Multiple lens oxygen sensor for medical electrical lead

Details Multiple lens oxygen sensor for medical electrical lead Multiple lens oxygen sensor for medical electrical lead

1998-10-30

2001-03-06

Winakur, Eric F. (Department: 3736)

Surgery

Diagnostic testing

Measuring or detecting nonradioactive constituent of body...

C600S333000, C602S022000

Reexamination Certificate

active

06198952

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to implantable physiologic sensors.
BACKGROUND OF THE INVENTION
Implantable medical devices (IMDs) for cardiac monitoring or for delivering therapy typically include one or more sensors positioned in a patient's blood vessel, heart chamber or other portion of the body. Examples of IMDs include heart monitors, therapy delivery devices, pacemakers, implantable pulse generators (IPGs), pacer-cardio-defibrillators (PCDs), implantable cardio-defibrillators (ICDs), cardiomyo-stimulators, nerve stimulators, gastric stimulators, brain stimulators and drug delivery devices. In a cardiac therapy or monitoring context, such IMDs generally include electrodes for sensing cardiac events of interest and sense amplifiers for recording or filtering sensed events.
In many currently available IMDs, sensed events such as P-waves and R-waves are employed to control the delivery of therapy in accordance with an operating algorithm. Selected electrogram (EGM) signal segments and sense event histogram data and the like are typically stored in IMD RAM for transfer to an external programmer by telemetric means at a later time.
Efforts have also been made to develop implantable physiologic signal transducers and sensors for monitoring a physiologic condition other than, or in addition to, an EGM, to thereby control delivery of a therapy, or to filter or store data. In respect of cardiac monitoring, sensing and recording such additional physiologic signals as blood pressure, blood temperature, pH, blood gas type and blood gas concentration signals has been proposed.
One type of ideal physiologic sensor provides information concerning a patient's exercise level or workload and operates in closed loop fashion. In other words, such an ideal physiologic sensor operates to minimize divergence from an ideal operating point or set of points. Blood oxygen saturation provides a direct indication of the amount oxygen consumed by a patient when exercising. Moreover, in a rate responsive pacing context, oxygen saturation is generally inversely related to pacing rate. That is, as oxygen saturation decreases due to exercise, pacing rates correspondingly increase so that divergence from the optimum operating point is minimized. Thus, development of a reliable, accurate sensor for monitoring blood oxygen saturation for use in conjunction with an IMD is desirable.
Those skilled in the art have therefore toiled for years to develop an implantable oxygen sensor capable of not only accurately and reliably sensing blood oxygen saturation levels, but also of being manufactured easily at a reasonable cost. Such efforts have included attempts to develop systems for recording oxygen saturation and absolute pressure simultaneously, or to initiate or modify therapy on the basis of blood oxygen saturation. The exemplary prior art pertaining to implantable blood oxygen sensors includes the U.S. Patents listed in Table 1 below.
Considerable effort has been expended in designing chronically implantable temperature sensors and relative or absolute pressure sensors. Nevertheless, a need still exists for a body implantable, durable, long-lived and low-power-consuming pressure sensor capable of accurately sensing absolute or relative pressure in the body over a period of many years. Likewise, a need still exists for a body implantable, durable, long-lived and low-power-consuming temperature sensor capable of accurately and reliably sensing temperature in the body over a period of many years.
Various medical devices have been developed to receive information from one or more physiologic sensors or transducers. A typical physiologic sensor transduces a measurable parameter of the human body, such as blood pressure, temperature or oxygen saturation for example, into a corresponding electrical signal. A conventional approach to attaching a physiologic sensor to a multiple conductor lead extending from an implantable medical device involves connecting the sensor to at least two conductors provided in the lead.
Connecting two physiologic sensors to an implantable medical device in a conventional manner typically involves connecting the medical device to two multiple conductor leads, with a dedicated lead connected to each of the two sensors. The additional number of leads and associated connection hardware generally complicates the design of the leads and medical device electronics, increases power consumption and the cost of the device, and reduces overall device reliability.
An improved approach to connecting a medical device to two or more physiologic sensors is disclosed in U.S. Pat. No. 5,593,430 issued to Renger. The disclosed approach involves connecting each of the sensors in parallel to a two conductor lead.
Various implementations of systems for sensing blood oxygen and pressure, or for interconnecting one or more physiologic sensors in an implantable medical device are known in the art. Some examples of such sensors may be found in the patents, patent applications or publications listed in Table 1 below. Note that we admit none of the patents, patent applications or publications set forth in Table 1 below as necessarily constituting prior art in respect of the present invention.
TABLE 1
Issue/Publication
Patent/Document No.
Inventor(s)
Date
H1114
Schweitzer et al.
December 1, 1992
B1 4,467,807
Bornzin
June 30, 1992
3,746,087
Lavering et al.
July 17, 1973
3,847,483
Shaw et al.
November 12, 1974
4,114,604
Shaw et al.
September 19, 1978
4,202,339
Wirtzfeld et al.
May 13, 1980
4,399,820
Wirtzfeld et al.
August 23, 1983
4,407,296
Anderson
October 4, 1983
4,421,386
Podgorski
December 20, 1983
4,444,498
Heinemann
April 24, 1984
4,467,807
Bornzin
August 28, 1984
4,523,279
Sperinde et al.
June 11, 1985
4,554,977
Fussell
November 26, 1985
4,623,248
Sperinde
November 18, 1986
4,651,741
Passafaro
March 24, 1987
4,697,593
Evans et al.
October 6, 1987
4,727,879
Liess et al.
March 1, 1988
4,730,389
Baudino et al.
March 15, 1988
4,730,622
Cohen
March 15, 1988
4,750,495
Moore et al.
June 14, 1988
4,791,935
Baudino et al.
December 20, 1988
4,807,629
Baudino et al.
February 28, 1989
4,807,632
Liess et al.
February 28, 1989
4,813,421
Baudino et al.
March 21, 1989
4,815,469
Cohen et al.
March 28, 1989
4,827,933
Koning et al.
May 9, 1989
4,830,488
Heinze et al.
May 16, 1989
4,877,032
Heinze et al.
October 31, 1989
4,903,701
Moore et al.
February 27, 1990
4,967,755
Pohndorf
November 6, 1990
5,005,573
Buchanan
April 9, 1991
5,040,538
Mortazavi
August 20, 1991
5,052,388
Sivula et al.
1 October 1991
5,058,586
Heinze
October 22, 1991
5,067,960
Grandjean
November 26, 1991
5,113,862
Mortazavi
May 19, 1992
5,176,138
Thacker
January 5, 1993
5,199,428
Obel et al.
6 April 1993
5,267,564
Barcel et al.
December 7, 1993
5,275,171
Barcel
January 4, 1994
5,312,454
Roline et al.
May 17, 1994
5,324,326
Lubin
28 June 1994
5,329,922
Atlee, III
July 19, 1994
5,342,406
Thompson
August 30, 1994
5,358,519
Grandjean
October 25, 1994
5,377,524
Wise et al.
3 January 1995
5,411,532
Mortazavi
May 2, 1995
5,438,987
Thacker et al.
August 8, 1995
5,490,323
Thacker et al.
February 13, 1996
5,535,752
Halperin et al.
July 16, 1996
5,564,434
Halperin et al.
October 15, 1996
5,556,421
Prutchi et al.
17 September 1996
WO 80/01620
Kraska et al.
August 7, 1980
5,593,430
Renger
January 14, 1997
5,601,611
Fayram et al.
February 11, 1997
5,743,267
Nikolic et al.
April 28, 1998
5,758,652
Nikolic et al.
June 2, 1998
5,788,647
Eggers
August 4, 1998
All patents listed in Table 1 hereinabove are hereby incorporated by reference herein, each in its respective entirety. As those of ordinary skill in the art will appreciate readily upon reading the Summary of the Invention, the Detailed Description of the Various Embodiments, and the Claims set forth below, at least some of the devices and methods disclosed in the patents of listed herein may be modified advantageously in accordance with the teachings of the present invention.
SUMMARY OF THE INVENTION
The present invention has certain objects. That is, various embodiments of the pre

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