U.S. patent number 3,655,306 [Application Number 05/003,749] was granted by the patent office on 1972-04-11 for apparatus for molding heart valves.
Invention is credited to Derek Barrie Ray, Donald Nixon Ross.
United States Patent |
3,655,306 |
Ross , et al. |
April 11, 1972 |
APPARATUS FOR MOLDING HEART VALVES
Abstract
The invention relates to an apparatus and method for
manufacturing replacement aortic heart valves using tissue taken
from a patient's own thigh. The tissue is moulded between first and
second complementary surfaces of two complementary forming members,
the complementary surfaces corresponding to the configuration of
the heart valve. The tissue when moulded is secured to a
support.
Inventors: |
Ross; Donald Nixon (London W.1,
EN), Ray; Derek Barrie (London W.1, EN) |
Family
ID: |
21707396 |
Appl.
No.: |
05/003,749 |
Filed: |
January 19, 1970 |
Foreign Application Priority Data
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|
|
|
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Dec 8, 1969 [GB] |
|
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59,842/69 |
Jul 7, 1969 [GB] |
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34,158/69 |
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Current U.S.
Class: |
425/521; 425/2;
623/26; 623/2.11; 623/901; 425/506 |
Current CPC
Class: |
A61F
2/2415 (20130101); Y10S 623/901 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61f 001/22 (); B29d 031/00 () |
Field of
Search: |
;3/1HV,DIG.3 ;137/525.1
;18/5R,5.1,1R,16R,34R,22,47R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Spicer, Jr.; Robert L.
Claims
We claim:
1. An apparatus for manufacturing a replacement heart valve
comprising tissue taken from a patient, and further comprising
forming means including first and second forming members having
first and second complementary surfaces, respectively, the first
surface being defined by a plurality of projections which conform
to the configuration of the cusps of a heart valve, and the second
surface being defined by a plurality of recesses which also conform
to the configuration of the cusps of a heart valve.
2. An apparatus according to claim 1, including mounting means
mounting said first and second forming members for relative linear
movement toward and away from each other.
3. An apparatus according to claim 2, wherein the mounting means
includes spring means for resiliently urging the first and second
forming members in a direction toward each other.
4. An apparatus according to claim 1, including stationary support
means, frame means rotatably mounted on said support means, means
coacting with said frame means and said support means for
selectively fixedly securing said frame means in a selected
position relative to said support means, and means mounting said
first and second forming members on said frame means for permitting
relative linear movement of said forming members toward and away
from each other.
5. An apparatus according to claim 4, wherein said frame means
includes a substantially U-shaped member rotatably mounted on said
support means for rotation about a substantially horizontal axis,
and said first and second forming members being mounted on said
U-shaped member substantially adjacent the free ends of the legs
thereof for relative linear movement in a direction substantially
transverse to said horizontal axis.
6. An apparatus according to claim 5, further including spring
means coacting between said U-shaped member and one of said forming
members for resiliently urging said one forming member into
engagement with said other forming member.
7. An apparatus according to claim 1, wherein said first and second
forming members are cylindrical, and wherein the projections formed
on said first forming member are constructed of an elastomeric
material so as to act as a cushion when the forming members are
positioned in engagement with one another so as to not damage the
tissue placed therebetween.
8. An apparatus according to claim 7, further including a
sleeve-like support member positioned in surrounding relationship
to said forming members, said support member having projections
adjacent one end thereof having a configuration conforming to the
shape of the cusps of the heart valve and being made of a plastics
material for permitting the edges of the tissue, when positioned
between the forming members, to be sewn thereto.
9. An apparatus according to claim 1, wherein the plurality of
projections comprise three finger-like members spaced equidistantly
around the periphery of one of said forming members for
co-operating with said other forming member.
10. An apparatus according to claim 9, wherein two of said
finger-like members include means whereby the two finger-like
members are demountable from said one forming member.
11. An apparatus according to claim 9, wherein the finger-like
members each include a pad at one extremity, which pads conform to
the configuration of said recesses.
12. An apparatus according to claim 1, wherein the plurality of
projections comprise three finger-like members spaced equidistantly
around the periphery of one of said forming members, two of said
two demountable dismantled from said one forming member.
13. An apparatus according to claim 12, wherein said one forming
member includes securing means mounted on said forming member
coactig with said two demountable members for securing said
finger-like members in said one forming member when inserted in
said one forming member.
14. An apparatus according to claim 13, wherein said securing means
comprise spring means rotatably mounted on said one former member
for coacting with respective stem means of said two finger-like
members.
Description
The present invention relates to surgical apparatus and method.
A technique has been developed for manufacturing a replacement
heart valve using tissue taken from the thigh region of a patient
undergoing treatment. Because the patient's own tissue is used,
this so-called autograft technique avoids the serious problems of
degeneration and calcification associated with the so-called
homograft technique in which a faulty heart valve is replaced by a
similar valve taken from a cadaver.
However, the manufacture of the replacement valve requires the
tissue to be cut and shaped into the form of the cusps of the valve
by the surgeon performing the operation. This is a time-consuming
process and demands a high standard of competence on the part of
the surgeon.
It is an object of the invention to provide a surgical apparatus by
means of which the manufacture of autogenous tissue heart valves is
facilitated.
It is a further object of the invention to provide apparatus which
includes formers which mould tissue to the shape required.
It is also among the objects of the invention to provide for
relative movement of the formers towards and away from each other
during manufacture of a valve.
Further objects of the invention will be evident when reading the
following description in conjunction with the accompanying
diagrammatic drawings, which illustrate by way of example
embodiments of the invention, in which:
FIG. 1 is a representation of one embodiment of the invention
mounted in a frame;
FIG. 2 shows a perspective view of the co-operating surfaces of
formers according to one embodiment;
FIG. 3 shows in perspective a second embodiment of one former;
and
FIG. 4 shows a support for use with the embodiments shown in FIGS.
2 and 3.
Referring to the drawings, a male former 11 and a female former 12
(FIG. 2) have complementary surfaces 13 and 14 respectively, which
are so shaped as to conform to the configurations of the three
cusps of an aortic valve.
The formers 11 and 12 are cylindrical and have respective recesses
15 and 16 in their bases into which fit locating pegs 17 and 18
that form part of a frame 19. The peg 17 is in the form of a
spring-loaded plunger to facilitate the insertion of the formers 11
and 12 into the frame 19. The peg 17 is also arranged to be
adjustable, so that the spring pressure can be varied and thus
provides varying pressure on the tissue. The frame 19 is mounted
upon a stand 20 by means of a universal joint 21.
The shapes of the co-operating surfaces 13 and 14 are determined by
taking a cast of an aortic valve and transferring the configuration
of the cast to the female former 12. The former 12 is then used to
cast a male reproduction 22 in a silicone rubber, which is mounted
on a poly methyl methacrylate cylinder 23 to form the male former
11. The male former 11 is made in this fashion so that the silicone
rubber would act as a cushion and reduce the possibility of damage
to tissue placed between the male and female formers.
A support 24 is used to maintain the tissue in the shape formed by
the formers 11 and 12 when the tissue is placed therebetween. The
support 24, which conforms accurately to the shape of the cusps of
the aortic valve, is made of the plastics material known as
polypropylene and is covered by biologically compatible woven or
knitted plastics material such as Dacron or Teflon.
Referring now to the second embodiment shown in FIG. 3, the male
former 11' includes a base 37 from which depend three finger-like
members, 38, 39 and 40. The free ends of the members each include a
pad 31, 32 and 33 respectively. The pads may be made from silicone
rubber.
The member 38 is integral with the base 37. The members 39 and 40
are removable from the base 37, a spring clip 34 and 35 pivoted to
the base 37 securing the respective member in seatings (not shown)
in the base. The base 37 also includes a recess 15.
As described above with reference to FIG. 2, the former 12 is used
to cast and mould to the required shape the pads 31, 32 and 33. The
members 38, 39 and 40 and base 37 of the former 11 may suitably be
of stainless steel.
In use of the embodiment shown in FIG. 2 to make an autogenous
heart valve, the support 24 which is to form part of a valve to be
made, is placed in position on the female former 12 with
projections 24' coincident with the ridges 14'. Suitable pieces of
tissue (not shown) taken for example from the thigh of a patient
being operated upon, is then placed between the formers 11 and 12.
There are three pieces of tissue, one being placed between each
pair of co-operating surfaces 13 and 14. The formers 11 and 12 are
then held together and mounted in the frame 19 by means of the pegs
17 and 18. The exposed edges of the tissue are then attached to the
support 24 using standard surgical sutures or careful glueing or
stapling and trimmed with scissors. The tissue is attached along
the curves of the support, conforming to the shape of the valve.
This operation is facilitated by the universal joint 21. The
formers 11 and 12 are then removed from the frame 19 and separated
and the tissue is cut along the lines where the valve cusps meet,
again with the aid of scissors.
In use of the embodiment shown in FIG. 3 the support 24 is placed
in position on the former 12 with fingers 24' coincident with
ridges 14' as previously described. The curved surfaces in the
support 24 then correspond with the curved edges on the former
12.
The former is then mounted on the frame 19, the peg 18 on the frame
entering the recess 16. The former 11' with members 39 and 40
removed, is then mounted on the frame, the peg 17 which is spring
mounted, entering the recess 15. A single piece of autogenous
tissue having one straight edge is then wrapped around the former
12 and then held in position between the pad 31 on the fixed member
38 and one cusp 14 of the former 12. The tissue is then folded into
a second cusp and the demountable member 39 is secured in position
in the base 37, the spring clip 34 being pivoted downwardly to
engage the member 39 and hold it securely in position. The tissue
is then securely held between the second cusp 4 and the pad 32 as
well as between the first cusp and the pad 31. The same procedure
is used with respect to the other member 40. The tissue is thus
moulded into the form of a tri-cuspic aortic valve. The edges of
the tissue are then attached as before to the support 17 using
standard surgical sutures or careful stapling or glueing and
trimmed with scissors.
This operation is facilitated by a universal joint 21 on the stand
18.
When the mould is dismantled and the support is removed, a
tri-cuspic heart valve is obtained using autogenous fresh tissue,
and can be placed in a defective heart.
Thus both embodiments of the invention provide a process which can
be carried out quickly and simply by unskilled personnel.
Furthermore, the aortic valve produced in the process and apparatus
of the invention can be manufactured in the operating theatre while
the surgeon is engaged in the early stages of an operation. This
enables the surgeon and his assistant to concentrate on the
operation and removes the onus of manufacturing the replacement
from them, shortens the operation and reduces the risk of
infection.
* * * * *