Method of manufacturing elastomer articles having embedded electronics
Inventors
Drake, Kerry • GRUEN, Heike • LAUBACH, Jeffrey M. • McGarry, Martin • KRIZAN, Jason • Dowling, Patrick • WORMAN, Joel
Assignees
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Publication Number
US-11919208-B2
Publication Date
2024-03-05
Expiration Date
Abstract
A method of manufacturing a medical component includes molding a first member of the medical component from an elastomeric material. The first member includes a first end defined by a closed base wall, an opposing second end which is an open end, a sidewall extending between the first and second ends, and an internal recess to receive at least one electronic device. The method further includes positioning the electronic device within the recess of the first member to form an assembly, such that the electronic device is received in an inverted open cavity defined by the sidewall. The method further includes applying a protective film on the second end of the first member, such that the protective film covers an exposed surface of the electronic device. In addition, the method includes overmolding the assembly with the elastomeric material to form the medical component having the electronic device embedded therein.
Core Innovation
The invention relates to a method of manufacturing a medical component in which electronic devices are embedded in an elastomeric structure. A first member of the medical component is molded from a first elastomeric material, and the first member includes a closed base wall at a first end, an open second end, an exterior sidewall, and an inner sidewall projecting inwardly away from the closed base wall to define a recess configured to receive a first portion of at least one electronic device.
The first portion of the at least one electronic device is positioned within the recess so that a second portion of the at least one electronic device is exposed outside of the recess. The exposed second portion is then overmolded together with the first member using a second elastomeric material, encapsulating the at least one electronic device and the inner sidewall of the first member and forming the medical component with the at least one electronic device embedded therein.
The disclosed approach is motivated by smart drug-delivery devices that include electronic components and seeks to protect sensitive electronics from heat and pressure during manufacturing while providing complete encapsulation. The document describes manufacturing routes that embed electronics in elastomeric medical component parts such as pistons, plungers, and closures for a syringe, cartridge, or vial.
Claims Coverage
The document provides one independent claim that defines the core manufacturing sequence. Dependent claims refine the recess geometry, device exposure, material selection, and molding or overmolding conditions.
Molded elastomeric recess for receiving electronic device portion
Molding a first member of the medical component from a first elastomeric material, wherein the first member includes a closed base wall, an open second end, an exterior sidewall, and an inner sidewall that define a recess configured to receive a first portion of at least one electronic device.
Exposed second portion prior to encapsulation
Positioning the first portion of the at least one electronic device within the recess such that a second portion of the at least one electronic device is exposed outside of the recess.
Overmolding to encapsulate embedded electronics
Overmolding the second portion of the at least one electronic device and the first member with a second elastomeric material to encapsulate the at least one electronic device and the inner sidewall of the first member and to form the medical component with the at least one electronic device embedded therein.
Geometric relationship of exterior and inner sidewalls
The exterior sidewall having a first diameter and the inner sidewall having a second diameter that is less than the first diameter.
Orientation of inner sidewall relative to closed base wall
The inner sidewall is perpendicular to the closed base wall.
Fractional constraint on the portion exposed
The first portion of at least one electronic device is less than half of the electronic device.
Different elastomeric materials for member and encapsulation
Using a second elastomeric material that is different from the first elastomeric material.
Molding and overmolding conditions
Either molding of the first member or overmolding is performed at a temperature between 120°C and 310°C and a pressure between 40 kg/cm2 and 350 kg/cm2 for up to 30 minutes.
Overall claim coverage is directed to manufacturing a medical component by molding an elastomeric first member that defines a recess for a first portion of an electronic device, exposing a second portion, and then overmolding with a second elastomeric material to encapsulate the electronic device and the inner sidewall. Dependent refinements address recess geometry, the exposed fraction of the device, differences between elastomeric materials, and specified molding or overmolding conditions.
Stated Advantages
Embeds at least one electronic device within the medical component by encapsulating the electronic device and the inner sidewall.
Allows a second portion of the at least one electronic device to be exposed outside the recess during manufacturing prior to encapsulation.
Provides protection of sensitive electronics from heat and pressure during manufacturing.
Documented Applications
“Smart” drug-delivery devices in which the electronic devices are embedded in elastomeric medical component parts such as pistons, plungers, and closures for a syringe, cartridge, or vial.
Medical components for drug delivery that include embedded electronics, exemplified by insulin-related devices in the document background context.
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