MICRO PROJECT ON

‘Report on medical implants design by additive manufacturing ’

Course: Solid modelling and additive manufacturing

Course Code: 22053
Academic Year: 2021-2022
Semester: 5I

Name: Ayush Kshirsagar

Roll No.: 2031
Enrollment No: 1901410298

Name of Micro Project Guide: Mr. Mangesh Bhave

All India Shri Shivaji Memorial Society’s Polytechnic

Kennedy Road, Near RTO, Pune-411001 Institute Code: 0141
 All India Shri Shivaji Memorial Society’s Polytechnic,
Pune-01

CERTIFICATE
Certified that this micro project report titled Report on medical implants design by
additive manufacturing is the bonafide work of Ms. /Mr. Ayush Kshirsagar Roll no.
2031 of Second year diploma in Mechanical engineering for the course: Solid
modelling and additive manufacturing Course code: 22053 during the academic year
2021-2022 who carried out the micro project work under my supervision.

Mr. Mangesh Bhave

Name & signature
Subject teacher
 Acknowledgement

I would like to express my special thanks of gratitude to my teacher Mr. Mangesh Bhave as
well as our principal Prof. S.K.GIRAM Sir who gave me the golden opportunity to do this
wonderful project on the topic ‘Report on medical implants design by additive
manufacturing’, which also helped me in doing a lot of research and I came to know about
so many new things I am really thankful to them.

Secondly, I would also like to thank my parents and friends who helped me a lot in finalizing
project within the limited time frame.
 INDEX

Sr. No. Content Page No.

1. Micro Project Proposal

2. Rationale

3. Aims/Benefits of the Micro Project

4. Course Outcome achieved

5. Literature Review

6. Actual Methodology Followed

7. Actual Resources Used

8. Output of the Micro Projects

9. Skill Developed / Learning outcome of the Micro Project

10. Applications of the Micro Project

 VANNEXURE I

Micro Project Proposal

Report on Medical implants design by additive manufacturing

1.0 Aims/Benefit of the Micro Project

1. This project will help me to know more about additive manufacturing.

2. We also understand the topic in deep for future study.

3. The main purpose of this project is to know detail knowledge of medical implant.

2.0 Course Outcomes Addressed:

C22053: A: Generate 3D solid models from 2D sketch using part workbench of any parametric
CAD software.

3.0 Proposed Methodology

1. Finalize the topic

2. Find and Collect information
3. Arrange information
4. Proofread the information
5. Review from the teacher
6. Edit project report as per the suggestions of the teacher
7. Proofread and finalize the report
8. Submission of the report

4.0 Action Plan:

Sr. No. Detail of Activity Planned Planned Name of Responsible

Start date Finish Team Members
Date

1. Finalize the topic 1/10/21 4/10/21 Ayush Kshirsagar

2. Find and collect 6/10/21 13/10/21 Ayush Kshirsagar

information

3. Arrange information 18/10/21 20/10/21 Ayush Kshirsagar

4. Edit project report 22/11/21 28/11/21 Ayush Kshirsagar

5. Submission of report 15/12/21 30/12/21 Ayush Kshirsagar

5.0 Resource Required:

Sr. No. Name of Resource/Material Specificatio Qty. Remark

n

1. Internet -

2. Newspaper -

3. Magazine -

6.0. Name of Student with Roll No. :

Sr. No Name of Students Roll No

1. Ayush Kshirsagar 2031

Mr. Mangesh Bhave

(Name and Signature of faculty)
 ANNEXURE - II

Micro Project Report

“Report on medical implants design by additive manufacturing”

1.0 Rationale:
Medical implants are devices or tissues that are placed inside or on the surface of the body.
Many implants are prosthetics, intended to replace missing body parts. Other implants deliver
medication, monitor body functions, or provide support to organs and tissues.

2.0 Aims/Benefits of the Micro Project:

1. This project will help me to know about additive manufacturing.

2. And we also understand the topic in deep for future study.

3. The main purpose of this project is to know detail knowledge of medical implants.

3.0 Course Outcomes Achieved:

Co.22053.A. Generate 3D solid models from 2D sketch using part workbench of any
parametric CAD software.

4.0 Literature Review:

www.wikipedia.com
www.encyclopedia.com
www.zetascience.com
www.scribd.com
www.makezine.com
5.0 Actual Methodology

Sr. No./ Date Time Work Done

Hour No.
1. 1/10/21 4.00 to 5.00 Finalized the topic of micro project

2. 4/10/21 4.00 to 5.00 Collected the information of micro project

3. 6/10/21 5.00 to 6.00 Arrange the information in proper order

4. 8/10/21 3.00 to 4.00 Created the word document of micro project

5. 13/10/21 4.00 to 5.00 Proof the document

6. 16/10/21 2.00 to 3.00 Make the change in document according to

correct information.
7. 20/10/21 4.00 to 5.00 Take the review from the teacher.

8. 25/10/21 4.00 to 5.00 Edit according to teacher suggestion.

9. 28/10/21 3.00 to 4.00 Proof the read information.

10. 4/10/21 4.00 to 5.00 Arrange the information in proper order.

11. 8/10/21 3.00 to 4.00 Make the editing.

12. 15/10/21 3.00 to 4.00 Take print out of micro project.

13. 20/11/21 2.00 to 3.00 Show micro project guide.

14. 24/11/21 5.00 to 6.00 Proof and report the project.

15. 15/12/21 4.00 to 5.00 Proof read and finalized the topic

16. 30/12/21 2.00 to 3.00 Submitted the project

6.0 Actual Resource Required:

Sr. No. Name of Resource/Material Specification Qty. Remark

1. Internet -

2. Newspaper - -

3. Magazine - -

7.0 Outputs of the Micro project.

 Medical implants are artificial substitutes for body parts, and materials
brought into the body for functional, cosmetic, or therapeutic purposes,
either permanently or removed once they are no longer needed. Prostheses
can be either functional (artificial arms and legs) or aesthetic/cosmetic
(artificial eye). Implants, however, tend to be used therapeutically (to heal)
and are made of metal, plastic, ceramic, and even body tissues (skin, bone,
etc.).

Although the implant industry has recently developed quickly, there are still no ideal devices
to replace or repair bones damaged by trauma and diseases. Moreover, the human body is a
very corrosive medium for implanted materials and no ideal biomaterial was invented yet to
eliminate the processes occurring at the interaction with the living organism.
To readily fulfill their mission (maintain, assist or restore a person’s mobility) implants have
to fit as much as possible to the patient’s unique body and be quickly tolerated.

ADDITIVE MANUFACTURING SOLVES CLEAR AND PERSISTENT PROBLEMS IN

ORTHOPEDICS
For the production of medical devices, doctors and patients are reliant upon custom-made designs or
individualized small series. The high costs of metallic biocompatible materials and their processing
increase total expenses. Cobalt alloys are difficult to machine as shape complexity rises. Therefore
some implants are obtained by casting or traditional metal powder processing methods, which require
tooling and is costly for small or unique series. As titanium is relatively difficult to cast in
complicated shapes, titanium ingots are machined.

Recently, medical equipment manufacturers are increasingly adopting metal additive manufacturing
technologies (direct metal laser sintering and electron beam melting) into the design and
manufacturing of medical implants. The early use of this advanced manufacturing route for patient
specific implants is encouraging. In conjunction with surgeons, engineers can produce more advanced
and anatomical conforming implants and prosthesis, exploiting the power of medical imaging (X-ray,
MRI, CT scans, etc…). They can build medical implants in nearly any imaginable geometry and
sometimes within 24 hours.
Rapid manufacturing of custom implant is a highly valuable ability where standard implants are often
insufficient for some patients facing complex cases. Previously, surgeons had to perform bone graft
surgeries, use scalpels or drill implants in metal and plastic to obtain a desired shape, size, and fit.

1. Define Additive manufacturing.

Additive manufacturing (AM) or additive layer manufacturing (ALM) is the industrial production
name for 3D printing, a computer controlled process that creates three dimensional objects by
depositing materials, usually in layers.
Additive manufacturing (AM) techniques, also known as three-dimensional (3D) printing, are
considered as the most cutting-edge manufacturing technologies to manufacture patient- specific
implants based on a layer-wise method.
Using additive technology, an implant is built layer-by-layer using a high-powered laser or electron
beam to selectively melt titanium alloy powder according to computer aided design data. Complex
geometries, such as porous structures, or windows can be produced in one manufacturing step.

In the medical field, every patient is unique, and therefore, AM has a high potential
To be utilized for personalized and customized medical applications. The most common
Medical clinical uses are personalized implants, medical models and saw guides. In
The dental field, AM is utilized on splints, orthodontic appliances, dental models and drill
Guides. However, AM has also been explored for making artificial tissues and organs.
In medicine, there is a background in digitalization of medical imaging, and that digitalization allows
for reconstructing 3D models from patients’ anatomy. A typical workflow
For personalized medical devices starts with imaging or capturing the patient’s geometry
Using computed tomography or other 3D scanning methods. Then, these data are
Manipulated to obtain a 3D model of the patient’s anatomy, and this can be an example
Already of additive manufacturing such as a medical model.

Medical Implants:
Medical implants are devices or tissues that are placed inside or on the surface of the body. Many
implants are prosthetics, intended to replace missing body parts. … Implants can be placed
permanently or they can be removed once they are no longer needed. For example, stents or hip
implants are intended to be permanent.

Advantages of additive manufacturing for medical applications are:

 Individualization: Customized prosthesis/implants involve a shorter and less painful and
stressful adaptation phase for the patient. Best-fit devices also make the surgical operation less
difficult and stressful for the surgeon.
 Complex geometries: Some free-form structures are hardly or not feasible with conventional
manufacturing methods (milling, turning or casting, etc.) while there is a growing desire to
mimic bionic principles of complexity in order to accelerate the patient’s healing process.
 Functional integration: Additively manufactured medical devices are able to fulfill multiple
functions with fewer components and manufacturing steps. Post-built, they can feature both a
porous structure and a rough surface, improving bone integration. No further additional spray-
on coating or surface texturing is required.
 Reduced surgical costs: When a patient is cared for with an efficient product, financial outlays
for the hospital stay and follow-on treatment are reduced. As AM productivity increases and
in-hospital process of 3D-scan-to-part speeds up, finely customized devices will enable
ambulatory surgery to suffice so that patients are not kept in the hospital.
 Rapid availability: The lead time is shortened and 3D-printed medical devices can be applied
sooner to patients, which is better.

Medical Applications of Additive Manufacturing

Medical applications of additive manufacturing can be classified in several ways

But this article follows application classes-based classification. AM applications can be
Classified into the following classes: “models for preoperative planning, education and
Training”, “inert implants”, “tools, instruments and parts for medical devices”, “medical
Aids, supportive guides, splints and prostheses” and “bio manufacturing”. For a more
General classification, this can be modified so that implants do not need to be inert, and
Models for preoperative planning, education and training could also include postoperative
And operative models using the term “medical model
Classification of medical applications of additive manufacturing:

1. Medical models.
2. Implants.
3. Tools, instruments and parts for medical devices.
4. Medical aids, supportive guides, splints and prostheses.
5. Bio manufacturing

Application of additive manufacturing in medical field

Additive Manufacturing (AM) provides extensive customization as per the individual patient data and
requirements for Medical applications. Many other methods such as laser scanning, Ultrasound,
Positron emission tomography are also used for obtaining patient data.
Environmental control systems (ECS) ducting, custom cosmetic aircraft interior components, rocket
engines components, combustor liners, tooling for composites, oil and fuel tanks and UAV
components. 3D printing delivers complex, consolidated parts with high strength.
BONE, THE ULTIMATE BIOMATERIAL AND A SOURCE OF INSPIRATION
Fractures are doubtlessly a disastrous health issue, but bone, as a living tissue, almost instantly
begins a healing process. Bone is light and strong, adapts its structure to the functional
demands and self-repairs. As so, it is often perceived as the ultimate biomaterial.
Two major kinds of osseous tissues exist: trabecular (cancellous) and cortical (compact). 

Major kinds of osseous tissues.

Cortical bone forms the outer shell (cortex) of most bones and accounts for about 80% of the
weight of a human skeleton. It is dense and thus, relatively hard, strong and stiff.
Compared to cortical bone, trabecular bone is less dense. It has a higher surface area to mass
ratio and is thus softer, weaker and more flexible. Trabecular bone is typically found at the
ends of long bones, proximal to joints and within the interior of vertebrae. The greater surface
area makes trabecular bone highly vascular and suitable for metabolic activity. It frequently
contains red bone marrow where the production of blood cells occurs.
Plastic is often used for implants even though it is the worst material for bone formation
because bone doesn’t attach to it. Most of the other implants on the market are made of bulk
metal, thus are stiff and don’t deform.
The design freedom of additive manufacturing allows redistributing the material
through a truss structure, it’s possible to get a significant strain with a strong metal such
as titanium. Bone attach to titanium. If the titanium structure is elastic enough to
deform significantly, attached cells deform with it, which triggers an osteogenic
response, meaning bone formation.
MAIN SEGMENTS IN THE MARKET OF ORTHOPEDIC DEVICES
The market of medical implants is an ever growing field of applications and innovation. It is
segmented into 3 main classes of implants: joints, spinal and trauma.
Joint replacement remains the largest segment
Arthroplasty is a surgical procedure to restore the integrity and function of a joint, during
which an artificial joint may be used. The market for reconstructive joint replacements is
gaining upward momentum from the rising number of persons suffering from injured or
degenerative joints. One of the causes is the aging population.
Knees and hips are highly vulnerable to degeneration caused by arthritic conditions. They
account for the vast majority of reconstructive joint replacements. Other reconstructive joint
replacements are shoulder systems, in a strong demand due to the advantages of orthopedic
surgery over alternative therapies to reduce pain and restore arm mobility.
Advances in materials, design and processing keep improving the safety and performance of
knee, hip and shoulder implants and expand their use in the treatment of severe arthritis.
Spinal implants are growing fast
A strong demand for spinal implants is created by the increasing prevalence of chronic back
conditions – due to long hours spent sitting at office, for example - and a better acceptation of
motion preservation surgeries as the most relevant alternative over drug and physical
therapies.
This trend is fed by an availability of high value-added devices such as fusion cages, artificial
discs and improved procedures for the repair of vertebrae, spinal cord injuries or
abnormalities and the replacement of degenerative discs.
Trauma implants
The global orthopedic trauma market promises some growth due to increased fracture cases.
More people practicing sports and the aging population result in a higher demand for
orthopedic trauma internal and external fixation devices. Plate and screw systems are the
most-used internal fixators for fixing a traumatized fracture and represent a sector of
promising growth.
BENEFITS OF METAL ADDITIVE MANUFACTURING FOR MAJOR TYPES OF
IMPLANTS?
Hip joint replacements: AM helps reducing aseptic loosening to delay revision surgery
When the hip joint doesn’t function, due to disease or fracture, it can be replaced by a
prosthetic implant either as a hemi (half) replacement or total replacement.
Today, total hip replacement is a successful and widely used surgical procedure. The concept
is  still based on Sir Charnley’s design and composed of a femoral prosthesis with a small
diameter head, a cup and a polymer-made socket between them, to favor a low friction and
smooth articulatory motion, which is critical.
 Normal hip joint morphology and hip implant. The low friction polymer (HDPE) is visible
within the cup.
The stem is either cemented into the femur by the means of a polymethylmetacrylate (PMM)
mixture (used as a grout between the bone and the implant) or fixed cementlessly, through
bone ingrowth into the implant.
Even though they need one, patients often have to wait to get an implant because surgeons
know it doesn’t last for a lifetime and revision surgeries are often more complicated than the
initial orthopedic surgery. Most people can only go through 1-3 revision surgeries. Improving
hip implant's durability is crucial for patients. Mechanical fatigue failure is rare and the most
common reason for revision surgery is “asceptic loosening”, which usually occurs 10 to 20
years after implantation and is caused by mechanical and biological factors.
An important biological factor is the biological response to wear debris, primarily generated
from the prosthetic joint articular surface. The sustained chronic inflammatory response
initiated at the implant-bone interface is manifested by recruitment of various cell types
including most importantly osteoclasts, the principal bone resorbing cells. Signs and
symptoms of the subtle progression of tissue destruction around the implant may not be
clinically apparent until late stages of failure, which is insidious. Reducing as much as
possible the friction coefficient of the material at the joint helps reduce biological factors.
Mechanical factors include implant-bone “micro-motions” and “stress shielding”. Micro-
motions result from an inadequate initial fixation leading to a mechanical loss of fixation over
time. Stress shielding is caused by the unnaturally high stiffness of the implant compared to
the bone material. The stiff implant bears too large a share of the load and the surrounding
living bone tissue adapts to the low stress level and resorbs.
Additive manufacturing offers a way to counteract aseptic loosening due to mechanical
factors. In addition to the achievement of a better stability during the initial orthopedic
surgery with patient-specific geometry, complex surface structures such as open cellular
structures (for example acetabular cups that integrate trabecular structure) are
designed for good bone ingrowth and improved flexibility to reduce or eliminate stress
shielding.
Knee joint replacement: Patient-specific systems allow perfect fit and higher load bearing
capacity
In the knee are found the most complicated joints of our body. It is composed of two joints
between the leg’s bones.
 The prominent joint is located between femur and tibia while the smaller one is between the
kneecap (patella) and the femur. 
 A smooth and tough articular cartilage that covers the ends of the bones and facilitates sliding
over each other.
 A lubricating synovial fluid, produced by the synovial membrane over the other surfaces of
the knee joint to reduce friction.

Anatomy of the human knee.

Many factors can aggravate the wear rate of the bearing surface and increase the likelihood of
osteolysis (active resorption of bone matrix). Femoral and tibial components loosening, torn
ligaments and mobile bearing components are examples.
 Indeed, the flexibility and articulation of the joint is jeopardized if articular cartilage is
damaged or worn to the extent that the ends of the bones rub or grind against each other.
Ultimately, it will lead to severe pain, swelling and stiffness. To alleviate the effects of severe
knee damage, the patient may be oriented to the knee replacement surgery during which
damaged cartilage and bone from the surface of the knee joint are removed and replaced with
artificial surfaces.
In the long run, an implant’s stability depends on how well bone grows into it (screws can be
used to stabilize the implant too).
Conventional knee systems are standardized and approximated to patients’ knees, based on
anatomy data collected in a specific region. A standard model used to be selected first by
surgeons, based on a patient’s knee shape and size, and necessary adjustments were performed
during the surgical procedure.

Illustration of a traditional knee implant.

The typical causes of complications associated with traditional knee systems are:
 An uneven stress distribution in the femur that may lead to loosening of the joint
 The use of an imperfect size of tibial implant when the surgeon is unable to find a perfect one
in the product portfolio. An oversized implant might damage the soft tissues and ligaments
around the knee joint while an undersized implant might protrude into the cancellous bone. In
both case, post-surgical pain can be expected.
 The Ultra High Molecular-Weight Polyethylene (UHMWPE) placed over the tibial tray can
wear-out. Wear particles of UHMWPE induce osteolysis, a lack of mobility and pain.
Eventually, a revision surgery is required. UHMWPE serves to avoid metal-to-metal contact
between the femoral and tibial implants but this problem occurs if there is unintended micro
motion between the tibial tray and the UHMWPE. In the worst cases, the bearing surface
completely wears out until the metal-to-metal contact occurs. 
 The insertion of the femoral implant might require resurfacing the patella to fit, which in
many cases causes post-operative pain.
Beside this, traditional manufacturing methods like CNC machining, investment casting or
plastic molding have a long lead time because they need specific tool’s design, development
and production.
In recent times, the appeal of personalized knee systems has increased among surgeons and
clinicians because they are designed on a principle that factors in the patient’s unique anatomy
and lifestyle.
With a just in-time response to a surgeon’s request, metal additive manufacturing is a
technique that allows the fabrication of personalized knee system that exhibit an almost
perfect fit, uniform stress distribution and thus a higher load bearing capacity.
The better alignment allows the surgeon to perform cuts in the bone and soft tissue
exactly where they need to be which reduces the risk of fat embolism and intraoperative
bleeding due to minimal bone removal. There is also less tissue loss, a shorter recovery
time and less postoperative pain or infection.
Finally, less instrumentation is needed and fewer efforts are required for the orthopedic
surgery to position adequately 3d-printed implants.
Spinal implants: A superior design empowered by additive manufacturing
Anterior cervical discectomy and fusion (or ACDF) surgery serves to remove herniated or
degenerative spinal discs. A discectomy literally "cuts out the disc" anywhere along the spine
from the neck to the low back. Along this procedure, different devices can be inserted to
restore patient's motion:
Interbody fusion cage
“Anterior cervical discectomy” has matured into a safe and effective procedure for the
treatment of degenerative disc disease. In this procedure a hollow implant can be inserted in
the spine to restore physiological disc height, allowing bone growth within and around them
to stimulate bone fusion. Interbody fusion cages (or spine cages) have a load-sharing function
and stabilize the spine. Traditionally made of PEEK, they are normally used in conjunction
with titanium-made screws in patients suffering from spinal instability stenosis or others
spinal degenerations.
Metal additive manufacturing improves usual fusion cages by compining the
biocompatibility of titanium with the flexibility of plastic PEEK. The porous titanium cage
fabricated by SLM could achieve fast bone ingrowth and better osseointegration with a
superior mechanical stability than the conventional PEEK cage.
The particular density distributions give to titanium parts the same flexibility as traditional
PEEK products, which is customised to be embedded in the spine. The higher strength of
titanium allows the integration of inspection windows in the sidewalls of the 3d-printed
implants. Thus, bone growth can be evaluated through medical imaging. The geometric
freedom and functional integration of additive manufacturing offer a multitude of new
options in spinal column reconstruction.
Customised disc prostheses
Instead of a bone graft or fusion cage, an artificial disc device may be inserted into the empty
disc space. In select patients, it may be beneficial to preserve motion. It acts as a vertebral
spacer to strengthen the spine and can be designed to fit perfectly into the vertebral plate. Both
design and spacing dimensions can be adjusted precisely to the patient's anatomy in
accordance with the surgeon's specifications. With laser-melting, these 3d-printed implants
can be manufactured in a "one-shot" process, a solution that gets rid of downstream
assembly processes.
Trauma implants, a plethora of one-off challenges
Trauma implants are intended for the surgical treatment of fractures, deformities, and tumor
diseases of bones, such as those of the arms, legs, shoulders, or skull.
Cranial implants
Requirements placed on the manufacture of cranial implants are stringent. It’s really hard to
standardize them because skulls have unique and irregular shapes. Naturally cranial implants
need to be biocompatible, fit precisely and induce bone ingrowth into the edges of the 3d-
printed implants. They also have to be permeable to allow brain fluid to pass through while
minimal heat is being conducted to the cerebral tissue (especially in a sunny climate).
Additive manufacturing has been used to produce 3d-printed implants designed for
individual patients in craniomaxillofacial surgery, with optimal size, shape and
mechanical properties.
Internal fixation devices
Plates are devices fastened to a fractured bone to provide fixation. Bone anatomy is extremely
complex in some areas. The plate may have to be bent in two directions and twisted.
Traditionnaly, surgery time is needed to shape the plate until it fits the fracture as much as
possible.
For surgeons, additive manufacturing provides a way to improve patient’s healing, by
producing plates, with traumaspecific geometry, within the time limit associated with
fractures.
Shaping the plate to the exact geometry and digitally pre-planning the screws will provide a
better attachment of plates and a good foundation to accomplish low invasive surgery, which
gives small scars, a shorter open-wound time and shorter recovery time.
 Internal plates and fracture: Geometry is necessarily complex.
The concept of orthopedic implants obtained from metal additive manufacturing demonstrates
a great potential for clinical applications. Better bone cell ingrowth and vascularization
provide the basis for new orthopaedic innovations promoting better reliability and 3d-printed
implants-body compatibility. As it changes the traditional paradigm, a new set of design,
manufacturing and regulatory challenges have to be addressed to encourage further
penetration in medical applications.

8.0 Skill development /Learning outcomes:

1. To work in time.

2. Make own decision

3. To make the report.

4. How to collect and edit information.

5. How it is important to make projects and understand it.

9.0 Applications of the Micro-Project:

Medical implants are devices or tissues that are placed inside or on the surface of the body.
Many implants are prosthetics, intended to replace missing body parts. Other implants deliver
medication, monitor body functions, or provide support to organs and tissues.

Conclusion:
Paper deals with the literature review of the Medical application of Additive Manufacturing
and its future. Medical models which are customised and sourced from data of an individual
patient, which vary from patient to patient can well be modified and printed. Medical AM
involves resources of human from the field of reverse engineering, medicine and biomaterial,
design and manufacturing of bones, implants, etc. Additive Manufacturing can help solve
medical problems with extensive benefit to humanity.

Mr. Mangesh Bhave

(Name and Signature of faculty)