the Colonoscope shaft that provides a physician with a real-time feedback on the force and torque applied during colonoscopy.

The CFM is designed to improve training of people which operated endoscopy and establish best practices for performing colonoscopy by quantitative characterization of expert skill.

Control Unit:

Control unit plays a vital role to avoid loop formation. It has two knobs i.e. Knob A and Knob B and both of them are controlled by Doctor. When doctor controls the knob the Tip gets particular orientation.

Here we will use both Models which were proposed by Wubin Cheng. His first Model was to give the information to Doctor about the contact force and position on tip in the colon so if there is any chance for the self-locking to occur so doctors should get warning in advance through the display system.

Second model describes relation between two knobs and the tip in order to compute the tip orientation information.

Interface through a Block Diagram: (Flowchart # 3)

Result:

By applying this new system Medical doctor will be able to identify current situation of a colonoscopy procedure. If there will be any loop problem or a self-locking mechanism will occur then doctor will be able to overcome it because information will be coming from CFM which is connected outside human body and doctor will be able to see force exerted to the tip of insertion tube and if it is not correct so they will be change the orientation of the tip.

System Flow in case of Loop Formation: (Flowchart # 4)

1. It will be a web based application which will be showing different information

2. There will be a live monitoring of a procedure so doctors will be able to examine the procedure on run time

3. Interface will be integrated to the CFM which will be providing the information of torque and force so if there will be an extra torque or force that doctors will be applying then they will receive a message on interface that Loop formation can occur

4. Interface will be integrated to the Knob which will be receiving the message of the Tip of the orientation so if there will be any requirement for the change of the orientation of the tip then doctors will be able to change it. For the change of orientation doctors will able receive a message on the live inteferace

Evaluation of a Model:
Here we will be doing evaluation of a proposed model of this project. The parameters defining the model as a Good or a Bad model is taken from Zhang – Lin FCBPSS modelling presentation.

Validity:
Upon receiving the information over a display panel of a CFM if doctors follow the procedure as per defined over a display panel so process can be performed smoothly and validity of a system will remain as designed i.e. output will be accomplished in a perfect way.

Utility:
Information coming from CFM will be accurate it will be dependent of medical staff on how they actually perform a process. Otherwise, it will be a perfect utility to give required output.

Reliability:
Process applied on a same patient multiple times in regular interval for a particular day, the results will always be obtained as same.

Comprehensiveness:
Colonoscope is only required to be integrated with different companies of display panel or control unit, this is only area for the comprehensiveness. The system will be designed in such a way the integration will remain uniform whenever it combines with any other device.

Ease of use (Usability):
it will be a user friendly device; uses will be designed as easy for the use of staff.

Product Screening and Benefits:

Since the new proposed system will be capable to overcome many problems which were occurring in past therefore this will be a top benefit of the new designed procedure.

There is a huge market present for users which will be able to use this new design procedure, currently there is a big market which are in need to use the process of a colonoscopy but they are unable to utilize it because of a looping problem. There are many medical facilities round the world which are looking to utilize the best procedure of a Colonoscopy.

There are some facts and figures which have been mentioned in a website related to Colorectal Cancer and that describes requirement of this product in a market with desperate measures

• 630,000 deaths expected
• Highest rates in Japan, Korea and Asia in general
• Risks increase with age, with 90% of cases being people over 50
• Screening reduces mortality since it can detect cancer at early stage. 5 year increases to 90% from 64%
• Many countries are adopting screening programs for people over 50
• Current tests available: FOBT (fecal occult blood test), sigmoidoscopy and colonoscopy, barium enema [6]

Expected Market Size:

The new procedure of a colonoscopy will be able to capture a huge market size. Globally a gigantic level of market is available for this device by making this new technology with software integration will be able to huge market immensely.

Routine colorectal cancer screening is something that tens of millions in the United States go through every few years. After the age of 50 patients are encouraged to have a colonoscopy every 5-10 years. Between these colonoscopies, they can use non-invasive tests that can sometimes determine the presence of cancer or even pre cancers. [7]

Currently, there are three main types of tests that are used: Fecal occult blood tests (FOBT), Fecal immunochemical tests (FIT), and stool DNA tests (sDNA). [7]

Of these three, fecal occult blood tests are used the most frequently – probably because they are quite cheap (<$25). [8]

The number of virtual colonoscopy procedures performed in the United States is expected to increase through 2014. Growth in the over-50-years-of-age demographic will drive procedure volumes in this market. In addition, public awareness of colon cancer and the importance of early detection are encouraging people to receive regular screenings. [9]

As the number of virtual colonoscopy procedures increases, the market for virtual colonoscopy software is also expected to increase, with companies such as General Electric (GE) leading the change. However, prices are estimated to decrease as competition within the virtual colonoscopy software market intensifies. [9]

But as inconvenient as it is, CRC screening saves lives. A little over 50,000 US patients die of this disease each year, making it the second deadliest cancer in the United States. About 20-40% of patients are diagnosed with the disease in the later stages, when surgical removal is not curative. However, the majority of screens that catch polyps will find them while they are still adenomas. Adenomas are typically asymptomatic, meaning that patients would not have been able to detect them without a colonoscopy. [10]

Figure 7: Herrick, Devon, Colonoscopy Market, Image adapted from

“The Emerging Market for Medical Care”

Concept Development of a Procedure:

Concept development of this new equipment initiates from the new features which will be embedded in it. For example CFM, Software Integration and Run Time information of a Loop Formation during a Colonoscopy so the Doctor can be informed and necessary actions can be taken in order to make it a perfect Colonoscopy Procedure.

Characteristics	Benefits
Software Integration	Run Time or Live Information
Live Display	Parameters showing up on Display Panel for correct forces or torques
Loop Formation Alerts	Early indication of Loop formation in case of extra force etc.

Table 1: Product Benefits, Type of Table adapted from

“Knauf Insulation and Technical Solutions”, United States, 2014

Though, there are many products related to Colonoscopy are available in Market which holds different type of Procedures and features. Therefore, a special Marketing campaign needs to be design through which consumers and target audience can be aware of this new designed procedure.

Marketing Strategies:

After proper concept development and procedure design following marketing strategies will be applied in order to capture major market.

Business Analysis:
Since there will be more features will be add up in a new procedure and therefore more additional hardware will also be required. So keeping such things under consideration price for a new Colonoscope will be more as compared to older devices but still the benefits which can medical industry will get from a new device will be a big reason for the success of this device.

Figure 8: Botha, Deon, Product Life Cycle, Image adapted from

“Product Maturity and Stages“

 

Figure 9: Botha, Deon, Product Life Cycle with Extension, Image adapted from
“Product Maturity and Stages”

The above two mentioned graph shows the idea of the product growth that how product will survive in market and will coupe up the desired sales volume in order to capture the biggest share of the market

Beta and Market Testing:

As Colonoscope is a medical device therefore its Beta Test product will be tested in labs only. After completing all necessary stages of testing then it can be only taken out in market otherwise it has to complete all testing and verification stages.

Beta Testing will only be out in Market after completing following stages:

Customer interviews will also be conducted in order to get best input when product will be under designing phase also the output when product will be developed completely

Figure 10: Hoover, Ryan, Customer Requirements and Necessities, Image adapted from “Tactics for Better Customer Interviews”, January 2013

Commercialization of a Product:

Product will be commercialize in following methods

• Consumer/Doctors Awareness Programs
• Brochure Distribution to Doctors
• Trade Shows (Health Care Show Preferably)
• Digital Marketing

Examples in images for these types of Marketing are described as under

Figure 11: Tradeshow Example, Image adapted from

“Tradeshows Exhibit“, Belgium 2014

 

Figure 12: Colonoscopy Brochure Example, Image adapted from

“Colorectal Cancer Awareness“, USA 2014

Pricing for Colonoscopy:

Since pricing is the top most concern for any buyer or customers therefore the pricing for this new procedure will be set per the requirement of market so it is not too costly and will be a best procedure for industry

Following methods and strategies will be applied for Product Pricing and Costing

Value Analysis Table
Step Number	Value Analysis	Description
1	Audit Process	For Costing Purpose
2	Implementation	Functioning properly
3	Final Negotiation	Final Pricing
4	Clinical Trial or Approval	Testing of a Product
5	Preliminary Negotiations	Early negotiation of a product
6	Structure Opportunity	Overall Infrastructure
7	Gather Data	Requirement Gathering
8	Product Opportunity	Benefits of a Product

Table 2: Value Analysis, Type of Table adapted from “Health Care Online”, England, 2008

Product costing will be applied by considering general requirements. Those requirements are mentioned in a table below

Table 3: Product Costing Table, Type of Table adapted from

“Product Costing Template”, USA, 2013

There are various colonoscopy devices which are already available in market and are also integrated with different software but to overcome the looping problem in run-time i.e. during procedure software does not provide enough information but this software will be good enough to provide such information for the procedure.

References

[1] James Bill, Colorectal Cancer Health Center, USA, 2010

[2] Dr. Jay Marks, How Colonoscopy Process is Performed, USA, 2011

[3] Wubin Cheng, Development of a Kinetic Model for Loop – Free Colonoscopy Technology, Canada, 2013

[4] Arnold Wax, Colorectal Cancer Guide, USA, 2012

[5] Dr. Todd N Witte, The difficult colonoscopy, Canada, 2007

[6] Lionel Abraham, The information about Bio Mark Technology, Australia, 2011

[7] Brian Wilson, Multi-Billion Dollar Colorectal Cancer Diagnostics Market, USA, 2014

[8] Greenwald B, Colorectal Cancer Screening Awareness, Belgium, 2005

[9] Bailey George, Virtual Colonoscopy Market Expected to Raise Rapidly, France, 2010

[10] Vaughan Harris, Colorectal Cancer Screening Analysis, Sweden, 2013

[11] Dr. James Aw, My first colonoscopy, Canada, 2010

[12] Adam Husney, Colonoscopy Devices, Canada, 2013

[13] M Winston, Understanding Colonoscopy, Belgium, 2011

[14] SJ Winawer, Guidelines of Colonoscopy Surveillence, USA, 2006

[15] Dr Oz, Dr Oz’s Colonoscopy, UK, 2010

[16] Tracey Williams, What is Force Gauge Used for, Denmark, 2010