Implantable blood oxygen sensor and method of use

• US 4,815,469 A
• Filed: 03/10/1988
• Issued: 03/28/1989
• Est. Priority Date: 10/08/1987
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Siemens Pacesetter, Inc. (Abbott Laboratories)
• Inventors: Hooven, Michael D., Cohen, Donald M., Barcel, James E.
• Primary Examiner(s): Chambers, A. Michael
• Application Number:
  US07/166,580
• Time in Patent Office: 383 Days
• Field of Search: 128/633, 128/419 PG, 128/634, 364/413, 364/417
• US Class Current: 600/333
• 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

Abstract

An implantable medical sensor (42) determines the oxygen content of blood. The sensor includes a miniaturized hybrid circuit (130) that includes light-emitting diode means (32), phototransistor means (34, 36), and a substrate (110) to which the light-emitting diode means and phototransistor means are bonded in a desired circuit configuration. The hybrid circuit is hermetically sealed within a cylindrical body (140) made from a material that is substantially transparent to light, such as glass. Feedthrough terminals (132, 134) provide means for making an electrical connection with the hybrid circuit. The light-emitting diode means is driven with a stair-stepped current pulse. In one embodiment, the sensor is embedded within a bilumen pacemaker lead (60) and positioned near the distal electrode (66) of the lead so that the sensor resides within the heart when the lead is implanted within a patient, thereby allowing the sensed oxygen content (MVO₂ concentration) of the blood within the heart to be a physiological parameter that can be used to control the pacing interval of a rate-responsive pacemaker (56).

Claims

1. A body-implantable sensor and lead comprising:

an implantable stimulating lead having a connector at one end thereof and electrode means at the other end thereof, the electrode means comprising means for electrically contacting body tissue when the lead is implanted in a body, and the connector comprising a means for interfacing the lead, both electrically and physically, with a desired stimulating device;

a first insulated conductor having a distal end coupled to the electrode means and a proximal end couplled to the connector;

sensor means forming an integral part of the lead for quantitatively sensing a specified characteristic of a body fluid proximal the sensor means, the sensor means including means responsive to a drive signal for generating an output signal that varies as a function of the specified body fluid characteristic;

means for transmitting the drive signal and the output signal between the sensor means and the connector; and

means for hermetically sealing said sensor means.

2. The body-implantable sensor and lead of claim 1 wherein said sensor means comprises

means for emitting a measuring signal into said body fluid in response to said drive signal;

and

means for receiving a portion of said measuring signal reflected back to said sensor by the body fluid, the portion of the measuring signal reflected back to said sensor being proportional to the specified characteristic of said body fluid.

3. The body-implantable sensor and lead of claim 2 wherein said emitting means comprises means for emitting an optical signal, and said receiving means comprises means for receiving that portion of said optical signal that is reflected back into said sensor by the body fluid.

4. The body-implantable sensor and lead of claim 3 wherein said optical signal emitting means comprises a light-emitting diode (LED), and wherein said optical signal receiving means comprises at least one photo-sensitive semiconductor device, said LED and said photo-sensitive device being sealed within a housing that is embedded within said lead.

5. The body-implantable sensor and lead of claim 4 wherein said drive signal comprises a stair-step current pulse that excites said LED with a first current for a first time period and that excites said LED with a second current for a second time period immediately subsequent said first time period.

6. The body-implantable sensor and lead of claim 4 wherein said LED emits an optical signal having characteristics that cause the amount of the optical signal reflected back to the sensor to vary as a function of the oxygen content of the body fluid.

7. The body-implantable sensor and lead of claim 4 wherein said photo-sensitive semiconductor device comprises at least two phototransistors, each of which is mounted on a substrate;

said LED also being mounted on said substrate;

said substrate further having resistor means placed thereon for providing a specified resistance;

said substrate having connection means thereon for connecting said phototransistors and said resistance means in a parallel network, and for connecting said LED in series with said parallel network;

said substrate and the components mounted thereon being hermetically sealed in said housing, said housing having window means for allowing optical signals emitted by said LED, and optical signals received by said pair of phototransistors, to pass out of and into said sealed housing;

said sealed housing further having feedthrough means for making electrical contact with the connection means on said substrate;

said sealed housing being embedded within said lead.

8. The body implantable sensor and lead of claim 7 wherein said hermetically sealed housing comprises a hollow tube made from soda lime glass;

said housing further comprises a titanium metal ring that is inserted into each end of said hollow tube;

said metal ring having said feedthrough means sealably passing therethrough;

said metal rings being sealably bonded to said hollow tube around the edges of said tube so as to form a tight seal of at least 10^-8 cc air/sec at one atmosphere pressure, and wherein the sealed bonded between said metal rings and the edges of the hollow soda lime glass tube is a chemical bond formed between the titanium and the soda lime glass.

9. The body-implantable sensor and lead of claim 7 further comprising a diode and a second conductor;

wherein said proximal end of said first conductor is coupled to said distal end of said first conductor through said diode;

said proximal end is also electrically connected to said means for transmitting said drive signal to said sensor;

said second conductor is electrically connected to a ring electrode located near a distal end of said second conductor and to said feedthrough means to said housing.

10. The body-implantable sensor and lead of claim 7 wherein said means for transmitting said drive signal to said sensor means comprises a second conductor coupled at a proximal end to said connector and coupled at a distal end to the feedthrough means of said housing.

11. The body-implantable sensor and lead of claim 10 wherein the feedthrough means of said housing is further coupled to said first conductor.

12. The body-implantable sensor and lead of claim 10 wherein said lead further includes a third conductor, electrically insulated from said first and second conductors, said third conductor being electrically connected to a ring electrode located near a distal end of said lead.

13. The body-implantable sensor and lead of claim 12 wherein said third conductor passes through a portion of said sensor means without making electrical contact therewith.

14. The body-implantable sensor and lead of claim 12 wherein said third conductor makes electrical contact with said sensor means.

15. The body-implantable sensor and lead of claim 12 wherein said first and third conductors are coaxial within said lead.

16. The body-implantable sensor and lead of claim 10 wherein said lead comprises a bipolar lead having a ring electrode and a tip electrode, and wherein said feedthrough means of said housing includes first and second feedthrough terminals, and further wherein one of said first and second conductors is electrically connected to said first feedthrough terminal, and the other of said first and second conductors is electrically connected to said second feedthrough terminal.

17. The body-implantable sensor and lead of claim 16 wherein said first and second conductors are coaxial within said lead.

18. The body-implantable sensor and lead of claim 10 wherein said lead further includes a third conductor, electrically insulated from said first and second conductors, said third conductor being connected to the proximal end of said housing, and wherein the body of said housing is also used as the ring electrode.

19. An implantable oxygen sensor and lead used with an implantable rate-responsive pacing system;

said pacing system including timing means for generating timing signals and for defining a pacing interval, and pulse generator means for generating stimulating pulses at appropriate times within said pacing interval;

said timing means including control circuits for automatically adjusting the pacing interval of said pacing system as a function of the oxygen content of body blood sensed by said oxygen sensor, said implantable oxygen sensor and lead comprising;

means responsive to a drive signal for emitting a measuring signal into said body blood, said measuring signal being of a type that is affected by the oxygen content of said blood;

means for receiving the measuring signal after it has been emitted into said body blood and affected by the oxygen content thereof;

lead means for delivering the stimulation pulses from the pulse generator to a desired body location;

an implantable hermetically sealed case within said lead means wherein said emitting means and receiving means are housed;

control means for generating said drive signal; and

processing means coupled to said receiving means for processing the receiving measuring signal and for generating an output signal indicative of the oxygen content of said blood.

20. The implantable oxygen sensor and lead of claim 19 wherein said control means and processing means are located within the rate-responsive pacemaker, and further including means for sensing signals between the control means and processing means within said pacemaker and the emitting means and receiving means within the hermetically sealed case of said sensor.

21. The implantable oxygen sensor and lead of claim 20 wherein the output signal of said processing means is coupled to the control circuits of said timing means, said output signal providing the basis for said control circuits to adjust the pacing interval of said pacemaker as a function of the sensed oxygen content of the blood.

22. The implantable oxygen sensor and lead of claim 21 wherein said emitting means comprises an LED that emits an optical signal having characteristics that cause the optical signal to be reflected back to the sensor as a function of the oxygen content of the blood, and further wherein said receiving means comprises at least two phototransistors, each of which is mounted on a substrate;

said LED also being mounted on said substrate;

said substrate further having resistor means placed thereon for providing a specified resistance;

said substrate including connection means for connecting said phototransistors and said resistance means in a parallel network, and for connecting said LED in series with said parallel network;

said substrate and the components mounted thereon being hermetically sealed in said case;

said case having window means for allowing optical signals emitted by said LED, and optical signals received by said pair of phototransistors, to pass out of and into said case;

said case having feedthrough means for making electrical contact with said substrate.

23. A hermetically sealed, implantable medical sensor used to sense a desired parameter associated with body tissue, including body fluids, in which said medical sensor is implanted, said sensor comprising:

a hollow tube having sealed window means therein;

a substrate inserted into said tube;

light-emitting diode means placed on said substrate for emitting light of a prescribed frequency range in response to a drive signal, said light-emitting diode means being positioned on said substrate so as to permit at least a portion of said light to pass through said window means, contact body tissue outside of said window means, and reflect back through said window means;

phototransistor means placed on said substrate for receiving light of a prescribed frequency range received through said window means, and for generating an output signal having characteristics that vary as a function of at least one parameter of the light received through said window means;

connection means for connecting said light-emitting diode means and said phototransistor means is a desired circuit configuration, and for connecting a first terminal to said light-emitting diode means, and for connecting a second terminal to said phototransistor means;

sealing means sealably secured to each end of said tube for sealing said substrate, light-emitting diode means, phototransistor means, and connection means within said tube, said sealing means including feedthrough means for making electrical contact from a point external said tube with said first and second terminals;

means for generating said drive signal and applying it through said first and second terminals to said light-emitting diode means; and

means for monitoring through said first and second terminals the output signal generated by said phototransistor means, and for processing said signal to provide a sensor signal indicative of said at least one parameter of the light received through said window means, said sensor signal thereby providing a measure of a desired characteristic of said body tissue as measured by the manner in which said at least one parameter of light is affected by coming in contact with said body tissue.

24. The medical sensor of claim 23 wherein said drive signal generating means includes means for generating a stair-stepped drive current tht excites said light-emitting diode means with a first current level for a first prescribed time period, and that excites said light-emitting diode means with a second current level for a second time period immediately subsequent to said first time period.

25. The medical sensor of claim 24 wherein said means for monitoring and processing the output signal generated by said phototransistor means comprises means for determining the amount of change in the output signal as a result of the change in the amount of light reflected back into said window means for said first time period to said second time period.

26. The medical sensor of claim 23 wherein said hollow tube is made from a material that is substantially transparent to the light emitted by said light-emitting diode means and the light received by said phototransistor means, said light transparent material thereby comprising the sealed window means through which said light passes.

27. The medical sensor of claim 26 wherein said hollow tube material comprises soda lime glass.

28. The medical sensor of claim 26 wherein said sealing means comprises a metal ring that is inserted into each each of said hollow tube, said metal ring having said feedthrough means sealably passing therethrough, said metal rings being sealably bonded to said hollow tube around the edges of said tube so as to form a tight seal of at least 10^-8 cc air/sec at one atmosphere pressure.

29. The medical sensor of claim 28 wherein said metal rings are made from titanium, said hollow tube is made from soda lime glass, and wherein the sealed bond between said metal rings and the edges of the hollow soda lime glass tube is a chemical bond formed between the titanium and the soda lime glass.

30. The medical sensor of claim 23 wherein said light-emitting diode means comprises a light-emitting diode chip bonded to said substrate substantially in the center thereof, and further including a reflector envelope placed between said light-emitting diode chip and a portion of the window means of said hollow tube, whereby the light emitted by said light-emitting diode chip is directed substantially upward and out through said window means.

31. The medical sensor of claim 30 wherein said phototransistor means comprises at least two phototransistor chips that are bonded to said substrate, one phototransistor chip being positioned on one side of said light-emitting diode chip and reflector envelope, but still under a portion of said window means;

and the other phototransistor chip being positioned on the other side of said light-emitting diode chip and reflector envelope, but still under another portion of said window means;

said at least two phototransistor chips being electrically connected in parallel by said connection means.

32. A method of using a medical sensor that includes light-emitting diode means for emitting a light pulse that is directed to a desired type of organic material to be analyzed, which light pulse is then received by phototransistor means, a desired property of said organic material being determinable in accordance with the manner in which at least one detectable property of the light pulse is affected by the organic material;

said method comprising the steps of;

(a) exciting said light-emitting diode means with a first drive current for a first period of time;

(b) exciting said light-emitting diode means with a second drive current for a second period of time immediately subsequent said first period of time;

(c) monitoring the light pulses received by said phototransistor means during said first and second periods of time to determine the change in said light pulses as a result of having come in contact with the organic material; and

(d) processing the amount of change identified in step (c) to determine a desired property of the organic material.

33. The method of claim 32 wherein the second drive current level used in step (b) to excite said light-emitting diode means is less than the first drive current level used in step (a).

34. The method of claim 32 wherein said organic material being analyzed by said medical sensor comprises blood, and further wherein the detectable property monitored by said medical sensor is the amount of the light pulse that is reflected from said blood, said reflected light amount being relatable by the processing of step (d) to the amount of oxygen in the blood.