Method and apparatus for enhancing the integrity of an implantable sensor device
First Claim
1. An implantable sensing apparatus comprising:
- a sensor module having internal elements;
an outer tubing surrounding said sensor module, wherein said outer tubing and said internal elements define one or more voids; and
back-fill material disposed in said one or more voids.
1 Assignment
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Accused Products
Abstract
A method and apparatus for enhancing the integrity of an implantable sensor. Voids formed between an outer tubing and a sensor substrate or spacing element may be back-filled with a curable, implantable material, minimizing the extent to which unwanted fluids diffuse within the sensor. An enzyme or protein matrix pellet below the sensor window may be pre-treated with a reducing agent to enhance its bond stability, and to reduce undesired swelling that may cause the sensor window to detach or leak. The bonding between the enzyme pellet and a hydrogel layer may be reinforced by application of an intervening bonding layer of a protein material, such as human serum albumin (HSA). The size of the window may be minimized by minimizing the size of an underlying electrode, providing reduced flux and lengthening sensor. A coating may be deposited on the surface of the sensor leads, providing stiffening and lubrication.
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Citations
90 Claims
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1. An implantable sensing apparatus comprising:
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a sensor module having internal elements;
an outer tubing surrounding said sensor module, wherein said outer tubing and said internal elements define one or more voids; and
back-fill material disposed in said one or more voids. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of making an implantable sensing apparatus comprising:
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surrounding a sensor module with an outer tubing, said sensor module having internal elements;
forming a window opening in said outer tubing; and
through said window opening, back-filling one or more voids between said outer tubing and said internal elements. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. An implantable sensing apparatus comprising:
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a substrate having an electrode;
an outer tubing surrounding said substrate, said outer tubing having a window opening; and
an enzyme aligned between said electrode and said window opening, said enzyme treated with a reducing agent to inhibit excessive swelling. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37)
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38. A method of making an implantable sensing apparatus comprising:
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surrounding a substrate with an outer tubing;
forming a window in said outer tubing above said electrode;
treating an enzyme with a reducing agent to inhibit excessive swelling; and
inserting said enzyme into said window. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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49. An implantable sensing apparatus comprising:
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a substrate comprising an electrode;
an outer tubing surrounding said substrate, said outer tubing having a window opening;
an enzyme aligned between said electrode and said window opening;
an hydrogel layer sealing said window opening; and
a bonding layer between said enzyme and said hydrogel layer. - View Dependent Claims (50, 51, 52, 53, 54, 55, 56, 57, 58, 59)
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60. A method of making an implantable sensing apparatus comprising:
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surrounding a substrate with an outer tubing, said substrate having an electrode;
forming a window in said outer tubing above said electrode;
inserting an enzyme into said window;
applying a bonding layer over said enzyme; and
applying a layer of hydrogel to fill said window, wherein said bonding layer bonds said hydrogel to said enzyme. - View Dependent Claims (61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76)
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77. An implantable sensing apparatus comprising:
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a substrate comprising an electrode;
a spacing element adjacent to said substrate, an outer tubing surrounding said substrate and said spacing element, said outer tubing having a window opening, wherein geometrical tolerances between said outer tubing and one or more of said spacing element and said substrate define one or more voids;
a backfill structure filling said one or more voids, said backfill structure comprising a curable, implantable material;
an enzyme aligned between said electrode and said window opening, said enzyme being pre-treated with a reducing agent;
a layer of hydrogel sealing said window above said enzyme; and
a layer of protein bonding said enzyme to said layer of hydrogel. - View Dependent Claims (78, 79, 80, 81, 82, 83)
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84. A method of making an implantable sensing apparatus comprising:
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placing a spacing element adjacent to a substrate having an electrode;
surrounding said spacing element and said substrate with an outer tubing;
forming a window in said outer tubing above said electrode;
applying a curable, implantable material through said window to backfill a void defined by said outer tubing and one or more of said spacing element and said substrate;
treating an enzyme with a reducing agent;
inserting said enzyme into said window;
applying a bonding layer of protein material over said enzyme; and
applying a layer of hydrogel to fill said window, wherein said layer of protein material bonds said hydrogel to said enzyme pellet. - View Dependent Claims (85, 86, 87, 88, 89, 90)
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Specification