U.S. patent number 3,903,549 [Application Number 05/478,732] was granted by the patent office on 1975-09-09 for acetabular cup prosthesis component for total or subtotal hip prosthesis system.
Invention is credited to William Minor Deyerle.
United States Patent |
3,903,549 |
Deyerle |
September 9, 1975 |
Acetabular cup prosthesis component for total or subtotal hip
prosthesis system
Abstract
An acetabular cup prosthesis assembly for total or subtotal hip
replacement, including a metallic, unitary cup member having a dome
portion defining a socket larger than the head of the femur or
femoral prosthesis component to be accommodated, and including an
integral flange rim to seat against the acetabulum and be secured
thereto by screws. The cup has sharp edged fins to be seated in the
acetabulum and restraining ribs on the interior surface of the
socket. A replaceable plastic liner insert of hemispheric
configuration interfits in the socket and has grooves shaped to
provide a snap fit with the restraining ribs.
Inventors: |
Deyerle; William Minor
(Richmond, VA) |
Family
ID: |
23901149 |
Appl.
No.: |
05/478,732 |
Filed: |
June 12, 1974 |
Current U.S.
Class: |
623/22.36;
606/309; 623/22.28 |
Current CPC
Class: |
A61F
2/34 (20130101); A61F 2002/30884 (20130101); A61F
2002/305 (20130101); A61F 2220/0033 (20130101); A61F
2002/30403 (20130101); A61F 2002/30879 (20130101); A61F
2002/3082 (20130101); A61F 2002/30331 (20130101); A61B
17/86 (20130101); A61F 2002/3432 (20130101); A61F
2220/0025 (20130101); A61F 2002/30841 (20130101); A61F
2002/3417 (20130101); A61F 2002/30367 (20130101); A61F
2002/30378 (20130101); A61F 2002/3429 (20130101); A61F
2002/3054 (20130101); A61F 2002/3401 (20130101) |
Current International
Class: |
A61F
2/32 (20060101); A61F 2/34 (20060101); A61F
2/00 (20060101); A61F 2/30 (20060101); A61F
001/24 () |
Field of
Search: |
;3/1,1.9-1.912
;128/92C,92CA,92R |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Vitallium Surgical Appliances (catalog), Austenal Co., New York,
N.Y., 1974, "McBride Acetabulum Cups," No. 6429 on p. 30..
|
Primary Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Mason, Fenwick & Lawrence
Claims
What is claimed is:
1. An acetabular cup prosthesis assembly to be fixed on the
acetabulum of a patient in connection with total or sub-total hip
prosthesis surgery, comprising an integral unitary metal cup
prosthesis component and a replaceable liner insert, the cup
prosthesis component having a dome portion extending in a
hemispherical path from a proximal end plane of the prosthesis
formed of a substantially hemispherical metal wall having a convex
spherical outer surface and a concave spherical inner surface
defining a generally hemispherical cup socket having an entrance
opening at said proximal end plane and having a diameter of
predetermined greater size than the head of an associated femur or
femoral prosthesis component to be located in said cup socket, said
cup prosthesis component also including an annular rim flange
extending radially outwardly from the end of said hemispherical
metal wall at said proximal end plane defining an integral annular
ring portion encircling said entrance opening to abut against
surface portions of a recipient acetabulum and be secured thereto
to locate and aid in supporting the cup prosthesis thereon, said
dome portion including rotation and tilting resisting and liner
retaining rib formations protruding radially inwardly from said
spherical inner surface, said rib formations being formed of a pair
of semicurclar ribs spanning the cup socket along meridians
disposed in a pair of diametric planes intersecting at the zenith
of the inner surface of said wall defining patterns of meridian rib
segments extending from the entrance opening to the zenith
intersection to present surfaces to the liner resisting tilting and
rotation thereof in the socket and for frictionally retaining the
liner seated in the socket, and the replaceable liner insert being
formed of an integral molded body of plastic material of generally
hemispherical configuration interfitted in said cup socket having
an outer spherical surface conforming closely to the size and
complementing the configuration of the inner spherical surface and
meridian rib segments of the dome portion to restrain the liner
insert in said cup socket by tight frictional interengagement
therewith, and said liner insert having a concave spherical inner
surface defining a liner socket of a diameter corresponding to the
heads of the femur or femoral prosthesis to be located therein.
2. An acetabular cup prosthesis assembly as defined in claim 1,
wherein said diametric planes of the semicircular meridian ribs are
located at right angles to each other whereby said meridian rib
segments define a cruciate pattern.
3. An acetabular cup prosthesis assembly as defined in claim 2,
wherein said meridian rib segments are continuous uninterrupted
ribs of uniform height and thickness throughout their extent from
said entrance opening to the zenith of the inner surface of said
wall, the ribs thereby defining diametric planes along which the
liner may be cut, subdividing the liner into four quadrants for
ease of removal from the socket without having to cut through the
full thickness of the liner portions intervening between rib
segments.
4. An acetabular cup prosthesis assembly as defined in claim 1,
wherein fin formations of truncated crescent configuration in
profile are located in quadrature relation about the outer surface
of the hemispherical wall with the truncated end edges of the fin
formations integrally joined to said annular rim flange and
extending outwardly from said wall to the outer periphery of said
annular rim flange, the outer edges of the fin formations extending
along outwardly convex arcs and merging into said convex spherical
outer surface of said wall adjacent the zenith thereof.
5. An acetabular cup prosthesis assembly as defined in claim 1
wherein said meridian rib segments are continuous uninterrupted
ribs of uniform rectangular cross section throughout and of uniform
height and thickness throughout their extent from said entrance
opening to the zenith of the inner surface of said wall, the ribs
thereby defining diametric planes along which the liner may be cut,
subdividing the liner into four quadrants for ease of removal from
the socket without having to cut through the full thickness of the
liner portions intervening between said rib segments and said outer
spherical surface of said liner insert having grooves therein of
uniform rectangular cross section closely conforming to the cross
section and configuration of said meridian rib segments to receive
the latter in tightly interfitted relation therein.
6. An acetabular cup prosthesis assembly as defined in claim 1,
wherein said dome portion includes a plurality of circumferentially
spaced, outwardly extending fin formations projecting from the
outer concave surface thereof and having sharp outer edges
extending in diametric planes of the hemisphere defined by said
metal wall to be forced into the bone structure of the acetabulum
at plural locations surrounding the dome portion.
7. An acetabular cup prosthesis assembly as defined in claim 1,
wherein the outer spherical surface of said liner insert includes
grooves formed therein precisely conforming to said inwardly
extending elongated ribs on the inner surface of said wall and
shaped to provide a snap fit therewith frictionally restraining the
insert in the cup socket.
8. An acetabular cup prosthesis assembly as defined in claim 2,
wherein the outer spherical surface of said liner insert includes
grooves formed therein precisely conforming to said inwardly
extending elongated ribs on the inner surface of said wall and
shaped to provide a snap fit therewith frictionally restraining the
insert in the cup socket.
9. An acetabular cup prosthesis assembly as defined in claim 3,
wherein the outer spherical surface of said liner insert includes
grooves fomred therein precisely conforming to said inwardly
extending elongated ribs on the inner surface of said wall and
shaped to provide a snap fit therewith frictionally restraining the
insert in the cup socket.
10. An acetabular cup prosthesis assembly as defined in claim 1,
wherein said liner insert has an incident annular planar face
spaced outwardly a slight distance from said proximal end plane
surrounding an entrance opening for said liner socket, said
spherical inner surface of said insert having its center in the
plane of said planar face and said outer spherical surface of said
insert having its center spaced toward the zenith of said cup
socket from said planar face.
11. An acetabular cup prosthesis assembly as defined in claim 3,
wherein said liner insert has an incident annular planar face
spaced outwardly a slight distance from said proximal end plane
surrounding an entrance opening for said liner socket, and the
spherical inner surface of said insert having its center in the
plane of said planar face and said outer spherical surface of said
insert having its center spaced toward the zenith of said cup
socket from said planar face.
12. An acetabular cup prosthesis assembly as defined in claim 4,
wherein said liner insert has an incident annular planar face
spaced outwardly a slight distance from said proximal end plane
surrounding an entrance opening for said liner socket, said
spherical inner surface of said insert having its center in the
plane of said planar face and said outer spherical surface of said
insert having its center spaced toward the zenith of said cup
socket from said planar face.
13. An acetabular cup prosthesis assembly as defined in claim 7,
wherein said liner insert has an incident annular planar face
spaced outwardly a slight distance from said proximal end plane
surrounding an entrance opening for said inner socket, said
spherical liner surface of said insert having its center in the
plane of said planar face and said outer spherical surface of said
insert having its center speced toward the zenith of said cup
socket from said planar face.
14. An acetabular cup prosthesis assembly as defined in claim 1,
wherein said cup prosthesis has a plurality of screw holes solely
located in said annular rim flange in a circumferential path spaced
radially outwardly from the periphery of said liner for receiving
fixation screws to extend into the recipient acetabulum of the
patient for fixation of the cup prosthesis component thereon.
15. An acetabular cup prosthesis assembly as defined in claim 3,
wherein said cup prosthesis has a plurality of screw holes solely
located in said annular rim flange in a circumferential path spaced
radially outwardly from the periphery of said liner for receiving
fixation screws to extend into the recipient acetabulum of the
patient for fixation of the cup prosthesis component thereon.
16. An acetabular cup prosthesis assembly as defined in claim 7,
wherein said cup prosthesis has a plurality of screw holes solely
located in said annular rim flange in a circumferential path spaced
radially outwardly from the periphery of said liner for receiving
fixation screws to extend into the recipient acetabulum of the
patient for fixation of the cup prosthesis component thereon.
Description
BACKGROUND AND OBJECTS OF THE INVENTION
The present invention relates in general to prosthetic devices for
use in total and subtotal hip replacements, and more particularly
to an acetabular cup assembly which may be implanted on the
acetabulum to correct hip problems, usable with or without a
femoral prosthesis component.
Heretofore, total hip prosthesis surgery has been performed wherein
a cup is fitted in the acetabulum and a head or femoral prosthesis
member, which comprises a stem or shank portion and an artificial
head, is fixed to the femur to provide a prosthetic hip joint.
Also, to relieve certain conditions, particularly in young patients
where there is no immediate need for amputating the head of the
femur and substituting a femoral prosthesis member, subtotal hip
replacement surgery such as a cup arthorplasty may be performed
where a cup is implanted in the acetabulum or cupshaped socket in
the pelvis. In either case, the acetabulum cup or cup prosthesis
component provides a socket for receiving the head of the femur or
the head of the femur prosthesis component.
Heretofore, metal acetabulum cups have been employed, for example,
for protrusio-acetabuli and in rheumatoid arthritic cases, or in
performing total hip prosthesis surgery, wherein the cup provides a
metal surfaced socket for receiving the head of the femur or the
head of the femoral prosthesis component, providing either a bone
to metal or a metal to metal contact in the hip socket. While
methyl methacrylate bone cement has been previously used for
fixation of the acetabular cup used in the prior art in the
recipient pelvis, this bone cement may present a serious hazard to
the patient, as pointed out in the recent article by Edith R.
Kedes, M.D., et al entitled "Inoperative Deaths Associated With
Acrylic Bone Cement", Journal American Medical Association, Vol.
222, No. 5, pp. 575-577, Oct. 30, 1972. Furthermore, improved
acetabular cup fixation means is desired, as methyl methacrylate is
notorious for its brittleness and lack of resistance to shear.
Also, if it becomes necessary to replace the acetabular cup
prosthesis at any time in the future, fixation with methyl
methacrylate may require badly chopping the recipient pelvis
attempting to remove the methyl methacrylate.
I have found it desirable to provide a rimmed acetabular cup which
may be securely fixed in the recipient pelvis by the use of screws
extending through flanged portions of the rimmed cup into the
acetabulum to securely fix the metal cup in position. The flanged
rimmed cup gives many options in the selection of the proper
treatment in a specific hip problem. In a young patient where it is
thought that a cup arthroplasty may give the patient six to ten
years of good function and postpone the need for a total hip, the
rimmed cup can be implanted. The femur head can be reshaped and
used in that situation until such time as the head and neck are
absorbed. At that time a total hip can then be inserted in the
exact same position as the rimmed cup with less surgery and no
stock is lost by the use of the rimmed cup for the cup
arthroplasty. The cup should be place between 30.degree. and
45.degree. verticle and 10.degree. forward facing to provide
stability for the cup arthroplasty and later stability for the
total hip.
Furthermore, I have found it desirable to provide a replaceable
plastic liner for the concave socket formed by the acetabular cup
prosthesis, formed of a high density monomer plastic insert that
may be removed at seven to ten years or at any time that sufficient
wear occurs and replaced without removing the acetabular cup from
the pelvis. The concave socket portion of the acetabular cup
prosthesis is specially formed to receive and support the plastic
liner or insert, and to facilitate its removal and replacement when
required. A further advantage of the metal encased plastic liner is
that this avoids the slight but definite tendency of a high density
monomer to stretch or drape, since the metal encasement formed by
the body of the acetabular cup will give a more symmetrical support
than would methyl methacrylate cement in which plastic acetabular
cups have been heretofore embedded to fix it in the acetabulum.
An object of the present invention, therefore, is the provision of
a novel flanged rimmed acetabular cup prosthesis formed of a metal
body defining a socket for reception of the head of the femur or a
femoral prosthesis component, which is fixed to the acetabulum by
screws extending into the recipient pelvis without use of methyl
methacrylate bone cement and which has a replaceable plastic liner
or insert which can be removed and replaced from the acetabular cup
without removing either the femoral component or the metallic
component of the acetabular cup. Even if methyl methacrylate or any
other substance were used as a filler, my flanged rimmed cup would
still stabilize and prevent movement of the cup.
Other objects, advantages and capabilities of the present invention
will become apparent from the following detailed description, taken
in conjunction with the accompanying drawings illustrating the
preferred embodiment of the invention.
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 is an exploded perspective view of an acetabular cup
prosthesis assembly embodying the present invention;
FIG. 2 is a front or bottom view of the cup component of the
assembly;
FIG. 3 is a side elevation of the cup component;
FIG. 4 is a rear or top view of the cup component;
FIG. 5 is a section view through the cup and insert components of
the assembly, taken from the section plane of line 5--5 of FIG.
2;
FIG. 6 is a rear or top view of the insert or liner of the
assembly; and
FIG. 7 is a side elevation of the insert.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The acetabular cup prosthesis component assembly of the present
invention is indicated generally by the reference character 10 and
comprises a rimmed metal acetabular cup 12 illustrated best in
FIGS. 1 and 2, and a replaceable high density plastic liner or
insert 14 removably assembled with the rimmed metal acetabular cup.
The rimmed metal cup component 12 is a solid unitary, integral cast
structure comprising a dome shaped body portion 16 forming a socket
for reception of the head of the femur or the head of the femoral
prosthesis component, such, for example, as that described and
illustrated in my earlier U.S. patent application Ser. No. 183,418,
now U.S. Pat. No. 3,814,089, the dome shaped body 16 having an
interior concave, generally spherical surface 18 and an exterior
convex, generally spherical surface 20 both formed about a common
center. The metal cup 12 forms a generally spherical socket 22 for
reception of the head of the femur or of the femoral prosthesis,
surrounded or bounded at the entrance opening to the socket 22 by
an annular rim or rim flange 24 which in the preferred embodiment
has an incident or lower surface 24a facing towards the femur or
femoral prosthesis component which lies in an upwardly flaring or
upwardly diverging truncated conical path as will be apparent from
FIG. 3. The upper or posterior surface 24b of the annular rim
portion 24, relative to the femur, may lie in a plane perpendicular
to the center line or axis of the dome portion intercepting the
zenith of the dome, or it may also be in an upwardly and outwardly
diverging conical path, as desired. In the preferred form herein
illustrated, three reinforcing flanges or webs are provided at
positions faced 90.degree. apart extending from the exterior convex
spherical surface 20 of the dome portion 16 to the outer edge of
the rim portion 24, having a truncated crescent shaped lateral
profile, forming reinforcing web flanges 26 strengthening the dome
portion and further fixing the position of the rim portions
relative thereto. Also in the illustrated embodiment, three pairs
of holes 28 are provided in the rim at positions spaced
circumferentially approximately 90.degree. apart, for reception of
fixation screws 30 to be inserted in the drill holes in the
acetabulum to fix the cup 12 in position.
The interior concave spherical surface 18 of the dome portion 16 is
interrupted by a plurality of inwardly projecting arcuate lugs or
ridges 32, of rectangular cross section, which in the illustrated
embodiment are in cruciate or cruciform configuration alined with a
pair of diametric bisectors of the dome disposed at right angles to
each other and forming meridian rib segments extending from the
socket entrance to an intersection at the zenith of surface 18.
The replaceable plastic liner or insert 14, best shown in FIGS. 5
and 6, is also a generally dome shaped body 36 having a spherically
concave inner surface 38 whose center of revolution is in the plane
of the lower or anterior face 40 of the insert, and includes a
spherically convex outer surface 42 having its center of revolution
spaced upwardly or posteriorly of the plane of the incident or
anterior surface 40, as will be apparent from inspection of FIG. 7.
The spherically convex outer surface 42 is shaped and sized to
conform to the interior concave spherical surface 18 of the dome
shaped body portion 16 of the cup, and is provided with arcuate
slots or kerfs 44, of cruciate configuration in the illustrated
embodiment, conforming in configuration precisely to the cruciate
lugs or ridges 32 of the cup, and having, if desired, a slight
45.degree. chamfer or bevel formation along all of the exterior
edges of the slots. The insert or liner 14 is made of an ultra high
molecular weight polyethylene or similar high density plastic
material or other suitable material and is designed to be received
by a snap fit in the socket 22 formed by the dome portion 16 of the
cup 12.
To prepare the acetabulum and install the acetabular cup assembly
of the present invention, the acetabulum is exposed by known
surgical procedures, and the approximate location of the acetabular
cup prosthesis site and the position to be assumed by the cup is
preferably determined by using a Kuntschner nail, for example, a 10
or 12 mm. nail which is held parallel with the anterior iliac
crests and a 45.degree. angle flag is slipped on to form a guide
for placing the cup. The cup is to be placed between 45.degree. and
30.degree. . A 30.degree. angle flag is also tested and by trial
insertion of the cup prosthesis, the amount of reaming necessary
can be determined. In some cases of large acetobuli or
protrusio-acetabuli it is only necessary to remove the cartilage
lining of the acetabuli with little reaming of the bone.
Before the acetabulum is reamed, one is careful to leave between a
quarter and a half inch of the lateral cartilagenous margin of the
acetabulum intact, and to assist in this marks this portion with an
osteotome. In some cases there is no cartilage in which case the
hard bone is left intact. Using an osteotome and a gauge, the
medial wall and the medial two-thirds of the acetabulum are denuded
of all cartilage down to bleeding bone with an osteotome before any
reaming. This tends to displace the cup as far medially as possible
and still maintain sufficient medial wall support to avoid fracture
into the pelvis. Again, the angle to be assumed by the cup is
checked with the 45.degree. measurement flag inserted on the
Kuntschner nail held alined with the anterior iliac crests, and a
cup reamer of the exact size of the exterior convex spherical
surface 20 of the dome is applied to ream the dome shaped socket in
the acetabulum to receive the cup body 12. The cup prosthesis is
preferably disposed so that it is faced downwardly between
30.degree. and 45.degree. with forward facing of 10.degree. which
is the normal forward facing of the average acetabulum. After the
acetabulum is reamed with the dome shaped cup reamer to a point
where the edge of the reamer is about one-eighth inch under the rim
of the acetabulum, a rim reamer is then inserted, which has a
smooth 1-7/8 inches dome the exact size of the outer surface 20 of
the cup, and having reamer teeth on an annular portion outwardly
surrounding the smooth dome shaped portion. This rim reamer does
not ream anywhere except in the rim region, and is employed to ream
a recess the exact size to receive the annular rim portion 24 of
the cup prosthesis.
After the rim reamer has been used, the cup prosthesis 12 is
reinserted with the three reinforcing flanges or webs 26 positioned
anterior and posterior and absent on the medial side. Using a nylon
insertim impactor having a 15/8 inch nylon domeshaped head for
impacting the metal cup, the cup prosthesis 12 is tamped lightly to
mark a place within the acetabulum for the three flanges 26.
Frequently a cutting is required for the superior and inferior
flange, and occasionally for the lateral flange. The lateral flange
is not usually sunk into the edge of the acetabulum.
Throughout the reaming procedure, the lateral one-half or
one-fourth inch cartilage rim or hard bone is still left in place,
tending to force the cutting medially as the reamer will not cut as
well on the cartilage as on the denuded bone. This also preserves a
good lateral lip displacing the cup medially. The cup is firmly
seated, with the impactor, using several hammer blows, after the
sites for the three reinforcing flanges or webs 26 have been cut as
required, to firmly seat the cup in the acetabulum, drill holes are
then drilled in the acetabulum to receive the mounting screws, and
two or three chrome cobalt molibidum screws or screws of other
acceptable material are inserted into the drill holes. These screws
have an average length of 1-1/4 inches. All of the anterior and
lateral holes are carefully checked for depth by a depth gauge as
well as palpating with the finger within the pelvis, as extreme
caution must be taken to avoid penetrating the pelvis in the region
of the sciatic notch. The two or three fixation screws 30 through
selected ones of the holes 28 serve the purpose of maintaining the
position of the cup after it has been well impacted. After 8 to 10
weeks, the rim and flanges provide the main stabilizing effect. The
advantage of screws not being over 2 inches long is that the
plasticity of the pelvis is much greater than the plasticity of the
metal and or acrylic which may be buried in it, thus minimizing the
length of dissimilar material relative to longer screw lengths and
reducing the potential motion between them.
In one satisfactory example, the rimmed metal acetabular cup had a
maximum diameter of about 2.43 inches at the outer periphery of the
rim 24, the dome shaped portion 16 had a height from the posterior
or upper surface 24b of the rim to the zenith or peak of the dome
of about 0.837 inch, the distance from the zenith of the dome to
the plane of the entrance to the socket was about 1.085 inches, and
the thickness of the rim at its outer periphery was about 0.090
inch. The interior concave spherical surface 18 of the socket 22
was sized to exactly conform to and accept the exterior surface 42
of the insert 14, which in a preferred embodiment had a spherical
radius of about 0.875 inch. The radius of the inner spherical
surface 38 of the insert in the preferred embodiment was about 0.55
inch, or a diameter of about 1.105, and the radium of the bottom of
the kerfs or slots 44 was about 0.77 inch.
With the removable plastic liner 14 in the dome portion of the cup
12, the cup assembly accepts a 28 mm. head on a femur prosthesis
component. The liner 14 is held in position by the cruciate lugs or
ridges 32 that are snapped immovably into position in the
conforming kerfs or slots 44 in the insert when the insert is
installed in the cup using a nylon impactor having a 28 mm. nylon
head. The initial cup when installed in the acetabulum is usually
installed in one piece with the liner already inserted. This offers
the option of replacement of the liner after any period of time
when wear becomes significant. To replace the liner, the hip is
merely dislocated and using an oscillating saw and osteotome, two
cross cuts are made along the diametric planes of the ribs into the
remaining liner to cut the liner into four pieces for ease of
removal from the cup 12 without having to cut through the full
thickness of the liner portions intervening between the rib
segments. A removable new plastic liner of similar construction and
configuration may then be inserted with a nylon impacter.
If desired, an annular washer may be alined with one of the screw
holes 28 in the annular rim overlying the outer surface thereof
through which one of the fixation screws is inserted, the washer
being of sufficient diameter so that an edge portion thereof
outwardly overlaps the edge of the flat lower face 40 of the insert
to bear tightly against the face 40 and provide added insurance
against motion. The real fixation of the plastic liner, however, is
secured by the self locking cruciate conformation of the cup and
plastic liner. The liner will not move in the metal cup due to the
fact that the friction at the periphery will be greater than the
friction in the center portion with the 28 mm. prosthesis head.
Of course, if there is any difficulty in removing the liner from
the cup, by removing the fixation screws in the holes 28 of the
annular rim 24, the entire cup can be removed and replaced with a
new plastic liner. It is highly advantageous to be able to offer
the patient the option of a new liner, which is made available by
the construction of the present invention, when the liner of the
existing installation becomes either mechanically unstable or
causes symptoms from debris or products from the wearing of the
plastic in the head and socket region. By the construction of the
invention, the old liner can be replaced by a new liner to avoid
these difficulties without the necessity of replacing the entire
hip and without the necessity of massive surgery to extricate cups
which have been seated and fixed with methyl methacrylate as
sometimes practiced in the prior art.
* * * * *