Low temperature encapsulate welding

• US 8,704,124 B2
• Filed: 01/29/2010
• Issued: 04/22/2014
• Est. Priority Date: 01/29/2009
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Wilson, Darren James, Ritchey, Nicholas S., Taylor, Stephen James Guy
• Primary Examiner(s): Ross, Dana
• Assistant Examiner(s): WASAFF, JOHN SAMUEL
• Application Number:
  US13/146,988
• Publication Number:
  US 20120010709A1
• Time in Patent Office: 1,544 Days
• Field of Search: 219/121.64, 623/16.11, 295/921
• US Class Current: 219/121.64
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2002/30451 soldered or brazed or welded
• CPC Class Codes: A61F 2002/30668 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

A load-bearing medical implant is disclosed that includes a load-bearing structure with a cavity extending into the outer surface of the structure. The cavity accommodates a sensor that is held in a fixed position within the cavity by an encapsulant. The cavity is covered by a plate that is welded over the cavity in close proximity to the sensor and encapsulant to provide a seal over the cavity and the electronic component without causing thermal damage to the encapsulant or sensor despite the close proximity of the encapsulant and sensor to the welded areas of the plate and structure. Methods for encapsulating the sensor in the cavity, methods for encapsulating a wire bus leading from the sensor through a channel in the implant and methods for pulsed laser welding of weld plate over the sensor and encapsulant with thermal damage to either are disclosed.

Claims

1. A method for hermetically sealing an electronic component in a load-bearing implant, the method comprising:

providing a load-bearing implant with a cavity for accommodating the electronic component, the load-bearing implant defining an inner bore;

providing a weld plate configured to cover the cavity with an offset margin extending around a periphery of the cavity;

encapsulating the electronic component in the cavity within an encapsulant;

curing the encapsulant at a first temperature;

heat treating the cured encapsulant to a second temperature;

placing a heat sink in the inner bore of the load-bearing implant; and

while the heat sink is located in the inner bore of the load-bearing implant, welding the weld plate over the cavity along the offset margin so the weld plate provides a seal over the cavity.

2. The method of claim 1 wherein providing the load-bearing implant comprises providing an implant defining a channel in an outer surface, the channel extending from the cavity and along the outer surface of the implant, the electronic component is connected to at least one wire, the at least one wire extends through the channel;

wherein the encapsulating comprises forming a barrier that prevents body fluids from entering the cavity and reaching the electronic component; and

wherein the welding comprises welding the weld plate over at least a portion of the channel as well as the cavity without causing thermal damage to the encapsulant.

3. The method of claim 2 wherein the encapsulating comprises encapsulating the electronic component in the cavity within a silicone encapsulant that is temperature stable below about 150°

C.; and

wherein the welding comprises welding the weld plate over the cavity and the channel such that the welding of the weld plate does not result in temperatures of the encapsulant reaching 150°

C. or above.

4. The method of claim 3 wherein the encapsulating comprises filling the channel and the cavity with the silicone encapsulant without leaving void spaces.

5. The method of claim 3 wherein the encapsulating comprises encapsulating the electronic component in the cavity within a two-component silicone.

6. The method of claim 1 wherein the welding comprises welding the weld plate over the cavity using pulsed laser energy in the range of from about 1 to about 3 J.

7. The method of claim 1 wherein the welding comprises welding the weld plate over the cavity using laser pulses having a duration of from about 2 to about 8 msec.

8. The method of claim 1 wherein the welding comprises welding the weld plate over the cavity using laser pulses repeated at a rate of from about 2 to about 8 Hz.

9. The method of claim 1 wherein the welding comprises welding the weld plate over the cavity using a traverse speed in the range of from about 50 to about 150 mm/min.

10. The method of claim 1 wherein the welding comprises overlapping weld spots generated by a pulsed laser by an amount ranging from about 35 to about 80%.

11. The method of claim 1 wherein the welding comprises using a pulsed laser that generates weld spots having a weld penetration ranging from about 40 to about 85%.

12. The method of claim 1 wherein the welding comprises using a pulsed laser with welding parameters comprising a pulse energy of about 2 J, a pulse duration of about 5 msec, a pulse repetition of about 5 Hz and a traverse speed of about 100 mm/min.

13. The method of claim 1 wherein the welding comprises using a pulsed laser with welding parameters comprising a pulse energy of about 2 J, a pulse duration of about 5 msec, a pulse repetition of about 5 Hz, a traverse speed of about 100 mm/min, a weld overlap ranging from about 35 to about 80%, and a weld penetration ranging from about 40 to about 85%.

14. The method of claim 1 wherein providing the load-bearing implant comprises providing a load-bearing implant in which an outer surface defining the cavity is metallic.

15. The method of claim 1 further comprising coupling a second heat sink to the implant.

16. The method of claim 15 wherein coupling the second heat sink to the implant comprises coupling to the implant a heat sink comprising an external sleeve with an aperture that surrounds the cavity and the offset margin.

17. The method of claim 1 wherein the second temperature is greater than the first temperature.

18. The method of claim 1, wherein providing the load-bearing implant comprises providing a load-bearing implant having a proximal end, a distal end, and an outer surface that extends along a longitudinal extent of the load-bearing implant between the proximal end and the distal end, the cavity having an opening defined in the outer surface, the opening extending along a portion of the longitudinal extent of the load-bearing implant;

and

wherein welding the weld plate over the cavity comprises welding the weld plate over the opening of the cavity.

19. The method of claim 18, wherein providing the load-bearing implant comprises providing a load-bearing implant defining a longitudinal channel in the outer surface adjacent the opening of the cavity;

and

wherein welding the weld plate comprises welding the weld plate over the opening of the cavity and a portion of the channel along the offset margin without causing substantial thermal damage to the encapsulant, the weld plate forming a seal over the cavity and the portion of the channel.

20. The method of claim 18, wherein providing the load-bearing implant comprises providing an intramedullary nail that defines the channel in the outer surface from the opening of the cavity to the proximal end of the intramedullary nail.

21. The method of claim 1, further comprising, after encapsulating the electronic component in the cavity within the encapsulant, placing a clamp configured to mold a surface of the encapsulant over the opening of the cavity;

and

wherein curing the encapsulant comprises curing the encapsulant with the clamp located over the opening of the cavity.

22. The method of claim 1, further comprising, after encapsulating the electronic component in the cavity within the encapsulant and before curing the encapsulant:

placing the load-bearing implant in a pressurization chamber; and

performing one or more vacuum cycles that decrease the pressure in the pressurization chamber below atmospheric pressure.

23. The method of claim 1, further comprising, after encapsulating the electronic component in the cavity within the encapsulant and before curing the encapsulant:

placing the load-bearing implant in a pressurization chamber; and

performing one or more pressurization cycles that increase pressure in the pressurization chamber above atmospheric pressure.

24. A method for hermetically sealing an electronic component in a load-bearing implant, the method comprising:

providing a load-bearing implant with a cavity for accommodating the electronic component, the cavity having a length, a width, and a depth, wherein the length is greater than the width and the depth;

providing a weld plate configured to cover the cavity with an offset margin extending around a periphery of the cavity;

encapsulating the electronic component in the cavity within a silicone encapsulant;

curing the silicone encapsulant at a first temperature;

heat treating the cured silicone encapsulant to a second temperature; and

welding the weld plate over the cavity at the offset margin in a direction along the length of the cavity to form a seal over the cavity.

26. The method of claim 24, wherein providing the load-bearing implant comprises providing an orthopaedic implant defining a proximal opening, a distal opening, and an interior cannulation extending from the proximal opening to the distal opening, the orthopaedic implant having a wall disposed between the interior cannulation and an outer surface of the orthopaedic implant, wherein the cavity is positioned in and defined in part by the outer surface and the wall of the orthopaedic implant and is disposed between the proximal opening and the distal opening;

and

wherein welding the weld plate over the cavity comprises welding along the offset margin at locations between the proximal opening and the distal opening.

27. The method of claim 24, further comprising selecting welding parameters for achieving a weld penetration within a predetermined range;

wherein welding the weld plate over the cavity comprises applying pulsed laser energy along the offset margin according to the selected welding parameters to create a weld having a weld penetration within the predetermined range.

28. The method of claim 27, wherein selecting the welding parameters comprises selecting parameters that achieve a weld penetration between 30% and 85%, the selected parameters including a pulse energy, a pulse duration, and a weld overlap.

29. The method of claim 28, wherein selecting the welding parameters comprises:

selecting a pulse energy between about 1 J to about 3 J;

selecting a pulse duration between about 2 milliseconds and about 8 milliseconds; and

selecting a weld overlap between about 35% and 80%.

30. The method of claim 24, further comprising, while welding the weld plate over the cavity, applying a shield gas to the load-bearing implant or the weld plate.

31. The method of claim 30, wherein applying a shield gas to the load-bearing implant comprises applying the shield gas at a rate between about 10 liters/minute to about 30 liters/minute at a pressure between about 2 bar to about 4 bar.

25. A method for hermetically sealing an electronic component in a load-bearing implant, the method comprising:

providing a load-bearing implant with a cavity for accommodating the electronic component;

providing a weld plate configured to cover the cavity with an offset margin extending around a periphery of the cavity;

encapsulating the electronic component in the cavity within an encapsulant;

after encapsulating the electronic component in the cavity within the encapsulant, subjecting the load-bearing implant to (i) one or more vacuum cycles that expose the load-bearing implant to pressure below atmospheric pressure, or (ii) one or more pressurization cycles that expose the load-bearing implant to pressure above atmospheric pressure;

curing the encapsulant at a first temperature;

heat treating the cured encapsulant to a second temperature; and

welding the weld plate over the cavity along the offset margin so the weld plate provides a seal over the cavity.