Ultrasonic septum monitoring for implantable medical devices

• US 20030204165A1
• Filed: 04/26/2002
• Published: 10/30/2003
• Est. Priority Date: 04/26/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Houben, Richard, Donders, Adrianus
• Granted Patent: US 6,740,076 B2
• Time in Patent Office: Days
• US Class Current: 604/93.01
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61M 2039/0244 having means for detecting an inserted needle
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

Methods and systems for monitoring the condition of a septum in an implantable medical device are disclosed. Monitoring of the septum provides the ability to determine whether a needle has pierced the septum to effect the transfer of fluids into or out of a reservoir in the implantable medical device. Septum monitoring may provide the ability to determine whether the septum is maintaining its ability to seal the reservoir against leakage. The systems of the present invention include an ultrasonic transducer acoustically coupled to the septum to emit ultrasonic energy directly into the septum. Insertion of a needle through the septum can be detected by the acoustical changes caused by the needle located within the septum.

Claims

1. A system for monitoring an implantable medical device comprising:

an implantable medical device that comprises;

a reservoir defining a volume, the reservoir comprising an opening formed therein;

a septum attached to the reservoir, the septum sealing the opening, such that the volume defined by the reservoir is enclosed by the reservoir and the septum;

an ultrasonic transducer arranged to emit ultrasonic energy into the septum;

a detector arranged to detect the ultrasonic energy emitted by the ultrasonic transducer after the ultrasonic energy passes through at least a portion of the septum, whereby changes in the condition of the septum can be identified based on detection of the ultrasonic energy by the detector; and

a transmitter capable of generating output signals.

2. A system according to claim 1, wherein the ultrasonic transducer is directly acoustically coupled to the septum.

3. A system according to claim 1, wherein the detector comprises the ultrasonic transducer.

4. A system according to claim 1, further comprising a reflector positioned to reflect the ultrasonic energy to the detector after the ultrasonic energy passes through at least a portion of the septum.

5. A system according to claim 4, wherein the reflector comprises the opening sealed by the septum.

6. A system according to claim 1, wherein the opening defines an opening plane and an insertion axis normal to the opening plane, and wherein the ultrasonic transducer emits ultrasonic energy in a direction transverse to the insertion axis.

7. A system according to claim 1, wherein the ultrasonic transducer emits ultrasonic energy in a direction across the opening.

8. A system according to claim 1, wherein the detector generates a signal indicative of the ultrasonic energy detected by the detector, and wherein the system further comprises a signal processing device operatively coupled to the detector, the signal processing device capable of comparing the signal generated by the detector at different times to identify changes in the condition of the septum.

9. A system for monitoring an implantable medical device comprising:

an implantable medical device that comprises;

a reservoir defining a volume, the reservoir comprising an opening formed therein, the opening defining an insertion axis;

a septum attached to the reservoir, the septum sealing the opening, such that the volume defined by the reservoir is enclosed;

an ultrasonic transducer arranged to emit ultrasonic energy into the septum in a direction transverse to the insertion axis;

a detector arranged to detect the ultrasonic energy emitted by the ultrasonic transducer after the ultrasonic energy passes through at least a portion of the septum, whereby changes in the condition of the septum can be determined based on detection of the ultrasonic energy by the detector; and

a transmitter capable of generating output signals.

10. A system according to claim 9, wherein the ultrasonic transducer is directly acoustically coupled to the septum.

11. A system according to claim 9, wherein the detector comprises the ultrasonic transducer.

12. A system according to claim 9, further comprising a reflector positioned to reflect the ultrasonic energy to the detector after the ultrasonic energy passes through at least a portion of the septum.

13. A system according to claim 12, wherein the reflector comprises the opening sealed by the septum.

14. A system according to claim 9, wherein the direction transverse to the insertion axis extends across the opening.

15. A system according to claim 9, wherein the detector generates a signal indicative of the ultrasonic energy detected by the detector, and wherein the system further comprises a signal processing device operatively coupled to the detector, the signal processing device capable of comparing the signal generated by the detector at different times to identify changes in the condition of the septum.

16. A system for monitoring an implantable medical device comprising:

an implantable medical device that comprises;

a reservoir defining a volume, the reservoir comprising an opening formed therein;

a septum attached to the reservoir, the septum sealing the opening, such that the volume defined by the reservoir is enclosed by the reservoir and the septum;

an ultrasonic transducer arranged to emit ultrasonic energy into the septum;

a load sensor operatively coupled to the ultrasonic transducer, the load sensor capable of determining the acoustic load of the ultrasonic transducer when the ultrasonic transducer is emitting ultrasonic energy, whereby changes in the condition of the septum can be identified; and

a transmitter capable of generating output signals.

17. A system according to claim 16, wherein the ultrasonic transducer is directly acoustically coupled to the septum.

18. A system according to claim 16, wherein the opening defines an opening plane and an insertion axis normal to the opening plane, and wherein the ultrasonic transducer emits ultrasonic energy in a direction transverse to the insertion axis.

19. A system according to claim 16, wherein the ultrasonic transducer emits ultrasonic energy in a direction across the opening.

20. A system according to claim 16, wherein the load sensor generates a signal indicative of the acoustic load sensed by the load sensor, and wherein the system further comprises a signal processing device operatively coupled to the load sensor, the signal processing device capable of comparing the signal generated by the load sensor at different times.

21. A system for monitoring an implantable medical device comprising:

an implantable medical device that comprises;

a reservoir defining a volume, the reservoir comprising an opening formed therein, the opening defining an insertion axis;

a septum attached to the reservoir, the septum sealing the opening, such that the volume defined by the reservoir is enclosed;

an ultrasonic transducer arranged to emit ultrasonic energy into the septum in a direction transverse to the insertion axis;

a load sensor operatively coupled to the ultrasonic transducer, the load sensor capable of determining the acoustic load of the ultrasonic transducer when the ultrasonic transducer is emitting ultrasonic energy, whereby changes in the condition of the septum can be identified; and

a transmitter capable of generating output signals.

22. A system according to claim 21, wherein the ultrasonic transducer is directly acoustically coupled to the septum.

23. A system according to claim 21, wherein the direction transverse to the insertion axis extends across the opening.

24. A system according to claim 21, wherein the load sensor generates a signal indicative of the acoustic load sensed by the load sensor, and wherein the system further comprises a signal processing device operatively coupled to the load sensor, the signal processing device capable of comparing the signal generated by the load sensor at different times.

25. A method of monitoring an implantable medical device, the method comprising:

providing an implantable medical device that comprises;

a reservoir defining a volume, the reservoir comprising an opening formed therein;

a septum attached to the reservoir, the septum sealing the opening, such that the volume defined by the reservoir is enclosed by the reservoir and the septum; and

an ultrasonic transducer;

emitting ultrasonic energy from the ultrasonic transducer into the septum;

detecting the ultrasonic energy after the ultrasonic energy passes through at least a portion of the septum; and

identifying a change in condition of the septum based on detecting the ultrasonic energy after the ultrasonic energy passes through at least a portion of the septum.

26. A method according to claim 25, wherein the determining a change in condition of the septum comprises:

generating an output signal based on the detecting the ultrasonic energy after the ultrasonic energy passes through at least a portion of the septum; and

comparing the output signal generated at a first time with the output signal generated at a second time to identify the change in condition of the septum.

27. A method according to claim 25, wherein the ultrasonic transducer is directly acoustically coupled to the septum.

28. A method according to claim 25, wherein the detecting comprises detecting the ultrasonic energy using the ultrasonic transducer.

29. A method according to claim 25, further comprising reflecting the ultrasonic energy before detecting the ultrasonic energy.

30. A method according to claim 29, wherein the reflecting comprises reflecting the ultrasonic energy within the opening sealed by the septum.

31. A method according to claim 25, wherein the opening defines an opening plane and an insertion axis normal to the opening plane, and wherein emitting ultrasonic energy comprises emitting the ultrasonic energy in a direction transverse to the insertion axis.

32. A method according to claim 25, wherein emitting ultrasonic energy comprises emitting ultrasonic energy in a direction across the opening.

33. A method according to claim 25, further comprising notifying an operator of the change in condition of the septum after comparing the output signal generated at the first time with the output signal generated at the second time.

34. A method according to claim 25, wherein the change in condition of the septum comprises a leak in the septum.

35. A method according to claim 25, further comprising advancing a needle towards the septum, wherein the change in condition of the septum comprises presence of the needle in the septum.

36. A method according to claim 35, further comprising transferring a fluid using the needle after identifying that the change in condition of the septum comprises the presence of the needle in the septum.

37. A method according to claim 25, further comprising advancing a needle towards the septum, wherein the change in condition of the septum comprises no change in condition of the septum, and wherein the method further comprises adjusting a position of the needle, followed by advancing the needle towards the septum.

38. A method of monitoring an implantable medical device comprising:

providing an implantable medical device that comprises;

a reservoir defining a volume, the reservoir comprising an opening formed therein;

a septum attached to the reservoir, the septum sealing the opening, such that the volume defined by the reservoir is enclosed by the reservoir and the septum; and

an ultrasonic transducer;

emitting ultrasonic energy from the ultrasonic transducer into the septum;

sensing an acoustic load on the ultrasonic transducer to obtain a sensed acoustic load at different times when the ultrasonic transducer is emitting ultrasonic energy; and

identifying a change in condition of the septum based on the sensed acoustic load.

39. A method according to claim 38, wherein the identifying a change in condition of the septum comprises comparing the sensed acoustic loads.

40. A method according to claim 38, wherein the ultrasonic transducer is directly acoustically coupled to the septum.

41. A method according to claim 38, wherein the opening defines an opening plane and an insertion axis normal to the opening plane, and wherein emitting ultrasonic energy comprises emitting the ultrasonic energy in a direction transverse to the insertion axis.

42. A method according to claim 38, wherein emitting ultrasonic energy comprises emitting ultrasonic energy in a direction across the opening.

43. A method according to claim 38, further comprising notifying an operator of the change in condition of the septum.

44. A method according to claim 38, wherein the change in condition of the septum comprises a leak in the septum.

45. A method according to claim 38, further comprising advancing a needle towards the septum, wherein the change in condition of the septum comprises presence of the needle in the septum.

46. A method according to claim 45, further comprising transferring a fluid using the needle after identifying that the change in condition of the septum comprises the presence of the needle in the septum.

47. A method according to claim 38, further comprising advancing a needle towards the septum, wherein the change in condition of the septum comprises no change in condition of the septum, and wherein the method further comprises adjusting a position of the needle, followed by advancing the needle towards the septum.

48. A method of transferring fluid to or from a reservoir located in an implantable medical device, the method comprising:

providing an implantable medical device that comprises;

a reservoir defining a volume, the reservoir comprising an opening formed therein;

a septum attached to the reservoir, the septum sealing the opening, such that the volume defined by the reservoir is enclosed by the reservoir and the septum; and

an ultrasonic transducer;

emitting ultrasonic energy from the ultrasonic transducer into the septum at a first time;

detecting the ultrasonic energy emitted at the first time after the ultrasonic energy passes through at least a portion of the septum;

advancing a needle towards the septum;

emitting ultrasonic energy from the ultrasonic transducer into the septum at a second time;

detecting the ultrasonic energy emitted at the second time after the ultrasonic energy passes through at least a portion of the septum;

identifying a change in condition of the septum based on detecting the ultrasonic energy emitted at the first time and the second time; and

transferring fluid to or from the reservoir using the needle if the change in the condition of the septum indicates the presence of the needle in the septum.

49. A method according to claim 48, wherein the identifying a change in condition of the septum comprises:

generating a first output signal based on detecting the ultrasonic energy emitted at the first time;

generating a second output signal based on detecting the ultrasonic energy emitted at the second time; and

comparing the first output signal and the second output signal to identify the change in condition of the septum.

50. A method according to claim 48, wherein the ultrasonic transducer is directly acoustically coupled to the septum.

51. A method according to claim 48, wherein the detecting comprises detecting the ultrasonic energy using the ultrasonic transducer.

52. A method according to claim 48, further comprising reflecting the ultrasonic energy before detecting the ultrasonic energy.

53. A method according to claim 52, wherein the reflecting comprises reflecting the ultrasonic energy within the opening sealed by the septum.

54. A method according to claim 48, wherein the opening defines an opening plane and an insertion axis normal to the opening plane, and wherein emitting ultrasonic energy comprises emitting the ultrasonic energy in a direction transverse to the insertion axis.

55. A method according to claim 48, wherein emitting ultrasonic energy comprises emitting ultrasonic energy in a direction across the opening.

56. A method of transferring fluid to or from a reservoir located in an implantable medical device, the method comprising:

providing an implantable medical device that comprises;

a reservoir defining a volume, the reservoir comprising an opening formed therein;

a septum attached to the reservoir, the septum sealing the opening, such that the volume defined by the reservoir is enclosed by the reservoir and the septum; and

an ultrasonic transducer;

emitting ultrasonic energy from the ultrasonic transducer into the septum;

sensing a first acoustic load on the ultrasonic transducer while emitting ultrasonic energy from the ultrasonic transducer into the septum at a first time;

advancing a needle towards the septum;

sensing a second acoustic load on the ultrasonic transducer while emitting ultrasonic energy from the ultrasonic transducer into the septum at a second time;

identifying a change in condition of the septum based on the first acoustic load and the second acoustic load; and

transferring fluid to or from the reservoir using the needle if the change in the condition of the septum indicates the presence of the needle in the septum.

57. A method according to claim 56, wherein the identifying a change in condition of the septum comprises comparing the first acoustic load and the second acoustic load.

58. A method according to claim 56, wherein the ultrasonic transducer is directly acoustically coupled to the septum.

59. A method according to claim 56, wherein the opening defines an opening plane and an insertion axis normal to the opening plane, and wherein emitting ultrasonic energy comprises emitting the ultrasonic energy in a direction transverse to the insertion axis.

60. A method according to claim 56, wherein emitting ultrasonic energy comprises emitting ultrasonic energy in a direction across the opening.

61. A method according to claim 56, wherein emitting ultrasonic energy from the ultrasonic transducer into the septum comprises driving the ultrasonic transducer using a swept sine wave signal.