GB2143740A - Implant device - Google Patents

Abstract

An implant device (31) has a passageway (33), an anchor (35) for establishing a biological anchor and a grafting mesh (39) annularly disposed about, and spaced apart from, the exterior of the passageway. The passageway, anchor means, and grafting mesh are all formed from either pyrolytic carbon disposed on a graphite substrate or vitreous carbon. <IMAGE>

Description

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GB 2 143 740 A

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SPECIFICATION Implant device

5 The present invention relates to an implant device.

There are many situations 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 10 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 15 opening is normally found on the abdomen. Generally, the wall of the vessel and the dermis of the skin surrounding the opening orthesubdermal tissue and muscle surrounding the opening will grow together to permanently secure the vessel to the 20 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 discharged from the vessel. These excrements may be acidic due to the pressure of the enzymes et 25 cetera, and when they contact the surface of the skin, they cause ulceration. 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 30 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 necessary to provide for fluid communication 35 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 re-40 moved 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 45 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 needle into a 50 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 55 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 in a limb and providing an external communication or shunt between the tubes, which 60 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. Were such circulating blood flow not required, a blood clot 65 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. 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 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 is performed by joining, within a body, openings between an artery and an adjacent vein, thereby forming a fistula. One ortwo needles are 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 into 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 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, 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 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 grafting mesh annularly disposed about, and spaced apart from, at least a portion of the exterior of said implant device, said grafting mesh also being formed from a material selected from the group comrising (1) pyrolytic carbon disposed on a graphite substrate and (2) vitreous carbon.

The invention also 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 the exterior of said implant device being roughened in order to provide improved coaption;

an annular rim positioned about said passageway thereby forming an annular recess between said annular rim and said anchor means; and a grafting mesh annularly disposed about, and spaced apart from, at least a portion of the exterior of said implant device, said grafting means also being formed from a material selected from the group comprising (1) pyrolytic carbon disposed on a

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GB 2 143 740 A

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graphite substance and (2) vitreous carbon.

An implant device constructed in accordance with the invention will now be described byway of example only with reference to the accompanying 5 drawings, in which:

Figures 1 and 2 are pictorial views of the implant device,

Figure 3 is a cross-sectional view of the implant devoce. and

10 Figure 4 is a partial cross-sectional view of the implant device.

Referring now to Figure 1,the implant device, generally referred to as 31, will be discussed. The implant device 31 includes a passageway 33 extend-15 ing therethrough and an anchor means 35 for establishing a biological anchor. Anchor means 35 preferably includes a plurality of apertures 37 extending therethrough.

Implant device 31 also includes an annular rim 313 20 which forms an annular recess 315 between the annular rim 313 and the anchor means 35.

A valved implant device of a type which grafting mesh 39, later described, is suitable for use with is that described in issued United States Patent No. 25 4,164,221, issued August 14,1979 of which the inventor of this invention was a coinventor and which is hereby incorporated by reference.

Grafting mesh 39 is positioned annularly about at least a portion of the exterior of the implant device 30 31. The grafting means mesh 39 is spaced apart from the implant device 31 as, for example, by means of a spacer 311 in order to allow for tissue ingrowth between the implant device 31 and the grafting mesh 39. Preferably, the exterior of the implant 35 device 31 is roughened in orderto promote tissue coaption.

The implant device passageway, anchor means and grafting mesh are formed from either pyrolytic carbon disposed on a graphite substance or vitreous 40 carbon. Preferably the grafting mesh and the exterior of the implant device are coated with collagen.

Claims (8)

1. 45 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 50 attachment to an opened vessel;

   said anchor means for establishing a biological anchor; and a grafting mesh annularly disposed about, and spaced apart from, at least a portion of the exterior 55 of said implant device, 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. 2. An implant device as claimed in Claim 1, 60 wherein the exterior of said implant device is roughened in orderto provide a plurality of interstices in orderto facilitate tissue coaption.
3. 3. An implant device as claimed in Claim 1 or 2, wherein an annular rim is positioned about said

   65 passageway thereby forming an annular recess between said annular rim and said anchor means.
4. 4. An implant device as claimed in Claim 1,2 or 3, wherein at least a portion of the exterior of said implant device is coated with collagen. 70
5. 5. An implant device as claimed in Claim 1,2 or 3, wherein at least a portion of said grafting mesh is coated with collagen.
6. 6. An implant comprising:

   a passageway having an anchor means, both of 75 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 80 anchor, and the exterior of said implant device being roughened in orderto provide improved coaption;

   an annular rim positioned about said passageway thereby forming an annular recess between said annular rim and said anchor means; and 85 a grafting mesh annularly disposed about, and spaced apart from, at least a portion of the exterior of said implant device, said grafting mesh also being formed from a material selected from the group comprising (1) pyrolytic carbon disposed on a 90 graphite substrate and (2) vitreous carbon.
7. 7. An implant device as claimed in Claim 6, wherein said grafting mesh and at least a portion of the exterior of said implant device are coated with collagen.

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8. 8. An implant device substantially as herein described with reference to, and as illustrated by, the accompanying drawings.

   Printed in the UKforHMSO,D8818935,12/84,7102.

   Published by The Patent Office, 25 Southampton Buildings, London,

   WC2A1 AY, from which copies may be obtained.