A Project Report On:

CONCEPTUAL DESIGN OF PEN-INSULIN

POST GRADUATE DIPLOMA IN CAD/CAM FOR TOOL ENGINEERING

Prepared By: ANJUL SHARMA (PGDCTE-10-03) KAPIL MANOHARAN (PGDCTE-10-11)

MSME TOOL ROOM, HYDERABAD

CENTRAL INSTITUTE OF TOOL DESIGN
(A Govt. of India Society, Ministry of MSME) BALANAGAR, HYDERABAD - 500 037 A.P. (An ISO 9001:2000 Institution)

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ACKNOWLEDGEMENT It is a great pleasure to present this report carried out at Zuti Engineering Solution Pvt. Ltd. ,Hyderabad in Design Department. It is pertinent to mention my heartfelt gratitude to Mr. VIJAY BHASKER REDDY SEELAM (M.D) & my guide Mr. VIKRAM NAMA (Manager Design Dept.) for their untiring guidance and valuable support and encouragement for the completion of this project work. I express my heartfelt gratitude to Mr. V. KRISHNASWAMI, Director, (Trg.), C.I.T.D., & Late Mr. VIJAY KUMAR, Assistant Director, C.I.T.D. I am also thankful to C.I.T.D. for providing academic assistance during the course. Last but not the least, I am thankful to all those who have helped me directly or indirectly for completion of my project work; specially to Ms. Rupa Kongar (H.R.), Mr. Harshavardhan (Manager CAE Dept.) and Ashish Singh(CAD Engg) and the entire team members of Zuti Engineering Solution Pvt. Ltd. Hyderabad.

ANJUL SHARMA P.G.D.C.T.E. (05-10-03) KAPIL MANOHARAN P.G.D.C.T.E. (05-10-11) C.I.T.D., Hyderabad

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Preview:
Clinical trials have convincingly demonstrated that improved glycemic control significantly reduces the risk of diabetes-related complications. However, tight control is not always easy for patients to achieve. To help overcome some of the problems linked with tight control, insulin pen devices have been developed to offer easier, safer, more accurate, and more discreet insulin injection.

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INDEX:
S.No. 1. TOPIC PREVIEW Insulin delivery using pen devices SUB-TOPIC PAGE No. 05

07

Modelling Approach 2. STUDY Rack and Pinion Mechanism Plastics Patents 3. 4. 5. 6. NEED AND REQUIREMENT DESIGN CONCLUSION BIBILOGRAPHY

17 18 23 24 36 40 48 49

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STUDY
Insulin delivery using pen devices
With the rapid pace of modern life, the time required to optimally manage diabetes may be hard to find. New insulin and insulin delivery systems can make this easier while offering additional benefits of lifestyle flexibility and improved glycemic control. Insulin analogues, such as insulin lispro (Humalog), also improve convenience by their rapid action; this allows insulin injection immediately before meals, rather than the 30- to 60-minute interval needed for the best postprandial glucose control with regular insulin. Insulin pens are another innovation designed to provide the patient with an easy-to-use, convenient, and accurate method of insulin delivery. The goal is to improve glycemic control by making it less difficult to follow the current recommendations for intensive insulin regimens. Two types of insulin pens are available today: prefilled and reusable. Prefilled pens are simply discarded when the insulin cartridge is spent, whereas reusable pens contain a replaceable insulin cartridge that is loaded into and removed from the pen by the patient. Most pens function on simple mechanical principles and are durable. The technique for insulin delivery is similar for both prefilled and reusable pens.

Technical advances
Medical therapy for diabetes mellitus has changed dramatically since Banting and Best discovered insulin in 1921. Not only have therapies for diabetes advanced significantly, but the technology for the delivery of insulin has also changed. Nonetheless, syringes were the sole method of insulin delivery for decades. The original glass syringes and their large, reusable needles had to be boiled for sterilization. The needles were sharpened with a pumice stone for reuse. Syringes continue to play a prominent role in patient care today, but they are now disposable plastic devices that deliver as little as 0.5-unit dosing increments through 30-gauge, short, attached needles.

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Although advancements in technology have provided various sizes of syringes and needle systems, the traditional insulin injection process remains time-consuming, cumbersome, inconvenient, and somewhat painful. Furthermore, insulin dosing via syringe is associated with a high risk of dosage errors; as many as 80% of patients carry out some aspect of insulin administration via syringe incorrectly. Now, to allow more flexibility and convenience, patients are seeking options other than the traditional vial-and-syringe delivery method. Insulin pens meet this need and also address issues of patient and environmental safety, social concerns, and more accurate dosage control (table 1).

Advantages of insulin pen devices over conventional insulin syringes:

1. More convenient insulin delivery 2. More accurate dosing 3. Less pain because smaller-gauge needles are used 4. Better quality of life 5. Easier compliance with insulin regimen 6. Simpler for specific populations to use (eg, older adults, children and adolescents, pregnant women) 7. Improved social acceptability, especially at school 8. More flexibility because of disposable or reusable options

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Insulin pen devices are unique in that they combine the insulin container and the syringe in a single unit. Their compact size allows discreet insulin administration but still provides extremely accurate insulin delivery. Advances in the technology of needle manufacturing continue to make needles more comfortable to use. With all these refinements combined, insulin pens improve the likelihood that patients will adhere more closely to recommended insulin dosing schedules.

Pen types and styles:

Insulin pens have become extremely popular throughout the world; in some countries, 70% to 90% of all insulin is delivered by pen. However, in the United States only about 2% of insulin is injected via pen. This is probably because of difficulties with reimbursement from insurance companies or a lack of knowledge on the part of patients and physicians about pen availability. The fact is that insulin pens are available in various types and styles and can benefit a large number of patients.

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Features of commercially available insulin pen devices: B-D B-D Autope Huma- NoNoPen Pen n AN log, voPen voPen Clas- Mini 3000, Hu1.5 mL 3.0 mL sic (Bec- AN mulin (Novo (Novo 1.5 ton 3100 pens Nord- NordmL Dickin (Owen (R, isk) isk) (Bec- son) Mum- NPH, ton ford) 70/30) Dicki 3.0 mL nson) (Lilly) Physical characteristics Prefilled Reusable 1.5 mL, 150 units 3.0 mL, 300 units 3.15 mL, 315 units Pediatric "POP" pens Special color graphics Viewed size of dose numbers greater than or equal to 0.1 in. Dosing features N Y Y N N Y Y N N Y Y N N Y N N N Y Y N N N N Y Y N N Y N N N Y N Y Y N N N Y N

NoDisvolin etPre- ronic filled pen pen (R, 3.15 NPH, mL 70/30) (Dis1.5 mL et(Novo ronNord- ic) isk)

N Y N Y N N Y

Y N Y N N N N

N Y N N Y N N Y

N (Y) N

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Manufac1 turer's stated dosing increment (units) Minimum/ma 1/30 ximum dose (units) Dark dosing number on light background Dial and dose using same knob Two-way dose dialing Audible click when dialing Audible click when injecting End of injection stroke indication Insufficient remaining dose (predose indication) Indicator returns to zero at dose completion Y

0.5

3000, 1 1 3100, 2 0.5/15 3000, 1/60 1/1631 00, 2/32 Y N Y

1/40

2/70

2/58

1/80

Y N Y Y Y N

Y N Y Y Y N

N N Y N N Y

Y Y Y N Y Y

Y N Y Y Y N

Y N Y Y Y N

N Y Y N N Y

Y Y Y Y Y Y

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Prefilled pens Prefilled pens contain a built-in, single-use insulin cartridge. Because this device requires no loading by the patient, it is especially convenient and easy to use. These portable, durable, and lightweight delivery systems are particularly helpful for patients who have difficulty handling the cartridges in reusable pens or people with busy schedules who prefer not to have to stop to change cartridges. However, prefilled pens may be slightly more expensive over time, compared with reusable pens. Also, both types of pens are more expensive than vialand-syringe insulin therapy. In the United States, the first prefilled pen was the Novolin 70/30, introduced in 1993; the newest prefilled pens are the insulin lispro (Humalog) and human insulin (Humulin) devices manufactured by Eli Lilly & Company. These pens have single-unit dosing increments, audible clicks when dialing the dose, a large magnifying window that shows unit dose, two-way dose setting that allows the user to decrease the dose without taking the pen apart or discharging insulin from the pen, and an end-of-dose click that indicates that the full dose has been delivered. Reusable pens With the reusable pen, the patient inserts an insulin cartridge into the pen's delivery chamber. For some patients, this allows greater flexibility (ie, changing types of insulin without needing to buy another pen if prescription changes), and it may be more economical than using prefilled pens. In addition to being durable and easy to use, the reusable pens are designed for longer duration of use. Disadvantages of the reusable pens are the potential loss of sterility with use (4,5) and the possible damage that may occur to the pen over time. With individual use of the pen device, the risk of infection is minimized (5). Among the reusable pens currently on the US market are: Autopen AN 3000 and AN 3100 (Owen Mumford, Inc.), B-D Pen Classic and B-D Pen Mini (Becton Dickinson), Novo-Pen 1.5 and NovoPen 3.0 (Novo Nordisk), and Humalog and Humulin pens (Lilly). Device preparation Regardless of whether a patient chooses the prefilled or the reusable pen design, the techniques for dose preparation and insulin delivery are generally similar. Once a disposable needle is screwed on to the pen and the pen is primed, the patient simply dials to the appropriate dose, which can be seen in the device's display window and can be heard as audible clicks in many pen devices. The needle is inserted subcutaneously, and the plunger injection button is depressed to deliver the dose. One disadvantage of pen devices is that the injection itself takes slightly longer than does the traditional syringe injection. The pen needle should remain in the subcutaneous tissue for 5 seconds after complete depression of the plunger.

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Insulin cartridges are available in either a 1.5-mL or 3.0-mL volume (150 U or 300 U, respectively) and are specific for the pen size (ie, a 150-U cartridge will not fit in a 300-U pen, and vice versa). The following insulins are currently available in 1.5 mL cartridges: regular human insulin (Humulin R, Novolin R), human isophane insulin suspension (Humulin N, Novolin N), 70% human isophane insulin suspension with 30% regular human insulin (Humulin 70/30, Novolin 70/30), and insulin lispro (Humalog). The cartridges should be stored in the refrigerator before use. However, once a cartridge is placed in a reusable pen, the pen can be kept at room temperature (<86F) for a month, as long as it is away from direct heat and light. The pen and cartridge configurations vary, so that only Lilly 3.0-mL cartridges fit Lilly, Becton Dickinson, and Owen Mumford 3.0-mL pens. Novo Nordisk 3.0-mL cartridges fit only 3.0-mL NovoPens. The Disetronic pens accept any insulin but require use of Disetronic cartridges. The disposable needles that are attached to insulin pens have some advantages over standard syringe needles. Manufacturers offer pen needles that are one third shorter (12.7 mm) than standard-length needles and are a larger gauge (thus a smaller bore diameter) for greater patient comfort. Because the pen needle does not puncture the stopper of an insulin vial before injection, the needle maintains its sharpness and beveled angle, thereby potentially reducing the pain of injection, compared with the traditional vial-andsyringe technique. Clinical studies Although insulin pens have been available for more than a decade, few clinical studies in the United States have evaluated their use. After the pen's introduction in 1985, Jefferson and associates (6) evaluated patient preferences and blood-glucose control indexes in 10 adolescents with diabetes, aged 12 to 17 years. Over a 3-month period, mean glycosylated hemoglobin (HbA1c) levels decreased from 13.7 2.7% to 11.7 3.4%. Most patients, including those who had increased their injections from once daily to four times a day, reported the pen's advantages outweighed the inconvenience of multiple injections. One of the first pen devices on the market was used in this study. Since that time, pens have undergone many significant improvements. With type 2 diabetes. Most of the patients had been treated with insulin for 6 months to 43 years before the study; 22 of the 64 patients were new insulin users. During the 4-week study, mean fasting blood glucose concentration decreased from 197 mg/dL to 171 mg/dL (P<.05), and none of the patients reported an episode of moderate or severe hypoglycemia. Patient comments regarding the pen were extremely positive: 98% reported the pen was convenient and easy to use, and 91% wanted to continue its use.

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In an Italian study (1), the safety, efficacy, and acceptability of a prefilled insulin injection pen device was assessed in 60 patients with diabetes who were over 50 years of age and were using conventional insulin syringes. Hypoglycemic episodes did not differ significantly among patients using syringes compared with those using pens, and no marked hypoglycemia was noted. Blood glucose profiles were similar for both types of insulin administration, except for prelunch blood glucose values, which were lower with pen use (157 52 mg/dL versus 166 49 mg/dL [P<.01]). About 90% of patients administered insulin more quickly and easily with the pen than with the conventional syringe. The investigators concluded that the prefilled insulin pen was safe, efficacious, and highly accepted in patients with diabetes over age 50 (1). Ease of accurate dosing is particularly important for older patients, who may have impaired vision, arthritis, or reduced motor coordination. Two multicenter surveys (8) of 1,310 adult insulin users were conducted to assess the effect of prefilled and reusable pens on compliance with insulin, diet, and exercise regimens and on perceived well-being. Attitudes toward use of the pen and toward traditional syringe injections were also reviewed. Most patients found the pen easy to use (92% when using prefilled pens and 98% when using reusable pens). The survey showed that patients were very positive about the pen devices: 77% of pen users found it easier to comply with the insulin regimen using the pen than with conventional syringes, and 73% of pen users achieved more accurate insulin dosing than when syringes were used. More important, 85% of pen users never missed a scheduled injection, compared with 72% of patients using the vial-and-syringe method. In general, the fewer missed injections, the greater the likelihood of improved glycemic control and better therapeutic outcome. The investigators reported that patients' attitudes improved regarding insulin therapy; they had greater confidence in managing their disease (8).

Who benefits? All patients with diabetes should be considered candidates for insulin pen devices. Diabetic patients with erratic eating habits may especially benefit. However, people who take regular or lispro insulin before meals or snacks and NPH insulin at bedtime usually need two pens, one for each type of insulin. Also, patients who take mixtures of two kinds of insulin in one syringe (eg, regular or lispro and NPH or lente other than the 70/30 premixed insulin) would need to use two pens and two injections for each dose. This often is less desirable than the single-syringe injection of mixed insulin.

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Children, adolescents, and young adults Children, whose perceptions of syringe injections include pain and rejection by peers, often have more positive feelings about the pens. The pens are particularly convenient for administering an accurate dose of insulin in a timely fashion for children with busy sports or activities schedules. In addition, the lower insulin doses typically used in children are easier to measure with the pen device. For young children, pediatric "POP" pens are available in various bright colors or patterns that easily differentiate rapid-acting insulin devices from those containing intermediate-acting insulin. Because of the stereotypical association of syringes with illicit drug use, insulin administration is a special concern for young people with diabetes. In many elementary schools, the vial-andsyringe method of injecting insulin often is relegated to the principal's office, which carries negative connotations. By comparison, the pen device generally can be used right in the classroom. In one study (6), children reported that they could inject their prelunch insulin dose directly into their thigh or abdomen without leaving their desk or disrupting the classroom. The current pen devices do not require refrigeration, so they can be conveniently carried in a pocket, purse, or backpack for flexibility and proper timing of insulin dose. It appears logical to conclude that the use of pen devices by children and adolescents may decrease the social impact of diabetes in this age-group. College students often have schedules that vary from day to day, with irregular hours of eating and activity (which may also include days with vigorous exercise or periods of carbohydrate loading). The ease of use of insulin pens and the flexibility of fitting insulin injections into a busy lifestyle may improve diabetes control with much less effort and disruption of normal college life.

Women with gestational diabetes Treatment of women with gestational diabetes requiring pharmacologic therapy is limited to insulin. This is because oral agents may cause hypoglycemia or teratogenic effects in the fetus. Davidson and Roberts (9) reported, "the risk of complications in newborns of mothers with gestational diabetes is thought to be secondary to hyperglycemia during pregnancy and is markedly reduced when optimal control of glucose levels is established and maintained." The convenience, flexibility, and ease of use of insulin pen devices can simplify treatment and reduce therapy-related stress for pregnant women during an already stressful time.

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Older patients The number of patients with diabetes over the age of 60 who are being treated with insulin is steadily growing. The majority of these patients are taking numerous medications, and many have some type of physical disability. As previously mentioned, insulin injections using a vial and syringe are associated with a high risk of error in this age-group (1).

In patients with vision problems, air bubbles that are drawn into the syringe may go unnoticed, leading to potentially tremendous variations in insulin delivery from day to day. Not only do insulin pens improve dosing accuracy and compliance, they also may be easier for patients with compromised fine-motor coordination to use. Therefore, the older person who has special challenges (eg, visual problems, tremor, poor injection technique) may particularly appreciate the pen (10).

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MODELLING APPROACH
The top-down modeling approach follows the general product design process in general. However, in contrast with the bottom-up modeling approach, the layout of a product (skeleton model) is created at the conceptual design phase in the top-down modeling approach. All the product design processes beginning after the planning phase and ending prior to the production phase are summarized at the Fig. 2. They are classified into conceptual design, preliminary design, and detail design. At the conceptual design phase, configuration design is performed according to the requirements for components standardized according to the functional design of a product. The skeleton model is generated at the phase where the overall layout of a product is designed by referring to the initial product configuration that standardizes components of the product and relations among them.

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SKELETON MODELLING:
In the product design process based on a collaborative top-down modeling approach, the design information that is exchanged between OEMs and suppliers can be summarized into four categories :-

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The geometric entities of the skeleton model

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RACK AND PINION MECHANISM

A rack and pinion is a type of linear actuator that comprises a pair of gears which convert rotational motion into linear motion. A circular gear called "the pinion" engages teeth on a linear "gear" bar called "the rack"; rotational motion applied to the pinion causes the rack to move, thereby translating the rotational motion of the pinion into the linear motion of the rack. The pinion rotates and moves the rack in a straight line - another way of describing this is to say rotary motion changes to linear motion. A good example of a rack and pinion gear system can be seen on trains that are designed to travel up steep inclines. The wheels on a train are steel and they have no way of griping the steel track. Usually the weight of the train is enough to allow the train to travel safely and at speed along the track. However, if a train has to go up a steep bank or hill it is likely to slip backwards. A rack and pinion system is added to some trains to overcome this problem. A large gear wheel is added to the centre of the train and an extra track is, with teeth, called a rack is added to the track. As the train approaches a steep hill or slope the gear is lowered to the track and it meshes with the rack. The train does not slip backwards but it is pulled up the steep slope.A rack is a gear whose pitch diameter is infinite, resulting in a straight line pitch circle.

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Applications:
The rack and pinion arrangement is commonly found in the steering mechanism of cars or other wheeled, steered vehicles. This arrangement provides a lesser mechanical advantage than other mechanisms such as recirculating ball, but much less backlash and greater feedback, or steering "feel". The use of a variable rack (still using a normal pinion) was invented by Arthur Ernest Bishop, so as to improve vehicle response and steering "feel" especially at high speeds, and that has been fitted to many new vehicles, after he created a specialised version of a net-shape warm press forging process to manufacture the racks to their final form, thus eliminating any subsequent need to machine the gear teeth. For every pair of conjugate involute profile, there is a basic rack. This basic rack is the profile of the conjugate gear of infinite pitch radius. A generating rack is a rack outline used to indicate tooth details and dimensions for the design of a generating tool, such as a hob or a gear shaper cutter.

Features such as high reliability and repeatability ensure that rack and pinion systems are the first choice for linear and angular measurement applications. By butting lengths of rack together, extremely long axes can be measured to the highest accuracy.

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RACK ACCURACY GRADES:

Grade 5 4 0.008 4b 0.008 3 0.02 2 0.03 1 0.05

Max. pitch error between any 0.005 two points per 300 mm of rack Max end to end pitch error up to 300 mm of rack* Adjacent tooth error Pitch Height Variation

0.004 0.004 0.008 0.008 0.013 0.025 0.0025 0.0025 0.0025 +0 +0 -0.013 -0.013 +0 -0.013 0.005 +0 -0.013 0.010 +0 -0.018 0.013 +0 -0.025

All dimensions in mm *Applies pro data to lengths > 300 mm Approximately equivalent to A.G.M.A. grades 9 to 14

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PLASTICS
Plastics are natural/synthetic materials. They are produced by chemically modifying natural substances or are synthesized from inorganic and organic raw materials. On the basis of their physical characteristics, plastics are usually divided into thermosets, elastomers, thermoplastics These groups differ primarily with regard to molecular structure, which is what determines their differing thermal behavior.

Advantages:
Corrosion resistance Low electrical and thermal conductivity Low density High strength-to-weight ratio Noise reduction Wide choice of colors and transparencies Ease of manufacturing and part complexity Relatively low cost

Disadvantages:
Low strength; high thermal expansion; low melting temp.

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PATENTS
There has been 12 patents already been made to this product which have mostly been concepts. The following are the 12 patents : 1.

2.

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3.

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4.

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5.

6.

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7.

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8.

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9.

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10.

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11.

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12.

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NEED AND REQUIREMENTS

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This project is about Insulin administration by injection and what could be done to make it more affordable. Diabetes, which is quite common in society is now growing even more and has become a major health risk for all age categories. Apart from health factors it is also a burden with huge cost factor. Many types of medications have been developed and Insulin shots are the quickest method. Different types of Insulin shots are available, such as the common Insulin ampoule and syringe method, Insulin pens reusable and disposable, Insulin Jets, pumps that are selfmonitored etc. Most handy and cheaper to use are found to be Insulin Pens.

Advantages and Disadvantages of Insulin Pens:

The reasons why some insulin users prefer insulin pens include: Insulin pens are portable, discreet, and convenient for injections away from home. o They save time because there is no need to draw up insulin from a bottle - it is already pre-filled in the self-contained cartridge. o They usually let you set an accurate dose by the simple turn of a dosage dial, and that may make it easier to set an accurate dose for people who have vision or dexterity problems. o There are also reasons why insulin pens are not right for all users, including: o Insulin in pens and cartridges is often more expensive than insulin in bottles for use in syringes. o Some insulin is wasted when pens are used: one to two units of insulin are lost when the pen is primed before each injection; and there is usually some insulin left in the pen or cartridge (but not enough to inject) when they are used up. o Not all insulin types are available for use in insulin pen cartridges. o Insulin pens do not let you mix insulin types, which mean that if the insulin mixture you need is not available as a pre-mix, two injections must be given - one for each type of insulin.

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This study will consider the disadvantages as mentioned above and make the Novolet design a reusable one. Development of a disposable insulin pen, known as "NovoLet", is designed with focus on simple mechanical parts, plastic components, low cost price and suitability for fully automated assembly.

Description:
The pen is based on a simple idea. One product - a combination of syringe and insulin ampoule - includes everything needed for treatment in a single ready-to-use device. The challenge was to manufacture a disposable pen at a cost price of less than 1/10 of pen systems already known (for multiple use) but with the same high standard when it comes to comfort and reliability. The operation is easy. A transparent barrel allows patient to see what they're injecting. The functions can be seen, heard and felt. Each injection is accompanied by clicks to assist diabetics with poor eyesight to administer a correct dose. The pen is a self-contained disposable unit. No reuse or refilling. The price of the pen is low, and the pen is only slightly more expensive than the normal packages. The disposable pen with extreme requirements for the function of the plastic parts and precision is an innovation and the first of its kind. The internal sophisticated mechanical parts are well matched with the external design and the finish, which is far beyond normal standard when it comes to mass-produced products with limited life.

Design Technique
The many functions of the pen have been established using only seven plastic components. (Refer Fig on pg3): 1. The Push button 2. Push button scale 3. Plunger shaft 4. Plastic tube with Level indication 5. Main tubular body 6. Ampoule neck end 7. Cap

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The mechanical properties of the plastic parts have been fully exploited to give each component as many functions as possible and to reduce the number of components. When setting the actual dose the two outer parts are turned in proportion to each other. The needle is exposed, the button on top is pressed, and the dose set is injected. The cap is put on and the pen is ready for the next setting/dosing.

The Technique:
The plastic shaft that moves the plunger rubber one way has to be fixed together with the rubber so that the Insulin chamber can be refilled again just like a normal syringe. To refill, the plastic shell that contained the ampoule of Insulin needs to be rotated to the opposite direction as when it was rotated for calculating the units of Insulin shots. When rotated backwards i.e., reference to the marking on the dosage indicator the shaft moves upwards in units (makes click noise) pulling the plunger rubber. It is also observed that the rotating shaft has been locked from going both directions as for fool proof ing. The locks can be removed from the new design concept and make to go/rotate to both the directions. Design challenges to considered: 1 Accuracy in measurement of insulin (need medical data for backup) 2 Durability of plastics ( No. of reuses) 3 Choosing the right plastic considering strength, elasticity and other factors. 4 Accidental fall 2mtrs height.

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The pen-insulin available in the market of disposable type of company named NOVOLET.

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DESIGN
The main aim of the project is to either reduce the cost of the pens available in the market of disposable type or make it reusable.

CONCEPT:
It is based on rack and pinion mechanism with self lock. In this system firstly we set the dosage as required on the dial indicator which is connected to the pinion. The turning of the dial indicator causes the spring connected to pinion to twist and store the kinetic energy in it. After the dosage is set the pinion doesnt return back due to the locking system. The person then injects the needle into his body. The push button is pressed which causes the locking system to release the pinion which starts rotating due to springs stored energy which starts to unwind. The pinion moves the rack and in turn rack start moving with the plunger rubber and dosage is injected to the body. Exploded View:

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1. Cap

2. Capsule

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3. Capsule Cover

4. Needle Cap

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5. Needle

6. Outer Cover

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7. Outer Cover 2

8. Pen-Insulin Skeleton Model 9. Pinion with Dial Indicator

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10.Plunger

11.Plunger Head

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12.Spring

13.Stopper

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14.Stopper Rod

15.Stopper Spring

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CONCLUSION
The study and design of this concept has proven that it is cost effective than the available ones in the market. The cost effectiveness can be seen from the fact that it contains less number of parts to be manufactured and the parts are also less complex, the full system is reusable, only the capsule of insulin has to be changed. It contains 250 units of insulin so that a user can use it average 10 times. It is portable, discreet, and convenient for injections in and away from home.

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BIBILOGRAPHY
1. U.S. PATENTS APPPLICATION PUBLICATIONS. 2. MACHINE DESIGN By KHURMI 3. ENGINEERING PLASTICS BY LAXNESS PUBLICATION.

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