AU615247B2 - Occluding device - Google Patents

Occluding device Download PDF

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Publication number
AU615247B2
AU615247B2 AU28075/89A AU2807589A AU615247B2 AU 615247 B2 AU615247 B2 AU 615247B2 AU 28075/89 A AU28075/89 A AU 28075/89A AU 2807589 A AU2807589 A AU 2807589A AU 615247 B2 AU615247 B2 AU 615247B2
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AU
Australia
Prior art keywords
balloon
catheter
occluding device
aneurysm
sac
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 - Fee Related
Application number
AU28075/89A
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AU2807589A (en
Inventor
Alexei Vasilievich Kobtsev
Sergei Andreevich Romodanov
Alexandr Grigorievich Savenko
Viktor Ivanovich Scheglov
Fedor Andreevich Serbinenko
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KIEVSKY NAUCHNO-ISSLEDOVATELSKY INSTITUT NEIROKHIRURGII
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KI NII NEIROKHIRURGII
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Publication of AU2807589A publication Critical patent/AU2807589A/en
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Publication of AU615247B2 publication Critical patent/AU615247B2/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Reproductive Health (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Description

t6,j 5ZT7 OPI DATE 25/08/89 AOJP DATE 28/09/89 APPLN. I D 28075 89 PCT NUMBER PCT/SU88/00021 3AABKA, OilYbJlkIKUlJAHHA)i B U UI BLIC IUikIn N*Wb C ~aorOBOPOM 0 rIATEHTHOA KOOIEPAUJII14 (PCT) (51) Meciyap ax llacelfmcifwfnn. (11) Homep mewK1yImpo~mofi 1nmaumm: WO 89/0~6984 1137~ee~l~ Al (43) /A2Ta mewaCyHmpoamfl i m1KammH: A61 M 25/00 10 aary C~a 1989 (10.08.89) (21) Hoiwep meI iyinpom~oi mAB":c PCT/SU88/00021 (SU) [SERBINENKO, Fedor Andreevich, Moscow KOJ3LJEB Ajmece~i Bacamrpixei [SU/SU]; (22) AST& mewVjyaapoanfi uojlaqH: KaMeHetu-IlonionbcKHilf 281900, Xme~mHKUKaM o6.n., 27 qampsi 1988 (27.01.88) yn. KpaCHoapmeicmasI 9, KB. 41 (SU) L[KOBTSEV, Aiexei Vasilievich, Kamenets-Podoiskcy (SU)I.
(71) 3axBnrreju (OAR 6eeyKa3aHH1 X 2ocydapcme, Kpome US): (74) AreHT: roprOBO-rPOMbIIIJIEHHASI rAJIATA KI4EBCKf4h HAYqHO-HCCJ1EaOBATEJlh- CCCP; MOCKaa 103735, yn. Kyf16b~uueBa,.ai. 5/2 (SU) CKHM IHHCTHTYT HEfIPOXHPYPrHH [SU/ [THE USSR CHAMBER OF COMMERCE AND SU]; KHeB 252655, yn. MaHyimbcKoro, z. 32 (SU) INDUSTRY, Moscow [KIEVSKY NAUCHNO- ISSLEDOVATELSKY IN- STITUT?!EIROKHIRURGII, Kiev (81) YKa:Iaimm e rocy~iapcm AT (eaporiefcK~fi naTeHT), (72) H3o6peTaTejm, H AU, BE (eBponexcKfi4 naTeHT), BR, CH (eiaponeih- H3o6peTaTejm/3axinwrejm (mo~qbKo 6A US): IIUEFJIOB CKHHi naTeHT), DE (eoponeficKmfi naTeHT), DK FR BH1KTOp HiaHOBH9 [SU/SU]; KmeB 252119, yni. Be- (eaporiehcICKPH riaTeHT), GB (eBponeficKfi riaTeHT), YopyccKasI, a. 156, KB. 51 (SU) [SCHEGLOV, Vik- IT (eaponeAiCK11f naTeHT), LU (eBporieRcKHA nator Ivanovich, Kiev CABEHKO AnieKcarnxp TeHT), NL (eBPoneficKmfi naTeHT), SE (eaponeficKii rpliropbeBulq [SU/SU]; KHeB 252050, yni. MypauKo, riaTeHT), US 5, K~n. 100 (SU) [SAVENKO, Alexanrir Grigorievich, Kiev POMOUAHOB Ceprefl AHitpeefii[SU/SU]; KmeB 252036, yn. ApTema, it. 8, KB. 56 OnryG.iffoBaila (SU) [ROMODANOV, Sergei Andreevich, Kiev C omqemom o me-4,CdyHap06How noucxe CEPEHHEHKO (Ieaop AHitpeeBMT4 [SU/ SUI; MOCKBa 121165, KYTY3OBCKHfi nip.,a. 33, KB. 43 (54) Title: OCCLUDINCIj DEVICE (54) Hanaime HMo6peTeHM: OKKJII1O3I4PY1-OIIIEE YCTPOACTBO 2 /1 (57) Abstract Occluding device comprising an inflatable balloon connected through a sphincter to an insertable catheter the wails of said balloon being provided with at least one annular thickening around the sphincter
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(57) Pe4vepai: OfHDgp Jg8YCTpot4CT 710H /1,Co8gr4H6HHU9 nloCP8A HUMB £FaTeTepom npntwu c ZruaiOT no ueHnlleL mape oAEio BoRpyr C iZHrTepa Oco~ep ta1ee HaAyBHoI baii- CTBOMJ C ZHFepa CO BcTaB- TeH~iz yifa3aH~oPo baviio~a IonIueodpa3Hoe YTOnneHPI6 HCKAIIOtHTEAL]HO AAR5 IWIER HH0bOPMAIHI Kumn~, HCnOJMh3yembie anH o 0oa~e~m c-IpaH-tu*eHoB PCT Ha THTYJTbHbIX .IICTax 6powlop, B KOTOPb[X rny6nYIyOTC~ me2KM~HapoflHbie 3aAlBC B COOTBeTCTBI41H c PCT: ABCTPH31 Sap~anoc SenbrHR B onrapmi SeHHH Spa3HJIH UjeHTPaJnkHoac pHxaHCKaBl PeCn7Y6nlica KOHro WIBeguapiHR Ka~mePYH I~enepaTXBHaji Pecny~iiea repmaHHH
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(paHUHSI ra6oii BernHxo6pH1TatHxe BeHrpHR HTamisi RnOHlHR KoPeiACeas HaponlHo-JjeMOpaTHlieCKasi Pecny6jnHKa KopeACKaR; Pecny6niiea JIHXTeHWJTef4H iWpH 'IaHea Jltoicem6ypr MoHa~o Manaaracicap Maimranl HinepniaHnbl Hop Beri PY.Mb]HHR CyaaH 111Be UH B CCH eraui COBICTCCHII COK)3 q aa Toro COenHHeHHble WfraTbi AmepmKH -low R iED TRANSLATION OF 28075 OCCLUDING DEVICE Technical Field The invention relates generally to medicine, particularly to radiological surgery, and is concerned with occluding devices and is applicable for treatment of the various vascular diseases, specifically, vascular aneurys's and carrying out reconstructive vasoplastic surgery.
Prior Art One of the most widespread diseases affecting human beings nowadays are vasculopathies of the brain, heart, and other organs. It is surgical treatment that is the most efficacious way of remedying the vascular diseases. Apart from being adequately effective, surgical treatment of vasculopathies and its practical implementation involves high degree of traumatism, sophisticated technique and high cost.
Cerebrovascular surgery is accompanied rather freq,.ently by complications concerned wit,. further injury to the vitally important cerebral structures.
Of late radiological or endovascular surgery is gaining evergrowing ap'lication, which involves but low degree of traumatism, is readily available and entails minimum postoperative morbid complications.
Building-up and development of radiological surgery has called for fundamentally novel unprecedented devices for performing such surgical procedures.
Quite a number of devices for performing radiological surgery on blood vessels, catheters with detachable small-sized balloons (cf. FR, A, 2,36I,I24). One prior-art device consists of a catheter connected to a detachable balloon through a coupling. Detachable balloons may be of different construction, viz., with a thickened wall facing the balloon sphincter, with a self-sealing opening provided in the thickened wall opposite the sphincter. Manipulation with the balloon-catheter of the aforesaid construction is ^^El i i I 2 carried out by its being introduced through a puncture needle into the vessel involved and brought to the pathologically changed vessel portion, followed by complete occlusion of the affected vessel by distending the ballon, filling it with a quickly sodifying matter, and removing the catheter. The device in question, however, finds but very restricted application due to imperfection of its construction and is only capable of completely cutting the morbid vessel out of the blood flow. Surgical procedures carried 1O out with the aid of the present device are fraught with postoperative complications provoked by disturbed physiology of circulation.
l Another occluding device close to that of the present invention is an occluding device made likeqise as a catheter with a detachable balloon (cf. GB, A, 2,115,289). The device comprises a distensible balloon connected to a catheter through a coupling. A heating wire coil is put on the coupling and is electrically connected, via one or two wire conductors, to a source of electric current. The balloon is detached from the catheter by burning out or fusing i: the coupling.
Treatment of vascular diseases with the use of the j aforediscussed device is carried out as follows. Having K passed the device through the puncture needle one should I 25 approach it to the pathologically changed vessel portion, i whereupon the balloon is distenLed by being filled with a quick-solidifying matter, thus attaining complete vessel occlusion. Then the wire coil heater is energized from the current source, whereby the coil heater burns out or fuses the coupling interconnecting the catheter and the balloon, the catheter is disengaged from the balloon and withdrawn along with the coil heater and wire conductors.
However, the aforementioned balloon is of a rigid construction and thereby fails to be introduced into the aneurysmal sac and the efferent vessels, which restricts prac- I- 3 tical application of the device. Thus, the device is only applicable for complete occlusion of large-calibre arterial Svessels, while constructional imperfection of attachment and detachment of the balloon might result in some cases in severe morbid postoperative events.
An occluding device that proves to be the closest to that disclosed in this invention is the occluding: device that has gained most widespread application and propagation, viz. the Debrun's balloon-catheter (cf. FR, A, 2,383,673).
The device incorporates a catheter and a detachable distensible balloon provided with a built-in radiopaque marker, which is essentially a metallic clip located in a thickened portion of the balloon wall arranged opposite to the sphincter of the balloon. The latter sphincter is curved inwards into the interior of the balloon and of the catheter placed on the balloon outer wall. The catheter is provided with another movable catheter located over the main catheter. Upon cutting the aneurysmatic vessel out of the blood flow the balloon is detached from the catheter and both of them are then removed from the vessel.
The operative procedure for cutting the pathologically changed vessel portion out of the blood flow is carried out as follows.
The Debrun's balloon-catheter is introduced through a i 25 puncture needle into the affected vessel and is approached to the pathologically changed vessel portion. Thereupon the balloon is distended and filled with a quickly solidifiable matter, while the sphincter of the balloon starts turning inside out upon distending of the latter, with the result that the degree of the balloon-to-catheter adhesion is reduced. To complete disengagement of the balloon from the catheter, a second (accessory) catheter is put over the main ballon carrying catheter and made to slide along the vessel towards the balloon. As a result, the distended balloon is formly held in the vascular lumen. To remove the R 7-
A
I
4 ballon the main catheter is withdrawn from the vascular bed, while the sphincter is turned inside out. The accessory catheter is made to travel towards the balloon to put the balloon, as it were, from the main catheter. The balloon having been disengaged from the catheter, both catheters are extracted from the vessel operated upon. The Debrun's balloon-catheter features a rigid construction,thereby failing to provide penetration of the balloon into the efferent vessels and the aneurysmal chambers, which re- IO stricts practical application of the Debrun's balloon-catheter as a rule to stationary occlusion of the efferent vessels and the aneurysm-carrying vessels. This in turn affects drastically the blood supply and involves severy morbid postoperative events.
To detach the balloon from its carrying catheter much effort is to be applied, which is likewise fraught with danger. Even in cases of successful attempts to bring the Debrun's balloon-catheter into the chamber of an extensive aneurysm or a wide-neck aneurysm in order to cut it out of the blood flow, as many as ten balloons are necessary to be brought into the aneurysmal sac. However, when in the latter sac the balloons are fixed neither to one another nor to the aneurysmal wall, with the result that the ballons are liable to migrate in the aneurysaml sac and to get expelled therefrom by virtue of the blood flow, which in turn is causative of such most severe postoperative complications as ischemia and necrosis of irgans and tissues of various degrees, various speech disturbances, dyskinesia of the lower and upper extre:ities, complex dysesthesia, and in some cases even of fatal outcomes. Besides, vascular aneurysms cut out of the blood flow with the aid of the heretofore-known balloons are liable to develop recurrent bleeding.
Applicability of the balloon-catheters described above is limited by their rigid construction, which prevents them to penetrate through siphon-shaped flexures of the internal
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r carotid artery. The balloons feature such a structure that makes it impossible to insert them into the aneurismal sac.
With all the foregoing in view application of such balloons catheters for cutting saccular aneurysms out of the blood flow and carrying out reconstructive vasoplasty is much restricted.
An aim of the present invention is to ameliorate at i least some of the problem of the prior art.
Accordingly, the present invention provides an occuluding device, comprising a detachable distensible balloon accommodating a radiopaque marker and connected, via a sphincter, to an insertable catheter, wherein the balloon incorporates at least one first annular bead or collar arranged round the sphincter.
An advantage of a preferred embodiment of the present invention is that it provides an occluding device that makes it possible, due to an appropriate construction arrangement of its balloon, to cut the aneurysms of minor and medium-caliber vessels out of the blood flow and to carry 20 out reconstructive vasoplastic operations without disturbing *physiological blood supply.
i :Furthermore, with a preferred embodiment of the Spresent invention, the first collar makes it possible to get access of the second and third order vessels and of saccular i 25 aneurysms of said vessels to reliably cut them out of blood flow, making use of blood flow turbulence in the vessels, i *without disturbing physiology of circulation in the regions r of said vessels. This enables also reconstructive vasoplastic surgery to be performed and false traumatic aneurysms to be cut out of blood supply.
It is expedient that the balloon have at least one isolated section filled with an adhesive substance, the outer wall of said section having a through perforation.
This enables one to deliver an adhesive and thrombosing agent which contributes to a reliable blocking of a small size aneurysmal sac by the balloon and makes is i74%1_ possible to reliably hold said balloon in the aneurysmal sac, 8748A/KLS/19.06.91 -1 1
I
6 thus preventing postoperative complications caused by washing said balloon out of the aneurysmal sac by blood flow, as well as occlusion of vitally important blood vessels.
It is possible to provide the balloon with at least one additional annular bead or collar.
This adds to reliability of surgery for cutting mediumand large-size aneurysms out of blood flow and makes it possible to avoid relapses of the disease due to a stronger holding of the balloon in the aneurysmal sac attainable by 1O the fact that a larger area of the balloon is bonded both with the thrombus and the aneurysmal wall.
It is practicable that at least one retaining element shaped as a hollow projection provided with side holes be installed on the surface of the balloon. This provides for a reliable blocking of small- and medium-size aneurisms having broad or narrow neck and precludes washing the balloon out of the aneurysmal sac due to increased adhesive forces of the thrombus with the balloon which is attained on account of thrombus penetration into the aforesaid hollow projection.
It is expedient that the catheter be made bifurcated.
This enables one to carry-out. X-ray-monitored'surgery in hard-of-access places featuring extensive'vascular bed.
Summary of the Drawings In what follows the present invention will be illustrated by a description of some specific exemplary embodiments thereof to be considered .,ith reference to the accompanying drawings, wherein: FIG.I is a general longitudinal sectional view of an occluding device, according to the invention; FIG.2 illustrates the occluding device of FIG.I while in action, according to the invention; FIG.3 is a longitudinal sectional view of an occluding device incorporating an isolated section, according to the invention; ~~-~---~'~lllle~llll1111111~- Ir IE~i~ 7 FIG.4 illustrates an occluding device incorporating an isolated section while inserted in the aneurysmal sac, according to the invention; is a longitudinal sectional view of an occluding device provided with additional annular beads or collars, according to the invention; FIG.6 illustrates the occluding device of FIG.5 while in working position, according to the invention; FIG.7 presents the occluding device of FIG.5 while in the aneurysmal sac, according to the invention; FIG.8 is a longitudinal sectional view of an occluding device provided with a projection on the side surface thereof, according to the invention; FPG. 9 is an occluding device provided with a projection on its side surface while in the aneurysmal sac, according to the invention; FIG.IO is a fragmentarily cutaway view of an occluding device provided with bifurcated catheters, according to the invention; and FIG.II depicts an occluding device when applied for excluding the vascular aneurysm of the vertebrobasilar vascularity, according to the invention.
Preferred Embodiment of the Invention The occluding device of the invention comprises a detachable distensible balloon I (FIG.I) provided with a radiopaque marker 2 and connected, through a sphincter 3, to an insertable catheter 4. According to the invention, the walls of the balloon I features an annular collar 5 arranged round the sphincter 3. When the balloon I (FIG.2) is introduced through a vessel 6 into an aneurysm 7, air is fed to the interior of the balloon I through the catheter 4.
As a result, the end of the balloon I gets inflated and is entrained by the blood flow into the sac of the aneurysm 7, while the collar-shaped end 5 of the balloon I remains invariable as for size. Then the ballon end inserted into 8 the aneurysm 7 is still more inflated and brought into the aneurysm 7, whereas the marker is freely arranged in the balloon I which fills up the aneurysm 7.
The balloon I (FIG.3) of tho occluding device being claimed herein may have at least one isolated section 8.
FIG.3 presents such a section provided in the top portion of the balloon I; it should however be noted tLat the section 8 may be situated anywhere else in the ballon I and several such sections may be provided. An adhesive 10 is contained in the section 3, which causes rapid thrombus-formation of the blood in the sac of the aneurysm 7 and reliable bonding of the balloon I together with the wall of the aneurysm 7.
Next the balloon I (PIG.4) introduced into the sac of the aneurysm 7 is distended and a quick-solidifying matter 11 is injected thereinto. h'.,ile being distended the balloon I (FIG.4) increases in size, thus deforming "-ie isolated section 8. Upon being deformied the section 8 exposes through perforations 9 through which the adhesive 0O makes its way to the sac of the aneurysm 7, thus establi, hing reliable bonding of the wall of the aneur; sm 7 together with the balloon I.
The balloon I (FIGo5) of the occluding device disclosed herein may have at least one additional annular collar 12.
FIGS 5 and 6, according to the invention, represent two such annular collars 12 provided in the top portion of the balloon I; it should however be pointed out that a plurality of such annular collars 12 may be spaced differently apart.
Then the balloon I brought into the sac of the aneurysm 7 (FIG.7) is filled with the quick-solidifying matter II.
As a result, the balloon I, while being distended, acquires a definite shape depending on the dimensions of the annular collars 12 and of the spaces therebetween. The distended section 8 gets deformed, thus exposing the through perforations 9 through which the adhesive IO finds its way -T ~I I I _I 1 9 to the sac of the aneurysm 7, thus causing blood 13 contained in the sac of t- e aneurysm 7 to form thrombus. The thusformed thrombus gets bonded together with the balloon I and the wall of the aneurysm 7, thereby excluding reliably the aneurysm 7 from the blood flow.
The occluding device of the invention may be provided with at least one retaining element 14 shaped as a hollow projection having side holes 15. FIG.8 presents the hollow retaining element 14 and the isolated section 8 provided on the side surface of the balloon I. The retaining element 14 may have any shape but it should be hollow and have the through holes 15. The number of the retaining elements 14, their mutual arrangement and position on the balloon I are not specified.
Once the balloon I has been introduced into the sac of the aneurysm 7, it is filled with the quick-solidifying matter II, the radiopaque marker 2 being in any position within the balloon I. '/hile getting distended the balloon I closes the neck of the aneurysm 7, expands the isolated section 8 to expose the perforations 9, thus discharging the adhesive 1O into the sac of the aneurysm 7 to form the thrombus 13.
The thus-formed thrombus 13 gets bonded together with the balloon I and, making its way through tie open-end perforations 15, passes through the retaining element 14, thus estabilishing additional links that hold reliably the balloon I in the sac of the aneurysm 7.
The occluding device of the invention .,ay have a bifurcated catheter. FIG.IO depicts the catheter I having two channels 16 and 17, merge quietly into a single-channel catheter. The dimensional ration of the single-channel and bifurcated catheters may be arbtirary.
The balloon I (FIG.II) is introduced into the sac of the aneurysm 7 of the vertebrobasilar vascularity via a femoral artery 18 and is then guided through an abdominal I
I
I0 aorta 19 and a vertebral artery 20. To monitor how the aneurysm 7 is being filled up a radiopaque agent is fed along the cheannel 16 of the catheter 4 and, as soon as t-e agent reaches the balloon I the channel 17 of tho catheter 4 is closed. Upon extracting the radiopaque agent from the balloon I both of the channels 16 and 17 of the catheter 4 are opened.
The balloon I Ls filled with the ,uick-solidifying matter II via the channel 17 of the catheter 4 with the IO channel 16 of said catheter open and evPn at some negative pressure therein. Once the balloon I has been partially filled with the quick-solidifying matter II, the channel 16 of the cctheter 4 is closed, whereupon the balloon I is fillel with the quick-solidifying matter completely.
Having diagnosed a large-size aneurysm with a normalsize aneurysmal opening, one should select the balloon having two an.-ular collars (PIGS Then the artery is punctured with a special needle, whereupon the occluding device is passed into the artery 6 through the puncture needle, the isolated section 8 of the occluding device being filled with the adhesive-and-thrombosing agent 10, which is delivered, by virtue of surgeon's manipulations and of the blood flow, to the opening of the aneurysm 7.
.aaking use of the specific features of hemodynamics, the balloon I is brought into the sac of the aneurysm 7. Then the radiopaque agent is supplied along the catheter 4 to the balloon I, whereupon its position in the sac of the aneurysm 7 is monitored against the degree of filling with the radiopaque agent and by the radiopaque m:arker 2. Thereupon the radiopaque agent is let out of the balloon I along the catheter 4. Next the quick-solidifying matter II is syringeinjected into the ballon I through the catheter 4. ,While being distended the balloon I increases in size and fills up the sac of the aneurysm 7.
The walls of the balloon I are expended in different 3 ill I II degree due to the provision of the annular collars 12, with the result that the balloon I acquires an intr:.cate shape (FIG.6). As a result, the isolated section 8 preliminary filled with the adhesive-and-thrombosing agent gets deformed and th-e agent 10 makes its way through the open-end perforations 9 to the sac of the aneurysm 7, thus causing the thrombus 13 to form, which encompasses the body of the balloon I and holds it reliably in the sac of the aneurysm 7 (FIG.7), while the catheter 4 retains the balloon I by virtue of the sphincter 3. Then while performing light manipulations pulling at the catheter one should to remove the catheter 4 fro: the balloon I and the sphincter 3 is drawn up.
The herein-proposed occluding device differs from all the heretofore-known balloon-catheters in its being capable of excluding from the blood flow arterial aneurysms of any location provided its diameter exceeds 0.5 mm and its neck is accessible for the ballon to introduce into the aneurysmal sac.
Industrial Applicability It is extremely valuable that in a ma-jority of cases the occluding devices of the invention are suitaole for a reconstructive vasoplastic surgery, an ideal surgical procedure aimed at occluding the sac of an arterial aneurysm form blood circulation and retaining the passability of th- cerebral artery carrying the aneurysm, or of such an artery of any other organ. A great deal of experience that has been amassed for many-year practice in treat:ent of patients suffering from arterial aneurysms demonstrates that endovascular exclusion of such aneurysms proves to be most physiological, highly efficacious and reliaole and involves but minimized operation injury, whereas preservation of the parental vessel and occlusion of the aneurysmal sac testify to a fundametally new and unprecedented aim of endovascular surgery for arterial aneurysms.
-I I- 12 Using the occluding devices of the invention one can manage to effect reconstructive vasoplastic surgery in various carotid-cavernous anastomoses, to successfully exclude various arterio-sinusal anc.stomoses, and to conduct treatment of the vascular aneurysms of the abdominal viscera and the aneurysm of the abdominal aorta.
Endovascular surgery with the aid of the detachable balloon-catheters of tho present invention when applied for false traumatic aneurys:s of the cavernous portion of the IO internal carotid artery -akes it possible to perform a reconstructive surgical procedure in a majority of patients, and thus becomes the operation of choice, since a reconstructive surgery can be pe:'formed in such aneurysms only with the use of the detachable balloon-catheters proposed herein.
Using easy-to-detach balloon catreters one can successfully exclude from circulation diverse intracranial and extracraniai arteriovenous aneurysms. There is a good deal of many-year positive ex.erience in treatment of arterial aneurysms by endovacular surgery.
Furthermore the occluding devices of the invention are in extensive application for treatment of carotid-cavernous and arteriosinusal anastomoses and for the vascular blockage of abuddantly vascularized meningiomas. The devices have been employed to good advantage for occlusion of diverse arteries of internal organs, neck and brain.
The occluding devices of the invention provide for reliable prevention of bleeding due to possible recurrent ruptures of aneurysms and practically rule out rupture of the aneurysmal and vascular walls and tearing the vessels off the organs and tissues.
1 4 OC CL U DL G DEV I C T Abstract of the Disclosure An occluding dev~ce cor-prisinE a distensible ballon connected through a sphincter to an insertable catheter tLh- wialls of the balloon having at least one annular bead or collfar arranged around the Fphincter

Claims (4)

1. An occuluding device, comprising a detachable distensible balloon accommodating a radiopaque marker and connected, via a sphincter, to an insertable catheter, wherein the balloon incorporates at least one first annular bead or collar arranged round the sphincter.
2. An occluding device as claimed in claim 1, wherein the balloon incorporates at least one additional annular bead or collar spaced from the said first annular bead or collar.
3. An occluding device as claimed in either claim 1 or 2, wherein the balloon has at least one isolated section filled with an adhesive substance with the outer wall of the isolated section having a through perforation. *0
4. An occluding device as claimed in either claim 1 or 20 claim 2, wherein the surface of the balloon incorporates at least one retaining element formed as a hollow projection S. provided with side holes. An occluding device substantially as herein described with reference to the accompanying drawings. II b K 4 I DATED this 21st day of June 1991 30 KIEVSKY NAUCHNO-ISSLEDOVATELSKY INSTITUT NEIROKHIRURGTT By their Patent Attorneys GRIFFITH HACK CO 874CA/KLS/19.06.91
AU28075/89A 1988-01-27 1988-01-27 Occluding device Expired - Fee Related AU615247B2 (en)

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PCT/SU1988/000021 WO1989006984A1 (en) 1988-01-27 1988-01-27 Occluding device

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AU615247B2 true AU615247B2 (en) 1991-09-26

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BR (1) BR8807461A (en)
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Also Published As

Publication number Publication date
DK472689A (en) 1989-11-27
EP0358767A1 (en) 1990-03-21
AU2807589A (en) 1989-08-25
BR8807461A (en) 1990-03-27
DK472689D0 (en) 1989-09-26
WO1989006984A1 (en) 1989-08-10
EP0358767A4 (en) 1991-01-23

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