U.S. patent number 3,710,789 [Application Number 05/095,240] was granted by the patent office on 1973-01-16 for method of repairing bone fractures with expanded metal.
This patent grant is currently assigned to The Regents of the University of Minnesota. Invention is credited to Robert A. Ersek.
United States Patent |
3,710,789 |
Ersek |
January 16, 1973 |
METHOD OF REPAIRING BONE FRACTURES WITH EXPANDED METAL
Abstract
A method of repairing fractures of the bone utilizing expanded
metal or similar openwork metal sheeting as a fracture fixation
device. Where possible the sheeting is wrapped around the bone,
extending on opposite sides of the fracture site, and fastened. For
other fractures a strip of the sheet material is secured to the
bone on opposite sides of the fracture site or inserted within the
medullary cavity. The fixation device holds the bone immobilized
while permitting knitting and, at the same time, the surrounding
tissue grows into and through the many fenestrations of the metal
sheeting to permanently fix the device to the fractured bone.
Inventors: |
Ersek; Robert A. (Saint Louis
Park, MN) |
Assignee: |
The Regents of the University of
Minnesota (Minneapolis, MN)
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Family
ID: |
22250869 |
Appl.
No.: |
05/095,240 |
Filed: |
December 4, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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35815 |
May 8, 1970 |
3657744 |
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Current U.S.
Class: |
606/60; 606/281;
606/285; 606/286; 606/298; 606/907; 606/62; 606/74; D24/155 |
Current CPC
Class: |
A61B
17/8085 (20130101); A61F 2/2846 (20130101); A61F
2002/30912 (20130101); Y10S 606/907 (20130101) |
Current International
Class: |
A61B
17/68 (20060101); A61B 17/80 (20060101); A61F
2/28 (20060101); A61F 2/30 (20060101); A61f
005/04 () |
Field of
Search: |
;128/92R,92BA,92BC,92D,92G,89R,334R |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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590,290 |
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Mar 1925 |
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FR |
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745,872 |
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May 1944 |
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DD |
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Other References
"Internal Fixation of Fractures" by E. B. Mumford, Surgery,
Gynecology and Obstetrics, 1934, pps. 194-204. .
"Preliminary Report on a Device for Intramedullary Fracture
Splinting" by E. O. Kane, The International Journal of Surgery,
Vol. XXIX, No. 2, Feb. 1916, pages 33-35..
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
This application is a continuation-in-part of my copending
application Ser. No. 35,815, filed May 8, 1970, entitled Method For
FIxing Prosthetic Implants In A Living Body, now U.S. Pat. No.
3,657,744.
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A method of rapidly and positively repairing a fractured bone in
a living body which comprises:
A. separating the surrounding muscle and subcutaneous tissue from
the fractured bone on opposite sides of the fracture site and
bringing the ends of the fractured bones together into normal
relation,
B. shaping a fixation device into conformity with the bone surfaces
to stabilize the broken segments of the fractured bone, said device
comprising:
1. a thin expanded metal openwork member of strong easily
deformable material capable of being shaped into conformity with
the surfaces of the fractured bone, and formed from inert non-toxic
material compatible with body fluids and tissues,
2. said member including a plurality of longitudinally extending
ribbon-like undulating portions interconnected to define a
plurality of staggered closely spaced uniformly sized and
distributed apertures, the ribbon-like portions being disposed to
extend angularly with respect to the bone surfaces, thereby being
adapted for mechanical attachment to the fractured bone and for
attachment to the surrounding tissue in a living host body,
C. positioning the device against the exposed bone surfaces on
opposite sides of the fracture site,
D. bringing the ends of the fractured bones together into normal
relation, and
E. while the ends of the bone are held in fixed position, securing
the fixation device to the bone on opposite sides of the fracture
site, and then restoring the separated muscle and tissue around the
fixation device.
2. A method according to claim 1 further characterized in that the
fixation device is formed into a cylinder surrounding the bone and
spanning the fracture site.
3. A method according to claim 2 further characterized in that said
fracture is a multiple fracture, the unstable bone fragments are
encased within the cylinder of expanded metal and the cylinder is
secured to the stable end bone members on opposite sides of the
fracture site.
4. A method according to claim 1 further characterized in that the
fixation device is formed into a rolled resilient cylinder, said
cylinder is inserted in the medullary cavities of the fractured
bone ends and permitted to unwind into contact with the cavity
walls, and secured by fastening means extending into the cylinder
from the external bone surface.
5. A method according to claim 1 further characterized in that:
A. said fracture is a multiple fragmented fracture,
B. a first fixation device is formed into a rolled resilient
cylinder, inserted into the medullary cavities of the stable end
bone members and permitted to unwind into contact with the cavity
walls as a core,
C. bone fragments are packed around the first core cylinder,
and
D. a second fixation device is formed into an outer cylinder
enveloping the bone fragments and core cylinder.
6. A method according to claim 1 further characterized in that said
openwork member is generally rectangular, and at least one of the
edges of said member is hemmed by being folded back upon itself
prior to being shaped into conformity with the bone surfaces.
7. A device according to claim 6 further characterized in that all
of the edges of the member are hemmed.
8. A method according to claim 1 further characterized in that the
fracture is a simple fracture and the fixation device is a
rectangular strip extending longitudinally along the fractured
bone.
9. A method according to claim 1 further characterized in that said
device is secured to said bone by truss head screws.
Description
This invention relates to a new system for the repair of fractures
of the bone utilizing expanded metal or similar openwork metal
sheeting as a fracture fixation device.
Expanded metal has been used successfully according to the
teachings of my copending application Ser. No. 35,815 as an implant
device into the aorta of several animals including dogs, calves and
pigs. In that use total success with the implantation of the
expanded metal has been achieved. That is to say, there is no
rejection phenomenon, there is no foreign body reaction and there
is no measurable corrosion of the expanded metal, thus implying
that it is biologically accepted.
In the past fractures of bones in the human or lower animals have
been repaired by strict immobilization of the opposing fracture
surface. This immobilization has been achieved in two principal
ways. Firstly, by external fixation with splints, baskets, plaster
casts, and other similar means to maintain alignment and
immobilization. This has worked well for simple fractures in which
the bone is not completely severed. It has worked less well, but
satisfactorily, for those simple fractures where the bone is
completely severed. It has worked poorly in those cases where there
are more than two bone fragments, several of which may be
unstable.
Secondly, immobilization has been achieved by internal fixation
wherein metal plates have been used to secure the two or more
fractured ends to each other with long bone screws passing through
two surfaces of the bone and thus securing the unstable ends.
Internal fixation has also been employed in the form of nails,
wires, pins and intramedullary rods. In this application a metal
piece is passed through the soft center of the bone to maintain
longitudinal alignment and some rotational stability. Often these
intramedullary rods in place have been secured with bone plates
that are applied to the outside of the bone and sometimes attached
by screws and bolts to the inside of the bone.
In the prior art some attempts at transplantation of bone have been
made wherein a step is cut in each end of the opposing bone
surfaces and a transplanted piece of bone from a cadaver donor or
from another species is then cut to size to fit in the two
corresponding steps. Screws have been used to fix these steps of
the similar bone to each other.
Defects in the cranium and maxillae and mandible have been repaired
by solid plates of stainless steel, silver and other metals. Wire
and silicone rubber have also been used to make up such contour
defects.
In the case of multiple fractured ribs, where a loose segment of
the thoracic cage existed from several ribs being broken in more
than one place, a condition known as flail chest, the fixation of
the flailing portion of the chest has been achieved by securing
towel clips to an overhanging orthopedic frame and partially
hanging the patient by his chest. In this way the loose segment of
the thorax can be stabilized so that the patient is able to breathe
adequately.
In the prior art, bone screws and intramedullary pins have served
well in many cases. However, long range results are less gratifying
and removal of bone plates and screws and pins is often recommended
because the passage of time often allows these devices to minutely
work loose. In cases where multiple fragments of bone have resulted
from gunshot wounds, or multiple breaks, there has been no
convenient way to stabilize many small fragments of bone. In the
prior art there is no totally satisfactory method of bridging a gap
where a segment of a few inches of bone has been destroyed, to
allow the packing of autogenous bone chips to grow long enough to
form new bone and bridge the gap.
The use of solid plates for cranium wounds prevents the later use
of diagnostic X-rays in the area for a tumor or the like. The use
of large bone plates to repair smaller bones has often been a
cumbersome procedure and erosion of the bone plate through the
thinner overlying muscles and skin has taken place. Attempts to
repair ribs in flail chest with large bone plates would result in
erosion of the plates and screws through the thin overlying skin
and in their present configuration most of the prior art screws
would pierce through the rib and possibly pierce the lung.
This invention relates to fracture fixation means and more
specifically to expanded metal as a means for the fixation of
fractures. In the case where a simple fracture exists with only one
crack or break through the bone, the expanded metal is wrapped
around the bone and small truss head screws are placed through the
lapped seam and into one cortex of bone, in this way giving
longitudinal, rotational and length stability. In the application
where there are two or more bone fragments, the unstable members
are encased within the cylinder of expanded metal and the screws
secured to the more stable end members.
The invention is illustrated in the accompanying drawings in
which:
FIG. 1 is a fragmentary perspective view of a cylinder of expanded
metal;
FIG. 2 is a fragmentary perspective view of one edge of the sheet
material forming the cylinder, showing a preferred form of
structure;
FIG. 3 is a schematic perspective view of a fractured bone repaired
with an expanded metal cylinder and affixed with screws;
FIG. 4 is a schematic perspective view of a fractured rib having
been repaired with expanded metal and small screws;
FIG. 5 is a schematic elevation, partly in section, of a fractured
bone repaired with an expanded metal cylinder inserted into the
medullary cavity; and
FIG. 6 is a schematic representation of a portion of the perimeter
of the devices of FIGS. 1 and 3 shown in transverse section.
Referring to FIG. 1, there is shown a portion of a sheet of
expanded metal 10 formed generally into the shape of a cylinder.
The longitudinal edges 11 and 12 are provided with a hem by folding
the sheet material over and crimping flat. The end edges 13 are
desirably also provided with a hem in the same manner. Preferably,
as shown in FIG. 2, a double hem is produced at leading edge 12A so
that it may pass easily over the other portions of mesh and will
tend to lock it in place.
In FIG. 3 there is shown schematically a repair in which the
proximal end 14 of fractured bone fragment and the distal end 15 of
the bone are joined together by the circumferentially applied
cylinder of overlapped expanded metal 10, the cylinder of expanded
metal having been secured to these bone fragments, as by the
previous drilling of holes and the installation of truss head
screws 16. Alternatively, the expanded metal sleeve can be secured
by wire or metal straps or bands passed around the sleeve. The
fracture site 17 is completely encased in the expanded metal and
will get its blood supply from its uninterrupted medullary blood
supply since no long screws protrude through the cortex of the
bone, and through the myriad of tiny windows in the expanded
metal.
The repair of a fractured rib is shown in FIG. 4. The proximal
segment 18 and distal segment 19 of rib are here joined at the
fracture site 20 by a rectangular section of expanded metal 21 that
has secured the two loose ends and is held by truss head screws
22.
In FIG. 5 there is illustrated the use of a cylinder of expanded
metal as an internal fracture fixation device. The proximal segment
23 and distal segment 24 of the bone are joined at the fracture
site 25 by a cylinder 26 of expanded metal positioned within the
medullary cavity 27 and secured by truss head screws 28. The
fixation device may be forced through the soft spongy cellular
material within the bone cavity, or, if necessary, a rod or similar
tool may be used to initiate a passage for insertion of the
expanded metal cylinder. The resiliency of the rolled cylinder as
it tends to unwind urges the fixation device into contact with the
cavity wall. If desired, both internal and external fixation
devices may be used, particularly in the case of fractures where
the multiple bone fragments are present. These may be packed around
an internal cylinder as a core and enveloped by an outer cylinder
holding the chips and fragments in place.
Preferably the openwork fixation device, whether in the form of a
flat strip of shaped sheet or a sleeve is formed from so-called
"expanded metal" sheeting which is produced by forming a series of
staggered parallel slits in an impervious metal sheet and then
stretching the sheet in a direction perpendicular to the slits to
open the slits into apertures and expand the metal sheet in that
direction while contracting it slightly in the opposite direction.
The stretching operation by which the metal sheet is expanded
imparts a twist or bend to the undulating flat ribbon-like portions
of the metal sheet separating the diamond-shaped apertures which
are generally uniformly sized and distributed. This twisting or
bending of the metal members between adjacent apertures imparts an
angle or direction to the apertures themselves and to the
ribbon-like members.
The expanded metal sheeting is desirably not flattened prior to
forming into a fixation device of appropriate shape. The result, as
seen schematically in FIG. 6, is that the ribbon-like portions of
the sleeve extend angularly relative to the perimeter of the sleeve
providing multitude of narrow projecting edges which embed
themselves into the tissue wall. The edges may be cuffed if desired
or simply smoothed to facilitate entry. The fixation devices are
formed to be a size appropriate for the repair being made. The
strands and apertures are sized proportionately. It has been found
convenient to hem the edges with a few millimeter bend of the
expanded metal on all exposed edges. This enables the expanded
metal to be passed around the bone and over the muscle and fascia
layers. Desirably the surface is sandblasted to provide maximum
surface area and mechanical roughness to enable the surrounding
biological tissues to adhere to it. Because of the twisted relation
of the ribbon-like portions of the sleeve, protrusion of the
surrounding tissue is facilitated.
The fixation device is made of deformable material such that it
retains its expanded dimensions. It is formed from a non-toxic
material compatible with blood and other body fluids, such as
stainless steel. Its walls desirably have a large percentage of
open area so as to permit proliferation of the tissues through the
openings and over the intervening strand-like or ribbon-like
members. The stainless steel expanded metal has great strength and
yet is easily worked. Sheet material with multiple fenestrations
produced by other means may be used, for example perforated sheet
material in which many closely spaced openings are produced by
drilling or stamping.
Expanded metal mesh such as is herein described is especially
useful in the repair of cranial and maxillary defects where molding
must take place at the operating site by the surgeon. This material
is easily stretched and bent to form any three-dimensional shape
and easily attached to the surrounding bone by fine screws of the
same metal. The great surface area of this substance and the many
windows allow for total tissue ingrowth so that it acts in a manner
similar to the reinforcing rods in reinforced concrete and it is
anticipated that this stainless steel substance can remain within
the body permanently without adverse effect. The use of expanded
metal provides a simple unobtrusive means for the fixation of
multiple fractures of ribs, where microscrews are used to fasten a
small section of expanded metal right over the fractured site and
in this way gaining stability.
Expanded metal has been shown to be useful at the University of
Minnesota Hospitals laboratory where 304 stainless steel expanded
metal as is herein described has been implanted in canine, porcine
and bovine experimental animals. It has been found that the
material is well accepted for long periods of implantation with no
appreciable change in geometry, with no foreign body reaction and
with no rejection and with minimal infection.
A series of experiments has been performed with 10 dogs wherein
their radius was sawed through at approximately its midpoint and
the surrounding muscle and subcutaneous tissue was separated from
the bone. A piece of expanded metal was then wrapped around the
bone at the site of the fracture for a distance of approximately 1
inch on each side of the fracture and overlapping about one-half
inch. The overlapping ends were then secured with small truss head
screws. Of the 10 dogs, one died of infection, one died of
anesthesia overdose 22 days after the operation, and the other
eight are alive and well and living in Minneapolis. An autopsy was
done on the dog that died of anesthesia overdose and it was found
that tissue had grown in all the many little windows and that the
bone was very well fixed. Movies were made of this dog running
across the lawn at the end of 11 days. The eight dogs which are
alive several months after the operation are being studied for long
term effects. All dogs performed some weight bearing on their
broken leg within a week after the operation.
It is apparent that many modifications and variations of this
invention as hereinbefore set forth may be made without departing
from the spirit and scope thereof. The specific embodiments
described are given by way of example only and the invention is
limited only by the terms of the appended claims.
* * * * *