U.S. patent number 3,656,185 [Application Number 05/008,564] was granted by the patent office on 1972-04-18 for cardiac valvular support prosthesis.
This patent grant is currently assigned to Rhone-Poulenc S.A.. Invention is credited to Alain F. Carpentier.
United States Patent |
3,656,185 |
Carpentier |
April 18, 1972 |
CARDIAC VALVULAR SUPPORT PROSTHESIS
Abstract
A cardiac valvular prosthesis, e.g., for the mitral valve,
consisting solely of an annular or part-annular member adapted to
fit against the base of the cusps of a human heart valve, and
suture means for securing the member in place. The prosthesis
cooperates with the natural valve cusps of the patient to form the
valve.
Inventors: |
Carpentier; Alain F. (Paris,
FR) |
Assignee: |
Rhone-Poulenc S.A. (Paris,
FR)
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Family
ID: |
26214822 |
Appl.
No.: |
05/008,564 |
Filed: |
February 4, 1970 |
Foreign Application Priority Data
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Feb 4, 1969 [FR] |
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6902441 |
Dec 19, 1969 [FR] |
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6944124 |
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Current U.S.
Class: |
623/2.36 |
Current CPC
Class: |
A61F
2/2448 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61f 001/24 () |
Field of
Search: |
;3/1,DIG.3
;128/334R,1 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"A Prosthetic Stented Aortic Homograft For Mitral Valve
Replacement" by C. S. Weldon et al., Journal of Surgical Research,
Vol. 6, No. 12, Dec. 1966, pgs. 548-552 .
"Simplified Insertion of Aortic Homograft Valves With
Nonthrombogenic Prosthetic Frames" by Nina S. Braunwald et al.,
Transaction American Soc. For Artificial Internal Organs, vol.
XIII, 1967, pgs. 111-113 .
"The In Vivo Comparison of Hemodynamic Function of Ball, Disk, and
Eccentric Monocusp Artifial Mitral Valves" by R. W. M. Frater et
al., Prosthetic Heart Valves, Charles C. Thomas-Publisher,
Springfield, Illinois, 1968, pgs. 262-266.
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Primary Examiner: Truluck; Dalton L.
Assistant Examiner: Frinks; Ronald L.
Claims
I claim:
1. A cardiac valve support for supporting the cusps of a natural
human heart valve without excising said valve and cusps, consisting
solely of: an elongated member curved along its length to define a
generally ring-shaped rigid member of a size and shape to fit
against the base of the cusps of a natural human heart valve, the
central axis of said curved elongated member lying substantially in
a single plane, and suture means for suturing the member in place,
said suture means being substantially coextensive with said
elongated member.
2. A cardiac valve support as claimed in claim 1, wherein the
elongated member comprises a rigid frame, and wherein said frame
and suture means are enclosed in a textile sheath.
3. A cardiac valve support as claimed in claim 2, wherein said
frame comprises an asymmetric, outwardly hollow, channel section
having unequal length flanges defining an external groove, and said
suture means comprises a suturable cord disposed within said
external groove.
4. A cardiac valve support as claimed in claim 3, wherein a
reinforcing filament extends along said elongated member within
said cord.
5. A cardiac valve support as claimed in claim 1, wherein said
elongated member is curved in an annular shape, including a
circular sector portion and a substantially straight portion
together defining the annular periphery of said elongated member,
said straight portion comprising between one-quarter and one-half
of said periphery.
6. A cardiac valve support as claimed in claim 1, wherein said
member is a part-annular member curved in an annular shape but
omitting between one-quarter and one-half of the total peripheral
length of said total annular shape, said part-annular member having
spaced apart ends, the annular arcuate spacing between said ends
being not less than about one third of the actual peripheral length
of said part-annular member.
Description
The present invention relates to a prosthesis intended for the
surgical correction of valvular diseases and notably diseases
affecting the mitral valve.
In the case of mitral disease, it is known to preserve the natural
cusps of a valve and to correct the defects therein. However, Kay's
annuloplasty, Wooler's asymmetrical annuloplasty and Reed's
annuloplasty give uncertain results, because leakage may persist.
In addition, the mitral ring may continue to distend and the
stitches made in the commissuroplasty may yield under the action of
the tensile forces to which they are subjected. This results in a
reduction in the efficiency of the valve with a frequency which is
given as 10 to 40 percent by the authors.
It is also known, in order to obviate valvular deformation,
especially mitral valve deformation, to proceed with ablation of
the defective cusps and to replace them by a prosthesis.
Such a prosthesis is described in U.S. Pat. No. 3,374,489 and
includes an annular member which is inserted into the mitral ring
and a valve disc provided with hooks, the disc oscillating between
two extreme positions and alternately opening and closing the
mitral orifice. The annular member performs the double function of
retaining the valve disc and constituting the valve seat.
Such a prosthesis has various disadvantages, in that it interferes
with the normal physiology of the mitral apparatus, it necessitates
the prolonged use of anticoagulants and it may cause a thrombosis
or a sudden mechanical defect.
According to the present invention, there is provided a cardiac
valvular prosthesis consisting solely of an annular or part-annular
member adapted to fit against the base of the cusps of a human
heart valve, and suture means for securing the member in place.
With such a prosthesis the natural valve cusps are retained, and
the prosthesis is inserted at the base thereof.
The annular or part-annular member may consist of a rigid frame,
suture means and a textile sheath enclosing the frame and suture
means.
The invention will be more readily understood from the following
description, given merely by way of example reference being made to
the accompanying drawings, in which:
FIG. 1 is an elevation of one embodiment of prosthesis according to
the invention;
FIG. 2 is a section taken along the line A--A, of FIG. 1, and drawn
to a large scale;
FIG. 3 is a view of the mitral valve in the course of the
positioning of the prosthesis of FIG. 1;
FIG. 4 is a view of the mitral valve after the positioning of the
prosthesis of FIG. 1;
FIG. 5 is an elevation of a second embodiment of prosthesis
according to the invention; and
FIG. 6 is a view of the mitral valve after the positioning of the
prosthesis according to FIG. 5.
The prosthesis shown in FIG. 1 closely follows the form of the base
of the valve cusps and it has substantially the form of a closed
ring 1, which is plane, circular, oval or, as shown, slightly
flattened at 2 over a length between one-quarter and one-half of
its periphery. Substantially straight portion 2 corresponds to the
curvature of the large cusp and the complementary zone corresponds
to the curvature of the small cusp. The ring has in its plane an
axis of symmetry, its largest dimensions, along this axis and along
a perpendicular axis, being generally between 15 and 30 mm. and 20
and 40 mm. respectively.
As seen in FIG. 2, the ring comprises a rigid frame 3, for example
of stainless steel. This frame is light since it has an asymmetric,
outwardly hollow channel section defining an external groove. The
flanges of the channel section are of unequal widths, the lower
edge 4, which is flat being narrower and intended to rest on the
mitral ring, while the upper flange 5 has a rounded profile. The
width of the lower flange is generally between 0.5 and 2 mm. and
that of the upper flange between 1 and 3 mm. This arrangement makes
it possible for the suture stitches to be automatically
embedded.
Within the groove is disposed a stitchable cord 6, which is
maintained within the groove by a filament 8 of large caliber,
formed for example of polytetrafluorethylene. The ring also
comprises a woven textile sheath 7, for example also of
polytetrafluorethylene, which simultaneously encloses or covers the
frame 3 and the cord 6.
A prosthesis according to the invention may be made from any inert
materials which are well tolerated by the organism and have
appropriate strength, and stainless steel and
polytetrafluorethylene have only been referred to by way of
example. For example ethyleneglycol polyterephthalate may be used
instead of polytetrafluoroethylene.
As seen in FIG. 5 and 6, the prosthesis may be in the form of an
open ring, i.e., it may be part of an annulus 1, which is slightly
flattened to fit closely against the base of the cusps. This
part-annulus is open over a length generally between one-quarter
and one-half of its periphery, so that the space between the free
ends is between one-third and one times the peripheral length of
the part annular member itself. This length corresponds
substantially to the length of the base of the cusp which it is
desired to allow to have free movement. In FIGS. 5 and 6, the ring
is open over a length equal to one-third of its periphery, this
length corresponding substantially to the base of the large cusp
12. The ring thus closely fits against the base of the small cusp
13 and allows the large cusp to have free movement.
The ends 14 and 15 of the ring are rounded in order not to damage
the tissues in which they are disposed.
The profile of the ring is similar to that of the construction of
FIGS. 1 to 4, i.e., its cross section is as shown in FIG. 2. Thus,
it has an external groove, the lower flange intended to rest on the
mitral ring again being plane, while the upper edge has a rounded
profile. Situated inside the groove is a large-caliber filament of
polytetrafluoroethylene or of ethyleneglycol polyterephthalate,
which maintains a stitchable cord within the frame, after having
been stretched between the two ends of the frame. For this purpose,
the ends of the frame are each formed with a hole, the filament is
pulled between these holes and is fused on either side of the holes
so as to produce beads, and then released.
The annular mitral prosthesis of FIGS. 1 to 4 is positioned between
the left auricle and the left ventricle by the surgical technique
described below with reference to FIGS. 3 and 4.
First of all, the dilatation of the mitral ring is checked, and it
is verified that the cusps are sufficiently supple, that the large
cusp has sufficient freedom of movement and that there is no lesion
of the ligaments by which the large cusp is fixed.
Two appropriate suture filaments 10 and 11 are disposed in U-form
and stitched with the aid of a needle into the thickness of the
mitral ring, parallel to the latter, at the ends of the large cusp
12. The distance between these two filaments corresponds to the
width of the flattened zone 2 of the annular prosthesis and permits
of defining the dimension of the prosthesis appropriate for the
orifice under consideration.
About 20 filaments constituting as many absolutely equidistant
stitches are positioned in the same way between the filaments 10
and 11 and around the whole periphery of the mitral ring, at the
base of the cusps and immediately above. These filaments are then
passed through the cord of the prosthesis, with an identical
spacing for the filaments corresponding to the large cusp and with
a reduced spacing for the filaments corresponding to the small cusp
13.
The prosthesis is then slid along the filaments against the mitral
ring and thereafter fixed by knotting the filaments. The knots are
substantially invisible and the projection of the prosthesis is
insignificant, so that it can be rapidly overlapped and
incorporated by the neighboring organic tissues.
The surgical technique of positioning the open ring is similar to
that described above.
The described prosthesis permit of treating mitral inadequacies
due, for example, to contraction of the large cusp, to opening of
the commissural curvatures, to distension of the mitral ring in the
zone of attachment of the small cusp, and so on. They also permit,
after commissurotomy, of treating an orificial stricture due to a
fibrous fusion of the commissures.
A prosthesis according to the invention has many advantages other
than its simplicity and its safety of use. Owing to its particular
form, it permits the preservation and repositioning of the valvular
elements, as also the correction of various anomalies. For example,
it permits repositioning and development of the large cusp,
commissural remodelling, and reduction of the small cusp. Thus, it
renders possible recontacting of the cusps in a mitral orifice of
normal surface. The open ring prosthesis permits free movement of
one of the cusps of a valve, notably the free movement of the large
cusp in the mitral valve. In addition, owing to the rigid frame it
is possible to distribute the tractive forces over a large number
of points and to counteract secondary distension of the mitral
ring. Finally, owing to the woven sheath to which the fibrin can
adhere, it is rapidly incorporated in the tissues and therefore
requires no prolonged anticoagulant treatment and involves no
danger of thrombosis.
Although only two particular embodiments of mitral prosthesis have
been described by way of example, a prosthesis according to the
invention may undergo various modifications of construction and may
readily be adapted to other valves, notably to the tricuspid valve,
by using a ring of the same type, of circular form, or to the
aortic valve by using a ring adapted to the trifoliate form of the
aortic valvular orifice.
* * * * *