WO2006067534A1 - Prothese pour le traitement non invasif des anevrysmes - Google Patents

Prothese pour le traitement non invasif des anevrysmes Download PDF

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Publication number
WO2006067534A1
WO2006067534A1 PCT/HU2005/000137 HU2005000137W WO2006067534A1 WO 2006067534 A1 WO2006067534 A1 WO 2006067534A1 HU 2005000137 W HU2005000137 W HU 2005000137W WO 2006067534 A1 WO2006067534 A1 WO 2006067534A1
Authority
WO
WIPO (PCT)
Prior art keywords
prosthesis
aneurysm
shape
passages
biocompatible polymer
Prior art date
Application number
PCT/HU2005/000137
Other languages
English (en)
Inventor
Gábor KERESZTURY
Original Assignee
Euromed Consult Bt.
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
Priority claimed from HU0402670A external-priority patent/HU0402670D0/hu
Priority claimed from HU0500906A external-priority patent/HU227178B1/hu
Application filed by Euromed Consult Bt. filed Critical Euromed Consult Bt.
Priority to EP05822972A priority Critical patent/EP1843720A1/fr
Publication of WO2006067534A1 publication Critical patent/WO2006067534A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses

Definitions

  • the object of the invention is a prosthesis for the non-invasive treatment of aneurysms, and a method for filling the aneurysm with the inventive prosthesis.
  • Technical field Blood vessel dilations are circumscribed dilations of arteries.
  • an aneurysm is a blood vessel section with a diameter at least 50% greater than the diameter of a normal blood vessel section. Measurements carried out on a large number of adult persons show that the diameter of the normal abdominal aorta is 2 ⁇ 0.3 cm. Thus, according to the above definition, in case the diameter of the abdominal aorta exceeds 3-4 cm, an aneurysm is diagnosed.
  • Aneurysms are dangerous because the continually dilating blood vessel may eventually rupture and cause internal haemorrhage (e.g. in the abdominal cavity), in which case the mortality rate is very high.
  • aneurysms need to be repaired by surgery before a rupture would occur.
  • the first of these is conventional artificial blood vessel implantation, which is carried out by clamping off the artery below and above the affected section and making a longitudinal incision on the aneurysm. Then a biocompatible artificial blood vessel is implanted to provide a replacement for the incised section, the implanted prosthesis being secured (by anastomosis) to the extremities of the vessel sections below and above the aneurysm.
  • the main disadvantage of this method is that suturing the bleeding vessel branches and making the anastomosis are lengthy procedures that require great concentration and sophistication on the part of the operator, meaning that even an experienced surgeon may need as much as 40-50 minutes to complete the procedure.
  • the closed-off areas suffer from ischemia, which results in vital organs (e.g. liver, intestines, kidneys, spinal cord) being ischemic and may potentially lead to permanent damage to these organs.
  • the other widely known method is the so-called endoluminal method, which was developed with the intention to alleviate the patent's operative strain.
  • Major advantages of this method are that the time during which the blood vessel is excluded can be decreased, and it is not necessary to make a cut on the aneurysm.
  • the procedure involves a so-called stent-prosthesis being utilized for excluding the aneurysm from circulation.
  • the stent- prosthesis is deployed through an opening made at a site that is easily accessible for surgery (usually the loins), with the device being worked to the aneurysm under constant x-ray supervision.
  • a stent-prosthesis is a thin-walled artificial blood vessel made of biocompatible plastic, which is pressed against the wall of the blood vessel at the upper and bottom attachment points by inbuilt stents.
  • TW 553951 describes the application of modified polysaccharides.
  • HU 216066 discloses an improved biocompatible polymer where the polypeptides built into the material effectively prevent platelet agglomeration. Disclosure of Invention The aim of the present invention is to eliminate the disadvantages of known methods and to provide a device suitable for that purpose.
  • the invention is based on the recognition that the aneurysm can be completely filled utilizing a customised casting-like vessel prosthesis made of biocompatible material, the prosthesis protecting at the same time the wall of the aneurysm against expansive forces and thereby preventing rupture.
  • the prosthesis is firmly held in place by the aneurysm wall, so the implanted prosthesis will not get displaced.
  • the prosthesis is advantageously configured that the wall thereof gradually becomes thinner towards the upper and bottom "necks" of the aneurysm and fits tightly against the normal vessel portions.
  • the prosthesis comprises a central passage that is necessary for maintaining normal blood flow. Also, in case there are important vessel branches originating from the aneurysm, branch passages are provided to connect the main passage to these branches.
  • the inventive objective is realised by providing a method for manufacturing a cast prosthesis for the non-invasive treatment of aneurysms that is characterised by taking, with the application of computer tomography known per se, the two- or three-dimensional image of the aneurysm and determining - by means of a three-dimensional CAD application - the thickness and location of the main passage of the prosthesis responsible for sustaining blood flow and, if necessary, the thickness and location of side passages; producing, preferably by means of computer aided manufacturing (CAM) technology and expediently with a 4-axis milling macine, the 1 :1 scale negative shape of the aneurysm and the core pieces providing for the formation of passages; casting to the negative shape (with the core pieces inserted) a biocompatible polymer or polymers; surface treating the outer and inner surfaces of the prosthesis and marking the prosthesis with direction marks; then, depending on the size of the prosthesis either leaving it integral or cutting it into multiple pieces that can be assembled to restore the original shape of the prosthesis; and finally steriliz
  • the biocompatible material of the prosthesis is selected from the group consisting of: polytetrafluoroethylene, polysilanes, hydrophilic polysiloxanes, polycarbonates, polyacrylates-metacrylates, polyaminoacids, polyethers, modified polyethylenes, aliphatic polyesters, segmented polyurethanes, and hydrophilic polyethylene oxides.
  • the inventive objective is further realised by providing a prosthesis for the non-invasive treatment of aneurysms that is characterised by being cast from customised biocompatible polymer, having an outer shape conforming to the shape of the aneurysm such that the prosthesis fits tightly against the wall of the aneurysm, with the wall of the prosthesis gradually becoming thinner towards the upper and bottom extremities of the aneurysm and the prosthesis fitting tightly against the normal section of the blood vessel, with the prosthesis comprising an internal passage portion ensuring the normal flow of blood, and in specific cases further comprising internal branch passages connected to the branches of the aneurysm.
  • a preferred embodiment of the inventive prosthesis comprises a polysiloxane coating on its outer surface.
  • Fig. 1 shows the schematic view of an aneurysm having no originating blood vessel branches that are to be preserved
  • Fig. 2 shows the inventive prosthesis adapted for being implanted into the aneurysm of Fig. 1 ,
  • Fig. 3 shows the prosthesis according to Fig. 2 implanted in the aneurysm shown in Fig. 1 ,
  • Fig. 4 is the schematic view of an aneurysm having branches to be preserved after the implantation
  • Fig. 5 shows an embodiment of the inventive prosthesis adapted for being implanted into the aneurysm of Fig. 4, and
  • Fig. 6 shows the prosthesis according to Fig. 5 implanted into the aneurysm shown in Fig. 4. Best Mode of Carrying out the Invention
  • the procedure of producing and implanting the inventive prosthesis is different depending on the characteristics of the aneurysm to be treated.
  • Fig. 1 shows an aneurysm with no preservable vessel branches.
  • the direction of blood flow in blood vessel 2 is indicated by the arrow 1.
  • the blood vessel 2 has a diameter of D 2 .
  • the diameter of the aneurysm increases to D 3 and then again decreases to D 2 .
  • Fig. 2 shows a prosthesis 4 adapted for the treatment of the aneursysm shown in Fig. 1.
  • the prosthesis 4 has an outer shape conforming to the shape of aneurysm 3, with a passage portion 5 being disposed in the prosthesis 4.
  • the passage portion 5 is essentially a channel which constitutes the continuation of the blood vessel 2.
  • the inventive prosthesis 4 is prepared according to the procedure described below. As the location and shape of the aneurysm may differ from patient to patient, prosthesis 4 should be customized to match the needs of the patient.
  • prosthesis 4 undergoes surface treatment to prevent blood coagulation on the surfaces exposed to blood flow. Finally, direction marks are applied to prosthesis 4 which is sterilized and implanted at the appropriate location.
  • Implantation is carried out by first clamping off the artery above and below the aneurysm, and making an incision at the frontal surface thereof, at the portion with the greatest diameter, the incision having a length allowing the insertion of prosthesis 4 into the internal cavity of aneurysm 3.
  • the prosthesis 4 is then inserted, paying attention to the correct orientation indicated by the direction marks, into the internal cavity of the aneurysm 3 through the opening produced in the previous step. Finally, the opening is sutured and the clamping is removed.
  • FIG. 4 shows aneurysm 3 with blood vessel branches 6, 7 to be preserved.
  • D 2 is indicated by the arrow 1.
  • the diameter D 2 of the vessel increases to D 3 in the dilated vessel portion constituting aneurysm 3.
  • the aneurysm 3 according to Fig. 4 is repaired by utilizing a prosthesis
  • the prosthesis 8 shown in Fig. 5.
  • the prosthesis 8 comprises, in addition to passage portion
  • prosthesis 8 according to Fig. 5 is prepared and implanted in the manner described above. Once prosthesis 8 has been implanted, passage portion 9 thereof forms the continuation of blood vessel 2, while blood flow through branch passages 10, 11 into vessel branches 6, 7 is also sustained
  • biocompatible polymer material can be utilized as the material of the prosthesis 4, 8 and for the surface treatment material thereof. Solely for the purposes of exemplification the materials most expediently applicable are listed below:
  • any other commercially available partially or fully hardening biocompatible polymer can be utilized for the manufacture of the prosthesis 4, 8.
  • the outer surface of the prosthesis 4, 8 is coated with a not fully cross-linked, "sticky” biocompatible polymer, for instance polysiloxane, while the inner surface is coated with antithrombogenic coating.
  • a biocompatible polymer for instance polysiloxane
  • antithrombogenic coating As a result prosthesis 4, 8, once in place, practically “sticks” to the wall of the blood vessel, and thus displacing of the implanted prosthesis becomes virtually .
  • An advantageous feature of the inventive prosthesis is that no time- consuming vascular suture is needed during the implantation, and so thus, the length of the implantation procedure is reduced from 40-50 minutes to 4-5 minutes.

Abstract

La présente invention concerne une prothèse pour le traitement non invasif des anévrysmes et un procédé de fabrication de cette prothèse. Le procédé de l’invention comprend les étapes consistant à prendre, en appliquant une technique connue de tomographie informatique, l’image bi- ou tridimensionnelle de l’anévrysme et à déterminer, à l’aide d’une application de CAO tridimensionnelle, l’épaisseur et l’emplacement du passage principal de la prothèse responsable du maintien du flux sanguin et, si nécessaire, l’épaisseur et l’emplacement de passages latéraux ; produire, de préférence à l’aide d’une technique de fabrication assistée par ordinateur (FAO) et rapidement à l’aide d’une fraiseuse à 4 axes, le négatif à l’échelle 1 : 1 de l’anévrysme et les morceaux de noyau pour la formation de passages ; couler dans le négatif (les morceaux de noyau étant insérés dans celui-ci) un ou des polymères biocompatibles ; traiter les surfaces extérieure et intérieure de la prothèse et marquer la prothèse à l’aide de signes indiquant la direction ; puis, en fonction de la taille de la prothèse, la laisser entière ou la couper en plusieurs parties pouvant être assemblées pour rétablir la forme d’origine de la prothèse ; et enfin stériliser et emballer la prothèse terminée. La prothèse est coulée à partir d’un polymère biocompatible personnalisé et sa forme extérieure est conforme à la forme de l’anévrysme, de sorte qu’elle s’insère fermement contre la paroi de l’anévrysme, la paroi de la prothèse devenant progressivement plus fine vers les extrémités supérieure et inférieure de l’anévrysme et la prothèse s’insérant fermement contre la section normale du vaisseau sanguin, où la prothèse comprend une partie de passage intérieur assurant l’écoulement normal du sang et, dans des cas spécifiques, comprend en outre des passages de ramification interne connectés aux ramifications de l’anévrysme.
PCT/HU2005/000137 2004-12-22 2005-12-16 Prothese pour le traitement non invasif des anevrysmes WO2006067534A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05822972A EP1843720A1 (fr) 2004-12-22 2005-12-16 Prothese pour le traitement non invasif des anevrysmes

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
HU0402670A HU0402670D0 (en) 2004-12-22 2004-12-22 Moulded prothesis especially for treating aneurism
HUP0402670 2004-12-22
HUP0500906 2005-09-29
HU0500906A HU227178B1 (en) 2005-09-29 2005-09-29 Prothesis for invaziv treatment of aneurysm

Publications (1)

Publication Number Publication Date
WO2006067534A1 true WO2006067534A1 (fr) 2006-06-29

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/HU2005/000137 WO2006067534A1 (fr) 2004-12-22 2005-12-16 Prothese pour le traitement non invasif des anevrysmes

Country Status (2)

Country Link
EP (1) EP1843720A1 (fr)
WO (1) WO2006067534A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10888414B2 (en) 2019-03-20 2021-01-12 inQB8 Medical Technologies, LLC Aortic dissection implant

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5156777A (en) * 1991-03-21 1992-10-20 Kaye Alan H Process for making a prosthetic implant
US20020137014A1 (en) * 2001-03-06 2002-09-26 Anderson James H. Simulation method for designing customized medical devices
US20030088311A1 (en) * 1998-07-06 2003-05-08 Greene George R. Vascular embolization with an expansible implant

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5156777A (en) * 1991-03-21 1992-10-20 Kaye Alan H Process for making a prosthetic implant
US20030088311A1 (en) * 1998-07-06 2003-05-08 Greene George R. Vascular embolization with an expansible implant
US20020137014A1 (en) * 2001-03-06 2002-09-26 Anderson James H. Simulation method for designing customized medical devices

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
IMAI Y ET AL: "A system for computer-assisted design of stent-grafts for aortic aneurysms using 3-D morphological models.", CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. 2001 JUL-AUG, vol. 24, no. 4, July 2001 (2001-07-01), pages 277 - 279, XP002376989, ISSN: 0174-1551 *
SAITO ET AL: "Successful endovascular repair of an aneurysm of the ductus diverticulum with a branched stent graft: Case report and review of literature", JOURNAL OF VASCULAR SURGERY, ST. LOUIS, MO, US, vol. 40, no. 6, 6 December 2004 (2004-12-06), pages 1228 - 1233, XP005209021, ISSN: 0741-5214 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10888414B2 (en) 2019-03-20 2021-01-12 inQB8 Medical Technologies, LLC Aortic dissection implant

Also Published As

Publication number Publication date
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