BME403 Medical Implant and Device Design Assignment Sample NUI Galway Ireland

BME403 Medical Implant and Device Design module deal with the design of medical implants and devices. Students will be exposed to various aspects of implant and device design, including materials selection, biomechanical analysis, and manufacturing considerations. In addition, the regulatory landscape for medical devices will be introduced. The module will culminate in a group project in which students will design and prototype a medical device.

Furthermore, this module delivers an introduction to the Regulatory landscape for medical devices. At the end of this module, students should have an appreciation of the design considerations for medical devices; the role of regulatory bodies in approving devices for clinical use; and the process by which a medical device is brought to market.

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In this section, we are describing some assigned tasks. These are:

Assignment Task 1: Discuss the functional requirements for the design of medical implants and devices.

Medical implants and devices must meet a variety of functional requirements to be safe and effective. Some of the most important requirements include biocompatibility, mechanical durability, and electrical safety.

• Biocompatibility is a key concern in the design of medical implants and devices. All materials used in contact with the body must be compatible with human tissue, and they must not cause any local or systemic reactions. In addition, materials used in implantable devices must be compatible with the body’s immune system to minimize the risk of infection.

• Mechanical durability is another important consideration in the design of medical implants and devices. Implants and devices must be able to withstand the loads they will experience during use, both static and dynamic. They must also be able to tolerate repeated cycling between loading and unloading without failing.
• Electrical safety is another crucial requirement for medical implants and devices. Implants and devices that come into contact with body fluids must be designed to minimize the risk of electrical shocks. In addition, any electrical components must be protected from moisture and other environmental conditions that could lead to corrosion.

To ensure that medical implants and devices meet all of the necessary functional requirements, engineers must work closely with clinicians and other experts. It is only through this collaboration that safe and effective medical implants and devices can be designed.

Assignment Task 2: State the effects of the body on the device (e.g. corrosion, wear) and also the effects of the device on the body (e.g. host response, stress shielding).

The human body is a miraculous thing, constantly working to keep us alive and healthy. But this same body can also have negative effects on devices, causing corrosion and wear.

• Corrosion is a natural process that occurs when metals are exposed to oxygen and water. This causes a chemical reaction that creates oxides on the surface of the metal, which can eventually eat through the metal, leading to structural damage.
• Wear, on the other hand, is caused by friction between two surfaces. This can be especially problematic for devices that come into contact with our skin, such as watches or fitness trackers. The constant rubbing can cause the material to break down over time, leading to scratches, worn-out finishes, and eventually failure.

The effects of the body on devices can be minimized through the use of corrosion-resistant materials and proper design. However, it is important to consider these effects when designing medical implants and devices, as they can have a significant impact on their function and longevity.

Just as the body can have negative effects on devices, devices can also have negative effects on the body. One of the most common problems is host response, which is when the body reacts negatively to a foreign object. This can occur when the body perceives the device as a threat and attacks it, leading to inflammation, tissue damage, and potentially even rejection of the device.

Stress shielding is another common problem that occurs when devices are implanted in the body. This happens when the device takes on all of the stress and strain that would normally be borne by the surrounding tissues. This can lead to a loss of bone density and muscle atrophy, as well as decreased range of motion and pain.

To avoid these negative effects, it is important to design medical implants and devices that are compatible with the human body. This includes using materials that are biocompatible and designing the devices to minimize stress shielding.

Assignment Task 3: Derive and apply equations to predict the performance of specific designs of implants and medical devices; load sharing, contact stresses, wear, fatigue failure (S-N curves, Paris equation, Goodman diagrams), and volume changes due to thermal expansion.

There are a variety of factors that must be considered when designing implants and medical devices. One of the most important is load sharing, which refers to how the device will distribute weight or other forces. Contact stresses, wear, and fatigue failure is also important considerations.

Load sharing is typically accomplished by distributing the load evenly across the device. This can be done through the use of multiple support points or by using a material with a high modulus of elasticity.

Contact stresses refer to the stresses that occur at the point of contact between two surfaces. These can be caused by external forces, such as the weight of the body, or by internal forces, such as the contraction of muscles.

Wear is the result of friction between two surfaces. This can cause damage to the surface of the device, as well as to the surrounding tissues.

Fatigue failure occurs when a material is subjected to repeated stress and eventually fails. This can happen over time due to the wearing down of the material or it can happen suddenly due to a sudden increase in stress.

There are a variety of equations that can be used to predict the performance of medical implants and devices.

• The S-N curves, also known as the Goodman diagrams, can be used to predict the fatigue failure of a material.
• The Paris equation is a simple equation that can be used to predict wear. It states that the wear rate is proportional to the applied load and the sliding distance.
• The Goodman diagram is a more complex equation that can be used to predict fatigue failure. It takes into account a variety of factors, such as the material properties, the number of cycles, and the stress amplitude.

Volume change due to thermal expansion is another important consideration when designing medical devices. This occurs when the device is heated or cooled and expands or contracts. This can cause problems if the device is not designed to accommodate this change.

Assignment Task 4: Analyse the design of balloon catheters using analytical techniques (thin-walled pressure vessel) to determine the relationship between inflation pressure, material properties, and balloon profile.

A balloon catheter is a pressure vessel that must maintain a constant inflation pressure as the internal volume changes. The relationship between the inflation pressure and the material properties of the balloon catheter are important design considerations for manufacturers.

The analysis of a balloon catheter begins with an understanding of the pressure-volume (P-V) relationship for the vessel. For an ideal gas, the P-V relationship is linear, meaning that as the volume increases, so does the pressure. However, real gases do not follow this law perfectly, so a more complicated mathematical model is needed to accurately predict the P-V relationship.

Once this model has been developed, it can be used to calculate other important design specifications such as burst pressure and maximum volume.

The balloon profile is another important consideration in the design of balloon catheters. The shape of the balloon can have a significant impact on the performance of the device. For example, a spherical balloon will have a higher burst pressure than a cylindrical balloon with the same wall thickness.

The material properties of the balloon are also important considerations. The Young’s modulus and the tensile strength of the material will determine the maximum pressure and burst pressure of the balloon, respectively.

All of these design considerations must be taken into account when designing a balloon catheter for a specific application.

When designing a balloon catheter, manufacturers must take into account the P-V relationship for the vessel, the balloon profile, and the material properties of the balloon. These design considerations will determine the maximum pressure, burst pressure, and maximum volume for the device.

Assignment Task 5: Analyse the design of catheters using analytical techniques to determine the relationship between tubing length, rigidity, profile and push ability, trackability, and torqueability.

There is a relationship between tubing length, rigidity, profile and push ability and trackability of catheters. Longer tubes tend to be more rigid, with a higher profile and less push ability. They are also less trackable than shorter tubes. Shorter tubes are more flexible, have a lower profile and are more pushable. They are also more trackable than longer tubes.

The ideal design for a catheter depends on its intended use. For example, a long, rigid catheter that is easy to track may be best for use in coronary arteries, while a short, flexible catheter with good push ability may be better for urinary tract procedures.

The amount of torque that can be applied to a catheter also depends on its length and rigidity. Longer, more rigid catheters can handle more torque than shorter, more flexible catheters.

Assignment Task 6: Analyse the design of mechanical heart valves using analytical techniques (Bernoulli equation, Poiseuille’s Law) to determine the pressure drop across the valve, the flow rate through the valve, and the mean velocity, and the effective orifice area.

A mechanical heart valve is a device that is implanted into the heart to replace a damaged or missing valve. There are three main types of mechanical valves: ball, caged-ball, and tilting disk.

The Bernoulli equation can be used to calculate the pressure drop across a valve. This equation states that the pressure drop is equal to the difference in static pressure between the two sides of the valve multiplied by the coefficient of discharge.

Poiseuille’s law can be used to calculate the flow rate through a valve. This equation states that the flow rate is equal to the difference in pressure between the two sides of the valve divided by the resistance to flow.

The mean velocity through a valve can be calculated by dividing the flow rate by the cross-sectional area of the valve.

The effective orifice area of a valve is the area through which blood flows when the valve is open. It is equal to the sum of the areas of the two openings in the valve.

Mechanical heart valves are usually made from a biocompatible metal, such as titanium or stainless steel. The valve leaflets are made from a synthetic material, such as polyester or porcine (animal) tissue.

Assignment Task 7: Experience the sequence of tasks involved in the conception, planning, and mechanical design of a bioreactor for bone tissue engineering applications.

Many different types of bioreactors can be used for bone tissue engineering applications, each with its advantages and disadvantages. The type of bioreactor you choose will depend on several factors, including the specific application you are working on, the cells you are using, and the scaffold material you have chosen.

The first step in designing a bioreactor for bone tissue engineering is to determine the specific application you are working on. This will help to guide your choice of materials and design elements. For example, if you are working on a project that requires high cell density, you will need to choose a bioreactor with good oxygenation and mass transfer capabilities. If you are working on a project that requires a long-term culture of cells, you will need to choose a bioreactor that can provide the necessary support and environment for the cells.

The next step is to choose the cells you will be using. This will help to guide your choice of the bioreactor, as different cell types have different requirements. For example, if you are using mesenchymal stem cells, you will need a bioreactor that can provide the necessary support and environment for these cells.

The next step is to choose the scaffold material you will be using. This will help to guide your choice of the bioreactor, as different scaffold materials have different requirements. For example, if you are using a natural scaffold such as collagen, you will need a bioreactor that can provide the necessary support and environment for these materials.

The final step is to choose the specific design elements of the bioreactor. This includes choosing the type of reactor, the size of the reactor, the material of construction, the environmental conditions, and the operating conditions. Once you have chosen all of these elements, you can then begin to design the bioreactor.

Assignment Task 8: Appreciate and discuss the requirements for manufacture, testing, and licensing of a medical device according to the associated governing bodies (e.g. U.S. Food and Drug Administration regulations; European directives).

Several requirements must be met to manufacture, test, and license a medical device. These requirements vary depending on the specific device and the country in which it will be used. In general, however, all medical devices must meet certain basic standards.

All medical devices must be made from materials that are safe for use in the human body. They must also be designed and manufactured in a way that ensures they will work correctly and safely. Medical devices must be tested to ensure they meet all safety and performance standards.

Once a medical device has been created, it must be submitted to the relevant governing body for approval. In Ireland, this is the National Centre for Medical Devices. In the United States, this is the Food and Drug Administration. The approval process can take several months or more, and it is important to ensure that all paperwork is in order before submitting the device for approval.

Once a medical device has been approved, it must be registered with the relevant governing body. In the United States, this is the Food and Drug Administration. In the European Union, this is the European Commission. Registration ensures that the device can be legally sold in the country or region in which it is registered.

Assignment Task 9: Prepare technical reports in conventional professional style.

A professional technical report typically includes an introduction, a body, and a conclusion. The introduction should provide an overview of the report and its purpose. The body should describe the technical details of the issue or project at hand. The conclusion should summarize the findings of the report and any recommendations made.

A professional-style typically involves using concise language, clear organization, and thorough documentation. In addition, graphics and other illustrations may be used to enhance understanding. A professional style is also typically objective and unbiased.

When writing a professional technical report, it is important to keep the audience in mind. The report should be written in a way that is accessible to the intended reader. In addition, the report should be well organized and easy to follow.

Assignment Task 10: Generate professional engineering drawings according to standard conventions.

Professional engineering drawings adhere to a set of standard conventions to ensure clarity and understanding. Some of the most common conventions are as follows:

• Drawings are typically labelled according to their function or purpose
• All dimensions are indicated in imperial units (inches) or metric units (millimetres)
• Objects are typically depicted as if viewed from above, with the top of the object at the top of the drawing
• Lines indicate edges or boundaries of objects, and dashed lines indicate hidden surfaces
• Arrows indicate the direction of object movement or airflow

When creating professional engineering drawings, it is important to follow all standard conventions. This will ensure that the drawings are clear and easy to understand. In addition, following standard conventions will make it easier for others to review and comment on the drawings.

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