WO2010076838A1 - Cathéter d'embolisation par approche transcave d'une endofuite de type i et de type ii consécutive à un traitement par application d'une greffe de stent endovasculaire d'un anévrisme de l'aorte abdominale - Google Patents

Cathéter d'embolisation par approche transcave d'une endofuite de type i et de type ii consécutive à un traitement par application d'une greffe de stent endovasculaire d'un anévrisme de l'aorte abdominale Download PDF

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Publication number
WO2010076838A1
WO2010076838A1 PCT/IT2009/000586 IT2009000586W WO2010076838A1 WO 2010076838 A1 WO2010076838 A1 WO 2010076838A1 IT 2009000586 W IT2009000586 W IT 2009000586W WO 2010076838 A1 WO2010076838 A1 WO 2010076838A1
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WO
WIPO (PCT)
Prior art keywords
catheter
type
treatment
cannula
endoleak
Prior art date
Application number
PCT/IT2009/000586
Other languages
English (en)
Inventor
Roberto Gandini
Original Assignee
Roberto Gandini
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 Roberto Gandini filed Critical Roberto Gandini
Publication of WO2010076838A1 publication Critical patent/WO2010076838A1/fr

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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
    • A61M25/00—Catheters; Hollow probes
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A61M2025/0092—Single injection needle protruding laterally from the distal tip
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure

Definitions

  • the present invention concerns a catheter for the embolization with transcaval approach of type I and type Il endoleak subsequent to the endovascular treatment of abdominal aorta aneurysm.
  • the invention refers to the field of endovascular treatment devices.
  • the aneurysm of abdominal aorta (AAA) consists of a dilation of the arterial wall which tends to increase over the time and, due to intrinsic fragility thereof, is subjected to highest rupture risk, often leading to lethal consequences.
  • abdominal aorta aneurysms is of surgical type, and consists of resection of the involved aortic segment in combination with prosthetic replacement.
  • This approach consists of the exclusion of the aneurysm by means of modular or not modular, self-expandable endovascular stent graft which is possibly bifurcated depending on the extension of iliac artery aneurysm.
  • the endovascular stent graft is inserted directly inside of the abdominal aorta using put ting devices which are inserted by means of mono or bilateral femoral arteriotomy, said endovascular stent graft by expansion adheres to the walls of the aorta and the iliac arteries, excluding the aneurysm feeding.
  • endovascular stent graft involves the exclusion of the aneurysmal sac from any direct blood feeding resulting in detention and pulsatility loss
  • the aneurysmal sac is subjected to a complete thrombosis and successively, in absence of a blood feeding, resorption and re-adaptation phenomena occur.
  • endovascular stent graft treatment can result from stent graft directly inherent factors, surgery operator error and patient anatomy relatable factors. More frequent complications are: migration, stent graft failure, separation of various segments in modular prostheses, i.e. so-called endoleak, so-called endotension, prosthesis occlusion.
  • Endoleaks are classified according to five types.
  • Type I endoleak is correlated to the failure of the prosthesis anchoring to the native artery proximally (Ia) or distally (Ib). This complication occurs where the neck diameter is under-estimated resulting in an inadequate choice of the prosthesis which does not adhere effectively to the vessel walls and consequently it is not suitable to exclude the aneurysmal bag. This type of endoleak makes the endovascular stent graft ineffective and it is to be corrected.
  • the treatment involves the positioning of a new prosthesis or possibly the use of proximal or distal cuffs or conversion to traditional surgery resulting in endovascular stent graft removal.
  • Type Il endoleak results from the feeding inversion of an artery from the aneurysmal bag (lumbar arteries and lower mesenteric artery) which supplies the aneurysm.
  • This endoleak type is the most frequent and is detected only in later TC scanning.
  • the aneurysmal bag remains stable, however only the presence of a type Il endoleak needs a continuous monitoring with semi-annual angio-TC controls resulting in the exposition of the patient to ionizing radiations and administration of organo-iodinated contrast media.
  • volumetric increase >1 cm
  • the endovascular approach generally is carried out by means of embolization of the supplying branch using coils or injection of thrombogenic substances, or by endoscopic application of clips.
  • Type III endoleak results from a prosthesis fault that can be related to a disjunction of the modular prosthesis members or graft breach. This occurrence is not very frequent and can be treated by means of positioning of another prosthesis excluding the bag supply.
  • Type IV endoleak results from the porosity of the prosthesis and generally occurs within 30 days from the positioning. Currently described cases of type IV endoleak when last generation prostheses are used, are very rare. The treatment is conservative.
  • type V endoleak results from an increase of the pressure inside of the bag resulting in enlargement thereof without evidence of blood feeding. This phenomenon is very debated not being clear the effective incidence thereof and how much it can be related to follow-up carried out with inadequate imaging techniques.
  • type Il endoleaks can be treated by means of a femoral venous approach and transcaval puncture under fluoroscopic control.
  • This radiological technique consists of the insertion of a guidewire in the femoral vein and advancement therein of a10 Fr inserting device inside of which successively a 40° angled metallic cannula at distal end thereof is inserted which is normally used in order to provide a porto- istic trans-jugular shunt. This is carried out under fluoroscopic guide allowing the system guideline with respect to the aneurysm to be verified by opportune projections.
  • a flexible cannula is advanced which, following the direction of the metallic cannula, pricks the caval and, by contiguity, aortic wall.
  • the metallic needle is removed and using the cannula a guide is advanced distally through not thrombus affected zones of the aortic aneurysm and then on this guide the cannula suitable to carry out the embolization treatment is moved.
  • the guide is advanced into the zone wherein the endovascular stent graft does not adhere correctly.
  • the cannula which will be localised at the level of the peri-prosthesis zone and used for the release of metallic coils.
  • the abdominal wall is continuously monitored.
  • kit is unknown to the majority of the specialised medical workers involved in endovascular procedures (for example vascular surgeons and cardiologists), with the exclusion of the radiologists.
  • endovascular procedures for example vascular surgeons and cardiologists
  • radiologists the exclusion of the radiologists.
  • the insufficient tendency of these professional workers to the use of adapted instruments and anyway outside of specific use designed to, is to be added to above.
  • the solution according to the present invention is presented aiming to provide for a dedicated catheter suitable to allow in a standardized and reliable way the aneurysmal bag of the abdominal aorta to be pricked directly from the inferior vena cava and a wireguide to be advanced on the needle in the aneurysm, allowing therefore a second catheter to be advanced on the same wireguide for the embolization treatment. Thanks to the commercial availability of the described system exclusively dedicated to the embolization with transcaval approach, the possibility this technique for endovascular treatment to be used also by specialist workers who currently do not use the same, is suggested.
  • a further object of the invention is that said catheter can be produced at substantially reduced costs, both the production and operating costs.
  • Not last object of the invention is the production of a substantially simple, safe and reliably usable catheter.
  • a catheter for the treatment through embolization with transcaval approach of a type I and type Il endoleak after the application of an endovascular stent graft for endovascular treatment of an abdominal aorta aneurysm comprising an exit hole for a cannula having a 40° to 60° variable angle with respect to catheter body .
  • said catheter further comprises a distal probe for endoluminal ecography using intravascular ultrasound technique (IVUS).
  • IVUS intravascular ultrasound technique
  • the advancement of said cannula outside of the catheter is adjustable using the external handle of said catheter and said catheter further comprises a stabilizing balloon 180° angled with respect to the exit hole of said cannula.
  • said catheter comprises a folded portion having a 40° to 90°, preferably 40° to 60° angle with respect to the catheter body at the distal end of said folded portion, said cannula being provided with an exit hole and a flexible stylet too.
  • - figure 1 shows a schematic view of transcaval embolization operation area with a catheter according to the present invention
  • - figure 2 shows a schematic view of the end portion of a first catheter according to the present invention
  • FIG. 3 shows a schematic view of the end portion of a second catheter according to the present invention.
  • the abdominal aorta 10 is shown, wherein an endovascular stent graft 11 is implanted and which presents an aneurysmal bag 12 and the flanking vena cava 13, inside of which the terminal end of a catheter 14 according to the present invention is shown.
  • the catheter 14 can have a length variable from 60 to 100 cm with diameter from 9 to 12 Fr (from
  • This cannula 15 must have a variable angle (from 40° to 60° and up to 90°) and an advancement outside of catheter 14 adjustable using the external handle.
  • the catheter 14 can be used in combination with a distal probe 16 for intravascular endoluminal echography by ultrasound technology (IVUS), in order to facilitate the detection of the catheter 14 position inside of the vena cava 13 and particularly the position of the cannula 15 exit hole 20.
  • IVUS intravascular endoluminal echography by ultrasound technology
  • an alternative solution consisting of a guide catheter 17 with a rigid (metallic) distal IVUS probe 18 having a portion 22 folded with respect to the catheter body 23 with a 40°-60° (up to 90°) angle ⁇ , at the distal end of this portion being present an exit hole of a 5 Fr (1 ,67 mm) cannula 19 provided with a flexible stylet allowing the aneurysmal bag 12 to be pricked following the direction of refolded portion 22, angled for an angle ⁇ with respect to the body 23 of guide catheter17.
  • guide catheter 17 comprises a distal portion 24, parallel to the body 23 of catheter 17, whereon said probe IVUS 18 is localised.
  • the length of folded portion 22 is such that, considering the angle ⁇ , the body 23 and the distal portion 24 of catheter 17 are based on the opposite sides of the vena cava 13, the exit hole 21 of cannula 19 being in contact with the caval wall.
  • the stylet can be removed and, by advancing a 0,035 inch (0,889 mm) guide, the cannula can be used to perform the embolization.
  • the rigid catheter, leaning on the walls of the inferior vena cava offers greater stability during the pricking and embolization and approaches more the needle tip to the caval wall and therefore to the aneurysm, thus eliminating the need of a stabilizing balloon resulting in the fact that the system gauge is not to be increased in order to allow the passage of stabilizing balloon feeding ducts.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention porte sur un cathéter (14, 17) de traitement par embolisation à l'aide d'une approche transcave d'une endofuite de type I et de type II consécutive à l'application d'une greffe de stent endovasculaire (11) pour traitement endovasculaire d'un anévrisme (12) d'aorte abdominale (10). Le cathéter comprend un orifice de sortie (20, 21) pour canule (15, 19) dont l'angle varie de 40° à 90° par rapport au corps du cathéter.
PCT/IT2009/000586 2008-12-30 2009-12-29 Cathéter d'embolisation par approche transcave d'une endofuite de type i et de type ii consécutive à un traitement par application d'une greffe de stent endovasculaire d'un anévrisme de l'aorte abdominale WO2010076838A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000697A ITRM20080697A1 (it) 2008-12-30 2008-12-30 Catetere per l embolizzazione con approccio transcavale di un endoleak di tipo i e ii successivo al trattamento endovascolare di un aneurisma dell aorta addominale.
ITRM2008A000697 2008-12-30

Publications (1)

Publication Number Publication Date
WO2010076838A1 true WO2010076838A1 (fr) 2010-07-08

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Family Applications (1)

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PCT/IT2009/000586 WO2010076838A1 (fr) 2008-12-30 2009-12-29 Cathéter d'embolisation par approche transcave d'une endofuite de type i et de type ii consécutive à un traitement par application d'une greffe de stent endovasculaire d'un anévrisme de l'aorte abdominale

Country Status (2)

Country Link
IT (1) ITRM20080697A1 (fr)
WO (1) WO2010076838A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4235506A1 (de) * 1992-10-21 1994-04-28 Bavaria Med Tech Katheter zur Injektion von Arzneimitteln
US5672153A (en) * 1992-08-12 1997-09-30 Vidamed, Inc. Medical probe device and method
WO1998046119A1 (fr) * 1997-04-11 1998-10-22 Transvascular, Inc. Catheters et dispositifs associes permettant de former des passages entre des vaisseaux et autres structures anatomiques
US20030109809A1 (en) * 2001-12-07 2003-06-12 Jimmy Jen Catheter deployment device
US6692466B1 (en) * 2000-12-21 2004-02-17 Advanced Cardiovascular Systems, Inc. Drug delivery catheter with retractable needle

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5672153A (en) * 1992-08-12 1997-09-30 Vidamed, Inc. Medical probe device and method
DE4235506A1 (de) * 1992-10-21 1994-04-28 Bavaria Med Tech Katheter zur Injektion von Arzneimitteln
WO1998046119A1 (fr) * 1997-04-11 1998-10-22 Transvascular, Inc. Catheters et dispositifs associes permettant de former des passages entre des vaisseaux et autres structures anatomiques
US6692466B1 (en) * 2000-12-21 2004-02-17 Advanced Cardiovascular Systems, Inc. Drug delivery catheter with retractable needle
US20030109809A1 (en) * 2001-12-07 2003-06-12 Jimmy Jen Catheter deployment device

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
G. MANSUETO ET AL.: "Treatment of Type II Endoleaks After Endovascular Repair of Abdominal Aortic Aneurysms: Transcaval Approach", CARDIOVASC INTERVENT RADIOL, vol. 28, 2005, pages 641 - 645, XP035987494, DOI: doi:10.1007/s00270-004-0328-6

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Publication number Publication date
ITRM20080697A1 (it) 2010-06-30

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