BONE IMPLANTS FOR THE TREATMENT OF INFECTION

• US 20110054612A1
• Filed: 08/27/2010
• Published: 03/03/2011
• Est. Priority Date: 08/27/2009
• Status: Active Grant

• Current Assignee: Silver Bullet Therapeutics, Inc.
• Original Assignee: Silver Bullet Therapeutics, Inc.
• Inventors: Dehnad, Houdin, Chirico, Paul E., Chopko, Bohdan Wolodymyr
• Granted Patent: US 8,221,396 B2
• Time in Patent Office: Days
• US Class Current: 623/16.11
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/561 Implants with special means for releasing a drug
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2310/00113 Silver or Ag-based alloys
• CPC Class Codes: A61L 2300/102 Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
• CPC Class Codes: A61L 2300/104 Silver, e.g. silver sulfadiazine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

Described herein are devices, systems and methods for treating disease and/or infection by the release of silver from an implant over an extended period of time. In particular, the devices described herein may be used to treat infections such as osteomyelitis by the controlled release of silver ions from multiple sites of an extended-use implant. This implant typically includes a plurality of arms that both anchor and help distribute the released ions within the tissue. Power may be applied to release the silver ions into the tissue.

Claims

1. An implant for insertion in to bone to treat infection, the implant having a collapsed insertion configuration and an expanded deployed configuration, the implant comprising:

a plurality of arms configured to extend from the implant in the deployed configuration, wherein each of the arms comprises a reservoir of silver configured to be released from the implant into the bone;

an elongate and rigid guide comprising a plurality of deflection pathways, wherein the plurality of arms are movably coupled to the elongate guide so that they may be extended from the deflection pathways and deployed to different bone regions to convert the implant from the collapsed insertion configuration into the expanded deployed configuration; and

a silver-release driver coupled to the reservoirs of silver to drive release of silver ions from each of the plurality of arms.

2. The implant of claim 1, further comprising a bone anchor configured to secure the implant at least partially within a bone.

3. The implant of claim 1, wherein the elongate guide comprises an elongate hollow member.

4. The implant of claim 3, wherein the deflection pathways comprise windows along the long axis of the elongate hollow member.

5. The implant of claim 1, wherein the elongate guide comprises an elongate inner member having a longitudinal axis and a deflection ramp region forming the plurality of deflection pathways that is configured to deflect the arms from longitudinal axis as they are extended into the deployed configuration.

6. The implant of claim 1, wherein the plurality of arms comprise a shape-memory material.

7. The implant of claim 1, wherein the plurality of arms comprise a nickel titanium alloy covered by an adhesion layer and a silver coating, wherein the adhesion layer is formed after removal of a titanium oxide layer from the outer surface of the nickel titanium alloy and before the silver coating.

8. The implant of claim 1, wherein the arms are curved when extended in the deployed configuration.

9. The implant of claim 1, wherein the plurality of arms comprises tissue-penetrating ends configured to expand within cancellous bone.

10. The implant of claim 1, wherein the plurality of arms are distributed asymmetrically about the radius of the elongate guide in the insertion configuration.

11. The implant of claim 1, wherein the plurality of arms comprise arms of different lengths.

12. The implant of claim 1, wherein the plurality of arms are configured to release silver along their entire expanded length.

13. The implant of claim 1, wherein the plurality of arms are configured to release silver from a plurality of discrete locations along their length.

14. The implant of claim 1, wherein the reservoir of silver comprises a silver coating.

15. The implant of claim 1, wherein the reservoir of silver comprises a silver core.

16. The implant of claim 1, further comprising a delivery device coupling region at a proximal end of the elongate guide, wherein the coupling region is configured to couple the implant to a delivery device so that the plurality of arms may be expanded or retracted relative to the elongate guide.

17. The implant of claim 16, wherein the coupling region comprises a threaded region.

18. The implant of claim 1, further comprising a first delivery device coupling region at a proximal end of the elongate guide and a second delivery device coupling region coupled to a proximal end of the plurality of arms, wherein the first delivery device coupling region and the second delivery device coupling region are each configured to couple the implant to a delivery device so that the plurality of arms may be expanded or retracted relative to the elongate guide.

19. The device of claim 1, wherein the silver-release driver comprises a battery.

20. The device of claim 1, wherein the silver-release driver comprises logic configured to provide pulsatile stimulation to drive release of the silver ions.

21. The device of claim 1, wherein the silver-release driver comprises a galvanic reactor metal.

22. The device of claim 1, further comprising a sampling member for taking a biopsy sample of the bone upon removal of the device.

23. An implant for insertion into a bone to treat infection, the implant having an expanded deployed configuration configured for long-term release of silver ions and a collapsed insertion configuration, the implant comprising:

an elongate outer housing having a plurality of channel windows along the length of the elongate body;

an inner treatment member comprising a plurality of radially-expandable arms configured to extend from the channel windows of the elongate outer body;

wherein each of the radially-expandable arms comprises a silver reservoir, and wherein the inner treatment member is axially slideable relative to the outer housing to expand the plurality of radially-expandable arms from the collapsed to the deployed configuration; and

a silver-release driver coupled to the reservoirs of silver to drive release of silver ions from each of the plurality of arms.

24. The implant of claim 23, wherein the plurality of radially-expandable arms are coated with silver.

25. The implant of claim 23, wherein the plurality of radially-expandable arms are formed of a material having sufficient stiffness to allow the arms to penetrate the target bone region when extended from the channel windows.

26. The implant of claim 25, wherein the inner treatment member is formed of a nickel titanium alloy.

27. The implant of claim 23, wherein the distal tips of the arms comprise chisel-shaped tissue-penetrating distal tips.

28. The implant of claim 23, further comprising a first applicator coupling region on a proximal end of the outer housing and a second applicator coupling region on the proximal end of the inner treatment member, wherein the coupling regions are configured to couple the implant to a delivery device so that the plurality of arms of the inner treatment member may be expanded or retracted relative to the outer housing.

29. An implant for insertion into a bone to treat infection, the implant having an expanded deployed configuration configured for long-term release of silver ions, the implant comprising:

a plurality of deflection arms having a first axially elongated delivery configuration and a second radially deflected delivery configuration, wherein each of the deflection arms comprises a silver reservoir, and wherein the deflection arms are further configured to slide axially relative to the other deflection arms to convert the deflection arm from the delivery configuration into the delivery configuration;

further wherein the plurality of deflection arms are adjacent to each other;

a deflection ramp on each deflection arm configured to convert an adjacent deflection arm from the delivery configuration to the deployed configuration as the adjacent deflection arm is moved axially against the deflection ramp; and

a silver-release driver coupled to the reservoirs of silver to drive release of silver ions from each of the plurality of deflection arms.

30. A system for treating osteomyelitis by inserting an implant configured for the long-term release of silver ions over a region of bone, the system comprising:

a silver-releasing implant having a collapsed insertion configuration and an expanded deployed configuration, the implant comprising;

a plurality of arms configured to extend from the implant, wherein each of the arms comprises a reservoir of silver configured to be released from the implant into the bone;

an elongate guide forming a plurality of deflection pathways for the arms, wherein the plurality of arms are movably coupled to the elongate guide so that the arms may be extended from the elongate guide at different locations and orientations when the implant is converted to the deployed configuration;

a first coupling member on a proximal end of the elongate guide configured for releasably coupling to a delivery device; and

a silver-release driver coupled to the reservoirs of silver to drive release of silver ions from each of the arms; and

a delivery device comprising;

an elongate insertion member having a distal coupling region configured to releasably couple with the first coupling member; and

an arm-extender member configured to couple with and extend the arms of the implant; and

a handle at a proximal end of the delivery device.

31. The system of claim 30, wherein the delivery device comprises a control on the distal end configured to control extension/retraction of the arms of the implant.

32. The system of claim 30, wherein the arm-extender of the delivery device comprises a coupling region at the distal end configured to releasably couple with a coupler on the plurality of arms.

33. The system of claim 30, wherein the arm-extender comprises a push rod.

34. The system of claim 30, wherein the arm-extender is slideably disposed within the elongate insertion member for extending or retracting the arms.

35. The system of claim 30, wherein the arm-extender is configured to separately engage one or a subset of the plurality of arms and to separately control extension or retraction of the one or a subset of arms.

36. The system of claim 30, further comprising a retriever configured to engage one or a subset of the plurality of arms and to engage the guide and to withdraw the arms from the bone, so that all or a portion of the implant can be withdrawn from the bone.

38. The method of claim 36, wherein the step of inserting comprises pre-forming passageways for the implant and the expanded arms.

39. The method of claim 35, wherein the step of inserting comprises inserting a passage forming implant having a plurality of expandable members to pre-form the passageways.

40. The method of claim 36, further comprising driving the arms of the implant through the bone by extending the arms from the implant, wherein the arms are sufficiently stiff and/or sharp to penetrate bone.

41. The method of claim 36, further comprising anchoring the implant in the bone.

42. The method of claim 36, wherein the step of releasing silver ions comprises applying energy to drive the release of ions.

43. The method of claim 36, wherein the step of releasing silver ions comprises applying less than 50 microAmps of power to release ions.

44. The method of claim 36, wherein the step of releasing silver ions comprises applying pulsatile energy to release ions.

45. The method of claim 36, wherein the step of releasing silver ions comprises applying energy in pulses to maintain the silver ion concentration above a minimum inhibitory concentration.

46. The method of claim 36, wherein the step of releasing silver ions comprises releasing silver ions to maintain the silver ion concentration above a minimum inhibitor concentration in the region of the bone surrounding the implant for a period of at least one week.

47. The method of claim 36, wherein the step of releasing silver ions comprises releasing silver ions to maintain the silver ion concentration above a minimum inhibitor concentration in the region of the bone surrounding the implant for a period of at least one month.

48. The method of claim 36, wherein the step of releasing silver ions comprises releasing silver ions to maintain the silver ion concentration above a minimum inhibitor concentration in the region of the bone surrounding the implant for a period of between about one day and six months.

49. The method of claim 36, wherein the step of inserting comprises inserting the implant with a delivery device configured to hold one region of the implant while longitudinally moving another region of the implant to extend the arms.

50. The method of claim 36, wherein the step of removing comprises removing the implant with a delivery device configured to secure a proximal region of the implant while longitudinally moving another region of the implant to contract the arms.

51. The method of claim 36, further comprising sampling the tissue when removing the implant.

52. The method of claim 36, further comprising sampling the tissue using a sampling member on the implant when removing the implant.

37. A method of treating infection in a bone, the method comprising:

inserting a silver-releasing implant into a bone in a collapsed configuration;

expanding a plurality of arms from the implant into the bone from the collapsed configuration into an expanded configuration wherein the expanded arms extend in a pattern having multiple pathways through the bone;

releasing silver ions from one or more silver reservoirs on the arms into the bone over an extended period of time at a sustained level; and

removing the implant after a predetermined period of time that is longer than a week.