DRUG ELUTING IMPLANT

• US 20070141106A1
• Filed: 10/17/2006
• Published: 06/21/2007
• Est. Priority Date: 10/19/2005
• Status: Abandoned Application

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter, Cremens, Matthew
• Application Number:
  US11/549,994
• Publication Number:
  US 20070141106A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00411 actuated by application of energy from an energy source outside the body
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30668 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2002/4495 having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0068 : the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/602 : Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2430/34 : for soft tissue reconstruction
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• 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 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/048 : obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61N 1/306 : Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/327 : for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: B05D 1/02 : performed by spraying
• CPC Class Codes: B05D 1/18 : performed by dipping
• CPC Class Codes: B05D 1/28 : performed by transfer from the surfaces of elements carrying the liquid or other fluent material, e.g. brushes, pads, rollers

Abstract

The present invention provides a medical system for the administration of a pharmaceutical agent in vivo to a patient. The medical system includes a medical implant positionable in a body of a patient. A pharmaceutical agent in disposed on the medical implant and at least partially coated with a reactive coating. The reactive coating act to controls the release of the pharmaceutical agent. An energy unit is provided for transmitting an energy signal to the reactive coating, wherein the reactive coating reacts to the energy signal to increase the release rate of the pharmaceutical agent.

Claims

1. A medical system for the administration of a pharmaceutical agent in vivo comprising:

a medical implant positionable in a body of a patient and including the pharmaceutical agent and a reactive coating thereon, wherein the reactive coating controls the release of the pharmaceutical agent; and

an energy unit for transmitting an energy signal to the reactive coating, wherein the reactive coating reacts to the energy signal to increase the release rate of the pharmaceutical agent.

2. The medical system of claim 1, further comprising a plurality of reactive coatings, wherein the plurality of reactive coatings are layered.

3. The medical system of claim 2, wherein the pharmaceutical agent is interposed between each of the layers of the plurality of reactive coatings.

4. The medical system of claim 3, wherein at least one different pharmaceutical agent is disposed between at least one of the layers of the plurality of reactive coatings.

5. The medical system of claim 1, wherein the pharmaceutical agent is mixed within the reactive coating.

6. The medical system of claim 5, further comprising a plurality of reactive coatings, wherein the plurality of reactive coatings are layered.

7. The medical system of claim 6, wherein at least one different pharmaceutical agent is mixed within at least one of the layers of the plurality of reactive coatings.

8. The medical system of claim 1, wherein the reactive coating is biodegradable.

9. The medical system of claim 8, wherein the medical implant is biodegradable.

10. The medical system of claim 9, wherein the energy signal increases the degradation rate of the biodegradable coating.

11. The medical system of claim 9, further comprising a plurality of biodegradable coatings, wherein the plurality of biodegradable coatings are layered.

12. The medical system of claim 11, wherein the pharmaceutical agent is interposed between each of the biodegradable layers.

13. The medical system of claim 12, wherein at least one different pharmaceutical agent is disposed between at least one of the biodegradable layers.

14. The medical system of claim 11, wherein the pharmaceutical agent is mixed within each of the biodegradable layers.

15. The medical system of claim 14, wherein at least one different pharmaceutical agent is mixed within at least one of the biodegradable layers.

16. The medical system of claim 11, wherein the energy signal separates at least one biodegradable coating layer from the medical implant to release the pharmaceutical agent.

17. The medical system of claim 1, wherein the reactive coating is a porous coating and the application of the energy signal increases the uniform pore size to increase the release rate of the pharmaceutical agent.

18. The medical system of claim 17, wherein the porous coating has a uniform pore size.

19. The medical system of claim 17, where the discontinuation of the energy signal returns the uniform pore size to an original pore size.

20. The medical system of claim 17, wherein the porous coating has a plurality of different pore sizes.

21. The medical system of claim 20, where each of the plurality of different pore sizes is attuned to react to a different energy signal frequency.

22. The medical system of claim 21 wherein the energy signal selectively increases at least one of the plurality of pore sizes to selectively release the pharmaceutical agent.

23. The medical system of claim 1, wherein the reactive coating substantially prevents release of the pharmaceutical agent and the energy signal disrupts the coating thereby allowing elution of the pharmaceutical agent through the coating.

24. The medical system of claim 23, further comprising a second coating positioned between the reactive coating and the medical implant, wherein the second coating is impregnated with the pharmaceutical agent.

25. The medical system of claim 23, wherein the energy signal creates fissures in the reactive coating.

26. The medical system of claim 23, wherein the medical implant has a first coefficient of thermal expansion and the coating has a second coefficient of thermal expansion.

27. The medical system of claim 26, wherein the first coefficient of thermal expansion is greater then the second coefficient of thermal expansion.

28. The medical system of claim 23, wherein the coating includes a non-resorbable polymer.

29. The medical system of claim 28, wherein the pharmaceutical agent is mixed within the non-resorbable polymer.

30. The medical system of claim 1, wherein the medical implant is made of a biological material.

31. The medical system of claim 1, wherein the energy unit is an external energy unit positioned on a skin portion of the body of the patient proximal to the medical implant.

32. The medical system of claim 1, wherein the energy unit is an internal energy unit positionable within the body of the patient.

33. The medical system of claim 32, wherein the internal energy unit in operable connected to an external power source.

34. The medical system of claim 33, wherein the internal energy unit includes an internal power source.

35. The medical system of claim 34, wherein the internal energy unit includes a control unit.

36. Then medical system of claim 35, wherein the control unit is programmed to activate the internal energy unit at set time intervals.

37. The medical system of claim 35, where the control unit activates the internal energy unit in response to an external signal.

38. The medical system of claim 34, wherein the internal power source includes a rechargeable battery.

39. The medical system of claim 1, wherein the external energy unit transmits an energy signal selected from the group consisting of radio frequency (RF), magnetic, electro magnetic (EM), acoustic, microwave, thermal, vibratory, radiation, extracorporeal shockwave (ESW) energies, and combination thereof.

40. The medical system of claim 1, wherein the pharmaceutical agent is selected from a group consisting of a drug, therapeutic agent, and biological agent.

41. The medical system of claim 1, wherein the medical implant is selected from a group consisting of a stent, hip replacement, knee replacement, spinal implant, tissue, scaffold, biological implants, graft, tissue graft, screws, plate, rods, and prosthetic device.

42. The medical system of claim 1, wherein the reactive coating comprise a plurality of capsules bonded together.

43. The medical system of claim 42, wherein the pharmaceutical agent is disposed within each of the capsules.

44. The medical system of claim 42, wherein the capsules have a uniform size.

45. The medical system of claim 42, wherein the capsules have a plurality of different sizes.

46. The medical system of claim 45, wherein a different pharmaceutical agent is disposed within each of the different capsule sizes.

47. The medical system of claim 45, where each of the plurality of different capsules sizes is attuned to react to a different energy signal frequency or wavelength.

48. The medical system of claim 42, wherein the plurality of capsules are made of a biodegradable material.

50. The method of claim 4S, wherein the energy directed at the implantable device creates fissures in the barrier.

51. The method of claim 50, wherein the barrier is a first coating covering the implantable device.

52. The method of claim 51, further comprising a second coating positioned between the first coating and the implantable device and wherein the pharmaceutical agent is found in the second coating.

53. The method of claim 48, wherein the implantable device is made of an implant material having a first thermal expansion coefficient and the barrier is made of a barrier material having a second thermal expansion coefficient and wherein the energy directed at the implantable device heats the implantable device and barrier.

54. The method of claim 53, wherein the barrier material includes a non-resorbable polymer.

55. The method of claim 54, wherein the pharmaceutical agent is mixed with the non-resorbable polymer.

49. A method of releasing a pharmaceutical agent from an implantable device comprising the steps of:

providing an implantable device impregnated or coated with a pharmaceutical agent, the implantable device having a barrier substantially limiting release of the pharmaceutical agent therethrough;

implanting the implantable device in tissue in a body; and

directing energy at the implantable device,

wherein the energy directed at the implantable device disrupts the barrier thereby allowing elution of the pharmaceutical agent through the barrier to the tissue.

56. The method of claim 49, wherein the energy directed at the implantable device is selected from the group consisting of radio frequency (RF), magnetic, electro magnetic (EM), acoustic, microwave, thermal, vibratory, radiation, extracorporeal shockwave (ESW) energies, and combination thereof.

57. A medical implant for the administration of a pharmaceutical agent in vivo comprising:

a body portion including a reservoir therein;

a pharmaceutical agent disposed within the reservoir; and

a cover portion attachable to the body portion, covering the reservoir and the pharmaceutical agent.

58. The medical implant of claim 57, wherein the body portion comprises a plurality of reservoirs, wherein each of the reservoirs contains the pharmaceutical agent.

59. The medical implant of claim 58, where each of the reservoirs contains a different pharmaceutical agent.

60. The medical implant of claim 57, wherein the pharmaceutical agent is selected from a group consisting of a drug, therapeutic agent, and biological agent.

61. The medical implant of claim 57, wherein the body and cover portions are made of a biodegradable material.

62. The medical implant of claim 61, wherein the degradation rate of the body and cover portions controls the release of the pharmaceutical agent.

63. The medical implant of claim 57, where the thickness of the body and cover portions controls the release of the pharmaceutical agent.

64. A method for administration of a pharmaceutical agent into a patient, comprising:

selecting a medical implant for insertion into the patient;

selecting the pharmaceutical agent;

dispensing the pharmaceutical agent into the medical implant prior to insertion of the medical implant into the patient; and

inserting the medical implant into the body of the patient.

65. The method of claim 64, wherein the medical implant comprises:

a body portion including a reservoir therein; and

a cover portion attachable to the body portion, covering the reservoir

66. The method of claim 65, wherein dispensing the pharmaceutical agent comprises;

positioning the pharmaceutical agent in the reservoir of the body portion, and

attaching the cover portion to the body portion, covering the reservoir and the pharmaceutical agent therein.

67. The method of claim 66 wherein the pharmaceutical agent elutes through the medical implant.