U.S. patent number 3,671,979 [Application Number 04/860,341] was granted by the patent office on 1972-06-27 for catheter mounted artificial heart valve for implanting in close proximity to a defective natural heart valve.
This patent grant is currently assigned to The University of Utah. Invention is credited to Spyridon Moulopoulos.
United States Patent |
3,671,979 |
Moulopoulos |
June 27, 1972 |
CATHETER MOUNTED ARTIFICIAL HEART VALVE FOR IMPLANTING IN CLOSE
PROXIMITY TO A DEFECTIVE NATURAL HEART VALVE
Abstract
An artificial heart valve for implantation in close proximity to
a malfunctioning or damaged natural aortic or mitral heart valve by
remote means without performing an open chest or other major
surgical operation. The artificial heart valve comprises a flexible
membrane in the form of an umbrella in that the apex of the
umbrella resides in the direction that blood flow is to be
periodically prevented while the distal end opens sufficiently to
contact the inner walls of the vessel to prevent the reverse flow
of blood and the membrane collapses about the axis of the umbrella
to allow the forward flow of blood.
Inventors: |
Moulopoulos; Spyridon (Athens,
GR) |
Assignee: |
The University of Utah (Salt
Lake City, UT)
|
Family
ID: |
25332997 |
Appl.
No.: |
04/860,341 |
Filed: |
September 23, 1969 |
Current U.S.
Class: |
623/2.11;
604/247; 623/2.17; 600/486 |
Current CPC
Class: |
A61F
2/2412 (20130101); A61F 2/2427 (20130101); A61F
2250/0059 (20130101) |
Current International
Class: |
A61F
2/24 (20060101); A61f 001/22 (); A61b 005/02 () |
Field of
Search: |
;3/1
;128/1,241-246,2.05,245,214,341-345,348-351,2.5D,2.5F |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
516,301 |
|
Oct 1920 |
|
FR |
|
520,263 |
|
Feb 1921 |
|
FR |
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Claims
I claim
1. An artificial heart valve operable in the presence of a
malfunctioning natural heart valve and implantable by remote means,
said remote means comprising an elongated flexible catheter having
a proximal end and a closed imperforate distal end insertable
through a blood vessel from a point near an external body surface
to a point adjacent a malfunctioning natural heart valve, said
artificial heart valve comprising a flexible imperforate membrane
affixed at its epicenter to said distal end of said catheter, said
membrane being formed generally as a surface of a right circular
cone with a cylindrical section extending from the circular base of
said conical surface longitudinally in a direction towards said
proximal end, the apex of said cone residing in a direction in
which said membrane is operable to substantially prevent return
flow of blood back through said malfunctioning natural heart valve,
said membrane being operable to collapse about said catheter to
allow blood flow opposite the direction of said apex, said
artificial heart valve being operable solely by blood flow and in
the absence of external power means.
2. An artificial heart valve as defined in claim 1, wherein said
catheter is hollow and a pressure sensing hole is provided in a
wall of said catheter, said hole being located downstream from said
reverse flow preventing valve membrane between said apex and the
proximal end of said catheter.
Description
Historically, there has long existed a need for an artificial heart
valve for use in persons in whom a natural heart valve has been
damaged by disease in such a manner that it no longer prevents the
reverse flow, or regurgitation, of blood back through the valve
with the subsequent loss of blood pressure. The prevention of two
way flow through the heart valve is very important for the
maintenance of proper flow, pressure, and perfusion of blood
throughout the body. Generally, the defect in the natural valve is
an acquired versus congenital defect caused, to a very minor
degree, by syphilis but primarily by rheumatic fever contracted by
the patient at a fairly early age. This defect in the heart valve
does not hamper the activities of the patient at this early age
since the young heart is able to compensate for the blood pressure
loss resulting from the defective valve. However, it is when the
patient reaches middle age that the heart begins to tire and is
less able to compensate for the losses caused by the defective
valve. It is at this time that an artificial heart valve proves to
be of great benefit to the patient.
Aortic or mitral regurgitation is presently corrected by opening
the chest and replacing the diseased valve with an artificial
valve. This is a serious operation with a resulting rather high
mortality rate. There are other instances wherein the operation
cannot be performed for such reasons as the critical condition of
the patient, co-existing infection, or advanced age, to mention a
few.
Therefore, it is an advancement in the art to develop a heart valve
which is placed in close proximity to and effectively duplicates
the normal functions of a natural heart valve without having to
perform any major surgery upon the patient. Such an invention is
disclosed herein.
The artificial heart valve disclosed in this invention is in the
form of a flexible imperforate membrane which is periodically
distended to occlude a major blood vessel to prevent the reverse
flow or regurgitation of blood through a defective or
malfunctioning natural heart valve. The membrane is in the form of
an umbrella wherein the apex of the umbrella resides in the vessel
in the direction in which the flow of blood is to be prevented. In
this embodiment the valve is affixed at or near the closed
imperforate distal end of a flexible catheter and is emplaced in a
major vessel in close proximity to the natural valve by inserting
the catheter into a branch of the blood vessel a distance from the
natural heart valve. In this manner, it is unnecessary to perform
any form of major surgery to expose the area of the blood vessel
which would then have to be opened for placement of the artificial
heart valve. Instead, a branch vessel of the major vessel at some
distance from the heart, preferably a branch vessel located near
the external surface of the body, is easily opened with little
danger to the patient, and the artificial heart valve, which has
been affixed to the tip of a catheter, is inserted through the
blood vessel until it resides in close proximity to the
malfunctioning natural heart valve. In this manner, the patient is
spared the inherent dangers that accompany major surgery. If
necessary, the artificial heart valve can be left in place for life
or removed after the patient has regained sufficient physical vigor
to undergo the rigors of major surgery. If the valve is left in
place for life it can still be periodically removed and replaced as
conditions warrant by removal and reinsertion of the replacement
valve through the same branch vessel as previously used for the
initial insertion.
A normally functioning natural heart valve opens under the pressure
of the flow of blood in the proper direction but closes as the
blood starts to flow in the reverse direction and thus prevents the
reverse flow of blood through the valve with the resultant
maintenance of the proper blood pressure in the body.
The preferred embodiment of the artificial heart valve is a
membrane whose shape represents the surface of a right circular
cone which has a cylindrical section of membrane extending from the
circular base of the cone. The membrane is attached at or near the
apex of the conical section to a catheter of relatively small
cross-sectional diameter which passes parallel to the axis of the
surface thus formed by the membrane. The catheter serves as
retention, insertion, and withdrawal device for the valve and also
serves as a blood pressure detection conduit for detecting the
blood pressure in the blood vessel by using a catheter which has a
hole in the catheter wall at the position desired for detecting the
blood pressure.
In the above-described form, the valve resides within the blood
vessel with the apex of the cone extending in the direction in
which the flow of blood is to be prevented and the axis of the
valve is substantially parallel to the axis of the blood
vessel.
In operation, the membrane of the valve collapses and enfolds the
catheter to permit the almost unrestricted flow of blood in the
proper direction, but when flow in that direction ceases and starts
to flow in the reverse direction, the force of the blood flow
causes the membrane to open in such a manner that the cylindrical
section of the valve membrane contacts the inner wall of the vessel
and the entire membrane occludes the vessel to further reverse flow
of blood. Blood flow in the proper direction again collapses the
membrane about the catheter for the free passage of blood past the
valve.
To assist in the close fit of the membrane about the catheter when
the membrane of the valve is in the collapsed state, inwardly
extending folds along the length of the valve parallel to the valve
axis are preformed in the membrane to provide predetermined fold
lines along which the membrane folds during its collapsed period of
operation.
In view of the foregoing, it is an object of this invention to
provide an artificial heart valve for placement in close proximity
to a defective natural heart valve.
Another object of this invention is to provide an artificial heart
valve which is placed in close proximity to the natural heart valve
by means of a catheter inserted into a blood vessel at some
distance from the heart.
These and other objects will become apparent when viewed in
conjunction with the following drawings and description.
FIG. 1 is a projection of one embodiment of an artificial heart
valve shown in a partially opened condition in a cutaway section of
a blood vessel;
FIG. 2A and 2B show the artificial heart valve of FIG. 1 in cross
section in the open-to-flow and closed-to-back-flow positions
respectively, as the valve operates in close proximity to a
defective natural heart valve;
Referring to FIG. 1, an artificial heart valve in a partially
opened state is shown generally at 10 as it resides within a blood
vessel 11. The insertion, withdrawal, and retention means for the
valve 10 is the catheter 12 which is suitably attached to the
membrane 13 of the valve at the apex of the membrane at position
14. A plurality of folds or creases 15 in the membrane 13 extend
substantially the entire length and parallel to the axis of the
membrane, which folds expedite the collapse of the membrane about
the catheter 12 when the blood flows in the proper direction. When
the valve is fully opened to where the outer cylindrical surface of
the membrane 13 contacts the inner surface of the blood vessel 11
to prevent the back flow of blood, the profile of the cylindrical
section is generally circular in cross section and the folds 15
merge with the rest of the membrane 13 to form a smooth cylindrical
surface which contacts the inner wall of the blood vessel.
A hole 16 is drilled or otherwise excavated in the wall of the
catheter 12 to provide a pressure sensing opening for communicating
the blood pressure in the region of the hole 16 to an external
pressure sensing device 16A.
Referring to FIGS. 2A and 2B, a natural heart valve is shown at 17
through which holes 18 form the defect in the heart valve which
defect allows the reverse flow or regurgitation of blood through
the natural valve. The arrows indicate the direction of blood flow
in the vessel. As can easily be seen from FIG. 2A, a forward flow
of blood in the blood vessel 11 causes the membrane 13 of the valve
to collapse about the catheter 12 to permit the relatively
unrestricted flow of blood past the valve; however, when the valve
17 closes to prevent the reverse flow of blood, the defects 18 in
the valve 17 allow the reverse flow of blood in the vessel. This
reverse flow is sufficient to distend the membrane 13 of the valve
as shown in FIG. 2B such that the membrane contacts the inner wall
of the blood vessel 11 and it thus substantially occludes the blood
vessel against the reverse flow of blood.
* * * * *