Method and apparatus for medical treatment of the pathological state of bones

A method is disclosed for medically treating a patient suffering from a pathological bone condition of a limb, which comprises the steps of: anesthetizing the patient; fixing the limb affected with the pathological bone condition and centering its pathological site; treating the pathological site, once, consecutively, and extracorporeally with impact waves of from 300 to 600 impacts with a frequency of impacts of from 0.5 to 4 per second at a pressure of from 700 to 2500 bars and a pulse duration of from 0.5 to 4 microseconds for a period of 10 to 120 minutes; and subsequently immobilizing the limb for a period of from 15 to 90 days.

FIELD OF THE INVENTION 
This invention relates to a method and an apparatus for medical treatment 
of bone pathology which finds application in orthopaedic traumatologic 
practice for medical treatment of pseudoarthrosis, delayed consolidation, 
bone deformations, correction of the length of long tubular bones, 
performing arthrodesis, acceleration of the normal bone knit, treatment of 
bone tumors, aseptic necrosis, delay of bone growth (epiphysiodesis), a.o. 
BACKGROUND OF THE INVENTION 
In a known method for medical treatment of pseudoarthrosis, delayed 
consolidation and bone deformations, after anesthesis the skin of the limb 
in the place of injury is cleaned to prepare for operation and then the 
bone is drilled through the skin in several places and the limb is 
immobilized. See Diffenbach-Beck I. Koptchev, Trawmatologya na 
oporno-dvigatelnaya aparat; Sofia, Medizina i Fizkoultoura; P. 137 (1976). 
The drawbacks of this method lie in that it is invasive and frequently 
there occur complications, such as suppurations, osteomyelitis. There are 
not provided proper conditions for consolidation and, therefore, the 
method is not sufficiently effective. 
Another known operative method for medical treatment consists in that, 
after anesthesis of the limb, the latter is fixed to the operation table, 
there is performed by operation a penetration to the bone, the periosteum 
is opened and the edges of the injured bone ends are scraped, while in 
case of bone deformations a bone triangle is cut out. A proper or 
preserved bone transplant is put in place. The fragments are aligned and 
are osteosynthesized with different materials. The periosteum and the soft 
tissues are restored and finally there is effected an external 
immobilization for a period of from 60 to 180 days. See R. Watson-Jones, 
Fractures and Joint Injuries, Vol. 1, pp 22-50 (1976). 
The drawbacks of this method lie in that it is invasive with the 
possibility of post-operation complications occurring. A prolonged stay in 
the hospital is required. After the healing of the injury, a second 
operation is necessary for the removal of the osteo-sythesizing materials. 
In some cases there are several operative interventions necessary in the 
event of relapse. 
A known apparatus for the fragmentation of kidney stones, the design of 
which is similar to that of the apparatus for medical treatment of bone 
pathology according to the present invention, comprises a generator of 
impact waves, over which there is disposed the patient carriage, 
underneath which there is fastened the head of an ultrasonic emitter, the 
vertical axis of which coincides with the vertical axis of the generator 
of impact waves and passes through the zone of fragmentation of the kidney 
stones. The generator of impact waves consists of a housing, shaped as a 
vessel containing an acoustic liquid, in the bottom end of which there is 
disposed a discharger which is covered by the liquid contained in the 
housing, and in its top end there is provided a flexible membrane see U.S. 
Pat. No. 4,610,249. 
The drawback of this device is in that in cannot be used for medical 
treatment of bone pathology. 
OBJECTS OF THE INVENTION 
It is therefore a general object of this invention to develop a method for 
medical treatment of bone pathology which is non-operative, extracorporal, 
ambulatory, and can shorten the duration of the recovery process. 
It is another object of this invention to develop an apparatus for the 
treatment of bone pathology which is of compact design and makes possible 
a quick and painless carrying out of the treatment. 
SUMMARY OF THE INVENTION 
The object is achieved by a method for medical treatment of bone pathology 
in which, after anesthesis, the limb is fixed to the carrying carriage of 
the apparatus and is finally immobilized. According to the invention, 
after the fixation of the limb and the centering of the pathological place 
and before the immobilization, it is subjected once, consecutively and 
extracorporally to the action of 300 to 6000 impact waves with a frequency 
of 0.5 to 4 per second, at a pressure in the range of from 700 to 2500 
bars, at a pulse duration of from 0.5 to 4 microseconds for 10 to 120 
minutes, with a subsequent immobilization from 15 to 90 days. 
The object is also achieved by a method for medical treatment of bone 
pathology, pseudoarthrosis, delayed consolidation and bone deformations, 
in which the treatment at the site of pathology is effected by impact 
waves of from 1000 to 5000 impacts with a frequency of 1 to 2 per second, 
at a pressure of from 1200 to 2000 bars and pulse duration of from 1.5 to 
3 microseconds for 20 to 110 minutes, with a subsequent immobilization of 
from 40 to 90 days. 
The object is also achieved by another method for medical treatment of bone 
pathology for the correction of the length of long tubular bones, in which 
a device for extrafocal fixation is placed on the bone and the site of 
pathology is subjected to the action of impact waves of from 1000 to 6000 
impacts with a frequency of 1 to 3 per second, at a pressure of from 1100 
to 1700 bars and a pulse duration of from 1 to 3.5 microseconds for 30 to 
115 minutes and subsequent immobilization of from 60 to 85 days. 
The object is also achieved by a method for medical treatment of bone 
pathology for extracorporal performance of arthrodesis, in which the 
pathological place is subjected to the action of impact waves of from 750 
to 6000 impacts with a frequency of from 0.5 to 3.5 per second, at a 
pressure of from 1200 to 2500 bars and pulse duration of from 0.5 to 2.5 
microseconds over 15 to 120 minutes, and subsequent immobilization of from 
30 to 80 days. 
The object is also achieved by a method for medical treatment of bone 
pathology for acceleration of the normal bone knit, in which the site of 
pathology is subjected to the action of impact waves of from 300 to 3000 
impacts, with a frequency of from 1 to 3.5 per second at a pressure of 
from 700 to 1500 bars and a pulse duration of from 1.5 to 4 microseconds 
for 10 to 90 minutes, and subsequent immobilization of from 15 to 60 days. 
The object is also achieved by a method for medical treatment of bone 
pathology in the case of bone tumors, in the which the pathological place 
is subjected to the action of impact waves of from 500 to 5000 impacts 
with a frequency of from 0.5 to 4 per second, at a pressure of from 850 to 
1700 bars and pulse duration of from 1.5 to 3.5 microseconds over 15 to 
95 minutes, and subsequent immobilization of from 15 to 60 days. 
The object is also achieved by a method for medical treatment of bone 
pathology in the case of delay of bone growth (epiphysiodesis), in which 
the pathological place is subjected to the action of impact waves of from 
1000 to 5500 impacts with a frequency of from 1 to 4 per second at a 
pressure of from 950 to 1900 bars and a pulse duration of from 0.5 to 3.5 
microseconds over 20 to 110 minutes, and subsequent immobilization of from 
15 to 90 days. 
The object is also achieved by a method of medical treatment of bone 
pathology in the case of aseptic necrosis, in which the pathological place 
is subjected to the action of impact waves of from 350 to 4000 impacts 
with a frequency of from 1 to 2.5 per second at a pressure of from 750 to 
1600 bars and a pulse duration of from 1.5 to 3 microseconds over 10 to 
105 minutes, and subsequent immobilization of from 15 to 30 days. 
The object is also achieved by an apparatus which comprises a housing, 
inside which there is disposed a generator of impact waves, on the base of 
which there are fastened guiding rolls which are in contact with the 
internal surface of the outer housing, opposite to which there is disposed 
an x-ray generator. The top end of the generator of impact waves is shaped 
as a vessel containing a transmitting medium, which is an acoustic liquid, 
and it covers the discharger fastened to the bottom of the vessel, while 
in its top end there is disposed a flexible membrane. Over the generator 
of impact waves there is disposed a light diaphragm, and over it there is 
disposed an electronic optical converter, which is connected to a 
television camera, the longitudinal axis of which coincides with the 
longitudinal axis of the x-ray generator, and its point of intersection 
with the longitudinal axis of the light diaphragm forms the point of 
action. To the outer housing, behind the television camera, there is 
positioned a protective barrier. 
The object is also achieved by an apparatus in which the generator of 
impact waves is rigidly connected to the central part of a carring arm, 
which can rotate around its axis and is connected to the external housing. 
The advantages of the invention lie in that the medical treatment is 
non-operative, extra-corporal, ambulatory and less dangerous to the health 
of the patient. The potential for complications is reduced a minimum. The 
duration of treatment is reduced, too. The apparatus is compact, 
convenient and easy to operate and repair.

SPECIFIC DESCRIPTION OF THE DRAWINGS 
The apparatus for medical treatment of bone pathology comprises an outer 
housing 1, inside which there are disposed a generator of impact waves 2, 
on to the base of which there are fastened guiding rolls 3 which are in 
contact with the internal surface 4 of the outer housing 1, opposite to 
which there is disposed an x-ray generator 5. The top end of the generator 
of impact waves 2 is shaped as a vessel 6 which contains a transmitting 
medium, which is an acoustic liquid 7--water in this case, and it covers 
the high-voltage electrode 8 fastened to the bottom of the vessel 6, while 
in its top end there is disposed a flexible membrane 24. Over the 
generator of impact waves 2 there is disposed a patient carriage 9, 
opposite to which and over the generator of impact waves 2 there is 
disposed a light diaphragm 10, and over it there is disposed an electronic 
optical converter 11, to which there is connected a television camera 12. 
The longitudinal axis 13 of which coincides with the longitudinal axis of 
the x-ray generator 5, and its point of intersection with the longitudinal 
axis 14 of the light diaphragm 10 forms the point of action 15. To the 
outer housing 1, behind the television camera 12, there is positioned a 
protective barrier 16. The apparatus is connected to a block circuit which 
consists of a supply block 17, the output of which is connected to the 
block for centering the patient 18, and its output is connected to the 
carriage with the object 9. The output of the supply block 17 is also 
connected to the television block 19, while the latter, for its part, is 
connected to the monitor 20, the television camera 12 and the block of the 
electronic optical converter 21 which, for its part, is connected is 
connected via its output to the block of the x-ray system 22, which is 
connected to the input of the x-ray generator 5. The supply block 17 is 
directly connected to the block of the high-voltage generator 23 of the 
generator of impact waves 2, which are interconnected. The television 
block 19, the block of the electronic optical converter 21 and the x-ray 
block 22 are provided with feedforwards and feedbacks. 
The is also another preferred embodiment of the apparatus for medical 
treatment of bone pathology, which consists of an outer housing 1, to 
which there fastened movably to one of its ends a carrying arm, while to 
its other end there is attached a generator of electrohydraulic waves 2. 
Between the electrohydraulic generator 2 and the outer housing 1 there is 
fastened rigidly to the arm 14 an arch-shaped arm 25, to the bottom end of 
which there is fastened rigidly the x-ray generator 5, while to its top 
end there is fastened rigidly the electronic optical converter 11, to 
which the television camera 12 is fastened rigidly. The carrying arm 14 
can rotate around its own axis at .+-.30.degree.. To the generator of 
electrohydraulic waves 2 there is fastened rigidly a vessel for the 
transmitting medium 6, which contains an acoustic liquid 7--in this case 
water, and it covers the high-voltage electrode 8 which is fastened to the 
bottom of the vessel 6 for the transmitting medium, and to its top end 
there is fastened a flexible membrane 24. Opposite to the generator of 
electrohydraulic waves 2 there is disposed the carriage for centering the 
patient 9, on which the patient is lying with the point of action 15. To 
the outer housing 1 there is fastened rigidly a protective barrier 16. 
The apparatus is connected to a block circuit, which consists of a supply 
block 17, the output of which is connected to the block for centering the 
patient 18, while its output is connected to the carriage with the object 
9. The output of the supply block 17 is connected to the television block 
19 which, for its part, is connected to the monitor 20, the television 
camera 12 and the block of the electronic optical converter 21, which is 
connected with its output to the block of the x-ray system 22, which is 
connected to the input of the x-ray generator 5. The supply block 17 is 
directly connected to the block of the high-voltage generator 23, which is 
connected to the generator of electrohydraulic waves 2. The television 
block 19, the electronic optical converter 21 and the x-ray system 22 are 
provided with feedforwards and feedbacks. 
The invention is also explained by means of the following examples of 
medical treatment of bone pathology: 
EXAMPLE 1 
FIG. 4 shows a pseudoarthrosis or delayed consolidation of a radius bone 
with a bottom edge 26 and an upper edge 27. A regional intravenous 
anesthesis of the limb with a non-healed radius bone is paerformed, and 
the latter is fixed to the patient carriage 9 shown in FIG. 1, being in 
contact with the flexible membrane 24 as shown in FIGS. 1 and 5. After the 
positioning of the point of action 15 there are delivered on the bone edge 
26 1200 electrohydraulic impacts with a frequency of 2 impacts per second 
at a pressure of 1300 bars and a pulse duration of 3 microseconds over 20 
minutes. The same actions are also applied to the upper bone edge 27. FIG. 
6 shows the result of the action of the electrohydraulic impact waves with 
formation of bone sand admixed with blood coming from the opened 
microvessels and microfissures of the edges of the bone fragments 26 and 
27. After the termination of the procedure the limb of the patient is 
released from the patient carriage 9 and there follows an external 
immobilization for 80 days. 
EXAMPLE 2 
FIG. 7 shows the deformation of a radius bone 28. After performing a 
regional intravenous anesthesis of the limb with a deformed radius bone, 
the latter is fixed to the patient carriage 9 shown in FIG. 1, being in 
contact with the flexible membrane 24 as shown in FIGS. 1 and 8. After 
positioning, the point of action 15 is set up on the bone deformation 28. 
There are delivered 3000 electrohydraulic impacts with a frequency of 2 
impacts per second at a pressure of 1500 bars and pulse duration of 3 
microseconds over 50 minutes. FIG. 9 shows the result of the action of the 
electrohydraulic impact waves with formation of fracture of the 
deformation 29 at preserved periosteum 30 and subsequent manual correction 
of the deformation. After the termination of the procedure, there is 
carried out an external immobilization of the limb of the patient, which 
he must bear for 90 days. FIG. 10 shows the result with knit in straight 
position deformation of the radius bone 28. 
EXAMPLE 3 
FIG. 11 shows a shortened tubular bone 31 mounted on an apparatus for 
extrafocal fixation 32, and before its mounting there is performed a 
regional intravenous anesthesis for upper limb or peridural anesthesis for 
bottom limb. The limb is fixed to the patient carriage 9 shown in FIG. 1 
where it comes in contact with the flexible membrane 24 shown in FIG. 12. 
After positioning, the point of action 15 is set up on the tubular bone 31 
subsequently in three spots, the distance between them being up to 20 mm, 
and in each spot there are delivered 1000 electrohydraulic impacts for the 
upper limb and 1900 electrohydraulic impacts for the bottom limb. FIG. 12 
shows the result of the action in obtaining a fracture 33 of bone 31 at 
preserving the periosteum 30. FIG. 13 shows the elongation of the bone 31, 
consisting of two parts 34 and 35 after a fracture, which are extended by 
means of the apparatus 32 daily over 20 days until reaching the length of 
the sound limb. Between both parts 34 and 35 of the bone 31 there is 
obtained a gap 36, which is filled with blood and bone sand as a result of 
the action. After the elapsing of the 20 days, the apparatus with the 
elongated bone remains for immobilization until the total consolidation 
for 4 months; the healed and elongated zone of the bone 37 is shown in 
FIG. 14, the length of the bone 31 being normalized. 
The apparatus for medical treatment of bone pathology according to the 
invention operates as follows: 
After the switching-on of the supply block 17, a voltage is supplied to the 
block for centering the patient 18 and, as a result, the patient carriage 
with the object 9 is centered. Then the voltage is supplied to the x-ray 
block 22 which actuates the x-ray generator 5. The rays produced by the 
x-ray generator 5 are propagated along its longitudinal axis 13, they pass 
through the point of action 15 and reach the electronic optical converter 
11, in the output of which there is obtained the image of action 15. The 
image is received by the television camera 12, the signal of which is 
transmitted to the television block 19, where it is processed and then 
transmitted to the monitor 20 and via the feedbacks to the block of the 
electronic optical converter 21 and the block of the television system 22. 
The voltage supplied by the supply block 17 passes through the block of 
the high-voltage generator 23 for the supply of the generator of impact 
waves 2. After entering a command in the block of the high-voltage 
generator 23 by electrode 8, the generator of impact waves 2 begins to 
generate impact waves, which via the acoustic medium 7 reach the point of 
action 15 of the object 9. This cycle is repeated until the necessary 
healing effect is achieved. 
In a second modification of the apparatus, after switching-on the supply 
block 17, there is supplied a voltage to the block for centering the 
patient 18 and, as a result, the patient carriage with the object 9 is 
centered. Then a voltage is supplied to the x-ray system 22 which actuates 
the generator of x-rays 5. The rays produced by the x-ray generator 5 are 
propagated along its longitudinal axis 13. By rotation of the carrying arm 
24 around its axis 14 there is achieved a rotation of the longitudinal 
axis 13 at .+-.30 degrees with respect to the axis 14, which is an axis of 
the generator of impact waves, thus achieving an accurate determination of 
the spot of action 15. Passing through the point of action 15, the rays 
reach the electronic optical converter 11, at the output of which there is 
obtained the image of the object of action 15. The image is received by 
the television camera 12, the signal of which is transmitted to the 
television block 19, where it is processed and transmitted to the monitor 
20 and via the feedbacks--to the block of the electronic optical converter 
21 and the block of the x-ray system 22. The voltage supplied by the 
supply block 17 passes through the block of the high-voltage generator 23 
for supplying the generator of impact waves 2. After entering a command in 
the block of the high-voltage generator 23 by electrode 8, the generator 
of impact waves 2 begins to generate impact waves, which via the acoustic 
medium 7 reach the point of action 15 of the object 9. This cycle is 
repeated until the necessary healing effect is achieved. 
The impact waves can also be produced by an ultrasonic generator of impact 
waves, a magnetostriction generator of impact waves or a microexplosive 
generator of impact waves. 
The scope of the invention is not limited only to the aforementioned 
generator types. It should be understood that there can also be used other 
generators which can generate impact waves and can be used for medical 
treatment of bone pathology. 
CITED LITERATURE 
1. Diffenbach-Beck. Cited in I. Koptchev, "Trawmatologya na 
oporno-dvigatelnya aparat", Sofia, Medizina i Fizkoultoura, 1976, p. 137.