Subcutaneous Staple-Actuated Catheter Fixation
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Solution Overview
Problem
Existing catheter fixation devices secured externally to the skin of a patient are prone to migration due to patient movement, leading to mispositioning and potential damage of intracardiac pumps.
Innovation Solution
A subcutaneously implanted catheter fixation device with moveable wings that can be clamped to secure the catheter, using a biocompatible material with a resilient inner layer and a rigid outer layer, and secured with staples or sutures to stabilize the catheter relative to the patient's anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If catheter fixation devices are secured externally to the skin, then ease of application is improved, but catheter migration occurs due to patient movement
Solution Approach 1:
The fixation device transitions from external skin attachment (superficial dimension) to subcutaneous embedding (deeper anatomical dimension), positioning the fixation point closer to the catheter insertion site. This dimensional change in placement depth reduces the lever arm for movement forces and minimizes migration while maintaining ease of application through a standardized implantation procedure
2Reliability
If subcutaneous fixation is used to reduce migration, then catheter position stability is improved, but device complexity increases
Solution Approach 1:
The fixation device is segmented into distinct functional components: a body portion for subcutaneous embedding, a catheter engagement portion with clamping mechanism, and a fixation element. This segmentation allows each component to perform its specific function optimally while keeping the overall device design modular and manageable, balancing stability with complexity
Solution Approach 2:
The device employs composite construction with a rigid outer layer (metal or rigid polymer) providing structural integrity and resistance to movement forces, combined with a resilient inner layer (flexible polymer) that allows for controlled deformation during clamping and provides cushioning. This composite approach achieves high reliability through material properties rather than complex mechanical structures
3Reliability
If moveable wings with clamping mechanism are used, then catheter securement is improved, but manufacturing complexity increases
Solution Approach 1:
The clamping function is extracted as a separate, focused mechanism within the fixation device - the moveable wings with clamping feature are designed as a distinct functional module that can be manufactured independently using standard precision machining or molding techniques, then integrated into the overall device assembly, simplifying the manufacturing process while maintaining securement reliability
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Reduces catheter migration and improves stability of intracardiac pumps by minimizing the distance between the fixation device and the heart, ensuring proper positioning and reducing the risk of movement-related damage.
Implementation Method 1
The body includes an inner layer formed of a substantially resilient material and an outer layer formed of a substantially rigid material
Data Source
AI summary
A catheter fixation device for securing a catheter within a cardiovascular system of a patient. The catheter fixation device includes a body formed of biocompatible material arranged to be subcutaneously secured within a patient, the body including a catheter receiving portion defining a cavity, and first and second wings extending from the catheter receiving portion. The first and second wings are moveable relative to one another from an unclamped position, in which a catheter is moveable within the catheter receiving portion, and a clamped position, in which the catheter is fixed within the catheter receiving portion. A method of delivering and stabilizing a medical device within a cardiovascular system of a patient is also provided.