Hydrogel implant for sensing metabolites in body tissue

Inventors

MUELLER ACHIM, null • Müller, Achim • Herbrechtsmeier, Peter • Knuth, Monika • Nikolaus, Katharina

Assignees

Eyesense AG

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Publication Number

US-8647271-B2

Patent

Publication Date

2014-02-11

Expiration Date


Abstract

An implant (110) for detecting at least one analyte (126) in a body fluid, in particular an eye fluid, is proposed. The implant (110) is designed to be implanted in a tissue layer and/or a chamber of an eye of a patient, the implant (110) having a hydrogel matrix (110) with at least one hydrogel (114). The implant (110) also has sensor particles (116) dispersed in the hydrogel matrix (110), the sensor particles (116) having at least one sensor matrix (120) with a sensor matrix material (122) and at least one sensor material (124).

Core Innovation

The implant is designed to detect at least one analyte in a body fluid and is designed to be implanted in a body tissue of a patient. The implant comprises a hydrogel matrix with at least one hydrogel, wherein sensor particles are dispersed homogeneously in the hydrogel matrix, and reference components are also dispersed homogeneously in the hydrogel matrix, wherein the reference components are at least substantially analyte-invariant.

The sensor particles comprise at least one sensor matrix comprising a sensor matrix material and at least one sensor material. The sensor material is responsive to analyte diffusion and detects analyte by changing chemical and/or physical properties of the sensor material that can be detected via such changes. A design principle is presented in which mechanical and network properties of the hydrogel are separately optimized relative to sensor/protein activity.

Sensor matrix material and hydrogel network properties are selected so that analyte diffusion toward the sensor material is supported in the sensor matrix, including cases in which the sensor matrix material has a higher diffusion coefficient in the sensor matrix material than in the hydrogel matrix. Additional relationships between the sensor matrix hydrogel and the hydrogel matrix are described, including density, water content, and crosslinking degree.

The implant can also include optional semipermeable coatings configured to retain proteins while allowing analyte diffusion, including a semipermeable shell and layer-by-layer (LBL) coatings. The implant additionally includes a shaped hydrogel article intended for implantation, including substantially flat, round configuration with constrained diameter and geometric parameters such as surface-volume ratio, curvature, edge shape, and edge area thickness.

Claims Coverage

The relevant independent claims cover an implant for detecting at least one analyte in a body fluid using a hydrogel matrix with homogeneously dispersed sensor particles and analyte-invariant reference components. Across the independent claims identified, there are inventive feature themes for homogenous sensor particles and analyte-invariant references, sensor-matrix diffusion coefficient relative to the surrounding hydrogel matrix, water content and crosslinking relationships between the hydrogel matrix and the sensor matrix, and shaped hydrogel article form-factor constraints.

An implant for detecting analytes with homogeneously dispersed sensor particles and analyte-invariant reference components

An implant for detecting at least one analyte in a body fluid, designed to be implanted in a body tissue of a patient, comprising a hydrogel matrix with at least one hydrogel and sensor particles dispersed homogeneously in the hydrogel matrix, wherein the sensor particles comprise at least one sensor matrix comprising a sensor matrix material and at least one sensor material, and wherein reference components are also dispersed homogeneously in the hydrogel matrix and are at least substantially analyte-invariant.

A sensor matrix having a higher diffusion coefficient than the hydrogel matrix

An implant comprising a hydrogel matrix with at least one hydrogel and sensor particles dispersed in the hydrogel matrix, wherein the sensor particles comprise at least one sensor matrix comprising a sensor matrix material and at least one sensor material, wherein the sensor matrix material has a higher diffusion coefficient in the sensor matrix material than in the hydrogel matrix.

A sensor matrix hydrogel with higher water content than the hydrogel matrix hydrogel

An implant comprising a hydrogel matrix with at least one hydrogel and sensor particles dispersed in the hydrogel matrix, wherein the sensor particles comprise at least one sensor matrix comprising a sensor matrix material and at least one sensor material, wherein the sensor matrix material comprises a hydrogel with a water content that exceeds the water content of the hydrogel of the hydrogel matrix.

Chemically identical hydrogels with higher crosslinking in the hydrogel matrix than in the sensor matrix

An implant comprising hydrogel matrix with at least one hydrogel and sensor particles dispersed in the hydrogel matrix, wherein the sensor particles comprise at least one sensor matrix comprising a sensor matrix material and at least one sensor material, wherein the hydrogel matrix and the sensor matrix material comprise a chemically identical hydrogel, wherein the hydrogel of the hydrogel matrix has a higher degree of crosslinking than the hydrogel of the sensor matrix material.

A shaped hydrogel article with substantially flat, round configuration, constrained diameter, and surface-volume ratio

An implant having a shaped hydrogel article, the shaped hydrogel article having a substantially fiat, round configuration, the diameter of the shaped hydrogel article being not greater than 10 mm, and wherein the shaped hydrogel article has a surface-volume ratio of at least 5.

A shaped hydrogel article with a substantially right-angled edge

An implant having a shaped hydrogel article, the shaped article having a substantially right-angled edge.

A shaped hydrogel article with substantially flat, round configuration and constrained curvature radius

An implant having a shaped hydrogel article, the shaped hydrogel article having a substantially flat, round configuration, the diameter of the shaped hydrogel article being not greater than 10 mm, wherein the shaped article has a curve with a radius of curvature of between 5 mm and 20 mm.

A shaped hydrogel article with constrained edge thickness

An implant having a shaped hydrogel article, the shaped hydrogel article having a substantially flat, round configuration, the diameter of the shaped hydrogel article being not greater than 10 mm, wherein the edge area of the shaped article has a thickness of not more than 250 micrometers.

A shaped hydrogel article with substantially flat, round configuration and a rounded edge

An implant having a shaped hydrogel article, the shaped hydrogel article having a substantially flat, round configuration, the diameter of the shaped hydrogel article being not greater than 10 mm, wherein the shaped article has a rounded edge.

The claims collectively define an implantable hydrogel-based analyte detector in which sensor particles containing sensor matrices are homogeneously dispersed in a hydrogel matrix, with reference components that are at least substantially analyte-invariant. Further independent claim sets specify comparative diffusion, water-content, and crosslinking relationships between the sensor matrix and the hydrogel matrix, and constrain the geometry of a shaped hydrogel article including diameter, surface-volume ratio, curvature, edge shape, and edge thickness.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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