Microporous drug delivery system

• US 6,361,780 B1
• Filed: 11/12/1998
• Issued: 03/26/2002
• Est. Priority Date: 11/12/1998
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Knapp, Christopher Paul, Ley, Gregory R.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): DI NOLA BARON, LILIANA
• Application Number:
  US09/190,902
• Time in Patent Office: 1,230 Days
• Field of Search: 424/400, 424/432, 424/443, 424/484, 424/486, 424/422, 424/423, 604/264, 604/265
• US Class Current: 424/400
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• 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
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A drug delivery device is described comprising a porous biocompatible solid having at least one therapeutic drug within its pores, the therapeutic drug being removable from the pores by immersion in an aqueous solution. This may also be described as a drug delivery device comprising a porous annulus comprising a biocompatible solid having at least one therapeutic drug within its pores, the therapeutic drug being removable from the pores by immersion in an aqueous solution, the annulus having a top outer surface with an outside diameter, an inner surface with an inside diameter, and a side surface, at least one of the side surface and the top outer surface having openings of the pores exposed on that surface.

The device may comprise pores having an average size of the greatest dimensions within the pores of between about 10⁻⁶ and 10⁻¹ mm.

The device may have a medical device or component of a medical device pass through an opening in the annulus. Examples of such medical devices may include, but not be limited to medical devices or components of medical devices selected from the group consisting of catheters, tubes, and electrical leads. A catheter or electrical lead may have at least a portion of its length surrounded by the porous drug delivery device.

A more specific description of an aspect of the present invention would include a catheter or cardiac lead having a collar comprising a porous, solid material surrounding at least a length of the catheter or cardiac lead, the collar comprising a porous material selected from the group consisting of inorganic oxides, metals, polymers, and composite materials, the porous material having pores with an average greatest dimension of between about 10⁻⁶ and 10⁻¹ mm, and the collar having a largest dimension of less than 5 mm.

Claims

1. A drug delivery device comprising a rigid porous biocompatible solid in the shape of a collar or annulus having an exterior surface that defines an opening therethrough, and a medical device having an outer surface where the outer surface of the medical device passes through the opening and is fixed to the rigid porous biocompatible solid, and where the rigid porous biocompatible has at least one therapeutic drug within its pores, said therapeutic drug being removable from said pores by immersion in an aqueous solution.

2. The device of claim 1 wherein said pores have an average size of between 10⁻

6 and 10<sup>−

1</sup> nm.

3. The device of claim 1 wherein said pores have an average size of between about 10⁻

6 and 10<sup>−

3</sup> mm.

4. The device of claim 1 wherein said medical device or component of a medical device is selected from the group consisting of catheters, tubes, and electrical leads.

5. A catheter or electrical lead having at least a portion of its length surrounded by the device of claim 1.

7. The drug delivery device of claim 1, where the rigid porous biocompatible solid is a ceramic.

8. The drug delivery device of claim 1, where the rigid porous biocompatible solid is a metal.

9. The drug delivery device of claim 1, where the rigid porous biocompatible solid is a polymer.

10. The drug delivery device of claim 1, where the rigid porous biocompatible solid is a composite material.

6. A catheter or cardiac lead having a collar comprising a rigid, porous, solid material surrounding at least a length of said catheter or cardiac lead.

11. The catheter or cardiac lead of claim 6, wherein the porous, solid material includes pores with an average greatest dimension of between about 10⁻

6 and 10<sup>−

1</sup> mm.

12. The catheter or cardiac lead of claim 6, where the porous, solid material is an inorganic oxide.

13. The catheter or cardiac lead of claim 6, where the porous, solid material is a metal.

14. The catheter or cardiac lead of claim 6, there the porous, solid material is a polymer.

15. The catheter or cardiac lead of claim 6, where the porous, solid material is a composite material.

16. The catheter or cardiac lead of claim 6, where the collar has a largest dimension of less than 5 mm.