MEMBRANE FOR USE WITH IMPLANTABLE DEVICES
First Claim
1. An implantable sensor, the sensor comprising:
- an analyte measuring device configured to measure an analyte concentration in a host;
a sensing membrane located over the analyte measuring device; and
a biointerface membrane located over the sensing membrane, wherein the biointerface membrane comprises a fibrous barrier-cell disruptive domain and a non-fibrous domain, wherein the fibrous barrier-cell disruptive domain is configured to support tissue ingrowth and to allow cells and cell processes to pass therethrough, wherein the non-fibrous domain is adjacent to the fibrous barrier-cell disruptive domain, and wherein the non-fibrous domain is permeable to analytes and is impermeable to cells or cell processes.
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Abstract
The present invention provides a biointerface membrane for use with an implantable device that interferes with the formation of a barrier cell layer including; a first domain distal to the implantable device wherein the first domain supports tissue attachment and interferes with barrier cell layer formation and a second domain proximal to the implantable device wherein the second domain is resistant to cellular attachment and is impermeable to cells. In addition, the present invention provides sensors including the biointerface membrane, implantable devices including these sensors or biointerface membranes, and methods of monitoring glucose levels in a host utilizing the analyte detection implantable device of the invention. Other implantable devices which include the biointerface membrane of the present invention, such as devices for cell transplantation, drug delivery devices, and electrical signal delivery or measuring devices are also provided.
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Citations
18 Claims
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1. An implantable sensor, the sensor comprising:
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an analyte measuring device configured to measure an analyte concentration in a host; a sensing membrane located over the analyte measuring device; and a biointerface membrane located over the sensing membrane, wherein the biointerface membrane comprises a fibrous barrier-cell disruptive domain and a non-fibrous domain, wherein the fibrous barrier-cell disruptive domain is configured to support tissue ingrowth and to allow cells and cell processes to pass therethrough, wherein the non-fibrous domain is adjacent to the fibrous barrier-cell disruptive domain, and wherein the non-fibrous domain is permeable to analytes and is impermeable to cells or cell processes. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13, 14, 15, 16, 17)
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11. An implantable device for continuous measurement of an analyte concentration, comprising:
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a sensing region configured to continuously measure a signal associated with an analyte concentration in a host; and a membrane located over the sensing region, wherein the membrane comprises a first copolymer comprising a silicone segment and a polyvinylpyrrolidone segment and a second copolymer comprising a polycarbonate-based polyurethane; wherein the device is configured to achieve a level of accuracy corresponding to having, over a long period of time, 90% of measured analyte values within an “
A”
region and a “
B”
region of a standard Clarke error grid when sensor measurements are compared to a standard reference measurement; andwherein the membrane is resistant to cellular attachment.
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18. An implantable device for continuous measurement of an analyte concentration, comprising:
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a sensing region configured to continuously measure a signal associated with an analyte concentration in a host; and a membrane located over the sensing region, wherein the membrane comprises a first copolymer comprising a silicone segment and a polyvinylpyrrolidone segment and a second copolymer comprising a polycarbonate-based polyurethane; wherein the device is configured to achieve a level of accuracy corresponding to having, after 12 weeks in vivo, 90% of measured analyte values within an “
A”
region and a “
B”
region of a standard Clarke error grid when sensor measurements are compared to a standard reference measurement; andwherein the membrane is resistant to cellular attachment.
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Specification