Steroid Eluting Collar Undermolding for Cardiac Leads
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Solution Overview
Problem
The existing methods for manufacturing implantable medical devices, such as cardiac leads, face challenges in consistently reducing the capture threshold due to scar tissue formation and variability in drug elution rates from adhesively bonded drug collars, which can lead to manufacturing issues like yield fallout.
Innovation Solution
The method involves undermolding a medical device body directly onto a mold insert, using injection molding to create an annular-shaped collar or ring without adhesives, allowing for a secure, gap-free bond and controlled drug delivery through thermal bonding, eliminating the need for adhesives and reducing manufacturing variability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If adhesive bonding is used to attach drug collars to lead bodies, then the manufacturing process is simple and components can be assembled separately, but the drug elution rate varies due to contact surface area variability and manufacturing yield is reduced
Solution Approach 1:
The patent merges the drug collar and lead body into a single integrated component through co-molding, eliminating the separate adhesive bonding step. The drug collar is formed directly on the lead body during the molding process, ensuring consistent contact surface area and uniform drug elution without the variability introduced by separate assembly operations.
Solution Approach 2:
The drug collar is pre-formed directly onto the lead body during the molding process before any assembly operations. This preliminary integration ensures that the contact interface is established with precise geometric control during molding, eliminating subsequent variability in contact surface area that would affect drug elution rates.
2Adaptability or versatility
If adhesive bonding is used to attach drug collars to lead bodies, then separate components can be manufactured independently, but manufacturing yield is reduced due to bonding failures and defects
Solution Approach 1:
The patent combines the manufacturing of the drug collar and lead body into a single co-molding operation, eliminating the separate adhesive bonding step that causes yield losses from bonding failures. The integrated process removes the intermediate assembly operation entirely, preventing bonding-related defects and improving overall manufacturing yield.
3Ease of manufacture
If adhesive bonding is used to attach drug collars to lead bodies, then the manufacturing process is straightforward, but the bond creates gaps that affect drug delivery consistency
Solution Approach 1:
The patent merges the drug collar and lead body into a single integrated component through co-molding, eliminating the adhesive layer that creates gaps. The direct monolithic structure ensures consistent drug delivery pathways without the interfacial gaps and voids that occur with adhesive bonding, improving reliability of drug delivery.
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
This approach ensures consistent and controlled drug delivery directly to the tissue interface, reducing inflammation and improving the capture threshold without the manufacturing issues associated with adhesive bonding, thereby enhancing the performance and reliability of implantable medical devices.
Implementation Method 1
injection molding an annular-shaped ring onto the interior surface of the mold insert
Implementation Method 2
injection molding
Implementation Method 3
undermolding the elongate medical device body directly to the member
Data Source
AI summary
Methods of manufacturing implantable medical devices with one or more undermolded features are disclosed. An example method includes injection molding an annular-shaped member onto an inner surface of a sacrificial mold insert, and then undermolding an elongate medical device body directly to the member. The member is directly coupled to the device body without the use of adhesives or bonding agents, thus eliminating the presence of gaps or surface irregularities that can affect device performance.