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Claims  |
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What is claimed is:
1. A bone growth stimulator comprising, in combination:
(a) a first pair of fixature pins for extending into a fractured bone, one
pin on each side of the fracture site of the bone;
(b) a second pair of fixature pins for extending into the fractured bone,
one pin on each side of the fracture site of the bone;
(c) means for fixing the position of said first pair and second pair of
pins with the distal end thereof secured to the fractured bone to fix the
position of the fractured bone or both sides of the fracture therein, and
thus fixing the position of the fracture site thereof;
(d) at least one cathode comprising an electrically conductive wire
externally insulated along a major central portion thereof, having a
biologically compatible electrically conductive distal tip for contacting
the fractured bone proximate the fracture therein;
(e) means for fixing the position of said at least one cathode with the
distal tip in electrical contact with the bone proximate the fracture site
therein;
(f) means electrically isolating the at least one cathode and pins from
each other; and
(g) means for applying electrical voltage to the at least one cathode and
the pins cyclically for a plurality of time periods during each cycle,
each cathode at all times having either no voltage or negative voltage
applied thereto, the pins having either positive, negative or no voltage
applied thereto, either the first pins or the second pins being positive
when a negative voltage is applied to any cathode, the voltage application
being cycled to cause electron flow from a cathode to the first pins in a
first period, from the first pins to the second pins during a second
period, from a cathode to the second pins in third period, and from the
second pins to the first pins in fourth period.
2. The apparatus of claim 1 comprising at least one additional cathode and
wherein the means for applying electrical voltage comprises means to cycle
the application of voltage to cause electron flow from one cathode during
the first period and from another cathode during the third period.
3. The apparatus of claim 1 comprising three additional cathodes and
wherein the means for applying electrical voltage comprises:
means for applying electrical voltage to the cathodes and the pins
cyclically for a plurality of time periods during each cycle, the cathodes
at all times having either no voltage or negative voltage applied thereto,
the pins having either positive, negative or no voltage applied thereto,
either the first pair of pins or the second pair of pins being positive
when a negative voltage is applied to any cathode, the voltage application
being cycled to cause electron flow from a first cathode to the first pins
in a first period, from the first pins to the second pins during a second
period, from the second cathode to the second pins in third period, from
the second pins to the first pins in fourth period, from the third cathode
to the first pins in the fifth period, from the first pins to the second
pins in the sixth period, from the fourth cathode to the second pins in
the seventh period, and from the second pins to the first pins in the
eighth period.
4. The bone growth stimulator of claim 1 further comprising means for
adjusting the lateral position of each cathode with respect to the
fractured bone.
5. The bone growth stimulator of claim 1 further comprising means for
adjusting the axial position of each cathodes about the fractured bone.
6. A combined external fixation and bone growth stimulating means
comprising the combination of:
(a) first and second pairs of fixation pins;
(b) at least one cathode;
(c) frame means for electrically isolating and fixing the position of the
pins and at least one cathode, including means for fixing the first pair
of pins one on each side of the fracture site, and the at least one
cathode proximate said fracture site, said frame means comprising means
for adjusting the position of said at least one cathode with respect to
the position of said pins and said bone; and
(d) means for applying a voltage for a first period between a cathode and
the first pairs pins, during a second period between the first and second
pins pairs, during a third period between a cathode and the second pair of
pins, and during a fourth period between the second and first pairs of
pins, the cathode being negative during the first and third period and
neutral during the second and fourth periods, the first pair of pins being
negative during the second period and positive during the fourth period.
7. A bone growth stimulating means comprising the combination of:
(a) first and second pairs of fixation pins;
(b) first and second cathodes;
(c) means for electrically isolating and fixing the position of the pins
and cathodes, including means for fixing the first pair of pins one on
each side of the fracture site of a bone, the second pair of pins one on
each side of said fracture site, and the cathodes proximate said fracture
site; and
(d) means for adjusting the position of said cathodes with respect to the
position of said pairs of pins and said bone; and
(e) means for applying a voltage for a first period between the first
cathode and the first pair of pins, during a second period between the
first and second pairs of pins, during a third period between the second
cathode and the second pins, and during a fourth period between the second
and first pairs of pins, the first cathode being negative during the first
and third periods and neutral during the second and fourth periods, the
first pair of pins being negative during the second period and positive
during the fourth period, the second cathode being neutral during the
first and third periods and negative during the second and fourth periods.
8. A combined external fixation and bone growth stimulating means
comprising the combination of:
(a) first and second pairs of fixation pins;
(b) a plurality of cathodes;
(c) frame means for electrically isolating and fixing the position of the
pins and cathodes, including means for fixing the first pair of pins one
on each side of the fracture site of a bone, the second pair of pins one
on each side of said fracture site, and the cathodes proximate said
fracture site; and
(d) said frame means further including means for adjusting the position of
said cathodes with respect to the position of said pairs of pins and said
bone; and
(e) means for applying a voltage cyclically during time periods, said
voltage applied during odd numbered time periods between the cathodes
alternately and the pairs of pins alternately, the cathodes being negative
during said odd numbered cycles, said voltage being applied during even
numbered time periods between the pairs of pins alternately, the polarity
being reversed between said pairs of pins during alternate even numbered
time periods.
9. A method of treating a bone fracture comprising the steps of:
(a) fixing the site of the bone fracture including the steps of inserting a
first pair of fixation pins one on each side of said site, and inserting a
second pair of fixation pins one on each side of said site;
(b) orienting a cathode with the distal end thereof in electrical contact
with the bone adjacent the fracture site therein; and
(c) applying a voltage cyclically during odd numbered and even numbered
time periods, applying said voltage during odd numbered time periods
between said cathode and the pairs of pins alternately, the cathode being
negative during said odd numbered cycles, applying said voltage during
even numbered time periods between the pairs of pins alternately, the
polarity being reversed between said pairs of pins during alternate even
numbered periods.
10. The method of claim 9 further comprising the step of adjusting the
lateral position of the cathode with respect to the fractured bone.
11. The method of claim 9 further comprising the step of adjusting the
axial position of the cathode about the fractured bone.
12. A method of treating a bone fracture comprising the steps of:
(a) fixing the site of the bone fracture including the steps of inserting a
first pair of fixation pins one on each side of said site, and inserting a
second pair of fixation pins one each side of said site;
(b) orienting at least one cathode with the distal end thereof in
electrical contact with the bone adjacent the fracture site therein; and
(c) applying a voltage cyclically during odd numbered and even numbered
time periods, applying said voltage during odd numbered time periods
between at least one cathode alternately and the pairs of pins
alternately, at least one cathode being negative during said odd numbered
cycles, applying said voltage during even numbered time periods between
the pairs of pins alternately, the polarity being reversed between said
pairs of pins during alternate even numbered time periods.
13. A method of treating a bone fracture comprising the steps of:
(a) fixing the site of the bone fracture with a fixation device, including
inserting a first pair of fixation pins one on each side of said site, and
inserting a second pair of fixation pins one on each side of said site;
(b) fixing a plurality of cathodes to said external fixation device;
(c) adjusting the position of said cathodes with the distal end thereof in
electrical contact with the bone adjacent the fracture site therein; and
(d) applying a voltage cyclically during odd numbered and even numbered
time periods, applying said voltage during odd numbered time periods
between the cathodes alternately and the pairs of pins alternately, the
cathode being negative during said odd numbered cycles, applying said
voltage during even numbered time periods between the pairs of pins
alternately, the polarity being reversed between said pairs of pins during
alternate even numbered time periods.
14. A method of treating a bone fracture comprising the steps of:
(a) fixing the site of the bone fracture with an external fixation device,
including inserting a first pair of fixation pins one on each side of said
site, and inserting a second pair of fixation pins one on each side of
said site;
(b) fixing first, second, third and fourth cathodes to an adjustable member
forming a portion of said external fixation device;
(c) adjusting the position of said member to orient said cathodes with the
distal end thereof in electrical contact with the bone adjacent the
fracture site therein; and
(d) applying a voltage cyclically during odd numbered and even numbered
time periods, the cathodes at all times having either no voltage or
negative voltage applied thereto, the pins having either positive,
negative or no voltage applied thereto, either the first pair of pins or
the second pair of pins being positive when a negative voltage is applied
to any cathode, the voltage application being cycled to cause electron
flow from the first cathode to the first pair of pins in a first period,
from the first pair of pins to the second pair of pins during a second
period, from the second cathode to the second pair of pins in third
period, from the second pair of pins to the first pair of pins in fourth
period, from the third cathode to the first pair of pins in the fifth
period, from the first pair of pins to the second pair of pins in the
sixth period, from the fourth cathode to the second pins in the seventh
period, and from the second pair of pins to the first pair of pins in the
eighth period. |
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Claims  |
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Description  |
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FIELD OF THE INVENTION
This invention relates to orthopedic surgery and, more specifically, to
external fixation and bone growth stimulation apparatus.
BACKGROUND OF THE INVENTION
It has been known for three decades that bone structures have bioelectric
properties. It is known, for example, that bones tend to be
electronegative in areas of compression and electropositive in areas of
tension, and that areas of active growth and repair tend to be
electronegative. Many workers have demonstrated the phenomenon of electric
current stimulated osteogenesis at the cathode. Electric currents, both AC
and DC, including pulsating DC, in the range of from about 10 to 100
microamperes is known to stimulate bone growth in some but not necessarily
all subjects. The literature on this subject is extensive, see, e.g.
Spadaro JA: Electrically Stimulated Bone Growth in Animals and Man, A
review of the Literature, Clin. Orthop. 122: 325, 1977.
Implantable electric current bone growth stimulator devices have been
reported, see, e.g., U.S. Pat. Nos. 3,745,995; 3,783,880; 3,890,953;
3,915,151; 3,968,790; 4,011,861; 4,052,754; 4,306,564; 4,313,438;
4,315,503; 4,333,469 and 4,414,979. Prostheses having electrically
stimulated bone growth devices have also been proposed; see, e.g., U.S.
Pat. Nos. 3,964,473; 4,195,367; 4,214,322 and 4,216,548. Non-invasive bone
growth stimulators, see, e.g. U.S. Pat. Nos. 4,056,097; 4,066,065;
4,153,060; 4,175,565 and 4,244,373, and bone growth stimulators with
specific current and voltage patterns, see, e.g., U.S. Pat. Nos.
4,105,017; 4,266,532; 4,266,533; and 4,315,503, have been described.
Semi-invasive bone growth stimulators have also been disclosed, see, e.g.,
Zimmer, "The Alternate Treatment of Fracture Nonunion, Electrical
Stimulation to Induce Osteogenesis, Zimmer USA, Warsaw, Ind. 46580,
September 1979 revision, and U.S. Pat. Nos. 3,842,841 and 3,918,440.
U.S. Pat. No. 4,026,304 reviews the state of the art and early developments
and is incorporated herein by reference. This patent also discusses the
problem of polarization and proposes, as a solution, an implantable source
of electric potential to generate a train of electric pulses.
U.S. Pat. No. 3,893,462 discloses another method of bone growth stimulation
utilizing electrical signals undulating in both the positive and negative
directions in an asymmetric manner reactively coupled to the bone.
The general approach in the prior art has been to provide an electric
current bone growth stimulator separately from any external fixation which
may be used. While efforts have been made to avoid or mitigate the problem
of polarization which results when current flows in a given direction
through an electrode. The present invention addresses the problems of
external fixation and bone growth stimulation, including the problem of
polarization.
SUMMARY OF THE INVENTION
The present invention comprises an apparatus for both fixing a bone
fracture and stimulating the bone growth repair of the fracture, while
eliminating or at least mitigating the effects of polarization in electric
current induced osteogenesis. The present invention includes a method for
accomplishing these results. The invention may be described, in its
various facets as follows:
A combined external fixation device and bone growth stimulator comprising,
in combination: a first pair of fixature pins for extending into a
fractured bone, one pin on each side of the fracture site of the bone; a
second pair of fixature pins for extending into the fractured bone, on pin
on each side of the fracture site of the bone; external fixation frame
means for rigidly fixing the position of said first and second pins with
the distal end thereof secured to the fractured bone and the proximal end
secured proximate the frame means to thereby fix the position of the
fractured bone on both sides of the fracture therein and thus fixing the
position of the fracture site thereof; at least one cathode each
comprising a relatively rigid electrically conductive wire externally
insulated along a major central portion thereof, having a biologically
compatible electrically conductive distal tip for contacting the fractured
bone proximate the fracture therein; means secured to the external
fixation frame means for fixing the position of said cathodes with the
distal tip in electrical contact with the bone proximate the fracture site
therein; means electrically isolating the cathodes and pins from each
other thereby preventing electrical contact with one another through the
frame means; and means for applying electrical voltage to the cathodes and
the pins cyclically for a a plurality of time periods during each cycle,
the cathodes at all times having either no voltage or negative voltage
applied thereto, the pins having either positive, negative or no voltage
applied thereto, either the first pins or the second pins being positive
when a negative voltage is applied to any cathode, the voltage application
being cycled to cause electron flow from a cathode to the first pins in a
first period, from the first pins to the second pins during a second
period, from a cathode to the second pins in third period, and from the
second pins to the first pins in fourth period
Preferably the apparatus comprises at least two cathodes and the means for
applying electrical voltage comprises means to cycle the application of
voltage to cause electron flow from one cathode during the first period
and from another cathode during the third period.
In a still more preferred embodiment, the apparatus includes four cathodes
and the means for applying electrical voltage comprises: means for
applying electrical voltage to the cathodes and the pins cyclically for a
a plurality of time periods during each cycle, the cathodes at all times
having either no voltage or negative voltage applied thereto, the pins
having either positive, negative or no voltage applied thereto, either the
first pins or the second pins being positive when a negative voltage is
applied to any cathode, the voltage application being cycled to cause
electron flow from a first cathode to the first pins in a first period,
from the first pins to the second pins during a second period, from the
second cathode to the second pins in third period, from the second pins to
the first pins in fourth period, from the third cathode to the first pins
in the fifth period, from the first pins to the second pins in the sixth
period, from the fourth cathode to the second pins in the seventh period,
and from the second pins to the first pins in the eighth period.
The invention may also be described as a combined external fixation and
bone growth stimulating means comprising the combination of: first and
second pairs of fixation pins; at least one cathode; frame means for
electrically isolating and fixing the position of the pins and cathodes,
including means for fixing the first pair of pins fixed one on each side
of the fracture site of a bone, the second pair of pins one on each side
of said fracture site, and the cathodes proximate said fracture site; and
means for applying a voltage for a first period between a cathode and the
first pins, during a second period between the first and second pins,
during a third period between a cathode and the second pins, and during a
fourth period between the second and first pins, the cathode being
negative during the first and third periods and neutral during the second
and fourth periods, the first pins being negative during the second period
and positive during the fourth period.
The invention also comprehends a method of treating a bone fracture
comprising the steps of: fixing the site of the bone fracture with an
external fixation device, including inserting a first pair of fixation
pins one on each side of said site, and inserting a second pair of
fixation pins one on each side of said site; fixing at least one cathode
with the distal end thereof in electrical contact with the bone adjacent
the fracture site therein; and applying a voltage cyclically during odd
numbered and even numbered time periods, applying said voltage during odd
numbered time periods between a cathode and the pairs of pins alternately,
the cathode being negative during said odd numbered cycles, applying said
voltage during even numbered time periods between the pairs of pins
alternately, the polarity being reversed between said pins during
alternate even numbered time periods.
In a specific method of treating a bone fracture, the invention comprises
the steps of: fixing the site of the bone fracture with an external
fixation device, including inserting a first pair of fixation pins one on
each side of said site, and inserting a second pair of fixation pins one
on each side of said site; fixing a plurality of cathodes with the distal
end thereof in electrical contact with the bone adjacent the fracture site
therein; and applying a voltage cyclically during odd numbered and even
numbered time periods, applying said voltage during odd numbered time
periods between the cathodes alternately and the pairs of pins
alternately, the cathode being negative during said odd numbered cycles,
applying said voltage during even numbered time periods between the pairs
of pins alternately, the polarity being reversed between said pins during
alternate even numbered time periods.
The preferred method of treating a bone fracture according to this
invention comprises the steps of: fixing the site of the bone fracture
with an external fixation device, including inserting a first pair of
fixation pins one on each side of said site, and inserting a second pair
of fixation pins one on each side of said site; fixing at least four
cathodes with the distal end thereof in electrical contact with the bone
adjacent the fracture site therein; and applying a voltage cyclically
during odd numbered and even numbered time periods, applying said voltage
during odd numbered time periods between the cathodes alternately and the
pairs of pins alternately, the cathode being negative during said odd
numbered cycles, applying said voltage during even numbered time periods
between the pairs of pins alternately, the polarity being reversed between
said pins during alternate even numbered time periods.
In an exemplary embodiment, the method of treating a bone fracture of this
invention comprises the steps of: fixing the site of the bone fracture
with an external fixation device, including inserting a first pair of
fixation pins one on each side of said site, and inserting a second pair
of fixation pins one on each side of said site; fixing at least four
cathodes with the distal end thereof in electrical contact with the bone
adjacent the fracture site therein; and applying a voltage cyclically
during odd numbered and even numbered time periods, the cathodes at all
times having either no voltage or negative voltage applied thereto, the
pins having either positive, negative or no voltage applied thereto,
either the first pins or the second pins being positive when a negative
voltage is applied to any cathode, the voltage application being cycled to
cause electron flow from a first cathode to the first pins in a first
period, from the first pins to the second pins during a second period,
from the second cathode to the second pins in third period, from the
second pins to the first pins in fourth period, from the third cathode to
the first pins in the fifth period, from the first pins to the second pins
in the sixth period, from the fourth cathode to the second pins in the
seventh period, and from the second pins to the first pins in the eighth
period.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the apparatus of this invention, the frame
being shown in simplified form.
FIG. 2 is an enlarged perspective view of a portion of the apparatus of
this invention.
FIG. 3 is a very schematic view illustrating the principle of application
of voltage to the cathodes and pins of FIGS. 1 and 2.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The invention is described as applied to the Ace-Fischer (Trademark)
external fixation device, which in very simplified form is shown in FIGS.
1 and 2; however, it is to be understood and emphasized that the invention
includes and comprehends any external fixation device which is capable of
fixing fixature pins and cathodes. The Ace-Fischer (Trademark) external
fixation device is described in detail in U.S. Pat. No. 4,308,863.
The invention includes an external fixation device 100 which may be in any
configuration. In the depicted embodiment, which is merely exemplary and
non-limiting, the fixation device includes a pair of semicircular frame
members 102 and 104 secured in spaced relation about the fractured bone by
adjustable rod means one of which is depicted at 106. Pin holders 110 and
120 are secured in any convenient manner to the frame members and fix the
fixature pins 112 and 114, in holder 110, and 122 and 124, in holder 120,
in position. Electrically insulating means 116 and 118 in holder 110 and
insulating means 126 and 128 in holder 120 electrically isolate the pins
112, 114, 122 and 124 from each other such that there is no electrical
connection between them through the frame. Insulating means may be, for
example, Teflon (Trademark) polytetrafluoroethylene or other insulative
sleeves. The distal ends of the pins are screwed, or otherwise secured, in
the usual manner to the bone. One pair of pins, 112 and 122, are secured
one pin on each side of the fracture site, and the other pair of pins, 114
and 124, are secured also one pin on each side of the fracture site. The
pins on each side are spaced apart sufficiently to avoid electrical
shorting therebetween.
A bracket 130 secures a rod 134 to the frame means such that the rod
extends approximately parallel to the axis of the bone proximate the
center of the frame where it supports an arcuate mounting bracket 136.
Cathode mounting blocks 140 and 150 are secured to the mounting bracket
136 in a conventional way, such as by a bolt and nut arrangement. The
block 140 mounts cathodes 142 and 144 preferrable by means of electrically
insulative sleeves 146 and 148. In like manner, the block 150 mounts
cathodes 152 and 154 by means of sleeves 156 and 158 as will be obvious
from the structure illustrated at FIGS. 1 and 2, the position of the
cathodes with respect to the pins and the fractured bone by adjustment of
the extension of rod 134 from bracket 130, and by movement of the arcuate
mounting bracket 136 with respect to the rod 134. Thus, the lateral and
axial position of the cathodes may be adjustably varied and subsequently
fixed in the desired position.
As pointed out, the specific structures by which the pins and cathodes are
mounted are of no consequence insofar as this invention is concerned so
long as they perform the necessary function of mounting the pins in fixed
relation with the distal ends of the pins secured to the bone to fix the
fracture site of the bone and mounting the cathodes with the distal ends
of the cathodes in electrical contact with the bone in the proximity of
the fracture site. The tips of the pin may be in the fracture site, in the
bone adjacent the fracture site or in the soft tissue adjacent the bone
fracture site, all of which locations are referred to herein as being in
electrical contact with the bone. The cathodes and pins are electrically
isolated from each other, except, of course, through the bone and the
source of voltage which will be described, such that a voltage can be
applied between any cathode and either pair of pins and between the pairs
of pins.
The means for applying a voltage is illustrated for the sole purpose of
describing the manner in which the voltage is applied. It will be
instantly understood that in practice solid state voltage regulators,
switches, etc. will be used. Since the exact circuitry and devices for
generating and applying a voltage are of no importance to the operation of
the invention, so long as the voltage is applied as described, a
simplified schematic representation has been selected to more clearly and
simply illustrate the voltage applying means.
As shown in FIG. 3, a voltage in a particular cyclical pattern to be
described is applied from the voltage applying means 170. Typically, a
stable battery having long term constant voltage, indicated at 170, will
be used. A current regulator depicted generally at 172 will be included.
This, of course, will be a solid state device rather than the functionally
schematic variable resister shown. To illustrate the cyclic manner of
applying voltage, a pair of wiper switches 174 and 176 driven by motor 178
are shown simply to illustrate that the voltage will be applied
sequentially to a number of electrical conductors in cable 180 and thence
to the pins 112, 114, 122, and 124, and the cathodes 142, 144, 152 and
154. Again, it is emphasized that solid state switching is conveniently
used and that the switching shown is functionally schematic to illustrate
the principle. Since solid state circuitry of the type suitable for use in
the invention is well known and conventional, and since so many circuits
can suitably be used is is deemed unnecessary to describe the same in
detail. Reference is made to the aforecited patents for various circuits
which may used or modified for use. Reference is also made to standard
electronic circuitry texts and manuals.
The operation of the voltage apply means is as follows:
In the preferred embodiment, the apparatus includes four cathodes and two
sets of pins. The means for applying electrical voltage applies electrical
voltage to the cathodes and the pins cyclically for a a plurality of time
periods during each cycle. The cathodes at all times having either no
voltage or negative voltage applied thereto. The pins having either
positive, negative or no voltage applied thereto, either the first pins or
the second pins being positive when a negative voltage is applied to any
cathode. The conductors in cable 80 are connected to the switching
mechanism such that the voltage application is cycled to cause electron
flow from a first cathode to the first pins in a first period, from the
first pins to the second pins during a second period, from the second
cathode to the second pins in third period, from the second pins to the
first pins in fourth period, from the third cathode to the first pins in
the fifth period, from the first pins to the second pins in the sixth
period, from the fourth cathode to the second pins in the seventh period,
and from the second pins to the first pins in the eighth period.
The connection of the conductors between the switching mechanism and the
cathodes and pins and the operation of the switching mechanism is fully
defined by the following table.
TABLE I
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Time Cathode Polarity Pin Polarity
Period 112 114 122 124 142 152 144 154
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-- 0 0 0 + + 0 0
2 0 0 0 0 - - + +
3 0 -- 0 0 0 0 + +
4 0 0 0 0 + + - -
5 0 0 -- 0 + + 0 0
6 0 0 0 0 - - + +
7 0 0 0 -- 0 0 + +
8 0 0 0 0 + + - -
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Current was controlled in the range of 5 to 20 microamperes. The full
sequence of pulsing occurs at 10 Hz timed intervals. Each sequence
involves eight events--four firings (negative charging of a cathode) and
four discharges of the anodes (pins). Each of these eight events requires
12.5 milliseconds. Thus, the full eight events requires 100 milliseconds
and the sequence repeats itself 10 times each second.
It will, of course, be understood that the specific order of voltage
application is not critical and can be altered. What is important is that
the electron flow be controlled such that it is always from the cathode to
one or the other of the sets of pins, when the cathodes are active, and
that there be period flow between the pins opposite the direction of flow
when the cathode current flows to the pins. The intensity of the current
does not differ from that taught in the prior art and may typically range
from about 10 microamps to 100 microamps, normally being from 10 to 20
microamps. These ranges are, of course, typical and not critical.
DISCUSSION
Animal studies of the invention were conducted at the Cleveland Research
Institute using a canine model. Torsional strength values were almost
double for stimulated tibias as compared with a control series. The
histological and microradiographic analysis demonstrated earlier evidence
of cellular activity (1-2 weeks post operatively) in the stimulated
groups. The 6 weeks post operative analysis showed a more dense and more
mature material tibial deposit in the stimulated tibial fractures.
Significantly, the incidence of pin loosening was only one-fourth as
frequent in the stimulated series as in the control series. Additionally
the degree of loosening was 3.5 times greater in the control series as in
the stimulated series. The level of trace elements in the model was
slightly higher in the stimulated series than in the control, but the
difference was marginal and the levels for both groups were well within an
acceptable range. It was concluded from this series that the invention was
both safe and effective in promoting fracture healing in the canine model.
Clinical trials are being planned and it is predicted from the animal
tests that the invention will be both safe and effective in promoting
human bone growth.
It will be understood that considerable variation can be made within the
principle of the invention without departing therefrom, especially as
regards the structure of the fixation device, the manner of producing the
electric voltage for current flow, and the specific order of cycling the
voltage to the cathodes and pins.
INDUSTRIAL APPLICATION
This invention will find industrial application in veterinary medicine and
in orthopedic surgery.
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