Endoluminal device for in vivo delivery of bioactive agents

• US 8,697,175 B2
• Filed: 03/05/2012
• Issued: 04/15/2014
• Est. Priority Date: 11/17/2000
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Boyle, Christopher T.
• Primary Examiner(s): Yuan, Dah-Wei
• Assistant Examiner(s): BOWMAN, ANDREW J
• Application Number:
  US13/412,407
• Publication Number:
  US 20120221098A1
• Time in Patent Office: 771 Days
• Field of Search: 606/198, 623/1, 361/302
• US Class Current: 427/2.25
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

The present invention consists of an implantable structural element for in vivo delivery of bioactive active agents to a situs in a body. The implantable structural element may be configured as an implantable prosthesis, such as an endoluminal stent, cardiac valve, osteal implant or the like, which serves a dual function of being prosthetic and a carrier for a bioactive agent. Alternatively, the implantable structural element may simply be an implantable article that serves the single function of acting as a time-release carrier for the bioactive agent.

Claims

1. A method of forming a stent structure, comprising the steps of:

a. forming a region of an internal cavity of a strut with a sacrificial material;

b. depositing a layer of structural material over the sacrificial material;

c. forming one or more holes in the structural material providing fluid communication between the sacrificial material and the area external the structural material; and

d. removing the sacrificial material forming the region of the internal cavity.

2. The method of claim 1, wherein the step of removing the sacrificial material forming the region of the internal cavity is performed by etching.

3. The method of claim 1, further comprising the step of forming regions of one or more holes with sacrificial material, wherein the step of forming one or more holes in the structural material comprises removing the sacrificial material forming the regions of one or more holes by etching.

4. The method of claim 3, wherein the step of depositing a layer of structural material over the sacrificial material does not include depositing structural material over the sacrificial material forming regions of one or more holes.

5. The method of claim 1, wherein the step of forming one or more holes in the structural material comprises one of the methods of formation selected from the group consisting of microdrilling, laser cutting, etching, and EDM.

6. The method of claim 1, wherein the step of depositing a layer of structural material comprises using a vacuum deposition technique selected from the group consisting of sputtering, reactive ion etching, chemical vapor deposition, and plasma vapor deposition.

7. The method of claim 1, further comprising the step of depositing a bioactive agent within the internal cavity.

8. The method of claim 1, wherein the resulting stent structure is generally tubular in shape.

9. A method of forming a stent structure, comprising the steps of:

a. providing a base layer of structural material;

b. depositing sacrificial material onto the base layer, forming a region of an internal cavity of a strut;

c. depositing a layer of structural material over the sacrificial material;

d. forming one or more holes in the structural material providing fluid communication between the sacrificial material and the area external the structural material; and

e. removing the sacrificial material forming the region of the internal cavity.

10. The method of claim 9, wherein the resulting stent is generally tubular in shape.

11. The method of claim 9, further comprising the step of forming regions of one or more holes with sacrificial material, wherein the step of forming one or more holes in the structural material comprises removing the sacrificial material forming the regions of one or more holes by etching.

12. The method of claim 11, wherein the step of depositing a layer of structural material over the sacrificial material does not include depositing structural material over the sacrificial material forming regions of one or more holes.

13. The method of claim 9, wherein the step of forming one or more holes in the structural material comprises one of the methods of formation selected from the group consisting of microdrilling, laser cutting, etching, and EDM.

14. The method of claim 9, wherein the step of depositing a layer of structural material comprises using a vacuum deposition technique selected from the group consisting of sputtering, reactive ion etching, chemical vapor deposition, and plasma vapor deposition.

15. The method of claim 9, further comprising the step of depositing a bioactive agent within the internal cavity.

16. The method of claim 9, wherein the step of removing the sacrificial material forming the region of the internal cavity is performed by etching.