Telemetric differential pressure sensing method

• US 4,206,762 A
• Filed: 04/13/1978
• Issued: 06/10/1980
• Est. Priority Date: 06/21/1976
• Status: Expired due to Term

• Current Assignee: Radionics, Inc. (Integra LifeSciences Holdings Corporation)
• Original Assignee: Eric R. Cosman
• Inventors: Cosman, Eric R.
• Primary Examiner(s): Howell, Kyle L.
• Application Number:
  US05/895,956
• Time in Patent Office: 789 Days
• Field of Search: 128/675, 128/660, 128/673, 128/748, 73/701, 73/708, 73/716-719, 73/722
• US Class Current: 600/438
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

A differential pressure sensing device is fully implanted in the body of a patient to monitor internal pressure such as intracranial pressure. A movable element in the sensor communicates with the internal pressure of the body to be measured on one side and the atmospheric pressure on the other, the latter communicated through the intact skin and a nearly coplanar membrane. The movable element'"'"'s differential pressure dependent displacement changes a physical characteristic of the sensor, such as the resonant frequency of a tuned L-C circuit, and the change is detected external to the body by a radiating detector system, such as a frequency swept radio frequency oscillator, by which the internal pressure is read out.

Claims

1. A method for remotely detecting in vivo pressure, said method comprising the steps of:

(a) implanting in a living body a differential pressure sensor comprising;

(1) a housing having means defining an opening extending therethrough;

(2) flexible diaphragm means extending across said housing opening and being secured with respect to said housing, said diaphragm means communicating with pressures in two separate regions external to the sensor with the pressure in one of the regions being an internal bodily pressure when the sensor is implanted in a living body;

(3) means for defining a mechanical contact reference position of said flexible diaphragm means with respect to said housing; and

,

(4) means having a preselected, detectable parameter, the preselected, detectable parameter being detectable by detection means located outside the living body, said means having a preselected, detectable parameter being at least in part cooperatively connected to and movable with said flexible diaphragm means so that said preselected detectable parameter will change with movement of said flexible diaphragm means, such that the value of said preselected, detectable parameter changes as a known function of the displacement of said flexible diaphragm means from the reference position, said displacement being a known function of the differences in the external pressures on said flexible diaphragm means;

(b) calibrating the implanted sensor by;

(1) manipulating the sensor through the intact skin of the body to cause the flexible diaphragm means to assume the mechanical contact reference position;

(2) remotely detecting the value of the preselected, detectable parameter when the flexible diaphragm means is at the mechanical contact reference position;

(3) terminating the manipulation of the sensor; and

,

(c) thereafter remotely detecting any change in the value of the preselected, detectable parameter from the value at the mechanical contact reference position, said detecting being accomplished without any connection to the sensor which requires a break in the skin, whereby a change in said value represents the difference in pressures on the flexible diaphragm means.

2. A method for remotely detecting in vivo pressure, said method comprising the steps of:

(a) implanting in a living body a differential pressure sensor comprising;

(1) a housing having means defining an opening extending therethrough;

(2) flexible diaphragm means extending across said housing opening and being secured with respect to said housing, said flexible diaphragm means communicating with pressures in two separate regions external to the sensor with the pressure in one of the regions being an internal bodily pressure when the sensor is implanted in a living body;

(3) means for defining a mechanical contact reference position of said flexible diaphragm means with respect to said housing, said mechanical contact reference position corresponding to a known pressure relationship between the pressures in the two separate regions; and

(4) means having a preselected, detectable parameter, the preselected, detectable parameter being detectable by detection means located outside the living body, said means having a preselected, detectable parameter being at least in part cooperatively connected to and movable with said flexible diaphragm means so that said preselected detectable parameter will change with movement of said flexible diaphragm means, such that the value of said preselected, detectable parameter changes as a known function of the displacement of said flexible diaphragm means from the mechanical contact reference position, said displacement being a known function of the difference in the external pressures on said flexible diaphragm means;

(b) calibrating the implanted sensor by;

(1) manipulating the sensor to cause the flexible diaphragm means to assume the mechanical contact reference position;

(2) remotely detecting the value of the preselected, detectable parameter when the flexible diaphragm means is at the mechanical contact reference position;

(3) terminating the manipulation of the sensor; and

,

(c) thereafter remotely detecting any change in the value of the preselected, detectable parameter from the value at the mechanical contact reference position, said detecting being accomplished without any connection to the sensor which requires a break in the skin, whereby a change in value represents the difference in pressures on the flexible diaphragm means.

3. A method for measuring an in vivo pressure, said method comprising the steps of:

(a) implanting in a living body a differential pressure sensor comprising;

(1) a housing having an opening therein;

(2) a flexible diaphragm means having a first side and a second side, said flexible diaphragm means extending across said housing opening and being secured with respect to said housing so that when the sensor is implanted in the living body, the first side of said flexible diaphragm means is in pressure communication with an internal bodily pressure to be measured and the second side of said flexible diaphragm means is in mechanical pressure communication with the interior side of a portion of skin and thereby in pressure communication across the intact skin with atmospheric pressure external to the living body on the exterior side of the portion of skin, whereby the motion of said flexible diaphragm means is responsive to the changes in the difference between said internal bodily pressure and atmospheric pressure on said exterior side of the portion of skin whereby the sensor is compensated for said atmospheric pressure;

(3) means defining a mechanical contact reference position with respect to said housing of said flexible diaphragm means, said mechanical contact reference position corresponding to a known pressure relationship between the pressures in the two separate regions;

(4) means having a preselected, detectable parameter, the preselected, detectable parameter being detectable by detection means located outside the living body, said means having a preselected, detectable parameter being at least in part cooperatively connected to and movable with said flexible diaphragm means so that said preselected detectable parameter will change with movement of said flexible diaphragm means, such that the value of said preselected, detectable parameter is detectable by detection means external to said living body, said preselected, detectable parameter changing as a known function of changes in said difference of pressures on said flexible diaphragm means from the predetermined pressure relationship at said mechanical contact reference position;

(b) calibrating the implanted sensor by;

(1) manipulating the sensor through the intact skin of the body to cause the flexible diaphragm means to assume said mechanical contact reference position;

(2) remotely detecting the value of the preselected, detectable parameter when the flexible diaphragm means is at said mechanical contact reference position;

(3) termination of the manipulation of the sensor; and

,

(c) thereafter remotely detecting any change in the value of the preselected, detectable parameter from the value at the mechanical contact reference position by the external detection means, said detecting being accomplished without any connection to the sensor which requires a break in the skin, whereby a change in value is related to the difference in said pressures on said flexible diaphragm means.

4. The method of claim 3 wherein said flexible diaphragm means comprises a multiplicity of pressure responsive diaphragms that are incompressibly motion coupled together, and further comprising the step of implanting said sensor in the living body so that at least one side of one of said pressure responsive diaphragms is in pressure communication with said internal bodily pressure to be measured, and at least one side of one of said pressure responsive diaphragms is in mechanical contact with said interior side of said portion of skin.

5. The method of claim 3 in which said means for defining a mechanical contact reference position comprises a mechanical stop for at least a portion of said flexible diaphragm means relative to said housing, and further comprising the step of varying said known external variable pressure until said flexible diaphragm means is driven against said mechanical stop.

6. The method of claim 3 wherein said reference position defining means includes electrode contacts that touch at a reference position relative to said housing of (i) at least a portion of said diaphragm means or (ii) a portion of said first or said second fluid communication means, said means having a preselected, detectable parameter includes circuit means within said sensor cooperative with said electrode contacts further comprising the step of forcing said contacts to touch to produce a detectable characteristic response of said circuit means.

7. The method of claim 3 further comprising the step of establishing said mechanical contact reference position so that said position corresponds to the balance of pressures in communication with said first and said second sides of said flexible diaphragm means.

8. The method of claim 7 wherein said preselected, detectable parameter is selected to provide changes in the parameter with changes in the difference in pressures on said first and said second sides of said flexible diaphragm means.

9. The method of claim 3 wherein said sensor is manipulated to establish its zero point calibration by pressing on the intact skin above the sensor so that said flexible diaphragm means assumes said mechanical contact reference position.

10. The method of claim 3 further comprising the step of precalibrating said preselected, detectable parameter as a function of the difference in pressures on said first and said second sides of said flexible diaphragm means.

11. The apparatus of claim 3 further comprising the step of precalibrating said external detection means to read the internal bodily pressure automatically by precalibrating said implanted sensor'"'"'s preselected, detectable parameter as a function of the difference in pressures on said first and second sides of said flexible diaphragm means.

12. The method of claim 3 wherein said means having a preselected detectable parameter comprises electronic circuit means, said preselected detectable parameter being a characteristic response parameter of said electronic circuit means further comprising the step of detecting said preselected detectable parameter by electromagnetic coupling to an electronic apparatus means located external to said living body.

13. The method of claim 3 wherein said electronic circuit means comprises a resonant electronic circuit, and said preselected, detectable parameter being a parameter of the resonant frequency response of said resonant circuit and detecting the parameter of the resonant frequency of said resonant circuit.

14. The method of claim 3 wherein said resonant electrical circuit is a parallel resonant circuit and wherein said preselected, detectable parameter is the resonant frequency of said parallel resonant circuit and detecting the parameter of the resonant frequency of said parallel resonant circuit.

15. The method of claim 3 further comprising the step of enabling bodily fluid from an internal bodily region to communicate with one side of said flexible diaphragm means such that pressure of said bodily fluid is sensed.

16. The method of claim 3 wherein said sensor housing has an extension that forms part of a chamber on the first side of said flexible diaphragm means, and wherein a second flexible diaphragm means extends across the end of said housing opening and is fluid pressure sealed with respect to said housing so that said first and second diaphragm means and a portion of said housing form a closed volume, said closed volume being filled with a fluid to provide incompressible motion coupling of said two diaphragm means, and further comprising the step of implanting said sensor so that said second diaphragm means is in pressure communication with said internal bodily pressure to be measured.

17. A method for remotely detecting in vivo pressure, said method comprising the steps of:

a. implanting in a living body a differential pressure sensor comprising;

(1) a housing having means defining an opening extending therethrough;

(2) flexible diaphragm means extending across said housing opening and being secured with respect to said housing;

said flexible diaphragm means communicating with pressures in two separate regions external to the sensor that are separated by the flexible diaphragm means with the pressure in one of the regions being an internal bodily pressure when the sensor is implanted in a living body;

(3) means for defining a reference position of said flexible diaphragm means with respect to said housing; and

,

(4) means having a preselected, detectable variable parameter that is a known function of the displacement of said flexible diaphragm means from the reference position, said displacement being a known function of the differences in the external pressures on said flexible diaphragm means;

b. calibrating the implanted sensor by;

(1) manipulating the sensor through the intact skin of the body to cause the sensor to assume the reference position;

(2) remotely detecting the value of the variable parameter when the sensor is in the reference position;

(3) terminating the manipulation of the sensor;

c. thereafter remotely detecting any change in the value of the variable parameter from the value at the reference position without any connection to the sensor which requires a break in the skin, said change in value representing the differences in pressures on the flexible diaphragm means of the sensor.

18. A method for remotely detecting in vivo pressure, said method comprising the steps of:

a. implanting in a living body a differential pressure sensor comprising;

(1) a housing having means defining an opening extending therethrough;

(2) flexible diaphragm means extending across said housing opening and being secured with respect to said housing;

said flexible diaphragm means communicating with pressures in two separate regions external to the sensor that are separated by the flexible diaphragm means with the pressure in one of the regions being an internal bodily pressure when the sensor is implanted in a living body;

(3) means for defining a reference position of said flexible diaphragm means with respect to said housing; and

,

(4) means having a preselected, detectable variable parameter that is a known function of the displacement of said flexible diaphragm means from the reference position, said displacement being a known function of the differences in the external pressures on said flexible diaphragm means;

b. calibrating the implanted sensor by;

(1) manipulating the sensor to cause the sensor to assume the reference position;

(2) remotely detecting the value of the variable parameter when the sensor is in the reference position;

(3) terminating the manipulation of the sensor;

c. thereafter remotely detecting any change in the value of the variable parameter from the value at the reference position without any connection to the sensor which requires a break in the skin, said change in value representing the difference in pressures on the flexible diaphragm means of the sensor.