Overmolded Access Port Anchoring and X-Ray Identification
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Solution Overview
Problem
Existing access ports for subcutaneous access in patients lack effective anchoring and identification features, leading to potential misplacement and infection risks, and do not provide adequate comfort or antimicrobial protection.
Innovation Solution
An implantable access port with a compliant silicone outer cover, a flange that serves as both a needle guard and anchoring feature, and identification features observable via x-ray imaging, along with an antimicrobial/antithrombotic coating to reduce infection risks and enhance patient comfort.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing access ports are used without anchoring features, then the device structure is simpler, but the reliability of port placement and patient comfort deteriorates
Solution Approach 1:
The flange is integrated into the port body as a unified structure, combining the anchoring function with the existing port design. The flange extends from the port body and includes both anchoring features (protrusions engaging with recesses) and identification features, eliminating the need for separate anchoring components while maintaining structural simplicity.
Solution Approach 2:
The flange is divided into distinct functional zones: anchoring features with protrusions and recesses for securing the port, identification features for imaging visibility, and a needle guard portion. This segmentation allows each feature to perform its specific function independently while maintaining overall structural integrity.
2Measurement precision
If existing access ports lack identification features, then the device structure is simpler, but the measurement precision for port location and orientation deteriorates
Solution Approach 1:
The identification features utilize radiopaque materials that appear distinct on x-ray images, allowing clinicians to visually identify the port's location, orientation, and sometimes even the direction of the septum. This provides clear visual contrast and precise localization without adding complex electronic or mechanical identification systems.
3Ease of operation
If the outer cover is made compliant for patient comfort, then the ease of operation improves, but the strength of the port structure deteriorates
Solution Approach 1:
The port employs a composite construction where the port body is made from a rigid material (such as medical-grade plastic or metal) to maintain structural integrity, while the outer cover is made from a compliant material (such as silicone elastomer) to provide patient comfort and tissue compatibility. This combination allows the rigid body to maintain strength while the compliant cover ensures comfort and ease of needle access.
4Reliability
If the flange extends radially to guard against needle misplacement, then the reliability of needle access improves, but the volume of the port increases
Solution Approach 1:
The flange extends radially only in the specific region where needle guidance is needed, rather than uniformly around the entire port. The flange includes a needle guard portion that projects toward the septum to prevent excessive needle insertion, while maintaining a compact overall profile. This localized extension provides safety functionality without significantly increasing the port's total volume.
Data Source
AI summary
An access port for providing subcutaneous access to a patient is disclosed. In one embodiment, the port includes an internal body defining a fluid cavity that is accessible via a septum. A compliant outer cover including silicone is disposed about at least a portion of the body. A flange is included with the port body and is covered by the outer cover. The flange radially extends about a perimeter of the port body proximate the septum so as to impede penetration of a needle substantially into the outer cover in instances where the needle misses the septum. The flange can further include both an anchoring feature for securing the outer cover to the port body and an identification feature observable via x-ray imaging technology for conveying information indicative of at least one attribute of the access port. The outer cover provides a suitable surface for application of an antimicrobial/antithrombotic coating.