GB2056282A

GB2056282A - Implant device

Info

Publication number: GB2056282A
Application number: GB7944069A
Authority: GB
Original assignee: Bentley Laboratories Inc
Current assignee: Bentley Laboratories Inc
Priority date: 1979-08-15
Filing date: 1979-12-21
Publication date: 1981-03-18
Also published as: DE2948949A1; JPS5628752A; IT7928361A0; BR7908443A; CA1144705A; GB2056282B; FR2474316A1

Abstract

An implant device 1 which may be permanently implanted into a patient's skin for providing communication from an internal vessel to the exterior surface of the patient's skin, comprises a passageway having a flange means (not shown) at one end, for attachment to an internal vessel (e.g. blood vessel 13, colon, bladder, ureter) and an anchor flange (15 Fig. 1 not shown), having a plurality of apertures (17), positioned around the external circumference of the passageway to provide a secure biological anchor. When access to the internal vessel is not required, the passageway may be closed by inserting a plug therein. The implant may also be provided with a vascular grafting material 19 which is positioned annularly around the passageway, in order to provide structural support for tissue ingrowth. A micro-pore size material 11 may also be included around the said flange means to reduce blood loss during the implanting operation and subsequent healing. <IMAGE>

Description

SPECIFICATION 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 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 discharged from the vessel. These excrements are normally corrosive due to the presence 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 enzymes, urine, et cetera, which exist 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, 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 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 provided 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 of shunt between the tubes, which 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 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 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 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 the needles are inserted in the fistula. Morevoer, 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 artierie'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 implantation.

Other objects and advantages of this invention will become apparent upon a reading of the entire specification, including the drawings and claims.

Summary of the Invention The present invention provides for an implant device which may be permanently implanted through a patient's skin providing access to an internal body vessel.

According to the invention an implant device comprises 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 mocro-pore size means for minimizing blood loss extending from said passageway and being adjacent said flange means.

Further according to the invention a surgical method of installing an implant device within a body comprises opening a body vessel, positioning an implant device, having a passageway threrethrough, adjacent to said vessel such that one end of said implant device passageway 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 attachment of the flange means to the opened vessel. The device includes an anchor flange means positioned about the external circumference of the blood passageway for establishing a boilogical anchor and vascular grafting material positioned about the device for providing structural 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 1 and 2 are pictorial views of an implant device of this invention.

Figure 3 is a pictorial view and partial crosssection illustrating 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 illustrating a surgical method for placing an implant device of this invention in communication with the colon.

Figures 8 and 12 are cross-sectional views of an implant device of this invention.

Figure 11 is a cross-sectional view illustrating a surgical method of placing an implant device of this invention in communication with the bladder.

Figure 14 is a cross-sectional view illustrating a surgical method of placing an implant device of this invention in communication with the ureter.

Description of Preferred Embodiments Referring now to Figure 1, the implant device, 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 relatively smooth surfaced nonporous, nonbiodegradable biocompatible material such as vitreous carbon or as 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 1 5 may be positioned about the external circumference of the passageway 3 having a plurality of uniformly spaced apertures 17 passing therethrough. Again, as shown in Figure 3, such apertures 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 1 5 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 implantation. 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 1 5 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 8 Co. trademarked product of polyester fiber made from polyethylene terephthalate, 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 1 7 of the anchor flange 15 and may be secured to the anchor flange 1 5 at the apertures 1 by means of suitable suture fiber. A small pore size material 11 such as "impra graft", a trademarked product made from micro-porous polytetraflu roethylene may extend in a plane generally parallel 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 accommodate 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 1 3, it may be 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 deformable 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 31.

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 cosmetically 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 configuration referred to as an ileal (when connected to the ileum) conduit for the passage of urine. Annual rim 56 and anchor flange 15 form an annular recess 58 about which the porous ingrowth matrix 19 and the micropore seal means 1 1 may be secured by suture or the like. In the embodiments 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 importance. Accordingly, a second annular rim 56A is provided producing second and third annular recesses 58B and 58C in addition to the first annular recess 58 between rim 56 and anchor flange 1 5. 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 configuration 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 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 1.

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 accommodate the ureter 52.

Claims

1. An implant device comprising a passageway having a flange means at one end thereof for attachment of said flange means to an opened vessel; an anchor flange means positioned 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.

2. The implant device claimed in claim 1 wherein said device is further provided with an anchor rim about said passageway and between said flange means and said anchor flange means thereby forming an annular recess between said annular rim and said annular flange means.

3. An implant device as claimed in others claim 1 or claim 2 wherein means and said biological anchor are integrally formed from a material selected from the group comprising vitreous carbon and pyrolytic carbon disposed on a graphite substrate.

4. A surgical method of installing an implant device within a body comprising an opening body vessel; positioning an implant device, having a passageway therethrough, adjacent to said vessel such that one end of said implant device passageway 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.

5. A surgical method as claimed in claim 4 including 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.

6. A surgical method of claim 4 wherein said body vessel is a blood vessel and providing blood access including clamping the blood vessel thereby substantially preventing blood flow from said blood vessel; opening said blood vessel to be removed; positioning a plugging means within said implant device passageway; and unclamping said blood vessel. The surgical method claimed in claim 6 wherein said plugging means is defined as having a configuration for substantially expeling blood from said blood access device passageway and for preventing blood flow through said blood access device passageway when said plug is restrained within said blood access device passageway.