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Publication Number
US-8038650-B2
Publication Date
2011-10-18
Expiration Date
Abstract
A drug delivery device is formed from an elastomeric element, including an inflatable drug reservoir and a flexible sleeve, and an insert inserted within the flexible sleeve. The insert cooperates with the flexible sleeve to form an at least partially pressure compensated flow regulating mechanism.
Core Innovation
The invention relates to a slow release liquid drug delivery device. The device includes an elastomeric element comprising an inflatable drug reservoir and a flexible sleeve attached to or integrally formed with the inflatable drug reservoir, and the inflatable drug reservoir provides a pressure that acts on the flexible sleeve.
An insert is inserted within the flexible sleeve and cooperates therewith to form an outlet flow path for releasing a drug from the drug reservoir. At least part of the outlet flow path passes between the flexible sleeve and the insert, and the flexible sleeve is disposed so as to be acted upon by a pressure within the drug reservoir to change a flow impedance of the outlet flow path when the pressure within the reservoir varies.
This arrangement provides an at least partially pressure compensated flow regulating mechanism for changing the flow impedance when reservoir pressure varies. Embodiments include a helical flow channel with variable geometry and an outlet diffuser formed by a porous body, with optional pressure-responsive regulation implemented by a porous insert with a regulating portion and arrangements where the extent of contact between the insert and the flexible sleeve varies as a function of the pressure within the inflatable drug reservoir.
Further embodiments include configurations using bioresorbable materials for at least one of the elastomeric element, the insert, or a portion thereof, and examples of percutaneous refilling and deep target placement. The document also describes an external skin-mounted drug infusion device variant, including use of a needle adapter and an adhesive pad in the external configuration.
Claims Coverage
The document provides one independent claim defining the core pressure-compensated flow regulating mechanism, with multiple dependent claims refining structural and material features. The inventive features focus on the elastomeric inflatable reservoir with a flexible sleeve, the cooperating insert that defines an outlet flow path, and the pressure-actuated change in flow impedance to provide partial pressure compensation.
Inflatable reservoir with flexible sleeve pressure-actuated flow regulation
An elastomeric element comprising an inflatable drug reservoir and a flexible sleeve attached to or integrally formed with the inflatable drug reservoir, where the flexible sleeve is disposed so as to be acted upon by a pressure within the drug reservoir to change a flow impedance of an outlet flow path when the pressure within the reservoir varies, thereby providing an at least partially pressure compensated flow regulating mechanism.
Insert cooperating with flexible sleeve to form outlet flow path
An insert inserted within the flexible sleeve and cooperating therewith to form an outlet flow path for releasing a drug from the drug reservoir, wherein at least part of the outlet flow path passes between the flexible sleeve and the insert.
Integrally formed flexible sleeve with inflatable drug reservoir
The flexible sleeve is integrally formed with the inflatable drug reservoir.
Porous insert material for outlet regulation
The insert is primarily made from a porous material.
Pressure-dependent contact extent between insert and sleeve
The extent of contact between the insert and flexible sleeve varies as a function of the pressure within the inflatable drug reservoir.
Elongated circumferential channel in insert
The insert has an elongated circumferential channel.
Bioresorbable insert material
The insert is primarily made from a bioresorbable material.
Overall claim coverage centers on a pressure-compensated outlet flow regulation concept: an inflatable drug reservoir with an associated flexible sleeve, and an insert cooperating with the sleeve to define an outlet flow path whose flow impedance changes in response to reservoir pressure, with refinements for integrally formed sleeve structure and optional porous or bioresorbable insert material and pressure-dependent contact characteristics.
Stated Advantages
Provides an at least partially pressure compensated flow regulating mechanism by changing flow impedance when reservoir pressure varies.
Documented Applications
Percutaneous refilling and deep target placement configurations for the drug delivery device.
An external skin-mounted drug infusion device variant using a needle adapter and adhesive pad in the external configuration.
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