U.S. patent number 3,831,583 [Application Number 05/329,643] was granted by the patent office on 1974-08-27 for implantable bulb for inflation of surgical implements.
This patent grant is currently assigned to The Regents of the University of California. Invention is credited to Silas A. Braley, Louis Henry Edmunds, Jr..
United States Patent |
3,831,583 |
Edmunds, Jr. , et
al. |
* August 27, 1974 |
IMPLANTABLE BULB FOR INFLATION OF SURGICAL IMPLEMENTS
Abstract
A device, completely implantable within the human body, for
restricting the flow of blood through a major blood vessel, such as
an artery, especially the pulmonary artery. An inflatable, flexible
annulus, generally circular in shape but not a closed circle, has a
non-distensible outer wall so that upon inflation all distension or
expansion is inward. The device is placed around an artery or other
blood vessel, and the ring may then be closed, as by suturing
together preformed tabs attached to the annulus, or by suturing
together the ends of an overlapping tape, for instance, to firmly
hold the vessel. Upon inflation, inward distension of the
inflatable annulus constricts the vessel, and flow of blood
therethrough is accordingly restricted. Inflation and deflation are
effected through a self-sealing hollow bulb and a non-distensible
tube connecting the bulb to the interior of the inflatable annulus,
pressure fluid being introduced into the bulb by a fine hypodermic
needle. The device may be wholly contained within the patient's
body, and all surfaces thereof are of a substance, such as a
medical elastomer, that is compatible with and resistant to the
action of body fluids.
Inventors: |
Edmunds, Jr.; Louis Henry
(Piedmont, CA), Braley; Silas A. (Midland, MI) |
Assignee: |
The Regents of the University of
California (Berkeley, CA)
|
[*] Notice: |
The portion of the term of this patent
subsequent to May 1, 1990 has been disclaimed. |
Family
ID: |
26819427 |
Appl.
No.: |
05/329,643 |
Filed: |
February 5, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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121406 |
Mar 5, 1971 |
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Current U.S.
Class: |
128/899;
606/202 |
Current CPC
Class: |
A61F
2/004 (20130101); A61B 17/122 (20130101); A61M
39/0208 (20130101); A61B 2017/00557 (20130101) |
Current International
Class: |
A61B
17/122 (20060101); A61B 17/12 (20060101); A61B
17/28 (20060101); A61F 2/00 (20060101); A61M
39/02 (20060101); A61B 17/00 (20060101); A61b
019/00 () |
Field of
Search: |
;128/325,326,327,344,346,DIG.25,1R ;3/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
In Vivo Metric Systems Bulletin, March 1968, 2 shts. of
Bulletin..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Owen, Wickersham & Erickson
Parent Case Text
This is a continuation, of application Ser. No. 121,406, filed Mar.
5, 1971.
Claims
Having described the invention, what is claimed is:
1. A bulb, adapted to be implanted in a human body,
said bulb being non-distensible and self-sealing, and
comprising
an upper chamber,
a lower chamber,
an impervious diaphragm separating said chambers,
a shield means in said lower chamber to protect said lower chamber
from puncture by a needle, said shield means being a metal sink
having a bottom and a side wall, said sink fitting snugly within
said lower chamber substantially covering said side wall and bottom
of said chamber, and having an aperture in said bottom, a flexible
tube having a central passage registering with said aperture,
and
means to anchor said bulb within said body.
2. A totally implantable, flexible, non-distensible self-sealable
bulb having a hollow interior and being adapted to penetration by a
hypodermic needle, and comprising
an upper chamber,
a lower chamber,
an impervious diaphragm separating said chambers,
silicone rubber gel disposed in said upper chamber,
shield means in said lower chamber to protect said lower chamber
from penetration by a needle, said shield means being a metal sink
having a bottom and a side wall,
said sink fitting snugly within said lower chamber substantially
covering the side wall and base of said chamber, and having an
aperture in said bottom registering with the central passage of a
flexible connecting tube, and
a non-distensible flexible, twist-resistant tube having a central
passage providing a conduit leading from the interior of said
bulb.
3. The bulb of claim 2 wherein said non-distensible tube is formed
of silicone rubber.
4. The bulb of claim 2 wherein said tube is relatively thin-walled
whereby to resist twisting and kinking so as to enable free and
rapid flow of liquid therethrough.
5. The bulb of claim 2 wherein said shield means is a metal sink
having a bottom and a side wall, said sink fitting snugly within
said lower chamber substantially covering the side wall and base of
said chamber, and having an aperture in said bottom.
6. The bulb of claim 2 wherein said diaphragm extends to form an
annular flange around said bulb.
7. The bulb of claim 5 wherein said metal is titanium.
8. The bulb of claim 5 having a baffle in said sink spaced from and
protecting said aperture.
9. The bulb of claim 5 wherein said sink has an aperture of a
plurality of small holes arranged in a pattern to register with
said central passage.
Description
BACKGROUND OF THE INVENTION
This invention concerns a means for restricting the rate of flow of
blood through an animal blood vessel and particularly through an
artery. More especially, it relates to an internal pulmonary
arterial band, i.e., a device implantable within a human body for
restricting blood flow through the pulmonary artery. The device is
suitable for prolonged use within the human body, i.e., for months
or even years of such use.
The invention described herein was made in the performance of work
under a research grant from the United States Public Health
Service.
It has been recognized that approximately eight babies per thousand
have congenital heart disease, and, of these, four have greater
than normal pulmonary arterial blood flow. Such mechanical defects
have led to attempts to develop a safe, reliable, adjustable device
to effect arterial banding. Attempts previously have required that
mechanical control be applied from outside the body, as by a screw
device to manipulate a tape encircling a blood vessel, and
heretofore no such device has been capable of being implanted in
the body for permanent or at least long-term use.
The present invention provides a device for arterial banding and
mechanical restriction of blood flow through an artery, or other
major blood vessel. It is safe, is compatible with body fluids, and
is controllable externally while being totally contained within the
patient's body. An advantage of the present invention is that the
device is adjustable to conform to the size of the artery being
banded and can be permanently emplaced, while yet periodic
adjustments continue to be possible, as desired. Furthermore, the
device is wholly implanted in the body and yet is later
controllable without surgery. Further advantages are that
adjustments can easily be made in the amount of inflation to
accommodate for somatic growth, pulmonary pressure can be
determined with the aid of this device, the band or annulus can be
easily reached in order to close it upon emplacement and the
connecting tube is short and non-twisting thus preventing
interference in any desired flow of liquid.
SUMMARY OF THE INVENTION
The present invention provides, in combination, (1) an unclosed
annulus or "doughnut" ring, capable of inward distention only, (2)
a non-distensible bulb, (3) a non-distensible tube connecting the
bulb to the annulus, and (4) means to control penetration by a
later-inserted needle or the like and to protect the bulb from
undesired punctures.
The annulus is shaped to form an unclosed circle, the circle being
left open to enable insertion around an artery. The annulus is
closed at both ends and has a distensible inner wall and a
non-distensible or substantially non-distensible outer wall. The
small non-distensible tube is affixed to the outer wall of the
annulus at any convenient point and provides a conduit in open
communication with the interior of the annulus through a suitable
aperture in the outer wall of the latter. At the end of the tube
distant from the annulus is the bulb, which is used to pump fluid
through the conduit and into the banding annulus, thereby inflating
the annulus and distending the inner wall. The distending of the
inner wall exerts pressure on the enclosed portion of the artery or
other blood vessel and completely or partially restricts the flow
of blood therethrough.
The purposes of having a non-distensible outer wall of the annulus
are (1) that the effect of inflation of the annulus be directed
substantially entirely inwardly toward the enclosed artery, and (2)
that any pressure on the surrounding body structure be avoided or
minimized. The desired restraint on the outer wall can be effected
in any desired manner, one advantageous means being to affix
thereto a reinforcing layer of Teflon (tetrafluoroethylene)
tape.
The banding annulus can be made in several sizes to accommodate
different situations or needs. For instance, annuli can be supplied
in various internal diameters of from about 1.0 cm. to 3.0 cm.,
e.g., in steps of 0.5 cm. of intervals, the diameters being
measured when the annuli are uninflated.
The tube that connects the interior of the annulus to the interior
of the bulb is not distensible and is suitably made of Dacron or
possibly of hard, non-distensible medical elastomer, such as
silicone rubber. The hollow bulb is also not distensible and can be
made from the same or similar material. The volume of this bulb is
suitably about from 3 to 6 ml. A sink or pan of suitable
body-compatible metal, e.g., titanium, and having a base and a side
wall conforming to the interior shape of the bulb is disposed
within the base of the bulb and facilitates location of the
injection chamber with a needle and prevents perforation of the
floor or lower wall of the bulb itself. This will be further
explained in the more detailed description below. In the insertion
or emplacement of the device, the bulb is preferably disposed on
the sternum just underneath the patient's skin, where it can be
readily located by palpation and inflated by means of a needle
inserted through the skin.
The interior of the ring, tube and bulb are in open communication
with each other and are self-sealing, and they must not leak. All
surfaces of such a device to be wholly implanted in the body are
made of a substance compatible with and resistant to the action of
body fluids. Such a substance is suitably a medical elastomer such
as silicone rubber, of varying degrees of hardness or cure to
accommodate the need for distensible or non-distensible
portions.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention and an advantageous mode of carrying it out are
illustrated by the following description and by the annexed
drawings, wherein:
FIG. 1 is a view in front elevation of an embodiment of an
implantable pulmonary arterial band with the annulus partially
inflated; the inner periphery is shown deflated in a broken
line.
FIG. 2 is a view in side elevation of the band of FIG. 1.
FIG. 3 is a view in section taken on the line 3--3 of FIG. 1 of an
inserted inflated annulus and its relationship to an enclosed
artery.
FIG. 4 is a somewhat schematic view in side elevation of the device
in place around the pulmonary artery of a patient.
FIG. 5 is a cross-sectional view of an embodiment of a
non-distensible bulb of a device according to this invention
showing the interior elements.
DETAILED DESCRIPTION OF THE INVENTION
For purposes of illustration only, the invention is illustrated by
the device shown in the accompanying drawings.
This device is a pulmonary arterial band or extravascular occluder
and comprises an inflatable non-closed ring or annulus 10 of
flexible material to enable its introduction around an artery to
enclose it, a connecting tube 11 and a bulb 12. Each of these
components is made of or covered by material which is non-toxic and
resistant to attack by body fluids, i.e., does not deteriorate
within the body, because the entire device is to be implanted.
The annulus 10 includes an inflatable or balloon inner portion 13
which is formed from a medical elastomer and is flexible and
distensible. An advantageous type of such elastomer is the silicone
rubber widely available in commerce in medical grades. Preferably,
it is made from or includes a self-sealing latex or elastomer. The
annulus 10 is in the form of an incomplete or non-closed ring or
circle, having two closed, sealed ends 14 and 15 forming an opening
16 therebetween. The outer wall 17 of the annulus 10 is reinforced
so that it is not distensible when internal fluid pressure is
applied although it, too, remains flexible. This reinforcement can
be accomplished in one embodiment as shown by incorporating or
embedding a fabric 18, such as nylon or Dacron mesh or cloth,
within the outer portion 17 of the silicone rubber annulus 10. The
curvature of the casing or annulus 10 helps to direct the
non-reinforced inflatable or balloon portion 13 inwardly as it is
inflated and to prevent rolling or distortion of such portion 13.
An advantageous method of incorporating the fabric 18 in the
annulus 10 is to form a coating piece or wire, of the required size
and curvature, of such fabric molded into silicone rubber and to
weld such tire to the outer surface of an inflatable tube of
medical rubber.
The connecting tube 11 can be made from a harder, nondistensible
silicone rubber, or of Dacron-reinforced silicone rubber, so that
it remains of constant dimensions under the pressures to be
applied. It is relatively short and relatively thickwalled so as to
be twist-resistant and non-kinking. That is, the wall thereof may
be from 0.062 to 0.065 inch thick and the tube is of such length as
to extend in a substantially straight path, i.e., without curling
upon itself, from adjacent the inner surface of the skin to the
blood vessel to be treated. For example, the tube so extends from
the sternum to the pulmonary artery area, in one embodiment, and is
about 4 inches long. The tube 11 connects with a suitable aperture
in the reinforced casing portion 17 and debouches into the interior
of the annulus 10, being sealed thereto to prevent leakage. At the
end remote from the annulus 10, the tube connects with a suitable
aperture in the bulb 12 similarly and is also sealed thereto.
Advantageously, the tube 11 connects tangentially to the outer
surface of annulus 10, which provides for smoother flow of liquid
therethrough and makes easier the placement of the annulus 10
relative to the artery.
The bulb 12 can be formed of a flexible, non-distensible and
self-sealing elastomer, such as a suitable reinforced or
nonreinforced silicone rubber. It is adapted to being punctured and
filled or emptied of a pressure-providing fluid, such as 0.9
percent aqueous saline solution, by using a very fine hypodermic
needle, e.g., a No. 22 or 25 needle. Upon withdrawal of the needle
the bulb 12 seals itself. This result may be advantageously
obtained by providing a bulb 21 of a self-sealing elastomer. In one
advantageous embodiment, the bulb 21 contains an upper chamber 26
and a lower chamber 27 separated by an impervious diaphragm 28.
Upper chamber 26 contains silicone gel 29, which acts to seal any
puncture in bulb 21 caused by insertion of the liquid-injecting
needle.
Disposed in lower chamber 27, fitting snugly therein and
substantially covering the base and side walls thereof, is a metal
sink or pan 30 having a base 31, a side wall 32, and an aperture 33
in the base 31 registering with the central passage 34 in the tube
11. A baffle 35 is spaced from the base 31 by a plurality of legs
36 to provide free flow of liquid into and from the passage 34. In
this manner, location of the receptacle for injected liquid is
faciliated during such operation and the bottom and side walls of
the bulb are protected by the metal from punctures due to insertion
of the needle. The diaphragm 28 is suitably extended beyond the
exterior wall of the bulb 12 to provide a sewing flange 37.
Advantageously aperture 33 can be in the form of a plurality of
small holes arranged to form a pattern to register with the
interior of tube 11 and to be protected by baffle 35. The elastomer
bulb 21 is then provided with a protective coating 22 of silicone
rubber which is reinforced with Dacron mesh or the like. Suitably,
diaphragm 28 with its flange portion 37 is also of such reinforced
rubber. There are also sometimes provided a pair of diametrically
disposed anchor or sewing tabs 38, 39, preferably disposed
transversely or at right angles to the direction of curvature of
the annulus 10 and affixed to its outer surface to enable suturing
to adventitia of the artery so that the device remains in stable
position on the artery being treated.
In using the device of this invention, the pulmonary artery 40 is
made accessible by suitable, known surgical procedures, and the
artery 40 is inserted within the annulus 10 by way of the opening
16, which may be pulled apart or enlarged as necessary, the ring 10
being quite flexible. After placement of the artery 40 in the
annulus 10, ends 24 and 25 of annulus 10 which extend beyond closed
ends 14 and 15 thereof may be trimmed if necessary by the surgeon
and are then sewn together, suitably using heavy ligatures. The
bulb 12 is placed on top of the sternum (not shown) just below the
skin where it can be located later by palpation and easily reached
by a hypodermic needle to fill or empty the bulb 12 and, through it
and connecting tube 11, the annulus 10 and the inflatable annulus
10, to inflate and force inwardly distensible portion 13 to
constrict the artery 40 as desired, as shown in FIG. 3. The
incision in the patient is then closed by the surgeon in the usual
manner, the implanted device remaining entirely subcutaneously
disposed.
In use of the device after it is emplaced and any incision closed,
the hollow bulb 12 is located by palpation and is filled by means
of a hypodermic needle, as noted above, introducing a fluid such as
0.9 percent aqueous saline, which flows through the connecting tube
11 into the hollow interior of the annulus 10 causing the inner
wall 27 to distend and constrict the artery 26, reducing flow of
blood therethrough. The flow of pressure fluid can be aided by
manual pressure on the bulb 12. Fluid can be withdrawn, when
desired, also by means of a needle. In each case the interior layer
of the bulb 12 seals itself, as described.
It will be understood that the above specific description and the
drawings have been given for purposes of illustration only and that
variations and modifications can be made therein without departing
from the spirit and scope of the appended claims. For instance,
instead of a permanently fluid pressure substance, the bulb 12 can
be filled with a fluid plastic mixed with a catalyst which will
cause it to harden in a predetermined time after it fills the
inflatable element.
* * * * *