U.S. patent number 3,926,198 [Application Number 05/574,199] was granted by the patent office on 1975-12-16 for cardiac pacer.
This patent grant is currently assigned to ARCO Medical Products Company. Invention is credited to Steve A. Kolenik.
United States Patent |
3,926,198 |
Kolenik |
December 16, 1975 |
Cardiac pacer
Abstract
The forces which are imparted by a cardiac pacer to adjacent
tissues are below the threshold of troublesome difficulty when the
body is subjected to acceleration or deceleration. Such
below-threshold forces are attributed to controlling the weight of
the cardiac pacer to be less than 100 grams, and to controlling the
specific gravity to be less than 1.7. Such low density and low
weight are attainable by reason of the use of a miniaturized
oscillator featuring complementary metal oxide semiconductors
consuming such a small power that more than 5 years of life are
attainable from the thionyl chloride-lithium type of battery having
a prolonged stable voltage of at least 3.3 volts. The cardiac pacer
is thin enough to avoid troublesome bulging of the skin adjacent
the implanting location.
Inventors: |
Kolenik; Steve A. (Leechburg,
PA) |
Assignee: |
ARCO Medical Products Company
(Leechburg, PA)
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Family
ID: |
27045602 |
Appl.
No.: |
05/574,199 |
Filed: |
May 2, 1975 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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477571 |
Jun 10, 1974 |
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Current U.S.
Class: |
607/36;
429/99 |
Current CPC
Class: |
A61N
1/378 (20130101); A61N 1/37512 (20170801) |
Current International
Class: |
A61N
1/375 (20060101); A61N 1/372 (20060101); A61N
1/378 (20060101); A61N 001/36 () |
Field of
Search: |
;128/419P,419PG,419PS,419R,421,422,423 ;136/86F,153
;307/304,313 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Greatbatch et al., "IEEE Transactions on Biomedical Engineering,"
V. BME-18, No. 5, Sept. 1971, pp. 317-323..
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Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Ewbank; John R.
Parent Case Text
RELATED APPLICATION
This is a continuation-in-part of Ser. No. 477,571, filed June 10,
1974, and now abandoned.
Claims
It is claimed:
1. A cardiac pacer consisting essentially of the combination
of:
a metal casing hermetically sealing the interior zones of the
cardiac pacer from exposure to body fluids in the cavity in which
the cardiac pacer is implanted, said casing being less than 20 mm
thick, and each other orthagonal dimension being less than 60 mm,
such small dimensions permitting implantation without troublesome
bulging of the skin adjacent the cardiac pacer, said metal casing
shielding electrical components from electro-magnetic interference
and constituting a grounding electrode for the cardiac pacer;
a hermetically sealed battery chamber and a hermetically sealed
circuitry chamber within said casing;
a plurality of batteries in said battery chamber, there being an
electrical conductor transmitting battery power from each battery
to said circuitry chamber, each battery generating no gas, each
battery having a lithium anode and an electrolyte consisting
predominantly of thionyl chloride, each battery having prolonged
low impedance and constant high voltage of at least 3.3 volts
during an expected life of more than 5 years, the voltage
diminishing significantly only during the terminal period of use of
the battery, whereby detection of battery depletion is manageable,
the positive pole of the batteries being grounded to the metal
casing;
wires and pass-throughs within the casing associating at least two
batteries in parallel and assuring the redundant reliability of
parallel batteries;
a circuitry unit employing complementary metal oxide semiconductor
circuit means for producing pulses adapted to stimulate the heart,
said circuit means being electrically energized by current from
said batteries, the casing of the circuit means being grounded to
the casing of the heart pacer, said circuit means being within said
circuitry chamber, said circuit means including an output wire,
said wires and pass-throughs being electrically connected to said
circuit means;
said complementary metal oxide semiconductors and said circuit
means consuming such a small amount of power that the battery life
is more than 5 years;
electrical socket means adapted to transmit to an electrical
conduit the output from said circuit means, said electrical conduit
being adapted to transmit the output from said circuit means to a
signal-receiving zone of a heart, electrical pass-through means
connecting said output wire to said socket means; and
said combination of casing, batteries, wires, pass-throughs,
circuit means, and electrical socket means having a weight less
than 100 grams and a specific gravity less than 1.7, whereby
changes in acceleration or deceleration of a body having such
implanted cardiac pacer impart only forces which are tolerable to
tissue adjacent the cavity in which the cardiac pacer is
implanted.
2. The cardiac pacer of claim 1 in which the casing consists of
titanium.
3. The cardiac pacer of claim 1 in which the electrical socket
means is an insert within a molded organic plastic shield.
Description
FIELD OF INVENTION
This invention relates to cardiac pacers suitable for implantation
and particularly to overcoming the adverse side effects heretofore
observed in connection with prior art use of some types of
implantable cardiac pacers.
HISTORY OF PRIOR ART
In a hospital in which a patient under intensive care can receive
electrical pulse signals from an external oscillator, the size and
complexity of the signal generating apparatus is of only minor
importance. Any implantable cardiac pacer, however, must be
sufficiently miniaturized to permit surgical placement in a cavity
within the body. As used herein, the lead (or conduit or catheter)
is deemed a supplement to the pacer, although others have
designated the combination of the lead and unit generating pulses
as a "pacer". An electrical conduit, sometimes called a catheter,
transmits the electrical signals from the implanted cardiac pacer
to an appropriate signal-receiving zone of the heart. A significant
portion of implanted cardiac pacers have employed batteries
comprising mercury. Such mercury batteries generate a gas which
must be vented from the battery chamber. Such venting has
complicated the problem of preventing the eventual penetration of
body fluids into undesired portions of the cardiac pacer. The
durability of a mercury battery has permitted usage for more than a
year but generally less than 4 years. A variety of other types of
batteries, including batteries comprising a lithium anode, have
been proposed for use with cardiac pacers but the numerous problems
related to the long-term reliability has left most of the needs
unanswered.
When a heart pacer, which generally weighs from about 200 to 500
grams, is implanted in the body, the bulge in the skin at the zone
of implantation is troublesome to the patient. The tissue adjacent
the cavity in which the heart pacer is implanted is subjected to
severe forces under certain jolting conditions or other rapid
acceleration or deceleration conditions in which the inertia of the
heart pacer imparts forces to such tissue adjacent the implantation
cavity. It is well known that bruising, sense of pain, and/or other
biological phenomena are influenced by threshold phenomena. As long
as the forces are below the threshold, no biological response is
apparent but above the threshold, increasing force involves
increasing biological response.
Initially, only older patients were treated with implanted heart
pacers. As their usefulness became better known, it was recognized
that certain types of cardiac problems in children are best treated
with heart pacers. Some children needing implanted heart pacers
were too small to permit implantation of the previously available
heart pacers, and the continuing reports of deaths of such children
has provided a long-standing demand for miniaturized pacers for
cardiac patients.
SUMMARY OF THE PRESENT INVENTION
In accordance with the present invention, a cardiac pacer is
maintained at a weight less than 100 grams and at a specific
gravity less than 1.7, whereby the inertia forces attributable to
acceleration and deceleration are below the threshold of
significant trouble to the tissue adjacent the cavity of
implantation, whereby the patient may wear the implanted cardiac
pacer with greater comfort than prior art cardiac pacers. Such
small size and low specific gravity for the heart pacer are
attributable in part to the utilization of oscillator means
featuring the use of complementary metal oxide semiconductor
devices which not merely occupy a small volume, but more
particularly utilize significantly less power per day, whereby the
battery life is significantly prolonged. In accordance with the
present invention, the sub-threshold weight, sub-threshold density,
and acceptable battery life are achieved in part by the combination
of said complementary metal oxide semiconductor devices and a
battery featuring the combination of a lithium anode and a thionyl
chloride electrolyte. No gas is evolved by the generation of
current from the thionyl chloride type battery. One of the most
significant and unique characteristics of such thionyl chloride
battery is the attainment of a voltage of about 3.3 volts or more
over a battery life of more than 5 years. The invention features a
metal casing effective in shielding the electric components from
electromagnetic interference. At least two lithium thionyl chloride
type batteries may desirably be maintained in parallel with circuit
means protecting the pacer from interferences attributable to
failure of one battery while assuring redundant reliability of
parallel batteries.
The smallness of the cardiac pacer permits its implantation in an
infant a few weeks old, thus fulfilling a long-standing demand for
a pediatric pacer for cardiac patients.
The nature of the present invention is further clarified by
reference to descriptions of appropriate embodiments which merely
illustrate and do not restrict the invention.
DESCRIPTION OF DRAWINGS
FIG. 1 is a schematic drawing showing a heart pacer implanted in a
body so that the electrical conduit can direct stimulating pulse to
an appropriate zone of a heart.
FIG. 2 is a schematic drawing of a sub-threshold inertia cardiac
pacer of the present invention.
FIG. 3 is a perspective view of the heart pacer.
FIG. 4 is a schematic partially sectional end view of FIG. 3.
FIG. 5 is a schematic showing of a heart pacer exerting forces upon
the tissue of the walls of the cavity in which it is placed.
Differential acceleration and/or deceleration attributable to
differential inertia of the heart pacer relative to such adjoining
tissue during periods when rapid shifts of acceleration and/or
deceleration occur, impart such forces upon such tissues.
DESCRIPTION OF INVENTION
As shown in FIG. 1, a heart pacer 10 is electrically and
mechanically connected to an electrical conduit 11 carrying
electrical impulses to a signal reception zone 12 of a heart 13 of
a mammal 14. The electrical conduit may be directed through a vein
15 toward the signal reception zone 12. The heart pacer 10 is
implanted within a cavity 16. Heretofore, surgeons have employed
any of several cavities such as 17a, 17b, and 17c as alternative
cavities for heart pacer implantation. The small size and weight of
the heart pacer of the present invention is so much less than that
of prior heart pacers that additional locations might be suitable
for implantation.
As shown in FIG. 5, a heart pacer 510 can be positioned within a
cavity 516. The walls 18 of cavity 16 transmit mechanical forces
arising from shifting of heart pacer 10 and may compress and/or
stretch tissue 519 near cavity walls 18.
In FIG. 5, there is a schematic showing of compression of tissue
519c and the stretching of tissue 519a as a result of inertial
shifting of heart pacer 510 toward wall 18c. The specific gravity
of heart pacer 510 is greater than the specific gravity of tissue
519 so that when mammal 14 is jerked back and forth, the inertia of
heart pacer 510 is not identical to the inertia of the tissue 519,
thereby causing differential inertial forces.
Using the heavy heart pacers of the prior art, differences in
weight and/or density amongst the heart pacers appear to be of
little consequence because all heart pacers had a weight and
density above the threshold of tissue modification from such
differential inertia forces. In accordance with the present
invention, however, the weight and density of the heart pacer are
below the threshold of tissue modification from conventional
differential inertial forces, whereby the heart pacer may be worn
with significantly greater comfort and with less likelihood of
trauma, infection, inflammation, and/or other adverse developments
in the tissue adjacent the walls of the cavity in which the heart
pacer is implanted.
In accordance with the present invention, there is greatly
decreased likelihood of discomfort for the person having an
implanted heart pacer by reason of the control of the density and
weight of the heart pacer to be so low as to be below the threshold
of significant discomfort from the differential inertial forces
arising from the plausible acceleration-deceleration forces to
which the wearer might be subjected.
As shown in FIG. 2, a heart pacer 210 comprises a casing 230. Such
casing is made of titanium to assure adequate inertness to the
biological fluids. In a preferred embodiment, a partition 231
divides the interior of the casing into a circuitry chamber 232 and
a battery chamber 233. A socket 234 is adapted to receive a plug
portion of electrical conduit 11. The socket 234 is an insert
within a molded organic polymeric shield 235 which protects a wire
236 extending from upper portion of an electrical pass-through 238
through the roof 239 of circuitry chamber 232. Any electrical
signal directed to the electrical pass-through 238 is transmitted
to the upper portion 237 and thence to wire 236 to socket 234, all
electrical components being anchored within plastic shield 235. The
electrical pass-through 238 comprises a pin 240, an insulating
member 241 constructed of pure alumina, and bonded to pin 240 and
brazed to the edges of an opening in roof 239 by a brazing
connection 242. The electrical pass-through 238 has the important
advantage of providing a hermetic sealing between the circuitry
chamber 232 and the zone of plastic shield 235.
Within circuitry chamber 232 is a circuitry unit 250 having an
output wire 251 directed to said pass-through pin 240. The
circuitry unit 250 is energized by the combination of wire means
from the negative pole of the battery and positive grounding to the
casing 230, as by having a casing of the circuitry unit in
electrical contact with casing 230.
The positive pole of batteries are associated electrically with
casing 230. Wires 252 and 253 from pass-throughs 254 and 255 are
energized respectively by wire 256 from a standard battery and by
wire 257 from a supplemental battery. A negative terminal 258 of
standard battery 260 supplies current to wire 256 and thence to
pass-through 254, and wire 252 and thence to circuitry means,
conveniently designated as circuitry unit 250. Similarly,
supplemental battery 261 supplies current to wire 257, pass-through
255, wire 253 and thence to circuitry unit 250. Thus, power from
parallel batteries 260 and 261 in chamber 233 is supplied to
circuitry unit 250 in chamber 232.
Each of the pass-throughs comprises an insulating member, desirably
constructed of alumina, sealed to a pin and brazed in an opening in
partition 231, thus closely resembling the structure of
pass-through 238. Wires 262 and 263 assure the good electrical
connection between the positive posts of batteries 260, 261 with
casing 230.
It should be noted that in a preferred embodiment, the batteries
260 and 261 are connected electrically in parallel within
hermetically sealed battery chamber 233 and that the power of two
batteries is transmitted through pass-throughs 254 and 255
independently to the circuitry unit 250. Various materials, such as
body fluids from cavity 16 and/or fluids within a battery might
adversely affect operation of the circuitry unit 250 if any leakage
occurred. However, because in such preferred embodiment circuitry
chamber 232 is hermetically sealed, both from cavity 16 and from
battery chamber 233, the circuitry unit 250 has appropriate
protection against any leakage which might occur. Of particular
importance, in all embodiments, casing 30 is hermetically sealed
from cavity 16 so that the heart pacer is protected from the
effects of liquids and/or gases in cavity 16.
Particular attention is directed to the fact that battery 260
features a lithium anode 270 and an electrolyte consisting
predominantly of thionyl chloride 271. Because battery 260 features
the combination of lithium anode 270 and thionyl chloride
electrolyte 271, its voltage can be as high as 3.64 volts and is
assuredly at least 3.3 volts during a lifetime of more than 5
years. Of particular importance, the voltage of such
lithium-thionyl chloride type battery remains substantially
constant during substantially all of the life expectancy of the
battery and diminishes significantly only during a few months of
the terminal period of use of the battery. The decreasing voltage
and thus alteration of the pulse rate, provides the clue indicative
of the appropriateness of a change of batteries. It is especially
important that there be a procedure for detection of battery
depletion. The combination of lithium anode and thionyl chloride
achieves this highly significant desiderata.
In a constant rate heart pacer, the signal pulses to the heart
represent only about 1/8 of 1 per cent of the time during which the
heart pacer is implanted. Accordingly, the battery life for a heart
pacer is significantly influenced by the current drain during the
799/800's fraction of the time when no pulse is sent even though
the circuitry unit must be operative. Any demand circuitry
sensitive to the normal operation of the heart delivers impulses to
the heart during a time fraction less than the delivery time
fraction for a fixed rate heart pacer. Early types of heart pacers
were based upon circuitry energized by a voltage supply of about 6
volts. Significant power was consumed by 6 volt circuitry, thereby
shortening battery life.
Circuitry unit 250 is characterized by oscillator means employing
complementary metal oxide semiconductor devices operable at a low
voltage, so that the two lithium batteries can be connected in
parallel instead of in series. Moreover, such complementary metal
oxide semiconductor devices of the oscillator means permit the
circuitry unit to function much of the time at a current drain
which is so small that battery life can be based to a significant
extent upon the dissipation of power at the signal reception zone
12 of the heart. The power consumption during the quasi-dormant
portion of use is particularly significant in connection with
demand pacers, in which the combination of thionyl chloride-lithium
batteries and complementary metal oxide semiconductor devices are
particularly advantageous.
The nature of the cardiac pacer of the present invention can be
clarified by noting that the pacer consists essentially of the
combination of a metal casing hermetically sealing the interior
zones of the cardiac pacer from exposure to body fluids in the
cavity in which the cardiac pacer is implanted, said casing being
less than 20 mm thick, and each other orthagonal dimension being
less than 60 mm, such small dimensions permitting implantation
without troublesome bulging of the skin adjacent the cardiac pacer,
said metal casing shielding electrical components from
electromagnetic interference; at least one battery in said casing,
each battery generating no gas, each battery having a lithium anode
and an electrolyte consisting predominantly of thionyl chloride,
each battery having prolonged low impedance and constant high
voltage of at least 3.3 volts during an expected life of more than
5 years, the voltage diminishing significantly only during the
terminal period of use of the battery, whereby detection of battery
depletion is manageable; in a preferred embodiment there are wires
and pass-throughs within the casing associating at least two
batteries in parallel and protecting other circuit means from
interference attributable to failure of one battery while assuring
the redundant reliability of parallel batteries; employing
complementary metal oxide semiconductor circuit means for producing
pulses adapted to stimulate the heart, said circuit means being
electrically energized by current supplied by the combination of
wire means from the negative pole of the battery and positive
grounding to the casing of the cardiac pacer, said circuit means
desirably being within a circuitry chamber within said samll
casing; said complementary metal oxide semiconductors and said
circuitry means consuming such a small amount of power that the
battery life is more than 5 years; electrical socket means adapted
to transmit to an electrical conduit said electrical pulses
suitable for stimulating the heart; and said combination of casing,
batteries, wires, pass-throughs, circuit means, and electrical
socket means having a weight less than 100 grams and a specific
gravity less than 1.7, whereby changes in acceleration or
deceleration of a body having such implanted cardiac pacer impart
only forces which are tolerable to tissue adjacent the cavity in
which the cardiac pacer is implanted.
Various modifications of the invention are possible without
departing from the scope of the appended claims.
* * * * *