Setscrewless connector assembly for implantable medical devices

• US 5,951,595 A
• Filed: 05/06/1997
• Issued: 09/14/1999
• Est. Priority Date: 05/13/1996
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Acken, deceased, Alfred D., Rourke, Edward Gene, Moberg, Sheldon B., Truex, Buehl E., Stutz, William H. Jr., Nason, Clyde K.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/852,161
• Time in Patent Office: 861 Days
• Field of Search: 607/36-38, 439/909, 439/851, 439/838, 439/836, 439/816, 439/669, 439/668, 439/370, 439/371, 439/271-275
• US Class Current: 607/37
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: H01R 13/5224 for medical use
• CPC Class Codes: H01R 2107/00 Four or more poles
• CPC Class Codes: H01R 2201/12 for medicine and surgery
• CPC Class Codes: H01R 24/58 Contacts spaced along longitudinal axis of engagement
• CPC Class Codes: Y10S 439/909 Medical use or attached to human body

Abstract

A connector assembly mounted on an implantable cardiac stimulation device has an actuator mechanism for fixing and sealing electrical leads inserted into lead receptacles within the connector assembly without the use of setscrews. Fixing and sealing of the leads is accomplished by compressing resilient lead lock seals of O-ring shape, disposed in annular recesses, with lip portions of a plunger drawn toward the molded support by the actuator mechanism. In a first embodiment of the actuator mechanism, rotation of a cam actuator transversely journaled within the support, using a torque wrench or similar tool, moves a cam slide attached to the plunger through a fixed displacement between lock and unlock positions as an offset camming portion of the actuator engages the surfaces of a slot within the cam slide. In a second embodiment, constant-force compression of the lead lock seals by the plunger is provided by using a torque wrench to rotate a screw actuator having one end coupled to the plunger and an opposite threaded end received within a screw block transversely disposed within the support. In a third embodiment, a rotatable toothed pinion engages a toothed slot within a slidable rack to provide incremental advancement of the rack, and thereby stepped displacement and force, with a resulting increased resolution. In a fourth embodiment, compliance provided by either a spring formed within the cam slide, or a spring nut mounted thereon, prevents excessive force from being exerted on leads of larger diameter.

Claims

1. A connector assembly for an implantable medical device comprising:

a support having a pair of apertures therein;

a pair of connector bore assemblies coupled to and extending from the apertures in the support and adapted to make electrical contact with leads inserted therein;

a plunger movably coupled to the support and having a pair of apertures therein aligned with the apertures in the support, the pair of apertures in the support and the pair of apertures in the plunger combining with the pair of connector bore assemblies to define a pair of lead-receiving bores;

a pair of locking seals disposed within the lead-receiving bores; and

means for selectively moving the plunger relative to the support to compress the locking seals and thereby fix and form seals around leads disposed in the lead-receiving bores.

2. The connector assembly, as defined in claim 1, wherein the support is made of molded material, and further including a mass of epoxy extending from the support and encapsulating the pair of connector bore assemblies therein.

3. The connector assembly, as defined in claim 1, wherein each of the pair of apertures in the support has an annular recess therein adjacent the plunger for receiving one of the pair of locking seals therein, and the locking seals comprise ring-shaped seals of elastomeric material.

4. The connector assembly, as defined in claim 2, further including a fastener assembly on the support for mounting the support on an implantable medical device.

5. In an implantable medical device having electronic circuits within a sealed housing, a connector assembly disposed at the outside of the housing for receiving a first and second lead and for electrically coupling the first and second lead to the electronic circuits within the sealed housing, the connector assembly comprising:

a main body having a first and second receptacle adapted to receive the first and second leads;

sealing means, made of compressable material and disposed within the first and second receptacles, for providing a seal around each of the first and second leads;

compressing means for compressing the sealing means around the first and second leads, thereby forming a first and a second fluid-tight seal, respectively; and

actuating means, coupled to the compressing means, for selectively locking and unlocking the first and second leads in place.

6. The connector assembly, as defined in claim 5, wherein the compressing means comprises:

a plunger, coupled to the main body, having bi-directional movement along a central axis of the lead; and

wherein the plunger simultaneously compresses both the first and the second leads within the first and second receptacles, respectively.

7. The connector assembly, as defined in claim 6, wherein:

the plunger has a shape that mates with the main body and further forms a portion of the connector assembly.

8. The connector assembly, as defined in claim 6, wherein the actuating means is responsive to a torquing force.

9. The connector assembly, as defined in claim 8, wherein:

the main body comprises a slide aperture; and

the actuator means comprises a cam slide, located within the slide aperture, and a cam actuator rotatably coupled to the cam slide, the cam actuator translating a rotational force to a longitudinal force along the central axis onto the plunger to thereby force the plunger against the main body.

10. The connector assembly, as defined in claim 8, wherein:

the main body has a slide aperture generally parallel to the central axis and a cam aperture generally perpendicular to and intersecting the slide aperture;

the actuating means comprises an elongated cam slide, coupled to the plunger and slidably disposed within the slide aperture, and a cam actuator rotatably disposed within the cam aperture;

wherein the cam actuator is rotatable between a locking position, in which the sealing means engages and seals the lead, and an unlocking position, in which the sealing means is disengaged from the lead to permit removal of the lead from the lead receptacle.

11. The connector assembly, as defined in claim 8, wherein:

the main body comprises a rack aperture;

the actuator means comprises a rack located within the rack aperture and slidably coupled to the plunger, the rack further having a toothed slot therein, and a toothed pinion rotatably coupled within the toothed slot.

12. The connector assembly, as defined in claim 8, wherein:

the plunger includes a threaded recess adjacent the first and second lead receptacles; and

the actuating means comprises a threaded screw received within the threaded recess which provides a longitudinal force along the central axis onto the plunger to thereby force the plunger against the main body.

13. The connector assembly, as defined in claim 8, wherein:

the main body comprises a rack aperture generally parallel to the central axis, and a pinion aperture extending generally perpendicular to and intersecting the rack aperture; and

the actuator means comprising an elongated rack coupled to the plunger and slidably disposed within the rack aperture and having a toothed slot therein extending through the rack in a direction generally perpendicular to the central axis, and a toothed pinion rotatably disposed within the pinion aperture, the toothed pinion extending through the toothed slot in the rack.

14. The connector assembly, as defined in claim 13, wherein:

the toothed slot has a plurality of relatively large teeth on a bottom portion thereof and a plurality of relatively small teeth on a top portion thereof; and

the pinion has a plurality of teeth around a circumference thereof which mesh with the relatively large teeth on the bottom portion of the toothed slot and engage the relatively small teeth on the top portion of the toothed slot to define a plurality of stepped positions of the pinion as it rotates within the toothed slot.

15. The connector assembly, as defined in claim 13, wherein the toothed slot has a first end thereof defining a fully closed stopping position.

16. The connector assembly, as defined in claim 15, wherein the toothed slot has a second end thereof opposite the first end which defines a fully opened position, the second end being configured to allow the pinion to free spin with further rotation thereof when the pinion reaches the second end.

17. The connector assembly, as defined in claim 16, wherein the toothed slot has at least one intermediate stopping location along the rack which provides a stepped-force, so that a desired amount of force is exerted on the first and second leads.

18. The connector assembly, as defined in claim 16, wherein the toothed slot has a plurality of intermediate stopping locations along the rack, the plurality of intermediate stopping locations providing a higher resolution stepped-displacement and stepped-force, so that a desired amount of force is exerted on the first and second leads.

19. The connector assembly, as defined in claim 18, wherein:

the main body includes an annular recess; and

the sealing means comprises an annular seal made of elastomeric material, the annular seal being located within the annular recess.

20. The connector assembly, as defined in claim 19, wherein:

the compressing means includes a plunger axially movable relative to the annular recess and having an annular portion for engaging the annular seal; and

the actuation means includes a mechanism for moving the plunger to selected axial positions relative to the annular recess.

21. The connector assembly, as defined in claim 20, wherein the mechanism for moving the plunger is movable between a first position in which the seal engages the lead to fix the lead in place and form a seal there around and a second position in which the seal is disengaged from the lead to permit removal of the lead from the lead receptacle.

22. The connector assembly, as defined in claim 20, wherein the slide is mounted in the main body for sliding movement in a direction of elongation of the lead receptacle and has an aperture therein for receiving the offset cam.

23. The connector assembly, as defined in claim 22, wherein the slide has a resilient portion thereof for providing the mechanism with increased compliance.

24. In an implantable medical device having electronic circuits within a sealed housing, a connector assembly disposed at the outside of the housing for receiving a lead and for electrically coupling the lead to the electronic circuits within the sealed housing, the connector assembly comprising:

a main body having a receptacle adapted to receive the lead;

sealing means, made of compressable material and disposed within the receptacle, for sealing around the lead;

compressing means, dimensioned to mate with the main body, for compressing the sealing means around the lead; and

actuation means for selectively locking and unlocking the lead in place, the actuation means including a slide coupled to the compressing means and an offset cam rotatably coupled to the slide, wherein the offset cam causes the slide to exert a force between the compressing means and the main body so that the sealing means is compressed against the lead to form a fluid-tight seal.

25. The connector assembly, as defined in claim 24, wherein the screw extends in a direction of elongation of the receptacle, and is rotatably journaled within the compressing means and has a tool receiving receptacle mounted thereon.

26. In an implantable medical device having electronic circuits within a sealed housing, a connector assembly disposed at the outside of the housing for receiving a lead and for electrically coupling the lead to the electronic circuits within the sealed housing, the connector assembly comprising:

a main body having a receptacle, adapted to receive the lead, and a threaded recess adjacent the receptacle;

sealing means, made of compressable material and disposed within the receptacle, for sealing around the lead;

compressing means, dimensioned to mate with the main body, for compressing the sealing means around the lead; and

actuating means for selectively locking and unlocking the lead in place, the actuating means including a screw for engagement within the threaded recess and advancable and retractable therein, wherein the screw, when advanced, exerts a force between the compression means and the main body so that the sealing means is compressed against the lead to form a fluid-tight seal.

27. In an implantable medical device having electronic circuits within a sealed housing, a connector assembly disposed at the outside of the housing for receiving a lead and for electrically coupling the lead to the electronic circuits within the sealed housing, the connector assembly comprising:

a main body having a receptacle adapted to receive the lead;

sealing means, made of compressable material and disposed within the receptacle, for sealing around the lead;

compressing means, dimensioned to mate with the main body, for compressing the sealing means around the lead; and

actuating means for selectively locking and unlocking the lead in place, the actuating means including a rack and pinion assembly, coupled to the compression means, which exerts a force between the compression means and the main body so that the sealing means is compressed against the lead to form a fluid-tight seal.

28. The connector assembly, as defined in claim 27, wherein:

the compressing means comprises a plunger axially movable towards the main body, the plunger having an annular portion for engaging the sealing means;

the rack is disposed within a slide which is directly coupled to the plunger, wherein the pinion, when coupled to the rack, causes the slide to move towards the main body, thereby causing the annular portion of the plunger to compress the sealing means to the form a fluid-tight seal.

29. The connector assembly, as defined in claim 28, wherein:

the rack comprises a plurality of toothed slots which define a plurality of stepped positions for the pinion, wherein the pinion rotates within the plurality of toothed slots causes the slide to exert a step-wise increase in force between the plunger and the main body so that the sealing means is compressed to form a fluid-tight seal.

30. In an implantable medical device having electronic circuits within a sealed housing, a connector assembly disposed at the outside of the housing for receiving a lead and for electrically coupling the lead to the electronic circuits within the sealed housing, the connector assembly comprising:

a main body having a receptacle adapted to receive the lead;

sealing means, made of compressable material and disposed within the receptacle, for sealing around the lead;

compressing means, dimensioned to mate with the main body, for compressing the sealing means around the lead; and

actuating means, coupled to the compressing means, for selectively locking and unlocking the lead in place using a variable amount of displacement to accommodate a desired lead having a desired lead diameter;

whereby a substantially uniform force is exerted on the sealing means independent of lead diameter.

31. The connector assembly, as defined in claim 30, wherein:

the main body comprises a threaded recess adjacent the receptacle; and

the actuating means comprises a screw for engagement within the threaded recess and advancable and retractable therein, wherein the screw, when advanced by a torque wrench, exerts a force between the compression means and the main body so that the sealing means is compressed against the lead to form a fluid-tight seal, wherein the screw will be limited when a desired amount of force is delivered to the desired lead.

32. The connector assembly, as defined in claim 30, wherein:

the actuating means comprises a rack and pinion assembly, the rack being disposed within a slide which is coupled to the compression means, the rack having a plurality of toothed slots which define a plurality of stepped positions for the pinion, wherein the pinion, when coupled to the rack, rotates within the plurality of toothed slots causes the slide to exert a step-wise increase in force between the compression means and the main body so that the sealing means is compressed against the lead to form a fluid-tight seal;

wherein the pinion, when advanced by a torque wrench, will be limited when a desired amount of force is delivered to the desired lead.

33. The connector assembly, as defined in claim 30, wherein:

the actuating means comprises a slide coupled to the compressing means and an offset cam rotatably coupled to the slide, the slide further have a spring formed therein, wherein rotation of the offset cam causes a linear displacement on the slide, which displacement is varied by the spring to produce a substantially linear force between the compressing means and the main body, so that the sealing means is compressed against the lead to form a fluid-tight seal.

34. The connector assembly, as defined in claim 30, wherein:

the actuating means comprises a slide coupled to the compressing means and an offset cam rotatably coupled to the slide, the slide being coupled to a spring nut, wherein rotation of the offset cam causes a linear displacement on the slide, which displacement is varied by the spring nut to produce a substantially linear force between the compressing means and the main body, so that the sealing means is compressed against the lead to form a fluid-tight seal.

35. The connector assembly, as defined in claim 34, wherein the cam slide has a spring formed therein, the spring having a predetermined amount of compliance so that a constant displacement exerted on the slide produces a substantially linear force between the main body and the plunger.

36. The connector assembly, as defined in claim 34, wherein the cam slide is coupled to the plunger by a spring nut, the spring nut having a predetermined amount of compliance so that a constant displacement exerted on the slide produces a substantially linear force between the main body and the plunger.

37. The connector assembly, as defined in claim 34, wherein:

the cam slide has a cam aperture for receiving the cam actuator and a pair of limit surfaces on opposite sides of the cam aperture; and

the cam actuator has a lobe extending therefrom which engages the pair of limit surfaces to define lock and unlock positions.

38. The connector assembly, as defined in claim 34, wherein the cam actuator has an enlarged head at an end thereof disposed outside of a first side of the support and having a drive-tool-receiving recess therein, and further including an enlarged cam retainer mounted on an end of the cam actuator opposite the enlarged head and disposed outside of an opposite second side of the support.

39. The connector assembly, as defined in claim 38, wherein the drive-tool-receiving recess of the enlarged head is adapted to receive a torque wrench for rotatably driving the cam actuator.

40. A connector assembly for releasably fixing and sealing a lead for an implantable medical device, comprising:

a support having a receptacle and a bore assembly for receiving the lead, the bore assembly having at least one contact therein for making electrical contact with the lead when a lead is seated therein;

an annular seal of deformable material seated in the receptacle;

a plunger, coupled to the support, having means for compressing the annular seal, the plunger chamber combining with the support chamber and the bore assembly to form the lead receptacle; and

a cam slide, coupled to the plunger, and a cam actuator rotatably coupled to the cam slide, the cam actuator translating a rotational force to a longitudinal force onto the plunger to thereby force the plunger against the main body which selectively compresses the annular seal against the outside of a lead to thereby fix in place and seal around the lead.

41. The connector assembly, as defined in claim 40, wherein the screw has an enlarged keeper at the first end thereof, and further including a retainer clip disposed within the first aperture between the screw block and the keeper and having an aperture therein which receives a portion of the screw therein and which is smaller than the keeper.

42. The connector assembly, as defined in claim 40, wherein the enlarged driver has a drive-tool-receiving recess therein.

43. The connector assembly, as defined in claim 42, wherein the drive-tool-receiving recess of the enlarged driver is adapted to receive a torque wrench for rotatably driving the screw.

44. A connector assembly for releasably fixing and sealing a lead for an implantable medical device, comprising:

a support having a receptacle and a bore assembly for receiving the lead, the bore assembly having at least one contact therein for making electrical contact with the lead when a lead is seated therein, the support having a threaded screw block within a first aperture;

an annular seal of deformable material seated in the receptacle;

a plunger, coupled to the support, having means for compressing the annular seal, the plunger chamber combining with the support chamber and the bore assembly to form the lead receptacle, the plunger having a second aperture aligned with the first aperture of the support; and

a screw, rotatably disposed within the first and second apertures, having a threaded portion at a first end for connection with the screw block and an enlarged driver at a second end, wherein the enlarged driver, when rotated, selectively compresses the annular seal against the outside of a lead to thereby fix in place and seal around the lead.

45. The connector assembly, as defined in claim 44, wherein:

the toothed slot has a plurality of relatively large teeth on a bottom portion thereof and a plurality of relatively small teeth on a top portion thereof; and

the pinion has a plurality of teeth around a circumference thereof which mesh with the relatively large teeth on the bottom portion of the toothed slot and engage the relatively small teeth on the top portion of the toothed slot to define a plurality of stepped positions of the pinion as it rotates within the toothed slot.

46. The connector assembly, as defined in claim 45, wherein the toothed slot has a second end thereof opposite the first end which defines a closed position.

47. The connector assembly, as defined in claim 45, wherein the toothed slot has a first end thereof defining an open position configured to allow the pinion to free spin with further rotation thereof when the pinion reaches the first end.

48. The connector assembly, as defined in claim 47, wherein the rack has a thin, elongated upper portion thereof defining an upper portion of the toothed slot, the upper portion being separated from and being resiliently movable relative to an opposite lower portion of the rack defining a lower portion of the toothed slot.

49. The connector assembly, as defined in claim 48, wherein the upper and lower portions have nubs which engage walls of the rack aperture to limit separation of the upper portion from the lower portion when the pinion is moved from the end of the toothed slot.

50. A connector assembly for releasably fixing and sealing a lead for an implantable medical device, comprising:

a support having a receptical and a bore assembly for receiving the lead, the bore assembly having at least one contact therein for making electrical contact with the lead when a lead is seated therein;

an annular seal of deformable material seated in the receptical;

a plunger, coupled to the support, having means for compressing the annular seal, the plunger chamber combining with the support chamber and the bore assembly to form the lead receptacle;

an elongated slide, coupled to the plunger and slidably disposed within the support, having a rack with a toothed slot therein; and

a pinion, rotatably disposed within the toothed slot, wherein the pinion, when rotated, selectively compresses the annular seal against the outside of a lead to thereby fix in place and seal around the lead.