Innovative Cardiovascular Stents- A Global Solution

Health in Fragile Contexts- Innovative Cardiovascular Stents- A Global Solution

Design and Development of self-expandable cardio-vascular Stent Based on Shape Memory Alloys (Nitinol) through Selective Laser Melting (SLM) Additive Manufacturing

• Solution Overview & Team Lead Details
  • Global health issue:

With 17.9 million fatalities a year attributed to cardiovascular disease, it is the leading cause of death globally. The use of stents, which are tiny mesh tubes used to prop open blocked or restricted arteries, is one of the treatments for cardiovascular disease. Traditional metal or polymer stents, however, may cause complications including restenosis, thrombosis, or inflammation, which might result in additional health issues.

Objectives of the project: -

One of the main objectives of this proposal is to make cardiovascular self-expandable nitinol stents affordable to all and reduce the mortality 

• Design & Development of self-expandable (SE) nitinol stent using additive manufacturing technology i.e., Selective Laser Melting.
• Mechanical characterization with compression & fatigue behavior analysis of SE nitinol stent.
• Investigation of various coatings for the enhancement in fatigue life of nitinol stent.
• Numerical modeling of nitinol stent based on FEM using Solidworks and Ansys software.

With the help of an experienced cardiovascular surgeon, improved stents can be manufactured for treating heart patients. Therefore, there is an opportunity for innovative design and development of self-expanding stents that could be used and customized for individual heart patients’ needs.

Overview of the solution:

The invention of Nitinol-based self-expandable cardiovascular stents using selective laser additive manufacturing is a viable response to this worldwide health issue. Nitinol is a biocompatible, flexible, and shape-memory alloy made of nickel and titanium. A 3D printing technique called selective laser additive manufacturing can produce complex and unique stent designs, enabling a more individualized approach to therapy.

These stents' self-expanding capability eliminates the requirement for balloon angioplasty, a procedure that raises the risk of complications and can harm the artery wall. The ability of Nitinol to adapt to the artery walls and offer support while keeping flexibility also helps to lower the risk of restenosis.

Overall, a promising solution to the global health issue of cardiovascular disease has been developed in the form of Nitinol-based, self-expandable cardiovascular stents using a selective laser additive manufacturing approach. With fewer risks of problems, these stents provide a more individualized and efficient treatment alternative.

Making cardiovascular self-expandable nitinol stents cheap for everyone and lowering mortality are two of the primary goals. 

It’s possible through Laser Additive manufacturing. Self-expandable stents are superior to balloon-expandable stents. The latter exerts more radial pressure on the walls of arteries, which enhances the fatigue stresses

Self-expandable nitinol stents produced by laser additive manufacturing have a substantial effect on people's life. Stents are frequently used to relieve artery blockages and restore blood flow, hence reducing the risk of heart attacks and strokes. Utilizing 3D printing technology to build specialized stents may help to enhance patient outcomes, lessen problems, and maybe cut healthcare expenditures. Additionally, the production of stents using laser additive manufacturing may result in the creation of brand-new, more sophisticated stent designs that are both safer and more efficient than the alternatives currently available.

Self-expanding stents made of shape memory alloys work differently from balloon-inflated stents. Nitinol stents can be designed and produced a little larger than the target artery size and brought constrained to a delivery system. After positioning, they fixed themselves against the artery wall with a small, chronic outward force. They counterattack outside forces with a higher resistive force which is radial in nature. Self-expanding stents are crimped to the artery diameter at a low temperature and then released while the blood heats them to the human body temperature. This model shows an example of such a stent that is first crimped, then heated up to 37°C.

SMAs have a high level of recoverable plastic strain that can be induced. Without permanent damage, these materials can sustain maximumly recoverable strain up to 8% as compared to 0.5% of stainless steel.

An in-depth walkthrough of the steps involved in creating a selective laser additively manufactured Nitinol self-expandable cardiovascular stent.

Step 1: Design

Using computer-aided design (CAD) software, the stent is designed as the initial stage in the procedure. With the use of this program, complex, unique stent designs can be made with exact measurements.

Step 2: Choosing the materials

The stent is made of nitinol because of its biocompatibility, flexibility, and shape memory capabilities. A nickel-titanium alloy known as nitinol has the capacity to recall its shape and revert to it after deformation.

Step 3: 3D printing

The stent is produced via selective laser additive manufacturing, sometimes referred to as 3D printing. In this method, metal powder is selectively melted and fused using a laser to create a 3D object layer by layer. Customized designs and complex geometries can be produced using 3D printing.

Step 4: Post-Processing

The stent is post-processed to eliminate any extra powder and improve its surface smoothness after it is printed. Processes like polishing, sandblasting, or chemical treatments can fall under this category.

Step 5: Testing

The stent is put through a lot of testing after it is made to make sure it complies with legal requirements and is secure for use. Mechanical and biocompatibility tests can be used to analyze a material's strength and flexibility, as well as how it interacts with living tissue.

Step 6: Clinical Trials

The effectiveness of the stent in treating cardiovascular disease is subsequently evaluated through clinical studies. Clinical studies involve putting the stent on real people and observing how their health changes over a certain time.

Step 7: Commercialization

Clinical trials must determine the stent's safety and efficacy before it can be commercialized and made available to the general population. Getting regulatory permission, mass-producing the stent, and shipping it to medical facilities all over the world are all necessary steps in this process.

The creation of a Nitinol self-expanding cardiovascular stent using selective laser additive manufacturing entails designing the stent with CAD software, choosing Nitinol as the material, 3D printing the stent, post-processing to enhance its surface finish, testing to ensure its safety and efficacy, conducting clinical trials to evaluate its efficacy, and finally marketing and dispersing the stent for use in hospitals and other medical facilities.

In conclusion, there are 3 novel aspects to this project, 1st is the design of an innovative self-expanding cardio-vascular stent, 2nd is the material, shape memory alloy, (Nitinol), a new material tried for making the precise stent by using its exceptional properties, such as the shape memory effect (SME) and super-elasticity. And the 3rd is a prominent additive manufacturing technology i.e., the Selective Laser Melting (SLM) process, which is used for fabricating nitinol stents, hence it is possible to produce customized patient-specific stents easily with mass production.

Step 1- Identification of the problem
Many people suffer from the following problems:
 damage to the artery where the sheath was inserted
 allergic reaction to the contrast agent used during the procedure
 damage to an artery in the heart
 excessive bleeding requiring a blood transfusion
 heart attack, stroke, or death

Step 2- Background research
After identifying the main problem we started to collect several researches similar to the topic and came to know that there is a need to develop a model which can perform the fatigue analysis. 

Step 3- Planning
Following the problem's identification and a thorough background investigation, we developed a strategy to analyze the cardiovascular stent prototype. We first chose to use the computer-aided drawing (CAD) software SolidWorks to present our concept, then we used ANSYS Workbench to analyze the cardiovascular stent, and we concluded by creating a
prototype.

Step 4- Design and Analysis
Project design is an important piece of executing a successful project. From gathering the necessary information and resources to coordinating with team members the job is to bring the details to life. It was feasible to demonstrate product drawing with the use of CAD software, and designing the project's necessary components was made simple with the help of Ansys Workbench.

Step 5- Prototyping
Prototyping is used to model and create a functional form of a newly redesigned or re-engineered component of a value stream. It is utilized to test alternative approaches and to validate that they represent real improvements. On the basis of the design and availability of material and operations that can be carried out for a product in the near locality, a prototype is developed to implement the idea of the cardiovascular stent concept.

Fig.CAD Model

Fig. Meshing in ANSYS
Fig.Total Deformation

Fig. 3D Printed Stent

Tests are going on...within a month it will be ready.

The need to submit a proposal to renowned SOLVE is dictated by a number of factors:

• Exposure:  The primary purpose is, the project and its objectives may be made known to a wider group of people, such as other researchers, potential co-workers, and business associates. This exposure may help to bring in more funding, knowledge, and support.
• Opportunities for collaboration: One of the main aims is, collaboration with the esteemed organization. Organizations frequently promote cooperation between academics and institutions, which can result in new alliances, information sharing, and interdisciplinary strategies.
• Credibility: Association with a reputed organization through team credibility on a global platform.
• Financial Support: This is the secondary aim, of funding. Funding organizations offer financial assistance that may be used to defray some of the project's associated expenses.
• Validation: The planned project may be validated and receive an outside evaluation of its scientific, technological, or social merit following a successful application review by an organization. This affirmation may be used to entice extra financing or assistance from other sources, such as philanthropic organizations or private investors.

More About the Solution:

Objectives of the project: -

One of the main objectives of this proposal is to make cardiovascular self-expandable nitinol stents affordable to all. It’s possible through Laser Additive manufacturing. Self-expandable stents are superior to conventional balloon-expandable stents. The latter exerts more radial pressure on the walls of arteries, which enhances the fatigue stresses.

• Design & Development of self-expandable (SE) nitinol stent using additive manufacturing technology i.e., Selective Laser Melting.
• Mechanical characterization with compression & fatigue behavior analysis of SE nitinol stent.
• Investigation of various coatings for the enhancement in fatigue life of nitinol stent.
• Numerical modeling of nitinol stent based on FEM using Solidworks and Ansys software.

With the help of an experienced cardiovascular surgeon, improved stents can be manufactured for treating heart patients. Therefore, there is an opportunity for innovative design and development of self-expanding stents that could be used and customized for individual heart patients’ needs.

An in-depth walkthrough of the steps involved in creating a selective laser additively manufactured Nitinol self-expandable cardiovascular stent.

Step 1: Design

Using computer-aided design (CAD) software, the stent is designed as the initial stage in the procedure. With the use of this program, complex, unique stent designs can be made with exact measurements.

Step 2: Choosing the materials

The stent is made of nitinol because of its biocompatibility, flexibility, and shape memory capabilities. A nickel-titanium alloy known as nitinol has the capacity to recall its shape and revert to it after deformation.

Step 3: 3D printing

The stent is produced via selective laser additive manufacturing, sometimes referred to as 3D printing. In this method, metal powder is selectively melted and fused using a laser to create a 3D object layer by layer. Customized designs and complex geometries can be produced using 3D printing.

Step 4: Post-Processing

The stent is post-processed to eliminate any extra powder and improve its surface smoothness after it is printed. Processes like polishing, sandblasting, or chemical treatments can fall under this category.

Step 5: Testing

The stent is put through a lot of testing after it is made to make sure it complies with legal requirements and is secure for use. Mechanical and biocompatibility tests can be used to analyze a material's strength and flexibility, as well as how it interacts with living tissue.

Step 6: Clinical Trials

The effectiveness of the stent in treating cardiovascular disease is subsequently evaluated through clinical studies. Clinical studies involve putting the stent on real people and observing how their health changes over a certain time.

Step 7: Commercialization

Clinical trials must determine the stent's safety and efficacy before it can be commercialized and made available to the general population. Getting regulatory permission, mass-producing the stent, and shipping it to medical facilities all over the world are all necessary steps in this process.

Want to commercialize the product for the benefit of mankind? and want to have a startup.

Change is always good. ready to change with the time and tecnology.

Innovative technology for the benefit of people.

I support diversity.

As a faculty member, I would build on my previous experiences to take an active leadership role in fostering diversity. The Society for Women in Graduate Studies in Engineering has many goals that endorse a diverse environment. Promoting diversity goes well beyond improving gender equality, and must include enabling opportunities for underrepresented minority students. 

I look forward to many opportunities to inspire students to pursue studies in mechanical engineering and related fields, whether through the aforementioned programs or through my roles as a teacher and research advisor. With these opportunities, I can actively support the diverse environment for the students that contribute to the overall cross- cultural collaborative and innovative atmosphere of the organization.

 Multidisciplinary Team Consists of:

1. Dr. Vijayalaxmi Sonkamble (Team Lead, Ph.D., IIT Bombay, India)
2. Dr. Prashila Dhaware (Member, MBBS, MD)
3. Mr.Vinod Gawai (Member, BE(Mechanical Engg., MBA), Manager, TATA MOTORS)
4. Dr.Jayshree Gawai (Member, Ph.D. Materials Chemistry)

Business Model:

The creation of a Nitinol self-expandable cardiovascular stent using a selective laser additive manufacturing technology is a huge effort that needs a strong financial backer and a workable business plan to be successful. Key elements of a potential business plan and funding options for this global cardiac problem include the following:

1. Research and Development Funding: The early phases of the stent's development will call for a sizable investment in research and development activities, such as stent design, material selection, and pre-clinical testing.

2. Venture Capital: If there is a chance that the stent will generate large financial returns in the future, venture capital firms may be interested in supporting its development.

3. Crowdfunding: Platforms for crowdfunding could be used to collect money from private investors who are enthusiastic about enhancing cardiovascular health.

4. Grants: To finance the development of novel medical devices, grants from governmental organizations, foundations, and other groups may be available.

5. Licencing Agreements: After the stent is commercialized, licensing agreements may be used to generate income. This would entail licensing the technology to a producer of medical devices in return for a cut of sales.

6. Sales revenue: Following commercialization and approval for use in clinical settings, the stent may be sold to hospitals and clinics all over the world, generating income.

7. Collaborations with Healthcare Providers: Funding the development and marketing of the stent may be facilitated by working with healthcare providers including hospitals and clinics.

In conclusion, significant money and a workable business plan are needed to create a self-expandable Nitinol cardiovascular stent using a selective laser additive manufacturing technology. Research and development finance, venture money, crowdsourcing, grants, licensing agreements, and sales revenue are a few potential funding options. To successfully develop and market the stent, a mix of these financial sources might be necessary.

Through sustained donations and grants, selling products or services, service contracts to governments, raising investment capital, or a combination of all. In the long term, your revenue streams should cover your expected expenses. 

Through sustained donations and grants, selling products or services, service contracts to governments,