U.S. patent number 3,818,511 [Application Number 05/307,641] was granted by the patent office on 1974-06-25 for medical prosthesis for ducts or conduits.
This patent grant is currently assigned to Medical Products Corporation. Invention is credited to Seymour Bazell, Edward M. Goldberg, Ralph G. Ostensen.
United States Patent |
3,818,511 |
Goldberg , et al. |
June 25, 1974 |
MEDICAL PROSTHESIS FOR DUCTS OR CONDUITS
Abstract
Medical prosthesis for ducts or conduits and method of
manufacture. An exemplary embodiment is an arteriovenous shunt
having a cannula terminated in a funnel in which the interior
included angle ranges from 15.degree. - 30.degree.. The funnel is
of an implantable, resilient silicone rubber into which a woven,
flexible Dacron skirt is molded to enable suturing and tissue
ingrowth at the anastomotic juncture. The silicone is of a medical
type which is body tissue-compatible, and has sufficient elasticity
and resilience to permit compliance during pulsatile fluid flow,
storage and return of fluid kinetic energy, and accommodation to
various sizes of vessels, ducts, or conduits. Actual experimental
use shows improved results compared to prior types of tip-type
cannulae.
Inventors: |
Goldberg; Edward M. (Glencoe,
IL), Bazell; Seymour (Skokie, IL), Ostensen; Ralph G.
(Morton Grove, IL) |
Assignee: |
Medical Products Corporation
(Skokie, IL)
|
Family
ID: |
23190595 |
Appl.
No.: |
05/307,641 |
Filed: |
November 17, 1972 |
Current U.S.
Class: |
623/1.31;
604/175; 264/257; 606/153; 623/9; 623/23.64 |
Current CPC
Class: |
A61M
1/3655 (20130101); A61M 1/3659 (20140204); A61B
2017/1139 (20130101) |
Current International
Class: |
A61M
39/10 (20060101); A61M 39/00 (20060101); A61B
17/11 (20060101); A61M 1/36 (20060101); A61B
17/03 (20060101); A61f 001/24 (); A61m 005/00 ();
A61m 025/00 () |
Field of
Search: |
;3/1,DIG.1
;128/214R,214B,348,334R,334C,1R |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
"A Large-Vessel Applique A-V Shunt For Hemodialysis" by G. I.
Thomas, Transactions Amer. Soc. Artif. Internal Organs, Vol. 15,
1969, pages 288-292..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Molinare, Allegretti, Newitt &
Witcoff
Claims
We claim:
1. A medical prosthesis for providing vascular access to an
arterialized vein which comprises:
a. a cannula;
b. a funnel assembly secured to an end of said cannula, said funnel
assembly comprising;
i. a connector portion connected to said cannula;
ii. a funnel portion with walls having an included interior angle
ranging from about 15.degree. to 30.degree., said walls tapering to
a smaller thickness at the mouth of the funnel;
c. said funnel assembly being a tissue compatible, silicone rubber
with sufficient flexibility and compliance so that in pulsatile
flow, the funnel walls expand upon systole and deliver energy
during diastole;
d. a flexible fabric skirt embedded in the walls of said funnel
portion and extending outward from the edges of the funnel mouth a
distance sufficient to provide for tissue growth therein and to
connect the prosthesis through the skirt to a vein or artery.
2. A prosthesis as in claim 1 wherein a plane defined by the distal
edge of said funnel mouth portion is oriented at an angle to the
longitudinal axis of said connector portion to provide an
elliptical funnel mouth.
3. A prosthesis as in claim 1 wherein a plane defined by the distal
edge of said funnel mouth is oriented at substantially a 90.degree.
angle to the longitudinal axis of said connector portion.
4. A prosthesis as in claim 1 where a portion of said fabric
adjacent said funnel mouth is impregnated with silicone rubber to
provide suture anchorage for anastomosis.
5. A prosthesis as in claim 1 wherein said connector portion
comprises a collar having an inner diameter suitable for fitting
over said cannula and a shoulder to abut the end of said
cannula.
6. A prosthesis as in claim 1 wherein said cannula is a body tissue
compatible tube.
7. A prosthesis as in claim 6 wherein each end of said cannula has
a funnel assembly secured thereto.
8. A prosthesis as in claim 6 wherein said cannula is silicone
rubber.
9. A prosthesis as in claim 1 wherein said silicone rubber is a
fluorosilicone rubber.
Description
FIELD OF THE INVENTION
This invention is directed to an improved prosthesis for access to,
and transport of ducted fluids, such as the vascular, lymphatic,
reproductive, regulatory (e.g. glandular) or excretory systems, and
repair, extension or access to other body ducts or tubes, such as
tracheal, esophago-gastrointestinal systems and the like. The
invention also includes methods of manufacture of the prosthetic
devices. More specifically, the invention is directed to a tipless,
funnel-terminated, tubular prosthesis in which the interior angle
of the funnel ranges from 15.degree. - 30.degree., which funnel is
molded of high compliance, body tissue-compatible, flexible,
resilient silicone rubber, and has molded therein a Dacron skirt
for tissue ingrowth at the anastomotic junctions.
BACKGROUND OF THE INVENTION
There is a clear need for artificial, implantable duct prosthesis
for treatment or cure of various medical conditions in animals and
humans. Examples include artificial veins or arteries used in
treatment of circulatory conditions. Likewise repair of, or access
to the G.I. tract may employ artificial ducting. All of such
ducting involves the connecting (anastomosing) of the ducts to body
tissue, usually the natural duct which is being replaced or
repaired, or connection to the organ or organs which communicate
with the natural duct. Frequently the artificial duct prosthesis is
led extracorporeally for treatment of the ducted fluid and return
to the body, e.g. blood for dialysis in cases of kidney
failure.
All such artificial duct prostheses pose serious medical problems
at their anastomotic juncture within the body, for example juncture
necrosis, chronic infection, leakage, thrombosis, stricture and the
like. This invention is directed to an improved juncture prosthesis
or duct terminus. The discussion which follows will be with
reference to an arteriovenous shunt by way of example, but it is to
be understood that the funnel prostheses of this invention may be
applied to any artificial implantable duct, or to a natural duct
that is being anastomosed to a natural or artificial duct, organ or
tissue, as the case may be.
In the United States, approximately 50,000 persons each year suffer
some degree of renal (kidney) failure. Of this number, fully 20
percent, or 10,000 patients, can be helped by dialyzing the blood
to remove the accumulated urea and other metabolic byproducts.
Kolff introduced direct dialysis of arterial blood, thereby
employing arteriostatic pressure to assist in the dialysis. Quinten
and Scribner developed an arteriovenous shunt system employing a
tipped cannula sutured at 90.degree. to an artery, tunneled
subcutaneously, exited through the skin, and connected externally
to a similar cannula which analogously was sutured to a vein. When
hemodialysis was required, the shunt was disconnected externally
and the arterial line was connected to the dialysis machine. The
return line from the machine was connected to the venous
cannula.
Such Quinten-Scribern shunts are often disfiguring and ineffective,
complicated by frequency infections and thrombosis. The tips of the
Scriber shunts are very inefficient, with significant turbulence,
and low flow rates, which contribute to the thrombosis. The cannula
"tip" is attached to the blood vessel by sutures, and causes
juncture necrosis and strictures.
Results of using tip-type cannulae were reported by Baillod et al.
at the 1969 meeting of the European Dialysis and Transplant
Association, reported at Proc. Europ. Dialysis Transplant Assn.,
6:65, 1969. 60 patients treated for more than one year exhibited
arterial cannula survival of 13.5 months, during which an average
of two and one half cannulae were required. Their venous cannulae
survived an average of 81/2 months, with four cannulae required per
patient.
Problems with shunts led Brescia and Cimino to the innovation of
the internal arteriovenous fistula which remains post-surgically
subcutaneous. In this procedure, the side of an artery is sutured
to the side of a vein to form a classical, side-by-side, h -shaped
shunt. When dialysis is desired the shunt loop is punctured with
hypodermic needles attached to the inlet and return lines of the
dialysis machine.
However, the Brescia-Cimino internal A-V fistula is not without its
serious problems. The use of the fistula requires training and
skill in venipuncture, which frequently mitigates against home
dialysis by the patient or other unskilled persons. After repeated
punctures with large bore needles, hematomas, scarring, induration
and false aneurysms develop.
There is, therefore, a great need for improved juncture prostheses
for ducts and conduits of all types, both internal and external
shunts to provide for vascular access, and access to the lymphatic
system, reproductive system, regulatory system, excretory system.
G. I. system and the like or to other organs or implanted
prostheses to or from which fluid (gas or liquid) transmittal is
desired. The ducts should be readily established and perform
continuously as long as needed. They must allow adequate fluid
(e.g., blood) flow, be non-thrombogenic and free of infection. They
should be easily declottable, and should be large enough to provide
adequate fluid volume exit or input.
THE INVENTION
Objects
it is among the objects of this invention to provide an improved
duct juncture prosthesis which overcomes the above-described
problems of the prior art tips and achieves the goals set forth for
improved medical ducts, e.g., A-V shunts and the like.
It is another object to provide a juncture prosthesis for ducts
which has fluid dynamics advantages, and presents improved survival
expectancy.
It is another object to provide a funnel juncture prosthesis for
ducts which may be used internally or externally, and which may be
used for access to any body organ or tissue from any other, or from
the exterior, and for transport of any fluid (gas or liquid) which
is input, withdrawn, administered or monitored.
It is another object of this invention to provide a funnel juncture
for a shunt prosthesis which exhibits low incidence of late
failure, thrombosis, provides smooth transition from body organ,
duct or tissue to the prosthesis, is simple to declot, has
excellent flow rates, an absence of major clinical complications,
and exhibits long survival.
Still other objects will be evident from the following summary and
detailed description.
SUMMARY
Our juncture prosthesis employs a "tipless" cannula having a
dacron-skirted silicone rubber funnel at an end for transmitting
fluids across an anastomotic site. We have discovered that best
hemodynamic and medical properties are obtained when the included
angle of the funnel ranges from about 15.degree. - 30.degree.,
whether the funneled orifice is anastomosed end-to-end or at an
acute angle to a body duct, organ or tissue. The flexibility,
resilience and compliance of the silicone rubber is selected to
permit sufficient elasticity to be responsive to natural pulsatile
flow, and to store and return fluid kinetic energy. The funnel is
also sufficiently elastic to be self-compensating within small
angles, thus permitting anastomosis to vessels or ducts of varying
size. The Dacron skirt permits tissue ingrowth with a
pseudoendothelium and a fibrous adventitia which prevents buildup
of fibrin at the anastomotic juncture. The juncture funnel
prostheses of this invention are applicable to internal A.V.
fistulae, arterialized vein shunts, external shunts, or to any
situation where fluid (gas or liquid) is to be transferred to or
from any body duct, organ or tissue to another, or to or from the
exterior. Improved results are demonstrated by the prostheses of
this invention.
BRIEF DESCRIPTION OF THE DRAWINGS
The following detailed description makes reference to the FIGURES
in which:
FIG. 1 illustrates in sectional view the funnel assembly for a
cannula prosthesis in accordance with this invention;
FIG. 2 illustrates in sectional view a molding apparatus employed
in the method of manufacture of the prostheses of this
invention;
FIG. 3 shows in perspective a funnel assembly in accordance with
this invention particularly useful for end-to-end anastomosis;
FIG. 4 shows in perspective a funnel assembly in accordance with
this invention for acute angle anastomosis;
FIG. 5 shows an exemplary prosthesis of this invention in use;
and
FIGS. 6a and 6b compare flow with the funnel prosthesis of this
invention to prior art "tipped" cannulae.
DETAILED DESCRIPTION
Referring to FIGS. 1, 3 and 4, the prosthesis of this invention
comprises a funnel assembly 1 mounted on a cannula tube 2. The
funnel assembly in turn includes a cloth skirt 3, typically a
sterile polyester (Dacron) cloth, for example, one about 0.007 inch
thick, embedded in the walls of the funnel mouth portion 4 as at 5.
The Dacron cloth may be flat or formed into a conical shape. Shank
portion 6 connects the funnel mouth portion 4 with connector
portion 7, into which is seated a cannula 2. The cannula 2 may be
secured into connector portion 7 with cannula tip 8 abutting
against shoulder 9 in a manner to provide a smooth interior passage
at 10. We prefer to use a silicone cement 11 to join the tube 2 to
the funnel assembly. The funnel walls may be tapered so that the
mouth edge 4' is thinner and more flexible than the shank end
portion 6. This flexibility permits a range of fit for various
sized ducts or blood vessels, and compensates for pulsatile fluid
flow by storage and return of kinetic energy.
Critical to our invention is the fact that the included angle
.theta., defined as the angle lying between the inner surfaces 12,
12' of the funnel mouth, is in the range of about 15.degree. -
30.degree.. This provides a smooth transition of flow of fluids,
e.g., blood, lymph, urine, oxygen or the like in either direction
through the tipless cannula prosthesis, and improves system
survival. In addition, the entrance energy loss using our
prosthesis is tenfold less than a constant diameter orifice
anastomosed end-to-end to a duct. In such constant diameter
juncture, the entrance loss is 0.5 (V.sup.2 /2 g), where V is flow
velocity and g is gravity. In our "tipless" funnel juncture
prosthesis, the entrance loss is one tenth, that is, 0.05 (V.sup.2
/2g) for the same flow velocity.
In addition to the end-to-end anastomosis, we have found that the
same type of funnel transition provided for by our tipless funnel
cannulae is beneficial when anastomosing vessels end-to-end to
ducts or cannulae. As seen in FIG. 6a in the prior art techniques
employing tip-type cannulae 28, there is almost always a stricture
or sudden reduction 29 of the internal diameter of the vessel which
is anastomosed to the body vessel or duct 30. This abrupt narrowing
of the diameter results in frictional energy losses and boundary
layer separation 31 contributing to hemolysis and the formation of
thrombi whether the flow is converging or diverging. In addition,
there is a pressure drop with up to 50 percent velocity head loss,
occasioned by the use of such tip-type cannula. In contrast, as
seen in FIG. 6b, end-to-end anastomosis using the tipless
funnel-type cannula 1 of this invention for either converging or
diverging flow affords a smooth translation and flow 32, improves
system survival, promotes more effective declotting, helps
eliminate the buildup of fibrin at the junction of the cannula and
vessel, and generally exhibits an absence of major clinical
complications. We have been able to observe cannula survival of
over two years, using the cannula of this invention.
The funnel juncture prosthesis, anastomosed to the arterial limb of
a fistula or any afferent flow duct, is the converging channel with
a short graduated contraction of diameter. The converging channel
or "nozzle" refers to a channel system in which the velocity of the
fluid is increased and the pressure is reduced. The fluid is
accelerated in the converging channel and some pressure head is
converted into velocity head. In general, this conversion is a
stable process and can be made with few losses.
The prosthesis anastomosed to the venous limb of the fistula or any
efferent flow duct is the diverging channel with a short gradual
enlargement of diameter. The diverging channel or diffuser refers
to a channel in which the velocity of fluid is decreased and the
pressure is increased. The flow involves a conversion of velocity
head to pressure head. As the fluid moves down stream, a greater
boundary layer forms and grows in thickness. The fluid may not fill
the channel completely, but separates by breaking away from the
walls. This results in eddy formation and dissipation of energy by
turbulent mixing. Flow in a diverging channel is more troublesome
than flow in a converging "nozzle" and can be an unstable
inefficient process.
In evaluating the efficiency of a diverging channel, it is
necessary to consider the velocity variations across the channel.
The diverging channel efficiency can be considered as a function of
the total included angle of divergence (.theta.). Theta represents
a particular expansion ratio or ratio of final area to initial
area. The efficiency is high (75 - 90 percent) in the region
between 0.degree. and 30.degree.. Beyond about 30.degree., the
efficiency decreases with an increase in the included angle.
We further have improved the system by the provision of flexibility
and compliance so that in pulsatile flow, the juncture expands upon
systoly storing kinetic energy, and delivers the energy to the
fluid on diastoly.
Turning now to FIG. 2, this figure illustrates the method of
construction of the funnel assembly of our invention. Mold 13
comprises a skirt holder plate 16 and body-forming plate 17. In
manufacture, a core, ring or "washer" of Dacron cloth, a medical
grade such as U.S. Catheter & Instrument Corp. No. 6103, is
centered over the central aperture 19 in the body-forming plate 17.
The Dacron cloth may be of any type which has sufficiently large
mesh to permit complete inpregnation of the silicone rubber around
the fibers. Thereafter, the skirt holder plate 16 is placed
thereover to securely retain the Dacron skirt in position during
molding. The skirt holder is shown as flat, but may be conical.
Centering pins 18, 18' are inserted to secure the mold parts
together, and the mold is then positioned on the bottom plate 15 of
the molding press. Centering pins 18 and 18' extend into recesses
20, 20' in the bottom plate of the press for proper centering of
the shoulder-forming projection 21 in the mold aperture. A tubular
slug of vinyl type silicone rubber molding compound, such as a
Dow-Corning "Silastic" brand rubber MDX-44512, is dropped into the
mold aperture 19, and top press plate 14 is lowered into position
to compression-mold the silicone rubber, for ten minutes at
260.degree.F. In the alternative, a fluorosilicone may be used;
this type silicone rubber exhibits lesser clotting characteristics
under dynamic flow conditions. The mold pin 22 projecting from the
top press plate 14 forces the gum-like silicone rubber into the
mold cavity. Optionally, the amount of the silicone rubber slug may
be chosen so that there may be very small excess of the silicone
rubber which extrudes into the cloth skirt beyond the outward edge
of the funnel mount portion 4. This is best illustrated in FIG. 1
as zone 23. The extrusion of this silicone provides a zone for
anchoring the sutures when anastomising the funnel mouth to the
body vessel or duct. The funnel mouth walls 12, 12' are thus free
of turbulence-causing sutures, yet there is a sufficient feather
edge of silastic-impregnated Dacron to provide for proper suture
anchorage while at the same time sealing against fluid loss. The
outer edge of the Dacron skirt 24 is open mesh which provides for
tissue ingrowth. The excess skirt may be trimmed as desired to fit
any given duct size. For a tipless funnel juncture prosthesis of
0.125 inch I.D. and a funnel mouth opening of 0.250 inches, we
employ approximately 0.1 gram of a silicone rubber slug for the
molding.
After the compression-molding for ten minutes at 260.degree.F., the
funnel assembly part is extracted from the mold and inspected.
Thereafter, the molded funnel assembly part is post-cured for four
hours at 350.degree.F. All flashing is trimmed from the part, and
after final inspection and washing, it is ready for assembly on a
cannula tube. In assembling the cannula tube, a clean, transversely
cut end of a cannula is painted on its exterior surface with a
medical grade silicone rubber adhesive, such as Dow-Corning medical
grade "Silastic" brand adhesive Type A, and inserted into the
connector portion of the funnel assembly. Excess may build up and
form a smooth transition shoulder, as 11, seen in FIG. 1. The final
tipless funnel cannula prosthesis is best seen in FIGS. 3 and 4.
FIG. 3 illustrates a prosthesis either for end-to-end anastomosis
with a body vessel, duct, tissue or organ, or for 90.degree.
end-to-side anastomosis. FIG. 4 shows a tipless funnel cannula
prosthesis having an oval or eliptical-shaped funnel mouth which is
oriented at an angle to the longitudinal axis of the shank and
connector portions. This oblique funnel is particularly adapted for
acute angle end-to-side anastomosis to body vessels, ducts, tissues
or organs.
The method of employing the tipless funnel cannula of this
invention may be seen with reference to FIG. 5. This description is
in reference to providing vascular access to an arterialized vein
although it should be understood that vascular access is merely
exemplary of the more general use of the cannula of this invention.
FIG. 5 shows the use, in a 2-step procedure, of our tipless funnel
cannula where external access is required. A suitably dilated
arterialized vein 33 is selected for cannulation. This vessel is
severed transversely at 34 and each end 35, 36 directly anastomosed
to a tipless, funnel-shaped skirted cannula 37, 38 of this
invention. The cannulae may be buried in subcutaneous tunnels 39
with open cell silicone rubber cuffs for fixation and seal. The
exterior loop 40 of the cannula tube 2 may be adapted to come apart
at collar 25 for attachment of the outlet segment 26 and inlet
segment 27 to the inlet tube 41 and outlet tube 42 of the dialyzer
43.
Optionally, a direct fistula can be created by directly
anastomising a cannula terminated at each end with a funnel
prosthesis of this invention and utilizing a vein graft for
juncture to the small artery. First, one end of a vein graft is
anastomosed to an artery and the other end anastomised to the mouth
of the funnel prosthesis-terminated cannula. A vein is then
selected for return flow to the heart and the distal branch of this
vein anastomised to the funnel prosthesis at the other end of the
cannula.
It is also possible to make a vein-to-vein shunt, as in a
porto-canal shunt to reduce portal hypertension. In the same manner
an artery-to-artery shunt can be performed (artery bypass). As
above, for access to small vessels, we use a vein graft anastomosed
to a funnel mouth, and for large vessels, we can directly
anastomose our funnel juncture prosthesis thereto.
Fourteen or our new external fistula systems using tipless,
funnel-skirted prostheses of this invention have been created for
external circulatory access useful in chronic hemodialysis. The
treatment periods range from 2 to 34 months. In all 14 patients
flow exceeded 300 ml/min. Taken as a whole 13 of 14 systems have
survived to date, representing an experience of 213 months with a
mean survival of 15.2 months. The 14 arterial prostheses had a mean
survival of > 15.0 months; the 13 venous prostheses had a mean
survival of > 12.4 months. All arterial and venous prosthesis
replacements have not been included in the above analysis.
Expression of data in this manner, however, is unsatisfactory. Any
series, with a number of patients having a short period of
observation will, when calculated in this manner, result in
spuriously low survival times. Thus, the survival times will
actually be greater than the number of months calculated in the
above manner. If survival data are computed only from patients
observed for more than 12 months, (including all failures even
under 12 months), the recalculated mean survival times are as
follows: for an arterial prosthesis 19.3 months, and for a venous
prosthesis 15 months. This compares to 13.5 months (arterial) and
8.5 months (venous) for tipped cannulae of the prior art.
A more meaningful representation of circulatory access survival
data would be to express it in terms of estimated survival curves
calculated by standard life table techniques described by Merrell
and Shulman "Determination of Prognosis of Chronic Disease
Illustrated by Systemic Lupus Erythematosus", J. Chronic Dis. 1,
(1955). The logarithm of the percent surviving is plotted against
the duration in months. These curves are of course provisional
since the numbers are small. They show the expected survival of an
arterial prosthesis is 80 percent, and for the venous prosthesis
about 50 percent under these circumstances.
It is to be understood that various modifications within the scope
of this invention can be made by one of ordinary skill in the art
without departing from the spirit thereof. We therefore wish our
invention to be defined by the scope of the appended claims as
broadly as the prior will permit, and in view of this specification
if need be.
* * * * *