Controlled release implantable devices

• US 20040034357A1
• Filed: 04/23/2003
• Published: 02/19/2004
• Est. Priority Date: 08/03/1999
• Status: Abandoned Application

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC), University Of Massachusetts
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC), University Of Massachusetts
• Inventors: Miller-Graziano, Carol L., Litwin, Demetrius, Niemann, Allison, Sikora, George, Beane, Richard M., Ek, Steve
• Application Number:
  US10/421,103
• Publication Number:
  US 20040034357A1
• Time in Patent Office: Days
• US Class Current: 606/73
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Implantable devices that deliver a drug to a target location are disclosed. In general, the devices include a portion that engages tissue near the target location and a section with an internal cavity that houses the drug. The drug can be incorporated into a controlled release agent, such as drug-polymer microspheres, which steadily or intermittently release the drug. Alternatively, instead of defining an internal cavity, the section can be formed from a material that includes the controlled release agent. The devices can be used, e.g., to deliver down-regulatory cytokines to a site of inflammation.

Claims

1. An implantable device for attaching tissue to a support structure inside a body and for delivering a drug to a target location near the support structure, the device comprising:

a first portion configured to engage the tissue, and a second portion configured to engage the support structure;

wherein the device includes a section that defines an internal cavity, the internal cavity having a size and shape for containing a controlled release agent comprising the drug.

2. The device of claim 1, further comprising the controlled release agent.

3. The device of claim 2, wherein the controlled release agent comprises the drug mixed with a polymer.

4. The device of claim 2, wherein the controlled release agent comprises microspheres of a polymer that contain the drug.

5. The device of claim 2, wherein the controlled release agent is configured to release the drug for a period of greater than two days.

6. The device of claim 2, wherein the controlled release agent is configured to release the drug intermittently over a period of time.

7. The device of claim 2, wherein the drug is selected from the group consisting of a down-regulatory cytokine, a pain killer, platelet derived growth factor, an antibiotic, a hormone, a prostaglandin, a protein, a peptide sequence, and a nucleic acid.

8. The device of claim 2, wherein the drug is interleukin-10.

9. The device of claim 2, wherein the drug is lidocaine.

10. The device of claim 1, wherein the second portion is configured to penetrate the tissue.

11. The device of claim 1, wherein the section has an aperture that exposes the interior cavity to bodily fluids when the device is implanted in the body.

12. The device of claim 11, further comprising a membrane that covers the aperture, wherein the membrane is permeable to bodily fluids and to the drug only when the drug is dissolved or suspended in bodily fluids.

13. The device of claim 1, wherein the support structure comprises bone.

14. The device of claim 13, wherein the device is a bone screw comprising a head and a rigid, threaded shaft, the shaft including both the second portion and the section.

15. The bone screw of claim 14, wherein the shaft defines an aperture that opens into the internal cavity.

16. The bone screw of claim 15, further comprising a membrane that covers the aperture, wherein the membrane is permeable to bodily fluids and to the drug only when the drug is dissolved or suspended in bodily fluids.

39. A method of attaching tissue to a support structure and delivering a drug to a target location inside a body, the method comprising:

obtaining the device of claim 1;

and

implanting the device within the body by engaging the second portion with the support structure, and the first portion with the tissue, whereby the agent releases the drug to the desired location over time.

40. The method of claim 39, wherein the device is made from a material degradable by bodily fluids.

17. An implantable device for attaching tissue to a support structure inside a body and for delivering a drug to a target location near the support structure, the device comprising:

a first portion that engages the tissue, and a second portion that engages the support structure;

wherein the device includes a section formed from a material that comprises a controlled release agent comprising a drug.

18. The device of claim 17, wherein the controlled release agent comprises microspheres of a polymer that contain the drug.

19. An implantable device for delivering a drug to a desired location inside a body, the device comprising:

a rigid exterior comprising a tapered end for penetrating tissue within the body and a projection for engaging tissue within the body; and

an internal cavity in fluid communication with the rigid exterior, wherein the cavity has a size and shape for containing a controlled release agent comprising the drug.

20. The device of claim 19, wherein the rigid exterior comprises a pointed, arrow-shaped head comprising both the tapered end and the projection.

21. The device of claim 20, wherein the arrow-shaped head comprises a shaft and two projections, each projection having a first pointed end, and a second end connected to the shaft, the first ends being movable between a first position flush with the shaft, and a second position displaced away from the shaft.

22. An implantable staple for delivering a drug to a desired location within a body, the staple comprising:

at least two prongs configured to penetrate and engage tissue; and

a shaft connecting the two prongs, wherein the shaft has an internal cavity that has a size and shape for containing a controlled release agent comprising the drug.

23. The device of claim 22, wherein the shaft comprises a material degradable by bodily fluids.

24. An implantable device for delivering a drug to a target location, the device comprising:

an elongated rod curved in a generally helical shape, wherein the helical shape tapers to a point that in use penetrates soft tissue, and wherein the helical shape forms a conical interior space configured to contain a solid controlled release agent comprising the drug.

25. An implantable device for delivering a drug to a target location, the device comprising:

a body comprising a controlled release agent that includes the drug, and the body defining a through-hole for passage of a guide wire therethrough.

26. The device of claim 25, wherein the body comprises a shell that surrounds the controlled release agent.

27. The device of claim 26, wherein the shell includes a head portion and a shaft portion and defines a bore, the bore containing a medicament core that comprises the controlled release agent, wherein the medicament core defines the through-hole.

28. The implantable device of claim 27, further comprising a tissue engaging projection connected to the shaft.

29. An implantable suture anchor for delivering a drug to a desired location in a body, the suture anchor comprising:

an exterior shell defining a hole for passage of a suture therethrough;

an internal cavity within the shell and in fluid communication with the hole, wherein the cavity has a size and shape for containing a controlled release agent comprising the drug; and

a membrane covering the hole to retain the agent within the cavity, the membrane being permeable to bodily fluids and the drug only when the drug is dissolved or suspended in bodily fluids.

31. An implantable suture anchor for delivering a drug to a desired location within a body, the suture anchor comprising:

a pellet formed from a mixture comprising the drug and a polymer formulated for controlled release of the drug; and

a suture passing through the pellet.

30. The suture anchor of claim 31, wherein the exterior shell comprises a material that is degradable by bodily fluids.

32. A splaying implantable device for delivering a drug to a desired location within a body, the device comprising:

a pellet comprising a controlled release agent comprising the drug;

a splaying anchor connected to the pellet, the anchor comprising at least two prongs that in use penetrate soft tissue, wherein a distance separating the two prongs increases when the prongs are inserted into the tissue.

33. An implantable staple for delivering a drug to a desired location within a body, the staple being formed from a material comprising a mixture of the drug and a polymer, the mixture being formulated for controlled release of the drug, the staple comprising at least two prongs configured to penetrate soft tissue and a shaft connecting the two prongs.

34. An implantable device for delivering a drug to a desired location inside a body, the device comprising:

a section formed from a sheet of one or more polymer threads molded to form the section; and

an internal cavity defined by the section, the cavity having a size and shape for containing a controlled release gent comprising the drug.

35. The device of claim 34, wherein the one or more threads are woven to form the sheet.

36. The device of claim 34, wherein the one or more threads are compressed to form a mesh sheet.

37. The device of claim 34, further comprising the controlled release agent.

38. The device of claim 37, wherein the controlled release agent comprises a pellet comprising the drug.

41. A method of treating inflammatory disease, the method comprising:

obtaining an implantable device that in use contains a down-regulatory cytokine;

implanting the device in proximity to a site of inflammation in the body, such that the implantable device releases the down-regulatory cytokine to the site of inflammation.

42. The method of claim 41, wherein the implantable device contains a sustained release formulation that comprises the down-regulatory cytokine, such that the device releases the down regulatory cytokine steadily over a period of time greater than two days.