U.S. patent number 3,814,547 [Application Number 05/177,264] was granted by the patent office on 1974-06-04 for nontraumatic heart pump.
This patent grant is currently assigned to Tecna Corporation. Invention is credited to Sotiris Kitrilakis, Thomas C. Robinson.
United States Patent |
3,814,547 |
Kitrilakis , et al. |
June 4, 1974 |
**Please see images for:
( Certificate of Correction ) ** |
NONTRAUMATIC HEART PUMP
Abstract
A blood pump including a pumping chamber provided with in-flow
and out-flow valves substantially aligned with the axis of the
pumping chamber. The valves are especially designed to eliminate
protrusions which may act as sites of possible thrombus formation,
to minimize turbulence and areas of stasis and to provide a smooth
flow of blood past the valve and through the pumping chamber. The
inner lining of the pump includes a surface which contains
microcavities to facilitate the attachment of fibrin and cellular
deposits to provide a pseudointimal lining compatible with
blood.
Inventors: |
Kitrilakis; Sotiris (Berkeley,
CA), Robinson; Thomas C. (Berkeley, CA) |
Assignee: |
Tecna Corporation (Berkeley,
CA)
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Family
ID: |
26759116 |
Appl.
No.: |
05/177,264 |
Filed: |
September 2, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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77291 |
Oct 1, 1970 |
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Current U.S.
Class: |
417/383; 417/430;
417/478 |
Current CPC
Class: |
F04B
43/10 (20130101); F16K 15/00 (20130101); F04B
53/102 (20130101); A61M 60/894 (20210101); A61M
60/148 (20210101); A61M 60/43 (20210101); A61M
60/268 (20210101); A61M 60/40 (20210101) |
Current International
Class: |
A61M
1/10 (20060101); F16K 15/00 (20060101); F04B
53/10 (20060101); F04B 43/10 (20060101); F04B
43/00 (20060101); F04b 035/02 (); F04b
021/06 () |
Field of
Search: |
;417/567,394,387,389,383,430,478 ;137/332 ;3/1 ;128/DIG.3 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
T Akutsu, "Design Criteria for Artificial Heart Valves," The
Journal of Thoracic & Cardiovascular Surgery, Vol. 60, p.
34-45, July 70.
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Primary Examiner: Freeh; William L.
Attorney, Agent or Firm: Flehr, Hohbach, Test, Albritton
& Herbert
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of our copending
application Ser. No. 77,291, filed Oct. 1, 1970 now abandoned.
Claims
We claim:
1. A blood pump comprising an external housing, a flexible bladder
disposed in said housing, said bladder and housing defining a
pumping chamber therebetween, said bladder including an inflow and
outflow opening, an inflow valve assembly associated with said
inflow opening and an outflow valve assembly associated with said
outflow opening, said inflow and outflow valve assemblies each
including a valve chamber and a valve disposed in said chamber,
said valve chamber including a valve seat upstream in said chamber,
said valve adapted to cooperate with said seat, said valve chamber
cooperating with said valve for defining a constant flow path
across section for constant flow velocity therethrough for
minimizing flow turbulence, each of said valves comprising a
central core having an upstream surface portion adapted to seat on
said valve seat and downstream outwardly extending vanes
cooperating with the valve chamber for guiding the valve and
limiting its movement between its seated and unseated position.
2. A blood pump as in claim 1 in which said vanes are inclined in
the axial direction whereby the flow of blood past the valve causes
the valve to maintain even contact with said valve seat and
minimize wear therebetween.
3. A blood pump as in claim 1 in which said flexible bladder
includes a central cylindrical portion with the ends inclined
inwardly to form said inflow and outflow openings, said cylindrical
portion including thick portions extended along diametrically
opposite sides for providing preferential collapse when subjected
to pumping pressure.
4. A blood pump as in claim 1 in which the inner surface of said
flexible bladder and in-flow and out-flow assemblies are provided
with a surface containing microcavities to promote anchoring of
fibrin and cellular deposits to form a pseudointimal lining.
5. A blood pump comprising a cylindrical housing having first and
second open ends, a flexible bladder disposed in said housing, said
bladder including an inflow and outflow opening extending beyond
said first and second open ends for presenting a continuous
internal surface to fluids flowing through for minimizing flow
turbulence, an inflow valve assembly associated with said inflow
opening and an outflow valve assembly associated with said outflow
opening, said inflow and outflow valve assemblies each including a
valve chamber, a valve seat surrounding the upstream ends of said
valve chambers, a valve disposed in each of said chambers, each of
said valves including a central core having an upstream surface
adapted to engage said valve seat and down stream outwardly
extending vanes cooperating with the valve chamber to guide the
valve and serving to define with said chamber a plurality of flow
passages providing a constant flow path cross section through said
valve chambers for constant flow velocity therethrough thereby
minimizing flow turbulence, and means for sealing the space between
the housing and the bladder near said open ends to provide a
pumping chamber surrounding the bladder, and an inlet to said
pumping chamber.
6. A blood pump as in claim 5 in which said vanes are inclined in
the axial direction whereby the flow of blood past the valve causes
the valve to rotate and attain a new seating orientation.
7. A blood pump as in claim 5 in which said bladder has a
substantially cylindrical central portion when distended and in
which said cylindrical portion includes thick portions extended
along diametrically opposite sides to provide for preferential
collapse of said flexible bladder.
8. A blood pump as in claim 5 wherein te inner surface of said
bladder contains microcavities to promote anchoring of fibrin and
cellular deposits to form a pseudointimal lining.
9. A blood pump as in claim 5 wherein said housing comprises first
and second disposable portions adapted to be connected to one
another to form the cylindrical housing and wherein said flexible
bladder is disposable and said means for sealing comprises means
for permanently adhering the bladder to the housing near said open
ends.
10. A blood pump as in claim 5 wherein the ends of the housing and
the bladder are shaped to form said valve chambers.
Description
BACKGROUND OF THE INVENTION
This invention relates generally to a nontraumatic blood pump.
In the course of the last ten years, the pumping of blood by
artificial means has been frequently used in connection with
cardio-vascular surgery and for emergency support in certain
disease and accidental injury situations. Although high blood
damage in the form of red cell destruction, loss of platelets,
protein denaturation, the formation of thromboemboli and the like
results from such pumping, the procedure continues to be used with
increased frequency since very often the alternative is death. The
duration of pumping is limited by the damage to blood elements
which must not exceed the upper limit imposed by the body's ability
to dispose of the debris of blood damage. Currently available blood
pumping systems can be used for periods up to 4 to 6 hours, an
amount of time adequate for the majority of open heart operations.
There are many instances, however, in which longer pumping time is
required; for example, circulatory support following heart failure
or circulatory support for accident victims with cardiac or
pulmonary damage. The need for artificial pumping may continue for
several days while the natural healing process allows the heart or
lung to resume normal functioning.
None of the currently available roller pumps nor the more recently
marketed pulsating pumps are capable of prolonged circulatory
support primarily because of the damage they cause to the blood
elements. A need, therefore, exists for a pump capable of pumping
blood for an indefinite period of time with low, physiologically
tolerable blood trauma.
As far as is known at this time, two general types of action are
responsible for damage to the blood elements. Biochemical processes
are initiated when certain blood elements come in contact with a
foreign, nonbiologic surface resulting in the destruction of the
elements. The second type of damage is mechanical in nature and
results from mechanical action or shear exerted on various blood
elements, especially the red blood cells. Squeezing or pressing of
blood elements between pump components or surfaces and excessive
turbulence are sources of mechanical damage to the blood. It
follows then that the key considerations which must be taken into
account in the design and construction of a blood pump are that the
surfaces of the pump which interface with the blood must not induce
biological changes in blood elements, i.e., they must not be
thrombogenic and that the fluid dynamics of the pump be designed to
avoid turbulence, shear, stagnation, flow separation and the like
which cause mechanical damage.
OBJECTS AND SUMMARY OF THE INVENTION
It is a general object of the present invention to provide a
nontraumatic blood pump which includes a blood interface which
promotes anchoring of the fibrin and cellular deposits from the
blood stream resulting in coverage of the internal structure by
biologic material and having a smooth flow of the blood through the
pump thereby minimizing mechanical damage to the blood
components.
The foregoing objects are achieved by a blood pump comprising a
flexible bladder, having in-flow and out-flow openings, defining a
pumping chamber, an in-flow valve associated with said in-flow
opening and an out-flow valve associated with said out-flow
opening, said in-flow and out-flow valves each including a valve
seat, a valve adapted to cooperate with said seat, guide means for
guiding said valve between its open and closed positions, and means
for limiting the movement of the valve, each of said valve means
comprising a central core having a surface portion adapted to seat
on said valve seat and outwardly extending vanes cooperating with
the guide means for guiding the valve between its open and closed
positions, and further defining a plurality of flow channels for
the flow of blood past the valve in a smooth even flow pattern free
of protrusions in the form of pins or other retaining structures
thereby minimizing turbulence and resulting mechanical damage to
the blood.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partial elevational view in section showing a blood
pump in accordance with the invention.
FIG. 2 is an end view of the valve taken along the line 2--2 of
FIG. 1.
FIG. 3 is a sectional view taken along the line 3--3 of FIG. 1
showing the bladder defining the pumping chamber.
FIG. 4 is a sectional view showing the bladder in its collapsed
position.
FIG. 5 is a sectional view of another embodiment of the
invention.
FIG. 6 is a sectional view of a disposable blood pump in accordance
with the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to the embodiment of FIG. 1, flexible bladder 11 forms
the pumping chamber. Each end of the bladder includes a rim 12
adapted to fit in a groove 13 formed in the retaining and valve
stop member 14. The rim 12 is held in the groove 13 by means of
disc 16 which is received by member 17 which cooperates with and
holds the retaining member 14. The member 17 forms the in-flow
connection 18. A plurality of screws 19 serve to secure the disc 16
to the member 17 and thereby hold the bladder in the member 14
which is, in turn, held in the member 17. The out-flow assembly is
similar in construction and has like reference numerals applied to
like parts.
The spaced discs 16 each include a circular groove 21 adapted to
receive the end of cylinder 22. The end of the cylinder includes
groove 23 and is provided with O-rings 24 to thereby form a seal
between the end of the cylinder and the associated disc. The
bladder 11, cylinder 22 and disc 16 define a chamber 25 which
surrounds the bladder and communicates with inlet 26 whereby air
pressure or vacuum may be applied to the chamber 25 to collapse or
expand the bladder for pumping. The pumping chamber is maintained
in assembled relationship by means of a plurality of spacers 28
which extend through the spaced members 16 and threadably receive
nuts 29.
Valves 31 and 32 are disposed in the chambers 33 and 34 defined by
the inclined opposed portions of the members 14 and 17.
The valves 31 and 32 each include a core portion 36 provided with
outwardly extending fins 37. The front or leading edge 38 of the
fins 37 defines a continuous surface with the front face 39 of the
core 36. The outer edges 41 of the fins lie on a surface of
revolution which is coaxial with the valve body. The outer edges 41
are adapted to cooperate with the cylindrical portion 42 of the
valve chambers 33 and 34. The other end of the fins merges with the
end of the valve body. The trailing edge 44 of the fins is rounded
and the fins taper towards the downstream end to thereby provide a
smooth transition for the flow of blood around the fins. The
downstream inclined area of the surrounding housings 14 or 17 acts
as the valve stop while the upstream end acts as the valve seat. It
is to be observed that the in-flow and out-flow valves are
identical and, therefore, like reference numerals are applied to
like parts. In the case of the in-flow valve, the valve seat is at
51 and formed in the member 17, while in the case of the out-flow
valve, the valve seat is at 52 and formed in the member 14. The
valve core or body and vanes are so formed that there is a
substantially constant cross-sectional area of the flow passage
between the valves and associated chamber to thereby minimize the
turbulence.
The formation of stagnant pools of blood within the pump is avoided
by the streamlined configuration of the pump and chamber. The
valves and their housing, as previously described, are designed
with nearly constant cross-section for flow which minimizes
acceleration and associated turbulence in the flowing blood as it
passes through the various passages and channels around the valve.
Preferably, the angle of the valve seats 51 and 52 is less than
50.degree., the limit which has been experimentally found necessary
for the avoidance of major separation and recirculation of blood in
this area. The blood flowing through the passages formed by the
vanes washes the central core 36 in the process of flow. The use of
the vanes and inclined surface as a valve stop provides a smooth
shape which prevents significant acceleration, turbulence and flow
separation and replaces the less satisfactory, more turbulent valve
guide struts or other protrusions found in the prior art.
The guide vane portions 41 of the valve keep the valve positioned
along the axis of the pump by coacting with the cylindrical portion
42 of the passage. The vanes are slightly tilted with respect to
the axis of the valve so that a certain amount of rotation occurs
each time the valve travels from left to right as it opens and
closes. This ensures that uniform contacting occurs between the
valve and its seat and that wear or deformation areas do not form
in the lining of the valve seat or along the valve retaining walls.
The shape of the valve guiding vanes and the central core portion
provide adequate washing to avoid the formation thrombus and they
are also so designed as to minimize turbulence eddies and the like.
The above precaution is necessary because the valve is not coated
with material that allows the formation of biologic lining.
The bladder itself is essentially a right cylinder in its central
portion and tapered at the two ends which define the ridges 12. The
cylindrical walls preferably include two thick portions 61 and 62
along the length on diametrically opposite sides to permit
preferential collapse as shown in FIG. 4. By including these
thickened portions, uniform and reproducible collapse of the
bladder is assured. This is an important feature which assures that
the maximum displacement volume is obtained without the risk of the
opposite walls of the bladder surface touching one another and
damaging the blood.
The inclined portions 63 of the bladder should have a thickness
adapted to avoid excess stress concentration which would result in
rupture, fatigue or permanent deformation. We have found it
preferable to make the angle of inclination about 40.degree.. In
general, the flexing of the bladder during collapse takes place
primarily at the point 64 which minimizes the excess stress
concentration.
In accordance with another feature of the present invention, the
bladder, the valve housing and the inlet and outflow members are
preferably lined with a material which is compatible with the blood
and which includes a plurality of microcavities which promote
anchoring fibrin and cellular deposits from the blood stream
resulting in complete coverage by biologic material within a short
time. These deposits eventually result in a pseudointimal lining
which is sufficiently thin to remain adherent and flexible and is
nourished from the blood flowing past it.
A preferable lining for such purpose is a lining containing a
plurality of microcavities such as are formed in accordance with
the process set forth in copending application Ser. No. 77,289,
filed Oct. 1, 1970.
In operation of the pump, air pressure is applied to chamber 25
through the inlet 26 to thereby collapse the bladder whereby the
inlet valve is closed and the outlet valve is opened to provide the
flow of blood outwardly. The amount of air applied to the chamber
25 is closely controlled whereby the walls 61 and 62 collapse and
come close to one another for maximum volume displacement but yet
do not touch whereby the blood elements are damaged. Thereafter,
the pressure is removed and a vacuum may be applied to the chamber
25 thereby expanding the bladder to draw blood into the pumping
chamber.
The blood pump shown in FIG. 5 operates in substantially the same
manner as that just described with reference to FIGS. 1 through 4
and like reference numerals are applied to like parts. The chamber
25 comprises an oval shaped shell 71 having threaded ends 72 and 73
and inlet 26. The threaded ends 72 and 73 receive couplings 74 and
76, respectively. Flexible disposable bladder 11 is accommodated in
the chamber 21 and includes retaining flanges 77 and 78. The
bladder 11 extends beyond the flanges and is shaped to define valve
chambers 33 and 34 with inlet and outlet connections 79 and 81
which can be connected directly to the patient. This provides a
single material in contact with the blood. The material is suitably
lined as, for example, a lining of the type described in said
copending application. The embodiments of FIGS. 5 and 6 utilize a
one-piece blood interface lining which incorporates the flexible
bladder and the valve linings. This one-piece structure is an
improvement over the multi-segment blood interface of the pump in
FIG. 1. It is an improvement because the hydrodynamic effects of
small nonuniformities such as gaps or steps at joints between parts
create local eddies, flow separation, or stasis. These in turn lead
to thrombus formation or thick pseudonitimal lining development at
these locations. A second advantage in a one-piece liner is the
continuity of the microporous blood interface which prevents ridges
or fibrin deposits associated with an interface discontinuity.
Retainers 82 and 83 are engaged by the couplings and retain the
lining by sandwiching the flanges 77 and 78 between surfaces 86, 87
and 88, 89, respectively. The retainers are shaped to receive the
bladder and provide a housing for the valve chambers 33 and 34. The
valves 31 and 32 are constructed as described above.
The blood pump may be constructed with a disposable housing. One
example of such a pump is shown in FIG. 6. The housing is formed of
two pieces of plastic 91 and 92 which are snapped together at 93.
The disposable flexible bladder includes valve chambers 33 and 34
which are formed by shaping the ends of the housing to define one
end wall 94 and 96 and by providing ridges 97 and 98 on the bladder
to define the other wall of the chamber. The space between the
bladder and the housing is sealed at the ends by applying suitable
adhesive to the bladder and housing in the regions 101 and 102. The
valves 31 and 32 may be of the type previously described. The
bladder is suitably lined as described above.
In summary then, there is provided a nontraumatic pump in which the
lining permits deposition and permanent anchoring of a
pseudointimal lining to avoid contact between blood elements and
foreign surfaces. The design of the pump chamber and valves
provides a substantially constant blood flow velocity with minimum
acceleration, deceleration and associated turbulence and no areas
of stagnation. The valve is designed to promote such constant
velocity and is continuously washed by the blood flowing past the
same. The valve is rotated by the flow whereby to provide
substantially uniform wear in the pseudointimal lining on the valve
housing and the valve seat.
* * * * *