MEDICAL AND DENTAL IMPLANT DEVICES FOR CONTROLLED DRUG DELIVERY

• US 20070016163A1
• Filed: 05/04/2006
• Published: 01/18/2007
• Est. Priority Date: 06/28/2005
• Status: Abandoned Application

• Current Assignee: MicroCHIPS Inc.
• Original Assignee: MicroCHIPS Inc.
• Inventors: Santini, John, Proos, Elizabeth, Hutchinson, Charles
• Application Number:
  US11/381,646
• Publication Number:
  US 20070016163A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61C 19/063 Medicament applicators for teeth or gums, e.g. treatment with fluorides
• CPC Class Codes: A61C 2008/0046 Textured surface, e.g. roughness, microstructure A61C8/0013 takes precedence
• CPC Class Codes: A61C 8/0012 characterised by the material or composition, e.g. ceramics, surface layer, metal alloy use of specific materials A61K6/00
• CPC Class Codes: A61C 8/0016 polymeric material
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2/3676 Distal or diaphyseal parts of shafts
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/482 Electrical means
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2828 Femoral head
• CPC Class Codes: A61F 2002/2832 Femoral neck
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/30266 : wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30652 : Special cut-outs, e.g. flat or grooved cut-outs
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30808 : parallel
• CPC Class Codes: A61F 2002/3081 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30873 : Threadings machined on non-cylindrical external surfaces
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30937 : with cut-outs
• CPC Class Codes: A61F 2002/4631 : the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0024 : made from both porous and non-porous parts, e.g. adjacent parts
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• 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 15/585 : Mixtures of macromolecular compounds
• CPC Class Codes: A61L 2300/252 : Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/402 : Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/406 : Antibiotics
• CPC Class Codes: A61L 2300/41 : Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 : Growth factors
• CPC Class Codes: A61L 2300/602 : Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 24/043 : Mixtures of macromolecular materials
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 28/0026 : Mixtures of macromolecular compounds
• CPC Class Codes: C08L 31/04 : Homopolymers or copolymers of vinyl acetate

Abstract

Implantable devices and methods for use in the treatment of osteonecrosisare provided. The device includes at least one implant device body adapted for insertion into one or more channels or voids in bone tissue; a plurality of discrete reservoirs, which may preferably be microreservoirs, located in the surface of the at least one implant device body; and at least one release system disposed in one or more of the plurality of reservoirs, wherein the release system includes at least one drug selected from the group consisting of bone growth promoters, angiogenesis promoters, analgesics, anesthetics, antibiotics, and combinations thereof. The device body may be formed of a bone graft material, a polymer, a metal, a ceramic, or a combination thereof. The device body may be a monolithic structure, such as one having a cylindrical shape, or it may be in the form of multiple units, such as a plurality of beads.

Claims

1. An implantable medical device for use in the treatment of osteonecrosis comprising:

at least one implant device body adapted for insertion into one or more channels or voids in bone tissue;

a plurality of discrete reservoirs located in the surface of the at least one implant device body; and

at least one release system disposed in one or more of the plurality of reservoirs, wherein the release system includes at least one drug selected from the group consisting of bone growth promoters, angiogenesis promoters, analgesics, anesthetics, antibiotics, and combinations thereof.

2. The device of claim 1, wherein the device body is formed of a bone graft.

3. The device of claim 1, wherein the device body is formed of a polymer, a metal, a ceramic, or a combination thereof.

4. The device of claim 1, wherein the device body is cylindrical shaped.

5. The device of claim 1, wherein the device body is in the form of a plurality of beads.

6. The device of claim 1, wherein the discrete reservoirs are microreserviors.

7. A method for treating osteonecrosis comprising the steps of:

removing necrotic bone tissue from a bone and creating one or more channels or voids in said bone; and

inserting at least one drug delivery device into the one or more channels or voids, wherein the drug delivery device comprises a body portion in which are provided a plurality of discrete reservoirs containing at least one release system comprising one or more therapeutic or prophylactic agents for release in vivo.

8. The method of claim 7, wherein the release system comprises a drug selected from bone growth promoters, angiogenesis promoters, or combinations thereof.

9. The method of claim 7, wherein two or more drug delivery devices are inserted into two or more channels formed in said bone.

10. The method of claim 7, further comprising utilizing a fluid delivery means to wet the at least one drug delivery device disposed in the one or more channels or voids.

11. The method of claim 10, wherein the fluid delivery means comprises a re-routed or grafted blood vessel.

12. The method of claim 10, wherein the fluid delivery means comprises a fluid source, a pump, and at least one catheter having a proximate end and a distal end, wherein the distal end of the catheter is inserted into at least one of the channels or voids containing the drug delivery device and delivers fluid from the fluid source via the pump.

13. The method of claim 12, wherein the fluid reservoir and pump are integrated into a single device.

14. The method of claim 12, wherein the fluid source comprises saline, blood, a blood component, hyaluronic acid, or a combination thereof.

15. The method of claim 7, wherein the body portion comprises a bone graft, a polymer, a metal, or a combination thereof

16. The method of claim 7, wherein the body portion is a monolithic structure.

17. The method of claim 7, wherein the body portion is in the form of a plurality of beads.

18. The method of claim 7, wherein the discrete reservoirs are microreservoirs.

19. The method of claim 7, wherein the step of removing necrotic bone tissue from a bone and creating one or more channels or voids in said bone involves a light bulb surgical procedure or trapdoor surgical procedure.

20. A joint resurfacing device comprising:

a body portion having a joint tissue interfacing surface and an opposing side;

a plurality of discrete reservoirs located joint tissue interfacing surface;

at least one release system disposed in one or more of the plurality of reservoirs containing at least one release system comprising one or more therapeutic or prophylactic agents for release in vivo; and

an anchor portion extending from the opposing side away from the joint tissue interfacing surface, wherein the anchoring portion is adapted to secure the joint resurfacing device to a bone in need of resurfacing.

21. The device of claim 20, wherein the one or more therapeutic or prophylactic agents are selected from the group consisting of BMPs, angiogenesis promoters, analgesics, anesthetics, antibiotics, and combinations thereof.

22. The device of claim 20, wherein the one or more therapeutic or prophylactic agents comprises a bone growth promoter.

23. The device of claim 20, wherein the joint tissue interfacing surface comprises a rounded cap.

24. The device of claim 20, wherein the reservoirs have chamfered openings in the surface of the joint tissue interfacing surface.

25. The device of claim 20, wherein the anchor portion comprises at least one screw.

26. An implantable infection control device comprising:

a plurality of beads tethered together to form a chain,

wherein the beads comprise a plurality of discrete reservoirs which are loaded with a release system comprising at least one anti-infective drug formulation for controlled release in vivo.

27. The device of claim 26, wherein the beads are cylindrical, spherical, or elliptical shaped.

28. The device of claim 26, wherein the beads comprise a biocompatible material selected from polytetrafluoroethylenes, polyesters, polymethylmethacrylates, silicones, metals, glasses, ceramics, bone cements, and combinations thereof.

29. The device of claim 26, wherein the release system comprises at least one antibiotic agent dispersed in a polymeric matrix material.

30. The device of claim 26, wherein the beads are tethered by at least one biocompatible string imbedded through the beads or threaded through apertures in the beads.

31. The device of claim 26, wherein a first group of the reservoirs comprises the at least one anti-infective drug formulation and a second group of the reservoirs comprises a second formulation of a drug, wherein the at least one anti-infective drug formulation and the second formulation have different compositions.

32. The device of claim 26, wherein at least one of the beads comprises a first drug and at least another of the beads comprises a second, different drug.

33. The device of claim 31, wherein the drug of the at least one anti-infective drug formulation is different from the drug of the second formulation.

34. The device of claim 33, wherein the second formulation of a drug comprises an anti-inflammatory agent.

35. The device of claim 31, which is adapted to provide simultaneous release of the two or more drugs.

36. The device of claim 31, wherein the release system is layered to provide serial release of two or more drugs.

37. A prosthetic dental device comprising:

a device body having an anchor portion adapted for engagement with a jaw bone of a patient in need thereof;

two or more discrete reservoirs located in spaced apart positions in the device body, the reservoirs formed with an opening at the surface of the device body and extending into the device body; and

a release system disposed in the reservoirs which comprises at least one therapeutic or prophylactic agent,

wherein following implantation into a patient the therapeutic or prophylactic agent is released in a controlled manner from the reservoirs.

38. The device of claim 37, further comprising a replacement tooth portion.

39. The device of claim 37, wherein the reservoirs are located in the anchor portion.

40. The device of claim 37, wherein the discrete reservoirs are microreservoirs.

41. The device of claim 37, wherein the device body comprises a stainless steel, a chrome-cobalt alloy, a titanium alloy, a ceramic, an ultra high molecular weight polyethylene, or a combination thereof.

42. The device of claim 37, wherein the anchor portion comprises at least one screw-like, threaded region.

43. The device of claim 37, wherein the therapeutic or prophylactic agent comprises one or more anti-infective, antibiotic agents, growth factors, or a combination thereof.

44. The device of claim 37, wherein the device is adapted to release two or more, different therapeutic or prophylactic agents.

45. The device of claim 44. wherein one of the therapeutic or prophylactic agents is disposed in a first array of reservoirs and a second of the therapeutic or prophylactic agents is disposed in a second array of reservoirs.

46. The device of claim 45, wherein the first array is located to release one or more anti-infective or antibiotic agents into gum tissues.

47. The device of claim 45, wherein the second array is located to release one or more growth factors into orthopedic tissues.

48. A prosthetic dental device comprising:

a device body having an anchor portion for engagement with a jaw bone of a patient in need thereof; and

at least one sensor or diagnostic agent integrated into the device body.

49. The device of claim 48, wherein the sensor can be used to measure temperature, pressure, or both in one or more areas in or around the site of in vivo implantation of the device.