DMLS ORTHOPEDIC INTRAMEDULLARY DEVICE AND METHOD OF MANUFACTURE

• US 20170027624A1
• Filed: 04/10/2015
• Published: 02/02/2017
• Est. Priority Date: 04/11/2014
• Status: Abandoned Application

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Wilson, Darren James, Harness, David Bradford, Faber, Henry
• Application Number:
  US15/302,899
• Publication Number:
  US 20170027624A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: B22F 10/28 Powder bed fusion, e.g. selective laser melting [SLM] or electron beam melting [EBM]
• CPC Class Codes: B22F 10/364 for post-heating, e.g. remelting
• CPC Class Codes: B22F 10/366 Scanning parameters, e.g. hatch distance or scanning strategy
• CPC Class Codes: B22F 10/64 by thermal means control of energy beam parameters for post heating B22F10/364
• CPC Class Codes: B22F 10/66 by mechanical means
• CPC Class Codes: B22F 2003/247 Removing material: carving, cleaning, grinding, hobbing, honing, lapping, polishing, milling, shaving, skiving, turning the surface
• CPC Class Codes: B22F 2003/248 Thermal after-treatment
• CPC Class Codes: B22F 2998/00 Supplementary information concerning processes or compositions relating to powder metallurgy
• CPC Class Codes: B22F 2998/10 Processes characterised by the sequence of their steps
• CPC Class Codes: B22F 3/15 Hot isostatic pressing
• CPC Class Codes: B22F 5/10 of articles with cavities or holes, not otherwise provided for in the preceding subgroups
• CPC Class Codes: B23K 26/08 Devices involving relative movement between laser beam and workpiece
• CPC Class Codes: B23K 26/103 the laser beam rotating around the fixed workpiece B23K26/28 takes precedence
• CPC Class Codes: B23K 26/354 by melting
• CPC Class Codes: B24C 1/086 Descaling; Removing coating films
• CPC Class Codes: B33Y 10/00 Processes of additive manufacturing
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: C22C 14/00 : Alloys based on titanium
• CPC Class Codes: C22F 1/183 : of titanium or alloys based thereon
• CPC Class Codes: Y02P 10/25 : Process efficiency

Abstract

An orthopedic device, such as an intramedullary nail for internal fixation of a bone and a method of manufacturing the same. The orthopedic device may be formed from a medical grade powder via an additive manufacturing process. The forming process may include heat treating the additive manufactured component and machining the heat treated additive manufactured component to form the orthopedic device. Further, the orthopedic device may be formed to include an internal sensor probe channel that extends within at least a portion of the wall of the device, but which does not protrude through an outer portion of the wall. Embodiments further include a dynamizing intramedullary nail that accommodate adjustments in the relative axial positions of one or more sections of the orthopedic device. The devise may include features in an inner region of the orthopedic device that may alter an elastic modulus of the orthopedic device.

Claims

1-21. -21. (canceled)

22. An intramedullary nail, comprising:

a wall comprising one or more laser sintered layers of a medical grade powder, the wall having an outer portion and an inner portion, the inner portion generally defining an inner region of the intramedullary nail; and

an internal sensor probe channel that extends into at least a portion of the wall, the internal sensor probe channel not extending through the outer portion of the wall.

23. The intramedullary nail of claim 22, wherein the internal sensor probe channel is sized to receive insertion of a sensor probe that is configured for intra-operative screw hole targeting.

24. The intramedullary nail of claim 23, wherein at least a portion of the internal sensor probe channel is generally parallel to, and does not extend through, the inner portion of the wall.

25. The intramedullary nail of claim 24, wherein the internal sensor probe channel is not in fluid communication with an aperture that is configured to remove un-sintered medical grade powder from the intramedullary nail.

26. The intramedullary nail of claim 22, wherein at least a portion of the inner portion includes a tapered inner wall.

27. The intramedullary nail of claim 26, wherein the tapered inner wall extends between a distal hole screw and a proximal hole screw of the intramedullary nail.

28. An intramedullary nail, comprising:

a first section coupled to a second section by a telescopic portion, the telescopic portion having an outer diameter sized to be slidingly received in an inner region of at least one of the first and second sections to accommodate adjustments in a relative axial position of the first and second sections, the first and second sections structured for implantation into a bone; and

an actuator adapted to provide a biasing force to bias the relative axial positions of the first and second sections.

29. The intramedullary nail of claim 28, wherein the telescopic portion is and end portion of either the first section or the second section.

30. The intramedullary nail of claim 28, wherein the telescopic portion is a sleeve that is positioned in the inner regions of both the first and second sections, the sleeve being adapted to accommodate axial displacement of both the first and second sections relative to the sleeve.

31. The intramedullary nail of claim 28, further comprising one or more protrusions that limit at least the relative axial displacement of the first and second sections.

32. The intramedullary nail of claim 28, wherein one of the telescopic portion and the inner region of either or both of the first and second sections include one or more flutes that are each received in a mating recess in the other of the telescopic portion and the inner region of either or both of the first and second sections, the one or more flutes and the mating recess structured to prevent rotational displacement of the first section relative to the second section.

33. The intramedullary nail of claim 28, wherein the actuator is a non-linear or variable rate spring.

34. The intramedullary nail of claim 28, wherein the actuator is embedded in a degradable polymer, the degradable polymer adapted to release, as the degradable polymer degrades, a bioactive agent that is structured to stimulate healing of a fracture of the bone and/or prevent infection in the bone.

35. The intramedullary nail of claim 34, wherein the degradable polymer is structured to provide a force to maintain the actuator in one of an expanded or compressed state until the degradable polymer degrades to a degree in which the biasing force of the actuator can overcome the force of the degradable polymer.

36. The intramedullary nail of claim 34, wherein the degradable polymer is adapted to at least partially degrade upon application of an external physical energy source to the degradable polymer.

37. The intramedullary nail of claim 28, wherein the actuator is an elastomeric bushing.

38. The intramedullary nail of claim 28, further comprising a collar positioned about at least a portion of the telescopic section, the collar being selectively adjustable between a first size and a second, smaller size to alter a compressive state of the actuator.

39. The intramedullary nail of claim 38, wherein the collar is a shape memory material that is adjusted between the first and second sizes by the application and removal of an activation energy source.

40. The intramedullary nail of claim 39, wherein the activation energy source is at least one of a threshold body temperature and a received electronic voltage.

41. The intramedullary nail of claim 28, wherein the actuator comprises a first spring and a second spring that are each positioned in a slot in the intramedullary nail, the first spring encapsulated in a first resorbably housing, the second spring encapsulated in a second resorbable housing, the first resorbable housing and the second resorbably housing exerting opposing forces on an intermediary element that is positioned between the first resorbable housing and the second resorbable housing.

42. The intramedullary nail of claim 28, wherein the first and second portions each include a wall having an outer portion and an inner portion, and wherein the wall of at least one of the first and second portions includes an internal sensor probe channel that extends into at least a portion of the wall and does not extend through the outer portion of the wall.

43. The intramedullary nail of claim 28, wherein the first and second portions each comprise one or more laser sintered layers of a medical grade powder.

44. The intramedullary nail of claim 43, wherein the medial grade powder is at least a grade 5 powder.

45. The intramedullary nail of claim 44, wherein the medical grade powder is a TiAl6V4 powder.

46. The intramedullary nail of claim 45, wherein the one or more laser sintered layers have been subjected to a heat treatment process.

47. The intramedullary nail, comprising:

a wall having an outer portion and an inner portion, the inner portion generally defining an inner region of the intramedullary nail;

a first screw hole and a second screw hole, the first and second screw holes extending through at least the outer portion of the wall; and

one or more protrusions in the wall between the first and second screw holes, the one or more protrusions not extending through the outer portion of the wall, the one or more protrusions structured to selectively alter an elastic modulus of the intramedullary nail.

48. The intramedullary nail of claim 47, wherein the one or more protrusions comprise one or more flutes that extend into the wall from the inner portion.

49. The intramedullary nail of claim 47, wherein the one or more protrusions comprise a plurality of channels that extend within an inner ware of the wall, the plurality of channels not extending through the inner and outer portions of the wall.

50. The intramedullary nail of claim 49, wherein at least some of the plurality of channels have a cylindrical configuration.

51. The intramedullary nail of claim 50, wherein the plurality of channels are generally parallel to a longitudinal axis of the intramedullary nail.

52. The intramedullary nail of claim 47, wherein the wall comprises one or more laser sintered layers of a medical grade powder.

53. The intramedullary nail of claim 52, wherein the medial grade powder is at least a grade 5 powder.

54. The intramedullary nail of claim 53, wherein the medical grade powder is a TiAl6V4 powder.

55. The intramedullary nail of claim 54, wherein the one or more laser sintered layers have been subjected to a heat treatment process.

56. The intramedullary nail, comprising:

a first section having a wall, the wall generally defining an inner region of the first section; and

a second section coupled to an inner section, the inner section sized for lateral displacement in at least a portion of the inner region of the first section, the inner section being selectively detachable from the first section by a locking screw to alter an elastic modulus of the intramedullary nail.

57. The intramedullary nail of claim 56, wherein the first section, the second section, and the inner section each comprises one or more laser sintered layers of a medical grade powder.

58-60. -60. (canceled)