Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders
First Claim
1. A method for delivering a substance to a location within a nasal cavity, paranasal sinus or opening into a paranasal sinus, of a human or animal subject to treat a disorder, said method comprising the steps of:
- (a) obtaining or providing a device that comprises;
(i) a reservoir that is substantially free of the substance but which may subsequently be loaded with said substance, said reservoir being sufficiently small to fit through an opening into the paranasal sinus,(ii) a catheter coupled with the reservoir for filling the reservoir with the substance, wherein a detachable portion of the catheter is detachable and removable after the reservoir has been filled, thereby leaving a non-detached portion of the catheter connected to the reservoir after the detachable portion of the catheter has been detached and removed,(iii) a closure apparatus comprising a one way valve that allows substance to be introduced through the catheter into the reservoir but prevents the substance from flowing back out of the reservoir, the detachable portion of the catheter being proximal to the closure apparatus such that the closure apparatus remains with the reservoir after the detachable portion of the catheter has been detached and removed, and(iv) a barrier surrounding at least part of the reservoir such that substance that has been loaded into the reservoir will pass out of the reservoir through the barrier at a known rate,wherein the reservoir is configured such that, when the reservoir is implanted and loaded with said substance, the reservoir will assume a configuration such that the reservoir defines at least one flow channel through which mucus or other biological fluid may drain, wherein the at least one flow channel is defined between an exterior surface of the barrier and an anatomical surface;
(b) inserting the reservoir of the device into the nasal cavity, paranasal sinus or opening into a paranasal sinus; and
(c) thereafter loading the substance into the reservoir, wherein the act of loading the substance into the reservoir includes urging the substance through a lumen extending longitudinally through the reservoir, wherein the lumen is contained within the reservoir.
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Accused Products
Abstract
Implantable devices and methods for delivering drugs and other substances to locations within the body of a human or animal subject to treat or diagnose sinusitis and a variety of other disorders. The invention includes implantable substance delivery devices that comprise reservoirs and barriers that control the rate at which substances pass out of the reservoirs. The delivery devices may be advanced into the body using guidewires, catheters, ports, introducers and other access apparatus. In some embodiments the delivery devices may be loaded with one or more desired substance before their introduction into the body. In other embodiments the delivery devices are loaded and/or reloaded with a desired substance after the delivery device has been introduced into the body.
802 Citations
33 Claims
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1. A method for delivering a substance to a location within a nasal cavity, paranasal sinus or opening into a paranasal sinus, of a human or animal subject to treat a disorder, said method comprising the steps of:
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(a) obtaining or providing a device that comprises; (i) a reservoir that is substantially free of the substance but which may subsequently be loaded with said substance, said reservoir being sufficiently small to fit through an opening into the paranasal sinus, (ii) a catheter coupled with the reservoir for filling the reservoir with the substance, wherein a detachable portion of the catheter is detachable and removable after the reservoir has been filled, thereby leaving a non-detached portion of the catheter connected to the reservoir after the detachable portion of the catheter has been detached and removed, (iii) a closure apparatus comprising a one way valve that allows substance to be introduced through the catheter into the reservoir but prevents the substance from flowing back out of the reservoir, the detachable portion of the catheter being proximal to the closure apparatus such that the closure apparatus remains with the reservoir after the detachable portion of the catheter has been detached and removed, and (iv) a barrier surrounding at least part of the reservoir such that substance that has been loaded into the reservoir will pass out of the reservoir through the barrier at a known rate, wherein the reservoir is configured such that, when the reservoir is implanted and loaded with said substance, the reservoir will assume a configuration such that the reservoir defines at least one flow channel through which mucus or other biological fluid may drain, wherein the at least one flow channel is defined between an exterior surface of the barrier and an anatomical surface; (b) inserting the reservoir of the device into the nasal cavity, paranasal sinus or opening into a paranasal sinus; and (c) thereafter loading the substance into the reservoir, wherein the act of loading the substance into the reservoir includes urging the substance through a lumen extending longitudinally through the reservoir, wherein the lumen is contained within the reservoir. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A method for delivering a substance to a location within a nasal cavity, paranasal sinus or opening into a paranasal sinus, of a human or animal subject to treat sinusitis, said method comprising the steps of:
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(a) obtaining or providing a system that comprises; (i) a substance delivery device, comprising; (A) a reservoir that is substantially free of the substance but which may subsequently be loaded with said substance, said reservoir being sufficiently small to fit through an opening into the paranasal sinus, wherein the reservoir comprises a porous material disposed about a porous lumen extending longitudinally through the reservoir, and (B) a barrier surrounding at least part of the reservoir such that the barrier substantially encompasses the porous material and at least part of the porous lumen and such that substance that has been loaded into the reservoir will pass out of the reservoir through the barrier at a known rate, wherein the reservoir is configured such that, when the reservoir is implanted and loaded with said substance, the reservoir will assume a configuration such that the reservoir defines at least one flow channel through which mucus or other biological fluid may drain, wherein the at least one flow channel is defined between an exterior surface of the barrier and an anatomical surface, (ii) a delivery catheter system comprising a catheter that is coupled with the reservoir for filling the reservoir with the substance, wherein a detachable portion of the catheter is detachable and removable after the reservoir has been filled, thereby leaving a non-detached portion of the catheter connected to the reservoir after the detachable portion of the catheter has been detached and removed, and (iii) a closure apparatus comprising a one way valve that allows substance to be introduced through the catheter into the reservoir but prevents the substance from flowing back out of the reservoir, the detachable portion of the catheter being proximal to the closure apparatus such that the closure apparatus remains with the reservoir after the detachable portion of the catheter has been detached and removed; (b) using the delivery catheter system to deliver the substance delivery device to a position where the reservoir is positioned in the paranasal sinus; and (c) loading the substance into the reservoir, wherein the act of loading the substance into the reservoir comprises urging the substance through a-the barrier and into the reservoir. - View Dependent Claims (30, 31, 32)
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33. A method for delivering a substance to a location within a nasal cavity, paranasal sinus or opening into a paranasal sinus, of a human or animal subject to treat a disorder, said method comprising the steps of:
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(a) obtaining or providing a device that comprises; (i) a porous lumen having a distal end and a proximal end, (ii) a porous barrier having a distal end and a proximal end, wherein the distal end of the barrier is coupled to the distal end of the lumen, wherein the proximal end of the barrier is coupled to an exterior surface of the lumen at a position distally of the proximal end of the lumen, (iii) a reservoir defined between an exterior surface of the lumen and an interior surface of the barrier and between the proximal end of the barrier and the distal end of the barrier such that the lumen extends the length of the reservoir, wherein the reservoir is substantially free of the substance but may subsequently be loaded with the substance, the reservoir being sufficiently small to fit through an opening into the paranasal sinus, wherein the reservoir is configured such that, when the reservoir is implanted and loaded with said substance, the reservoir will assume a configuration such that the reservoir defines at least one flow channel through which mucus or other biological fluid may drain, wherein the at least one flow channel is defined between an exterior surface of the barrier and an anatomical surface, (iv) a catheter configured to provide the substance to the reservoir, and (v) a closure apparatus coupled to the proximal end of the lumen, wherein the closure apparatus is selectively coupleable to the catheter, wherein the closure apparatus is configured to allow the substance to be introduced through the catheter into the reservoir but prevents the substance from flowing back out of the reservoir, (b) inserting the reservoir of the device into the nasal cavity, paranasal sinus or opening into a paranasal sinus; and (c) thereafter loading the substance into the reservoir, wherein the act of loading the substance into the reservoir includes urging the substance through the lumen.
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Specification