Drug-delivery pumps and methods of manufacture
First Claim
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1. A method of manufacturing an implantable pump, the method comprising:
- providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber;
providing a middle deflection layer adjacent the drug chamber;
providing a bottom layer comprising electrolysis electrodes;
bonding the upper layer, middle deflection layer, and bottom layer to form the pump; and
providing a casing at least partially surrounding the pump to provide a surface against which an outer wall of the drug chamber exerts pressure.
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Abstract
Embodiments of method of manufacturing an implantable pump, including providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber, providing a middle deflection layer adjacent the drug chamber, providing a bottom layer comprising electrolysis electrodes, and bonding the upper layer, middle deflection layer, and bottom layer to form the pump.
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Citations
19 Claims
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1. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; bonding the upper layer, middle deflection layer, and bottom layer to form the pump; and providing a casing at least partially surrounding the pump to provide a surface against which an outer wall of the drug chamber exerts pressure.
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2. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; bonding the upper layer, middle deflection layer, and bottom layer to form the pump; and providing a casing at least partially surrounding the pump, wherein the casing comprises a perforated shell located above at least a portion of the upper layer.
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3. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; bonding the upper layer, middle deflection layer, and bottom layer to form the pump; and the steps of; retaining a temporary opening between layers during the thermal bonding step to provide a fill port for at least one of the drug chamber or the electrolysis chamber; filling at least one of the drug chamber or the electrolysis chamber with a fluid through the temporary opening; and sealing the temporary opening. - View Dependent Claims (4, 5)
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6. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; and bonding the upper layer, middle deflection layer, and bottom layer to form the pump, wherein the upper layer is formed according to steps comprising; forming a hole in a wall of the dome structure; and bonding a proximal portion of the cannula to the wall of a hole using a biocompatible adhesive, wherein the hole is created through at least one of etching or insertion of a heated metal probe.
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7. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; bonding the upper layer, middle deflection layer, and bottom layer to form the pump; and providing a casing at least partially surrounding the pump, wherein the casing comprises a perforated shell located above at least a portion of the upper layer and wherein the dome structure is manufactured according to steps comprising; providing a first mold element having a domed shape; providing a second complementary mold element; conformably disposing a sheet of material between the first mold element and the second complementary mold element; heating the first mold element, the second complementary mold element, and the conformed sheet of material to anneal the sheet of material; and removing the first mold element and second complementary mold element from the annealed sheet of material.
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8. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; and bonding the upper layer, middle deflection layer, and bottom layer to form the pump; wherein the cannula is integrated with the dome structure according to steps comprising; forming a hole in an edge portion of the dome structure; inserting a proximal portion of the cannula into the hole; and bonding the proximal portion of the cannula a wall of the hole formed in the dome structure, wherein the hole is created through at least one of etching or insertion of a heated metal probe.
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9. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; and bonding the upper layer, middle deflection layer, and bottom layer to form the pump, wherein the dome structure is integrally formed with the cannula according to steps comprising; coating a first photoresist layer onto a silicon substrate as a sacrificial layer; depositing a first parylene layer comprising a first parylene sheet onto the photoresist layer, the first parylene sheet forming the dome structure; coating a second photoresist layer onto the first parylene layer; opening a bonding area in the second photoresist layer by lithography; depositing a second parylene layer on the second photoresist layer, wherein the second parylene layer forms the bottom of the cannula and bonds to the first parylene layer at the bonding area; creating a through hole in the first parylene layer; coating a third photoresist layer onto the second parylene layer; depositing a third parylene layer on the third photoresist layer, the third parylene layer forming a top and a side of the cannula; patterning the second parylene layer and third parylene layer to form a cannula shape;
removing the first, second, and third photoresist layers, thereby leaving the formed cannula bonded to the flat parylene sheet; andmolding the flat parylene sheet to form the dome structure. - View Dependent Claims (10, 11, 12)
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13. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; bonding the upper layer, middle deflection layer, and bottom layer to form the pump; and integrating at least one of a check valve, a flow sensor, a pressure sensor, or a chemical sensor into the pump, wherein an upper layer with integrated check valve and flow sensor is integrally formed with the cannula according to steps comprising; coating a first photoresist layer onto a silicon substrate as a sacrificial layer; depositing a first parylene layer comprising a flat parylene sheet onto the photoresist layer to form a bottom surface of the cannula; patterning a layer of first material on the first parylene layer to form at least one check valve ring; depositing a layer of a second material on the first parylene layer to form a flow sensor; patterning the first parylene layer to form a cannula shape; coating a second photoresist layer over the first parylene layer; depositing a second parylene layer over the second photoresist layer, wherein the second parylene layer forms a check valve diaphragm and a protective layer for the flow sensor; patterning tethers for the check valve; patterning the second photoresist layer to form a check valve chamber and a microchannel; depositing a third parylene layer to form a top and sides of a parylene channel; patterning the cannula channel by etching through the first, second, and third parylene layers; removing the photoresist layers by subjection to photoresist stripper, thereby leaving the formed channel with check valve and flow sensor; and molding the flat parylene sheet to form the dome structure. - View Dependent Claims (14, 15)
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16. A method of manufacturing an implantable pump, the method comprising:
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providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber; providing a middle deflection layer adjacent the drug chamber; providing a bottom layer comprising electrolysis electrodes; and bonding the upper layer, middle deflection layer, and bottom layer to form the pump; wherein the cannula is manufactured according to steps comprising; coating a first photoresist layer onto a silicon substrate as a sacrificial layer; depositing a first parylene layer onto the photoresist layer to form a bottom surface of the cannula; creating a through hole in the first parylene layer; coating a second photoresist layer over the first parylene layer; depositing a second parylene layer on the second photoresist layer, the second parylene layer forming a top and a side of the cannula; patterning the first and second parylene layers to form a cannula shape; and removing the first and second photoresist layers, thereby leaving the formed cannula, wherein manufacturing the cannula further comprises adding a tube around the formed cannula. - View Dependent Claims (17, 18, 19)
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Specification