U.S. patent number 3,672,352 [Application Number 04/814,760] was granted by the patent office on 1972-06-27 for implantable bio-data monitoring method and apparatus.
Invention is credited to George D. Summers.
United States Patent |
3,672,352 |
Summers |
June 27, 1972 |
IMPLANTABLE BIO-DATA MONITORING METHOD AND APPARATUS
Abstract
A system for monitoring a condition of a body function or organ
or device implanted within a body includes a sensor or transducer
responsive to that condition or a change in it connected to a
signal means capable of producing an audible, visual or heat signal
of variable intensity indication to control the energization of the
signal means from a source of energy. The sensor and signal means
and the source of energy may be implanted within the body with the
signal means sufficiently near the surface of the skin so that its
energized state may be detected from outside the body.
Inventors: |
Summers; George D. (Bethesda,
MD) |
Family
ID: |
25215939 |
Appl.
No.: |
04/814,760 |
Filed: |
April 9, 1969 |
Current U.S.
Class: |
600/476; 600/586;
607/33 |
Current CPC
Class: |
A61B
5/0031 (20130101); A61B 5/0002 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); A61f 005/00 () |
Field of
Search: |
;128/2,2.5D,2.5E,2.5F,2.5N,2.5Q,2.5R,2.5S,2.5T,2.6E,2.6F
;250/22R,215 ;340/378,379,380 ;116/70 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Van der Weide et al., "Medical & Biological Engineering," vol.
6, No. 4, Aug. 1968, pp. 447 & 448.
|
Primary Examiner: Kamm; William E.
Claims
What is claimed as new and desired to be secured by Letters Patent
of the United States is:
1. A method of indicating a condition inside a body comprising the
steps of: implanting sensing means sensitive to such a condition;
implanting light emitting means inside the body at a distance
whereby said light emitting means, when energized, will be
detectable through the skin of the body; interconnecting said
sensing means and said light emitting means; providing a source of
energy for said light emitting means so that said light emitting
means will be energized in response to the change in the condition
in the body sensed by said sensing means; sensing the condition
within the body with said sensing means; emitting light from said
light emitting means through the skin of the body when said light
emitting means is energized in response to a change in the
condition in the body sensed by said sensing means; and detecting
from outside the body the light emitted from said light emitting
means.
2. The method of claim 1 including the step of implanting switch
means in the body and interconnecting said switch means between
said sensing means and said light emitting means and the further
step of actuating said switch means to permit energization of said
light emitting means.
3. The method of claim 1 including the step of implanting said
source of energy for said light emitting means in the body.
4. The method of claim 1 wherein said step of providing a source of
energy comprises implanting an energy receiver in the body and the
steps of bringing an energy transmitter external to the body in
proximity to said energy receiver and activating said energy
transmitter to cause energy to be transmitted to said energy
receiver.
5. The method of claim 1 including the step of implanting switch
means in the body and interconnecting said switch means between
said sensing means and said light emitting means and the further
steps of providing external actuating means and actuating said
switch means by said actuating means when it is desired to sample
the condition within the body.
6. The method of claim 1 including the step of implanting at least
one additional light emitting means in the body and interconnecting
said additional light emitting means to said sensing means to
provide at least one additional indication of changes in the
condition within the body.
7. A bio-data transmission system having a portion thereof
implantable within a body comprising means adapted to be implanted
within the body for emitting light signals in response to different
sensed conditions within the body, sensing means adapted to be
implanted within the body and connected in circuit with said light
emitting signal means to control the level and interval of
excitation of said light emitting signal means, a source of energy
having at least one portion thereof adapted to be implanted within
the body and operatively connected to said signal means and said
sensor, and protective coating means coating said sensing means,
said signal means and the portion of said source of energy that is
adapted to be implanted within the body to protect said signal
means, said sensing means and said portion of said energy source
from harmful action of the body.
8. The bio-data transmission system of claim 7 wherein said light
emitting signal means comprises means for providing an indication
of a discrete change in a condition within the body.
9. The bio-data transmission system of claim 7 including a light
signal receiver locatable outside the body responsive to the light
emitted outside the body from said light emitting signal means.
10. The bio-data transmission system of claim 7 wherein said light
emitting signal means comprises means for providing an indication
of change throughout a range of a condition in the body.
11. The bio-data transmission system of claim 10 wherein said light
emitting signal means comprises a plurality of signal devices
connected in parallel with the output of said sensor.
12. The bio-data transmission system of claim 11 wherein said light
emitting signal means comprises light emitting elements capable of
emitting light of different colors.
13. The bio-data transmission system of claim 7 wherein said source
of energy comprises an energy receiver adapted to be implanted
within the body and an energy transmitter capable of being located
exterior to the body to transmit energy to said energy
receiver.
14. The bio-data transmission system of claim 13 wherein said
energy receiver comprises a receiving coil and said energy
transmitter comprises a radio frequency signal generator and a
transmitting coil operatively connected to said radio frequency
signal generator.
15. The bio-data transmission system of claim 13 wherein said
energy transmitter comprises a light source and said energy
receiver comprises at least one photovoltaic cell adapted to be
implanted within the body.
16. The bio-data transmission system of claim 7 wherein said source
of energy comprises a battery adapted to be implanted within the
body.
17. The bio-data transmission system of claim 16 including a switch
adapted to be implanted within the body connected in electrical
circuit with said light emitting signal means, said sensing means
and said battery.
18. The bio-data transmission system of claim 7 including a
calibrated standard adapted to be implanted within the body and a
switch adapted to be implanted within the body and to alternatively
connecting either said calibrated standard or said sensing means to
said light emitting means.
Description
BACKGROUND OF THE INVENTION
This invention relates to the art of obtaining information about
internal conditions in bodies. More specifically, it relates to
devices which can be implanted within bodies and provide
extracorporeal indications of internal conditions.
Obtaining information from inside the body without opening the skin
has been a problem since the beginning of the art of healing.
Historically, medical practitioners have been able to learn much
from such factors as patient's skin color, his temperatures,
respiration and heart beat. They could look into his mouth, ears
and eyes. The normal or abnormal fluids or solids given up by the
body could be examined. In addition, the body could be probed with
the hands and fingers.
Beyond this many clinical and laboratory instruments have aided
greatly in the diagnosis and treatment of many diseases and
conditions. Such instruments range from the simple stethescope,
thermometer, etc. to complex machines for inducing or measuring
ionizing radiation, ultrasonic pulses and electrical currents. Most
of these instruments and methods have been extracorporeal, and in
many cases are not always capable of obtaining all the data
required. In some cases, data is obtained by a surgical exploration
and direct visual examination. In other cases, instruments are
temporarily induced into the body to obtain samples of blood or
other matter or to make related measurements.
When the need for the data is on a one time only basis or is only
very rarely required, the above type of data acquisition technique
may be adequate. However, when the need for obtaining data is
permanent or very frequent, many of the procedures would become
intolerable to the patient and/or to the doctor.
Work has been done to perfect means whereby wires and tubes can be
maintained permanently through the skin. However, the use of this
so-called percutaneous "hardwire" telemetry to sensors within the
body carries too high a risk of infection for routine use. In
addition, there is often the problem, particularly encountered in
connection with laboratory animals, of having the wires protruding
through the skin torn out.
Some work has been done in implanting various kinds of sensing
devices within the body and deriving information therefrom.
However, these have been relatively complicated systems for use in
laboratories and very frequently are intended to be implanting only
for short periods of time. Many conditions and diseases which are
to be monitored and cared for adequately or to warn a patient or a
physician exist where a more or less permanent implant of a
telemetering or communications system is desirable. The criteria
for such systems would include that there be a suitable power
source, that it be of small size and weight, that it be reliable
and capable of surviving within the body. Other criteria would
require such means to have a long life, provide a reliable signal
and that no damage be done to the body. Further, it would be
desirable that such implants be economical to assure the widest
possible use and that it not interfere or that it interfere as
little as possible with a patient's conduct of his normal life.
Reference is made herein to the device described in my co-pending
application Ser. No. 741,117, filed June 27, 1968, now issued as
U.S. Pat. 3,527,220 in which a signaling device is shown in
conjunction with an implantable pump for the administration of
drugs and the like and actuated by means external to the body.
Therefore, in accordance with this invention, there is provided a
signal system capable of implantation within a body which is small
in size, reliable in operation and capable of long survival.
It is an object of this invention to provide a method for
indicating a condition inside a body.
It is another object of this invention to provide a signaling
system implantable within a body which may be arranged to provide
readily ascertainable indications of a condition or change in
condition within a body.
It is a further object of this invention to provide a signaling
system implantable within a body which may be arranged to provide
indications of a series of changes in an internal condition.
It is still a further object of this invention to provide a
signaling system implantable within a body which is capable of
providing information about the condition of a body function or
organ or of another device implanted within the body.
These and other objects of the invention are achieved by providing
a signaling system including a sensor responsive to an internal
condition and connected to a signaling means located near the
surface of the body so that an indication of a change in condition
produced by the signaling means will be transmitted through the
skin and sensed externally and which also includes a source of
energy which may be either implanted or external to the body.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention itself is set forth in the claims forming a part of
this application. For purposes of illustration various embodiments
of the invention are described and shown in the drawings in
which:
FIG. 1 is a block diagram illustration of an implantable signaling
system in accordance with the invention;
FIG. 2 is a block diagram illustration of another embodiment of a
signaling system in accordance with the invention;
FIG. 3 is a block diagram illustration of still another embodiment
of a signaling system in accordance with the invention;
FIG. 4 is a block diagram illustration of one form of the
embodiment of the invention illustrated in FIG. 1;
FIG. 5 is a block diagram illustration of another embodiment of the
invention;
FIG. 6 is a block diagram illustration of another form of the
embodiment of the invention illustrated in FIG. 1;
FIG. 7 is a block diagram illustration of another embodiment of the
invention illustrated in FIG. 1;
FIG. 8 is a block diagram illustration of another embodiment of the
invention;
FIG. 9 is a schematic illustration of the electrical circuit of an
embodiment of the invention;
FIG. 10 is a schematic illustration of the electrical circuit of
another embodiment of the invention; and
FIG. 11 is a schematic illustration of the electrical circuit of
still another embodiment of the invention.
An illustration of the general organization of a signaling system
in accordance with the invention is shown in FIG. 1. In this
figure, a signaling means 2 capable of producing an audible, visual
or heat signal is implanted in the body, preferably at a point just
below the surface of the skin 4. The signal means is selected to
produce a signal of variable intensity. By "variable intensity" is
meant a condition of the signal means which ranges from the
condition of being completely off, i.e., not energized to the
condition where it is on or producing signals in response to the
output of the sensor. Intended to be encompassed within this
meaning is the situation where the signal is going from off to on
repeatedly within a time of interval so that information about a
condition may be ascertained from the number of times it is on or
the interval between on times. Thus, if a visual signal is used,
the frequency at which light appears and is detected may be a
source of information about a condition.
The precise location is not critical but the factors to be
considered in locating this device include the ability of the skin
and other body tissue to transmit the signal. Therefore, in order
to achieve optimum output from the signaling means, it is desirable
to locate it as close to the surface of the skin as possible.
If the signal means selected develops a visual or light indication,
then such light emitting means may take the form of a so-called
light-emitting diode which is currently on the market. Such diodes
are made of gallium arsenide phosphide. These diodes require a
forward bias of about 11/2to 2 volts. They are less than a tenth of
an inch in diameter and have an overall length of about an eighth
of an inch. They are rated at 50 feet-Lamberts brightness at a
forward bias of 1.65 volts and a forward current rating of 50
milliamperes. It has been found that the region of peak
transparency of the skin is in the 750 to 1,250 millimicron range.
This region is just above the visible spectrum in the infrared
range so that the particular diode suggested represents a good
compromise if its wavelength is in the 600 to 700 millimicron
range; that is, near the range of peak skin transparency. When this
device is used, rich red color appears on the surface of the skin
which the eye may easily detect.
It may be desirable to use light-emitting diodes producing more
light in the visible range, as, for instance, when a series of such
light signals are implanted to provide information about different
levels of changing or changeable conditions inside the body.
Devices for this purpose that are presently available are diodes
capable of emitting green and amber lights.
If an audible signal producing device is desired, a vibrating
crystal or ceramic element energized in the audio range by an
exiting coil may be used and, when energized, will produce a signal
which may be detected by microphones external to the body.
A suitable heat signal may be provided by the use of an appropriate
electric heating element, the output of which may be measured by a
temperature sensitive device external to the body. When such an
element is used, it should be operated at temperatures which will
avoid discomfort to the host body and damage to surrounding
tissue.
A signaling system in addition to the signal 2 would also include a
source of energy 6 and sensing means such as a sensor or transducer
8. The source of energy 6 may be itself implanted within the body
or may include elements both implanted and external to the body.
The implantable sensor 8 may take any number of forms depending
upon the condition it is decided to monitor. Generally speaking,
the thing being monitored may be a body organ or fluid or may be
some other device implanted within the body such as an artificial
organ, a pump or a valve. Conse-quently, the sensor may be a device
responsive to changes in pressure, temperature, volume, flow rate,
conductivity, motion, position or the condition of an electrical
circuit. When connected to the signaling means 2 in the series
arrangement shown in FIG. 1, this sensor will control the flow of
electrical energy to the signaling means causing it to be energized
or de-energized or energized at various levels.
By way of specific illustration the sensor 8 can take the form of a
pressure sensitive device placed in the outlet of an implanted pump
operating within the body. The sensor could be responsive to a
decrease or an increase in the pressure of the fluid being pumped
to provide a signal which may be ascertained externally so that
corrective action can be taken if necessary. Alternatively, the
sensor could be a switch mounted on the rotor of the pump and
operated to a closed position if the pump should cease operation to
provide the desired indication. In still another application, the
sensor could be a pressure sensitive device measuring blood
pressure and providing an indication if the pressure either falls
or rises above predetermined values.
When implanted, all portions of the system which are implanted
should include two forms of protection, one designated by the
number 50 to protect the system itself from the harmful action of
any body fluids and to protect the body by electrically insulating
the system from the body and the other to insure that there is no
harmful interaction with the materials from which the elements are
formed with body tissue or fluids. A suitable outer coating for the
elements of the system and any connecting wires may be made of a
silicon rubber, such as "Silastic," manufactured by the Dow Corning
Company. Where this material is applied over the signaling means 2
it should be in a transparent form in the event a visual signal is
used in order not to impair the effectiveness of the signaling
means. A suitable inner coating may be "Dacron" or "Teflon" or an
epoxy which have been found to be compatible with body tissues and
fluids. If such materials are to be in contact with the blood or
the blood stream, they should be non-thrombogenic.
Appropriate anchoring devices such as wings or tabs of a fibrous or
net like material can be molded on the elements of the system. It
has been found that body tissue will grow through these anchoring
devices to secure an implanted device in position.
It is contemplated that the signal produced may be used in either
an analogue or digital fashion. That is, it can be used to derive
representations of a series of changes in a condition or to derive
a signal which merely indicates that the condition is in one state
or the other. FIG. 2 illustrates an embodiment of an analogue
device wherein three signal means, 2, 2' and 2 ", are connected in
parallel between the source 6 and the sensor 8. Thus, if the sensor
8 is a temperature sensitive resistor, such as a thermistor, the
signal means 2, 2' and 2" can be connected in the circuit to be
energized at various levels of output from the sensor 8 and thus
provide a more proportional or analogue signal representative of
the change in condition. If the signal means selected produce their
signals at the same level of applied voltage, they may be arranged
to respond to various changes in the condition being sensed by
connecting weighted resistors intermediate the means and the
sensor. The resistor having a value of R may be connected between
signal means 2" and the sensor 8 while resistors having values of
R/2 and R/4 may be connected between the sensor and the signal
means 2' and 2 respectively. Alternatively, signal means producing
signals at different voltage levels may be used.
FIG. 3 is an illustration of another embodiment of the analogue
form of the invention. In this embodiment a single signal means 2
is used in cooperation with a signal evaluator 10 external to the
body. Thus, if the signal is an audible signal, the signal
evaluator may be constituted by a suitable audio pickup, such as a
microphone, the output of which is supplied to an appropriate
indicating meter having a calibrated scale. Likewise, if the signal
means 2 produces a visual or heat signal, the signal evaluator 10
may constitute a light sensitive element, the output of which is
supplied to an appropriate calibrated instrument.
In FIG. 4 the embodiment illustrated is one in which the source of
energy is not implanted completely within the body, but rather
comprises a first element, namely, an energy transmitter 12
external to the body and a second element, an energy receiver 14,
implanted within the body and interconnected to the signal means
2,. When this arrangement is used, it would not be necessary to
implant a source of energy such as a battery within the body and
have the problem of opening up the body to implant new batteries or
finding ways to recharge the battery within the body.
FIG. 6 illustrates one form the embodiment of FIG. 4 may take. In
this form, the energy transmitter 12 includes a signal generator 16
producing electrical signals of radio frequency which are supplied
to a transmitting coil 18 and received by the receiver 14 inside
the body.
FIG. 7 illustrates another form of this embodiment of the
invention. In this figure, the energy transmitter constitutes a
light source 20 external to the body while the energy receiver
comprises a plurality of photovoltaic cells 22. When the light
source 20 is energized, a voltage produced by the photovoltaic
cells 22 will be available to energize the signal means 2. Using
this arrangement and the form illustrated in FIGS. 5 and 6, the
implanted signaling system can be interrogated as desired by
bringing the external energy source in proximity to the implanted
energy receiver to provide energy for the excitation of the signal
means if the sensor 8 has responded to the presence or absence of
the condition, as determined by its design.
If it is desired to implant a battery energy source within the body
but at the same time it is desired to conserve the battery so as to
reduce the frequency of its replacement or recharging, the
embodiment shown in FIG. 5 has a particular utility. In this form,
a battery 24 and normally opened switch 26 are implanted and
connected in the series circuit with the implantable sensor 8 and
signal means 2. The switch may include a magnetic element
responsive to the presence of a magnetic field produced by a switch
actuator 28 external to the body. Using this form of the invention
when it is desired to sample the condition, the switch actuator 28
may be brought in proximity to the switch 26 actuating or closing
the circuit and permitting the output of the sensor 8 to control
the energization of the signal means 2.
Under certain circumstances it may be desirable to obtain a
relatively high degree of precision in monitoring the condition
selected. For this purpose the embodiment of FIG. 8 may be used.
Included in this embodiment is a switch 29 capable of closing a
circuit to the sensor 8, or to a calibrated standard 30, or
shorting both of these elements and closing a circuit directly to
the signal means 2. As with the embodiment of FIG. 5, the
implantable switch 29 may be actuated by a means external to the
body so as to selectively connect the sensor 8 to the calibrated
standard in circuit with the signal means 2 and by this means
provide a reference to which the output of the signal means in
response to the condition of the sensor may be compared. By
operating the switch 29 to short the sensor 8 and standard 30 the
signal means will be connected directly to the source of energy. In
this way a greater resolution of measurement may be obtained. Thus,
when directly connected to the source, the signal means will be at
its highest level of intensity, and when connected to the sensor,
it will be at an intermediate value, and when connected to the
standard, it will be at a lower value. Additionally, this
arrangement affords the opportunity to test the elements in the
circuit. If the signal means does not function at all, the switch
may be operated to its various positions to sequentially connect
the signal means to the sensor, standard or directly to the source
as an aid in identifying a particular component which may have
failed.
It should be understood that various combinations of the apparatus
illustrated in these figures may be made. Thus, a source of energy
may be internal or external. If internal, it may include a battery,
fuel cell or a radioactive isotope fueled source from which
electrical energy may be derived by heat or direct conversion. If
external, it may comprise an inductive or radiative generator,
means coupling energy into the circuit or a source of light. Any
one of these may be combined with any type of sensor and with any
type of signal means using audible, visual or heat producing
indications or be of the binary or analogue variety. Alternatively,
a mechanical source of energy such as a wound spring can be
provided to actuate an audible signal device.
FIGS. 9, 10 and 11 illustrate schematically various embodiments of
the invention. In FIG. 9, the source of energy includes a rotatable
magnet 32 selected to have a strength such that when it is rotated
in proximity to the coil 34 a current will flow in the coil. The
sensor in this form comprises a normally open switch 36 and the
signal means is a light-emitting diode 38. The switch 36 may be a
pressure closable switch or may be closed in response to the
rotation or lack of it of a pump rotor or the like and when closed
will complete a circuit through the diode 37 to the diode 38. The
diode, when sufficient forward voltage is applied thereacross, will
emit light in the visible or near infrared ranges.
In FIG. 10, the energy source is a transformer 40 wherein the
primary 42 is external to the body while the secondary is implanted
within the body. The circuit also may include a protective diode 46
to prevent application of reverse voltage of the light-emitting
diode 38.
The circuit of FIG. 11 is a series circuit including a battery 47
and a normally opened switch 48. The switch 48 may be of the
magnetically operated type and closed by bringing a magnet to the
vicinity of the implanted circuit.
While various embodiments of the invention have been described and
illustrated, these are intended only as examples.
* * * * *