Produktutveckling av medicinteknisk produkt, Suture passer
Independent thesis Basic level (university diploma), 10 credits / 15 HE creditsStudent thesis
The following report has been prepared based upon an assignment given by the company, Ortopedic Care Scandinavia AB. The paper is an exam on basic level, 15 credit points at higher level education within product development.
Ortopedic Care Scandinavia AB is working with product development of medical technology products. What makes the corporate unique is the fact that the development is based upon problems encountered by surgeons in their daily work. Suggestions for improvement in technology are given directly by the end users. This paper is based upon such problems.
Product development was made on the medical instrument called, suture passer. The instrument is used in endoscopic surgery of the rotator cuff. The cuff is a group of four muscles (and their respective tendons) that stabilize the shoulder. In case of an accident, mostly sport related, these muscles can loosen from the bone. In surgery a suture passer is then used to penetrate the injured tendon with a needle with an attached suture. The passer creates a loop of suture that can be used to attach the damaged tendon.
The report is based upon the following problem formulations:
- The needle has an inconvenient edge that can damage the muscle.
- The strength of the suture thread is deteriorated by the design of the needle.
- The suture thread has been known to snap when the surgeon apply to much pressure when tying.
- If the patient is suffering from subacromial impingement the jaw of the instrument can appear to be clumsy and hard to open.
- The jaw has sharp teeth which have been known to get stuck in the tendon. The surgeon must then perform an uncontrolled movement which might damage the tendon.
- The jaw limits the surgeons’ choice of thickness of the suture thread.
- The thickness of the needle used in the suture passer is limited to one size.
The purpose of the project is to develop a new concept that minimizes the risk for the patient and at the same time the concept should facilitate the work of the surgeon. The concept should meet the set requirements and be presented in the form of renderings of CAD-models and drawings.
To achieve this process the instrument uses four different components. The needle, the jaw, the handle and an attachment between the needle and the handle. Under heading 5, the generating process, each component presents to together with arguments of its design. The instrument consist of 25 components that are all developed from the ground up.
The result should be viewed as a thorough concept that can be used for further development. It is recommended that the next step should be an investigation about material choice. When the material is specified a prototype should be manufacture and then used for testing.
Place, publisher, year, edition, pages
2016. , 69 p.
Suture passer, Produktutveckling, Medecinteknik
Medical Engineering Surgery
IdentifiersURN: urn:nbn:se:mdh:diva-33170OAI: oai:DiVA.org:mdh-33170DiVA: diva2:970464
Orthopedic Care Scandinavia AB; .
Subject / course
Product and Process Development
Gustafsson, Bengt, Universitetsadjunkt
Marcus, Bjelkemyr, Universitetsadjunkt