Spacing device for releasing active substances in the paranasal sinus
First Claim
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1. A substance delivering spacer device for implantation in an opening of a paranasal sinus, said device comprising:
- a tubular body having a wall, a hollow passage extending therethrough and being open at either end and perforations formed in the wall through which bodily secretions may flow into the hollow passage, the wall of said tubular body comprising;
an inner layer comprising a polymer that is devoid of therapeutic substance;
an outer layer comprising a polymer that is devoid of therapeutic substance; and
a therapeutic substance containing layer located between the inner and outer layers, said therapeutic substance containing layer being substantially solid and comprising a polymer combined with a therapeutic substance such that the therapeutic substance will elute therefrom when the device is implanted;
wherein said outer layer is constructed to allow a therapeutically effective amount of the therapeutic substance to elute through the outer layer and from the device while implanted,wherein said inner layer is substantially impervious to the therapeutic substance,wherein said therapeutic substance comprises at least one steroid;
said tubular body being flexible and sufficiently elastic to frictionally engage and remain in the opening following its insertion into the opening; and
the device having an outer diameter ra and an inner diameter ri, wherein the ratio Q of the outer diameter ra to the inner diameter ri is greater than or equal to 1.2 but less than or equal to 3.0.
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Abstract
A spacing device for use in fenestrations of the paranasal sinus, the device including a sheath which forms a hollow body defining at least two apertures. The sheath includes at least one layer loaded with an active substance. The ratio q of the external diameter ra of the hollow body to the internal diameter ri of the hollow body is about 1.2 to 3.0.
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Citations
29 Claims
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1. A substance delivering spacer device for implantation in an opening of a paranasal sinus, said device comprising:
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a tubular body having a wall, a hollow passage extending therethrough and being open at either end and perforations formed in the wall through which bodily secretions may flow into the hollow passage, the wall of said tubular body comprising; an inner layer comprising a polymer that is devoid of therapeutic substance; an outer layer comprising a polymer that is devoid of therapeutic substance; and a therapeutic substance containing layer located between the inner and outer layers, said therapeutic substance containing layer being substantially solid and comprising a polymer combined with a therapeutic substance such that the therapeutic substance will elute therefrom when the device is implanted; wherein said outer layer is constructed to allow a therapeutically effective amount of the therapeutic substance to elute through the outer layer and from the device while implanted, wherein said inner layer is substantially impervious to the therapeutic substance, wherein said therapeutic substance comprises at least one steroid; said tubular body being flexible and sufficiently elastic to frictionally engage and remain in the opening following its insertion into the opening; and
the device having an outer diameter ra and an inner diameter ri, wherein the ratio Q of the outer diameter ra to the inner diameter ri is greater than or equal to 1.2 but less than or equal to 3.0. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 29)
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20. A method for treating a disorder that affects a paranasal sinus, middle ear or trachea, said method comprising the steps of
A) providing a substance delivering spacer device for implantation in an opening of a paranasal sinus, said device comprising: -
a tubular body having a side wall, a hollow passage extending therethrough and being open at either end and perforations formed in the wall through which bodily secretions may flow into the hollow passage, the wall of said tubular body comprising; an inner layer comprising a polymer that is devoid of therapeutic substance; an outer layer comprising a polymer that is devoid of therapeutic substance; and a therapeutic substance containing layer located between the inner and outer layers, said therapeutic substance containing layer being solid and comprising a polymer combined with a therapeutic substance such that the therapeutic substance will elute therefrom when the device is implanted; wherein said outer layer is constructed to allow a therapeutically effective amount of the therapeutic substance to elute through the outer layer and from the device while implanted, wherein said inner layer is substantially impervious to the therapeutic substance, wherein said therapeutic substance comprises at least one steroid; said tubular body being flexible and sufficiently elastic to frictionally engage and remain in the opening following its insertion into the opening; and the device having an outer diameter ra and an inner diameter ri, wherein the ratio Q of the outer diameter ra to the inner diameter ri is greater than or equal to 1.2 but less than or equal to 3.0; and B) implanting the device in an opening of a paranasal sinus such that a therapeutic amount of the therapeutic substance is delivered to the opening of a paranasal sinus in which the device is implanted. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28)
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Specification