U.S. patent number 3,683,422 [Application Number 05/062,536] was granted by the patent office on 1972-08-15 for bone prosthesis.
This patent grant is currently assigned to Cutter Laboratories, Inc.. Invention is credited to Paul Kahn, August L. Stemmer, James A. Stubstad.
United States Patent |
3,683,422 |
Stemmer , et al. |
August 15, 1972 |
BONE PROSTHESIS
Abstract
A prosthetic device with sub-periosteal, periosteal, or bone
surface attachment for stress support, comprising a rigid
reinforcing member and an elastomer-impregnated fibrous or woven
fabric covering such member and firmly fixed to it. In one
embodiment, a fibrous reinforced elastomer condyle-like member is
affixed to one end of such reinforcing member, and a flexible
pedicle extends outwardly from such condyle-like member and has at
its remote end a bone-attaching head comprising a flat or disc base
with a bone-exposed covering or coating of a
tissue-ingrowth-receptive, open-pore fabric, to assist in providing
a joint function. There is also affixed to the bone-exposed face of
the elastomer-covered reinforcing member a coating of such
tissue-ingrowth-receptive, open-pore fabric. All the elements where
attached are firmly fixed to each other, the reinforcing member
being also suitably sutured to the elastomer-impregnated fabric.
The fiber and fabric parts are advantageously of Dacron, the fabric
being preferably of Dacron velour; and the elastomer is
advantageously silicone rubber. The device is adapted for insertion
as a load-bearing element. A method for making the above device is
also provided.
Inventors: |
Stemmer; August L. (San
Francisco, CA), Kahn; Paul (San Francisco, CA), Stubstad;
James A. (Lafayette, CA) |
Assignee: |
Cutter Laboratories, Inc.
(Berkeley, CA)
|
Family
ID: |
22043141 |
Appl.
No.: |
05/062,536 |
Filed: |
August 10, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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833824 |
Jun 16, 1969 |
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Current U.S.
Class: |
623/23.51 |
Current CPC
Class: |
A61F
2/2803 (20130101); A61F 2/2846 (20130101); A61F
2/3099 (20130101); A61F 2002/30563 (20130101); A61F
2002/3092 (20130101); A61F 2/30767 (20130101); A61F
2/30965 (20130101); A61F 2002/3007 (20130101) |
Current International
Class: |
A61F
2/28 (20060101); A61F 2/30 (20060101); A61F
2/00 (20060101); A61f 001/24 (); A61f 001/00 () |
Field of
Search: |
;128/92R,92C,92CA,92BC,334R ;3/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Silicone Rubber Implants for Replacement of Arthritic or Destroyed
Joints in the Hand" by A. B. Swanson, M.D., Surgical Clinics of
North America, Vol. 48, No. 5, Oct. 1968, pp. 1113-1127..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
This application is a continuation-in-part of application Ser. No.
833,824, filed June 16, 1969, now abandoned.
Claims
Having now described the invention, what is claimed is:
1. A prosthetic device for replacement or repair of a damaged or
missing bone structure and adapted to emplacement by
sub-periosteal, periosteal or bone surface attachment, including in
combination:
a shaped, relatively rigid reinforcing element, which when bent
retains its shape, extending continuously from one end to the
other,
an elastomer-impregnated fabric fully covering and fully enclosing
said element, and contoured thereto, and
an open-pore, tissue-ingrowth-receptive fabric coating disposed
over at least a portion of a surface of said impregnated fabric and
being adapted to abut upon a bone surface when emplaced,
said reinforcing element and elastomer-impregnated fabric being
firmly affixed to each other, and being compatible with body
fluids, and at least a portion of said open-pore fabric being
affixed to said elastomer-impregnated fabric.
2. The prosthetic device of claim 1 wherein said reinforcing
element is substantially flat.
3. The prosthetic device of claim 1 wherein said reinforcing
element is metal.
4. The prosthetic device of claim 1 wherein said reinforcing
element is covered on each side with a layer of woven fiber
compatible with body fluids and impregnated with silicone
rubber.
5. The prosthetic device of claim 1 wherein an amount of openpore
fabric is in part unattached to said impregnated fabric to form at
least one flap, said flap being adapted to fold over and attach to
a cut bone end and interior bone face when emplaced.
6. A prosthetic device for repair of a resected mandible and
adapted to emplacement by periosteal attachment, comprising in
combination:
a flat, rigid, mandible shaped metal reinforcing element,
a layer of woven fabric embedded in elastomer and disposed at each
flat surface of said reinforcing element, covering and enclosing
said reinforcing element, one said surface being adapted to face a
mandible bone when emplaced,
a coating of tissue-ingrowth-receptive cloth disposed over at least
a portion of said one flat surface and adapted to abut said bone
and to receive tissue ingrowth therefrom,
securing means for fastening together said cloth and said
elastomer, and
means for binding said metal element to said elastomer,
said elastomer being cured.
7. The prosthetic device of claim 6 wherein said securing means is
a layer of elastomeric adhesive disposed between said silicone
rubber and said cloth and polymerized to said silicone rubber.
8. The prosthetic device of claim 6 wherein said means for binding
comprises sutures passing around said metal element and through
said woven fabric layers.
9. A prosthetic device for repair of a damaged bone structure and
adapted to emplacement by periosteal attachment, comprising in
combination:
a. a substantially flat, shaped, rigid reinforcing element,
b. a elastomer-impregnated fibrous coating contoured to and
enclosing said element,
c. an open-pore, tissue-ingrowth-receptive fabric coating disposed
over at least a portion of a surface of said fibrous coating and
being adapted to abut upon and attach to a bone surface when
emplaced,
d. said reinforcing element, fibrous coating and fabric coating
being firmly affixed to each other and being compatible with body
fluids,
e. a condyle-like element extending from one end of said
reinforcing element and having a rigid stem and a rounded terminal
head,
f. a flexible pedicle projecting from said stem and having a flat
terminal head, said head having an outer face adapted to fit
against a bone surface when emplaced, and
g. a tissue-ingrowth-receptive fabric disposed over said outer
face,
h. all of said components being firmly affixed to each other, and
being compatible with body fluids.
10. The prosthetic device of claim 9 wherein said condyle-like
element is of non-porous, smooth silicone rubber, stiffened and
reinforced internally with woven Dacron fiber.
11. The prosthetic device of claim 9 wherein said pedicle is of
non-porous, smooth silicone rubber reinforced internally with
flexible Dacron fibers.
12. The prosthetic device of claim 9 wherein said
tissue-ingrowth-receptive fabric is Dacron velour.
13. The prosthetic device of claim 9 wherein sutures are disposed
around said reinforcing element and through said
elastomer-impregnated fibrous coating to bind the same
together.
14. The prosthetic device of claim 9 wherein said flat terminal
head is disc shaped and said fabric extends substantially beyond
the edges thereof.
15. In a bone prosthesis of physiologically compatible material
suitable for implantation in a living body,
a skeletal prosthetic element,
a generally flat imperforate disc adapted to serve as an ingrowth
anchor for said prosthesis on a periosteal surface adjacent the
intended position of said prosthesis, and
a single slender flexible pedicle joining said disc to said
skeletal prosthetic element for continuously guiding it into a
predetermined position by a hinge-like motion.
16. In a bone prosthesis
a skeletal prosthetic element having a condyle-like element
comprising part of said skeletal prosthetic element,
a generally flat disc adapted to serve as an anchor for said
prosthesis on a periosteal surface adjacent the intended position
of said prosthesis, and
a slender flexible pedicle joining said disc to said skeletal
prosthetic element for continuously guiding it into a predetermined
position by a hinge-like motion.
17. The prosthesis of claim 16 wherein said pedicle is joined to
said condyle-like element.
18. A bone prosthesis, comprising
a main member having a generally flattened shape,
a condyle-like member connected to said main member by a thick stem
portion and having a head, and
a pedicle having a thin stem connected to said thick stem portion
and a head.
19. The bone prosthesis of claim 18 wherein said main member, said
condyle-like member, and said pedicle comprise a physiologically
compatible elastomer, said main member containing a relatively
rigid reinforcing member.
20. The bone prosthesis of claim 19 wherein said main member, said
stem portion, and said pedicle are covered with s physiologically
compatible open-pore pile fabric.
21. The bone prosthesis of claim 20 wherein said main member is
oversize relative to intended installations enabling trimming at
time of surgery for each individual installation.
22. A prosthetic device for replacement or repair of a damaged or
missing bone structure and adapted to emplacement by
sub-periosteal, periosteal or bone surface attachment, including in
combination:
a shaped, relatively rigid reinforcing element, which when bent
retains its shape, extending continuously from one end to the
other,
an elastomeric covering fully enclosing said element, and contoured
generally thereto, and
an open-pore, tissue-ingrowth-receptive fabric coating disposed
over at least a portion of a surface of said elastomeric covering
and being adapted to abut upon a supporting tissue surface when
emplaced,
said reinforcing element and elastomeric covering being firmly
affixed to each other, and being compatible with body fluids, and
at least a portion of said open-pore fabric being affixed to said
elastomeric coating.
23. The prosthetic device of claim 22 wherein said reinforcing
element is substantially flat and sufficiently flexible for shape
conformation at the time of emplacement.
24. The prosthetic device of claim 22 wherein said elastomeric
element is reinforced by contained physiologically compatible
fibers.
25. The prosthetic device of claim 22 wherein said elastomeric
covering and the fabric coating thereon are oversize relative to
intended installations enabling trimming at time of surgery for
each individual installation.
Description
BACKGROUND OF THE INVENTION
There are many instances where foreign substances are of necessity
required for surgical implantation in human or animal tissue to
achieve structural continuity. In some cases the exact dimensions,
especially the length, are not attainable prior to the initial
surgical procedure. For this reason it has become necessary to
devise a solution to the problem of adaptability, regardless of
what material is used so long as it can be cut and fashioned to
some extent at the operating table. The particular form of the
invention which is used as an example is for the jawbone, and it
takes into account a flexible plastic which is in general use along
with the combination of another plastic that has a rough and
irregular surface for adaptation to bone.
In the instance where a flat bone must be dealt with from the
standpoint of loss of extension, a way has been needed for enabling
restoration without the necessity of multiple screws and other
cumbersome and time consuming methods of handling in the operating
room, most of which constitute short form repair, limited by the
biological incompatibility of screws, plates etc. Thus, although
methods may exist for extensions, they have been created for
implantation of foreign substances by their placement in the center
of a long bone directly into the bone marrow. There has as yet been
no development that would provide firm fixation to the outside of
the bone where it may or may not be flat and requires
extension.
It is important that affixation of the prosthesis to the exterior
of the bone be firm and long-term or even permanent, with minimal
risk of infection. It is also very important in the case of a
mandibular or temporomandibular prosthesis where a condyle or
ball-and-socket restoration is provided, that no fixation of such
condyle per se occur in situ, while means are provided to maintain
the ball-and-socket relationship and free normal movement on the
condyle stem.
The above and other objects and advantages are obtained by the
present invention as will be evident from the description below.
The present invention provides a prosthetic device which can be
affixed sub-periosteally to a bone surface and in an advantageous
embodiment provides also a condyle-like member and a pedicle, the
latter being likewise sub-periosteally attached to maintain the
condyle-like member in proper operating position and condition.
SUMMARY OF THE INVENTION
This invention concerns a prosthesis for the addition or repair to
a missing or damaged bone; in the addition the prosthesis may be
attached periosteally. The prosthesis may be applied to a
substantially flat bone surface, and then at least one component of
the prosthesis is a substantially flat element.
The design and plan as herein set forth encompasses the use of any
preformed readily modifiable plastic substance that permits
porosity and is sufficiently flexible to be lapped around the end
of the bone, while at the same time the center core of the
prosthetic device has sufficient rigidity to maintain support. By
simple cutting or separating along the perforations, the flattened
edges of the leaf-like configuration of the supporting area is then
rolled over the end of the bone and with or without further
fixation, it is possible in many instances to maintain extension
and support sufficient to carry the necessary load that is applied
in normal function after a suitable period of healing.
The additional or optional use of the flattened mushroom-like end
or disc of the pedicle permits the prefashioned prosthesis to be
fitted into any socket or flattened area, while its perforations
and the character of the plastic substances chosen will enable firm
union into the socket allowing permanent movement on a flexible
stem. There can be no permanent fixation of a ball and socket on a
stem-like narrow section of the same plastic substance that is not
subject to fatigue under repeated movements or stress. In the
invention a main stem carries compressive loads, with rotation at
the condyle; a pedicle carries tensile loads with flexibility.
In one embodiment the prosthesis comprises a flat, shaped, rigid
reinforcing element (which may be of relatively rigid plastic, or,
advantageously of light metal, especially titanium) and a covering
thereover (suitably of fibrous material impregnated with silicone
rubber or like material compatible with body fluids or tissues).
The elastomer-impregnated fibrous or fabric covering is also flat,
or substantially flat, and is contoured generally to the metal
element. The covering is preferably made of a layer of fabric at
each flat surface of the reinforcing element, preferably of Dacron
fabric. A layer of such impregnated fabric may be placed on each
flat face or surface of the metal or other rigid element and the
whole sutured or adhered or otherwise secured together and
eventually vulcanized in forming the desired prosthesis or
component thereof. In a mandibular prosthesis, the metal element is
suitably curved and tapered to conform to the shape of the mandible
section to be repaired or replaced. Advantageously, the metal piece
may also be sutured to the reinforced elastomer, e.g., by
cross-stitching which passes around the metal element and through
the layers of impregnated woven fabric. Alternatively, the metal
and cloth may be joined by adhesives or through chemical
priming.
The mandibular prosthesis is also provided at its bone-adjacent
surface with one or two flexible flaps of open-pore,
tissue-ingrowth-receptive fabric, especially of Dacron velour
laminated with silicone rubber, and the Dacron velour surface in
each instance is adapted to abut a bone surface when emplaced. In
use, each flap is folded over a cut end of bone, the periosteal
tissue layer having been laid back so that the flap can also abut
the bone surface itself inside and outside of the mandible, so that
tissue ingrowth can occur at these bone surfaces over a period of
time, thoroughly bonding the prosthesis to the mandible. In another
embodiment, part of the elastomer-impregnated fibrous layer,
properly surfaced with open-pore fabric, is cut and folded over the
cut end of bone. Affixation of the flap to the bone enables
extension of the load-bearing element across the resected portion
of the bone, which can also extend, if desired, to a bearing at the
next available portion of bone. In any event, firm affixation to
the mandible is effected by such flap or pair of flaps. The area of
the prosthesis between a pair of turned-back flaps bridges the
resected portion of the mandible, where this has occurred. Both
surfaces of such a flap are of the tissue-ingrowth-receptive
material, so that such ingrowth eventually occurs with respect both
to the bone and to the periosteum.
Yet another embodiment of the invention provides a
temporomandibular prosthesis with the mandibular component as
described above, but also having a condyle-like element extending
from one end of the rigid or metal reinforcing agent. This
condyle-like element comprises a rigid stem or center bar,
preferably terminating in a rounded head. A pedicle or ligamentous
element, which may be shaped like a mushroom, extends from the
rigid stem and has a terminal head, preferably shaped like a disc.
The terminal head may be flat, being flexible and adaptive, and it
supports a disc of tissue-ingrowth-receptive fabric, preferably of
Dacron and especially Dacron velour. Such a disc can be round,
square or of any desired shape, depending upon the bone surface
available or other conditions. The disc is joined or affixed to the
stem by a layer of silicone rubber. The pedicle extends from the
rigid stem; in an optimal arrangement it joins the stem about
midway of the stem's length, but it can originate at other
locations. The ligamentous element or pedicle stem is of flexible
elastomer internally reinforced with a fiber material such as
Dacron. The disc of the pedicle can abut upon and conform to a
tissue such as a bone surface freed of periosteal tissue and
affixes thereto by tissue ingrowth, bony tissue or other tissue,
especially fibrous tissue, being encouraged by the fabric structure
to grow into the pile or open pores and thereby fix or secure the
prosthesis to the bone. The rounded head of the condyle-like
element fits movably or rotatably into a recess in the bone
intended to receive it, such as a temporal bone, hip bone or other,
and it is held in place without affixation by the action of the
pedicle and disc or ligamentous element. Although this embodiment
is described with respect to a temporomandibular prosthesis, the
condyle-pedicle features are also useful at other skeletal sites,
specially where joint function is desired, and it may there be used
along with the straight or bridging element and the condyle-like
articular ball surface mentioned before.
In practicing the method of making the device of this invention, a
flat, shaped, relatively rigid reinforcing element, such as a
titanium element, is placed between two layers of fabric, e.g.,
woven Dacron cloth, which have each been thoroughly impregnated
with a silicone rubber or like physiologically compatible
elastomer. The fabric and reinforcing agent are then sutured or
adhered to bind them together. A layer of an open-pore fabric, such
as a mesh or pile fabric, for example, may be thoroughly coated on
the back, or non-pile face, with a dispersion of unvulcanized
silicone rubber or other polymerizable bonding agent, without
closing the pores of the face, and applied over the fabric layers
covering the reinforcing element. The whole is vulcanized and cured
to assure firm bonding.
Where a condyle-like or joint-like element is employed, it is
affixed to a rigid reinforcing agent covered with a fabric
impregnated with rubber as described above. The condyle stem is
splayed at the base and spread over the reinforcing element at one
end thereof, and the fabric overlayer is fixed in place by
suturing; or the open-pore fabric may be placed over the same
around the condyle element and the whole vulcanized.
BRIEF DESCRIPTION OF DRAWINGS
The invention and some modes of carrying it out will be illustrated
by the annexed drawings which, without limiting the invention, show
some embodiments of the device of the invention. In the
drawings:
FIG. 1 is a perspective view of a temporomandibular prosthesis.
FIG. 2 is a top view of a rigid reinforcing element useful in the
prosthesis.
FIG. 3 is a top or plan view showing a mandibular prosthesis. The
view is partially cut away to show the rigid element, the layers of
impregnated fabric, and the binding suturing.
FIG. 4 is a view in elevation of the condyle-like element and
pedicle of FIG. 1.
FIG. 5 is a view in elevation of the device of FIG. 4 taken
90.degree. from FIG. 4.
FIG. 5A is a view in section of a portion of the pedicle, taken on
the line 5A--5A of FIG. 5.
FIG. 6 is a plan view of a mandibular prosthesis, with the upper
layer partly turned back to show suturing of the rigid member and
attachment of the condyle element thereto.
FIG. 7 is a view in elevation of the mandibular prosthesis, showing
two flaps.
FIG. 8 is a view in section taken on line 8--8 of FIG. 7.
FIG. 9 is a top view of a human lower jaw, showing use or placement
of a mandible prosthesis when the condyle element is not used.
FIG. 10 is a view in side elevation of the skeletal structure only,
showing the device and placement of FIG. 9.
FIG. 11 is a top view of a human jaw showing use of the mandible
prosthesis when the condyle and pedicle are used.
FIG. 12 is a view in side elevation of the device and placement of
FIG. 11.
FIG. 13 is a view in perspective of a modified form of a mandible
prosthesis.
FIG. 14 is a side view in perspective of the prosthesis of FIG.
13.
FIG. 15 is a top plan view of the mandible prosthesis of FIGS. 13
and 14.
DETAILED DESCRIPTION OF THE INVENTION
The invention will be described more specifically with reference to
two embodiments and with reference to the accompanying
drawings.
In FIG. 1 is shown a temporomandibular prosthesis 10 comprising a
mandible element 11 which has a flat, shaped, rigid reinforcing
element 12 of titanium metal of curved configuration to conform to
that of the mandible portion to be replaced. The element 12 is
disposed between two layers 13 and 13' of woven Dacron fabric,
which has been impregnated on both sides with silicone rubber 14.
Apertures 15 may be provided at the ends of element 12 to receive
sutures and assist in affixing the element 12 and the layers 13,
13' to each other. Sutures 16 are applied, suitably in
cross-stitching as shown in FIG. 3, and through the apertures 15,
to pass around the element 12 and through the layers 13, 13'.
Dacron sutures are suitable. Alternatively, the metal element 12
may have its surface suitably primed and secured to the layers 13,
13' by an adhesive.
The condyle-like element 17 comprises a rigid stem 18 and rounded
head or knob 19. The stem 18 is preferably made of Dacron woven
fabric impregnated with silicone rubber, then rolled up in
jelly-roll fashion and coated with a smooth surface of elastomer.
The head 19 is vulcanized to the stem 18, and the base 20 is
affixed to the mandible member 11 by splaying the base 20, placing
the splayed ends over the end of the rigid or metal element 12, and
vulcanizing the base 20 to the upper layer 13', prior to placement
of the open-pore coating 14, which bears an adhesive layer 30, as
shown in FIG. 6. A suitable aperture 21 and split 22 are provided
in the fabric layer 14 to enable fitting this layer over the
condyle element and down over the layer 13', after which the layers
are vulcanized together. If desired, the condyle 17 can be sutured
in place on the element 12 and the layer 13', and the vulcanizing
done then in one step.
The condyle element 17 is shown in FIGS. 4, 5, and 5A also, and
these figures show the structure of the ligamentous element or
pedicle 23 in more detail. The pedicle 23 is made up of a flexible
stem 24 and a head 26. The stem 24 may suitably be of silicone
rubber internally reinforced with flexible Dacron fibers or fabric
25. The head 26 may be of flat or disc shape and to it is affixed a
disc 27 of open-pore, tissue-ingrowth-receptive fabric, suitably
substantially larger than the head or joining layer 26. The layer
26 is preferably of silicone rubber reinforced with Dacron. The
fabric 27 is preferably Dacron and preferably has a pile such as
Dacron velour, and it is coated on the back with medical rubber
cement and vulcanized to the support 26, which is vulcanized to the
stem 24; the latter, in turn, is vulcanized to the rigid stem 18.
Perforations 28 are made in the disc 27 and the support 26 to
promote gross tissue ingrowth.
In use, the condyle head 19 fits into a receptive skeletal bone
cavity, e.g., in the temporal bone, and the disc 27 is placed
against an adjacent face of the bone, underneath the periosteum,
where it attaches by tissue ingrowth and provides ligamentous
support for the condyle-like element 17 preventing its shifting or
dislocation.
At the bone-facing surface 31 of the mandible prosthesis or element
11 are provided in the embodiments shown in the present drawings, a
pair of flaps 32, 32', each of which is made up of two layers 35,
35' of the open-pore fabric described above, suitably Dacron
velour, joined together by a layer of medical rubber adhesive 34.
The flaps 32, 32' are affixed to one face of the mandible element
11, especially by vulcanizing through a layer of medical rubber
adhesive over only a pair of their length, sufficient to effect
firm bonding. The flaps 32, 32' then turn back upon themselves.
As shown in FIGS. 9 through 12, each flap abuts the concerned bone
face, beneath the periosteum 36, which is held away during surgery;
the device is temporarily bonded in place by suturing at 33, and
tissue ingrowth occurs in very few weeks at the interface of bone
and velour and replaced periosteum to effect firm bonding.
Where only the mandibular prosthesis 11 is required, the
condyle-pedicle combination can be removed from the prosthesis if
so furnished, or it can be omitted in the manufacture thereof and
the device applied in a lower jaw as shown in FIGS. 9 and 10. Where
the condyle element and pedicle are employed, such application is
shown in FIGS. 11 and 12, and the rear flap is cut away as
unnecessary.
FIGS. 13, 14, and 15 show another modification. A relatively rigid
reinforcing member 40 is embedded in an elastomeric covering 41,
which, in this instance is adhered to a bottom oversize layer 42 of
fabric, preferably Dacron velour. A condyle-like element 43 has a
pedicle 44 with a head 45 covered with Dacron velour 46 and a stem
47. The condyle-like element 43 has a knob 48. If desired, the
elastomeric member 41 may have a series of serrate-like extensions
49.
The above specific description and the drawings have been given for
purposes of illustration only and modifications and variations can
be made therein without departing from the spirit and scope of the
appended claims .
* * * * *