Safety adaptor for temporary medical leads

• US 6,397,108 B1
• Filed: 04/03/2000
• Issued: 05/28/2002
• Est. Priority Date: 04/03/2000
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Moumane, Farid, Camps, Antoine N. J. M., Deruyver, Benoit, Cuisset, Bernardt, Landheer, Gert, Robinet, Jean
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/542,698
• Time in Patent Office: 785 Days
• Field of Search: 607/1,115,116 128/897 600/372
• US Class Current: 607/115
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

Safety adaptors for connecting external medical devices to lead connector elements of temporary medical leads extending percutaneously into a patient'"'"'s body are disclosed. The safety adaptors comprise a first member attached to but movable in respect of a second member. An elongated bore receives a lead proximal end segment and includes the lead connector elements.

Claims

1. A safety adaptor for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body, comprising:

an elongated first member having an elongated bore extending between a first member first end and a first member second end for receiving a lead proximal end segment including the lead connector element upon insertion of the lead proximal end segment therein through the first member first end;

a second member having a breech for receiving the first member and the proximal end segment, the second member having at least one breech connector terminal located in the breech for making electrical contact with the at least one lead connector element within the elongated bore upon moving the first member into the breech; and

a hinge coupled between the first member and the second member to enable movement of the first member with respect to the second member between an open position wherein the lead proximal end is insertable into the elongated bore of the first member and a closed position wherein the at least one connector element is brought into contact with the at least one breech connector terminal such that the at least one connector element is electrically isolated within the safety adaptor.

2. The safety adaptor of claim 1, wherein the first member has an first member length between the first member first end and second end, the second member has an second member length between the second member first end and the second member second end, and the breech has a breech length shorter than the second member length and sufficient to receive the first member length in the closed position such that the second end of the first member is not exposed in the closed position.

3. The safety adaptor of claim 1 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle attached to the lead proximal end, wherein:

the elongated bore extends through a needle exiting opening of the first member second end, such that the percutaneous penetration needle is extended through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle.

4. The safety adaptor of claim 1 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle with a weakened zone attached to the lead proximal end, wherein:

a fulcrum is formed at the first member second end; and

the elongated bore extends through a needle exiting opening of the first member second end, such that the percutaneous penetration needle is extended through the needle exiting opening and the weakened zone is positioned in working relation with the fulcrum upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle by use of the fulcrum.

5. The safety adaptor of claim 1, wherein the second member further comprises:

an external safety adaptor connector located at the second member second end configured to connect with an external medical device connector or a cable; and

a safety adaptor conductor extending between the external safety adaptor connector and the breech electrical terminal.

6. The safety adaptor of claim 5, further comprising a lock mechanism that engages upon connection of the external safety adaptor connector located at the second member second end with an external medical device connector or a cable to prevent the movement of the first member from the closed position.

7. The safety adaptor of claim 1, further comprising a lock mechanism that engages upon movement of the first member into the closed position to prevent the movement of the first member from the closed position.

8. The safety adaptor of claim 1, wherein;

the first member is formed with at least one cut-out section along the elongated bore that exposes a portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore; and

the at least one breech electrical terminal is formed in a shape and located to engage the exposed portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore when the first member is moved into the breech.

9. The safety adaptor of claim 1, wherein:

the first member comprises an elongated adaptor arm, the first member first end is an adaptor arm free end, the first member second end is a an adaptor arm hinged end, and the elongated bore extends between a lead insertion bore end formed in the adaptor arm hinged end and the adaptor arm free end;

the second member comprises an elongated adaptor body, the second member first end is an adaptor body free end, and the second member second end is a an adaptor body hinged end; and

a hinge connects the adaptor body hinged end and the adaptor arm hinged end to enable movement of the adaptor arm from the open position to the closed position such that the elongated adaptor arm is fitted into the breech of the adaptor body.

10. The safety adaptor of claim 9, wherein the adaptor arm has an adaptor arm length between the adaptor arm hinged end and free end, the adaptor body has an adaptor body length between the adaptor body hinged end and the adaptor body free end, and the breech has a breech length shorter than the adaptor body length and sufficient to receive the adaptor arm length in the closed position such that the free end of the adaptor arm is not exposed in the closed position.

11. The safety adaptor of claim 9, further comprising a lock mechanism that engages upon movement of the adaptor arm into the closed position to prevent the movement of the adaptor arm from the closed position.

12. The safety adaptor of claim 9 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle attached to the lead proximal end, wherein:

the elongated bore extends through a needle exiting opening of the adaptor arm free end, such that the percutaneous penetration needle is extended through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle.

13. The safety adaptor of claim 9 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle with a weakened zone attached to the lead proximal end, wherein:

a fulcrum is formed at the adaptor arm free end; and

the elongated bore extends through a needle exiting opening of the adaptor arm free end, such that the percutaneous penetration needle is extended through the needle exiting opening and the weakened zone is positioned in working relation with the fulcrum upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle by use of the fulcrum.

14. The safety adaptor of claim 9, wherein the adaptor body further comprises:

an external safety adaptor connector located at the adaptor body free end configured to connect with an external medical device connector or a cable; and

a safety adaptor conductor extending between the external safety adaptor connector and the breech electrical terminal.

15. The safety adaptor of claim 14, further comprising a lock mechanism that engages upon connection of the external safety adaptor connector located at the adaptor body free end with an external medical device connector or a cable to prevent the movement of the adaptor arm from the closed position.

16. The safety adaptor of claim 9, wherein;

the adaptor arm is formed with at least one cut-out section along the elongated bore that exposes a portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore; and

the at least one breech electrical terminal is formed in a U-shape and located to engage the exposed portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore when the adaptor arm is moved into the breech.

17. The safety adaptor of claim 1, wherein:

the first member comprises an elongated adaptor door having door sides extending between adaptor door first and second ends;

the second member comprises an elongated adaptor body having a door frame surface against which the adaptor door closes in the closed position; and

a hinge extends between the adaptor body door frame and an adaptor door side to enable movement of the adaptor door from the open position to the closed position, such that the elongated adaptor door is fitted into the breech of the adaptor body and against the door frame surface.

18. The safety adaptor of claim 17, wherein the adaptor door has an adaptor door length between the adaptor door first end and second end, the adaptor body has an adaptor body length between the adaptor body first end and the adaptor body second end, and the breech has a breech length shorter than the adaptor body length and sufficient to receive the adaptor door length in the closed position such that the second end of the adaptor door is not exposed in the closed position.

19. The safety adaptor of claim 17 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle attached to the lead proximal end, wherein:

the elongated bore extends through a needle exiting opening of the adaptor door second end, such that the percutaneous penetration needle is extended through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle.

20. The safety adaptor of claim 17, further comprising a lock mechanism that engages upon movement of the adaptor door into the closed position to prevent the movement of the adaptor door from the closed position.

21. The safety adaptor of claim 17 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle with a weakened zone attached to the lead proximal end, wherein:

a fulcrum is formed at the adaptor door second end; and

the elongated bore extends through a needle exiting opening of the adaptor door second end, such that the percutaneous penetration needle is extended through the needle exiting opening and the weakened zone is positioned in working relation with the fulcrum upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle by use of the fulcrum.

22. The safety adaptor of claim 17, wherein the adaptor body further comprises:

an external safety adaptor connector located at the adaptor body second end configured to connect with an external medical device connector or a cable; and

a safety adaptor conductor extending between the external safety adaptor connector and the breech electrical terminal.

23. The safety adaptor of claim 22, further comprising a lock mechanism that engages upon connection of the external safety adaptor connector located at the adaptor body second end with an external medical device connector or a cable to prevent the movement of the adaptor door from the closed position.

24. The safety adaptor of claim 17, wherein;

the adaptor door is formed with at least one cut-out section along the elongated bore that exposes a portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore; and

the at least one breech electrical terminal is formed in a U-shape and located to engage the exposed portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore when the adaptor door is moved into the breech.

25. A method of using a safety adaptor having a first member and a second member for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body wherein a hinge between the first member and the second member enables movement of the first member with respect to the second member between an open position enabling the insertion of the lead proximal end into an elongated bore of the first member and a closed position enabling contact between the at least one connector element and at least one breech connector terminal, comprising:

inserting a lead proximal end segment including the lead connector element into the elongated bore of the first member, the elongated bore extending between a first member first end and a first member second end;

moving the first member into a breech of the second member that receives the first member and the proximal end segment;

making electrical contact between the at least one lead connector element within the elongated bore and the at least one breech connector terminal located in the breech upon moving the first member into the breach of the second member, such that the at least one connector element is electrically isolated within the safety adaptor; and

electrically coupling the safety adaptor to the external medical device.

26. The method of claim 25, wherein the first member has an first member length between the first member first end and second end, the second member has an second member length between the second member first end and the second member second end, and the breech has a breech length shorter than the second member length and sufficient to receive the first member length in the closed position such that the second end of the first member is not exposed in the closed position.

27. The method of claim 25 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle attached to the lead proximal end, wherein:

the elongated bore extends through a needle exiting opening of the first member second end, and

the inserting step further comprises;

extending the percutaneous penetration needle through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle; and

removing the percutaneous penetration needle.

28. The method of claim 25 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle with a weakened zone attached to the lead proximal end, wherein:

a fulcrum is formed at the first member second end; and

the elongated bore extends through a needle exiting opening of the first member second end; and

the inserting step further comprises;

extending the percutaneous penetration needle through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore such that the weakened zone is positioned in working relation with the fulcrum to enable removal of the percutaneous needle; and

removing the percutaneous penetration needle by bending the weakened zone against the fulcrum until the weakened zone breaks.

29. The method of claim 25, wherein the second member further comprises:

an external safety adaptor connector located at the second member second end configured to connect with an external medical device connector or a cable; and

a safety adaptor conductor extending between the external safety adaptor connector and the breech electrical terminal; and

wherein;

the electrically coupling step further comprises connecting the external safety adaptor connector with an external medical device connector.

30. The method of claim 29, wherein the electrically coupling step further comprises

locking the first member in the closed position upon connection of the external safety adaptor connector with an external medical device connector to prevent the movement of the first member from the closed position.

31. The method of claim 25, further comprising;

locking the first member in the closed position upon movement of the first member into the closed position to prevent the movement of the first member from the closed position.

32. The method of claim 25, wherein;

the inserting step further comprises exposing a portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore; and

the contacting step further comprises engaging the exposed portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore against the at least one breech electrical terminal when the first member is moved into the breech.

33. The method of claim 25, wherein:

the first member comprises an elongated adaptor arm, the first member first end is an adaptor arm free end, the first member second end is an adaptor arm hinged end, and the elongated bore extends between a lead insertion bore end formed in the adaptor arm hinged end and the adaptor arm free end;

the second member comprises an elongated adaptor body, the second member first end is an adaptor body free end, and the second member second end is a an adaptor body hinged end;

a hinge connects the adaptor arm hinged end to the adaptor body hinged end; and

the moving step comprises pivoting the adaptor arm about the hinge from the open position to the closed position such that the elongated adaptor arm is fitted into the breech of the adaptor body.

34. The method of claim 33, wherein the adaptor arm has an adaptor arm length between the adaptor arm hinged end and free end, the adaptor body has an adaptor body length between the adaptor body hinged end and the adaptor body free end, and the breech has a breech length shorter than the adaptor body length and sufficient to receive the adaptor arm length in the closed position such that the free end of the adaptor arm is not exposed in the closed position.

35. The method of claim 33, further comprising:

locking the adaptor arm in the closed position upon movement of the adaptor arm into the closed position to prevent the movement of the adaptor arm from the closed position.

36. The method of claim 33 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle attached to the lead proximal end, wherein:

the elongated bore extends through a needle exiting opening of the adaptor arm free end; and

the inserting step further comprises;

extending the percutaneous penetration needle through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle; and

removing the percutaneous penetration needle.

37. The method of claim 33 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle with a weakened zone attached to the lead proximal end, wherein:

a fulcrum is formed at the adaptor arm free end; and

the elongated bore extends through a needle exiting opening of the adaptor arm free end; and

the inserting step further comprises;

extending the percutaneous penetration needle through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore to position the weakened zone in working relation with the fulcrum enable removal of the percutaneous needle; and

removing the percutaneous penetration needle by bending the weakened zone against the fulcrum until the weakened zone breaks.

38. The method of claim 33, wherein the adaptor body further comprises:

an external safety adaptor connector located at the adaptor body free end configured to connect with an external medical device connector or a cable; and

a safety adaptor conductor extending between the external safety adaptor connector and the breech electrical terminal; and

wherein;

the electrically coupling step further comprises connecting the external safety adaptor connector with an external medical device connector.

39. The method of claim 38, wherein the electrically coupling step further comprises locking the adaptor arm in the closed position upon connection of the external safety adaptor connector with an external medical device connector to prevent the movement of the adaptor arm from the closed position.

40. The method of claim 33, wherein;

the inserting step further comprises exposing a portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore; and

the contacting step further comprises engaging the exposed portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore against the at least one breech electrical terminal when the adaptor arm is moved into the breech.

41. The method of claim 40, further comprising:

locking the adaptor arm in the closed position upon movement of the adaptor arm into the closed position to prevent the movement of the adaptor arm from the closed position.

42. The method of claim 25, wherein:

the first member comprises an elongated adaptor door having door sides extending between adaptor door first and second ends;

the second member comprises an elongated adaptor body having a door frame surface against which the adaptor door closes in the closed position;

a hinge extends between the adaptor body door frame and an adaptor door side; and

the moving step comprises pivoting the adaptor door about the hinge from the open position to the closed position such that the elongated adaptor door is fitted into the breech of the adaptor body and against the door frame surface.

43. The method of claim 42, wherein the adaptor door has an adaptor door length between the adaptor door first end and second end, the adaptor body has an adaptor body length between the adaptor body first end and the adaptor body second end, and the breech has a breech length shorter than the adaptor body length and sufficient to receive the adaptor door length in the closed position such that the second end of the adaptor door is not exposed in the closed position.

44. The method of claim 42, further comprising

locking the adaptor door in the closed position upon movement of the adaptor door into the closed position to prevent the movement of the adaptor door from the closed position.

45. The method of claim 42 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle attached to the lead proximal end, wherein:

the elongated bore extends through a needle exiting opening of the adaptor door second end; and

the inserting step further comprises;

extending the percutaneous penetration needle through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore to enable removal of the percutaneous needle; and

removing the percutaneous penetration needle.

46. The method of claim 42 particularly adapted for connecting an external medical device to at least one lead connector element of a medical lead extending percutaneously into a patient'"'"'s body and having a percutaneous penetration needle with a weakened zone attached to the lead proximal end, wherein:

the elongated bore extends through a needle exiting opening of the adaptor door second end;

a fulcrum is formed at the adaptor door second end; and

the inserting step further comprises;

extending the percutaneous penetration needle through the needle exiting opening upon insertion of the lead proximal end segment into the elongated bore to the position the weakened zone in working relation with the fulcrum enable removal of the percutaneous needle; and

removing the percutaneous penetration needle by bending the weakened zone against the fulcrum until the weakened zone breaks.

47. The method of claim 42, wherein the adaptor body further comprises:

an external safety adaptor connector located at the adaptor body second end configured to connect with an external medical device connector or a cable; and

a safety adaptor conductor extending between the external safety adaptor connector and the breech electrical terminal; and

wherein;

the electrically coupling step further comprises connecting the external safety adaptor connector with an external medical device connector.

48. The method of claim 47, wherein the electrically coupling step further comprises locking the adaptor arm in the closed position upon connection of the external safety adaptor connector with an external medical device connector to prevent the movement of the adaptor arm from the closed position.

49. The method of claim 42, wherein;

the inserting step further comprises exposing a portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore; and

the contacting step further comprises engaging the exposed portion of the circumference of the at least one lead connector element of the proximal end section of the lead disposed in the elongated bore against the at least one breech electrical terminal when the adaptor door is moved into the breech.

50. The method of claim 49, further comprising:

locking the adaptor door in the closed position upon movement of the adaptor door into the closed position to prevent the movement of the adaptor door from the closed position.