U.S. patent number 3,766,928 [Application Number 05/237,831] was granted by the patent office on 1973-10-23 for pacer with magnetic coupling means for external rate adjustment.
This patent grant is currently assigned to American Optical Corporation. Invention is credited to Jonathan E. Bosworth, Herbert E. Goldberg.
United States Patent |
3,766,928 |
Goldberg , et al. |
October 23, 1973 |
PACER WITH MAGNETIC COUPLING MEANS FOR EXTERNAL RATE ADJUSTMENT
Abstract
There is disclosed a pacer rate adjustment mechanism which
utilizes magnetic coupling. In one embodiment of the invention, a
diametrically magnetized disc magnet, mounted on a bearing, is
fixed to the shaft of a small rate-controlling potentiometer in the
pacer. The pacer rate can be adjusted by rotating a strong bar
magnet external of the patient, thereby rotating the pacer magnet
and turning the potentiometer shaft; continuous rate adjustment is
possible without requiring skin puncture. In another embodiment of
the invention, two flux-linked diametrically magnetized disc
magnets are provided in the pacer. One of them is fixed to the
potentiometer shaft and the other is connected to a needle port.
The latter magnet is turned by use of a Keith or other needle
extended through the skin of the patient; the turning of this
magnet causes the potentiometer magnet to rotate and the pacer rate
to be varied. Although this embodiment of the invention requires
skin puncture to change the pacer rate, it still offers one of the
main advantages of the first embodiment, namely, a total hermetic
seal with no possibility of fluid penetration into the pacer
circuit itself. This is accomplished by mounting the needle magnet
external of the enclosure in which the circuitry is potted, and
then covering the external magnet and needle port with the
conventional epoxy coating and/or silicone rubber boot.
Inventors: |
Goldberg; Herbert E. (Concord,
MA), Bosworth; Jonathan E. (Cambridge, MA) |
Assignee: |
American Optical Corporation
(Southbridge, MA)
|
Family
ID: |
22895385 |
Appl.
No.: |
05/237,831 |
Filed: |
March 24, 1972 |
Current U.S.
Class: |
607/27 |
Current CPC
Class: |
A61N
1/37217 (20130101); A61N 1/37512 (20170801) |
Current International
Class: |
A61N
1/375 (20060101); A61N 1/372 (20060101); A61n
001/36 () |
Field of
Search: |
;128/419P,421,422,35V,260 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Summers et al., "Journal of Association for Advancement of Medical
Instrumentation," Vol. 2, No. 3, May/June 1967, pp. 9-16..
|
Primary Examiner: Kamm; William E.
Claims
What we claim is:
1. An implantable heart pacer for stimulating the heart of a
patient, said pacer comprising a pacer circuit including a
multi-turn potentiometer, said potentiometer including a shaft
which when turned controls a continuous change in the rate at which
stimulating pulses are generated by the pacer circuit, magnet means
fixed to the potentiometer shaft for controlling the turning
thereof as the magnet is rotated, said magnet means being rotated
by rotating magnetic flux lines emanating external of said patient,
a magnetically permeable, hermetically sealed, package
encapsulating said pacer circuit for allowing rotating magnetic
flux lines which flow through said package to said magnet means to
cause said magnet means to rotate, a magnetically permeable can for
housing said magnet means, and bar means electrically disconnected
from said circuit and made of soft magnetic material disposed on
said can for braking said magnet means from rotating more than one
half-turn in the absence of externally emanating rotating flux
lines.
2. A heart pacer in accordance with claim 1 wherein said can
includes bearing means for mounting said magnet means therein.
3. A heart pacer in accordance with claim 2 wherein said magnet
means is a diametrically magnetized disc magnet whose axis is in
line with the axis of said potentiometer shaft.
4. A heart pacer in accordance with claim 1 wherein said magnet
means is rotated by rotating magnetic flux lines emanating external
of a patient and said pacer circuit further includes a magnetically
permeable can for housing said magnet means.
5. A heart pacer in accordance with claim 4 wherein said can
includes bearing means for mounting said magnet means therein.
6. A heart pacer in accordance with claim 1 wherein said magnet
means is a diametrically magnetized disc magnet whose axis is in
line with the axis of said potentiometer shaft.
7. A heart pacer in accordance with claim 6 further including
magnet means mounted for rotation external of said magnetically
permeable package, said potentiometer shaft magnet means and said
external magnet means being fluxlinked to each other, and means
responsive to the insertion and rotation therein of a needle tool
for rotating said external magnet means.
8. A heart pacer in accordance with claim 7 wherein said external
magnet means is a diametrically magnetized disc magnet whose axis
is in line with the axis of said potentiometer shaft.
9. A heart pacer in accordance with claim 8 further including a can
for housing said external magnet means in a plane parallel with
said potentiometer shaft magnet means.
10. A heart pacer in accordance with claim 1 further including
magnet means mounted for rotation external of said magnetically
permeable package, said potentiometer shaft magnet means and said
external magnet means being fluxlinked to each other, and means
responsive to the insertion and rotation therein of a needle tool
for roating said external magnet means.
11. A heart pacer in accordance with claim 10 further including a
can for housing said external magnet means in a plane parallel with
said potentiometer shaft magnet means.
Description
This invention relates to pacer rate adjustment mechanisms, and
more particularly to such mechanisms which allow a continuous
adjustment of pacer rate.
In a conventional heart pacer there is usually provided a
potentiometer whose setting controls the rate at which stimulating
pulses are generated. An illustrative pacer circuit is disclosed in
Berkovits U.S. Pat. No. 3,528,428 issued on Sept. 15, 1970 and
entitled "Demand Pacer." In the case of an external pacer, the
adjustment of the potentiometer allows hospital personnel to change
the pacer rate. In the case of an implantable pacer, the
potentiometer is usually set on the production line to provide a
predetermined rate, and that rate cannot be changed after the pacer
circuit is potted in the conventional encapsulating epoxy
compound.
There are many occasions, however, when a physician desires to
change the pacer rate after implantation. In the prior art, two
types of rate adjustment mechanisms for implantable pacers have
been proposed. In one, the pacer circuit includes a reed switch, or
some other type of magnetically actuated switch, which controls one
of two pacer rates depending upon the switch position. The pacer
rate can be switched by properly positioning a magnet pole of the
correct polarity near the skin of the patient in the vicinity of
the pacer. The disadvantage of this type of pacer rate control is
that the number of pacer rates is limited; continuous rate control
is not possible.
With the other type of pacer rate control mechanism, a continuous
adjustment of the rate is possible. A needle receptacle or port is
mounted on the exterior of the pacer, the receptacle being capable
of rotational movement. The receptacle is coupled through the pacer
epoxy package to the shaft of the pacer potentiometer. A Keith or
some other type of needle can be extended through the patient's
skin with the tip of the needle being positioned in the receptacle.
If the needle is then turned, the rotational motion is transmitted
through the epoxy package to the potentiometer shaft and the pacer
rate can be adjusted accordingly. There are two main disadvantages
with this type of continuous pacer rate control. First, to adjust
the pacer rate it is necessary to puncture the patient's skin.
Second, because of the mechanical coupling between the needle
receptacle and the internal pacer mechanism, there is a danger that
body fluids will flow along the coupling mechanism into the pacer
circuit and possibly cause it to become inoperative.
It is a general object of our invention to provide a pacer capable
of continous rate adjustment without danger of body fluids gaining
access to the pacer mechanism.
It is another object of our invention, in one embodiment thereof,
to provide such a continuous rate adjustment without requiring skin
puncture.
In accordance with the principles of our invention, the shaft of
the pacer rate potentiometer is fixed to a small diametrically
magnetized disc magnet. When the pacer is potted, the magnet along
with the rest of the mechanism is completely contained within a
sealed enclosure. The magnet is positioned near a surface of the
pacer, and it can be turned by positioning a strong external magnet
near the skin of the patient in the vicinity of the pacer magnet
and then turning the bar magnet. (The external magnet may be a bar
magnet, a horseshoe magnet, etc. In fact, any source of an external
rotating magnetic field can be used.) As the magnets turn, the
physician can observe the pacer rate on an oscilliscope until the
desired rate is achieved. This arrangement allows continuous rate
adjustment without skin puncture, and it also eliminates the
possibility of fluid penetration into the pacer mechanism. To
ensure that the potentiometer shaft does not turn inadvertently as
a result of its connection to the pacer magnet--which inadvertent
motion might be possible if the patient moves violently as a result
of the additional mass of the magnet -- a small bar of soft
magnetic material may be placed on the exterior of the assembly
which houses the pacer magnet. (The bar of magnetic material is
also inside the enclosure.) This bar locks the magnet once it has
been positioned by the physician. The locking mechanism cannot be
overcome by violet movement of the patient and the only way to
change the pacer rate is to use a strong external magnet as
described.
In the second embodiment of the invention, a similar magnet
(without the bar-locking mechanism) is utilized and the entire
pacer mechanism is housed in an enclosure as described above. A
second diametrically magnetized disc magnet is positioned in
face-to-face relationship with the first, but external to the
enclosure. A needle receptacle extends in the axial direction from
the second magnet and the magnet and the needle mechanism are
covered by the conventional silicone rubber boot which is applied
to the exterior of an implantable pacer. The second magnet can be
rotated by inserting a needle through the patient's skin into the
receptacle and then turning it. The magnetic coupling of the two
magnets (through the enclosure) causes the magnet attached to the
potentiometer shaft to turn with the needle magnet. The magnetic
coupling in this case also prevents fluid penetration into the
pacer, although with this pacer it is necessary to puncture the
skin of the patient in order to effect a rate adjustment.
It is a feature of our invention to mount on the shaft of the pacer
rate potentiometer a small magnet which can be turned under the
influence of a magnet external of the pacer epoxy package.
It is another feature of our invention, in one illustrative
embodiment thereof, to mount a second magnet having a needle port
in face-to-face relationship with the potentiometer shaft magnet
external of the pacer package.
Further objects, features and advantages of the invention will
become apparent upon consideration of the following detailed
description in conjunction with the drawing, in which:
FIG. 1 is a representation, partly in section, of the first
illustrative embodiment of our invention;
FIG. 2 is a view of the internal disc magnet incorporated in the
pacer of FIG. 1;
FIG. 3 is a cross-sectional view of the elements within housing 20
of the pacer of FIG. 1;
FIG. 4 is a representation, partly in section, of the second
illustrative embodiment of our invention; and
FIG. 5 depicts the face-to-face relationship of the two
diametrically magnetized disc magnets utilized in the embodiment of
the invention illustrated in FIG. 4.
FIG. 1 depicts a pacer 10, with only those elements being shown
which are necessary for an understanding of the present invention.
In the interior of the pacer, there is a magnetically permeable
closed can 12 (for example, made of brass) which contains the pacer
circuit. Although not shown in the drawing, around the can there
are disposed several batteries with wired connections from the
batteries to the circuit inside the can. A receptacle 14 is
provided into which a plug can be inserted at the time the pacer is
implanted in a patient. Two connectors 18 are provided for
connection to pins which extend from the plug, each of the pins
being extended from the plug along a lead to an electrode for
attachment to heart tissue. The two connectors are coupled to the
pacer circuit by wires not shown in the drawing. The entire pacer
is potted in an epoxy compound 22. Thereafter, a silicone rubber
boot 24 is formed around the entire pacer except that the
receptacle 14 is left open for insertion of the electrode plug.
The pacer is depicted only symbolically in FIG. 1. The details of
the pacer itself are unimportant insofar as the present invention
is concerned. What must be understood is the function of
potentiometer 16 and the mechanism inside housing 20. The
potentiometer includes a shaft which when turned controls the pacer
rate. As will be described below, the shaft is coupled to a magnet
inside housing 20, and on the outside of the housing there is a bar
40 of soft magnetic material. The potentiometer and the housing are
included with the rest of the pacer circuitry within can 12. The
can and housing 20 are magnetically permeable so that magnetic flux
lines can flow through the silicone rubber boot 24, the epoxy
package 22, the can and the housing to the magnet inside the
housing. The housing and the magnet inside it are disposed near a
surface of the pacer so that the pacer can be positioned in the
patient with the magnet as close as possible to the patient's skin
for maximum coupling of flux lines from the external bar magnet to
the magnet inside the housing.
FIG. 2 simply shows the shape of the magnet 30 included in housing
20. The magnet is in the form of a disc with a central hole, and it
is magnetized diametrically. That is, the north and south poles of
the magnet are at opposite ends of one of its diameters.
FIG. 3 is a cross-sectional view of potentiometer 16 and the
mechanism contained in housing 20. The potentiometer includes a
bushing 16b through which the end of shaft 16a extends. The end of
the shaft has a screw slot, and as ordinarily used the shaft can be
turned by using a screwdriver to change the potentiometer setting.
A typical potentiometer of this type is that marketed under the
name Trimpot by Bourns, Inc. The housing consists of two parts 32
and 36. The bottom of can 32 is cemented to the top of the
potentiometer, and after the elements in can 32 are assembled cover
36 is placed over it and an adhesive filler 38 is formed to seal
the cover to the can.
A bearing 44 is placed on can 32 in the position shown and then
plastic molded rotor 34 is placed on the bearing with projection
34a extending into the screw slot of shaft 16a. The disc magnet 30
is placed on top of the rotor 34. An adhesive layer is first placed
on the rotor on that part which holds the magnet so that the magnet
is rigidly secured to the rotor; the two of them rotate together
around the axis of shaft 16a and turn the shaft with them. After
the magnet is placed on the rotor, another bearing 42 is placed on
top of the rotor after which the cover is attached to the can as
described above. The entire unit is relatively small, with the
magnet having a diameter in the order of one-half of an inch and
being 3/16ths of an inch thick.
Rotor 34 can slide slightly in the axial direction, but at all
times at least a part of projection 34a is within the screw slot of
the shaft so that a positive drive condition is always obtained.
The purpose of the bearings on both sides of the rotor is to ensure
that low friction rotation is possible when the potentiometer shaft
is to be rotated.
The dimensions of the external magnet which can be used to cause
the internal magnet to rotate are 3 inch .times. 1-1/2 inch .times.
3/4inch with the north and south poles being at opposite ends of
the 3-inch dimension. Alnico material is used for both magnets, and
both are magnetized to saturation. With such magnets, the internal
magnet can be rotated by placing the external magnet on the
patient's skin in the vicinity of the pacer and then rotating it.
Preferably, the potentiometer which should be used is a multi-turn
device so that a single rotation of the internal magnet does not
drastically change the pacer rate; instead the rate should change
only slowly with each complete turn of the internal magnet. In one
embodiment of the invention, a 20-turn potentiometer was used.
It is possible if the pacer is subject to vibrations, for example,
during exercise by the patient, that the additional mass coupled to
the potentiometer shaft may cause it to rotate. To prevent this
from happening, a small bar of soft unmagnetized magnetic material,
for example, made of cold rolled steel, is cemented, as shown at
46, to the top of cover 36. Typically, the bar may be 1/32 inch in
width with relative length and height dimensions as shown. The flux
which flows out of the two poles of magnet 30 flows upward through
the cover 36 and through the steel bar. This has the effect of
locking or braking the magnet so that it does not move if it is
vibrated. The steel bar is used for making a rate setting more
stable. The effect of steel bar 40 is overcome by the strong
external magnet which diverts the flux from the bar. It is only in
the absence of the external magnet that the steel bar functions to
brake the rotor.
The embodiment of the invention depicted in FIG. 4 is similar to
that depicted in FIG. 1 except that bar 40 is omitted. Also, there
is an indentation in the surface of the epoxy package into which
brass can 54 is fitted. The brass can is secured to the epoxy
package by means of an adhesive. Before the can is secured to the
epoxy package, molded epoxy disc 56 is placed on the epoxy package
with the can being placed over it. Embedded in the disc is a
diametrically magnetized disc magnet 52. The epoxy disc contains an
axial bore 56a into which a needle can be fitted so that when the
needle is turned the disc and the embedded magnet turn with it. The
can is provided with an entrance port 54a for guiding the needle
into the bore of the epoxy disc. After the can is secured to the
package, they are covered with a conventional silicone boot 58.
Although not shown in the drawing, the boot can cover port 54a
since a conventional needle used for adjusting a pacer rate can
penetrate through the rubber boot.
Magnets 30 and 52 are shown in FIG. 5, and it is apparent that
because the north and south poles of different magnets are disposed
adjacent to each other, the flux lines flow in a loop through the
two magnets. If magnet 52 is turned, magnet 30 turns with it.
Consequently, by inserting a needle and turning disc 56 within can
54, magnet 30 rotates to change the pacer rate.
Locking bar 40 is not included on housing 20 in the embodiment of
FIG. 4. A brake is not necessary because magnet 30 is locked to
magnet 52, and magnet 52 is contained within an epoxy disc 56 which
is not mounted on bearings. Consequently, there is friction between
disc 56 and can 54, and disc 56 cannot rotate as a result of
vibrations. Magnet 52 thus serves as a lock for magnet 30. The only
way that the two magnets can be rotated is with the use of an
adjusting needle; by rotating the needle the frictional forces are
overcome and both magnets turn with it.
Although the embodiment of FIG. 4 does require skin puncture in
order to change the pacer rate, a continuous rate adjustment is
possible without any danger of fluid penetration into the pacer
circuit. This is because the pacer circuit is completely enclosed
by the sealed enclosure 12, and magnetic coupling is provided
through the wall of the enclosure for rotating the potentiometer
magnet.
Although the invention has been described with reference to
particular embodiments, it is to be understood that these
embodiments are merely illustrative of the application of the
principles of the invention. Numerous modifications may be made
therein and other arrangements may be devised without departing
from the spirit and scope of the invention.
* * * * *