U.S. patent number 3,866,616 [Application Number 05/378,636] was granted by the patent office on 1975-02-18 for heart pacer.
This patent grant is currently assigned to Coratomic Inc.. Invention is credited to George J. Magovern, David L. Purdy, Nicholas Smyth.
United States Patent |
3,866,616 |
Purdy , et al. |
February 18, 1975 |
Heart pacer
Abstract
A nuclear heart pacer having a heat-to-electricity converter
including a solid-state thermoelectric unit embedded in rubber
which is compressed to impress hydrostatic precompression on the
unit. The converter and the radioactive heat source are enclosed in
a container which includes the electrical circuit components for
producing and controlling the pulses; the converter and components
being embedded in rubber. The portions of the rubber in the
converter and in the container through which heat flows between the
radioactive primary source and the hot junction and between the
cold junction and the wall of the container are of thermally
conducting silicone rubber. The primary radioactive source material
Pu.sub.238 is encapsuled in a refractory casing of WC-222 which in
turn is encapsuled in a corrosion-resistant casing of platinum
rhodium, a diffusion barrier separating the WC-222 and Pt-Rh
casings. The Pt-Rh casing is in a closed basket of tantalum. The
tantalum protects Pt-Rh from reacting with other materials during
cremation of the host, if any. The casings and basket suppress the
transmission of hard X-rays generated by the alpha particles from
the Pu.sub.238. The outside casing of the pacer is typically of
titanium but its surface is covered by an electrically insulating
coating, typically EPOXY resin, except over a relatively limited
area for effective electrical grounding to the body of the host. It
is contemplated that the pacer will be inserted in the host with
the exposed titanium engaging a non-muscular region of the
body.
Inventors: |
Purdy; David L. (Indiana,
PA), Magovern; George J. (Pittsburgh, PA), Smyth;
Nicholas (Bethesda, MD) |
Assignee: |
Coratomic Inc. (Indiana,
PA)
|
Family
ID: |
23493920 |
Appl.
No.: |
05/378,636 |
Filed: |
July 12, 1973 |
Current U.S.
Class: |
607/36;
976/DIG.416; 607/37 |
Current CPC
Class: |
A61N
1/37512 (20170801); A61N 1/378 (20130101); G21H
1/103 (20130101) |
Current International
Class: |
A61N
1/372 (20060101); A61N 1/375 (20060101); G21H
1/00 (20060101); A61N 1/378 (20060101); G21H
1/10 (20060101); A61n 001/36 () |
Field of
Search: |
;128/419P,421R,422 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Myatl, "Biomedical Engineering," Vol. 6, No. 5, May, 1971, p.
192-196..
|
Primary Examiner: Kamm; William E.
Claims
1. A heart pacer for a host including a primary source of heat
energy, a converter connected to said source for converting said
energy into electrical energy, means, connected to said converter,
for deriving electrical pulses from said electrical energy,
output-conductor means including a catheter, connected to said
deriving means and to be connected to the heart of said host, for
impressing said pulses on said heart, and a container for said
source, converter and deriving means, the said container being
composed of electrically conducting material and being electrically
connected to said deriving means to serve as ground therefor, the
outer region of said container being coated with electrically
insulating material except over a relatively small limited area
thereof on one side only, the conducting material of said limited
area to be connected electrically to non-muscular body parts of
said host connecting
2. The heart pacer of claim 1 wherein the limited area is in the
form of a
3. The heart pacer of claim 2 wherein the insulating coating is
flush with
4. The heart pacer of claim 1 wherein the deriving means includes
electrical circuit-component means for converting the electrical
energy from the converter into pulses, and the output
circuit-conductor means includes output assembly means, said
output-assembly means including a feed-through assembly means, said
output assembly being connected through the feed-through assembly
means to the deriving means within the container and extending out
of the container and being connected outside of the
5. The heart pacer of claim 1 wherein the container is of generally
ellipsoidal form and the small limited area is a dimple of
generally oval form.
Description
REFERENCE TO RELATED DOCUMENTS
This application relates to an application to David L. Purdy for
Electrical Generator filed July 12, 1973 and assigned to CORATOMIC
INC.
BACKGROUND OF THE INVENTION
This invention relates to the generation of electricity by
thermoelectric conversion of heat from a local primary source and
has particular relationship to nuclear heart pacers or pacemakers.
To the extent that this invention has other uses than in heart
pacers it is understood that such uses are within the scope of this
application.
A nuclear heart pacer includes a primary source of radioactive
material, a thermoelectric converter which converts the heat from
the source into electricity and an electrical circuit powered by
the converter which converts the output of the thermoelectric
converter into pulsations and controls the flow of the pulsations
to the heart.
This prior-art heart pacer is encased in a conducting material such
as titanium. In the use of this pacer muscle twitching has on
occasions been experienced. In addition, the operation of this
pacer has at times been irregular.
It is an object of this invention to overcome these disadvantages
and to provide a heart pacer which shall not produce muscle
twitching and shall operate with stability.
SUMMARY OF THE INVENTION
This invention arises from the realization that the prior-art
pacer, having a conducting casing throughout, makes electrical
contact with muscles of the host in areas of the casing. The
current flow through the surface of the casing then actuates these
contacted muscles to twitch. In addition, these contacted muscles,
during the normal activity of the host, inject electrical
pulsations into the prior-art pacer which confuse its operation and
render this pacer at times unreliable.
The heart pacer in accordance with this invention is encased in a
metallic container which is coated with an insulator, typically
EPOXY resin, except over a limited area. The pacer is inserted into
the body of the host with the conducting area out of contact with
any muscular tissue of the heart.
BRIEF DESCRIPTION OF THE DRAWINGS
For a better understanding of this invention, both as to its
organization and as to its method of operation, together with
additional objects and advantages thereof, reference is made to the
following description, taken in connection with the accompanying
drawings, in which:
FIG. 1 is a view in perspective of a heart pacer in accordance with
this invention with parts of the outer container broken away to
show the interior;
FIG. 2 is a view in end elevation with parts sectioned of the heart
pacer shown in FIG. 1;
FIG. 3 is a view in section taken along lines III--III of FIG.
2;
FIG. 4 is a view in longitudinal section of the battery of the
heart pacer shown in FIGS. 1-3;
FIG. 5 is a plan view of the strap assembly which applies pressure
to compress the medium in which the thermoelectric unit is
embedded;
FIG. 6 is a view in end elevation of the cylindrical bracket for
positioning the radioactive block of the capsule shown in FIG. 4 as
viewed from one end;
FIG. 7 is a view in end elevation of this bracket as viewed from
the opposite end;
FIG. 8 is a view in section taken along line VIII--VIII of FIG.
7;
FIG. 9 is a view in section taken along line IX--IX of the portion
of FIG. 4 showing the thermoelectric unit;
FIG. 10 is a view in end elevation of the thermoelectric unit as
viewed from the hot-junction end;
FIG. 11 is a view in end elevation of the thermoelectric unit as
viewed from the cold-junction end;
FIG. 12 is a diagrammatic view showing the manner in which the
individual thermoelectric elements of the thermoelectric unit are
interconnected;
FIG. 13 is a block diagram of a typical electrical circuit of a
heart pacer in accordance with this invention;
FIG. 14 is a view in perspective showing one way in which the heart
pacer in accordance with this invention is installed in the host;
and
FIG. 15 is a view in perspective showing another way in which the
heart pacer in accordance with this invention is installed in the
host.
DETAILED DESCRIPTION OF EMBODIMENT
The apparatus shown in the drawings is a heart pacer 21 (FIGS. 1-3)
including a battery 23, printed circuit boards 25 and 27 (FIG. 2),
a solid-state electronics package 29, a storage capacitor 31, a
magnetic switch 33, a transformer 35 and an output assembly 37 for
connecting the output of the transformer 35 to the catheter or
heart lead 39 which is placed on the heart muscle. The boards 25
and 27 serve as a cradle for the battery 23. The battery 23 and the
circuit components 25-35 are embedded in a potting compound 41 of a
resilient material in a container 43 (FIG. 3) typically of
titanium. The potting compound 41 is typically predominately 2CN, a
silicone rubber which is thermally insulating and which responds to
pressure like a fluid, transmitting pressure uniformly in all
directions. The 2CN is sold by Emerson-Cummings Corp. of
Pittsburgh, Pa. However, a portion 47 of the compound between the
cold-junction end 49 of the battery 23 and the container 43 is
composed of a thermally highly-conducting material, typically
ECCOSIL 4952, a silicone rubber. ECCOSIL 4952 is sold by
Microtechtronics Corp., Buffalo, N.Y. The container 43 is encased
in a coating 50 of EPOXY resin except for a window 51. The
container 43 serves as ground for the electrical circuit 23-35 and
as a radio-frequency shield for the pacer and the window 51 serves
to connect the ground to the body of the host. The window 51
projects outwardly from the remainder of the container 43 and is
flush with the EPOXY coating 50 as shown in FIG. 2. Typically, the
heart pacer 21 has an overall length of 2.45 inches, a width of
1.88 inches and a depth of 0.80 inch. Typically, the window or
dimple 51 has a heighth of about 0.050 inch and is of oval shape
about 1.8 inches by 1.1 inches. While the outwardly extending
dimple is preferred, the conducting area could also be in a
recession.
The battery 23 (FIG. 4) includes a primary source 61 and a
solid-state thermoelectric converter 63. The source 61 is enclosed
in a highly evacuated container 65 encompassed by a heat shield
67.
The source 61 includes a ceramic block 71 formed of a powder of
plutonium-oxide, the plutonium being predominately Pu.sub.238.
Typically the source includes about 0.272 grams of Pu.sub.238
O.sub.2. This fuel is sufficient to operate the pacer according to
this invention for 20 years without renewal of the source. This
source delivers 117 milliwatts initially and 100 milliwatts at the
end of 20 years. The block 71 is mounted in positioning bracket 73
in inner capsule 75, a hollow sphere. The bracket 73 (FIGS. 7, 8,
9) is formed of a hollow cylinder 77 having tabs 79, spaced about
120.degree., projecting outwardly from one end and tabs 81,
interposed between tabs 79 and spaced about 120.degree., and
projecting inwardly from both ends. The block 71 is supported
within the bracket 73 by the tabs 81. The spacing between the tabs
81 is set to accommodate the length of the block 71 between the
tabs 81. Typically, tabs 81 at one end are first projected
inwardly; the block 71 is then inserted in cylinder 77 engaging
tabs 81; thereafter, tabs 81 at the other end are bent to engage
and hold the block 71. The tabs 79 engage the inner surface of
sphere 75 and help to secure the bracket 73 in the sphere 75. Tabs
79 are bent inwardly from the 90.degree. position about 15.degree.
as shown in FIG. 4.
The inner capsule 75 is formed of hollow hemispheres 83 and 85, the
rims of the hemispheres being provided with cooperative projections
87 and 89 respectively which are coextensively engaged to form the
sphere 75. The hemispheres 83 and 85 are closely dimensioned to
about 0.001 inch. Typically, the sphere is composed of a tantalum
alloy, WC-222, has an inside radius of 0.125 inch and an outside
radius of 0.155 inch. WC-222 has the following chemical
composition: W 9.6-11.2%, HF 2.2-2.8%, C 0.008-0.0175%, Ta balance.
The bracket 73 typically has a length of about 0.186 inch and a
diameter of about 0.125 inch. The inner capsule 75 is fire
resistance and has high strength so that the block 77 remains
locked in the inner capsule regardless of what impacts the heart
pacer may suffer and also if the host should be cremated. The
tantalum alloy also absorbs hard X-rays. The inner capsule 75 is
enclosed in an outer capsule 91 including a hood 93 formed of a
hemisphere from which a cylinder extends; a spherical dish-shaped
member 95 is sealed to the rim of the cylinder. Typically, the
hermisphere and cylinder of the hood 93 have an inner diameter of
0.316 inch and a thickness of about 0.010 inch. The member 95 has
the same thickness and is correspondingly dimensioned to seal to
the hood 93. The outer capsule 91 is compoxsed of platinum-rhodium
alloy Pt10Rh. The outer capsule 91 protects the source 61 against
corrosion and oxidation. A diffusion barrier 97, aluminum oxide,
typically of about 0.001 inch thickness is disposed between the
inner capsule 75 and the outer capsule 91. This barrier prevents
the alloying of the inner and outer capsules 75 and 91.
During assembly the block 71 is secured in the bracket 73 with the
tabs 81 holding the block. The bracket 73 and block 71 are then
inserted between the hemispheres 83, 85 and the hemispheres are
joined at the steps 87 and 89 into a sphere. The sphere is then
welded in an inert-gas (argon) atmosphere. The sphere 75 is then
inserted between the members 93 and 95 of the outer capsule 91 and
this capsule is welded at the joint 99 between these members.
The unit 71-75-91 is disposed in a basket 101 typically of
tantalum. The basket 101 is in the form of a hollow hemisphere
terminating at its rim in a hollow cylinder. Typically, the basket
101 is about 0.005 inch in thickness. Near its outward end the
basket 101 is welded to the flange 103 of a flanged sleeve 105,
typically of tantalum. The stem 107 of the sleeve 105 merges into
the flange 103, at their inner surfaces, the transition surface
being a spherical annular surface of the same radius as the
dish-shaped member 95. The dish-shaped member 95 is seated in this
surface. The stem 107 is welded to a disc 109, typically of
tantalum. The inner surface of the disc 109 is spherical and
coextensive with the spherical annular surface of the flange 105
and of the same radius and the member 95 is seated in this surface.
The disc 109 has an outwardly projecting rim 111.
A flanged disc 113 is brazed to the rim 111. This disc 113 is
composed of the titanium alloy Ti6A14V. A cylinder 115, also
typically of Ti6A14V, which contains the converter 63 is welded to
the flange 117 of the disc 113. The flange 117 is trepanned to
limit the flow of heat from the weld. The alloy Ti6A14V has high
strength and low thermal conductivity and is used for this
reason.
The evacuated container 65 is defined by outer sheel 121 and the
cylinder 115. These members 115 and 121 are joined by a ring 123
typically of Ti6A14V. The shell 121 is typically composed of
titanium and includes a hollow hemispherical end 125 from the rim
of which a cylinder extends. A hollow frusto-conical shell 127
extends from the rim of the cylinder. The cylindrical rim of the
end 125 and the shell 127 are joined by a weld. A backing annulus
128, typically of titanium, is provided behind the welded joint.
The end 125 and the shell 127, throughout the major portion of
lengths, have a thickness typically of 0.010 inch. But the shell
127 flares out at its constricted end 129, to a thickness of about
0.090 inch. The thickened end 129 is chamfered on the outside and
flattened on the inside and is welded to the ring 123 around the
flattened area. The ring 123 is internally welded to the cylinder
115. A reinforcing ring 124 internally of the cylinder 115 forms a
part of a welded joint between the cylinder 115 and the ring 123.
The ring is trepanned to suppress the flow of heat from the
weld.
The vacuum within container 65 is maintained by a getter 131
typically CERRALOY 400. The getter 131 is mounted in an annular
space provided between the sleeve 107, the flange 103, and a
cylinder 133 which extends from the rim of the basket 101 and is
bent inwardly at teeth 135 extending from its end. The getter 131
is held by a ring 137, typically of var-glass tubing.
The heat shield 67 has a hemispherical section 141, a cylindrical
section 143 and a conical section 145. The hemispherical section
141 includes a plurality of hemispheres 147, typically of MONEL
metal, concentric with sphere 75 and extending between the
spherical part of the basket 101 and the inner surface of the end
125. The hemispheres have dimples 149 so that their spacing is
maintained. The cylindrical section 143 includes a tape of
alternate layers of MONEL metal foil 151, typically 0.125 inch wide
by 0.001 inch thick, and "E" glass insulation 153, typically, 0.125
inch wide by 0.005 inch thick. The tape is wrapped about a center
formed of the cylindrical parts of the hood 93 and the basket 101
and the strip 133 which holds the getter 131. The cylindrical
section 143 firmly engages the basket 101 and the strip 133 and
supports the asembly 71-75-91, which is relatively heavy, radially
and prevents its displacement radially. Radial displacement of the
assembly 71-75-91 exerts a torque on the joint 115-123-124 and may
rupture this joint. So that the section 143 firmly engages the
assembly 71-75-91, dimples 144 are pressed into the shell 125. The
conical section 145 includes a plurality of hollow frusto-conical
shells 161 coaxial with the cylinder 115, typically composed of
MONEL metal, each extending from the cylindrical shield 143 to a
position above the ring 123. The shells 161 are bent over
perpendicularly to the cylinder 115 near the ring 123 and are
engaged by an annular spacer 163, typically of Ti6A14V.
The head 125 and the conical section 127 are initially separated
pieces with the backing ring 128 tack-welded to the hemispherical
head 125. In assembling the container 121 the ring 123 is welded to
the end 129 of the conical section 127 of the container 65. The
strip (typically 0.005 inch thick) which forms the holder 133 for
the getter 131 is wrapped around the cylindrical end of the basket
101. The getter 131 and the glass tubing 137 are inserted and the
teeth 135 of the strip are bent so as to hold the getter 131 and
the tubing. The tape 151-153 is wrapped around the assembly
133-101-93. The hemispherical shells 147 are positioned about the
hemispherical portion of the basket 101 and the head 125 is
positioned over the outermost shell 147. Th rims of the shells 147
engage the cylindrical shield 143. The frusto-conical shells 161
are stacked in the frusto-conical section 127 between the spacer
163 and the end of the section 127. Several of the larger shells
161a are of 0.005 inch thickness titanium; the other shells 161b
are of 0.004 inch thick MONEL. A tube 171 of E-glass insulation is
wound about each shell 161 supporting the adjacent shell. The
sections 125 and 127 are then abutted with backing ring 128
extending between the rims of these members (125, 127). The
assembly is then placed in a chamber which is evacuated to a
pressure of 10.sup..sup.-6 Torr and the joint between the rims of
the members 125 and 127 is welded and treated out so that the low
pressure is maintained.
The thermoelectric converter 63 is disposed in cylinder 115. The
converter 63 includes a solid-state thermoelectric unit 181
embedded or potted in a medium 183 which responds to compression
like a fluid, hydrostatically, transmitting the compression in all
directions.
The thermoelectric unit 181 includes a plurality of positively and
negatively doped strips 185 and 187, typically of bismuth
telluride, embedded in polymeric insulation 189 such as EPOXY. So
embedded this block is itself stress resistant and protects the
strips 185 and 187 from rupture. Typically, there may be 81 of such
strips 185 and 187 arrayed as shown in FIG. 10. Successive negative
and positive strips are interconnected by solder strips 191 (FIGS.
11, 12) at the hot-junction of the unit 181 and alternate pairs of
positive and negative strips are interconnected by solder strips
193 (FIGS. 10, 12) at the cold-junction. Typically, positive strip
185a and negative strip 187a are interconnected by solder strip
191a at the hot-junction and negative strip 187a and positive strip
185b are interconnected by solder strip 193b at the cold-junction.
Diagonally positioned positive and negative end strips 185c (FIG.
11) and 187c are connected to output conductors 201 and 203. The
pairs of strips 185 and 187 of the array of strips form
thermocouples connected in series between conductor 201 and
conductor 203.
The potting 183 includes a disc 211 (FIG. 4) of thermally
conducting resilient material, typically silicone rubber ECCOSIL
4952, interposed between the source 61 and the thermoelectric unit
181, a hollow cylinder 213 of thermally insulating material,
typically rubber, SYLGARD 184, encircling the unit 181, and a disc
215 of ECCOSIL 4952 having an internally generally frusto-conical
rearward projection. SYLGARD 184 is sold by Techtronic Corporation
of Buffalo, N.Y. The potting compound 211-213-215 serves as axial
support for the cylinder 115 and prevents the assembly
71-75-91-141-143 from buckling the cylinder 115.
The converter 63 is assembled in the cylinder 115. First, the
cylinder 211 is deposited on the trepanned disc 113. Next, the
thermoelectric unit 181 is positioned centrally on the disc 211.
Then the cylinder 213 is deposited around the unit 181. A washer,
216, typically of titanium, is then positioned to cover the trepan
groove 217 of the disc 123. A split ring 219, typically of Ti6A14V
alloy is placed coaxially with the cylinder 115 on the washer 216.
The ring 219 is resilient but has a high restoring force. A
cylindrical mass of thermally conducting material, typically
ECCOSIL 4952, is then deposited in the cylindrical space defined by
the ring 219, the washer 216 and the disc 123. Before this mass is
cured a plug 231 is positioned at the outer edge of the mass.
The plug 231 is typically composed of electrolytic grade copper and
has a head 237 split or slotted at the center and a body 239 which
terminates in a generally frusto-conical portion. The body 239 has
a central opening which Communicates with an opening 241 in the
head. The central opening has a ceramic bushing 243.
The conductors 201 and 203 are brought out centrally before the
cylindrical mass is deposited within the inner ring 219, the washer
216 and the disc 123. After the mass is deposited, but before it
cures, the conductors 201 and 203 are strung through the ceramic
bushing 243 of the plug 231 and brought out through the slot
between the parts of the head 237. The plug 231 is then set at the
outer end of the mass of thermally conducting material, while being
maintained coaxial with the cylinder 115. As the mass is cured the
ring 219 prevents the mass from expanding radially. Once the mass
is cured the plug 231 is pressed into the mass building up
hydrostatic pressure within the potting material 183. The split
ring 219 confines the mass radially but the gaps in this spring
open to a predetermined spacing which measures the compression of
the mass. The force exerted on the mass of ECCOSIL 4952 may be as
high as 150 pounds; however, where the thermoelectric unit 181 is
stress-resistant, the force may be as low as 15 pounds. When the
gap has the desired spacing the mass is secured by straps 233 of
spring 235. The spring 235 (FIG. 5) is composed of sheet titanium
alloy, typically about 0.005 inch in thickness. This spring has an
annular center 251 from which the straps 233 extend radially
uniformly spaced around its periphery. In securing the plug 231,
the center 251 is spot welded to the sloping shoulder 253 of the
head 237 and the straps 233 are bent around the head and spot
welded to the thickened portion 129 of the shell 127.
Initially the container 43 (FIG. 3) which is composed of
commercially pure titanium is in two parts. One part has an opening
261 for the output conductor 263 from the transformer 35.
Initially, the battery 23, the printed circuit boards 25 and 27,
block 29, containing the circuit components (integrated circuit and
separate transistors not shown) potted in EPOXY resin, the storage
capacitor 31, the magnetic switch 33 and the transformer 35 are
assembled and connected outside of the container 43.
The output conductor 263 is also initially connected into a
feed-through assembly 264 (FIG. 3). This assembly includes a
ferrite radio-frequency filter 265 which suppresses electromagnetic
disturbances and which encircles the conductor 263. The assembly
also inlcudes a ceramic insulating sleeve 267 throgh which the
conductor 263 is sealed gas-tight. The sleeve 267 is sealed into a
flanged sleeve 269, typically of titanium. The ferrite trap 265 is
secured to the inner side of the flanged sleeve 269 by a spring
washer 271. The conductor 263 is connected near its external end to
a flexible connector 272.
Once the components are interconnected the battery 23 and the parts
25-35 are mounted in one of the parts of the container 43 with the
battery cradled between the boards 25 and 27. The boards 25 and 27
are contoured to rest on the inner surface of the container 43. The
ground conductors (FIG. 13) are connected to the container 43. The
assembly 264 is disposed adjacent the opening 261 with the flanges
273 of sleeve 269 appropriately positioned adjacent the hole 261.
The two parts of the container 43 are then welded to form the
container. The ECCOSIL 4952 mass 47 between the cold-junction end
49 of the battery and the container 43 is injected with a syringe
inserted through opening 261. The 2CN potting rubber is then
injected through opening 261 and encompasses the parts 23 through
35. The container 43 and its content are then placed in a chamber
(not shown) which is evacuated and filled with an inert gas (argon)
at about one atmospheric pressure. The inert gas permeates the
converter 63 through the opening 231 and the bushing 243. Within
the chamber, in the inert-gas atmosphere, the flange 273 is welded
gas-tight to the rim of the hold 261 sealing the hole. The
conncector 272 is now connected to a terminal block 275.
The terminal block 275 is in the form of a rectangular
parallelapiped having a cylindrical opening through which the inner
end 277 of the catheter 39 passes. Laterally a set screw 279 (FIG.
2) is provided in the block 275. Over the head of the set screw 279
there is a silastic plug 281.
The catheter 39 is inserted in heart pacer 21 by the doctor who
installs it in the host's heart. During the construction of the
pacer 21 the catheter 39 is replaced by a pin (not shown) of the
diameter of the catheter 39. This pin is encircled by a suture boot
283. The pacer as now assembled is mounted in a mold (not shown)
with the dimple 51 which forms the window facing downwardly and
masked. The EPOXY resin 50 is then molded about the titanium casing
except at the dimple 51 and the EPOXY excapsulation 285 for the
conductor 263, the connector 272, the block 275, the bottom 283 and
the pin (not shown) is formed. The pin is then removed.
After installation in the heart of the host, the catheter 39 is
inserted in the opening formed by the pin and the end 277 is
secured by the set screw 279 in the terminal block. The head of the
set screw is closed by the plug 281 and the plug 281 can be sealed
by silastic insulation.
The electrical circuit (FIG. 13) used in the practice of this
invention is of the solid-state type and includes, in addition to
the magnetic switch 33, a DC to DC converter 301, and amplifier
303, a monostable 305, a noise-rate turn-on 307, a multivibrator
reset 309, a multivibrator 311, and an output 313.
The output of the battery 23 is about 0.6 volt open circuit; the
DC-DC converter 301 derives about -5.4 volts from this output for
operating the remainder of the circuit.
The amplifier 303 amplifies any input signal impressed on its input
terminal 305 which is greater than 1.5 millivolts to 2.0
millivolts. This stage amplifies R-waves from the heart, pacer
pulses and any noise which might be present at the input 315. The
gain of this amplifier 303 falls off rapidly once the frequency of
the incoming noise is out of the amplifier's band pass.
The monostable 305 performs two different functions. First, when it
is triggered by a signal from the amplifier 303, it puts out
typically a 0.275 second duration square pulse; and the monostable
305 cannot be triggered on again until it times out. This pulsing
interval serves as the pacer's refractory period. The pacer's mode
cannot be affected during this time. The amplifier 303 ramains
sensitive, but the multivibrator 311 cannot be reset until the
monstable 305 completes its pulse of 0.275 second. The amplifier
301 remains operative to drive the noise rate turn-on 307. Second,
the leading edge of the monostable pulse resets the multivibrator
311.
The multivibrator 311 controls the rate and width of the output
pulses of the pacer 21. The multivibrator 311 can operate in two
different modes. One mode is the normal rate which is 70.+-.2 beats
per minute. The other is the noise rate which is 85.+-.5 beats per
minute. In both modes the pulse duration remains at 1.1.+-..01
milliseconds.
The output 313 is the stage which produces the negative pulse which
actually paces the heart.
The multivibrator reset 309 stops the multivibrator 311 from
putting out a pulse (heart pacing pulse). If a monostable pulse
(duration 0.275) occurs because of an R-wave fed back from the
heart or a pacer pulse, this stage 309 resets the multivibrator
rate capacitor (not shown) to near zero volts. Every time the
multivibrator 311 is reset it waits for 850 milliseconds (70.6
beats per minute) before it puts out another pacer pulse. Every
time the pacer 21 itself puts out a heart pacing pulse it resets
itself.
The noise-rate turn-on 307 constantly monitors the output of the
amplifier 303. If the noise rate circuit senses that the
amplifier's output pusles are at a specific frequency (15 hertz
.+-.5 hertz, the noise turn-one frequency) it disables the
monostable stage 305. This in turn prevents the multivibrator reset
stage 309 from discharging the rate capacitor (not shown) in the
multivibrator 311. If the rate capacitor in the multivibrator is
not discharged, which happens every time the monostable stage 305
puts out its 0.275 second pulse, the multivibrator 311 continues to
run, but the capacitor does not discharge to zero on every pulse
and the rate increases to 85.+-.5 beats per minute (the noise
rate). When the magnetic reed switch 33 is closed by a magnet,
external of the body, the pacer 21 becomes a fixed rate unit at the
noise rate.
In the heart pacer under the control of the circuit shown in FIG.
13 R-waves, when they occur, disable the multivibrator 311 from
delivering heart-pacer pulses to the heart. Pulses are only
delivered in the absence of R-waves. The operation of such a heart
pacer is referred to as an R-wave-inhibited demand pacer.
Typical parameters of the heart pacer in accordance with this
invention are:
1. Pulse Duration -- 1.1 milliseconds, nominal -- 1.0-1.2
milliseconds, range. A sufficiently long pulse duratino to always
insure heart capture is provided. A minimum pulse duration is
desired to conserve electrical power output. If the pulse duration
were reduced substantially below the 1.1 milliseconds, the
amplitude requirement may become excessive, thereby causing
fibrillation.
2. Pulse Amplitude -- 8 milliamps, nominal -- 7.5 to 8.5 milliamps,
range. This amplitude is selected to always provide effective
capture after the rise of threshold levels after electrode
endothelialization. A higher amplitude, possibly 10 milliamps, may
be considered, since a nuclear powered system is not battery energy
sensitive, but the possibility of fibrillation might arise with
such high levels. A lower amplitude in some are cases could prevent
heart capture.
3. Basic Rate -- 70 beats per minute, nominal --68 to 72 beats per
minute range. This rate appears to be the most common required by
patients.
4. Noise Rate -- 85 beats per minute, nominal -- 80 to 100 beats
per minute, range. This is the rate at which the pacemaker operates
when noise interference is so great that it masks the normal Q-R-S
heart complex. A rate higher than the basic rate is selected to
minimize the possibility of competition with the normal heart rate
should it be in normal rhythm.
5. Noise Rate Turn-On -- Approximately 20 Hertz. This rate is
selected to prevent interference from all conceivable noise modes,
microwave ovens and the like, with the exception of a sporadic
impulse which would not be fatal. It is sufficiently low to rule
out 60 Hertz rates which are the most probable, particularly with
the expanding use of microwave ovens.
6. Magnetic Switch Rate -- 85 beats per minute, nominal -- 80 to
100 beats minute, range. This rate is a fixed rate, at which the
pacer operates when energized by a magnet placed near the patient's
magnetic reed switch. This turnon feature allows checking of the
pacemaker performance since in the R-wave inhibited mode with
normal Q-R-S complexes, the physican cannot tell whether the
pacemaker is operating.
7. R-Wave Sensitivity -- .+-. 1.75 millivolts, nominal -- 1.5 to
2.0 millivolts, range. This sensitivity is selected to assure
sensing of the R-wave, and is sufficiently high to prevent
interference from abnormal P waves.
8. Refractory Period -- 275 milliseconds, nominal -- 250 to 300
milliseconds, range. This electronic refractory period begins with
either a normal R-wave or the pacemaker stimulus. It is
sufficiently long to prevent stimuli during the T-wave onset or
decay--this period being the critical period for possible pacemaker
induced fibrillation, i.e., no stimulus occurs during the T-wave of
normal heart repolarization.
In installing the pacer according to this invention in the body of
the host, the surgeon makes an incision 401 in the body of the host
402 preferably in the chest above the heart. The catheter 39 is
then passed through a vein to the heart muscle. The catheter is
then inserted in the pacer 21 and the pacer is inserted in the
opening with the insulating coating 50 in contact with the muscles
403, FIG. 14, or 404, FIG. 15, and the window or dimple 51 away
from the muscles 303 and in engagement with a non-muscular part of
the chest, either the rib cage 405, FIG. 14, or the skin 406, FIG.
15.
While a preferred embodiment of this invention has been disclosed
herein, many modifications thereof are feasible. This invention is
not to be restricted except insofar as is necessitated by the
spirit of the prior art.
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