Note: Descriptions are shown in the official language in which they were submitted.
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DESCRIPTION
IMPLANT DEVICE
Technical Field
The present invention relates to an implant device and
surgical method for its implantation.
Background
There are many situations in which it is necessary to
perform an enterostomy on a patient. An enterostomy in-
volves 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 exter-
nalized 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 surround-
ing the opening will grow together to permanently securethe vessel to the surface of the body. ~fter the 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. These excrements a~e
normally corrosive due ~o the presence of enzymes et cetra
and when they contact the surface of the skin, they cause
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ulceration. For example, in an ileostomy, the ileum is externalized to the
abdomen of the patient and the enzymes, urïne~ etc., w~ich exit from the
ileum cause ulceration o~ the skin surrounding the poïnt of externalization.
This is primarily-due to the presence of active eniymes in the small
intestines.
Further, there are a number of situations in which it is necessary
to provide for fluid communication with the vascular system. For example,
patients suffering from kidney failure require the dialysis o~ their blood
by means external from the body. ~lood containïng toxic substances, such as
urea, uric acid, creatine, phosphorus 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 bodyts vascular system on at least a daily basis.
~ne prior method of providing fluid communication with the vascular
system involved the insertion of a needle into an artery from ~Jhich blood to
be treated was taken and the insertion of a needle into a patieTIt~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.
An external shunt involves the insertion of tubes, such as those
made of Teflon*, into an artery and an adjacent vein iTI a lim~ and providing
an external communication of shunt between the tubes, which extend from the
body of the patient. The shunt ~etween the tubes is required in order to pro~
vide flow through the tubes during that period of time ~hat access is not
required for blood treatment. ~ere such circulating blood flow not provided~
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a blood clot or thrombus could form as would be the case if the tuhes were
simply capped creating a static blood volume when the tubes were not in use.
Dialysis, for example, is accomplished hy connecting the arterial and venous
tubing to a s.uitable tubing to a suitable dialysis unit. However, such a
configuration traumatizes the skïn adjacent the Teflon tubes and a path is
provided through the skin for infection to enter the patient's body. Further-
more, even with ex*ernal shunts-, blood clots sometimes form within the tubes
and create a health hazaTd to the patient.
The disadvantages of external shunt 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. The pressure in the artery
being substantially greater than that in the vein causes the vein to become
distended, 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 t~le 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 formation of another shunt.
Both the internal and external shunts increase the loading Oll 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, in many
cases, the reduced circulation in the distal portion of the limb wherein the
shunt is effected impairs the adequate removal of waste products from the
muscles and other tissues resulting in weakness of the limb.
An object of the present invention is to provide an improved implant
device for externalizing an internal body vessel and methods of implanation.
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Other objects. and advantages of this invention will h.ecome apparent upon a
reading of the entire s.pecification, including the drawings and claims.
Summary of th.e Invention
The pres.ent invention provides for an implant devïce ~h;ch may he
permanently implanted t~rough a patient's skin
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providing access to an interrlal body vessel.
According to the invention an implant device com-
prises a passageway having a flange means at one end
thereof for attachment of said flange means to an
opened vessel, an anchor flange means positions about
the external circumference of said passageway for
establishing a biological anchor, and means for
vascular grafting positioned annularly about said
implant device and positioned at least between said
anchor flange and said flange means, and micro-pore
size means for minimizing blood loss extending from
said passageway and being adjacent said flange means.
Further according to the invention a surgica~ method
o installing an implant device within a body ~omprises
opening a body vessel, positioning an implant device,
having a passageway therethrough, adjacent to said
vessel such that one end of said implant device passage-
way is positioned adjacent a portion of said vessel
exterior; and securing said implant device to said
vessel thereby placing said vessel and said passageway
in communication.
Also according to the invention there is the step
of securing vascular grafting material means between
the exterior of said implant device and adjacent tissue
and securing micro-pore size seal material means in the
region of the vessel adjacent to that portion of the
opened vessel, thereby providing structural support for
tissue ingrowth and providing for the minimizing of
blood loss during healing following said implanting.
When used to provide for blood access to the
vascular system full circulation is allowed throughout
the system since no external or internal shunt is
required. The blood access device of this invention
may also be used for patients that have an internal
shunt.
The implant device includes a passageway having a
flange means at one end of the passageway for attach-
ment of the flange means to the opened vessel. The
device includes an anchor flange means positioned about
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the external circumference of the blood passageway for establishing a biological
anchor and vascular grafting material positioned abou-t the device for providing
s-tructural support for tissue ingrowth and a micropore size sealing material
for minimizing blood loss during healing following implantation.
A plug may be inserted into the passageway of the blood access implant
device in order to seal the passageway when access to the vascular system is
not required. Significantly, no shunt, external or internal, is required
because when the sealing plug is in place, there is no void volume within the
device and therefore no flow is required through the device in order to avoid
clotting.
Description of the Drawings
.
Figures l and 2 are pictorial views of an implant device of this
invention.
Figure 3 is a pictorial view and partial cross-section illus-trating
an implant device and a method of implantation of this invention.
Figure 4 is a cross-sectional view illustrating a surgical method for
placing an implant device of this invention in communication with a blood vessel.
Figures 5 and 6 are cross-sectional views illustrati.ng a surgical
method for placing an implant device of this invention in communication with
the colon.
Figures 7 and lO are cross-sec-tional views of an implant device
secured to a bowel.
Figures 8 and 9 illustrate the implant device in cross-section and
viewed from -the end.
Figure ll is a cross-sectional view illustrating a surgical method
of placing an implant device of this invention in communication with the blad-
der.
Figures 12 and 13 illustrate the Implant device in cross-section and
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viewed from the end.
Figure 14 is a cross-sectional view illustratlng a surgical method oE
placing an implant device of this invention in communication with the ureter.
Figure 15 illustrates the implant device viewed from the end.
Description of Preferred Embodiments
Referring now to Figure 1, the implant device,
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generally referred to as 1, and its method of implantation
to provide blood access will now be discussed. The implant
device 1 is preferably formed from a rela~ively smooth
surfaced nonporous, nonbiodegradable biocompatible material
such as vitreous carbon or a pyrolytic carbon disposed on a
graphite substrate and includes a passageway 3 and a flange
means 5 positioned at one end of the passageway 3. The
opposite end of the passageway 3 may be provided with an
external rim or lip 7 about the circumference of the
passageway 3.
As illustrated in Figure 2, the flange means 5 is
preferably of a generally oval configuration. An anchor
flange 15 may be positioned about the external circumference
of the passageway 3 having a plurality of uniformly spaced
aperatures 17 passing therethrough. Again, as shown in
Figure 3, such aperatures allow for the anchor flange means
15 to establish a biological anchor to the body within
which the access device 1 is implanted. The anchor flange
means 15 may be provided with at least one scalloped or
dished portion 9 which may be utilized in assisting in
preventing the access device from rotating after lmplanta-
tion. Figure 15 shows anchor flange 15 without scallops,
while the implant device of Figures 1-3, 8 and 13 have
scalloped or dished portions 9. During healing the body
tissues 21 may pull away somewhat from the upper portion of
the implant device for blood access as shown in Figure 3.
When this occurs the anchor flange 15 acts as an effective
barrier to the bacteria which might otherwise enter about
the device 1. A vascular grafting material 19, formed, for
example, from polyurethane, Dacron, an E. I. du Pont de
Nemours & Co~ trademarked product of polyester fiber made
from polyethylene terephthalatel or the like, may be
positioned about the exterior surface of the passageway 3.
The vascular grafting material 19 is preferably positioned
such that it partly overlaps the apertures 17 of the
anchor flange 15 and may be secured to the anchor flange
15 at the apertures 1 by means of suitable suture fiber.
A small pore size material 11 such as "impra gra~t", a
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t~ademarked product made from micro-porous polytetra-
fluroethylene may extend in a plane generally pa~allel
to that of the fact of the flange means 5.
During implanting surgery to provide blood acceSs~
the micro-porous material 11 may be trimmed somewhat as
shown in Figure 3 in order to accomodate the size and
shape of the blood vessel 13. While Figure 3 shows the
micro-porous material 11 positioned about a portion of
the circumference of the blood vessel 13, it may be
. 10 attached so as to completely surround blood vessel 13~
The micro-porous material 11 provides for the minimizing
of blood loss during healing following implantation
surgery as the material does not allow blood to pass
through it. The vascular` grafting material 19 provides
a structural support for tissue ingrowth which allows
the blood access device 1 to become secured to the
blood vessel 13 and the body tissues; referred to
generally in Figure 3 as 21. Figure 3 illustrates skin
18, fat 20, fascia 22 and muscle 24 in order to provide
orientation for the formation of the implant device 1.
- Figures 4 and 5 illustrate the implant device 1
having been secured to the blood vessel 13. The method
of implantation for blood access will now be discussed.
That portion of blood vessel 13 adjacent the implant
device 1 is clamped in order to prevent blood flow
through the vessel 13. The blood vessel 13 is slit
longitudinally and opened and the implant device 1
secured to the vessel 13 so as to be immediately in
communication with the vessel 13.
The plug means 31 is preferably formed of low
density polyethylene or other like elastically de~oxm-
able material and generally tapered along its exterior
and adapted to be inserted within the blood passageway
3. The plugging means 31 is of a configuration such
that it will completely seal the volume of the blood
passageway 3 so that no blood remains in the blood
access device 1 upon insertion of the plugging means
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As shown in Figure 5, the plugging means 31 may
be secured by means of a cap member 33 and a retaining
ring 35. The cap means 33 is preferably co~metically
colored and provided with an annular lip portion 37
which engages the lip or rim 7 of the blood access
device 1, thereby effecting a seal therebetween.
Figures 7 and 10 illustrate the implant device 1
having been secured to the bowel, referred to as 50. It
is understood that this connection could be made to either
the ileum or colon. In Figure 7, ureters 52 and 54 have
also been sutured to the bowel 50 creating a configura-
tion referred to as an ileal (when connected to the ileum)
conduit for the passage of urine. Annular rim 56 and
anchor flange 15 form an annular recess 58 about which
the porous ingrowth matrix 19 and the micropore seal means
11 may be secured by suture or the like. In the embodi-
ment shown in Figures 7 and 10 the section of the bowel
which is opened to allow for the securing of the implant
device 1, is doubled back on itself in the area referenced
to as 60. This may be done to take advantage of the
increased ingrowth that may be accomplished at the outer
surface of the bowel. Because the bowel connection of
Figure 10 must allow for the removal of enzymes waste
material, sealing of the device is of the utmost import-
ance. Accordingly, a second annular rim 56A is providedproducing second and third annular recesses 58B and 58C
in addition to the first annular recess 58 between rim
56 and anchor flange 15. Annular access 58B is formed
between annular rims 56 and 56A, while annular recess
58C is formed between the second annular rim 56A and the
end portion flared coniguration 72 of implant device 1.
This provision~for more than one access allows for the
device to be securely sutured at annular recesses 58,
58B and 58C. Figures 8 and 9 illustrate the implant
device used for connection to the bowel in cross
section and viewed from the end.
Figures 11-13 are directed to an implant device
for connection to the bladder 70. The implant device 1
fore this embodiment has an end portion 72 of generally
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bell shaped configuration. Again, the recess 58 allows
for securing the porous ingrowth material 19 and the
micro pore seal 11 to the implant device lu
Figures 14 and 15 illustrate the implant device
1 of this invention connected to ureter 52. Typically
two of such implant devices 1 would be used, one
connected to each ureter. After the ureter is secured
it is placed annularly about the implant device 1. In
this embodiment the end portion 72 is of relatively
constant diameter in order to accomodate the ureter 52.
