U.S. patent number 3,745,590 [Application Number 05/156,664] was granted by the patent office on 1973-07-17 for articulating prosthesis with ligamentous attachment.
This patent grant is currently assigned to Cutter Laboratories, Inc.. Invention is credited to James A. Stubstad.
United States Patent |
3,745,590 |
Stubstad |
July 17, 1973 |
ARTICULATING PROSTHESIS WITH LIGAMENTOUS ATTACHMENT
Abstract
A prosthesis useful in the repair or replacement of damaged or
diseased joints in the human body, in particular of those which
require unrestricted orbiting motion such as the base of the thumb,
carpal bones of the wrist, shoulder joints and the like. A molded
body portion replaces at least the articulating portion of the bone
to be treated and one or more ligamentous elements. The body
portion is suitably made of a biocompatible elastomer, especially
one which is reinforced with a fibrous material such as a web or
mesh of Dacron or Teflon. The ligamentous element can be a cord,
flat tape or a tube such as a fabric tube of Dacron or Teflon, and
in some embodiments is protected against tissue ingrowth over at
least its intermediate length. In a carpal-metacarpal prosthesis
for a thumb, for example, the body portion also has a metacarpal
stem portion having a tissue-ingrowth-receiving surface, such as a
complete or partial covering of Dacron velour, the core of such
stem being suitably a biocompatible elastomer.
Inventors: |
Stubstad; James A. (Lafayette,
CA) |
Assignee: |
Cutter Laboratories, Inc.
(Berkley, CA)
|
Family
ID: |
22560507 |
Appl.
No.: |
05/156,664 |
Filed: |
June 25, 1971 |
Current U.S.
Class: |
623/13.11;
128/DIG.21; 623/21.12 |
Current CPC
Class: |
A61F
2/30907 (20130101); A61F 2/4241 (20130101); A61F
2/4261 (20130101); Y10S 128/21 (20130101); A61F
2002/30448 (20130101); A61F 2002/30205 (20130101); A61F
2002/30462 (20130101); A61F 2002/30563 (20130101); A61F
2220/005 (20130101); A61F 2/40 (20130101); A61F
2002/30878 (20130101); A61F 2002/4292 (20130101); A61F
2220/0075 (20130101); A61F 2002/4258 (20130101); A61F
2230/0067 (20130101); A61F 2002/4276 (20130101); A61F
2/30965 (20130101); A61F 2002/3007 (20130101); A61F
2/0811 (20130101); A61F 2/4202 (20130101) |
Current International
Class: |
A61F
2/30 (20060101); A61F 2/42 (20060101); A61F
2/00 (20060101); A61F 2/08 (20060101); A61F
2/40 (20060101); A61f 001/24 () |
Field of
Search: |
;3/1
;128/92C,92CA,92R,DIG.21 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,061,009 |
|
Nov 1953 |
|
FR |
|
1,122,634 |
|
May 1956 |
|
FR |
|
Other References
"A Permanently Attached Artificial Limb" by C. W. Hall et al., The
Bulletin of the Dow Corning Center for Aid to Medical Research,
Vol. 9, No. 4, Oct. 1967, page 13. .
"Silicone Rubber Implants for Replacement of Arthritic or Destroyed
Joints in the Hand" by A. B. Swanson, Surgical Clinics of North
America, Vol. 48, No. 5, October 1968, pages 1113-1127..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
Having now described the invention, what is claimed is:
1. A prosthesis for replacement of at least the articular portion
of a bone to enable substantially unrestricted orbital motion in a
joint in an animate body, comprising in combination a shaped body
portion of biocompatible elastomer material conforming
approximately to the shape of the bone portion to be replaced and
having a contoured surface means to produce said orbital motion,
and
fabric ligamentous means secured to said portion for attachment by
tying to an adjacent structure in said body at least a portion of
said fabric being tissue ingrowth receptive so as to be adapted to
affixation by tissue ingrowth.
2. A prosthesis as in claim 1 wherein said shaped body portion is
of silicone rubber.
3. A prosthesis as in claim 2 wherein said rubber is reinforced
with fibrous material.
4. A prosthesis as in claim 3 wherein said fibrous material is a
mesh of fabric selected from the group consisting of Dacron and
Teflon.
5. A prosthesis as in claim 1 wherein said body portion has a
centrally concave end surface, and a rounded shoulder
therearound.
6. A prosthesis as in claim 1 wherein there are provided a
plurality of said ligamentous means.
7. A prosthesis as in claim 1 wherein said ligamentous means is a
tube of fabric selected from the group consisting of Dacron and
Teflon.
8. A prosthesis as in claim 7 wherein said tube is provided with at
least one inner cord extending through the length of said tube and
attached only to said shaped body.
9. A prosthesis as in claim 1 wherein said ligamentous means is of
tissue-ingrowth-receiving fabric and has a
tissue-ingrowth-resistant surface throughout its intermediate
length.
10. A prosthesis for replacement of the combination of the
articular portion of a first bone selected from the group
consisting of the metacarpal and metatarsal bones and a second bone
selected from the group consisting of the carpal and tarsal bones
at a joint to enable substantially unrestricted orbital motion
therein, comprising in combination:
a. a shaped body portion of biocompatible material conforming
generally to the shape of said articular portion and said second
bone and having a top face,
b. at least one fabric ligamentous element affixed to said body
portion and adapted to attach to an adjacent body structure, each
said ligamentous element being affixed at one of its ends to said
body portion,
c. means to attach said element to an adjacent body structure,
d. a conical stem extending from the bottom of said body portion
opposite said top face, and
e. a tissue-ingrowth-receiving fabric at least partially covering
the surface of said stem, said stem being formed of a biocompatible
elastomer.
11. A prosthesis as in claim 10 wherein said stem is made of
silicone rubber reinforced with mesh fabric selected from the group
consisting of Dacron and Teflon.
12. A prosthesis as in claim 10 wherein said ligamentous element
comprises a pair of flexible knitted Dacron tubes arranged side by
side and covered over the intermediate length of each with a
tissue-ingrowth-resistant flexible elastomeric coating.
13. A prosthesis as in claim 10 wherein each said ligamentous
element is a tube provided with a least one inner cord extending
through the length of said tube attached only to said shaped
body.
14. A prosthesis as in claim 10 wherein said fabric is Dacron
velour.
15. A prosthesis for replacement of a bone in a human joint having
orbital motion comprising a shaped body of biocompatible elastomer
reinforced with biocompatible fibrous material and comforming
generally to the shape of said bone and having a contoured surface
means to produce said orbital motion, and at least one flexible
fabric ligamentous element affixed to said body having at least a
portion which is tissue ingrowth receptive whereby it is adapted to
be attached to an adjacent body structure at the other end by
tissue ingrowth so as to stabilize said joint against
dislocation.
16. A prosthesis for replacement of a carpal lunate bone in a human
wrist comprising a shaped body conforming approximately to the
shape of said carpal lunate to be replaced and formed of silicone
rubber, said body having a contoured upper face adapted to
articulate with a carpal bone, at least one ligamentous element
disposed at each end of said upper face, each of said elements
being a flexible knitted tube of fabric selected from the group
consisting of Dacron and Teflon and adapted to attach to an
adjacent body structure to stabilize said shaped body when emplaced
in said wrist.
17. A prosthesis as in claim 16 wherein a flexible cord is freely
disposed within said tube and attached to said shaped body.
18. A bone prosthesis, comprising,
a. a molded body portion generally conforming to the shape of the
bone to be replaced and provided with a contoured surface means
adapted to produce an articulating motion with a cooperating joint
part, and having
b. a stem portion covered with biocompatible fabric, and
c. at least one fabric ligamentous element secured to said body
portion having at least a portion which is tissue ingrowth
receptive, and adapted to attach to a body tissue by tissue
ingrowth.
19. A prosthesis for replacement of a bone in a human joint having
orbital motion comprising
a shaped body of biocompatible elastomer reinforced with
biocompatible fibrous material and conforming generally to the
shape of said bone and having a contoured surface means to produce
said orbital motion,
a stem portion secured to said body portion and tapered therefrom
and covered with biocompatible tissue-ingrowth-receptive fabric,
and
at least one flexible fabric ligamentous element affixed to said
body having at least a portion which is tissue ingrowth receptive
whereby it is adapted to be attached to an adjacent body structure
at the other end by tissue ingrowth so as to stabilize said joint
against dislocation.
Description
BACKGROUND OF THE INVENTION
This invention concerns a prosthesis useful in the repair of
damaged or diseased joints of the body, especially of joints which
require an unrestricted orbiting motion. There are such joints at
the base of the thumb where the first metacarpal bone articulates
with the carpal bones, and also at the carpal bones of the wrist,
shoulder joint and the like.
It is recognized that joint prostheses commonly used for repair of
the metacarpal-phalangeal joints of the hand make use of integrally
molded stems fitted into the intramedullary bone canals on either
side of the joint as a means for maintaining alignment or resisting
dislocation of the joint. However, special problems exist in
certain joints of the body where the anatomy does not permit the
use of integral stems fitted into opposing bones on either side of
the joint. This is especially true in the wrist where the blood
supply to the carpal bones can be easily upset or damaged by
drilling or other gross manipulation of the bones. In addition, the
repair of some joints such as the carpal-metacarpal joint of the
thumb, carpal bones of the wrist, shoulder, ankle, etc., require an
unrestricted orbiting ball-and-socket motion that does not allow
use, in repair, of a reinforced stem and hinge prosthesis which has
merely a preferential single plane of bending.
Replacement of the carpal-metacarpal portion of the thumb joint
with a prosthesis has previously been attempted. However, the
prosthesis of the prior art has relied upon reconstruction of the
natural connective tissues to maintain position, although these
tissues are often insufficient for the purpose, being subject to
degenerative conditions similar to those affecting the joint
articular surfaces; hence dislocation has frequently resulted.
It is an object of the present invention to overcome the aforesaid
disadvantages of prostheses known to the prior art. The invention
does so by providing a prosthesis constructed of biocompatible
materials, particularly useful in a joint requiring the
unrestricted orbiting motion. It is a further object to provide
such a prosthesis having a flexible ligamentous attachment which
can be arranged to secure the articulating end of the prosthesis
into its natural position and wherein the prosthetic ligament can
be located to lie in a plane of neutral or nearly neutral
motion.
It is an advantage of this invention that orbiting motion is
preserved in the joint. Another advantage is that the stability of
the prosthesis is maximized. Further advantages are that motion is
substantially unrestricted and that dislocation is prevented along
the axis of the attached ligament or ligaments. Further advantages
will become apparent from the description which follows.
SUMMARY OF THE INVENTION
This invention relates to a prosthetic joint, particularly such as
is useful in joints requiring unrestricted orbiting motion, such as
a carpal-metacarpal joint of the thumb, carpal bones of the wrist,
shoulder joint, foot, and the like. In a particular manner, the
invention relates to a prosthesis of this typc comprising a shaped
body portion and incorporating or including a synthetic ligament
which is molded into or attached to the prosthesis, thereby
maintaining alignment and resisting dislocation of the joint.
The prosthesis of this invention comprises (1) a shaped body
portion adapted to replace a carpal or any other bone or an
articular portion thereof and (2) a synthetic flexible ligamentous
element affixed to said body portion and adapted to tie or affix by
tissue invasion to an adjacent tendon, ligament, or bone.
The shaped body portion is molded of a biocompatible elastomer,
especially silicone rubber, which is compatible with body fluids
and tissues, is resistant to attack by such fluids and tissues, and
has a long useful life with high resistance to breakdown by
exposure in the environment of its use. The elastomeric portion may
be suitable reinforced, and this is advantageously effected by
molding into the device, at the time of making, a reinforcing web
or mesh of a biocompatible material, such as a fibrous material,
advantageously Dacron mesh or web. The articular portion of the
prosthesis is shaped to conform generally to the shape of the
portion or bearing surface of the bony portion which the prosthesis
is to replace.
In addition, in one embodiment there is molded or otherwise formed
as an integral part of the whole device, a stem adapted to fit into
the medullary space in the bone to be repaired, after resection of
the articular head of such bone. The stem is molded also of
biocompatible elastomer and is provided with a complete or at least
a partial covering of a tissue-ingrowth-receiving, open pore fabric
surface, advantageously Dacron mesh or velour, so that the stem
receives an ingrowth of bony or other tissue in the intramedullary
area and becomes firmly attached to the bone. The body portion of
this embodiment, of which the stem portion is an integral part, is
designed to replace not only the resected articular head portion of
the bone into which the stem is implanted, but also the excised
bone adjacent to this bone. The interior of the stem and body
portions can be reinforced as described above. Such a prosthesis is
useful, for instance, in repairing a thumb joint. Thus, with tissue
ingrowth from the metacarpal bone into the stem and with the
attachment of the ligamentous member to carpal tissues, for
instance, a continuity of strength is provided through the
prosthesis, resisting dislocation of the thumb while providing
unrestricted natural orbital motion of the thumb.
The prosthesis also includes at least one ligamentous element
integral therewith which can be tied or otherwise attached to a
body tissue, for example, to an associated bone or other suitable
tissue. The ligamentous element can be made of a polymeric
material, advantageously Dacron (polyethylene terephthalate) or
Teflon (polymerized tetrafluoroethylene), adapted to invite
tissue-ingrowth and having suitable strength and flexural fatigue
resistance. Woven fabric, mesh or velour, forms are advantageously
used.
Ingrowth of tissue is in many instances desirable at the end
portion of the ligament, but often is undesirable over a
predetermined intermediate portion of its length, depending upon
the location of the device in the body. By "intermediate" is meant
that portion of the length of the ligamentous element between the
end portion to be attached to the bone or other tissue and the
shaped body portion of the prosthesis. Such restriction of ingrowth
enables the desired flexing and mobility of the ligamentous element
and orbital motion of the parts involved. Accordingly, the portion
which is not to attach to the tissue, i.e., which is to be
maintained free of attachment in the body, is made of or is
impregnated with a biocompatible elastomer, such as silicone
rubber, to prevent tissue ingrowth. However, in some locations the
ligamentous element can be attachable by reception of tissue
ingrowth at any point for its complete length, or it can be totally
resistant to tissue ingrowth and affixed by tying around a body
structure or by suturing thereto.
The ligamentous element can be in any desired form or shape, e.g.,
in the form of a cord, a tube (whether rounded or flat), or a tape,
and advantageously is in the form of a pair of soft, contiguous or
parallel, compliant or flexible fabric tubes of biocompatible
material, such as Dacron or Teflon, which pair of tubes transfer
tensile loads to an intended anchor or fixation site. The tubes may
be reinforced with one or more cords, preferably made of Dacron,
running through the interior of the tubes.
In one advantageous embodiment, the ends of the tubes where they
are to be attached to the body tissue are cut and fanned or spread
out into a flat sheet or sheets to develop still greater area of
contact and load distribution to further minimize mechanical
loading of the tissues to which the ligamentous element attaches,
thereby avoiding interference with vascular and nutrient supply to
the area. The flat type of attachment element or area of the
ligament achieves wider load distribution and can be used in areas
of the body where the simple tie cord or tube may not be tolerated
due to high contact forces imposed that would tend to pinch off
blood and nutrient supply. The attachment element is firmly affixed
to the end of the ligamentous element, including being integral
therewith.
In employing the article of this invention, where an articular
portion of a bone and an adjacent articulating bone are to be
replaced by the prosthesis, for instance, a metacarpal-carpal
joint, the head of the metacarpal bone is resected and a portion of
the medullary canal is drilled out. The trapezium then is excised,
and the stem of the prosthesis is inserted into the intramedullary
area of the metacarpus so exposed, and is sutured in place. The
ligamentous element is extended over the tissue to which the
prosthesis is to be anchored; for instance, in the case of
insertion of the stem into a metacarpal bone the end of the
ligamentous element is attached to carpal tissues. The attaching
end of the ligament is either sutured to the tissue to which it is
to attach, or the tissue may be incised and elevated to enable the
two ends of the prosthetic ligament to be looped gently around a
firm portion of tissue and the ligament ends secured by knotting
them together. Tissue-ingrowth begins while the structure is
immobilized. Thus, upon completion of the ingrowth process,
typically a period of two to six weeks, a continuity of strength is
provided through the prosthesis, resisting dislocation of the body
structure so tested while providing unrestricted natural orbital
motion of the thumb. The prosthetic ligament can be attached to the
tissue to which it is to be anchored in the body in any desired
manner, or a combination of several ways of so attaching the
ligament can be employed. Some ways of attachment are to tie or
suture the ligament around an adjacent tendon or around an adjacent
bone; to tie the ligament through a hole drilled in an adjacent
bone; by tissue ingrowth to the periosteum at the bone surface or
to adjacent soft tissue, or to natural ligamentous tissue.
In another embodiment of this invention, there is provided a carpal
lunate prosthesis which is molded of a biocompatible elastomer,
suitably reinforced with a biocompatible fibrous material or
fabric, such as described above. This prosthesis is made in the
shape of the bone to be replaced, and affixed thereto are at least
two ligamentous elements such as described above, disposed at each
side of the article; corresponding to the dorsal and palmar sides;
and advantageously there are two parallel ligament elements at each
side. Upon emplacement in a wrist, after excision of the carpal
lunate bone, the ligamentous elements are suitably affixed to
adjacent body structures, preferably to the natural dorsal and
palmar ligament sites for the lunate, in a manner similar to that
described above.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be illustrated more in detail and as to some
embodiments by the specific description herein and by the annexed
drawings, wherein:
FIG. 1 is a perspective view of a trapezium prosthesis embodying
the principles of this invention.
FIG. 2 is a cross-sectional view of the article of FIG. 1, taken on
line 2--2 therein.
FIG. 3 is a perspective view of a modified form of trapezium
prosthesis embodying the principles of this invention,
incorporating a single ligamentous element and that in the shape of
a flat tube.
FIG. 3A is a fragmentary enlarged view in perspective of the end
portion of the flat tube of FIG. 3 partially slit and fanned out in
order to provide a superior attachment to an adjacent bone.
FIG. 4 is a schematic palmar view of the skeletal structure of a
human hand with an article according to this invention in place and
having the ligaments attached to a tendon.
FIG. 5 is a perspective view of a carpal lunate prosthesis
according to this invention.
FIG. 6 is a cross-sectional view of the carpal lunate prosthesis of
FIG. 5, taken on line 6--6 therein.
DETAILED DESCRIPTION OF THE EMBODIMENTS
In FIGS. 1 and 2 is shown an embodiment of this invention suitable
as a thumb joint prosthesis 10. This prosthesis 10 comprises a
shaped body portion 11 of silicone rubber 12 reinforced with at
least one embedded layer of Dacron mesh 13, which can be just below
each surface of the body portion 11 or can be arranged as an
embedded coil or as a plurality of layers in the portion 11. The
body portion 11 also has a cylindrical outer wall 25. The body
portion 11 has a centrally concave or dished base surface 14 and a
rounded shoulder 15 therearound adapted to articulate with a carpal
bone in a wrist upon emplacement, as will be described below with
reference to FIG. 4.
At the surface of the body portion 11 opposite the concave surface
14 is a stem 16, and a shoulder 19 on the body portion 11. The stem
16 is conical in shape, tapering to a tip 17 remote from the body
portion 11, and it comprises a core 18, also of silicone rubber,
reinforced with Dacron mesh and having a Dacron velour coating 20
thereover completely covering the core 18 and secured thereto. This
securement may be suitably by means of an adhesive such as silicone
adhesive or preferably bonded by direct impregnation of raw
silicone rubber in an unvulcanized state, compression molded into
the underside of the Dacron velour fibers.
Extending from the outer wall 25 close to the edge 15 near the base
of the body portion 11 are two soft knitted tubes 22 and 22' of
Dacron or Teflon, of a sufficient length to enable ligamentous
attachment of the prosthesis 10 to a suitable adjacent body
structure. These two tubes 22 and 22' advantageously may be parts
of a single strand of knitted tubing which may be applied at the
time the prosthesis is made by tying it at its mid-portion 22.sup.a
to a looped tape 21 comprising the reinforcing fabric within the
stem portion 16. The two loose ends are held in a predetermined
position at the time of molding the body and stem portions 11 and
16 so that they project as the two tubes 22 and 22' from the
desired site of the body portion 11. Each tube 22, 22' may contain
one or more central cords 28 to strengthen it and also to
facilitate handling and placement of these ligamentous elements.
Each cord 28 is preferably made from Dacron fiber and is attached
to the body portion 11, and it can be either attached or not
attached to the tube 22 or 22', as desired; attachment may be
either by interweaving or by silicone rubber bonding. The cord 28
may be omitted, if that be desired.
As shown in FIG. 3, it is possible to use only one such ligamentous
element 122, in which case it is desirable to have a larger
diameter tube 122 in order to assure a strong connection and to
enhance the stability of the device 10 as emplaced.
In order to secure attachment of a ligamentous element 22 or 22' to
a body structure, the two elements 22 and 22' may be looped around
a body member, for example an incised tendon, and knotted (Cf FIG.
4). Alternatively, the attaching or outer end 123 of the element
122 of the prosthesis of FIG. 3, is preferably slit, opened or
fanned out or spread out flat, as shown in FIG. 3A and is then
sutured at the site of attachment to a bone, ligament, tendon or
other structure, to hold the end 123 in place while tissue ingrowth
occurs to effect permanent attachment. If it is desired that the
ligamentous element 22 or 22' or 122 does not attach elsewhere,
where loss or partial loss of mobility is unwanted, the
intermediate length 24 of the element 22 or 22', i.e., from its
connection with the body portion 11 to its distal end 23, is coated
with a tissue-ingrowth-resisting, body-compatible material, such as
silicone rubber. Alternatively, a suitable fiber-reinforced
elastomeric cord or tape can be employed, having a
tissue-ingrowth-receiving fabric affixed at its outer end. In other
words, the ligamentous element 22 or 22' is resistant to tissue
ingrowth throughout its length and has a tissue-ingrowth-receiving
outer or attaching end.
An embodiment of the emplacement of a prosthesis according to this
invention is shown schematically in FIG. 4, which illustrates the
restoration of a carpal-metacarpal thumb joint where orbital motion
is natural and desirable, and is provided by the present invention.
The articulating portion of the metacarpal bone 26 is resected, the
intramedullary canal is drilled to a suitable depth, and the
trapezium is excised. The stem 16 of a prosthesis 10, such as shown
in FIG. 1 is inserted into the drilled portion of the
intramedullary canal of bone 26 and is sutured in place. The body
portion 11 replaces both the articular portion of the bone 26 and
the trapezium, and the wall of the bone 26 is held snugly against
the shoulder 19 of the body portion 11. The ligamentous elements
22, 22' are brought to a suitably positioned adjacent tendon 27
(the flexor carpi radialis) where their outer ends 23 are inserted
through an incision and tied to the incised tendon with slight
slackness, and the excess ends are trimmed. The intermediate
lengths of the elements 22, 22' are secured under gentle tension,
so that the body portion 11 rotates freely in an orbital motion
when recovery of the patient is completed.
Alternatively, when the prosthesis of FIG. 3 is used, the procedure
is the same up to the point of securing the ligamentous element. In
this case, the cut and fanned out end 123 (FIG. 3A) of the element
122 is sutured to adjacent structural tissue, such as bone,
ligament, or tendon. For example, to attach to bone, the periosteum
is elevated or removed, and the bone surface scarified to invite
ingrowth. The fanned end 123 of the ligament 122 is then firmly and
closely approximated to the bleeding bony surface, the periosteal
and overlying tissue layers are then repositioned, sutured, and the
wound closed.
A carpal lunate prosthesis 30 is shown in FIGS. 5 and 6. The
prosthesis 30 comprises a shaped body portion 31 of silicone rubber
32 which may or need not be reinforced with a plurality of layers
33 of Dacron mesh. Molded into the body 31 at approximately
opposite ends of the long diameter of the top surface 34 of the
body 31 at approximately the same position as the natural lunate
ligaments are ligamentous elements 35, 36, 37, and 38, which are
like the elements 22 and 22' described above with respect to the
metacarpal articular trapezium prosthesis. Upon emplacement in a
wrist, after having first excised the carpal lunate bone, each pair
of the ligamentous elements 35, 36 and 37, 38 are spread out and
sutured to adjacent collateral ligaments, or they may be tied to
the nearest adjacent carpal bone through a suitably drilled hole,
or tied to an incised ligament or tendon.
It will be understood that the above specific description and
drawings have been given for purposes of illustration only and that
variations and modifications can be made therein without departing
from the spirit and scope of the appended claims. The term
"orbital" is used herein in the anatomical sense, i.e., having a
motion similar to that of the eyeball.
* * * * *