CA1144705A - Implant device - Google Patents
Implant deviceInfo
- Publication number
- CA1144705A CA1144705A CA000342658A CA342658A CA1144705A CA 1144705 A CA1144705 A CA 1144705A CA 000342658 A CA000342658 A CA 000342658A CA 342658 A CA342658 A CA 342658A CA 1144705 A CA1144705 A CA 1144705A
- Authority
- CA
- Canada
- Prior art keywords
- implant device
- passageway
- flange
- blood
- anchor
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0261—Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0294—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a specific shape matching the shape of a tool to be inserted therein, e.g. for easy introduction, for sealing purposes, guide
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- External Artificial Organs (AREA)
- Surgical Instruments (AREA)
Abstract
IMPLANT DEVICE
ABSTRACT
An implant device and surgical methods for its implantation. The implant device includes a passageway (3) having a flange means (5) for attchment to an internal vessel and an anchor means (15) extending from the exter-nal circumference of the passageway for establishing a biological anchor. The device may be provided with vascular grafting material (1)) which is utilized to pro-vide structural support for tissue ingrowth and a micro-pore size sealing material (11) to minimize blood loss during the implanting operation and subsequent healing.
ABSTRACT
An implant device and surgical methods for its implantation. The implant device includes a passageway (3) having a flange means (5) for attchment to an internal vessel and an anchor means (15) extending from the exter-nal circumference of the passageway for establishing a biological anchor. The device may be provided with vascular grafting material (1)) which is utilized to pro-vide structural support for tissue ingrowth and a micro-pore size sealing material (11) to minimize blood loss during the implanting operation and subsequent healing.
Description
7~)5 DESCRIPTION
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 in-volves 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 exter-nalized 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 surround-ing the opening will grow together to permanently securethe vessel to the surface of the body. ~fter 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 a~e normally corrosive due ~o the presence of enzymes et cetra and when they contact the surface of the skin, they cause .. .. .... ~ ... . . . .. . - . - .
.
7~5 ulceration. For example, in an ileostomy, the ileum is externalized to the abdomen of the patient and the enzymes, urïne~ etc., w~ich exit from the ileum cause ulceration o~ the skin surrounding the poïnt of externalization.
This is primarily-due to the presence of active eniymes 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 o~ their blood by means external from the body. ~lood containïng 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 bodyts vascular system on at least a daily basis.
~ne prior method of providing fluid communication with the vascular system involved the insertion of a needle into an artery from ~Jhich blood to be treated was taken and the insertion of a needle into a patieTIt~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*, into an artery and an adjacent vein iTI a lim~ and providing an external communication of shunt between the tubes, which extend from the body of the patient. The shunt ~etween the tubes is required in order to pro~
vide flow through the tubes during that period of time ~hat access is not required for blood treatment. ~ere such circulating blood flow not provided~
*Trademark a blood clot or thrombus could form as would be the case if the tuhes were simply capped creating a static blood volume when the tubes were not in use.
Dialysis, for example, is accomplished hy connecting the arterial and venous tubing to a s.uitable tubing to a suitable dialysis unit. However, such a configuration traumatizes the skïn adjacent the Teflon tubes and a path is provided through the skin for infection to enter the patient's body. Further-more, even with ex*ernal shunts-, blood clots sometimes form within the tubes and create a health hazaTd 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 t~le 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 intrusion, thus requiring the formation of another shunt.
Both the internal and external shunts increase the loading Oll 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 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 implanation.
" ~,..
s -~ -3a-Other objects. and advantages of this invention will h.ecome apparent upon a reading of the entire s.pecification, including the drawings and claims.
Summary of th.e Invention The pres.ent invention provides for an implant devïce ~h;ch may he permanently implanted t~rough a patient's skin ~a47~i providing access to an interrlal body vessel.
According to the invention an implant device com-prises 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 micro-pore size means for minimizing blood loss extending from said passageway and being adjacent said flange means.
Further according to the invention a surgica~ method o installing an implant device within a body ~omprises opening a body vessel, positioning an implant device, having a passageway therethrough, adjacent to said vessel such that one end of said implant device passage-way 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 attach-ment of the flange means to the opened vessel. The device includes an anchor flange means positioned about ~4~7~)S
the external circumference of the blood passageway for establishing a biological anchor and vascular grafting material positioned abou-t the device for providing s-tructural 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 l and 2 are pictorial views of an implant device of this invention.
Figure 3 is a pictorial view and partial cross-section illus-trating 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 illustrati.ng a surgical method for placing an implant device of this invention in communication with the colon.
Figures 7 and lO are cross-sec-tional views of an implant device secured to a bowel.
Figures 8 and 9 illustrate the implant device in cross-section and viewed from -the end.
Figure ll is a cross-sectional view illustrating a surgical method of placing an implant device of this invention in communication with the blad-der.
Figures 12 and 13 illustrate the Implant device in cross-section and ~,, ~ - 5 -'7~5 viewed from the end.
Figure 14 is a cross-sectional view illustratlng a surgical method oE
placing an implant device of this invention in communication with the ureter.
Figure 15 illustrates the implant device viewed from the end.
Description of Preferred Embodiments Referring now to Figure 1, the implant device, ~ J
- 5a -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 rela~ively smooth surfaced nonporous, nonbiodegradable biocompatible material such as vitreous carbon or a 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 15 may be positioned about the external circumference of the passageway 3 having a plurality of uniformly spaced aperatures 17 passing therethrough. Again, as shown in Figure 3, such aperatures 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 15 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 lmplanta-tion. 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 15 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 & Co~ trademarked product of polyester fiber made from polyethylene terephthalatel 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 17 of the anchor flange 15 and may be secured to the anchor flange 15 at the apertures 1 by means of suitable suture fiber.
A small pore size material 11 such as "impra gra~t", a ~44~S
~ 7- .
t~ademarked product made from micro-porous polytetra-fluroethylene may extend in a plane generally pa~allel 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 accomodate 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 13, it may be . 10 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 de~oxm-able 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~
s 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 co~metically 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 configura-tion referred to as an ileal (when connected to the ileum) conduit for the passage of urine. Annular rim 56 and anchor flange 15 form an annular recess 58 about which the porous ingrowth matrix 19 and the micropore seal means 11 may be secured by suture or the like. In the embodi-ment 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 import-ance. Accordingly, a second annular rim 56A is providedproducing second and third annular recesses 58B and 58C
in addition to the first annular recess 58 between rim 56 and anchor flange 15. 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 coniguration 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 . , . . .. .. .. . .. . . ... ... .. _ . . .. ,, ... .. .. .... . . .. .. . . . . . .... ... . ,, ., ..... . . , .. ... , . , . , ~ . ~ .... ..
s 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 lu 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 accomodate the ureter 52.
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 in-volves 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 exter-nalized 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 surround-ing the opening will grow together to permanently securethe vessel to the surface of the body. ~fter 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 a~e normally corrosive due ~o the presence of enzymes et cetra and when they contact the surface of the skin, they cause .. .. .... ~ ... . . . .. . - . - .
.
7~5 ulceration. For example, in an ileostomy, the ileum is externalized to the abdomen of the patient and the enzymes, urïne~ etc., w~ich exit from the ileum cause ulceration o~ the skin surrounding the poïnt of externalization.
This is primarily-due to the presence of active eniymes 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 o~ their blood by means external from the body. ~lood containïng 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 bodyts vascular system on at least a daily basis.
~ne prior method of providing fluid communication with the vascular system involved the insertion of a needle into an artery from ~Jhich blood to be treated was taken and the insertion of a needle into a patieTIt~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*, into an artery and an adjacent vein iTI a lim~ and providing an external communication of shunt between the tubes, which extend from the body of the patient. The shunt ~etween the tubes is required in order to pro~
vide flow through the tubes during that period of time ~hat access is not required for blood treatment. ~ere such circulating blood flow not provided~
*Trademark a blood clot or thrombus could form as would be the case if the tuhes were simply capped creating a static blood volume when the tubes were not in use.
Dialysis, for example, is accomplished hy connecting the arterial and venous tubing to a s.uitable tubing to a suitable dialysis unit. However, such a configuration traumatizes the skïn adjacent the Teflon tubes and a path is provided through the skin for infection to enter the patient's body. Further-more, even with ex*ernal shunts-, blood clots sometimes form within the tubes and create a health hazaTd 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 t~le 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 intrusion, thus requiring the formation of another shunt.
Both the internal and external shunts increase the loading Oll 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 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 implanation.
" ~,..
s -~ -3a-Other objects. and advantages of this invention will h.ecome apparent upon a reading of the entire s.pecification, including the drawings and claims.
Summary of th.e Invention The pres.ent invention provides for an implant devïce ~h;ch may he permanently implanted t~rough a patient's skin ~a47~i providing access to an interrlal body vessel.
According to the invention an implant device com-prises 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 micro-pore size means for minimizing blood loss extending from said passageway and being adjacent said flange means.
Further according to the invention a surgica~ method o installing an implant device within a body ~omprises opening a body vessel, positioning an implant device, having a passageway therethrough, adjacent to said vessel such that one end of said implant device passage-way 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 attach-ment of the flange means to the opened vessel. The device includes an anchor flange means positioned about ~4~7~)S
the external circumference of the blood passageway for establishing a biological anchor and vascular grafting material positioned abou-t the device for providing s-tructural 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 l and 2 are pictorial views of an implant device of this invention.
Figure 3 is a pictorial view and partial cross-section illus-trating 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 illustrati.ng a surgical method for placing an implant device of this invention in communication with the colon.
Figures 7 and lO are cross-sec-tional views of an implant device secured to a bowel.
Figures 8 and 9 illustrate the implant device in cross-section and viewed from -the end.
Figure ll is a cross-sectional view illustrating a surgical method of placing an implant device of this invention in communication with the blad-der.
Figures 12 and 13 illustrate the Implant device in cross-section and ~,, ~ - 5 -'7~5 viewed from the end.
Figure 14 is a cross-sectional view illustratlng a surgical method oE
placing an implant device of this invention in communication with the ureter.
Figure 15 illustrates the implant device viewed from the end.
Description of Preferred Embodiments Referring now to Figure 1, the implant device, ~ J
- 5a -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 rela~ively smooth surfaced nonporous, nonbiodegradable biocompatible material such as vitreous carbon or a 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 15 may be positioned about the external circumference of the passageway 3 having a plurality of uniformly spaced aperatures 17 passing therethrough. Again, as shown in Figure 3, such aperatures 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 15 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 lmplanta-tion. 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 15 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 & Co~ trademarked product of polyester fiber made from polyethylene terephthalatel 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 17 of the anchor flange 15 and may be secured to the anchor flange 15 at the apertures 1 by means of suitable suture fiber.
A small pore size material 11 such as "impra gra~t", a ~44~S
~ 7- .
t~ademarked product made from micro-porous polytetra-fluroethylene may extend in a plane generally pa~allel 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 accomodate 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 13, it may be . 10 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 de~oxm-able 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~
s 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 co~metically 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 configura-tion referred to as an ileal (when connected to the ileum) conduit for the passage of urine. Annular rim 56 and anchor flange 15 form an annular recess 58 about which the porous ingrowth matrix 19 and the micropore seal means 11 may be secured by suture or the like. In the embodi-ment 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 import-ance. Accordingly, a second annular rim 56A is providedproducing second and third annular recesses 58B and 58C
in addition to the first annular recess 58 between rim 56 and anchor flange 15. 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 coniguration 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 . , . . .. .. .. . .. . . ... ... .. _ . . .. ,, ... .. .. .... . . .. .. . . . . . .... ... . ,, ., ..... . . , .. ... , . , . , ~ . ~ .... ..
s 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 lu 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 accomodate the ureter 52.
Claims (3)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An implant device comprising a passageway having an external circum-ference and a flange at one end thereof; an anchor flange positioned about the external circumference of said passageway; and vascular grafting material posi-tioned annularly about said implant device and positioned at least between said anchor flange and said flange, and micro-pore size means 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 annular rim about said passageway and between said flange and said anchor flange thereby forming an annular recess between said annular rim and said annular flange.
3. An implant device as claimed in either claim 1 or claim 2 wherein said passageway and said anchor flange are integrally formed from a material selected from the group comprising vitreous carbon and pyrolytic carbon disposed on a graphite substrate.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US6685779A | 1979-08-15 | 1979-08-15 | |
| US66,857 | 1979-08-15 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1144705A true CA1144705A (en) | 1983-04-19 |
Family
ID=22072166
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000342658A Expired CA1144705A (en) | 1979-08-15 | 1979-12-27 | Implant device |
Country Status (7)
| Country | Link |
|---|---|
| JP (1) | JPS5628752A (en) |
| BR (1) | BR7908443A (en) |
| CA (1) | CA1144705A (en) |
| DE (1) | DE2948949A1 (en) |
| FR (1) | FR2474316A1 (en) |
| GB (1) | GB2056282B (en) |
| IT (1) | IT7928361A0 (en) |
Families Citing this family (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4776843A (en) * | 1980-11-21 | 1988-10-11 | Minntech Corporation | Blood access systems |
| US4321914A (en) * | 1980-04-22 | 1982-03-30 | W. L. Gore & Associates, Inc. | Percutaneous conduit having PTFE skirt |
| US4349021A (en) * | 1980-06-09 | 1982-09-14 | Bentley Laboratories | Atraumatic blood access device valve |
| US4421507A (en) * | 1980-12-24 | 1983-12-20 | Carbomedics, Inc. | Plug-type fluid access devices |
| US4557724A (en) * | 1981-02-17 | 1985-12-10 | University Of Utah Research Foundation | Apparatus and methods for minimizing cellular adhesion on peritoneal injection catheters |
| US4496349A (en) * | 1981-05-08 | 1985-01-29 | Renal Systems, Inc. | Percutaneous implant |
| IT1154510B (en) * | 1981-08-14 | 1987-01-21 | Bentley Lab | CONNECTOR DEVICE IMPLANTABLE IN THE BODY AND DEVICE OF VASCULAR IMPLANTATION ASSOCIATED WITH IT |
| JPS6092768A (en) * | 1983-10-28 | 1985-05-24 | 株式会社アドバンス | Living body terminal |
| DE3421001A1 (en) * | 1983-06-15 | 1984-12-20 | Luciano Luigi Botta | MECHANICAL VALVE FOR CLOSING A CUTANEOUS STOMA |
| ATE38938T1 (en) * | 1983-08-22 | 1988-12-15 | Univ Utah Res Found | PERITONEAL INJECTION CATHETER DEVICE. |
| US4897081A (en) * | 1984-05-25 | 1990-01-30 | Thermedics Inc. | Percutaneous access device |
| EP0164896B1 (en) * | 1984-05-25 | 1989-02-01 | Thermedics, Inc. | Percutaneous access device |
| US4668222A (en) * | 1984-05-25 | 1987-05-26 | Thermedics Inc. | Percutaneous access device with removable tube |
| FR2565826A1 (en) * | 1984-06-19 | 1985-12-20 | Aerospatiale | METHOD FOR PRODUCING A SURGICAL IMPLANTABLE PIECE IN AN ORGANISM AND PIECE THUS OBTAINED |
| SE445518B (en) * | 1985-02-27 | 1986-06-30 | Inst Applied Biotechnology | BUKVEGGSGENOMFORING |
| SE455666B (en) * | 1986-04-18 | 1988-08-01 | Dan Lundgren | implant passageway |
| WO1988001518A1 (en) * | 1986-08-29 | 1988-03-10 | Dan Lundgren | Implant passageway |
| FR2604907A1 (en) * | 1986-10-01 | 1988-04-15 | Galtier Claude | IMPLANT HAVING A VASCULAR OR SPINAL CATHETER FOR PARENTERICALLY ASSISTED FOOD |
| US4886502A (en) * | 1986-12-09 | 1989-12-12 | Thermedics, Inc. | Peritoneal access catheter |
| WO1989010727A1 (en) * | 1988-05-02 | 1989-11-16 | Jan Axel Svenson | Implant passageway |
| US4976680A (en) * | 1988-10-07 | 1990-12-11 | Hayman Michael H | Apparatus for in situ radiotherapy |
| US5057075A (en) * | 1989-12-13 | 1991-10-15 | Moncrief Jack W | Method for implanting a catheter |
| WO1998058691A1 (en) * | 1997-06-25 | 1998-12-30 | Biotap A/S | Intercutaneous implant device |
| AUPR514201A0 (en) * | 2001-05-21 | 2001-06-14 | Ventrassist Pty Ltd | Staged implantation of ventricular assist devices |
| GB2409978B (en) * | 2004-01-19 | 2008-02-13 | Peter Andrew Priest | Fistula connector |
| US20100298906A1 (en) * | 2007-09-20 | 2010-11-25 | Continence Control Systems International Pty Ltd | System, method and apparatus for control of enterostomies |
| ES2558590B2 (en) * | 2014-08-05 | 2016-11-17 | Universidad Politécnica de Madrid | FIXING, CLOSURE AND COUPLING DEVICE FOR INTRAVENOUS PERFUSION CATHETER |
| EP3067089A1 (en) | 2015-03-11 | 2016-09-14 | OzLobsters Pty Ltd | Implantable interface device |
| DE102015013936A1 (en) * | 2015-10-28 | 2017-05-04 | Marwan Nuwayhid | Port / pin system for incision of the skin and marking of the incision point |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1161436A (en) * | 1966-11-29 | 1969-08-13 | Chirana Zd Y Zdravotnicke Tech | Improvements in or relating to Gastrostomy Apparatus |
| US3540451A (en) * | 1967-02-28 | 1970-11-17 | William V Zeman | Drainage cannula with tissue connecting assemblies on both ends |
| US3783868A (en) * | 1971-05-06 | 1974-01-08 | Gulf Oil Corp | Percutaneous implant |
| GB2050175B (en) * | 1977-07-07 | 1982-07-14 | Bentley Lab | A traumatic valving mechanism |
-
1979
- 1979-12-05 DE DE19792948949 patent/DE2948949A1/en not_active Withdrawn
- 1979-12-21 GB GB7944069A patent/GB2056282B/en not_active Expired
- 1979-12-21 BR BR7908443A patent/BR7908443A/en unknown
- 1979-12-21 IT IT7928361A patent/IT7928361A0/en unknown
- 1979-12-24 JP JP16909379A patent/JPS5628752A/en active Pending
- 1979-12-27 FR FR7931788A patent/FR2474316A1/en not_active Withdrawn
- 1979-12-27 CA CA000342658A patent/CA1144705A/en not_active Expired
Also Published As
| Publication number | Publication date |
|---|---|
| IT7928361A0 (en) | 1979-12-21 |
| GB2056282B (en) | 1984-04-04 |
| JPS5628752A (en) | 1981-03-20 |
| DE2948949A1 (en) | 1981-03-26 |
| BR7908443A (en) | 1981-03-17 |
| GB2056282A (en) | 1981-03-18 |
| FR2474316A1 (en) | 1981-07-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |