Implantable medical device with enclosed physiological parameter sensors or telemetry link

• US 5,556,421 A
• Filed: 02/22/1995
• Issued: 09/17/1996
• Est. Priority Date: 02/22/1995
• Status: Expired due to Term

• Current Assignee: Intermedics Incorporated
• Original Assignee: Intermedics Incorporated
• Inventors: Paul, Patrick J., Prutchi, David
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/392,181
• Time in Patent Office: 573 Days
• Field of Search: 607/36, 607/37, 607/22
• US Class Current: 607/36
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers

Abstract

An implantable medical device, such as a cardiac pacer, defibrillator or drug delivery system, includes a container housing the required power source and circuitry and a header portion molded or glued to the container housing. Sensors, including physiological parameter sensors as may be necessary to control and implement the operation of the implantable device, or a telemetry link, or both, are disposed and sealed within the header. The header may include electromagnetic focusing devices to enhance the performance of the sensors. The sensors may include two pulse oximetry sensors that provide differential measurements to improve detection of arterial blood flow.

Claims

1. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor sealed and encapsulated within said header; and

leads electrically interconnecting said sensor and said electrical components.

2. The implantable device of claim 1 wherein said sensor comprises a physiological parameter sensor.

3. The implantable device of claim 2 wherein said sensor comprises a photodetector capable of receiving through said header an optical signal indicative of the measure of a physiological parameter.

4. The implantable device of claim 3 wherein said sensor further comprises a photoemitter capable of emitting through said header an optical signal to be received as reflected light by said photodetector.

5. The implantable device of claim 2 wherein said sensor comprises an oximetry sensor.

6. The implantable device of claim 1 wherein said sensor comprises a telemetry transducer for communicating with a device remote from said implantable device.

7. The implantable device of claim 1 wherein said header is made of epoxy.

8. The implantable device of claim 1 wherein said header is made of a ceramic material.

9. The implantable device of claim 1 wherein said header is made of plastic.

10. The implantable device of claim 1 wherein said header is made of glass.

11. The implantable device of claim 1 wherein said header is translucent.

12. The implantable device of claim 1 wherein said header is transparent.

13. The implantable device of claim 1 wherein said header has an optical transmission effective rate of at least 70% for wavelengths between 350 nanometers and 900 nanometers.

14. The implantable device of claim 13 wherein said header has an optical transmission effective rate of at least 70% for wavelengths between 3 micrometers and 10 micrometers.

15. The implantable device of claim 1 wherein said header has high optical transmissivity to wavelengths between 3 micrometers and 10 micrometers and between 350 nanometers and 900 nanometers.

16. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor within said header;

leads electrically interconnecting said sensor and said electrical components; and

wherein selected portions of said header are made of a material having a volume resistivity less than 10 megaohm cm.

17. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor within said header;

leads electrically interconnecting said sensor and said electrical components; and

wherein said header is made of a material having a volume resistivity higher than 1×

10¹² ohm-cm.

18. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor within said header;

leads electrically interconnecting said sensor and said electrical components; and

wherein said header has a dielectric constant greater than 3.

19. The implantable device of claim 18 wherein said header is made of a material having a volume resistivity higher than 1×

10¹² ohm-cm.

20. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor within said header;

leads electrically interconnecting said sensor and said electrical components; and

wherein said header has high optical transmissivity to wavelengths between 350 nanometers and 900 nanometers.

21. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor within said header;

leads electrically interconnecting said sensor and said electrical components; and

wherein said header has high optical transmissivity to wavelengths between 3 micrometers and 10 micrometers.

22. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor within said header;

leads electrically interconnecting said sensor and said electrical components; and

an electromagnetic focusing device on said header.

23. The implantable device of claim 22 wherein said electromagnetic focusing device comprises a body of material having an index of refraction that is different from the index of refraction of said header.

24. The implantable device of claim 22 wherein said header includes an outer surface, and wherein said electromagnetic focusing device comprises a plurality of grooves formed in said outer surface of said header.

25. The implantable device of claim 22 wherein said sensor includes a sensing surface, and wherein said electromagnetic focusing device comprises a lens attached to said header, said lens having a focal point adjacent to said sensing surface of said sensor.

30. The implantable device of claim 24 wherein said plurality of sensors include a physiological parameter sensor and a telemetry link.

26. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor within said header;

leads electrically interconnecting said sensor and said electrical components; and

wherein said header includes an outer surface, and wherein said sensor comprises a conductive plate disposed in said header a predetermined distance from said outer surface.

27. The implantable device of claim 26 wherein said predetermined distance is within the range of approximately 0.1 mm to 2.0 mm.

28. An implantable medical device for implantation into a living body, said device comprising:

a container having a chamber housing electrical components therein;

a header attached to said chamber;

at least one sensor within said header;

leads electrically interconnecting said sensor and said electrical components; and

wherein said header includes a plurality of sensors.

29. The implantable device of claim 28 wherein said plurality of sensors include a first physiological parameter sensor and a second physiological parameter sensor, and wherein said first and second sensors measure different physiological parameters.

31. The implantable device of claim 28 wherein said plurality of sensors include a first oximetry sensor having a first photodetector with a first light-sensing surface and a second oximetry sensor having a second photodetector with a second light-sensing surface, said first and second photodetectors disposed in said header so that said first and second light-sensing surfaces face in different directions.

32. The implantable device of claim 31 wherein said light-sensing surface of said first photodetector faces in a direction substantially 180 degrees apart from the direction faced by said light-sensing surface of said second photodetector.

33. An implantable medical device for implantation in a body, said device comprising:

a housing for containing electrical components;

an encapsulated module attached to said housing;

a sensor encapsulated within said encapsulated module and capable of sensing a predetermined physiological parameter.

34. The implantable medical device as in claim 33 wherein said encapsulated module is constructed of a material having an optical transmission effective rate of at least 70% for wavelengths between 350 nanometers and 900 nanometers.

35. The implantable medical device as in claim 34 wherein said encapsulated module is constructed of a material having an optical transmission effective rate of at least 70% for wavelengths between 3 micrometers and 10 micrometers.

36. An implantable medical device for implantation in a body, said device comprising:

a housing for containing electrical components;

an encapsulated module attached to said housing;

a sensor disposed in said encapsulated module and capable of sensing a predetermined physiological parameter; and

wherein said encapsulated module is constructed of a material with a volume resistivity higher than 1×

10¹² ohm-cm.

37. An implantable medical device for implantation in a body, said device comprising:

a housing for containing electrical components;

an encapsulated module attached to said housing;

a sensor disposed in said encapsulated module and capable of sensing a predetermined physiological parameter; and

wherein said encapsulated module is constructed of a material with a high optical transmissivity to wavelengths between 350 nanometers and 900 nanometers.

38. An implantable medical device for implantation in a body, said device comprising:

a housing for containing electrical components;

an encapsulated module attached to said housing;

a sensor disposed in said encapsulated module and capable of sensing a predetermined physiological parameter; and

wherein said encapsulated module is constructed of a material with a high optical transmissivity to wavelengths between 3 micrometers and 10 micrometers.

39. An implantable medical device for implantation in a body, said device comprising:

a housing for containing electrical components;

an encapsulated module attached to said housing;

a sensor disposed in said encapsulated module and capable of sensing a predetermined physiological parameter; and

wherein said encapsulated module is constructed of a material with a dielectric constant greater than 3.0.

40. The implantable medical device as in claim 39 wherein said encapsulated module is constructed of a material having a volume resistivity higher than 1×

10¹² ohm-cm.

41. An implantable medical device for implantation in a body, said device comprising:

a housing for containing electrical components;

an encapsulated module attached to said housing;

a sensor disposed in said encapsulated module and capable of sensing a predetermined physiological parameter; and

wherein selected portions of said encapsulated module are constructed of a material with a volume resistivity less than 10 megaohm-cm.

42. An implantable medical device comprising:

a sensor responsive to a physiological parameter and capable of producing a first signal indicative of the measure of the sensed physiological parameter;

a control circuit responsive to said first signal and capable of generating a control signal according to a predetermined algorithm relating said control signal to the measure of said sensed physiological parameter;

an output circuit responsive to said control signal and capable of producing an electrical pulse of a predetermined duration and magnitude in response to a control signal;

a container housing said control circuit and said output circuit;

a header closing and sealing said container, wherein said sensor is encapsulated within said header; and

means for coupling said sensor in said header to said control circuit in said container.

43. An implantable medical device comprising:

a container having a body portion housing a pulse generation circuit, a sensor evaluation circuit and a microprocessor for receiving signals from said sensor evaluation circuit and controlling said pulse generation circuit;

said container further including an opening in said body portion and a header portion positioned adjacent said body portion, in the region of said opening;

a sensor encapsulated within said header portion and in electrical communication with said sensor evaluation circuit in said body portion; and

a terminal disposed in said header portion and electrically insulated from said sensor, said terminal being electrically interconnected with said pulse generation circuit and being adapted for landing and terminating an electrical lead.

44. An implantable medical device for implantation into a living body, said device comprising:

a container having a hermetically-sealed chamber housing electrical components therein;

an aperture in said container;

a closure made of a translucent material sealing said aperture;

first and second photodetectors in said container each including a light-sensing surface capable of receiving through said translucent material an optical signal indicative of the measure of a physiological parameter;

wherein said light-sensing surfaces of said first and second photodetectors face in different directions.

45. The implantable medical device of claim 44 wherein said light-sensing surface of said first photodetector faces in a direction substantially 180°

apart from the direction faced by said light-sensing surface of said second photodetector.

46. The implantable medical device of claim 45 wherein said closure forms a header for said container, and wherein said photodetectors are encapsulated within said header.

47. The implantable medical device of claim 44 wherein said translucent material has an optical transmission effective rate of at least 70% for wavelengths between 350 nanometers and 900 nanometers.

48. The implantable medical device of claim 44 wherein said translucent material has an optical transmission effective rate of at least 70% for wavelengths between 3 micrometers and 10 micrometers.