GB2105197A

GB2105197A - Body implantable connector for connection to an implant device

Info

Publication number: GB2105197A
Application number: GB08223350A
Authority: GB
Inventors: Donald Andrew Raible
Original assignee: Bentley Laboratories Inc
Current assignee: Bentley Laboratories Inc
Priority date: 1981-08-14
Filing date: 1982-08-13
Publication date: 1983-03-23
Also published as: IT1154510B; DE3230049A1; GB8419375D0; GB2105197B; GB2143741B; GB8419376D0; CA1189415A; GB2143740B; GB2143741A; GB2143740A; IT8222801A0; BR8204764A

Abstract

An implantable connector (1) to replace a portion of a patient's body conduit and to connect this conduit to a vascular implant device in order to provide access to the body conduit externally from the body, includes a tubular member (3) having a bulbous portion (5) provided with a side port (7) for connection to the vascular implant device. 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. The implant device (71) may have a passageway, the inlet section of which is inclined at 45 DEG -75 DEG to its outlet section. <IMAGE>

Description

SPECIFICATION Body implantable connector, implant device and angular implant device The present invention relates to a body implantable connector to facilitate the installation of a vascular implant device, and implant device and an angular 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 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,thewall of the vessel and the dermis of the skin surrounding the opening or the subdermal tissue and muscle 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 discharged from 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 external- ized 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 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 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 external and, later internal shunts.

An external shunt involves the insertion of tubes, such as those made of Teflon (Registered Trade Mark), 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 ofthe 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 pro vided, a blood clot orthrombus 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 communi cation with the patient's vascular system. The pat riuent 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 ofthe 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 circula tion in the distal portionofthelimbwhereintheshunt is effected impairs the adequate perfusion of blood.

The present invention provides a connector to replace a portion of a patient's internal body fluid or solid carrying conduit arranged to connect said body conduit to a vascular implant device for providing external access to said body conduit, the connector comprising: a hollow tubular member, a portion of said tubular member being of expanded diameter to form a hollow bulbous portion positioned along the length of said tubular member; and a side port at the approximate midpoint of said tubular member bulbous portion.

The invention also provides a body implantable connector to replace a portion of a patient's internal body fluid or solid carrying conduit arranged to connect said body carrying conduit to a vascular implant device for providing external access to said body conduit, the connector comprising: a hollow, tubular member ofgrafting material, said tubular member being expanded to form a bulbous portion along the length of said tubular member; and a side port, of unitary construction with said tubular member, said side port being positioned at the approximate midpoint of said bulbous portion diameter, said bulbous portion having a lateral diameter at the midpoint of said bulbous portion, as measured along the centerline of said side port, of between about 1.5 and about 2.0 times greater than the diameter of said tubular member prior to the diameter expansion to form said bulbous portion.

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 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 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 mesh also being formed from a material selected from the group comprising (1) pyrolytic carbon disposed on a graphite substrate and (2) vitreous carbon.

The invention also 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 a bout 45 degrees and about 75 degrees.

A body implantable connector, an implant device and three angular implant devices each 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 pictorial view illustrating the body implantable connector, Figure2 is a cross-sectional view taken about 2-2 of Figure 1.

Figures 3 and 4 are pictorial views of the implant device.

Figure 5 is a cross-sectional view of the implant device, Figure 6 is a partial cross-sectional view of the implant device, Figure 7 is a cross-sectional view illustrating a first angular implant device, Figure 8 is a pictorial view illustrating a second angular implant device, and Figure9 is a partial cross-sectional view illustrating a third angular implant device.

A vascular implant device of a type for which the body implantable connector facilitates the installation thereof is, for example, the valved implant device disclosed in issued United States Patent No. 4, 164,221, (corresponding to British Patent No.

2,050,175) issued August 14,1979 ofwhichthe inventor of this invention was a coinventor and which is hereby incorporated by reference.

Referring to Figure 1, a body implantable connector, generally referred to as 1, is shown. The connector 1 is adopted to replace a portion of a patient's internal body fluid or solid carrying conduit such as blood vessel 19. The connector 1 is connected to the remaining body conduit 19 by means of annular suture 21, or the like. As an alternative to this "end to end" connection, the connector 1 may be "side to side" wherein, for example, the side of a vein is connected to the side of an artery.

Connector 1 includes a tubular member3 having an increased diameter bulbous portion 5. Aside port7 is provided at the approximate midpointofthe bulbous portion 5 of the tubular member 3. The tubular member 3 preferably includes inlet 9 and outlet 11 of substantially cylindrical cross-section and having a common cross-section 13. The side port 7 is also preferably of cylindrical centerline, having a centerline 15 which is substantially perpendicular to the common centerline 13 of inlet 9 and outlet 11 oftubular member 3.

The bulbous portion 5 preferably has a partial elliptical contour, the elliptical contour being truncated at its ends at the point 17 of diameter expansion from the diameter of tubular member 3 to the diameter of the bulbous portion 5. Preferably the diameteratthe midpoint of the bulbous portion 5 is between about one and one-half to two times the diameter of the tubular member 3 prior to the diameter expansion at point 17.

The connector 1 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 "impragraft", a trademarked product made from polytetrafluoroethylene. Preferably, 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, hereby incorporated by reference.

Referring now to Figure 3, the implant device, generally referred to as 31, will be discussed. The implant device 31 includes a passageway 33 extending 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 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.

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 ofthe exterior of the implant device 31.

The grafting means mesh 39 is spaced apartfromthe 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 device 31 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 oir vitreous carbon. Preferably the grafting mesh and the exterior of the implant device are coated with collagen.

Referring now to Figure 7, 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. 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 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 7) from between about 45 and 75 degrees in order to connect implant device 71 to ureter 713 with- out occluding or kinking the ureter 713 and thereby restricting or inpeding flow therethrough.

In Figure 7 the implant device 71 is illustrated as connected to a ureter7i3extendingfrom kidney72l.

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 the annular rim 717 and the anchor means 715. This annular recess 737 allows forthe securing ofvasculargrafting means 729 to implant device 71 as, for example, by means of suture 741.

The vascular grafting material means 719 is formed, for example, from Dacron, an E. l. du Pont de Nemours & Company product of polyester fiber. Pre ferably, at least a portion of the grafting material from which connector 71 is made is coated with collagen.

Referring to Figure 8, 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 respectively, 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 ureters 713.

Referring now to Figure 9, 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 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.

Claims

1. A connector to replace a portion of a patient's internal body fluid or solid carrying conduit arranged to connect said body conduit to a vascular implant device for providing external access to said body conduit, the connector comprising: a hollow tubular member, a portion of said tubular member being of expanded diameter to form a hollow bulbous portion positioned along the length of said tubular member; and a side port at the approximate midpoint of said tubular member bulbous portion.

2. A connector as claimed in Claim 1, wherein said tubular member is further defined as having a substantially cylindrical inlet and an outlet, said cylindrical inlet and outlet having a common centerline.

3. Aconnectoras claimed in Claim 1 or2,wherein said bulbous portion is further defined as having a partial elliptical contour, truncated at its ends at the point of diameter expansion from the diameter of said tubular member to form said bulbous portion.

4. A connector as claimed in Claim 2 or Claims 2 and 3, said side port is of substantially cylindrical shape and has a centerline substantially perpendicular to the common centerline of said tubular member inlet and outlet.

5. A connector as claimed in any preceding Claim, wherein said tubular member and said side port are of a unitary construction fabricated from a grafting material.

6. A connector as claimed in Claim 5, wherein said grafting material is further defined as being a fibrous material at least partially coated with collagen.

7. Aconnectoras claimed in any preceding Claim, wherein the lateral diameter of said connector at the midpoint of said bulbous portion is between about 1.5 and about 2.0 times greater than the diameter of said tubular member prior to the diameter expansion to form said bulbous portion.

8. A body implantable connectorto replace a portion of a patient's internal body fluid or solid carrying conduit arranged to connect said body carrying conduit to a vascular implant device for providing external access to said body conduit, the connector comprising: a hollow, tubular member of grafting material, said tubular member being expanded to form a bulbous portion along the length of tubular member; and a side port, of unitary construction with said tubular member, said side port being positioned at the approximate midpoint of said bulbous portion diameter, said bulbous portion having a lateral diameter at the midpoint of said bulbous portion, as measured along the centerline of said side port, of between about 1.5 and about 2.0 times greater than the diameter of said tubular member prior to the diameter expansion to form said bulbous portion.

9. A connector as claimed in Claim 8, wherein said grafting material is further defined as being a fibrous material having at least a portion of the exterior thereof coated with collagen.

10. A connector as claimed in Claim 8 or 9, wherein said tubular member is further defined as having a substantially cylindrical inlet and an outlet, said cylindrical inlet and outlet having a common centerline.

11. A connector as claimed in Claim 8, 9 or 10, wherein said bulbous portion is further defined as having a partial elliptical contour, truncated at its ends at the point of diameter expansion from the diameter of said tubular member to form said bulbous portion.

12. A connector as claimed in Claim 10 or Claims 10 and 11, wherein said side port is of substantially cylindrical shape and has a centerline substantially perpendiculartothe common centerline ofsaid tubular member inlet and outlet.

13. A connector to replace a portion of a patient's internal body fluid or solid carrying conduit arranged to connect said body conduit to a vascular implant device for providing external access to said body conduit, the connector being substantially as herein described with reference to, and as illustrated by, Figures 1 and 2 of the accompanying drawings.

14. 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 ofthe 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 graphite substrate and (2) vitreous carbon.

15. An implant device as claimed in Claim 14, wherein the exterior of said implant device is roughened in order to provide a plurality of interstices in order to facilitate tissue coaption.

16. An implant device claimed in Claim 14 or 15, wherein an annular rim is positioned about said passageway thereby forming an annular recess between said annular rim and said anchor means.

17. An implant device as claimed in Claim 14, 15 or 16, wherein at least a portion of the exterior of said implant device is coated with collagen.

18. An implant device as claimed in Claim 14, 15 or 16, wherein at least a portion of said grafting mesh is coated with collagen.

19. An implant comprising: a passageway having an anchor means, both of which are formed from a material selected from the group comprising (1) pyrolytic carbon disp -don a graphite substrate and (2) vitreous carboy r attachment to an opened vessel; said anchor means for establishing a i, logical anchor, and the exterior of said implant device being roughened in order to provide inlproved 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 mesh also being formed from a material selected from the group comprising (1) pyrolytic carbon disposed on a graphite substrate and (2) vitreous carbon.

20. An implant device as claimed in Claim 19, wherein said grafting mesh and at least a portion of the exterior of said implant devices are coated with collagen.

21. An implant device substantially as herein described with reference to, and as illustrated by, Figures 3 to 6 of the accompanying drawings.

22. A ureterostomy device comprising: a passageway having an anchor means, both of which are formed from a material selectred 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 centerofsaid passagewayoutletfrom between about 45 degrees and about 75 degrees.

23. A ureterostomy device as claimed in Claim 22, 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 centerline 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.

24. A ureterostomy device as claimed in Claim 22, wherein said passageway is rotatable with said anchor means, said anchor means being annularly extended about said passageway.

25. A ureterostomy device as claimed in Claim 22, 23 or 24, further comprising means for ureter attachment material attached to said implant device.

26. A ureterostomy device substantially as herein described with reference to, and as illustrated by, Figure 7 of the accompanying drawings.

27. Au ureterostomy device substantially as herein described with reference to, and illustrated by, Figure 8 of the accompanying drawings.

28. A ureterostomy device substantially as herein described with reference to, and as illustrated by, Figure 9 of the accompanying drawings.