Method of making implantable medical devices having controlled surface properties
First Claim
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1. A method for controlling surface properties of an implantable medical device, comprising:
- vacuum depositing a device forming biomaterial selected from one of elemental nickel and elemental titanium or nickel-titanium alloy onto a cylindrical substrate maintained at a temperature range between about 300 to 1100 degrees Centigrade, the substrate having a pre-determined pattern of recesses in an outer surface thereof to form a tubular device forming biomaterial on the cylindrical substrate;
controlling the formation of heterogeneities at a blood or tissue contacting surface of the tubular device forming biomaterial during the vacuum depositing step, such that controlled heterogeneities are formed at the blood or tissue contacting surface; and
removing the medical device from the substrate.
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Abstract
An implantable medical device that is fabricated from materials that present a blood or body fluid or tissue contact surface that has controlled heterogeneities in material constitution. An endoluminal stent-graft and web-stent that is made of a monolithic material formed into differentiated regions defining structural members and web regions extending across interstitial spaces between the structural members. The endoluminal stent-graft is characterized by having controlled heterogeneities at the blood flow surface of the stent.
155 Citations
20 Claims
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1. A method for controlling surface properties of an implantable medical device, comprising:
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vacuum depositing a device forming biomaterial selected from one of elemental nickel and elemental titanium or nickel-titanium alloy onto a cylindrical substrate maintained at a temperature range between about 300 to 1100 degrees Centigrade, the substrate having a pre-determined pattern of recesses in an outer surface thereof to form a tubular device forming biomaterial on the cylindrical substrate; controlling the formation of heterogeneities at a blood or tissue contacting surface of the tubular device forming biomaterial during the vacuum depositing step, such that controlled heterogeneities are formed at the blood or tissue contacting surface; and removing the medical device from the substrate. - View Dependent Claims (2, 3, 4, 19, 20)
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5. A method for controlling surface properties of an implantable medical device, comprising:
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forming a tubular nickel-titanium alloy biomaterial onto a substrate maintained at a temperature range between about 300 to 1100 degrees Centigrade and non-zero bias voltage present between about −
1000 and +1000 volts applied to the generally cylindrical substrate sufficient to impart a hyperthermal energy of energetic species arriving at the surface of the substrate to between about 0.1 eV and about 700 eV, the substrate having a pre-determined pattern of topographical features on an exterior surface thereof, wherein the pattern of topographical features comprises a positive or negative pattern that is imparted to the device forming biomaterial;controlling the formation of heterogeneities at a blood or tissue contacting surface of the biomaterial by fabricating the bulk material of the medical device to have a defined grain sizes that yield sites along the surface of the medical device having protein binding capability, wherein the controlled heterogeneities have a blood contact surface of diameter less than or equal to about 10 μ
m and an inter-heterogeneity boundary between about 0 and 2 μ
m; andremoving the medical device from the substrate. - View Dependent Claims (6, 7, 8, 9, 10, 11, 18)
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12. A method for controlling surface properties of an implantable medical device, comprising:
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vacuum depositing a generally tubular nickel-titanium alloy device onto a substrate, the substrate having a pre-determined pattern of recesses and the substrate is maintained at a non-zero bias voltage present between about −
1000 and +1000 volts applied to the generally cylindrical substrate sufficient to impart a hyperthermal energy of energetic species arriving at the surface of the substrate to between about 0.1 eV and about 700 eV;controlling the formation of heterogeneities at a blood or tissue contacting surface of the biomaterial during fabrication of the medical device, such that controlled heterogeneities are formed and have a substantially homogeneous surface energy and electrostatic charge across a blood contact surface of the metal film, wherein the controlled heterogeneities have a blood contact surface of diameter less than or equal to about 10 μ
m and an inter-heterogeneity boundary between about 0 and 2 μ
m; andremoving the medical device from the substrate. - View Dependent Claims (13, 14, 15, 16, 17)
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Specification