Implantable and sealable medical device for unidirectional delivery of therapeutic agents to tissues

• US 7,749,528 B2
• Filed: 03/15/2004
• Issued: 07/06/2010
• Est. Priority Date: 08/29/2001
• Status: Active Grant

• Current Assignee: Alan Linn Murphree, Edward E. Schmitt, Ricardo Azevedo Pontes De Carvalho
• Original Assignee: Alan Linn Murphree, Edward E. Schmitt, Ricardo Azevedo Pontes De Carvalho
• Inventors: De Carvalho, Ricardo Azevedo Pontes, Schmitt, Edward E., Murphree, Alan Linn
• Primary Examiner(s): Foley; Shanon A
• Assistant Examiner(s): ALAWADI, SARAH
• Application Number:
  US10/801,508
• Publication Number:
  US 20050113806A1
• Time in Patent Office: 2,304 Days
• Field of Search: 424/422, 424/423, 424/424, 424/427, 424/433, 424/434, 424/448, 604/288.01, 604/288.02, 604/288.03, 604/288.04
• US Class Current: 424/423
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants

Abstract

A device for selective delivery of therapeutic agents to internal body tissues is disclosed. Upon tight sealing of the device to targeted tissues the diffusion of therapeutic agents to the targeted tissue can be controlled, while minimizing exposure of adjacent organs to the agents being delivered. Mechanisms for replenishment of the device and methods for application of the device in remote sites of the body are disclosed.

Claims

1. An implantable delivery device for delivery of at least a first therapeutic agent into a target tissue, comprising:

a housing, said housing comprising a reservoir with a drug release port for release of at least a first therapeutic agent into a target tissue, said reservoir having at least a first wall that is substantially impermeable to a first therapeutic agent to be placed therein, a sealing base for sealing said release port to a target tissue, wherein when said release port is sealed to a target tissue a first therapeutic agent in said reservoir is substantially prohibited from release by said device other than through said release port into the target tissue, and an attachment mechanism to facilitate sealing of said release port to a target tissue, said attachment mechanism comprising at least one member of the group consisting of a sufficient amount of an adhesive for adhering said sealing base to a target tissue wherein said adhesive is held within at least one cavity or channel within said sealing base, a suture holder for engaging at least one suture operatively attached to the surrounding tissue, and a band for engaging said device with a target tissue, wherein said reservoir comprises a first cavity that is connected to a first refilling port through a first tube.

2. The device of claim 1, wherein said first tube is connected to said housing via a protruding part that permits said first cavity to communicate with said reservoir.

3. The device of claim 2, wherein said first refilling port comprises a first refilling port cavity.

4. The device of claim 1, wherein said first refilling port can be implanted at a different site from the device location.

5. The device of claim 1, wherein said first refilling port comprises at least one septum.

6. The device of claim 5, wherein said at least one septum comprises a self-sealing material selected from the group consisting of latex, a synthetic rubber and a silicone elastomer.

7. The device of claim 5, wherein said septum is identifiable by imaging techniques selected from the group consisting of magnetic resonance imaging, x-ray, computerized tomography and ultrasound.

8. The device of claim 1, wherein said reservoir has at least a second cavity, said second cavity connected to a second refilling port through a second tube.

9. The device of claim 1, wherein said first refilling port is shaped to facilitate its implantation onto or into tissues.

10. The device of claim 1, wherein said first refilling port comprises a pump.

11. The device of claim 10, wherein said pump is a mechanical pump.

12. The device of claim 1, wherein said therapeutic agent is a prophylactic agent.

13. The device of claim 1, wherein said attachment mechanism comprises an adhesive layer.

14. The device of claim 13, wherein said adhesive layer can be applied during implantation of said device.

15. The device of claim 13, wherein said adhesive layer comprises a pressure-sensitive adhesive.

16. The device of claim 15, wherein said pressure-sensitive adhesive is selected from the group consisting of a hydrocolloid, a hydrogel, an acrylate and a silicone.

17. The device of claim 13, wherein said adhesive layer comprises a release liner.

18. The device of claim 1, wherein said reservoir carries a solid, liquid, viscous or gel-state therapeutic agent.

19. The device of claim 1, wherein said release port comprises a structural element to retain a therapeutic agent in said reservoir, wherein said structural element comprises one of the group consisting of a crossing band, a strip, a net and flanges.

20. The device of claim 19, wherein said structural element comprises at least one biocompatible and non-dissolvable material selected from the group consisting of a poly-ester, a poly-orthoester, a silicone, a polyethylene, a polypropylene, a polyurethane, and a metal.

21. The device of claim 19, wherein said structural element comprises at least one biocompatible and bioerodible material selected from the group consisting of glycolic acid, lactic acid, poly-ethylene-glycol, poly-vinyl-alcohol, poly-vinyl-pyrrolidone and methacrylates.

22. The device of claim 1, wherein said release port comprises a film that is permeable to a therapeutic agent to be placed in said reservoir.

23. The device of claim 22, wherein said film comprises at least one compound selected from the group consisting of a glycolic acid, a lactic acid, a poly-ethylene-glycol, a poly-vinyl-alcohol, a polyvinylpyrollidone, a methacrylates, cellulose, starch, ethylene vinyl acetate, and gelatin.

24. The device of claim 1, further comprising a pressure-controlled pump for providing therapeutic agent to said reservoir.

25. The device of claim 1, wherein said therapeutic agent is a diagnostic agent.

26. The device of claim 2, wherein said valve comprises a septum.

27. The structural element of claim 19, comprising a porous barrier.

28. The porous barrier of claim 27, wherein said porous barrier can control the diffusion interface between said reservoir and a targeted tissue.

29. The porous barrier of claim 27, comprising at least a first porous membrane.

30. The porous barrier of claim 27, comprising a membrane formed of a material selected from the group consisting of a poly-orthoester, a poly-glycolic acid, a poly-lactic acid, a poly-caprolactone, a polyvinyl-alcohol, a polyvinyl-pyrrilidone, hyaluronic acid, fibrin, methyl-cellulose, collagen, ethylene vinyl acetate, a polyethylene, a polyurethane, a metal, and gelatin.

31. An implantable delivery device for delivery of at least a first therapeutic agent into a target tissue, comprising:

a housing, said housing comprising a reservoir with a drug release port for release of at least a first therapeutic agent into a target tissue, said reservoir having at least a first wall that is substantially impermeable to a first therapeutic agent to be placed therein, a sealing base for sealing said release port to a target tissue, wherein when said release port is sealed to a target tissue a first therapeutic agent in said reservoir is substantially prohibited from release by said device other than through said release port into the target tissue, and an attachment mechanism to facilitate sealing of said release port to a target tissue, said attachment mechanism comprising at least one member of the group consisting of a sufficient amount of an adhesive for adhering said sealing base to a target tissue, a suture holder for engaging at least one suture operatively attached to the surrounding tissue, and a band for engaging said device with a target tissue, further comprising an osmotic pump.

32. An implantable delivery device for delivery of at least a first therapeutic agent into a target tissue, comprising:

a housing, said housing comprising a reservoir with a drug release port for release of at least a first therapeutic agent into a target tissue, said reservoir having at least a first wall that is substantially impermeable to a first therapeutic agent to be placed therein, a sealing base for sealing said release port to a target tissue, wherein when said release port is sealed to a target tissue a first therapeutic agent in said reservoir is substantially prohibited from release by said device other than through said release port into the target tissue, and an attachment mechanism to facilitate sealing of said release port to a target tissue, said attachment mechanism comprising at least one member of the group consisting of a sufficient amount of an adhesive for adhering said sealing base to a target tissue, a suture holder for engaging at least one suture operatively attached to the surrounding tissue, and a band for engaging said device with a target tissue, further comprising at least one mechanism for retaining a solid or viscous therapeutic material in said reservoir.

33. An implantable delivery device for delivery of at least a first therapeutic agent into a target tissue, comprising:

a housing, said housing comprising a reservoir with a drug release port for release of at least a first therapeutic agent into a target tissue, said reservoir having at least a first wall that is substantially impermeable to a first therapeutic agent to be placed therein, a sealing base for sealing said release port to a target tissue, wherein when said release port is sealed to a target tissue a first therapeutic agent in said reservoir is substantially prohibited from release by said device other than through said release port into the target tissue, and an attachment mechanism to facilitate sealing of said release port to a target tissue, said attachment mechanism comprising at least one member of the group consisting of a sufficient amount of an adhesive for adhering said sealing base to a target tissue, a suture holder for engaging at least one suture operatively attached to the surrounding tissue, and a band for engaging said device with a target tissue, further comprising at least one reinforcement mechanism for preventing collapse of said reservoir.

34. The device of claim 33, wherein said at least one reinforcement mechanism comprises metal.