Implantable containment apparatus for a therapeutical device and method for loading and reloading the device therein
First Claim
Patent Images
1. An implantable containment apparatus comprising:
- a material in the form of a chamber;
wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;
the material comprising a laminate, the laminate comprising a first layer attached to a second layer, the first layer comprising a porous stretched polytetrafluoroethylene material that is impervious to cellular ingrowth across the interior surface of the chamber, the second layer comprising a porous stretched polytetrafluoroethylene material that is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the porous stretched polytetrafluoroethylene material up to, but not through, the first layer;
wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber;
wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and
wherein the therapeutical device is removable from the chamber though the access means of the chamber.
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Abstract
This invention relates generally to an implantable containment apparatus made of selectively permeable material. In particular, the implantable containment apparatus is used to contain a therapeutical device, such as a drug delivery device, a cell encapsulation device, or a gene therapy device. A therapeutical device can be easily placed and replaced in an apparatus of the present invention without damaging tissues associated with the selectively permeable material of the apparatus.
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Citations
38 Claims
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1. An implantable containment apparatus comprising:
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a material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber; the material comprising a laminate, the laminate comprising a first layer attached to a second layer, the first layer comprising a porous stretched polytetrafluoroethylene material that is impervious to cellular ingrowth across the interior surface of the chamber, the second layer comprising a porous stretched polytetrafluoroethylene material that is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the porous stretched polytetrafluoroethylene material up to, but not through, the first layer; wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber; wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and wherein the therapeutical device is removable from the chamber though the access means of the chamber. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. An implantable containment apparatus comprising:
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a material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber; wherein the material is impervious to cellular ingrowth across the interior surface of the chamber; wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber; wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; wherein the therapeutical device is removable from the chamber though the access means of the chamber; and wherein the implantable containment apparatus, in conjunction with a gene therapy device, serves as an implantable medical device.
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20. An implantable containment apparatus comprising:
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a porous material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber; the porous material comprising a hydrogel material that renders the material impervious to cellular ingrowth across the interior surface of the chamber; wherein the porous material is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the material up to, but not through, the hydrogel material; wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber; wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and wherein the therapeutical device is removable from the chamber though the access means of the chamber. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. An implantable containment apparatus comprising:
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a material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber, and a stent; wherein the material is impervious to cellular ingrowth across the interior surface of the chamber; wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber; wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and wherein the therapeutical device is removable from the chamber though the access means of the chamber. - View Dependent Claims (31, 32, 33)
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34. An implantable containment apparatus for a therapeutical device comprising:
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a material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber; wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length; wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber; wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and wherein the therapeutical device is removable from the chamber through the access means of the chamber.
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35. An implantable containment apparatus for a therapeutical device comprising:
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a material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber; wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length; wherein the second layer is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the stretched polytetrafluoroethylene material, up to, but not through, the first layer; wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber; wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and wherein the therapeutical device is removable from the chamber through the access means of the chamber.
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36. An implantable containment apparatus for a therapeutical device comprising:
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a material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber; wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length; wherein the second layer is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the stretched polytetrafluoroethylene material, up to, but not through, the first layer; wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber; wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; wherein the therapeutical device is removable from the chamber through the access means of the chamber; and wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device.
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37. An implantable containment apparatus for a therapeutical device comprising:
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a material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber; wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length; wherein the second layer is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the stretched polytetrafluoroethylene material, up to, but not through, the first layer; wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber; wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; wherein the therapeutical device is removable from the chamber through the access means of the chamber; wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device; and wherein the implantable medical device is an artificial organ.
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38. An implantable containment apparatus for a therapeutical device comprising:
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a material in the form of a chamber; wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber; wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length; wherein the second layer is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the stretched polytetrafluoroethylene material, up to, but not through, the first layer; wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber; wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; wherein the therapeutical device is removable from the chamber through the access means of the chamber; wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device; wherein the implantable medical device is an artificial organ; and wherein the artificial organ is an artificial pancreas.
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Specification