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EP0281574A1 - Regulation de l'irrigation sanguine d'un organe - Google Patents

Regulation de l'irrigation sanguine d'un organe

Info

Publication number
EP0281574A1
EP0281574A1 EP87904809A EP87904809A EP0281574A1 EP 0281574 A1 EP0281574 A1 EP 0281574A1 EP 87904809 A EP87904809 A EP 87904809A EP 87904809 A EP87904809 A EP 87904809A EP 0281574 A1 EP0281574 A1 EP 0281574A1
Authority
EP
European Patent Office
Prior art keywords
artery
occluder
blood flow
actuating
skin
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.)
Withdrawn
Application number
EP87904809A
Other languages
German (de)
English (en)
Other versions
EP0281574A4 (fr
Inventor
Rodney James Lane
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vaso Products Australia Pty Ltd
Original Assignee
Vaso Products Australia Pty Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Vaso Products Australia Pty Ltd filed Critical Vaso Products Australia Pty Ltd
Publication of EP0281574A1 publication Critical patent/EP0281574A1/fr
Publication of EP0281574A4 publication Critical patent/EP0281574A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord

Definitions

  • This invention relates to the control of blood flow to an organ of the body.
  • the invention will, in the main, be described in relation to the control of blood flow through the hepatic artery to the liver.
  • the invention is not limited thereto as it may be readily applied to control the amount of blood flow through the splenic artery to the spleen.
  • Both primary and secondary liver tumors are chiefly supplied by blood from the hepatic artery but normal liver tissue derives its blood supply from the portal vein as well as the hepatic artery.
  • the hepatic artery was prepared for later temporary occlusion and drug infusion by placing two thin polyethylene slings around the artery, one on each side of the gastroduodenal artery and drawn through separate larger polyethylene tubes. An infusion catheter was introduced through the right gastropyloric or gastroduodenal artery into the hepatic artery proper.
  • the slings and catheter were drawn through the abdominal wall via separate stab wounds. After the operation intraarterial infusion with glucose solution containing heparin and ampicillin was administered daily to keep the hepatic artery open. The arterial occlusion was performed two to five days after the operation by pulling the strangulating slings and securing them with surgical clamps thereby interrupting arterial blood flow. A disadvantage of the polyethylene slings was the need for external control of the occlusion process.
  • liver cancer Although it has not been proven that hepatic dearterialisation can prolong the life of liver cancer patents, there is evidence that it will improve the symptoms of liver cancer in some patients with metastic carcinoid disease (see TEMPORARY LIVER DEATERIALIZATION IN PATIENTS WITH METASTATIC CARCINOID DISEASE S. Bengmark, M. Ericsson et al. World J. Surg. 6: 46-53 (1982). There is also evidence that it causes necrosis of tumors (see Bengmark, 1982 above and HEPATIC DEARTERIALIZATION IN CANCER: NEW PERSPECTIVES by S. Bengmark et al Eur. Surg. Res. 18: 1510158 (1986)). Currently the treatment is practised only on a trail basis (not a standard procedure) to be used in combination with chemotherapy.
  • the present invention also has application to the control of the amount of blood flowing to the spleen in hypersplenic patients.
  • Such patients typically develop exaggerated hemolytic function of the spleen resulting in deficiency of peripheral blood elements, and hypercellularity of the bone marrow and splenomegaly.
  • the result of this condition is surgical removal of the spleen.
  • the present invention eliminates the need for a splenectomy, and, by reducing the blood flow to the spleen improves its function.
  • a blood flow control system for controlling the flow of blood from an artery to an organ, said system comprising an inflatable occluder adapted to be coupled to the artery and an implant device for the actuation and deactivation of the occluder adapted to be positioned beneath the skin but operable by means applied externally to the body.
  • the inflatable occluder consists of a flexible elastic bag placed around the hepatic artery which is in fluid communication with an actuation device placed completely beneath the skin.
  • the actuation device is a manually compressible reservoir-balloon located beneath the skin but easily operated by externally applied pressure.
  • a release valve which prevents fluid back-flow into the reservoir balloon is located adjacent to the reservoir balloon and is also operated and opened by externally applied pressure.
  • FIG. 1 is a perspective view of an implantable device for controlling and flow of blood according to one embodiment of the invention.
  • Fig. 2 is a cross-sectional view of an implantable device shown in Fig. 1
  • Fig. 3 is a schematic diagram of a first fistula arrangement used in the example of the invention.
  • Fig. 4 is a schematic diagram of a second fistula arrangement used in the example of the invention, and
  • Fig. 5 is a schematic diagram of a third fistula arrangement used in the example of the invention.
  • the blood flow control device shown in Fig. 1 and 2 includes an inflatable pressure means or cuff 10 mounted on a connector 11 having a passage-way 12 in communication with the interior of the occluder cuff 10 and a connecting tube 13.
  • a coupling 15a connects connecting tube 13 to connecting tube 14.
  • the other end of the connecting tube 14 is connected to a pump assembly 15 which includes a compressible reservoir 16, a valve 17 and a valve body 18.
  • a strap 19 is connected to the connector 11 above the cuff 10 and has an aperture 23 through which is fed the connecting tube 13 and the connector 11 so that the strap can be locked to the connector 11 after it has encircled the vein.
  • the valve 17 of Fig. 2 has a body of silicone or other implantable flexible material which defines a valve chamber 18.
  • the valve inlet is connected to the reservoir 16.
  • the outlet 20 (which is closed by diaphragm 24) is connected to the inflatable occluder cuff 10.
  • fluid from the reservoir 16 can be forced into the inlet 25 and through the bore of valve 17 where its pressure lifts the valve diaphragm 24 so that the fluid can pass through the outlet 20.
  • the diaphragm 24 returns to its original position in which it seals against the valve seat.
  • valve body When fluid is to be returned to the reservoir, the valve body is squeezed in the direction of arrows A to lift the diaphragm 24 so that the fluid can return to reservoir 16
  • the blood flow control system of the invention is particularly suitable to control the blood flow to secondary tumors of the liver by intermittent compression of the hepatic artery as an adjunct to the direct infusion of chemotherapeutic agents by infusing either the portal vein or the hepatic artery through any convenient delivery system such as "Infusaport".
  • the timing of the dearterialisationand drug infusion is variable dependent on the size of the tumor and its origin.
  • the aim of this study was to determine the effect of implanting a silicone cuff arund a vein which was made hypertensive by an arteriovenous fistula.
  • the inflatable silicone cuffs were injection moulded from medical grade liquid silicone rubber (SILASTIC (Reg. T.M.) Q7-4780, Dow Corning Corp.).
  • the cuffs were 1.5cm wide.
  • the strap on the outside of the inflatable cuff was made from DACRON (Reg. T.M.) reinforced medical grade silicone rubber (SILASTIC, Dow Corning Corp. Catalog NO. 501- 3).
  • These cuffs were inflatable by a bulb which is implanted in the nearby neck subcutaneously. The cuffs can be inflated (after closure of the skin) transcutaneously.
  • the cuff end of the device was the only part of the device in contact with the vein.
  • a reservoir which is used to inflate the cuff was implanted elsewhere in the neck.
  • Two surgical procedures were used. In the first procedure, an arteriovenous fistula was created to produce a hypertensive vein in sheep using a 6-0 continuous Prolene suture technique.
  • a circumferential inflatable cuff was placed around the vein proximal to the fistula to produce mild constriction. The wound was then closed and the sheep left to recover.
  • Type 1 a side-to-side fistula was created between the superficial femoral vein and the femoral artery of 2 sheep (nos. 27 and 28). The vein distal to the fistula was ligated to further increase intraluminal pressure.
  • Type 2 a side-to-side arteriovenous anastamosis was created between the internal jugular vein and the common carotid artery of 7 sheep (nos. 29, 30, 31, 32, 33, 35 and 42). The vein distal to the fistula was ligated to further inrease intraluminal pressure.
  • Type 3 the arrangement was identical to the second arrangment just mentioned and was applied to 2 sheep (nos. 37 and 41). In addition, the cuff was inflated 20 minutes a day, 6 days a week to maximally stress the vein.
  • Fig. 3 illustrates the first three fistulae arrangements used in the animal model of venous hypertension. Not shown is the fact that the distal vein was ligated in this study. Although Fig. 3 shows the internal jugular vein and common carotid artery, the type 1 arrangement was identical except that different vessels are used. The type 2 and type 3 arrangements differed only that in the type 3 arrangement, the cuff was periodically inflated.
  • Type 4 a cross-over fistula arrangement was used with 1 sheep (no. 62). The opposite jugular vein was mobilised and anastamosed end to side to the internal jugular vein. The internal carotid artery of the side under study was anastamosed end to side to this internal jugular vein. This arrangement is shown in Fig. 4.
  • the fistula was created using a DACRON (Registered T.M. ) "H" graft using an end to side anastamosis from the graft to the internal carotid artery to the internal jugular vein on 1 sheep (no. 68). This arrangement is shown in Fig. 5.
  • DACRON Registered T.M.
  • Macroscopic findings did not reveal any case in which there was thrombosis, fibrous obstruction or ulceration.
  • the vein wall was generally very dilated as a consequence of the high fistula pressures.
  • the vein wall under the silicone was smooth with no ulceration and minimal thickening. A fibrous sheath was always present.
  • the histology of the vein wall was very similar to that of the distal control specimens. There was mild fibrosis with hyalinisation and moderate sub-intimal neovascularisation. There was however, generally a more severe fragmentation of the internal elastic lamina as in the previous study. There was minimal endothelial denudation in most sheep but this was present in sheep 28, 29, 6 and 68.
  • the histological damage was in close proximity to the arterio-venous anastomosis and was possibly related to the high pressure and turbulence at this site.
  • the changes appear to be due to a repair process following dissection and from the damage caused by the fistula.
  • Comparison of the implant and control specimens from light microscopy shows that the majority of the changes were not due to implantation of the venous cuff. Similar changes are seen even without an implant (sheep 92 in protocol 22/1) and have been described in more severe form in vein grafts (28, 94, 102).
  • the silicone cuff can be placed around vessels with high pressure inside with safety.
  • the cuff can also be intermittently inflated with minimal problems. There was no problem with thrombosis or stenosis.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Le système décrit, qui permet de réguler la quantité de sang traversant une artère pour irriguer un organe, se compose d'un dispositif d'occlusion gonflable (10) placé autour de l'artère et d'un dispositif implanté (15) permettant d'actionner le manchon. Le dispositif implanté est en communication fluide (13, 14) avec le dispositif d'occlusion (10). La quantité de sang traversant l'artère est régulée par le fonctionnement transcutané du dispositif implanté (15). Ledit système de régulation de l'irrigation sanguine est particulièrement approprié pour réguler l'irrigation sanguine de tumeurs secondaires du foie par compression intermittente de l'artère hépatique, ce qui permet l'adaptation à l'injection directe d'agents chimiothérapeutiques. Ledit système peut également être utilisé pour occlure l'artère splénique afin de permettre le traitement de l'hypersplénisme.
EP19870904809 1986-07-17 1987-07-17 Regulation de l'irrigation sanguine d'un organe. Withdrawn EP0281574A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPH700086 1986-07-17
AU7000/86 1986-07-17

Publications (2)

Publication Number Publication Date
EP0281574A1 true EP0281574A1 (fr) 1988-09-14
EP0281574A4 EP0281574A4 (fr) 1989-07-20

Family

ID=3771721

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19870904809 Withdrawn EP0281574A4 (fr) 1986-07-17 1987-07-17 Regulation de l'irrigation sanguine d'un organe.

Country Status (5)

Country Link
EP (1) EP0281574A4 (fr)
JP (1) JPH01500404A (fr)
DK (1) DK147388D0 (fr)
FI (1) FI881021A7 (fr)
WO (1) WO1988000455A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990015630A1 (fr) * 1989-06-20 1990-12-27 Sphinx Medical Limited Ameliorations du flux sanguin
US5267940A (en) * 1989-11-29 1993-12-07 The Administrators Of The Tulane Educational Fund Cardiovascular flow enhancer and method of operation
EP1072282A1 (fr) 1999-07-19 2001-01-31 EndoArt S.A. Dispositif de régulation de débit
FR2798840A1 (fr) * 1999-09-27 2001-03-30 Innothera Lab Sa Structure de contention d'un canal anatomique, notamment d'un vaisseau
CN111417361B (zh) 2017-12-01 2023-08-11 C·R·巴德股份有限公司 用于定制的内径缩小的可调节的血管移植物及相关方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3538917A (en) * 1968-04-12 1970-11-10 Robert G Selker Balloon occlusion clip
GB1268034A (en) * 1970-02-07 1972-03-22 David Christy Dunn Inflatable tourniquet-sling for individual biological vessels
US3730186A (en) * 1971-03-05 1973-05-01 Univ California Adjustable implantable artery-constricting device
ZA803521B (en) * 1979-06-21 1981-06-24 Drg Ltd Vascular clamp
US4478219A (en) * 1982-03-24 1984-10-23 Manuel Dujovny Temporary microvascular occluder
US4828544A (en) * 1984-09-05 1989-05-09 Quotidian No. 100 Pty Limited Control of blood flow

Also Published As

Publication number Publication date
JPH01500404A (ja) 1989-02-16
FI881021A0 (fi) 1988-03-04
EP0281574A4 (fr) 1989-07-20
WO1988000455A1 (fr) 1988-01-28
DK147388A (da) 1988-03-17
DK147388D0 (da) 1988-03-17
FI881021A7 (fi) 1988-03-04

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