Note: Descriptions are shown in the official language in which they were submitted.
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BACKGROIJND OP TIIE INVENTION
The present invention relates to an implant device usecl in con-
nection with the vascular system.
This invention is divided from Canadian Patent Application Serial
No. 409,363, filed August 13, l9S2, which claims an implant device comprising:
a passageway having an anchor means, both of which are formed from a material
selected from the group comprising ~1) pyrolytic carbon disposed on a graphite
substrate and (2) vitreous carbon, for attachment to an opened vessel; said
anchor means for establishing a biological anchor; and said passageway being
further defined as having an inlet section initiated with a passageway inlet
and an outlet section terminated with a passageway outlet and in communication
with said inlet section wherein the axial centerline passing through the
center of said passageway inlet is inclined with respect to the axial center-
line passing through the center of said passageway outlet from between about
~5 degrees and about 75 degrees.
I'here are many situations in which it is necessary to perform an
enterostomy on a patient. An enterostorny involves externalizing an internal
vessel. Common vessels which commonly require externalizing are the ileum,
colon, ureter, and bladder~ Heretofore, enterostomies were accomplished
by severing the vessel which was to be externalized and then suturing the
wall of the vessel to an opening which has been formed on the surface of
the body. The opening is normally formed on the abdomen. Generally, the
wall of the vessel and the dermis of the skin surrounding the opening will
grow together to permanently secure the vessel to the surface of the body.
` After the operation has healed, a container is attached to the surface of
the skin. The container functions to receive the excrements which are
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discharged Prom the vessel. These excrements may be acidic due to the
pressure of enzymes et cetera, and when they contact the surface of the skin,
they cause ulceration. For example, in an ileostomy, the ileum is exter-
nalized to the abdomen of the patient and the enzymes, fecal material, et
cetera, which exit from the ileum cause ulceration o:E the skin surrounding
the point of externalization~ This is primarily due to the presence of
active enzymes in the small intestines.
Further, there are a number of situations in which it is neces-
sary to provide for fluid communication with the vascular system. For
example, patients suffering from kidney failure require the dialysis of
their blood by means external :Erom the body. Blood containing toxic sub-
stances, such as urea, uric acid~ creatine, phosphorous and calcium, must
be removed from the blood system, treated and then returned to the patient.
Patients requiring such blood dialysis require treatment at least two or
three times per week. Patients suffering from hypoalimentation require a
device for providing access to the body's vascular system on at least a
daily basis.
~ne prior method of providing fluid communication with the vascu-
lar system involved the insertion of a needle into an artery from which
blood to be treated was taken and the insertion of a needle into a patient's
vein for blood return. Such a method proved unsatisfactory due to the
difficulty in providing for the healing of the artery upon removal of the
needle and the trauma produced by the repeated needle insertions. Such
shortcomings led to the development of external and, later internal shunts.
~n external shunt involves the insertion of the tubes, such as
those made of Teflon*, into an artery and an adjacent vein in a limb and
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providing an external communication or shunt between the tubes, which ex-
tend from the body of the patient. The shunt between the tubes is requirecl
in order to provide flow through the tubes during that period of time that
access in not requlred for blood treatment. Where such circulating blood
flow not provided, a blood clot or -thrombus could ~form as would be the
case if the tubes were simply capped creating a static blood volume when
the tubes were not in use. Dialysis, for example, is accompl;shed by
connecting the arterial and venous tubing to a suitable dialysis unit.
However, such a configuration traumatizes the skin adjacent the Teflon
tubes and a path is provided through the skin for infection to enter the
patient's body. Furthermore, even with external shunts, blood clots some-
times form within the tubes and create a health hazard to the patient.
The disadvantages of external shunts led to the development of
the internal shunt. An internal shunt is performed by joining, within a
body, openings between an artery and an adjacent vein, thereby forming a
fistula. One or two needles were then inserted into the fistula in order
to achieve communication with the patient's vascular system. The patient
suffers major discomfort and pain each time the needles are inserted in
the fistula. Moreover, the continuous intrusion into the fistula causes
it to become layered with scar tissue which ultimately prevents further in-
trusion, thus requiring the formation of another shunt.
Both the internal and external shunts increase the loading on
the patient's heart due to the joining of the artery to a vein having a
lower pressure, thereby lowering the artery~s pressure, and requiring the
heart to attempt to regain the original arterial blood pressure. Further,
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in many cases, the reduced circulation in the distal portion of the limb
wherein the shunt is effected impairs the adequate perfusion of blood.
The present invention, together with that of the a-forementioned
Canadian Patent Application Serial No. 40~,363 will now be further discussed.
The present invention provides an implant device comprising: a
passageway having an anchor means, both of which are formed from a material
selected from the group comprising (1) pyrolytic carbon disposed on a
graphite substrate and (2) vitreous carbon, for attachment to an opened
vessel; said anchor means for establishing a biological anchor; and a graft-
ing mesh annularly and longitudinally disposed about, and longitudinally
spaced apart from, at least a portion of the exterior o:E said implant device
whareby tissue is permitted to grow between the exterior of the device and
the mesh, said grafting mesh also being formed from a material selected from
the group comprising (1) pyrolytic carbon disposed on a graphite substrate
and (2) vitreous carbon. A connector is used to repl.ace a portion of a
patient~s internal body fluid or solid carrying conduit adapted to connect
said body conduit to a vascular implant device for providing external access
to sa.id body conduit comprising: a hollow tubular member of a grafting mater-
ial, a portion of said tubular member being of expanded diameter to form a
hollow bulbous portion positioned along the length of said tubular member9
said bulbous portion being of a grafting material and being defined as having
a partial elliptical contour, the elliptical contour being elongated substan-
tially along a commom center line between an inlet and an outlet -to the hollow
tubular member, truncated at its ends at the point of diameter expansion
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from the diameter of said tubular member to form said bulbous portion; and
a side port of a grafting material at the approximate midpoint of said
tubular member bulbous portion, said side port communicating with the
exterior of the patient's body.
By way of illustration but not limitation, embodiments of the
invention will be hereinafter described with reference to the drawings, in
which:
Figure 1 is a cross-sectional view illustrating an implant device
with an angular passageway.
Figure 2 is a pictorial view illustrating an embodiment of the
angular implant device.
Figure 3 is a partial cross-sectional view illustrating an
embodiment of the angular implant device.
Figures 4 and 5 are pictorial views of the vascular implant device
with a grafting mesh o the invention.
Figure 6 is a cross-sectional view of the va~scular implant device
of Figures 4 and 5.
Figure 7 is a partial cross-sectional view of the vascular implant
device shown in Figures 4 and 5.
Figure 8 is a pictorial view illustrating the body implantable
connector which connects to the implant device.
Figure 9 is a cross-sectional view taken about 2-2 of Figure 8.
Referring now to Figure 1) an implant device, generally referred
to as 1, includes a passageway, generally referred to as 3, and an anchor
; nleans for establishing a biological anchor. ~nchor means 5 preferably
includes a plurality of apertures 39 which promote fibro-vascular ingrowth 37.
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Passageway 3 includes an inlet section 5 initiated by an inlet 9 and
terminated by an outlet 11. The axial centerline 35 passing through the
center of the passageway inlet 9 is inclined with respect to the axial
centerline 33 passing through the center of the passageway outlet 11
(indicated by the angle " x" in Figure 1) from between about 45 and 75
degrees in order to connect implant device 1 to ureter 13 without occluding
or kinking the ureter 13, thereby restricting or impeding flow therethrough.
In Figure 1 the implant device 1 is illustrated as connected to
ureter 13 extending from kidney 21. The implant device is shown passing
through skin 29, fat 27, fascia 25 and rectus 23 in attaching to ureter 13.
Implant device 1 also includes an annular rim 17 which forms an
annular recess 37 between the annular rim 17 and the anchor means 15.
This annular recess 37 allows for the securing of vascular grafting means
29 to implant device 1 as, for example, by means of suture 41.
The vascular grafting material means 19 is formed, for example,
~rom Dacron*, an E. I. du Pont de Nemours ~ Co. product of polyester fiber.
In a preferred embodiment at least a portion of the grafting material from
which connector 1 is made is coated with collagen.
Referring to Figure 2, an embodiment is shown having two inlets
: 20 sections 5a and 5b initiated with inlets 9a and 9b, respectively. The
axial centerlines 35a and 35b passing through the centers of inlets 9a and
9b respectively, are each inclined ~identified by angles " y " with respect
to the axial centerline 33 passing through outlet 11 in Figure 2) from
between about 45 and about 75 degrees. This embodiment allows a single
; implant device 1 to be connected to two ureters 13.
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Referrlng now to Figure 3, an embodiment of the implant device
of Figures 1 and 2 is shown wherein passageway 3 is rotatable with anchor
means 15. Preferably anchor means 5 is secured about passageway 3 by
means of the male 41 female 43 junction. The rotation of passageway 3
allows for connecting to ureter 13 without occluding or kinking the ureter
andthereby restricting or impeding flow therethrough.
Referring now to Figure 4, the vascular implant device, an
embodiment of this invention, referred to as 1, in Figure 4 will be discussed.
The implant device 1 includes a passageway 3 extending therethrough and an
anchor means 5 for establishing a biological anchor. Anchor means 5 pre-
ferably includes a plurality of apertures 7 extending therethrough.
Implant device 1 also includes an annular rim 13 and the anchor
means 5.
. valved implant device of the type for which grafting mesh 9,
later described, is adopted for use therewith is that described in issued
United States Patent No. 4,164,221, issued August 14, 1979 of which the
inventor of this invention was a coinventor.
Grafting mesh 9 is positioned annularly about at least a portion
of the exterior of the implant device 1. The grafting means mesh 9 is
spaced apart from the implant device 1 as, for example, by means of a
spacer 11 in order to allow for tissue ingrowth between the implant device
l and the grafting mesh 9. In a preferred embodiment the exterior of the
implant device 1 is roughened in order to promote tissue coaption.
The implant device passageway, anchor means and grafting mesh
are formed from either pyrolytic carbon disposed on a graphite substrate
or vitreous carbon. Preferably the g-rafting mesh and the exterior of the
implant devlce are coated with collagen.
Referring to Figure 8, a body implantable connector, referred
to as lb is shown. The connector lb is adopted to replace a portion of
a patient's internal body fluid or solid carrying conduit such as blood
vessel l9b. The colmector lb is connected to the remaining body conduit
l9b means of annular suture 21b or the like. In an alternate embodiment
to this "end to end" connection, the connection lb may be "side to side"
wherein, for example, the side of a vein is connected to the side of an
artery.
Connector lb includes a tubular member 3b having an increased
diameter bulbous portion 5b. ~ side port 7b is provided at the approxi-
mate mid-point of the bulbous portion 5b of the tubular member 3b. The
tubular member 3b preferably includes inlet 9b and outlet llb of sub-
stantially cylindrical cross-section and having a common cross-sec~ion
13b. The side port 7b is also preferably of cylindrical centerline~
having a centarline 15b which is substantially perpendicular to the
common centerline 13b of inlet 9b and outlet llb of tubular member 3b.
The bulbous portion Sb preferably has a partial elliptical
contour, the elliptical contour being truncated at its ends at the point
17b of diameter expansion from the diameter of tubular member 3b to the
diameter of the bulbous portion 5b. Preferably the diameter at the mid-
point of the bulbous portion 5b is between about one and one-half to two
times the diameter of the tubular member 3b prior to the diameter expansion
at point 17b.
I`he connec~or lb is preferably of unitary construction, being
fabricated of a grafting material which is formed, for example, from
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Dacron*, an E. I. du ~ont de Nemours ~7 Company product of polyester fiber,
or "impra graft*", a product made from polytetrafluoroethylene. In a
preferred embodiment at least a portion of the grafting material from
which connector 1 is made is coated wi~th collagen.
The side port 7 of connector 1 is adapted to receive therewithin
an end portion of a vascular implant device such as that of United States
Patent No. 4,164,221, or the present invention.
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