Silver implantable medical device

• US 6,530,951 B1
• Filed: 10/23/1997
• Issued: 03/11/2003
• Est. Priority Date: 10/24/1996
• Status: Expired due to Term

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Roberts, Joseph W., Bates, Brian L., Fearnot, Neal E., Kozma, Thomas G., Ragheb, Anthony O., Voorhees, William D. III, Osborne, Thomas A.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US08/956,715
• Time in Patent Office: 1,965 Days
• Field of Search: 623/1, 623/11, 623/12, 623/66, 623/1.15, 623/1.2, 623/1.46, 604/53, 604/265, 424/423, 424/426, 514/772.2, 514/772.3, 514/822, 523/112, 523/113, 606/76
• US Class Current: 623/1.45
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/106 Inorganic materials other than carbon
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A silver implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material posited on one surface of structure 12; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure 12 and the bioactive-material-free surface. Also included is a layer or impregnation of silver 45. Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor. Silver is included as a base material, coating or included in a carrier, drug, medicament material utilized with the implantable stent.

Claims

1. An implantable medical device, comprising:

a structure adapted for introduction into a patient, the structure being comprised of a base material and a layer of elemental silver having a uniform thickness posited on said base material, the elemental silver layer further having a specific surface energy density of about 20 to 30 dyne per centimeter.

2. The device according to claim 1, wherein said layer of elemental silver is posited directly on said base material.

3. The device according to claim 1, wherein a non-silver metal or metal alloy layer is posited on said base material and said layer of silver is posited on said non-silver layer.

4. The device according to claim 1, wherein said base material comprises a polymer coating and said elemental silver layer is posited on said polymer coating.

5. The device according to claim 4, wherein a non-silver metal or metal alloy layer is posited between said polymer coating and said elemental silver layer.

6. An implantable medical device, comprising:

a structure adapted for introduction into a patient, the structure being comprised of a base material wherein elemental silver, silver ions or a combination thereof in a bioactive effective amount is impregnated into a surface matrix of the base material, the elemental silver, silver ions, or combination thereof further have a specific surface energy density of about 20 to 30 dyne per centimeter.

7. The device according to claim 6, wherein the structure is configured as a vascular stent.

8. The device according to claim 6, wherein the structure is configured as at least one of:

a stent, a vascular or other graft, a vascular or other graft in combination with a stent, heart valve, an orthopedic device, appliance, implant or replacement, or portion thereof;

or a portion of any of these.

9. The device according to claim 6, wherein the base material is biocompatible.

10. The device according to claim 6, wherein the base material of the structure includes at least one of:

stainless steel, tantalum, titanium, Nitinol, gold, platinum, inconel, iridium, silver, tungsten, or another biocompatible metal, or alloys of any of these;

carbon or carbon fiber;

cellulose acetate, cellulose nitrate, silicone, polyethylene teraphthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, or another biocompatible polymeric material, or mixtures or copolymers thereof;

polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxy-butyrate valerate or another biodegradable polymer, or mixtures or copolymers of these;

a protein, an extracellular matrix component, collagen, fibrin or another biologic agent;

or mixture thereof.

11. The device according to claim 6, wherein said device is a balloon expandable vascular stent.

12. The device according to claim 6, wherein said device is a self-expanding vascular stent.

13. An implantable vascular device, comprising:

stent structure adapted for introduction into a vascular system of a patient, the stent structure comprising elemental silver or silver alloys having at least 50% by weight silver, the elemental silver, or silver alloys further have a specific surface energy density of about 20 to 30 dyne per centimeter.

14. The vascular device according to claim 13, wherein the device is produced from an alloy of silver and copper where the copper in the alloy can range from about 15% by weight to about 50% by weight.