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Surgical Clip Applier

What is a Clip Applier

A clip applier is used in endoscopy procedures in order to close two mucosal surfaces without the need for surgery and suturing. Its function is similar to a suture in gross surgical applications, as it is used to join together two disjointed surfaces, but, can be applied through the channel of an endoscope under direct visualization.

Once applied, these titanium clips will permanently reside within the patient and the body will form a mucus membrane around them to encapsulate the foreign object. 
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How I developed and improved it

The Sketch:
The development of the clip applier started out with a simple sketch I created to satisfy the design input.
 
This visual serves as a strong platform in showing management my approach to developing the product without generating cost.
 

Concept Modeling:
I generated simple 3D model from the initial sketch to create the first generation of the product.
Gen 1 Prototype:
The prototype can be created from various building techniques (3D printing, machining, casting, mini press molding, DMLS, ect..). 
Testing:
The testing phase is generated to help understand the strength, feel, size and overall design of the prototype. From here it is decided if the prototype satisfies the design input. If so, move forward to manufacturing processes. If not, the product will need to be redesigned and rebuild until it meets the design verification requirements.
Gen 2 and Final design:
This final prototype meets all design specifications while satisfying the design input requirements. From here all manufacturing processes will be modeled from this design. 

Manufacturing the Final Product

  • Manufacturing is one if the most important steps in developing products. Its imperative the concept and design are as accurate to the engineering drawings as possible in order to minimize cost and time consumption. This step is almost "the point of no return". 

  • The manufacturing process for this device will require multiple techniques to efficiently produce each part. For example, I designed a mold cavity from the outer shell of this device in order to have it injection molded. I also developed a stamping dye for multiple sheet metal components within the device. 

  • Once all components have efficiently been created and inspected, I then worked with automation to establish an efficient means of assembly. 

  • All components will undergo a Bioburden, Biocompatibility, Hazard Analysis and Sterilization test before any patient contact is made. 
Patent Submission:
All Intellectual Property discovered while creating the device was documented and a patent provisional was submitted. After the patent has been accepted it will take about 2-5 years for the public to view.
**The provided image is a reference from Patent NO 7,621,926
Clinical Development:
In this step of the product life cycle, I as the engineer will travel to an Operating Room to meet with the surgeon using the device. This is very important for not only company to further develop the product but for the surgeon to feel more confident while using the device for the first time. 
Quality Updates:
Although the product has been tried and trued, the process of collecting information while the product is in public hands is very important. As data is collected, further updates to the manufacturing process as well as the product design may change to lower cost and improve its functionality. These changes may cause a defect in the product line and needs constant quality control to insure a reliable product.