Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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724-1429D
The present invention relates to a body implantable connector
to facilitate the installation of an implant device when it is used for
connection to the vascular system.
This invention is divided from Canadian Patent Application Serial
No. 409~363, filed August 13, 1982, which claims an implant device compris-
ing: a passageway having an anchor means, both of which axe 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 out-
let and in communication with said inlet section wherein the axial center-
line passing through the center of said passageway inlet is inclined with
respect to the axial centerline passing through the center of said passage-
way outlet from between about 45 degrees and about 75 degrees.
There are many si~uations in which it is necessary to perform an
enterostomy on a patient. An enterostomy 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
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operation has healed, a container is attached to the surface of the skin.
The container functions to receive the excrements which are discharged
from the vessel. ~hese excrements may be acidic due to the pressure of enxymes
et cetera, and when they contact the sur:Eace of the skin, they cause ulcera-
tion. For example, in an ileostomy, the ileum is externalized to the abdomen
of the patient and the enzymes) fecal material, et cetera, which exit from
the ileum cause ulceration of the skin surrounding the point of externaliza-
tion. ~his is primarily due to the presence of active enzymes in the small
intestines.
~urther, there are a number of situations in which it is necessary
to provide for fluid communicati.on with the vascular system. For example,
patients suffering from kidney failure require the dialysis of their blood by
means external from the body. Blood containing toxic substances, 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.
One prior method of providing fluid communication with the vascular
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 exte nal and, later inte nal shunts.
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An external sh~m-t involves the insertion oE the tubes, such as
those made of TeElon*, into an artery and an adjacent vein in a limb and
providing an external communication or shunt between the tubes, which extend
from the body of the patient. The shunt between the tubes is required in
order to provide flow through the tubes during that period of time that
access is not required for blood treatment. ~here 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 accomplished by connecting the
arterial and venous tubing to a suitable dialysis unit. Ilowever, 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 bocly. Further-more, even with external shunts, blood clots sometimes 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 ls 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 sys*em. 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 intrusion,
thus requiring the :Eormation of another shunt.
* Trademark
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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 regaln the original arteria.l blood pressure. Purther, 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 aforementi.oned
Canadian Patent Application Serial No. 409,363, will now be f.urther discussed.
Canadian Patent Applicati.on Serial No. ~09,363 seeks to overcome
the preceding problems by providing an implant device comprising: a passage-
way having an anchor means, both of which are formed from a materi.al 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 establislling a biological anchor; and said passageway being further defined
as having an inlet secti.on 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 axia.l centerline passing
through the center of said passageway inlet is inclined with respect to the
axial centerline passing through the center of said passageway outlet from
between about ~5 degrees and about 75 degrees and an implant device comprising:
a passageway havi.ng 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 grafting mesh
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also being formed from a material selecte~ from -the group comprising
(1) pyroly~ic carbon disposed on a graphite substrate and (2) vitreous carbon.
The present invention seeks to overcome aformentioned problems by
providing a connector to replace a portion of the patient's internal body
fluid or solid carrying conduit adapted to connect said body conduit to a
vascular implant device for providing external a.ccess to said body conduit
comprising: a hollow tubular member of a grafting material, a portion of
said tubular member being of expanded dia.meter to form a hollow bulbous
portion positioned along the length of said tubular member, said bulbous
portion being o-~ a grafting material and bei.ng defined as having a partial
elliptical contour, the elliptical contour being elongated substantially
along a common center line between an inlet and an outlet to the hollow
tubular member, truncated at its ends at the point of diameter expansion
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 ex-
terior of the patient's body.
By way of illustration but not limitation, embodimentsof 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 em-
bod:iment of the angular implant device.
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Figures 4 and 5 are pictorial views of the vascular implant device
with a gra~ting mesh.
Figure 6 is a cross-sec-tional view of the vascular 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 of this invention 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
means for establishing a biological anchor. Anchor means 5 preferably includes
a plurality of apertures 39 which promote fibro-vascular ingrowth 37.
Passageway 3 includes an inlet section 5 initiated by an inlet 9 and ter-
minated by an outlet 11. The axial centerline 35 passing through the cen~er
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 a
ureter 13 extending from kidney 21. The implant device is shown passing
through skin 29J fat 27, fascia 25 and rectus 23 in attaching to ureter 13.
Implant ~evice 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
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implant device 1 as, for example, by means of suture 41.
The vascular grafting ma-terial means 19 is formed, for example,
from Dacron*, an E. I. du Pont de Nemours ~7 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
sections 5a and 5b initiated with inlets 9a and 9b, respectively. The
axial center]ines 35a and 35b passing through the centers of inlets 9a and
9b respectively, are each inclined (ldentified by angles " y " with respect
10 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 iTn-
plant device 1 to be connected to two ureters 13.
Referring 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 ]5. Preferably anchor means 5 is secured about passageway 3 by means
of the male 41 female 43 junction. The rotatlon of passageway 3 allows for
connecting to ureter 13 without occluding or kinking the ureter and thereby
restricting or impeding ~low therethrough.
Referring now to Figure 4, the vascular implant device, referred
to as 1, in Figure 4, will be discussed. ';he implant device 1 includes a
passageway 3 extending therethrough and an anchor means 5 for establishing
a biological anchor. Anchor means 5 preferably includes a plurality of
apertures 7 extending therethrough.
Implant device 1 also includes an annular rim 13 which forms
an annular recess 15 between the annular rim 13 and the anchor means 5.
* Trade Mark
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A valved implant devlce of the type -~or which grafting mesh 9,
later described, is adopted eor 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 1 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 grafting mesh and the exterior of the
implant device are coated with collagen.
Referring to Figure 8, a body implantable connector, according
to the present invention and referred to as lb, ls 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 connector 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
connector 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
dia~eter bulbous portion 5b, A side part 7b is provided at the approximate
mid-point of the bulbous portion 5b of the tubular member 3b. The tubular
member 3b preferably includes inlet 9b and outlet llb of substantially
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cylindrical cross-section and having a common c~oss~section 13b. The
side port 7b i.s also preferably of cylindrical centerline, having a center-
line 15b which is substantially perpendicular to -the common centerline
13b of inlet 9b and outlet llb of tubular member 3b.
The bulbous portion 5b preferably has a partial elliptical
con-tour, 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.
The connector lb is preferably of unitary construction, being
fabricated of a grafting material which is formed, for example, from
Dacron*, an E. I. du Pont de Nemours ~ 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 with 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 Canadian Patent Application Serial No. 409,363,
filed August 13, 1982.
