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Design of Atherectomy plaque removal system

Myocardial Infraction is a blockage of of blood flow in heart muscles, its a condition occurring due to cholesterol plaque buildup inside the blood vessels called arteries,In heavy blockages were stents are not able to deployed in the arteries a device known as Rotational athrectomy is used.This project deals with research and development of next generation Rotational athrectomy device which is more user friendly and requires less intervention to perform the tasks. Human factors , User experience and Industrial design are the design touch points which has been applied to this project. 

Initial Project Brief

To Design & Visualize a next generation rotablator device by performing usability research. Making the device opera-table by a single interventional cardiologist, without need of any additional assistance from other doctors or technical assistants.

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Procedure & task analysis

Task analysis of catheter insertion in patient before performing rotablation

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Tasks analysis of existing rotablator system setup 

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Procedure training & field visits

Hands on research with rotablator 

system & its procedure

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Field visits at different hospitals and collection of insights for new developments in the existing systems. 

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Field research analysis

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Cognitive walkthrough of procedure

At each operational scenario following set of questions were
asked to make sure if there were connection between action and task

 

What is the user action ?

 

What is the system response ?

 

Is the action Correct /Evident ?

 

Will the user know if he made a

 

correct choice ? Is there a connection between action and task ?

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User journey mapping & task load indexing

Mapping Tasks - These are the all the task that doctor performs with assistant during rotablator procedure 

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Mapping Load - for a given task mapping out how much activities the doctor or the assistant has to carry out simultaneously

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Representing the task load index in graphical form to understand the critical task which needs to be replaced or innovated with a new methodology so as to reduce load on interventional cardiology doctor and making the future rotablator ready for single handed usage.

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FMEA

Identifying & prioritizing insights from field visit,Cognitive walkthrough, user journey mapping by using FMEA

sorting out critical insights by using RPN ( Risk Priority number ) which are greater that 7 units

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Parallel intervention field study

An altogether different field study was conducted at a Dental clinic in mumbai to see how dental devices are used to treat calcium teeth plaques.

Since dental drills are also high RPM rotating devices which cuts through calcium teeths, parallel insights were drawn and taken into consideration to further develop Rotablation athrectomy device.

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Quick mechanisms & concept ideation

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Quick concept prototyping

The following foam prototypes were attached with imitated advancer knobs
Also Imitated elements such as burr catheter and guidewire were inserted in them so as to mimic an actual advancer working principle. Each prototype was tested and scrutinized to see if they satisfy all the need statements that were required to be fulfilled.

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Concept ranking & filteration

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Form Iterations for Final Concept  ( A )

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Use scenario of new Rotablator advancer

Final comments: The current ideation, though promising but has design limitations and has a greater learning curve for doctor to use such device, Design team recommends to take care of above mentioned critical comments and try to integrate it with modular Concept B.

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As per recommendation, new ideations were iterated which solved the above design limitations and integrated it with Concept A.

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Re Ideating concepts after team feedback

The concept A does not include motor inside the advancer,but is equipped with just gear transmitters, which makes it lightweight and handling is easy.


The burr catheter can thus be discarded after procedure is over, since it does not include electrical component and hence it reduces the burr catheter cost.

 

Display console were explored for this concept as it handles major electrical and moving components of the overall device

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Iterating new concepts for Rotablator console

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Iterating new concepts for Rotablator console

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Iterating new concepts for Rotablator Advancer

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New concept redefined

Console Iteration, which includes IV pump for self saline irrigation

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Internal details of Rotablator console

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New approved athrectomy advancer details

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Athrectomy advancer and burr catheter details

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Display interface details for console

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Placement of advancer, burr catheter and display console of rotablator atherectomy device in Cathlab

© 2022 Swapnil Ghutke

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