U.S. patent number 3,571,815 [Application Number 04/760,814] was granted by the patent office on 1971-03-23 for suture ring for heart valve.
Invention is credited to John V. Somyk.
United States Patent |
3,571,815 |
Somyk |
March 23, 1971 |
SUTURE RING FOR HEART VALVE
Abstract
A seamless suturing ring of textile material for a heart valve
which has a cylindrical collar with a portion extending radially
outwardly therefrom provided with formed openings for suturing to
the heart tissue and a peripheral selvage edge.
Inventors: |
Somyk; John V. (Lincoln,
RI) |
Family
ID: |
25060264 |
Appl.
No.: |
04/760,814 |
Filed: |
September 19, 1968 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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541789 |
Apr 11, 1966 |
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Current U.S.
Class: |
623/2.4; 66/172R;
623/2.41; 66/170 |
Current CPC
Class: |
A61F
2/2409 (20130101); A61F 2/2424 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61f 001/22 () |
Field of
Search: |
;3/1,1 (HV)/
;128/334,(Teflon &/ Silicone/ digests)/
;66/(Inquiry),169,170,172 ;287/(Inquiry) ;139/(Inquiry) |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
1 "Evolution of Aortic Valvular Prostheses" by E.B. Kay et al.,
Journal of Thoracic and Cardiovascular Surgery, Vol. 45, No. 3,
March 1963, pages 372--381. 3-1HV .
2. "Evaluation of Two Prostheses For Total Replacement of the
Mitral Valve" by F.S. Cross et al., J. of Thoracic &
Cardiovascular Surgery, Vol. 46, No. 6 Dec. 1963, pages 719--725.
3-1HV .
3. "A new Caged-ball Aortic and Mitral Value" by D.E. Harken, Mt.
Sinai Hospital Journal, Vol. 32 Pages 93--106, 1965. Copy in Group
335 3-1HV. .
4. "Aortic Valve Prostheses Incorporating Lightweight Titanium
Ball, Dacron Velour Covered Cage and Seat" by D.A. Cooley et al.,
Transactions American Society for Artificial Internal Organs, Vol.
XIII, pages 93--100, June 16, 1967. Copy in Group 335 -
3-1HV..
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of my application Ser.
No. 541,789 filed Apr. 11, 1966, now abandoned.
Claims
I claim:
1. A suturing ring for connecting an artificial heart valve body
with the heart tissues by sutures comprising a one-piece textile
fabric having a cylindrical collar of single thickness for
surrounding a portion of an artificial heart valve body and having
a fashioned skirt portion of a single-thickness periphery radially
outstanding from the cylindrical collar axis to a substantial
extent from said collar and at an angle thereto with a selvage
peripheral edge to prevent fraying, said skirt portion having a
plurality of annularly disposed holes of a size larger than the
porosity of the fabric mesh with said holes disposed inwardly from
the peripheral selvage edge thereof.
2. A suturing ring as in claim 1 wherein said ring is seamless.
3. A suturing ring as in claim 1 wherein said ring is seamless and
formed of textile fibers knitted together.
4. A suturing ring as in claim 1 wherein the textile fabric is a
velour to assist in the growth of heart tissues thereto.
5. A suturing ring as in claim 1 wherein said collar has slits
extending axially thereof for purposes of attachment to an
artificial heart valve.
6. A suturing ring as in claim 1 wherein said collar has preformed
enlarged openings for the passage of cage prongs of an artificial
heart valve therethrough.
7. A flexible suture ring as in claim 1 wherein said fabric skirt
has one loop cast over the next loop adjacent each of said holes
whereby in the case of rupture running will stop at the holes.
8. A heart valve comprising a valve body having an axially
outwardly opening channel, a movable valve member contained in said
body, a flexible suturing ring for connecting said valve body with
the heart tissues by sutures, said suturing ring having a
cylindrical collar connected to said valve body by said collar
extending into the open channel of the body and adhesive means
completing the filling of said channel holding and sealing said
collar therein, said ring comprising a one piece textile fabric of
a single thickness throughout having a fashioned skirt portion
periphery radially outstanding from the cylindrical collar axis to
a substantial extent from said collar and at an angle thereto with
a selvage peripheral edge to prevent fraying, said skirt portion
having a plurality of annularly disposed holes of a size larger
than the porosity of the fabric mesh with said holes disposed
inwardly from the peripheral selvage edge thereof.
Description
BACKGROUND OF THE INVENTION
As a result of disease processes, the valves of the heart become
incompetent and blood regurgitates or "leaks" back against the
general direction of flow of the circulation. Artificial valves are
now manufactured which may be used to replace the natural valves of
the heart. These artificial valves are replaced in the heart by
suturing the valves into the heart.
In installing such an artificial valve, the surgeon removes a
certain amount of tissue which form the natural valve and then
secures the artificial valve by sewing it to living tissue. This
invention deals primarily with the suture or sewing ring which is
attached to the valve by means of which the valve is sewed into the
heart.
In some cases the suture or sewing ring which provides a radially
outstanding skirt is trimmed by scissors or some sharp instrument
to the size which it is desired it shall have. This trimming often
releases small particles which may become a serious effect on life
if they get into the bloodstream. Sometimes attempts are made to
fuse the edge of the synthetic material to attempt the stopping or
fraying of the edge of the material. Such fusing will prevent the
blood from circulating through pores of the suture ring which
circulation is desirable.
There are also problems involved in the securing of the suture ring
to the valve which may allow blood to get into parts where it does
not circulate.
SUMMARY OF THE INVENTION
A knit fabric which is fashioned into a suitable shape and heat
shrunk into a tight porous construction. The fibers from which the
fabric is formed are Dacron.sup.* .sup.* Registered Trademark for a
polyester fiber. or Teflon.sup.**
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the suture ring;
FIG. 2 is a perspective view of the valve;
FIG. 3 is a perspective view of the suture ring and valve
attached;
FIG. 4 is an enlarged plan view of the knitted fabric in the skirt
area containing the holes for the sutures;
FIG. 5 is a sectional view of a fragmental portion of the valve
body on a larger scale and showing an initial step for securing the
suture ring in place;
FIG. 6 is a view similar to FIG. 5 showing the suture ring inserted
in the channel of the body of the valve;
FIG. 7 is a view similar to FIG. 6 but illustrating a modified form
in that the channel is at an angle to the valve body different from
that shown in FIG. 6;
FIG. 8 is a perspective view of a modified form of suture ring;
FIG. 9 is a sectional view illustrating the suture ring of FIG. 8
attached to a modified form of valve body showing the prongs of the
cage as passing through holes in the collar portion of the suture
ring;
FIG. 10 is a view similar to FIG. 9 but showing the suture ring
attached in a slightly different way;
FIG. 11 is a perspective view of a still further modified form of
suture ring; and
FIG. 12 is a perspective view of the suture ring of FIG. 11
attached to the valve body which is shown broken away.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIGS. 1--7 of the drawings, 10 designates generally
the seamless suture ring which is a one-piece knitted material from
some suitable fiber such as above mentioned and which may, for
example, be taken as Dacron. It is knitted in one circular piece
and fashioned to shape and then heat shrunk to provide a
cylindrical collar portion 11 from one edge of which a skirt 12
extends radially outwardly from the collar to a substantial extent.
A plurality of sets of openings are provided at radially spaced
locations one of which sets is a row close to the peripheral edge
14 of the suture ring with other sets of rows spaced therefrom. The
peripheral edge 14 is in a selvage form to prevent fraying of the
edge of the suture ring 12 and also to support the sewing which may
pass through the openings.
A plurality of rows or sets of openings are formed at 15, 16 and 17
circularly of the skirt 12, and as shown in the enlarged
diagrammatic view of FIG. 4, these openings are formed by casting
off one needle on to another at spaced intervals which is here
shown as every other needle circularly about the fabric with the
holes in the rows being formed in staggered relation. The row 17 is
adjacent the selvage which selvage is reinforced by passing a
plurality of strands 18 through the knitted loops at the edge and
also to hold the opening 17 intact. A helical strand 19 may be
wrapped about the plurality of strands 18 as shown in FIG. 4 to
provide a stronger selvage. This would be a hand operation. The
outer set of openings 17 are about 1 millimeter from the edge,
while a second set of openings 16 are formed about 5 millimeters
inwardly from this selvage, and the third row or set of openings 15
are provided a further 5 millimeters inwardly from the selvage,
although these distances may be varied.
This provides a nonbulky selvage edge which gives good support to
the threads when the needles are passed inwardly close to this
selvage edge or inward of the strands 18. The first row of suture
holes 17 are formed by hanging the yarn on every other needle. The
next row of stitches will push through the old loops and pick up
all of the needles to form a new row of stitches on adjacent
needles. The suture holes 16 are provided inward of the selvage
edge by casting one loop 20 over the other loop 21 to have two
loops 20, 21 on every other needle and leaving every other needle
without a loop. When the needle bed is passed over, the empty
needle will pick up a new loop 22 to continue with the uniform loop
effect.
A valve is designated generally 25 (FIG. 2) and is usually formed
of metal or plastic which is compatible with the human body having
a ring 26 in the form of a channel providing inner wall 27 and
outer wall 28 with a bridging portion 29 leaving an opening 30
between the walls. Fingers 31 extend upwardly from the bridging
portion 29 and are curved inwardly and joined at their upper ends
to provide a ball retaining cage such as illustrated. The valve is
in the form of a ball or sphere 32 and is usually formed of some
resilient material such as silastic silicone latex or silicone
rubber. It provides a seal against the curved inner edge of the
ring 26 although it may move off of this seat in order to permit
the passage of fluid, such as blood, as the pumping heart action
occurs.
The suture ring 10 is attached to the valve body 25 by first
inserting a soft ring 35 of silicone latex material or a material
similar to the valve 32 into the opening 30 between the walls 27
and 28, which will be in a soft pliable state. The collar 11 is
then inserted in the channel 30 as seen in FIG. 6 which will force
the silicone latex 35 now designated as 36 about the collar as seen
in FIG. 6 and will cause it to impregnate the collar and will
completely fill the opening in the channel leaving no chance for
any blood to enter. This silicone latex ring and the collar thus
completely fills the channel and cements the collar into the
channel, leaving the skirt 12 extending radially outwardly from the
body as seen in FIG. 3.
The ring 26 as shown in FIGS. 2, 5 and 6 in some instances may be
arranged as shown at 26' in FIG. 7 so that the walls 27' and 28'
will be at an angle of substantially 45.degree. to the general axis
of the valve rather than parallel to the axis as shown previously.
By this arrangement the height of the collar is less than shown in
FIG. 1.
In some cases the suture ring designated as 40 in FIG. 8 may have
additional openings 41 formed in the collar 42 in a similar manner
to that as above set forth except that the openings will be larger,
by casting one loop to the right and the next loop to the left, so
as to accommodate the prongs of the cage. Further the cage 25' will
have the prongs 31' spaced at their upper ends as at 43 so that the
ends 44 of these prongs may be passed through the openings 41 in
the collar. In FIG. 9 the collar 42 is placed inside the ring 26'
of the valve body, the prongs are passed thru the openings 41 and
the upper edge of the collar 47 is turned outwardly over the ring
26' and sewed as at 48 to the skirt 49 of the suture ring. In FIG.
10 the collar 42 is placed along the outside of the ring 26', the
prongs 31' are passed thru the openings 41 and the collar is turned
inwardly as at 50 and sewed to the skirt 49 as at 51.
In FIG. 11 the suture ring 55 is formed with spaces 56 at intervals
dividing the collar 57 into quarter segments 58, and this collar 57
is passed thru the spaces between the prongs 31 or 31' and doubled
over as at 59 and sewed to the skirts as at 60. The edges of the
segments 58 are selvaged.
In cases where the collar of the suture ring extends over the upper
edge of the ring such as 26', the ball valve 32 will contact the
edge of the suture ring which covers the annulus 26', thus covering
all of the base of the caged valve.
In some cases the suture ring may be made of a velour fabric which
is done by using two plied yarns of Dacron twisted together. One
end may be of 140 denier which is twisted and heat set and then
untwisted. The other end may be of 250 denier of regular yarn not
heat set which is plied with the first yarn above mentioned by
twisting. The two plied Dacron yarns are then knitted, after which
they are heat shrunk at 260.degree. F. which will cause the
unshrunk yarn to shrink and raise the preshrunk yarn into small
loops which provide a velour material with a silky feel which it is
found to facilitate in growth and attachment of the heart tissues
or inhibits growth of the heart tissues to it.
The suture ring will be formed in a size which in most instances
will not need to be trimmed. However, with the plurality of sets of
openings spaced at different radial distances, a trimming may be
had by cutting circularly the row before the holes of a set of
openings, and by reason of this knitted construction, the edge will
still be locked together and no frayed edge will appear.
By provision of a knit material such as this, there are sufficient
number of pores or openings so as to permit circulation of blood
through these pores which assist in preventing clotting and also
allow tissues to grow therethrough and assist in holding the valve
in place. Likewise as the fabric is all in one piece, clotting is
prevented and also by reason of the blood being completely blocked
from entering the channel by which the suture ring is secured to
the valve clotting is prevented.
However, experiments heretofore have shown that a knitted fabric is
the only textile construction possessing the desired elasticity
although this has the inherent structural characteristic of running
or forming "ladders" of dropped stitches whenever one or more of
its constituent loops are ruptured. By reason of the knitted
construction above described, it is possible to prevent a
reasonable degree of runs or ravel.
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