U.S. patent number 3,903,895 [Application Number 05/465,926] was granted by the patent office on 1975-09-09 for cardiovascular catheter.
This patent grant is currently assigned to Sherwood Medical Industries, Inc.. Invention is credited to Ralph D. Alley, David S. Sheridan.
United States Patent |
3,903,895 |
Alley , et al. |
September 9, 1975 |
Cardiovascular catheter
Abstract
A cardiovascular catheter for use particularly in open heart
surgery and related operations requiring varying forms of
cardio-pulmonary bypass. The catheter has a fixed ring provided on
the catheter proximal to drainage inlets and may have a sliding
ring snug fit on the catheter proximal to the fixed ring for
securing the catheter to a penetrated portion of the anatomy, such
as the heart wall, between the two rings to assist in holding the
catheter in place. In one form of the invention, the fixed ring is
used alone to secure the catheter in place, for instance, during a
drainage or perfusion application.
Inventors: |
Alley; Ralph D. (Loudonville,
NY), Sheridan; David S. (Argyle, NY) |
Assignee: |
Sherwood Medical Industries,
Inc. (St. Louis, MO)
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Family
ID: |
26983070 |
Appl.
No.: |
05/465,926 |
Filed: |
May 1, 1974 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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321673 |
Jan 5, 1973 |
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138770 |
Apr 29, 1971 |
3788328 |
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843863 |
May 3, 1969 |
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Current U.S.
Class: |
604/178;
128/DIG.26; 128/DIG.3 |
Current CPC
Class: |
A61M
25/007 (20130101); A61M 25/04 (20130101); A61M
1/3659 (20140204); A61M 25/0068 (20130101); A61B
90/39 (20160201); A61M 2025/0034 (20130101); A61M
2025/0037 (20130101); A61M 2025/0031 (20130101); A61M
2025/0293 (20130101); Y10S 128/26 (20130101); A61M
25/0069 (20130101); A61M 25/003 (20130101); Y10S
128/03 (20130101); A61M 25/0108 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 25/04 (20060101); A61M
25/02 (20060101); A61B 19/00 (20060101); A61M
1/36 (20060101); A61M 25/01 (20060101); A61M
027/00 () |
Field of
Search: |
;128/2A,245,246,348,35R,351,DIG.3,DIG.26 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Kamm; William E.
Attorney, Agent or Firm: Wegner, Stellman, McCord, Wiles
& Wood
Parent Case Text
This application is a streamline continuation of application Ser.
No. 321,673, filed Jan. 5, 1973, now abandoned, which application
was a divisional of application Ser. No. 138,770, filed Apr. 29,
1971 now U.S. Pat. No. 3,788,328, which application was a
streamline continuation of application Ser. No. 843,863, filed May
3, 1969, now abandoned.
Claims
We claim:
1. A catheter suitable for use during surgery and having a distal
end portion and a proximal end portion having a larger diameter
than said distal end portion and being joined by an intermediate
integrally formed partially tapered body portion, said distal
portion having an end opening and at least one side opening
communicating with the inside of said catheter, said proximal
portion being adapted to be connected to an externally operative
device, a non-inflatable ring fixedly secured on the outer surface
of the distal end of the catheter but proximal to the side opening,
said ring tapering from a distal end of said ring to an enlarged
diameter portion and having a proximal wall portion lying
substantially perpendicular to said catheter, said ring being
adapted to penetrate the incision together with the tip and distal
end of the catheter, and a second ring slidably mounted on the
catheter proximal to said first ring and having a distal wall
portion lying substantially perpendicular to said catheter, said
second ring being in snug forced slip fit with the catheter outer
surface permitting it to be moved with moderate force axially along
the catheter.
2. A catheter suitable for use during surgery and having a distal
end portion and a proximal end portion having a larger diameter
than said distal end portion and being joined by an intermediate
integrally formed partially tapered body portion, said distal
portion having an end opening and at least one side opening
communicating with the inside of said catheter, said proximal
portion being adapted to be connected to an externally operative
device, holding means for stabilizing the position of the catheter
against movement at the site of penetration through an incision in
a hollow viscus such as a heart or blood vessel, including a
non-inflatable ring secured on the outer surface of the catheter
adjacent the distal end of the catheter but proximal to the side
opening, said ring tapering from a distal end of said ring to an
enlarged diameter portion and having a proximal wall portion lying
substantially perpendicular to said catheter, said ring being
adapted to penetrate the incision together with the tip and distal
end of the catheter, and a second ring slidably mounted on the
catheter proximal to said first ring and having a distal wall
portion lying substantially perpendicular to said catheter, said
second ring being in snug forced slip fit with the catheter outer
surface permitting it to be moved with moderate force axially along
the catheter toward the said first ring to clamp the walls of the
hollow viscus therebetween.
3. A cannula suitable for use during surgery comprising a catheter
having an elongate uniform diameter distal portion with at least
one side inlet opening and with an open inlet end, said distal
portion being adapted to be inserted through a surgical incision in
the wall of a hollow viscus such as a heart or a blood vessel, said
catheter having an elongate proximal portion of increased diameter
as compared to the distal portion and being joined thereto by a
gradually tapering integral portion, said proximal portion having a
substantial axis length, said proximal portion being adapted to be
connected to a tube leading to an external machine, holding means
on said distal portion for stablizing the position of the catheter
against movement including a non-inflatable ring secured on the
outer surface of the catheter adjacent the distal end thereof but
proximal to the inlet opening, said ring having a tapered distal
portion and a planar transverse proximal portion, and a second ring
slidably mounted on the catheter proximal to said first ring, said
second ring being in snug forced slip fit with the catheter outer
surface permitting it to be moved with moderate force axially along
the catheter toward and away from said first ring, and said second
ring having a planar transverse distal portion lying parallel to
said planar portion on said non-inflatable ring for engaging the
surface of the wall surrounding said incision for holding said
catheter in position.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to cardiovascular catheters suitable for
positioning and retention in an incision in the anatomy of a
patient and in particular, during venting of a heart, during
drainage, during perfusion and the like.
2. Brief Description of the Prior Art
Various cardiovascular catheter structures have been provided for
use during different types of surgery. So far as is known, a
suitable vent catheter has not been provided for use in draining
the left ventricle of the heart. In addition, no catheter is known
which can be efficiently and simply, but still effectively, held in
a vein, artery and the like. Most present day catheters have
complicated systems for holding a catheter in position relative to
the anatomy of the patient. Such complicated systems include
threaded cap systems, expansible balloon systems and positive
clamping systems but these often do not even provide a proper tying
site for the surgeon to tie the catheter to the anatomy of the
patient, a normal practice. Further, when the catheter is not in
use, it is necessary to close the drainage channel usually by means
of an extraneous implement such as a clamp.
SUMMARY OF THE INVENTION
The present invention provides a cardiovascular catheter useful
during surgery for venting, draining or perfusion, particularly
during various open heart operations or cardio-pulmonary by-pass. A
feature of one form of the catheter is a vent channel which can be
in sump-like communication at its distal end with the distal end of
the catheter drainage channel. Another feature is a simplified
holding system having a stationary ring and a sliding ring for
clamping the catheter in position with respect to the heart, vein,
artery, or the like. Further, as another feature, one type of
catheter can be constructed so that the vent and drainage channels
terminate at their proximal ends as separate tubes which can be
joined in sealed flow communication with each other.
While this invention is susceptible of embodiment in many different
forms, there is shown in the drawings and will be described in
detail a specific embodiment of the invention together with
explanation of its use with the understanding that such description
and explanation is illustrative and is not intended to limit the
spirit or scope of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a form of catheter of this
invention;
FIG. 1A is a cross-sectional view taken on the line A--A of FIG.
1;
FIG. 1B is a cross-sectional view taken on the line A--A of FIG. 1,
only showing a modified distal end;
FIG. 2 is a section through a human heart showing the catheter of
FIG. 1 inserted;
FIG. 3 is a section along line 3--3 of FIG. 1;
FIGS. 4 and 5 are partially schematic illustrations of heart-lung
machine systems which can be used in combination with the catheter,
and
FIG. 6 is a perspective view of a vena caval catheter showing a
modified form of the invention.
BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS
Turning first to FIGS. 1 and 3, an embodiment of the present
invention is illustrated in the form of a catheter 10 having a
clear flexible double lumen tube 12 made of medical grade plastic
such as polyvinyl chloride or the like. The larger lumen 14 is for
drainage and the smaller lumen 16 functions as a vent or vacuum
breaker airway inlet. The drainage lumen 14 extends at its proximal
end through a main branch tube portion 18 of tube 12 which portion
18 has a fusiform or enlarged section 19 tapering inwardly to an
open end 20 while the airway lumen 16 extends at its proximal end
through a separate flexible tube 22 and terminates with its inner
surfaces tapered outwardly as a funnel shaped open end 24. Tube 22
is sufficiently long and open end 24 is properly shaped to serve as
a force fit cap over the open end 20 of the tube 18 to removably
connect and pressure seal the proximal ends of the lumens 14 and 16
in flow communication. The fusiform or enlarged bubble section 19
has a distal slope 21 and a proximal slope 23 such that the
proximal slope serves as a connector either to the tube 22 with its
funnel shape end 24 or with a straight tube or funnel shaped tube
connection to a source of vacuum. The fusiform section 19 has the
vent tube 22 connected to the main vent 16 in the distal slope 21
of the fusiform section 19. The connection between the vent tube 12
and the main vent 16 is such that there is no reduction in the
cross-sectional area of the main vent 16 at the point of
connection. The tube 12 is divided into the two lumens 14, 16 by a
septum or wall 25. The opening at the end of the vent 16 is plugged
between the end of the wall 25 and the inside wall of the tube 12
to close off the smaller lumen 16. The wall 25 has its distal end
terminated at 34 to provide communication between the lumens 14 and
16. The catheter is provided with suitable X-ray opaque lines 26
and 28 embedded in the walls of the tubes 12, 18, 22 and in the
walls of the fixed and movable flanges to be described hereinafter,
so that the location of the tube and its components can be readily
determined by X-ray procedures.
The distal end or tip 30 of catheter 10 is fused closed to provide
a rounded outer leading surface sometimes called a bullet tip. For
drainage use the catheter is provided with staggered inlet openings
32 penetrating the wall of tube 12 to communicate with lumen 14
exteriorly adjacent but spaced between the distal end 30 and the
fixed flange. The septum between the two channels is broken at 34
at the distal end adjacent the fused tip and distal to the openings
32, permitting sump-like communication between the two channels.
The X-ray opaque line 26 is interrupted by at least one opening 32
so that usual X-ray procedures can be used to locate the distal tip
if necessary. As shown in FIG. 1B, an opening 32A may be formed in
the distal tip of the tube 12 to form a whistle tip construction.
All of the other elements of FIG. 1A are present in FIG. 1B and the
description thereof will not be repeated.
A system is provided for assisting and stabilizing the position of
the catheter at the site of penetration of a heart chamber. This
system includes a narrow, non-inflatable, solid, medical grade
plastic such as, for instance, polyvinyl chloride, ring flange 36
which is bonded or otherwise immovably secured to the outer surface
of the catheter just proximal to the drainage inlet openings 32. A
longitudinally and axially larger, non-inflatable, solid, medical
grade plastic such as, for instance, polyethylene, collar flange 38
is slidably mounted with a snug fit on tube 12 proximal to the
fixed ring flange 36.
The fixed ring flange 36 has a tapered or beveled leading surface
40 facing toward the distal end of the catheter 10 which functions
as a camming surface during insertion of the catheter so that the
fixed ring flange 36 can be inserted within the heart. The trailing
end of ring flange 36 has an abrupt step down surface 42 facing
toward the proximal end of catheter 10.
The slidable collar flange 38 has abrupt shoulders 44 and 46 at the
distal end proximal ends and does not enter the heart cavity during
use but is slidable under moderate force through its snug slip fit
on tube 12 to engage the outer surface of the heart muscle wall at
the position of insertion with surface 42 engaging the inner
surface of the heart wall at the position of insertion. The edges
between shoulders 44 and 46 and the outer cylindrical surface 45
are rounded slightly to eliminate the sharp edges. The slidable
collar flange 38 also permits accommodation of variations in heart
wall thicknesses in use and is prevented from sliding off the
distal end of the catheter and becoming lost by means of the fixed
ring flange 36. The X-ray line 26 in the flanges 36 and 38 makes it
possible to be located in the event they become lost in a
patient.
Catheter 10 can be manufactured by first forming tube 22 and tube
12 as separate members, positioning collar flange 38 over the
distal end of the tube 12 and then sliding ring flange 36 over the
distal end of tube 12 to a point proximal to openings 32 and
bonding ring flange 36 to the outer surface of tube 12. Tube 22 is
formed with an open end 48 and has an internal diameter preferably
equal to or greater than the inner diameter of lumen 16 so as to
avoid any constriction at the connection between tube 22 and tube
12. An entry port 50 is formed in the distal slope 21 of the
fusiform section 19 of the wall of catheter 10 into communication
with the lumen 16. The open end 48 of tube 22 is inserted through
entry port 50 and into lumen 16 and secured and sealed, e.g. by
solvent seal or heat seal, in place. Since the tube 22 is secured
to the tube 12 in the distal slope 21 of the fusiform section 19,
it will not constrict the lumen 14 and since the inner diameters of
the lumen 16 and tube 22 are matched or the inner diameter of tube
22 is larger than lumen 16, no constriction in the vent 16 will be
effected. Lumen 16 can extend to adjacent the proximal end of tube
18 where it is plugged but this portion of lumen 16 between the
plug and the port 50 is sealed from the remainder of lumen 16 by
branch tube 22.
FIG. 6 illustrates a modified form of the invention, wherein a vena
caval catheter employs the hereinabove described structure in a
system for stabilizing the vena caval catheter in position in a
patient. Specifically, a medical grade plastic vena caval catheter
100 is formed by extruding or by other known techniques. The
proximal end portion 102 is of a somewhat uniform diameter which
diameter is larger than the distal end portion 104 of said
catheter. A gradually tapered portion 106 joins portion 102 to
portion 104 in a one-piece structure. The catheter can be formed in
parts and joined or manufactured in any other manner without
departing from the spirit of the invention.
The enlarged portion 102 is adapted to be connected to a system
which would connect a vena cava vein or an artery to a heart-lung
machine, for instance, in a known manner. The distal end portion
104 has the distal end 108 open and has plural openings 110 on the
sides thereof. A narrow, noninflatable, solid, medical grade
plastic, such as polyvinyl chloride, ring flange 112 is fixed to
the distal end portion 104 of the catheter proximal to the openings
110. The details of the ring flange 112 are the same as described
hereinabove with respect to the ring flange 36 in FIGS. 1-3.
As an optional member, a slidable collar flange 114 is provided
proximal of the fixed flange 112 and has the same physical and
functional details as described above with respect to the collar
flange 38.
USE OF THE CATHETER IN HEART SURGERY
The vent catheter as completely described hereinabove with respect
to FIGS. 1 to 3 has been designed for particular use and
application in heart surgery. To fully appreciate the need and
functions of the various parts of the catheter, a brief description
of a heart, a heart lung machine and a surgical procedure requiring
the use of a vent catheter is set forth and, in particular, in FIG.
2 the human heart has four chambers including a right ventricle 60,
a left ventricle 62, a right atrium 64 and a left atrium 66. The
right ventricle 60 pumps blood received from the right atrium 64 to
the lungs, while the left ventricle 62 pumps blood received from
the left atrium 66 to the body as a whole. To insert the catheter
in the heart, the surgeon makes a small incision as at 68 in the
apex of the left ventricle and the catheter 10 is then inserted
into the left ventricle until ring flange 36 is within the
ventricle. The surgeon then backs the catheter gradually away from
the heart wall until he feels the resistance caused by the back
shoulder 42 of ring 36 coming in contact with the inside wall of
the left ventricle. The sleeve or collar flange 38 is then worked
up the catheter until shoulder 44 bears against the outer wall of
the heart, thereby holding the catheter in position with inlet
openings 32 inside the left ventricle. No threading, inflating or
other positive locking procedure is needed to establish the
catheter at the site of incision. As a safeguard against accidental
penetration or avulsion of the catheter 12 after placement,
however, additional fixation my be provided by means of a
purse-string suture ligature 33 which immobilizes the catheter in
relation to the heart muscle by means of a snare. Specifically, a
purse-string suture ligature 33 is created by stitching the suture
35 through the heart muscle around the incision, the ends of the
suture then encircle the tube 12 proximal of the collar flange 38,
are crossed over and re-encircle the tube 12 and pass through the
snare shod 37 and are held in position against slackening by means
of the clamp 39. Upon completion of the use of the catheter in the
left ventricle of the heart, the clamp 39 is released, the shod is
removed and the suture is unwound from the flange 38 whereupon the
catheter is removed and the suture 35 can be used to close the stab
incision in the heart. Other methods of affixing the catheter in
the incision in the heart can be used such as the tying of the
suture to the catheter with a knot which requires clipping the
suture for removal. In this latter method the suture cannot be used
to close the stab incision in the heart.
In other possible uses for the catheter, the catheter can be
inserted through the left ventricle and the mitral valve into the
left atrium of the heart. Alternatively, the catheter may be
inserted into the left ventricle through the left atrium and mitral
valve. Basically, the catheter is intended for use in a system for
extracting blood from the heart during open heart surgery and to
extract air from the left ventricle after the heart is closed so as
to prevent air embolism in the blood circulation system before the
heart is put back into operation in the circulatory system.
FIGS. 4 and 5 illustrate diagrammatically two systems in which the
catheter of the present invention may be used. The catheter is
shown in use in combination with a heart lung machine in each
instance. For example, in order to bypass both the heart and the
lungs, the superior and inferior vena cava are cannulated and
snared, forcing all blood returning from the body to be diverted to
a heart lung machine as seen in FIGS. 4 and 5. In the heart lung
machine the blood passes through an oxygenator, i.e. an artificial
lung. Although there are various types of oxygenators, they
generally function on the principle causing the blood to be
distributed in a thin film which is exposed to a controlled
atmosphere containing oxygen. Provision is also made for controlled
escape of carbon dioxide. Usually the oxygenator is of a rotating
disc type as shown in FIG. 4 or a bubble oxygenator as shown in
FIG. 5. Other oxygenators such as those that accomplish oxygenation
of the blood by distribution on vertical screens or in contact with
semi-permeable membranes may also be used.
From the oxygenator the blood is pumped back to the arterial side
of the patient's circulation, usually into the femoral artery.
Before returning the blood to the patient, it passes through a
filter debubbler to eliminate any particular matter and micro-air
bubbles. A heat exchanger is also usually interposed in the
arterial return line to control the temperature of the blood being
returned to the body.
The catheter of this invention can be used in a number of ways. For
example, the catheter can be used as a specialized cardiotomy
return catheter during open heart surgery to return blood to a
heart lung machine for reuse and to prevent accumulation of blood
in the operative area.
The device can also be used as a measuring device for measuring the
rate at which blood is entering the left ventricle when the patient
is on cardio-pulmonary bypass. This is important, for blood
entering this chamber, other than coronary venous blood, is blood
lost to effective perfusion of the body as a whole and, therefore,
must be assessed and compensated. For example, in a system as
illustrated in FIG. 4, if oxygenated blood delivered to the patient
from the heart lung machine traverses the aorta and leaks into the
opened or drained left ventricle through an incompetent aortic
valve, this blood is lost to effective perfusion of the capillaries
of the body tissue. To measure the amount of blood lost to
effective use in this manner, the roller pump, connected by an
aspirating and drainage line to the catheter, is accelerated until
air starts entering the air inlet channel of the vent, i.e. lumen
16 at 34. At that instant, by computing the rpm of the
pre-calibrated pump, the rate of blood aspiration from the left
ventricle can be approximated to give a useful assessment of the
degree of aoretic valve incompetence. A measurement of the amount
of collateral blood flow through the lungs and into the left
ventricle can be similarly made in certain cases of congenital
heart disease, e.g. certain blue subjects.
The vent lumen 16 and sump opening at 34 also serve to prevent
excessive aspiration of the left ventricle during use of the
catheter. When a single lumen drainage catheter is employed,
collapse of the tube or suction line may offer the first signal of
excessive aspiration. Lumen 16 further functions in the prevention
of overdistension of the left ventricle. As long as sufficient
suction is applied to keep the lumen 16 free of blood and bubbles
of air are seen in the drainage lumen 14, overdistension cannot
occur. For this purpose, the catheter is preferably of transparent
material. Advantageously, prevention of excessive aspiration or
overdistension of the left ventricle is accomplished without
requiring frequent adjustments and this frees the surgeon to
concentrate on his task.
When the heart is closed and the patient is to be taken off the
heart lung machine, venous blood is again permitted to enter the
heart and follow its normal course on release of the snares around
the venal caval catheters. At this time it is essential that all
air be removed from the heart because even a small air bubble
invites ejection delivery to the brain resulting in neurological
damage or death. The catheter of the present invention can be kept
in operation until it is certain that all air has been eliminated.
As a final safeguard, when the catheter is to be removed, the apex
of the left ventricle is elevated, suction discontinued, the
catheter withdrawn to expose the most proximal drainage opening 32,
permitting the left ventricle to eject blood through this opening
and air will go with this blood, following the line of least
resistance.
Provided safeguards against air embolization have been met, if
desired, the catheter can be readily closed by moving the cap or
funnel end 24 of flexible tube 22 over the proximal end 20 of tube
18 so that the drainage lumen 14 is capped. The catheter is now in
closed position.
Occasionally it is desirable to measure the pressure in the cavity
of the left ventricle, especially at the conclusion of an
intracardiac repair. This can easily be done with the catheter in
its closed position as shown in phantom in FIG. 1. A hypodermic
needle is inserted into the funnel portion of tube 22 adjacent its
connection with tube 18. The hypodermic needle is connected to a
transducer and recorder for recording the pressure
measurements.
Advantageously, the vent lumen 16 and communicating opening 34 in
the present catheter provides sump action during aspiration.
Further, the tapered ring flange 36 permits easy entry of the
catheter into the heart chamber and provides the catheter with a
degree of self retention and the slidable collar flange can be
adjusted to the variations from patient to patient in the thickness
of the wall of the left ventricle. The simple collar flange also
serves as a fulcrum for the purse-string suture ligature which is
employed as an additional safeguard in preventing migration of the
catheter either inwardly or outwardly of the incision.
Referring now to FIG. 6, a vena caval catheter 100 is described for
illustrative purposes for use in connecting the two caval veins for
drainage of blood into a heart lung machine. (Those familiar with
the art will recognize that a similar configuration is equally
applicable in the design of catheters appropriate for arterial
perfusion from the machine, whether a stab incision in the aorta or
an arteriotomy in one of its branches is employed as the site of
entry.) The vena caval catheter 100 is usually positioned for use
by inserting its distal end portion 104 through a stab incision in
the right atrium and thence threaded into the superior or inferior
vena cava. Bleeding from the stab incision is prevented by means of
a snare controlled suture ligature stitched to the atrium around
the stab incision. That portion of the catheter distal to the fixed
ring flange 112 is held in place by means of a snared ligature
encircling the vena cava and its contained catheter at a point
downstream of the fixed ring flange. The movable collar flange 114
is employed as an additional point of fixation at the site of entry
of the catheter into the right atrium in a manner similar to that
described in detail in relation to the vent catheter when used as a
left ventricular vent. Additionally, the movable collar flange
serves as a buttress in the prevention of bleeding at the catheter
insertion site in this exceedingly thin-walled chamber, the right
atrium.
The vena caval catheter and the arterial perfusion catheter, with
fixed and/or movable flanges (such as 112, 114 respectively), are
single lumen tubes which may require internal and/or external
fixation by means of appropriate surgical techniques in conjunction
with the said fixed and/or movable flanges. The cardiovascular
catheters herein described are capable of retention at different
levels within the appropriate part of the heart and/or heart veins
and arteries, the fixed ring flange and movable collar flange
forming the anchoring elements for the fixation in place during the
surgery.
* * * * *