U.S. patent number 3,574,865 [Application Number 04/751,210] was granted by the patent office on 1971-04-13 for prosthetic sutureless heart valve.
This patent grant is currently assigned to Michigan Instruments, Inc.. Invention is credited to Ronald C. Hamaker.
United States Patent |
3,574,865 |
Hamaker |
April 13, 1971 |
PROSTHETIC SUTURELESS HEART VALVE
Abstract
This disclosure relates to a prosthetic sutureless heart valve
wherein a two-piece snapring is employed in fastening the valve to
the heart. The valve has an annular base which contains a check
valve and a plurality of pins which pierce the tissue around the
valve. The annular snapring fits into the base near the pins to
hold the valve and the tissue intact. A smooth, continuous surface
is provided for passage of the blood through the valve.
Inventors: |
Hamaker; Ronald C. (Royal Oak,
MI) |
Assignee: |
Michigan Instruments, Inc.
(Grand Rapids, MI)
|
Family
ID: |
25020974 |
Appl.
No.: |
04/751,210 |
Filed: |
August 8, 1968 |
Current U.S.
Class: |
623/2.34;
606/220; 623/2.38 |
Current CPC
Class: |
A61F
2/2424 (20130101); A61F 2/2409 (20130101); A61F
2250/006 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61f 001/22 () |
Field of
Search: |
;128/334,303 ;3/1 (HV)/
;251/149.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,180,087 |
|
Oct 1964 |
|
DT |
|
180,750 |
|
Sep 1966 |
|
SU |
|
Other References
"Beall Mitral Valve Prosthesis" Surgitool Inc. Advertisement, The
Journal of Thoracic & Cardiovascular Surgery, Vol. 55, No. 2,
Feb. 1968, Advertising Page 27. 3-1HV.
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
I claim:
1. A sutureless heart valve comprising:
an annular-shaped base member having a central aperture
therein;
valve means attached to said base member and operable within said
aperture to block flow through said aperture;
an annular-shaped snapring for joining said base and valve means to
the surrounding heart tissue, said snapring being joined to said
base member through a snap fit so that the heart tissue is firmly
held between said ring and base, the inner surfaces of said ring
and base being so shaped to form a smooth continuous surface over
said snapring and through said central aperture; and
a plurality of pins extending in an axial direction between said
base member and said snapring so that when said snapring is joined
to said base, said pins pierce said heart tissue to anchor said
tissue between said base and ring, said pins being spaced radially
from said aperture.
2. A sutureless heart valve according to claim 1, wherein said base
includes an axially and inwardly extending flange, and said ring
includes an axially and outwardly extending surface in juxtaposed
relationship with said base flange.
3. A sutureless heart valve according to claim 2, wherein said
outwardly and axially extending surface on said ring has a rounded
corner for camming against said base flange during assembly of said
valve.
4. A sutureless heart valve according to claim 3 wherein said pins
are mounted on said base, and said snapring flange is of sufficient
diameter to fit over said pins when said snapring is joined to said
base, said snapring flange further including an annular recess for
receipt of said pins when said snapring is joined to said base to
provide positive locking of the tissue between the base and
ring.
5. A sutureless heart valve according to claim 1, wherein said
valve means is a ball and said base is provided with a plurality of
spaced legs extending axially of said base member and having their
outer ends curved inwardly and joined at a central point along the
longitudinal axis of said base and enclosing said ball which is
reciprocatable within said legs and seats against said annular base
member to close off said central aperture.
6. A sutureless heart valve according to claim 1, wherein said
valve means comprises a movable disc operably adjacent a face of
said base member to block flow through said central aperture and
means on said base enclosing said disc, said disc being
reciprocable in said enclosing means to move away from said base to
permit fluid flow through said central aperture.
7. A sutureless heart valve comprising, in combination:
an annular-shaped base member having a central aperture
therein;
check valve means in said central aperture being attached to said
base member;
an annular shaped snapring;
means attaching said snapring to said base member through a snap
fit, the inner surface of said base member and said snapring being
so shaped to form a smooth, continuous surface over said snapring
and through said central aperture, said attaching means comprising
an axially directed flange with an outwardly extending wall on said
snapring and an axially and inwardly extending flange on said base,
spaced from said central aperture in juxtaposed relationship with
said snapring flange, the inner diameter of said base flange being
slightly smaller than the outer diameter of said outwardly
extending wall at opposing positions of said wall and said base
flange; and
a plurality of pins extending in an axial direction between said
base member and snapring spaced from said aperture.
8. A sutureless heart valve according to claim 7 wherein said
outwardly extending wall of said snapring has a rounded edge which
is adapted to cam against said inwardly extending flange during
assembly of said valve.
Description
This invention relates to sutureless heart valves. In one of its
aspects it relates to a sutureless heart valve containing an
annular shaped base member having a central aperture with a check
valve in the aperture, upwardly projecting pins on the base member
spaced about the outer portion thereof, an annular snapring having
a diameter sufficient to fit over the projecting pins, and means to
provide a snap fit between said snapring and said base members, the
snapring and the base being so shaped as to form a smooth,
continuous surface through the central aperture and through the
snapring.
In another of its aspects, the invention relates to a sutureless
heart valve as has been hereinbefore described, wherein the check
valve is a ball valve, a lenticular valve, or a leaflet valve.
It is not too uncommon to replace a heart valve with a permanent
mechanical valve. The original development of these prosthetic
valves was directed to sewing the valve into the heart tissue. This
method, while being suitable in some instances, is a relatively
long process which requires an extended period of cardiopulmonary
bypass and protection of the heart by coronary profusion or reduced
temperatures. It is highly desirable to have the valve placed in
the heart as quickly as possible without suturing.
Cromie, U.S. Pat. No. 3,143,742 discloses a prosthetic sutureless
heart valve in which an upper and lower ring contain curved pins
which project radially therefrom. A central ring is provided to
squeeze the two rings together and cause the pins to rotate about a
traverse axis to pierce the tissue surrounding the valve and
thereafter lock the tissue in engagement with the valve.
The circulatory system is very delicate and important part of the
body. If restrictions or rough surfaces appear within the
circulatory system, blood clots can sometimes result. In the
arteries and veins and other passageways through which blood flows,
it is desirable to provide as smooth as possible a surface in order
to avoid turbulent flow which is conducive to formation of blood
clots. Thus, in the construction of heart valves, the surface over
which the blood flows should be a relatively continuous and smooth
surface.
I have now discovered a sutureless heart valve which can be rapidly
installed in a heart and which, when assembled, has a smooth,
continuous, inner surface through which the blood can flow.
By various aspects of this invention, one or more of the following,
or other, objects can be obtained.
It is an object of this invention to provide a sutureless heart
valve which can be quickly installed in a heart passage.
It is a further object of this invention to provide a prosthetic
heart valve having a smooth, internal surface to minimize the
possibility of turbulent flow of blood through the valves.
It is a still further object of this invention to provide a
sutureless prosthetic heart valve having a smooth and continuous
inner surface to minimize the traumatic effects of prosthetic
valves on the circulatory system.
Other aspects, objects, and the several advantages of this
invention are apparent to one skilled in the art from a study of
this disclosure, the drawings, and the appended claims.
According to the invention there is provided a two-piece prosthetic
sutureless heart valve. The valve contains an annular shaped base
member having a central aperture with a smooth inner surface and
with a check valve positioned therein. The valve also has pins
projecting axially of the valve axis on the base and spaced about
the outer portion thereof. Tissue is locked into the base structure
by an annular shaped snapring which has a diameter sufficient to
cooperate with the projecting pins on the base. The annular
snapring also has means on the inner portion thereof for snapping
into engagement with a cam engaging surface on the base member. The
inner surface of the snapring is so shaped as to form a smooth,
continuous path over the snapring and through the central aperture
.
The invention will now be described with reference to the
accompanying drawings in which:
FIG. 1 is a perspective view of an embodiment of the invention;
FIG. 2 is a sectional view through a base member of the valve shown
in FIG. 1 as placed into a heart;
FIG. 3 is a sectional view of an assembled valve shown in part in
FIG. 2;
FIG. 4 is a sectional view of a modified valve according to the
invention;
FIG. 5 is a bottom view of the modified valve shown in FIG. 4;
FIG. 6 is a side view, partly in section, of the valve shown in
FIGS. 1 through 3, and a portion of an instrument for holding the
valve while it is inserted into the heart;
FIG. 7 is a view similar to FIG. 6 showing the complete instrument
for inserting the valve into the heart, and illustrating the method
of inserting the valve into the heart; and
FIG. 8 is an exploded view of the holding and positioning
instrument shown in FIGS. 6 and 7.
Referring now to the drawings, and FIGS. 1 through 3 in particular,
a novel sutureless heart valve has a base 2 and a snap engaging
ring 18. The base 2 has a plurality of spaced axially extending
ball retaining legs 8 having their outer ends curved inwardly and
joined at a central point along the longitudinal axis of the base
member. The base also includes a ball valve 10 which is seated
against inner annular surface 12 of base member 2. The inner
annular surface is smooth and provides a central aperture in the
base member. The ball 10 is free to reciprocate within the ball
retaining legs 8 to open and close the valve. The base comprises an
annular shoulder 14 and an axially and inwardly extending flange
member 16. A base further contains a plurality of axially directed
prongs 6 spaced about the outer periphery of the base. The snapring
18 comprises an annular ring of sufficient diameter to fit over the
projecting pins 6 and has a smooth inner surface 24. Shoulder 20 of
ring 18 abuts against shoulder 14 when the ring is snapped in
place. The snapring has an inwardly and axially extending shoulder
28 which cooperates with flange 16 of the base member to snap into
place. Shoulder 20 is slightly rounded so as to provide a camming
surface against flange 16 in the snap engagement of ring 18 with
base 2. The smooth inner surface 24 of ring 18 forms a continuous
smooth surface with upper flange portion 19. The pins 6 fit into an
annular recess 21 when the ring 18 is snapped into place in base
2.
In operation, the normal valve in a heart is removed, thereby
leaving an aperture. The base member 2 is pushed through the
aperture and pulled back slightly. Tissue 4 is then pulled over the
outer annular recess in base 2 and over the projecting pins 6. The
tissue does not extend over flange 16. The snapring is then pushed
into place with the rounded shoulder 20 camming against flange 16.
As can be seen from FIG. 3, the base 2 and the snapring 18 are so
shaped as to provide a smooth, continuous surface through the inner
aperture of the valve. As can also be seen from FIG. 3, the tissue
is held in place between the base 2 and snapring 18 by pins 6.
Referring now to FIGS. 4 and 5, wherein a second embodiment is
shown, a base 52 is provided with a bar 58 which retains flexible
disc 60, the check valve formed by the flexible disc seating
against the inner annular portion of the valve. The base 52 also
contains a plurality of axially projecting pins 56 spaced about the
outer periphery thereof. The base 52 also contains axially and
outwardly extending flange 62 which has a smooth, continuous inner
surface. The snapring 64 has a rounded shoulder 66 which cams
against the flange 62. The inner annular portion of snapring 64 is
shaped at an angle to the axial direction at flange 62 so that a
locking engagement is provided between the base 52 and the snapring
64. The external diameter of snapring 64 is sufficient to fit over
projecting pins 56 of base 52.
The snapring 64 can be provided with a plurality of axially
projecting pins extending toward base 52 in intermediate positions
between the outer and inner diameter thereof to further aid in
holding tissue 4 in place.
As can be seen from FIGS. 4 and 5, the valve provides a smooth
inner surface which mates with the upper snapring to provide a
substantially continuous, smooth surface over which the fluid can
flow without increasing dangers of turbulent flow.
Whereas the embodiment of FIG. 1 has been described with reference
to a sutureless valve having a ball valve, it is also within the
scope of the invention to provide other kinds of check valves in
combination with recited structure. Thus, for example, a lenticular
valve or the flat, leaflet-type of valve shown in the embodiment of
FIGS. 4 and 5 can be provided. Similarly, the ball valve of FIGS. 1
through 3 could be employed in place of the leaflet valve of FIGS.
4 and 5.
EXAMPLE
A valve of the type shown in the FIGS. 1 through 3 was placed into
the heart of a dog. During the operation, the normal valve in the
dog's heart was cut out and replaced by the valve of the invention.
The base of the valve was pushed through the aperture in the heart,
and the tissue around the aperture was placed over the pins in the
base member. The snapring was then placed on top of the valve and
the dog was sewn up. The total time required for insertion of the
valve was 7 minutes. An X-ray was taken of the valve, and indicated
that the valve was successfully and suitably placed in the
heart.
After the dog expired, the heart was removed and dissected. The
valve was firmly intact, and operated successfully.
Referring now to FIGS. 6, 7, and 8, a holding tube 70 having a
plurality of longitudinal slits 72 is employed in holding base 2 in
position within the heart. Positioned within the holding tube 70 is
a rod 76 having attached to the end thereof an expander 74. A
drawing tube 78 has an end member 80 which threadably engages a
threaded portion 82 of rod 76. Drawing tube 78 has a pair of
oppositely spaced holes 92 in which is removably positioned a
turning pin 84.
When the drawing tube 78 is rotated relative to the holding tube
70, for example in the direction of the arrow shown in FIG. 6, the
expander is drawn into holding tube 72 to expand the end of that
tube against the inner wall portion of base 2.
A snapring pusher 86 having a longitudinal slot 88 and an end
member 90 is provided to push the snapring 18 into fixed engagement
with base 2.
In operation, base 2 is positioned on the slotted end of holding
tube 70. Drawing tube 78 is rotated with the aid of pin 84 until
the expander 74 has forced the end of holding tube 70 against base
2 to firmly hold the same. The base 2 is then positioned in the
aperture in the heart and tissue 4 is folded over pins 6. The
turning pin 84 is then removed from drawing tube 78 and the
snapring 18 is placed over drawing tube 78 and holding tube 70
while the two tubes are held in position. The snapring pusher 86 is
then placed over the end of drawing tube 78 while holding the
slotted portion of holding tube 70. The longitudinal slots 88 of
snapring pusher 86 are positioned opposite holes 92 of drawing tube
78. The turning pin 84 is then inserted through longitudinal slots
88 into holes 92. The snapring pusher 86 is then forced against the
snapring by pushing the end 90 of snapring pusher 86, for example
with the palm of the hand, while holding the turning pin 84 with
two fingers of the same hand. In this manner, the snapring 18 is
snapped into place on the base 2.
The tube 70 can be removed by the opposite procedure. The snapring
pusher 86 is moved away from the heart while holding pin 84 until
the pin reaches the end of slots 88. The holding tube 70 can then
be held and the pin 84 is removed. After the snapring pusher 86 has
been removed from the end of drawing tube 78, the drawing tube 78
is rotated relative to holding tube 70, with the aid of pin 84, in
order to move the expander 74 out of the end of the holding tube
70. After this has been done, the holding tube 70 can be removed
from the valve.
Reasonable variation and modification are possible within the scope
of the foregoing disclosure, the drawings, and the appended claims
to the invention without departing from the spirit thereof.
The embodiment of the invention in which an exclusive property or
privilege is claimed are defined as follows:
* * * * *