GB2143741A

GB2143741A - Angular implant device

Info

Publication number: GB2143741A
Application number: GB08419376A
Authority: GB
Inventors: Donald Andrew Raible
Original assignee: Bentley Laboratories Inc
Current assignee: Bentley Laboratories Inc
Priority date: 1981-08-14
Filing date: 1984-07-30
Publication date: 1985-02-20
Also published as: IT8222801A0; CA1189415A; GB8419375D0; GB2143740A; GB2105197A; DE3230049A1; GB8419376D0; BR8204764A; IT1154510B; GB2105197B; GB2143741B; GB2143740B

Abstract

An implant device (71) has a passageway (73), the inlet section (79) (or inlet sections) of which is inclined at 45 DEG - 75 DEG to the outlet section (711). <IMAGE>

Description

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GB 2 143 741 A

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SPECIFICATION Angular implant device

5 The present invention relates to an angular implant device.

There are many situations in which it is necessary to perform an enterostomy of a patient. An enterostomy involves externalizing an internal ves-10 sel. 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 15 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 or the subdermal tissue and muscle surround-20 ing 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 discharged from 25 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 externalized to the abdomen of the patient and the 30 enzymes, fecal material, et cetera, which exit from the ileum cause ulceration of the skin surrounding the point of externalization. This is primarily due to the presence of active enzymes in the small intestines.

35 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 of their blood by means external from the 40 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 45 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 communica-50 tion 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 55 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.

60 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 extend from the body of the patient. The 65 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 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. 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 or two 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 present invention provides a ureterostomy 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 centerline passing through the center of said passageway outlet from between about 45 degrees and about 75 degrees.

Angular implant devices constructed in accordance with the invention will now be described by way of example only with reference to the accompanying drawings, in which:

Figure 1 is a cross-sectional view illustrating a first angular implant device,

Figure 2 is a pictorial view illustrating a second angular implant device, and

Figure 3 is a partial cross-sectional view illustrating a third angular implant device.

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2 GB 2 143 741 A

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Referring now to Figure 1, an angular implant device, generally referred to as 71, includes a passageway, generally referred to as 73, and an anchor means for establishing a biological anchor.

5 Anchor means 75 preferably includes a plurality of apertures 739 which promote fibro-vascular ingrowth 731. Passageway 73 includes an inlet section 75 initiated by an inlet 79 and terminated by an outlet 711. The axial centerline 735 passing 10 through the center of the passageway inlet 79 is inclined with respect to the axial centerline 733 passing through the center of the passageway outlet 711 (indicated by the angle "x" in Figure 1)

from between about 45 and 75 degrees in order to 15 connect implant device 71 to ureter 713 without occluding or kinking the ureter 713 and thereby restricting or impeding flow therethrough.

In Figure 1 the implant device 71 is illustrated as connected to a ureter 713 extending from kidney 20 721. The implant device is shown passing through skin 729, fat 727, fascia 725 and rectus 723 in attaching to ureter 713.

Implant device 71 also includes an annular rim 717 which forms an annular recess 737 between 25 the annular rim 717 and the anchor means 715.

This annular recess 737 allows for the securing of vascular grafting means 729 to implant device 71 as, for example, by means of suture 741. The vascular grafting material means 719 is 30 formed, for example, from Dacron, an E. I. du Pont de Nemours & Company product of polyester fibre. Preferably, at least a portion of the grafting mat-kerial from which connector 71 is made is coated with collagen.

35 Referring to Figure 2, a second angular implant device is shown having two inlets sections 75a and 75b initiated with inlets 79a and 79b, respectively. The axial centerlines 735a and 735b passing through the centers of inlets 79a and 79b respec-40 tively, are each inclined (identified by angles "y" with respect to the axial centerline 733 passing through outlet 711 in Figure 8) from between about 45 and about 75 degrees. This embodiment allows a single implant device 71 to be connected to two 45 ureters 713.

Referring now to Figure 3, a third angular implant device is shown wherein passageway 73 is rotatable with anchor means 715. Preferably anchor means 75 is secured about passageway 73 by 50 means of the male 741 female 743 junction. The rotation of passageway 73 allows for connecting to ureter 713 without occluding or kinking the ureter and thereby restricting or impeding flow therethrough.

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Claims

CLAIMS:

1. A ureterostomy device comprising: a passageway having an anchor means, both of 60 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 65 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 70 section wherein the axial 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 45 degrees and about 75 degrees. 75

2. A ureterostomy device as claimed in Claim 1, wherein said passageway is further defined as having two inlet sections each initiated with a passageway inlet and an outlet section terminated with a passageway outlet, wherein the axial center-80 line passing through the center of each passageway inlet is inclined with respect to the axial centerline passing through the center of said passageway outlet from between about 45 degrees and about 75 degrees.

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3. A ureterostomy device as claimed in Claim 1, wherein said passageway is rotatable with said anchor means, said anchor means being annularly extended about said passageway.

4. A ureterostomy device as claimed in Claim 1, 90 2 or 3, further comprising means for ureter attachment material attached to said implant device.

5. A ureterostomy device substantially as herein described with reference to, and as illustrated by, Figure 1 of the accompanying drawings.

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6. A ureterostomy device substantially as herein described with reference to, and illustrated by. Figure 2 of the accompanying drawings.

7. A ureterostomy device substantially as herein described with reference to, and as illus-100 trated by, Figure 3 of the accompanying drawings.

Printed in the UK for HMSO, D8818935, 12.'84, 7102.

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

WC2A 1AY, from which copies may be obtained.