U.S. patent number 3,818,514 [Application Number 05/275,053] was granted by the patent office on 1974-06-25 for femoral prosthesis with removable protective sheath.
This patent grant is currently assigned to Chas. F. Thackray Limited. Invention is credited to Bernard Clark.
United States Patent |
3,818,514 |
Clark |
June 25, 1974 |
FEMORAL PROSTHESIS WITH REMOVABLE PROTECTIVE SHEATH
Abstract
A protective sheath for at least the neck of a femoral
prosthesis, said sheath being substantially incompressible and
having an inner surface shaped so as to be complementary to the
shape of said femoral prosthesis neck, and an outer surface which
is substantially cylindrical. The sheath may also cover the head of
the prosthesis.
Inventors: |
Clark; Bernard
(Pool-in-Wharfedale, EN) |
Assignee: |
Chas. F. Thackray Limited
(Leeds, Yorkshire, EN)
|
Family
ID: |
10394946 |
Appl.
No.: |
05/275,053 |
Filed: |
July 25, 1972 |
Foreign Application Priority Data
|
|
|
|
|
Aug 9, 1972 [GB] |
|
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37247/72 |
|
Current U.S.
Class: |
623/22.12;
206/438; 606/86R |
Current CPC
Class: |
A61F
2/4607 (20130101); A61F 2/3609 (20130101); A61F
2/0095 (20130101); A61F 2220/0033 (20130101); A61F
2002/30975 (20130101); A61F 2002/30718 (20130101); A61F
2002/3625 (20130101); A61F 2002/30331 (20130101); A61F
2002/4628 (20130101) |
Current International
Class: |
A61F
2/46 (20060101); A61F 2/36 (20060101); A61F
2/00 (20060101); A61F 2/30 (20060101); A61f
001/24 () |
Field of
Search: |
;3/1
;128/92C,92CA,92R,92E,92EC,92F,92G,334C
;206/63.2R,63.2A,16S,46SG,46ST,DIG.7,DIG.11 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Factors in the Design of an Artificial Hip Joint" by J. Charnely,
Article appearing in Book entitled Lubrication and Wear In Living
and Artificial Human Joints by The Institution of Mechanical
Engineers, Proceedings 1966-1967, Vol. 181, Part 3J, pages 107-109
relied upon. .
Protective Caps for Vitallium Hip Prostheses, Vitallium Surgical
Appliances Catalog, Austenal Medical Division; Howmet Corp. New
York, N.Y., 1964 page 18..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Stevens, Davis, Miller &
Mosher
Claims
What I claim is:
1. A femoral prosthesis comprising: a shaft, a part-spherical head
and a neck joining said shaft and said head, a removable protective
sheath surrounding said neck, said sheath being of a material
softer than the material of said head and neck, being substantially
incompressible and having an inner surface substantially
complementary in shape to the shape of said neck and an outer
surface which is substantially cylindrical, said sheath being in at
least two parts, said parts having mating surfaces lying in radial
planes, and retaining means for holding said parts together.
2. A femoral prosthesis according to claim 1 in which said outer
surface of said sheath is of substantially circular cylindrical
form.
3. A femoral prosthesis according to claim 1 in which said sheath
also covers said head of said prosthesis.
4. A femoral prosthesis according to claim 1 in which said sheath
is formed with passages to facilitate penetration of a sterilizing
medium to all areas of said prosthesis.
5. A femoral prosthesis according to claim 1, wherein the outer
surface of said sheath is substantially cylindrical throughout a
major portion of its length.
6. A femoral prosthesis according to claim 1 in which said
retaining device comprises at least one peg on one of said mating
surfaces, said peg being a close fit into a mating hole on another
of said mating surfaces.
7. A femoral prosthesis according to claim 1 in which said sheath
is made from a plastic material.
8. A protective sheath for the neck in a femoral prosthesis, said
sheath being substantially imcompressible and having an inner
surface having convergent and divergent sections shaped for
complementing the shape of a femoral prosthesis neck, a
hemispherical surface section for complementing a hemispherical
head in a femoral prosthesis and an outer surface which is
substantially cylindrical, said sheath being in at least two parts,
said parts having mating surfaces lying in radial planes, and
retaining means for holding said parts together.
9. A protective sheath according to claim 8, wherein the outer
surface of said sheath is substantially cylindrical throughout a
major portion of its length.
10. A protective sheath according to claim 8 in which said sheath
is formed with axially extending passageways opening to said inner
surface thereof.
11. A protective sheath according to claim 8 in which said sheath
is formed with holes of small diameter extending from said outer
surface to said inner surface thereof.
12. A protective sheath according to claim 8 in which said
retaining means comprises at least one peg on one of said mating
surfaces, said peg being a close fit into a mating hole on another
of said mating surfaces.
Description
This invention relates to femoral prostheses for use in the
technique of arthroplasty of the hip joint.
Femoral prostheses have a shaft which is located in the femoral
canal which has been reamed to accept the shaft, and is often
secured therein by bone cement, a part-spherical head which seats
in an artificial socket implanted into the pelvis and a neck
joining the shaft and the head. In order to ensure the correct
range of flexion for the prosthetic joint, a special curved shape
has been evolved for the neck of the femoral prosthesis.
It is important that the shaft of the femoral prosthesis be located
in a predetermined direction in the femur in order that maximum
load-bearing is obtained. To ensure such location, a femoral
prosthesis is usually inserted into the femur with the aid of a
so-called neck punch. This neck punch comprises two arms having
head sections which are pivoted together, the head sections being
closable around the neck of the femoral prosthesis, and openable to
release the neck. The arms carry a releasable locking device for
moving the arms together over a small arc to grip the prosthesis
firmly between the head sections of the arms. When so gripped, and
with the prosthesis properly aligned in the head sections, the arms
and the shaft of the prosthesis extend parallel to each other, and
by driving the arms in the required direction the prosthesis is
also driven in the desired direction.
It is important that when gripped in the head sections the neck of
the prosthesis is not allowed to move relative to the head
sections. To obtain the required gripping pressure, it has
therefore been the practice to machine the head sections so that
the gripping parts thereof are substantially complementary in shape
to the shape of the neck. Because of the special shape of the neck
this machining of the head sections with sufficient accuracy is an
extremely difficult operation.
According to the present invention the neck of a femoral prosthesis
is provided with a removable protective sheath of a material softer
than the material of the prosthesis, the sheath being substantially
incompressible and having an inner surface substantially
complementary in shape to the shape of the neck and an outer
surface which is substantially cylindrical.
By using such a sheath, the prosthesis may be held in a neck punch
with the sheath in position on the prosthesis. Thus, the head parts
of the neck punch can be made with gripping parts complementary to
the substantially cylindrical outer surface of the sheath, rather
than to the complex surface of the neck. Manufacture of the neck
punch is thus considerably simplified. Furthermore, by fitting the
sheath immediately after manufacture the neck is protected from
damage during packing and transit. The sheath also prevents
metal-to-metal contact of the neck and the neck punch, so avoiding
any metallic pick-up on the neck.
Preferably the substantially cylindrical outer surface of the
sheath is of circular cross-section. Although square or other
polygonal cross-sections could be used, circular cross-section is
obviously most desirable from the standpoint of manufacturing the
neck punch.
Preferably the sheath is extended to cover the head of the
prosthesis as well as the neck. It is customary to supply femoral
prostheses with the head and neck protected from damage by a cover,
and the sheath of this invention may replace this cover. It is
found that effective sterilization of the neck and head can be
carried out with the sheath in position. To aid such sterilization,
if desired the sheath may be formed with passages such as grooves
or holes of small diameter from the outer to the inner surface
thereof to facilitate penetration of the sterilization medium to
the neck and head surfaces.
Desirably the sheath is made from a plastic material. Any one of a
number of plastic materials may be used, or blends of one or more
materials may be used. Specific examples of suitable materials are
polyvinylchloride and polyamide.
In order that the sheath may be removable it is desirably made in
two or more parts having mating surfaces lying in radial planes,
and retaining means are provided for holding the parts together. In
one possible arrangement one or more pegs on each surface may be a
press or snap fit into one or more holes on the respective mating
surface. After location of the prosthesis in the femur and removal
of the neck punch the parts of the sheath may then be pulled apart
and removed from the prosthesis leaving the sterile neck and head
exposed. In an alternative construction the retaining device may be
a band surrounding and secured to the surfaces of the parts, the
band being cut by a scalpel to release the parts.
If made of plastic material, the parts may readily be injection
moulded. To improve gripping of the outer face of the sheath this
may be moulded to have a patterned surface, or the moulding may
include inserts of high friction material exposed on the surface to
increase the grip onto the neck punch.
In order that the invention may be better understood, a specific
embodiment thereof will now be described in more detail, by way of
example only, with reference to the accompanying drawings in
which:
FIG. 1 is a cross-section through a femoral prosthesis held in a
neck punch;
FIG. 2 is an elevation of part of a sheath; and
FIG. 3 is a section through a complete sheath taken on line
III--III of FIG. 2.
FIG. 1 shows a femoral prosthesis 1 comprising a shaft 2, a neck 3
and a head 4. As will be seen from the Figure the neck is specially
shaped to allow sufficient freedom of movement in an artificial
socket. Fitted over the head and neck of the prosthesis is a sheath
5 having an outer surface including a circular cylindrical section
6. A neck punch 7 comprises two arms, one being shown as 8, each
having a head section such as 9, and the two head sections being
pivoted together by a pivotal link connected to head section 9
about axis 10. Each head section has a semi-circular cylindrical
internal gripping surface engageable around the cylindrical section
6 of the outer surface of the sheath 5. The two arms of the neck
punch can be pivoted away from each other, the sheath inserted
between the two head sections and the arms then pivoted together to
close the head sections around the sheath. A threaded stem 11 which
is captive in a boss 12 on the arm 8 is then engaged with a tapped
bore in the other arm and the arms are moved further together by
rotating the stem 11 by knurled wheel 13. By applying sufficient
tightening force the head sections can securely grip the sheath and
force this to grip the neck of the prosthesis so that there can be
no relative movement between the neck punch and the prosthesis
which, during tightening, have been aligned so that the arms of the
neck punch and the shaft 2 of the prosthesis are parallel.
The sheath 5 is shown in more detail in the enlarged views in FIGS.
2 and 3. The sheath is made in two parts 14 and 15 having radial
surfaces 16 and 17, and 18 and 19 respectively. The internal
surface of each part 14 and 15 is shaped so as to have a part 20
complementary in shape to the neck 3 of the prosthesis and a part
21 complementary in shape to the head 4 of the prosthesis. A groove
22 extends up each part of the sheath and opens into a semicircular
recess 23 in the head part 21 of the internal surface. The outer
surface of each part 14 and 15 has a circular cylindrical section
6, a part-spherical top section 24 and a flange 25 remote from the
top section. The radial faces 16 and 17 of part 14 have
respectively a peg 26 and a hole 27, while the radial faces 18 and
19 of part 15 have respectively a hole 28 and a peg 29. The pegs 26
and 29 are designed to be a light snap fit in the holes 28 and 27
respectively. Both parts 14 and 15 are moulded in polyamide,
polyvinylchloride or some other suitable plastic material.
After manufacture of the prosthesis the two parts of the sheath are
fitted around the neck and head and are pushed together so that the
pegs snap into the holes. The dimensions of the internal surfaces
of the parts 14 and 15 are such that when snapped together the
assembled sheath is a loose fit over the neck 3. During packing and
transit the head and neck are at all times protected by the sheath
from damage. As the head in particular is ground and polished to a
finish of very small tolerance such protection is most
important.
Before use, the prosthesis is sterilized, the grooves 22 assisting
penetration of sterilizing medium between the sheath and the
prosthesis so that the neck and head become fully sterile. A
sterile wrapping is then placed over the prosthesis. During surgery
the sterile wrapping is removed, the prosthesis inserted in the
neck punch as described and then fixed in the femur. After
securing, the neck punch is opened and removed, and the two parts
of the sheath are separated and removed to expose the head for
seating in the socket.
Thus, apart from simplifying the design of the neck punch,
provision of a sheath according to the invention also protects the
head and neck of the femoral prosthesis right up to the time when
implantation of the prosthesis is completed.
It will be understood that the sheath can be made from materials
other than plastics, and that it can be made in more than two
parts. To assist sterilisation more than two grooves 22 may be
provided, or small holes 30 may be formed through the thickness of
the sheath. To assist gripping the sheath in the neck punch without
slipping, the cylindrical section of the outer surface of the
prosthesis may be patterned, for example with axial,
circumferential or diagonal grooves, or may otherwise be roughened.
If necessary inserts of high friction material such as arcuate
pieces of rough metal may be implanted in the surface of this
section.
* * * * *