EP1253873A2 - Prothese non renforcee a profil reduit pour implantation transluminale - Google Patents

Prothese non renforcee a profil reduit pour implantation transluminale

Info

Publication number
EP1253873A2
EP1253873A2 EP00978112A EP00978112A EP1253873A2 EP 1253873 A2 EP1253873 A2 EP 1253873A2 EP 00978112 A EP00978112 A EP 00978112A EP 00978112 A EP00978112 A EP 00978112A EP 1253873 A2 EP1253873 A2 EP 1253873A2
Authority
EP
European Patent Office
Prior art keywords
prosthesis
linear
catheter
organ
trailing end
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Withdrawn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
EP00978112A
Other languages
German (de)
English (en)
Inventor
Sumit Roy
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP1253873A2 publication Critical patent/EP1253873A2/fr
Withdrawn legal-status Critical Current

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
    • A61F2/07—Stent-grafts
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/92—Stents in the form of a rolled-up sheet expanding after insertion into the vessel, e.g. with a spiral shape in cross-section
    • 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
    • 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
    • A61F2002/065—Y-shaped blood vessels
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821—Ostial stents
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/009—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof magnetic
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval

Definitions

  • This invention under consideration concerns a prosthetic device and related instrument for non-surgically treating diseases of tubular organs of the human body, and methods for using the using the said prosthesis for the said purpose.
  • a retrievable prosthesis comprising a flexible polymer tube provided with two encircling resilient loops for temporary fixation attached independently to two metals leads during implantation is the subject of US Patent 5,776,186.
  • the inherent resistance of a resilient loop to deformation limits the degree to which the prosthesis can be compacted during delivery into the arterial system.
  • the prosthesis also lacks any intrinsic longitudinal support once the manipulation leads are withdrawn following implantation, detracting from its potential safety profile (Resch T. et. al. J Vase Interv Radiol 1999; 10:257-64). Furthermore, in common with currently available prostheses, it cannot be used for treating aortic disease involving the craniocerebral, visceral, or renal branches. Perhaps for these reasons no reports about the use even in animal models has been published thus far in medical literature. Kerr described a conceptually similar prosthesis comprising a polymer tube supported by two bent guidewires each of which is bent to define a loop (US Patent 6,015,422).
  • an expandable device such as an angioplasty catheter is used to break the loops allowing the guidewires to be withdrawn.
  • an expandable device such as an angioplasty catheter is used to break the loops allowing the guidewires to be withdrawn.
  • the resilient loops limit the degree to which the prosthesis can be compacted during delivery into the target organ.
  • two guidewires are provided which are bent to form two outwardly-biased tines that are attached to the prosthesis with threads.
  • a prosthesis for transluminal implantation that has a low enough profile to be introduced into the body by the non-surgical, percutaneous, approach and yet has sufficient longitudinal rigidity to minimise the risk of complications.
  • the prosthesis should be suitable for treating vascular lesions involving the aorta and its craniocerebral, visceral, or renal branches.
  • FIG. 1A is a perspective view of the preferred embodiment of the implantable prosthesis
  • Figure 2 is a perspective view of an alternative embodiment of the implantable prosthesis, characterized by curvilinear members attached to the leading edge and the trailing edge of the prosthesis
  • Figure 3 is a perspective view of an alternative embodiment of the implantable prosthesis with additional curvilinear members attached to the proximal free edge of the prosthesis via a linear member
  • Figure 4 is a perspective view of a branched embodiment of the implantable prosthesis for deployment in a organ at its bifurcation
  • Figure 5 is a perspective view of an branched embodiment of the implantable prosthesis for deployment in a organ and its branches
  • Figure 6A is a perspective view of an alternative branched embodiment of the implantable prosthesis for deployment in an organ and its branch, characterized by curvilinear members attached to the leading edge and the trailing edge of the prosthesis
  • Figure 6B is a perspective view of an alternative branched embodiment of the implantable prosthesis for deployment in a organ and its branch, characterized by curvilinear members being attached to the edges of the prosthesis along the entire circumference of the prosthesis
  • Figure 7A is a perspective view of an alternative embodiment of the implantable prosthesis, characterized by one aperture
  • Figure 7B is a perspective view of an alternative embodiment of the implantable prosthesis, characterized by multiple apertures
  • Figure 8A is a end-on view of an aperture of an implantable prosthesis
  • Figures 8B & 8C are transverse sectional views through alternative embodiments of an aperture of an implantable prosthesis
  • Figure 9A is a perspective view of an alternative embodiment of the implantable prosthesis with multiple apertures
  • Figure 9B is a perspective view of an alternative embodiment of the implantable prosthesis with multiple apertures, characterized by curvilinear members attached to the leading free edge of the prosthesis along the entire circumference
  • Figure 10A is a perspective view of an alternative embodiment of the implantable prosthesis with a single aperture
  • Figure 10B is a perspective view of an alternative embodiment of the implantable prosthesis with a single aperture, characterized by curvilinear members attached to both free edges of the prosthesis along the entire circumference
  • Figure 11 is a perspective view of an alternative embodiment of the implantable prosthesis characterized by a supporting strut limited to the length of the prosthesis
  • Figure 12 is a perspective view of an alternative embodiment of the implantable prosthesis, characterized by a flanged trailing end
  • Figure 13 is a longitudinal sectional view of the delivery tool
  • Figure 14A and 14B are respectively longitudinal sectional views of the leading end of the delivery tool before and after detachment of the implantable prosthesis
  • Figure 15A is a longitudinal sectional view of the leading end of an alternative embodiment of the delivery tool
  • Figure 15B and 15C are respectively longitudinal sectional views of the leading end of the alternative embodiment of the delivery tool before and after detachment of the implantable prosthesis
  • Figure 16 is a longitudinal sectional view of the introducer catheter with its inner stiffening catheter in situ and locked to the introducer catheter
  • Figure 17 is a surface view of the introducer catheter without the inner stiffening catheter in situ
  • Figure 18 is a surface view of the inner stiffening catheter
  • Figure 19 is a longitudinal sectional view partly in section of the leading end of the introducer catheter with the inner stiffening catheter in situ and locked to the introducer catheter
  • Figure 20 is a longitudinal sectional view of the leading end of the introducer catheter after partial withdrawal of the inner stiffening catheter
  • Figure 21 is a longitudinal sectional view partly in section of the leading end of the introducer catheter with the inner stiffening catheter in situ and locked to the introducer catheter illustrating the engagement of the leading free edge of the introducer catheter in the sulcus at the base of the conical tip
  • Figure 22 is a transverse section through the sulcus of the leading end of a stiffening catheter
  • Figure 23 is a perspective view of the implantable prosthesis being prepared for insertion in its loading cartridge
  • Figure 24 is a perspective view of trailing end of a loading cartridge
  • Figure 25A is a perspective view of a loading cartridge containing an implantable prosthesis
  • Figure 25B is a perspective view partly in section of a loading cartridge containing an implantable prosthesis
  • Figure 26 is a perspective view partly in section of a loading cartridge containing an implantable prosthesis with multiple branches
  • Figure 27 is a surface view of the leading end of a loading cartridge for an implantable prosthesis with multiple apertures
  • Figure 28 is a perspective view of a loading cartridge containing an implantable prosthesis with one aperture
  • Figure 29 is a perspective view partly in section of a loading cartridge containing an implantable prosthesis with one aperture
  • Figure 30 is a perspective view partly in section of an implantable prosthesis within its loading cartridge attached to its delivery tool
  • Figure 31 is a perspective view partly in section of a implantable prosthesis being introduced into the abdominal aorta with an aneurysm
  • Figures 32 to 35 are longitudinal sectional views illustrating the implantation of a prosthesis in an abdominal aorta with an aneurysm according to the invention
  • Figures 36 to 45 are longitudinal sectional views illustrating the implantation of prostheses in a thoracoabdominal aorta with an aneurysm involving the craniocerebral branches according to the invention
  • Figure 46 to 51 are longitudinal sectional views illustrating an alternative procedure for implanting prostheses in a thoracoabdominal aorta with an aneurysm involving the craniocerebral branches according to the invention
  • the invention is made from biocompatible materials.
  • the materials used to make the components for permanent implantation are in addition characterised by long-term dimensional, structural, and configurational stability under cyclic loading.
  • the primary component of the invention is a uni- or multilamellar tube
  • tubular prosthesis 1 with circular or elliptical cross-section, made from a flexible polymer (Fig. 1A).
  • Multiple magnetised linear strips or wires (magnetic struts) la may be bonded to the prosthesis 1, parallel to the longitudinal axis of the prosthesis 1 (Fig. IB).
  • the strips la may be bonded to the inner or outer surface of the prosthesis 1, or sandwiched between two adjacent lamellae.
  • the magnetic struts la are aligned and spatially arranged to ensure that radial centrifugal forces are exerted along the entire length of the prosthesis 1.
  • the magnetised linear strips or wires may be substituted with symmetrical deposits of biocompatible magnetised particles.
  • the particles may either be bonded to the tubular prosthesis 1 or impregnated in a biodegradable matrix that is bonded to the tubular prosthesis 1.
  • the leading edge 2 and the trailing edge 3 of the prosthesis may or may not be parallel to each other, or perpendicular to the longitudinal axis of the tube.
  • To the leading free edge 2 of the tube is symmetrically attached a pair of outwardly biased, flexible curvilinear members 4 made from a material with good shape memory.
  • a narrow strip or wire (supporting strut) 5 of a material stiffer than the prosthesis material is attached to at least one of the curvilinear members 4 a narrow strip or wire (supporting strut) 5 of a material stiffer than the prosthesis material.
  • the support strut 5 is longer than the tubular prosthesis 1, and is bonded to the latter along its entire length, parallel to its long axis.
  • the supporting strut is bonded to the inner or outer surface of the prosthesis 1, or sandwiched between two adjacent lamellae.
  • the angle the curvilinear members 4 make with the supporting strut 5 is congruent to the angle the leading free edge 2 makes with the longitudinal axis of the tubular prosthesis 1.
  • the angle between the curvilinear members 4 and the supporting strut 5 can be reversibly altered by the application of force perpendicular to the plane defined by the curvilinear members 4. On removal of the force, the curvilinear members 4 return to their original position.
  • To the tip of the supporting strut may be attached a short, narrow, cylindrical peg (locking peg) 6 (Figs. 1A,1B).
  • the locking peg 6 has a larger cross-section than the supporting strut 5.
  • one or more curvilinear members 4a are also symmetrically attached to the trailing edge 3 of the tubular prosthesis 1 (Fig. 2). Curvilinear members 4b may also be attached to a prolongation 5" of the supporting strut beyond the leading edge of the prosthesis (Fig. 3).
  • the modifications to the tubular prosthesis 1, described in this and the preceding paragraph may also be incorporated singly or in various combinations in the remaining embodiments of the prosthesis.
  • An alternative embodiment of the prosthesis (aorto-bifemoral prosthesis) 7 has a branched configuration as illustrated in fig. 4 .
  • the crotch 8 and the two limbs 7a,7b of the prosthesis 7 are supported by a "V" shaped wire or strip (bifurcation supporting strut) 9 of a flexible material with good shape memory.
  • An alternative embodiment of the branched prosthesis (aortic arch- descending aorta prosthesis) 10 has the configuration as illustrated in fig. 5, and is provided with two branches: left carotid limb 11, and left subclavian limb 12. Each branch 11,12 is provided with a longitudinal supporting strut 5a, and one or more outwardly biased, flexible curvilinear members with good shape memory 4a at its leading edge, at least one of which is attached to the supporting strut 5a.
  • An alternative embodiment of the branched prosthesis (ascending aorta- aortic arch prosthesis) 13 has the configuration illustrated in fig. 6A and fig. 6B, and is provided with one branch: the brachiocephalic limb 14.
  • One or more outwardly biased, flexible curvilinear members with good shape memory 4,4b are symmetrically attached to the leading edge and the trailing edge of the prosthesis 13. At least one of the curvilinear members attached to each free edge is attached to or continuous with the supporting strut 5. The curvilinear members may be attached to the free edges along the entire circumference (Fig. 6B).
  • the prosthesis in an alternative embodiment of the prosthesis (descending aorta module) 15, the prosthesis is provided with one or more apertures 16,17 in its wall as illustrated in fig. 7A and fig. 7B Each aperture is reinforced along its entire circumference with a flat doughnut-shaped patch 18 of a non-elastic, polymer with low resistance to plastic deformation (Figs. 8A, 8B, 8C).
  • the patch 18 may incorporate a radio-opaque or ferromagnetic substance to facilitate detection with radiography and magnetic resonance imaging respectively.
  • Alternative embodiments of the prosthesis with aperture have the configurations illustrated in figs. 9A and 9B (aortic arch-descending aorta module) 19 and figs.
  • the aortic arch-descending aorta module 19 has two apertures, 19a,19b.
  • the ascending aorta-aortic arch module 20 has one aperture 20a.
  • the ascending aorta-aortic arch module 20 is characterized by both free edges having one or more symmetricallly attached outwardly biased, flexible curvilinear members with good shape memory 4,4b symmetrically attached to the trailing edge of the prosthesis 20. At least one of the curvilinear members attached to each free edge is attached to or continuous with the supporting strut 5 (Figs. 10A, 10B).
  • the curvilinear members may be attached to the free edges along the entire circumference (Fig. 9B,10B).
  • the supporting strut 5 does not extend beyond the trailing edge of the prosthesis.
  • the trailing free end 23 of the prosthesis 22 has a larger diameter than the rest of the prosthesis thereby giving a flanged configuration (Fig. 12).
  • To the trailing edge of the prosthesis 22 is symmetrically attached one or more outwardly biased, flexible curvilinear members with good shape memory 4b, at least one of which is attached to or continuous with the supporting strut 5.
  • the curvilinear members 4b may be attached to the trailing free edge along the entire circumference.
  • the delivery tool 24 to implant the invention is represented by fig. 13.
  • the hub of the locking catheter 25 incorporates a Tuohy-Borst valve 27.
  • the leading end 28 of detachment wire 26 may be recessed as illustrated in fig. 15A.
  • the length of the recess (locking recess) 29 exceeds by a small margin the length of the locking peg 6 (Fig. 15B).
  • a plug (detachment wire handle) 31 is attached to the trailing end 30 of the detachment wire handle) 31.
  • the trailing end of the supporting strut 5 is a tight fit within the lumen of the locking catheter 25 (Figs.
  • the locking catheter 25 snugly accommodates the detachment wire 26 and supporting strut 5, once the locking peg engages the locking recess 29 on the detachment wire 26, such that radial movement of the supporting strut with respect to the detachment wire 26 is substantially restricted, while axial movement of the locking catheter 25 over the detachment wire 26 is unhindered (Fig. 15B).
  • a commercially available introducer sheath fitted with a haemostatic valve and a female Luer hub is used to implant all embodiments of the prosthesis that do not have an aperture 1,7,10,13,21.
  • Prostheses with apertures 15,19,20, are implanted with the dployment tool 32 represented by fig. 16. It consists of a introducer catheter 33 (Fig. 17), and an inner, axially movable, coaxial stiffening catheter 34 with a central lumen 35 (Fig. 18).
  • the leading end 36 of the introducer catheter 33 is concentrically flared.
  • a Tuohy-Borst valve 37 carrying a female Luer hub 38.
  • the lumen of the introducer catheter 33 communicates with the lumen of the female Luer hub 38 via the Tuohy-Borst valve 37.
  • the side-ports 40,41 extend linearly to the leading end 36 of the introducer catheter 33 in the form of narrow slits 42,43 (Figs. 17,19,20,21).
  • the stiffening catheter 34 has one or multiple side-ports (Fig. 18), that spatially correspond to the sideports 34a, 34b of the introducer catheter 33 (Figs. 19,20,21).
  • the leading segment 44 of the stiffening catheter 34 tapers to a cone- shaped expansion 45 at the tip.
  • a circumferential sulcus 46 surrounding the leading segment 44 of the stiffening catheter 34 at its junction with the cone-shaped expansion 45 (Fig. 22).
  • the stiffening catheter 34 Prior to use, the stiffening catheter 34 is coaxially placed in the introducer catheter.
  • the leading end 36 of the introducer catheter 33 is engaged in the circumferential sulcus at the base of the cone-shaped expansion 45 on the tip of the stiffening catheter 34, and the Tuohy-Borst valve 37 tightened around the stiffening catheter 34 (Figs. 19,21).
  • the introducer catheter 32 presents a streamlined profile.
  • this step will be performed at the site of manufacture before the device is sterilised.
  • the prosthesis is flattened (Fig. 23) and tightly rolled such that it presents the lowest possible profile.
  • a short thin- wall cannula 47 is placed adjacent and parallel to the supporting strut 5, and the prosthesis rolled around them so that the cannula is coaxial to the prosthesis.
  • a thin-wall polymer tube serves as the loading cartridge 48.
  • the trailing end 49 of the cartridge 48 is flared and its free edge has two symmetrically placed slits 50,51 extending a short distance along the length of the loading cartridge 48, creating two flaps 52,53 (Fig. 24).
  • the loading cartridge 48 is drawn over the prosthesis to prevent it from unravelling (Figs. 25A, 25B).
  • the coaxial cannula 47 is placed through the limb ipsilateral to the side of the detachment wire 26.
  • a thin-wall cannula 47a,47b is introduced though each of the branches before the prosthesis is rolled up (Figs. 26).
  • a flexible, thin-wall cannula is introduced though each of the branches before the prosthesis is rolled up (Figs. 26).
  • the loading cartridge 56 is a thin-wall tube with slits 57,58 spatially corresponding to the position of the cannulae (Fig. 27). The loading cartridge 56 is drawn over the rolled-up prosthesis such that cannula 54 engages the respective slit 57 (Figs. 28,29).
  • Implantation of prosthesis A separate procedure is described for implanting each of the different embodiments in the vascular system are described. These represent only examples to illustrate some of the envisaged uses of the invention and do not limit in any way the scope of its application as set forth in this patent application. Furthermore the deployment of a single prosthesis per site is described. Multiple prostheses may be coaxially deployed using the same or similar procedure if warranted by the anticipated circumferential stresses at the site of the lesion, by using two access sites alternately.
  • a guidewire is placed traversing the lesion.
  • the guidewire and the introducer's dilator are removed.
  • the loading cartridge 48 is introduced into the hub of the introducer sheath.
  • Axial force is applied to the delivery tool 24 to backload the prosthesis 1 into the introducer sheath 59.
  • the loading cartridge 48 is split as described above and removed.
  • the prosthesis is advanced to the desired site under imaging guidance (Fig. 31).
  • the introducer sheath 59 is withdrawn exposing the leading edge 2 of the prosthesis 1.
  • the curvilinear members 4 attached to the leading edge 2 regain their original shape, unrolling the prosthesis 1.
  • the introducer sheath 59 is withdrawn further until the entire prosthesis is deployed (Fig. 32).
  • a guidewire is advanced coaxially through the prosthesis.
  • a stent 60 is deployed across the leading edge of the prosthesis 1 using procedures well known to those skilled in the art, securing the prosthesis 1 to the vessel (Fig. 33).
  • the Tuohy-Borst valve 27 of the delivery tool 24 is opened.
  • the locking catheter 25 is withdrawn detaching the prosthesis from the detachment wire 26.
  • the delivery tool 24 is withdrawn.
  • Another stent 61 is placed across the trailing edge of the prosthesis (Fig. 34). More stents 63 are place along the length of the prosthesis if deemed desirable (Fig. 35).
  • Deployment of the bifurcated prosthesis 7 is performed as explained above, ensuring that the entire device lies in the descending aorta.
  • the prosthesis 7 is withdrawn, if desired, using the delivery tool 24, so that the prosthesis limb 7b contralateral to the detachment wire 26 enters its corresponding common iliac artery.
  • a guidewire is advanced coaxially through the prosthesis.
  • a stent is deployed across the leading edge 2 of the prosthesis 7 securing it to the vessel.
  • Another stent is placed overlapping the free edge of the ipsilateral limb 7b of the prosthesis. This step may be preceded by the placement of an ilio femoral module 21.
  • Another stent is placed overlapping the trailing edge of the latter.
  • the bifurcated prosthesis 7 is detached from delivery tool 24.
  • a stent is placed across the trailing edge of the prosthesis limb 7a on the same side. This step may be preceded by the placement of an iliofemoral module 21. In that case, another stent is placed overlapping the trailing edge of the latter. More stents are place to bridge the gaps between the previously placed stents if deemed desirable.
  • Aorto-biiliac lesions may be alternatively treated by placing two tubular prostheses 1 in parallel, with one prosthesis extending into each iliac artery (Sakaguchi S, et. al. Twin-tube endografts for aortic aneurysms: an experimental feasibility study. J Vase Intervent Radiol 1999; 10:1092-98.)
  • One or multiple stents 64 are placed across the lesion (Fig. 36).
  • a guidewire is advanced into the left subclavian artery 65.
  • An angioplasty catheter 66 is advanced over the guidewire into the left subclavian artery 65.
  • the position of the catheter 66 is adjusted so that the balloon straddles the wall of stent 64.
  • the balloon is inflated to displace any stent strut crossing the ostium of the left subclavian artery 65 (Fig. 37).
  • the balloon catheter 66 is withdrawn.
  • a branch artery module 22 of appropriate size is implanted in the left subclavian artery 65, such that its flanged trailing edge 23 lies within the stent.
  • a stent is placed in the prosthesis 22 to secure it in place.
  • a branch artery module 22 is similarly placed in the left carotid 67 and in the brachiocephalic artery 68 via the same and contralateral access sites respectively. Stents are placed in the prostheses. The guidewires 69,70,71 are not removed (Fig. 38).
  • Another guidewire is placed in the descending aorta via the access used to place the branch artery module in the brachiocephalic artery 68.
  • the stiffening catheter is placed in the introducer catheter and their hubs locked together.
  • the trailing end of the guidewire is fed through the lumen of the stiffening catheter 34 until it exits from the hub of the stiffening catheter.
  • the trailing end of the guidewire 69 in the brachiocephalic artery 68 is fed through the sideports of the introducer catheter 33 and stiffening catheter 35.
  • the introducer catheter is advanced over the guidewires until the sideport of the introducer catheter is at the level of the ostium of the brachiocephalic artery 68.
  • the Tuohy-Borst valve 37 in the hub of the introducer catheter 33 is partially opened.
  • the stiffening catheter 34 is advanced slightly to disengage the tip 36 of the introducer catheter 37.
  • the stiffening catheter 35 is then withdrawn with its coaxial guidewire.
  • the trailing end of the guidewire 69 in the brachiocephalic artery 68 is fed through the cannula 54 lying in the slit 57 of a cartridge containing an ascending aorta-aortic arch module 20.
  • the cannula is removed and the prosthesis 20 is introduced in the hub 38 of the introducer catheter 34.
  • the Tuohy-Borst valve 37 is opened, and the prosthesis 20 backloaded into the introducer catheter 34, and the loading cartridge 56 removed.
  • the prosthesis 20 is advanced until the aperture on the prosthesis is at the level of the ostium of the brachiocephalic artery 68.
  • the introducer catheter 34 is withdrawn, deploying the prosthesis 20 (Fig. 39).
  • a stent 72 is placed overlapping the leading free edge 73 of the prosthesis 20, and securing it in place (Fig. 40).
  • the prosthesis 20 is detached from the delivery tool 24, and the latter withdrawn.
  • An angioplasty catheter 66 is advanced into ostium of the prosthesis 20 in the brachiocephalic artery 68 over the guidewire in situ.
  • the balloon is inflated to dilate the aperture of the prosthesis 20 (Fig. 41).
  • the angioplasty catheter is withdrawn (Fig. 42).
  • the trailing end of the guidewire lying with its tip in the aorta is fed through the lumen of the stiffening catheter 34 of an introducer catheter 32, with two side- ports until it exits from the hub of the stiffening catheter.
  • the trailing end of each of the guidewires 70,71 in the left carotid artery 67 and left subclavian artery 65 is fed through the appropriate sideport of the introducer catheter 33 and its coaxial stiffening catheter 34.
  • the introducer catheter-stiffening catheter ensemble is advanced over the guidewires until the sideports of the introducer catheter and stiffening catheter are at the level of the corresponding branch vessel ostium.
  • the Tuohy-Borst valve 37 in the hub of the introducer catheter 33 is partially opened.
  • the stiffening catheter 34 is advanced slightly to disengage the tip 36 of the introducer catheter 33, and then withdrawn with its coaxial guidewire.
  • each of the guidewires 70,71 in the left carotid 67 and subclavian arteries 65 is fed through the appropriate cannula 54,55 in the slits 50/51 of a cartridge containing an aortic arch-descending aorta module 19.
  • the cannulae are removed.
  • the prosthesis 19 is backloaded into the introducer catheter 33 as described for a prosthesis without apertures.
  • the prosthesis 19 is advanced until the each sideport 40,41 is at the level of the corresponding branch ostium.
  • the introducer catheter 33 is partially withdrawn, deploying the prosthesis with its leading edge 74 overlapping the trailing edge 75 of the prosthesis 20 already in situ (Fig. 43).
  • An angioplasty catheter is introduced into the aorta over the guidewire 70 and placed straddling the ostium of the left carotid artery 67.
  • the balloon is inflated dilating the corresponding aperture of the implanted prosthesis 19.
  • the same procedure is repeated for the left subclavian artery 65.
  • a stent 76 is placed overlapping the leading free edge 74 of the aortic arch-descending aorta module 19 securing it in place (Fig. 44).
  • the delivery tool is detached from the prosthesis 19 and withdrawn.
  • Another stent 77 is placed overlapping the trailing edge 78 of the prosthesis 19 (Fig. 44). More stents 79 are placed if deemed necessary (Fig. 45).
  • Repeat dilatation of the ostium of the craniocerebral branches may be performed using, procedures familiar to those skilled in the art, if deemed necessary.
  • One or multiple stents 64 are placed spanning the lesion (Fig. 46).
  • two microsnares 80,81 are placed in the aorta using procedures familiar to those skilled in the art (Fig. 47).
  • a loop snare is placed in the aorta.
  • the two microsnares 80,81 are exteriorised.
  • the introducer sheath 82 is advanced until its tip was immediately peripheral to the ostium of the left subclavian artery 65.
  • Each microsnare is placed around the corresponding limb 11,12 of an aortic arch-descending aorta branched prosthesis 10, loaded in its cartridge 48.
  • the snares are tightened and branched prosthesis 10 is backloaded into the introducer sheath 83 (Fig. 48).
  • the microsnares 80,81 are withdrawn and the aortic arch-descending aorta branched prosthesis 10 advanced until each prosthesis limb 11,12 has entered its respective branch artery (Fig. 49).
  • the introducer sheath 82 is withdrawn.
  • microsnares 80,81 are withdrawn further and the delivery tool 24 advanced in tact until a satisfactory orientation of the aortic arch-descending aorta branched prosthesis 10 is achieved (Fig. 50).
  • the prosthesis limbs 10,11, are released allowing them to open (Fig. 51).
  • a stent is placed in each prosthesis limb 11,12, securing it in place.
  • the aortic arch- descending aorta branched prosthesis 10 is detached from the delivery tool 24, and the latter withdrawn.
  • a microsnare 83 is introduced into the aorta (Fig. 52).
  • an ascending aorta-aortic arch branched prosthesis 13 is implanted ensuring that its trailing edge 84 overlaps the leading edge 85 of the previously implanted aortic arch-descending aorta branched prosthesis 10.
  • a stent 86 is placed overlapping the leading edge 87 of the ascending aorta-aortic arch branched prosthesis 13.
  • the prosthesis 13 is detached from the delivery tool 24, and the latter withdrawn.
  • Another stent 88 is placed across the trailing edge 89 of the aortic arch-descending aorta prosthesis 10 (Fig. 53). More stents are placed along the length of the prosthesis if deemed necessary.

Abstract

La présente invention concerne une prothèse implantable destinée à être placée dans des organes tubulaires creux, ainsi qu'un instrument servant à déployer ladite prothèse. En compactage radial, la prothèse présente un profil réduit qui permet son introduction dans le corps avec un instrument de déploiement de faible calibre. La prothèse présente une armature longitudinale servant de support longitudinal. Un ou plusieurs éléments flexibles circumlinéaires dirigés vers l'extérieur, ayant une bonne mémoire de formes, fixés symétriquement par rapport à l'extrémité avant de la prothèse, contribuent au déroulement de la prothèse durant son déploiement. Des fils ou de la poudre magnétisés peuvent être fixés sur la prothèse pour faciliter ce processus et donner en plus à la prothèse de l'élasticité radiale. La prothèse peut présenter des extensions tubulaires permettant le traitement de lésions qui touchent l'organe tubulaire parent et ses ramifications. Eventuellement, la prothèse peut présenter des ouvertures qui peuvent être élargies in vivo. Pour l'implantation dans des ramifications, la prothèse peut présenter une bride à son extrémité arrière.
EP00978112A 1999-10-16 2000-10-16 Prothese non renforcee a profil reduit pour implantation transluminale Withdrawn EP1253873A2 (fr)

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US15992099P 1999-10-16 1999-10-16
US159920P 1999-10-16
PCT/NO2000/000337 WO2001028453A2 (fr) 1999-10-16 2000-10-16 Prothese non renforcee a profil reduit pour implantation transluminale

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WO2001028453A2 (fr) 2001-04-26
WO2001028453A3 (fr) 2001-09-20

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