CA1195577A - Vascular implant device - Google Patents

Vascular implant device

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Publication number
CA1195577A
CA1195577A CA000467730A CA467730A CA1195577A CA 1195577 A CA1195577 A CA 1195577A CA 000467730 A CA000467730 A CA 000467730A CA 467730 A CA467730 A CA 467730A CA 1195577 A CA1195577 A CA 1195577A
Authority
CA
Canada
Prior art keywords
implant device
exterior
mesh
passageway
anchor means
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000467730A
Other languages
French (fr)
Inventor
Donald A. Raible
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
American Hospital Supply Corp
Jostra Bentley Inc
Original Assignee
American Hospital Supply Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CA000409363A external-priority patent/CA1189415A/en
Application filed by American Hospital Supply Corp filed Critical American Hospital Supply Corp
Application granted granted Critical
Publication of CA1195577A publication Critical patent/CA1195577A/en
Expired legal-status Critical Current

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Abstract

ABSTRACT

This invention relates to an implant device. It is well known in the art that there are various methods for externalizing an internal vessel, or providing fluid communication from the vascular system to a cleansing source outside the body. In the former, the ulceration of the skin, and in the latter the trauma of connecting and reconnecting arteries and veins with tubes or needles have proved to be serious problems. The present in-vention seeks to do away with these problems by providing an implant device which connects to an implantable connector in order to provide access to the body conduit or vessel external from the body. The implant device has a passageway, which is either straight or curved at the outlet, an anchor means for establishing a biological anchor, and a grafting mesh annularly and longitudinally diposed about, and longitudinally spaced apart from, at least a portion of the exterior of said implant device whereby tissue is permitted to grow between the exterior of the device and the mesh. The passageway, anchor means and grafting mesh are formed from a material se-lected from the group comprising pyrolytic carbon disposed on a graphite substrate and vitreous carbon.

Description

57~7 72~-1429E

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 55'~7 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 * 'rrademark ~35~77 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, 5~i7~

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.

* Trade Mark `:

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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 7~7 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.

,.~

* I~de Mark _ 9 _ , ,:

Claims (7)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. 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 grafting mesh annularly and longitudinally disposed about, and longitudinally spaced apart from, at least a portion of the exterior of said implant device whereby 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.
2. The implant device claimed in claim 1 wherein the exterior of said implant device is roughened in order to provide a plurality of in-terstices in order to facilitate tissue coaption.
3. The implant device claimed in claim 1 wherein an annular rim is positioned about said passageway thereby forming an annular recess between said annular rim and said anchor means.
4. The implant device claimed in claim 1, 2 or 3 wherein at least a portion of the exterior of said implant device is coated with collagen.
5. The implant device claimed in claim 1, 2 or 3 wherein at least a portion of said grafting mesh is coated with collagen.
6. 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 the exterior of said implant device being roughened in order to provide improved coaption; an annular rim is positioned about said passageway thereby forming an annular recess between said annular rim and said anchor means; and a grafting mesh an-nularly and longitudinally disposed about, and longitudinally spaced apart from, at least a portion of the exterior of said implant device whereby tissue is permitted to grow between the exterior of the device and the mesh being formed from a material selected from the group comprising (1) pyro-lytic carbon disposed on a graphite substrate and (2) vitreous carbon.
7. The implant device claimed in claim 6 wherein said grafting mesh and at least a portion of the exterior of said implant device are coated with collagen.
CA000467730A 1981-08-14 1984-11-13 Vascular implant device Expired CA1195577A (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US29284481A 1981-08-14 1981-08-14
US29284681A 1981-08-14 1981-08-14
US29284581A 1981-08-14 1981-08-14
US292,844 1981-08-14
US292,846 1981-08-14
CA000409363A CA1189415A (en) 1981-08-14 1982-08-13 Implant device
US292,845 1989-01-03

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA000409363A Division CA1189415A (en) 1981-08-14 1982-08-13 Implant device

Publications (1)

Publication Number Publication Date
CA1195577A true CA1195577A (en) 1985-10-22

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ID=27426357

Family Applications (2)

Application Number Title Priority Date Filing Date
CA000467730A Expired CA1195577A (en) 1981-08-14 1984-11-13 Vascular implant device
CA000467731A Expired CA1195578A (en) 1981-08-14 1984-11-13 Implant connector

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA000467731A Expired CA1195578A (en) 1981-08-14 1984-11-13 Implant connector

Country Status (1)

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CA (2) CA1195577A (en)

Also Published As

Publication number Publication date
CA1195578A (en) 1985-10-22

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