U.S. patent number 3,741,204 [Application Number 05/113,362] was granted by the patent office on 1973-06-26 for method of treating bone fractures and non-unions.
Invention is credited to Geraldine H. Thiele.
United States Patent |
3,741,204 |
Thiele |
June 26, 1973 |
METHOD OF TREATING BONE FRACTURES AND NON-UNIONS
Abstract
Fractures and nonunions of bones are more readily healed without
muscle atrophy, etc., by injecting a liquefied composition
containing a non-necrotic vascular sclerosing agent into the site
of the fracture or nonunion. No cast is used. The preferred
non-necrotic vascular sclerosing agent is sodium morrhuate.
Inventors: |
Thiele; Geraldine H. (Windber,
PA) |
Family
ID: |
22348992 |
Appl.
No.: |
05/113,362 |
Filed: |
February 8, 1971 |
Current U.S.
Class: |
606/60; 514/558;
606/93; 424/555; 606/76; 606/214 |
Current CPC
Class: |
A61K
9/0019 (20130101); A61B 17/3472 (20130101) |
Current International
Class: |
A61B
17/88 (20060101); A61K 9/00 (20060101); A61f
005/00 (); A61b 017/04 () |
Field of
Search: |
;128/92R,92G,95,334R,335,336 ;424/107,318 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Searle Pamphlet, "Hernia- The Injection Treatment," 1935, pp. 2-4,
relied on..
|
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed is:
1. A process of treating bone fractures, breaks and nonunions which
comprises injecting at least one dosage in an effective amount of a
liquefied composition comprised of a non-necrotic vascular
sclerosing agent of a fatty acid compound and a liquid carrier into
the site of the fracture, break or nonunion area of the bone, said
process being repeated until there is a substantially complete bone
union.
2. A process as described in claim 1 wherein said fatty acid
compound is a fatty acid salt or a fatty acid soap.
3. A process as described in claim 1 wherein said liquid carrier is
water.
4. A process as described in claim 1 wherein a dosage of said
liquefied composition is injected into the site of said fracture,
break or nonunion every week or two until there is a substantially
complete bone union.
5. A process as described in claim 1 wherein said dosage of said
liquefied composition are injected into the site of said fracture,
break or nonunion at its axis.
6. A process as described in claim 1 wherein the bone parts are
aligned into position for setting.
7. A process as described in claim 1 wherein said liquefied
composition has a pH between about 8 and about 11.
8. A process as described in claim 1 wherein said fatty acid
compound is a salt of an alkali metal and a fatty acid.
9. A process as described in claim 8 wherein said alkali metal is
sodium.
10. A process as described in claim 8 wherein said fatty acid is
oleic acid.
11. A process as described in claim 8 wherein said alkali metal is
sodium, wherein said fatty acid is oleic acid, wherein said
liquefied carrier is water, wherein said liquefied composition is a
solution, wherein said liquefied composition has a pH between 9 and
10, and wherein said fatty acid compound is present in an amount
between about 1 and about 5 percent.
12. A process as described in claim 8 wherein said fatty acid is an
unsaturated fatty acid.
13. A process as described in claim 8 where said fatty acid
compound is present in an amount between about 0.5 and about 10
percent.
14. A process as described in claim 8 wherein said liquefied
composition also contains ethanol.
Description
PRIOR ART
Known vascular sclerosing agents include phenol, zinc, sulphate,
glucose, strong sodium chloride solution, tannic acid and extracts
containing tannins, urea, quinine, resins and extracts containing
them, mineral acids, the salts or soaps of the fatty acids of
various oils, particularly cod liver oil, and psyllium seed oil,
amine soaps of fatty acids, ethanol, dextrose and invert sugar.
U.S. Pat. No. 1,621,118 teaches producing serume by treating
bacteria and/or their toxins with soluble salts of higher fatty
acids, and injecting the resultant antigens into the system of man
or animal. U.S. Pat. No. 1,936,456 discloses the use of sodium
ricinoleate and a fluid vehicle to treat internal body surfaces
which can only be reached through body orifices.
BROAD DESCRIPTION OF THE INVENTION
This invention involves a process of treating bone fractures breaks
and nonunions of man and animal. The process includes: aligning
(only when necessary) the bone parts to position for setting; and
then injecting at least one dosage of a liquefied composition
comprised of a non-necrotic vascular sclerosing agent and a liquid
carrier into the site of the fracture, break or nonunion area of
the bone until there is a substantially complete bone union.
Preferably another dosage is injected a week or two after the first
dosage and then every week or two thereafter, as needed, until
there is a substantially complete bone union. Preferably each
dosage of the liquefied composition is injected into the site of
the fracture, break or nonunion at its axis.
The non-necrotic vascular sclerosing agent can be, among other
things, a fatty acid compound, e.g., a fatty acid salt or a fatty
acid soap. The preferred non-necrotic vascular sclerosing agent is
sodium morrhuate. The preferred liquid carrier is water.
The preferred liquefied composition is comprised of sodium
morrhuate, enough sodium hydroxide to obtain a pH between about 9
and about 10 and water. It is also desirable to place up to 5
weight percent of benzyl alcohol in that liquefied composition.
Reduction of a fracture, heretofore, must be complimented by
immobilization of a cast as compression is put into effect.
Compression, per se, can only increase the mass, it cannot align.
My theory is that a cast leading to compression and atrophy of
muscle is not only undesirable, but in the case of the equine
reduction in many bones is impossible. I have proven that by
injecting a non-necrotic vascular sclerosing agent at the axis of
the fracture, I chemically introduce "struts," giving rise to
sheer, and thus alignment. The lack of the cast not only eliminates
atrophy of muscles, the complication of "lipping," but the movement
of bone against the tension of muscle insertion helps to promote
the flow blood to and from the damaged area.
The novel process of this invention can be used to heal (treat)
simple, compound, comminuted, linear, green-stick, multiple,
distracted and partial fractures as well as non-unions which have
been in existance as long as 1 year. This invention can also be
used for splints, diffused splints, and fusion of meta-carpals
and/or meta-torsals in regards to the three bone weight bearing
complex or any boney material.
The use of the liquefied composition of this invention allows the
healing of bone fractures, breaks and non-unions to be reduced from
as long as 18 months to 8 to 10 weeks, sometimes less.
The accepted four stages of the healing of fractures to date are:
(1) Stage of haematoma formation, (2) Stage of Callus formation,
(3) Stage of Consolidation, and (4) Remodelling of Callus.
DETAILED DESCRIPTION OF THE INVENTION
In the FIGURE, the bone is illustrated at 10, the locus of the
fracture being indicated at 11 and a blood clot 12 (hematoma in
periosteum). A syringe entity is indicated at 13 and includes
graduated cylinder 14, which cylinder converges toward one end and
is in communication with a polyvinyl tube 15 through sleeve 16.
Tube 15, in turn, is in communication with nylon adapter 17, the
latter emptying into a hypodermic needle socket 18, the needle
being indicated at 19. The point of needle 19 is engaged in the
interstice of fracture 11, as illustrated. Cylinder 14 is adapted
for the reception of a fluid composition containing a non-necrotic
vascular sclerosing agent. The fluid composition is forced from
cylinder 14 by plunger 20, which has finger-engaging head 21. The
heads are operated by thumb 22 of the user. Two of the fingers of
the user, 23 and 24, are interposed between terminal flange 25 of
cylinder 14 and clamp 26 as shown in the FIGURE.
The term liquefied composition includes slurries, suspensions,
solutions, etc.
All of the components of the liquefied composition must be
substantially non-toxic in the amounts and under the conditions of
use.
The pH of the liquefied composition should be between about 8 and
about 11, and preferably between 9 and about 10. Each non-necrotic
vascular sclerosing agent will produce a different pH at different
concentration levels so non-toxic agents may be added to adjust the
pH level, e.g., sodium hydroxide can be used when sodium morrhuate
is used.
Natural or synthetic fatty acids can be used to form the fatty acid
compound. Mixtures of fatty acids can be used.
Useful fatty acids for forming the fatty acid compounds may be
saturated or unsaturated. The useful saturated fatty acids are
represented by the general formula: RCOOH, where R can be H, an
alkyl group, branched or straight chain. Examples of useful
saturated fatty acids are formic acid, acetic acid, propionic acid,
n-butyric acid, isobutyric acid, N-valeric acid, n-caproic acid,
n-heptoic acid, caprylic acid, n-nonylic acid, capric acid,
undecylic acid, lauric acid, tridecylic acid, myristic acid,
pentadecylic acid, palmitic acid, margaric acid, stearic acid,
nonadecanoic acid, heneiscosanoic acid, triosanic acid, lignocerid
acid, pentacosanoic acid, cerotic acid, arachidic acid and behenic
acid. Example of useful unsaturated fatty acids are oleic acid,
linoleic acid, linolenic acid, licanic acid, eleostearic acid,
ricinoleic acid, clupanodonic acid and palmitoleic acid. The useful
unsaturated fatty acids can be those containing one double bond,
e.g., oleic acid, two double bonds, e.g., linoleic acid, three
double bonds, e.g., eleostearic, etc.
Useful fatty acids for forming the fatty acid salts which contain
one or more hydroxyl groups are, e.g., dihydroxystearic acid.
Useful hydrogenated fatty acids are cod liver oil fatty acids,
tallow fat fatty acids, caster oil fatty acids, rape oil fatty
acids, peanut oil fatty acids, cottonseed oil fatty acids, corn oil
fatty acids, soybean oil fatty acids, linseed oil fatty acids, tung
oil fatty acids, oiticia oil fatty acids, lard oil fatty acids,
neat's foot oil fatty acids, whale oil fatty acids, olive oil fatty
acids, coconut fat fatty acids, palm fat fatty acids, butter fat
fatty acids, lard fat fatty acids and fish oil fatty acids. The
useful hydrogenated fatty acids can be obtained from vegetable oils
and fats, and animal oils and fats. Polymeric fatty acids can be
used.
The fatty acid compound can be a fatty acid salt. The fatty acid
salts can be those prepared from metals, such as, aluminum and
alkaline earth metals, e.g., calcium, but are preferably those
prepared by alkali metals, e.g., sodium (preferred) lithium,
potassium, caesium and rubridium. (Ionic fatty acid compounds such
as, sodium morrhuate are preferred, even though the potassium salts
are usually more soluble.) The metals are used as compounds such as
hydroxides, carbonates, etc. The fatty acid salts can be prepared
from ammonia and similar non-metallic inorganic bases. The fatty
acid compounds can be esterified fatty acids, e.g., methyl formate,
ethyl propionate and n-amyl acetate. The fatty acid compounds can
be soaps such as the reaction products of the fatty acids and
organic bases, e.g., methylamine, triethanolamine,
monoethanolamine, diethanolamine, phenyl ethanol amine, ephedrine
and pseudoephedrine. Fatty acid soaps of mono -, di- and tri-alkyl
amines and aryl amines can be used.
U.S. Pat. No. 2,115, 491 teaches a method of preparing the sodium
salts or soaps of the fatty acids of psyllium seed oil. Amine soaps
of the fatty acids can be prepared by the method taught by U.S.
Pat. No. 2,090,456. U.S. Pat. No. 1,767,041 discloses a method of
making the product of alkali metals and fatty acids. The other
fatty acid compounds can be made by methods readily known by those
ordinarly skilled in the art.
The liquefied solutions should contain between about 0.5 and about
10 percent by weight of the fatty acid compound, and preferably
contain between about 1 and about 5 percent by weight of the fatty
acid compound.
Examples of specific useful compounds of fatty acids which can be
used as non-necrotic vascular sclerosing agents are: sodium
morrhuate (a mixture of the sodium salts of the fatty acids of cod
liver oil); sodium psylliate (a mixture of the sodium salts of
psyllium oil liquid fatty acids); sodium ricinoleate; ethylamine
oleate; monoethanolamine oleate; sodium formate; sodium acetate;
and calcium propionate. Salts of fatty acids are preferred,
particularly those formed from alkali metals, and the preferred
fatty acid salt is sodium morrhuate.
Examples of other useful non-necrotic sclerosing agents are
dextrose and invert sugar. (Invert sugar is a mixture of dextrose
and levulose obtained by the inversion of sucrose.) Solutions
containing, for example, dextrose (25 wt. percent) and sodium
chloride (15 wt. percent), or invert sugar (30 wt. percent) and
sodium chloride (10 wt. percent) can be used. Solutions containing
about 50 percent by weight of dextrose are preferred. Solutions
containing about 60 to about 75 percent by weight of invert sugar
are preferred.
The fatty acid compounds (preparations) are preferred over the
other useful non-necrotic vascular sclerosing agents because, for
among several reasons, less of the liquefied composition (dosage)
is needed. This means the less concentrated fatty acid compound
preparations are needed than the more concentrated preparations
such as those containing dextrose or invert sugar.
Solutions of dextrose or invert sugar or salts of fatty acids are
not very irritating and do not produce necrosis.
Examples of the liquid carrier for the non-necrotic vascular
sclerosing agent are water; monoglycerides; diglycerides; etc.
Water is the preferred liquid carrier, and salt (N.sub.a Cl) can be
added to make an isotonic aqueous solution as the liquid
carrier.
The useful vascular sclerosing agents must be non-necrotic in
effect or operation. Sclerosing agents' to be useful must not cause
the pathologic death of one or more cells, or a portion of tissue
or organ, resulting from irreversible damage to the nucleus.
Anodynes in amounts of up to and including about 5 percent by
weight may be added. An anodyne is an agent which has the power to
relieve pain. An example of a useful anodyne is benzyl alcohol. In
general small amounts of antiseptics or anaesthetics can be
used.
Suitable preservations can be added in an amount not to exceed 0.5
percent by weight.
In some instances it may be necessary to use traction, but a cast
as such is not used.
Unless otherwise stated or indicated, in the following examples,
all percentages and proportions are expressed on a weight
basis.
The following examples further illustrate, but do not limit, this
invention.
EXAMPLE 1
A liquefied composition containing 5 weight percent of sodium
morrhuate, 3 weight percent of ethanol, enough N.sub.a OH to obtain
a pH of 9.5 and the remainder water. The liquefied composition was
placed in several 2 c.c. ampoules. One of the ampoules was used to
fill a hypodermic needle syringe of the type shown in the Figure.
The liquefied solution was injected into the axis or plane of a
fresh break of the coffin bone of a horse, the ends being held
manually in alignment during the injection. No cast was used and
the horse was not suspended. The treatment was not painful. X-rays
indicated that "struts" were produced, giving rise to sheer and
thus alignment. The horse was able to "test out" the leg and
successfully put minor weight on the foot after about 10 days.
Another injection was made on the tenth day, and about every 10
days thereafter until the fracture was substantially cured after
about 3 months.
EXAMPLE 2
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (5 c.c. vial) containing 5
percent of sodium pyslliate and 2 percent by weight of benzyl
alcohol. That aqueous solution had a pH of 8.9 (enough 10 percent
N.sub.a OH solution was added to achieve that level). The fracture
was substantially cured in about 3 months after repeated
injections.
EXAMPLE 3
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. vial) containing 5
percent of sodium physlliate. A N.sub.a OH solution was added to
obtain a pH level of 8.7 The fracture was substantially cured in
about 3 months after repeated injections.
EXAMPLE 4
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. vial) containing 2
percent of sodium ricinoleate. That solution has a pH between 8.2
and 8.5. The fracture was substantially cured in about 3 months
after repeated injections.
EXAMPLE 5
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c.) containing 50
percent dextrose. The fracture was substantially cured in about 3
months after repeated injections.
EXAMPLE 6
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. ampul) containing 65
percent of invert sugar. The fracture was substantially cured in
about 3 months after repeated injections.
EXAMPLE 7
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. ampul) containing 5
percent ethylamine oleate and 2 percent benzyl alcohol. The
fracture was substantially cured in about 3 months after repeated
injections.
EXAMPLE 8
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. ampul) containing 5
percent ethylamine oleate. The fracture was substantially cured in
about 3 months after repeated injections.
EXAMPLE 9
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. ampul) containing 5
percent of sodium morrhuate, 3 percent of benzyl alcohol, and
enough N.sub.a OH to bring the pH up to 9.5. The fracture was
substantially cured in about 3 months after repeated
injections.
EXAMPLE 10
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. ampoule) containing 5
percent of sodium morrhuate and enough N.sub.a OH to bring the pH
up to 9.5. The fracture was substantially cured in about 3 months
after repeated injections.
EXAMPLE 11
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. ampoule) of 1 percent
of sodium morrhuate and enough N.sub.a OH to bring the pH up to
9.1. The fracture was substantially cured in about 3 months after
repeated injections.
EXAMPLE 12
Example 1 was repeated, except that the liquefied composition
containing the non-necrotic vascular sclerosing agent of Example 1
was replaced with an aqueous solution (2 c.c. ampoule) of a 3
percent solution of sodium morrhuate and enough KOH to bring the pH
up to 9.3. The fracture was substantially cured in about 3 months
after repeated injections.
EXAMPLE 13
Example 1 was repeated except that the treatment was done to an
apex sesamoid fracture of a horse. The fracture was substantially
cured in about 3 months after repeated injections.
EXAMPLE 14
Example 1 was repeated except that the treatment was done to a
distal sesamoid fracture of a horse. The fracture was substantially
cured in about 3 months after repeated injections.
EXAMPLE 15
Example 1 was repeated except that the treatment was done to a chip
fracture in the carpus of a horse. The fracture was substantially
cured in about 3 months after repeated injections.
* * * * *