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WO2013040663A1 - Coated stent-connector structural elements - Google Patents

Coated stent-connector structural elements Download PDF

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Publication number
WO2013040663A1
WO2013040663A1 PCT/BR2011/000351 BR2011000351W WO2013040663A1 WO 2013040663 A1 WO2013040663 A1 WO 2013040663A1 BR 2011000351 W BR2011000351 W BR 2011000351W WO 2013040663 A1 WO2013040663 A1 WO 2013040663A1
Authority
WO
WIPO (PCT)
Prior art keywords
endoprosthesis
stent
modular
segment
endopascular
Prior art date
Application number
PCT/BR2011/000351
Other languages
French (fr)
Portuguese (pt)
Inventor
Marco Antonio LOURENÇO
Charles Cristian Facchini DE SOUZA
Isaias Masiero Filho
Original Assignee
Biokyra Pesquisa E Desenvolvimento Ltda
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 Biokyra Pesquisa E Desenvolvimento Ltda filed Critical Biokyra Pesquisa E Desenvolvimento Ltda
Priority to PCT/BR2011/000351 priority Critical patent/WO2013040663A1/en
Priority to BR112014006630A priority patent/BR112014006630A2/en
Publication of WO2013040663A1 publication Critical patent/WO2013040663A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • A61F2002/067Y-shaped blood vessels modular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0067Three-dimensional shapes conical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063Nested prosthetic parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • It comprises an endoprosthesis composed of a straight or conical film body of polymeric material with a support structure made of biocompatible material containing an inner segment of polymeric material with the edge fixed to the inner cylindrical or conical wall of the endoprosthesis body, and this inner segment has a plurality of apertures, of equal or different sizes and shapes, all apertures having radiopaque marking in their contour. These openings allow the connection of already known arterial endoprostheses, in the present state of the art.
  • Endovascular treatment of aneurysms or aortic dissection is performed through the implantation of an endoprosthesis (a minimally invasive device consisting of a stent graft) to exclude the aneurysmal sac or dissection region and restore normal blood flow.
  • an endoprosthesis a minimally invasive device consisting of a stent graft
  • endoprosthesis a minimally invasive device consisting of a stent graft
  • In-situ fenestration makes the procedure commercially feasible because it overcomes the need for customization of endoprostheses.
  • the adaptation of the holes and the branch endoprostheses are part of the surgical procedure itself, which allows extending the scope of the endovascular treatment to cases that today can not be treated by the minimally invasive technique, implying lower risks for the patient and reduction of costs to the health system.
  • the fenestration is done via the subclavian artery, which facilitates the positioning of the fenestration device.
  • the fenestration is initiated by perforating a hole through a needle which is then dilated by a balloon catheter.
  • the force that must be applied to dilate the hole is considerable, hampering process control.
  • the hole dilation process can produce the graft rupture, compromising the integrity of the stent.
  • radiofrequency waves to produce holes in a controlled manner in endoprostheses - Bruszewski and Macaulay (2007) and Wallace and Sthaler (2009).
  • These devices employ an electronic apparatus with two electrodes that concentrate the radiofrequency waves in one of the wells and are therefore able to produce holes in coatings with low force application.
  • these devices also need an adequate electronic control so as not to injure the living tissues adjacent to the hole with an overload of energy.
  • these devices require a radiofrequency source, in addition to two separate electrodes that must be properly positioned to achieve the desired result.
  • Kasirajan 201 1
  • Kasirajan uses an innovative technique using arterial stents simply connected or connected in parallel, ie, connecting one or two endoprostheses in parallel inside another straight or bifurcated arterial endoprosthesis.
  • ENDOPASCULAR MODULAR ENDOPROTETIC SYSTEM comprises a straight or conical arterial endoprosthesis that allows the secure and efficient coupling or coupling of other coated arterial endoprostheses with different diameters and lengths, commercially available.
  • the stent graft is a device which will enable both the treatment of aortic arch aneurysms and thoracic-abdominal aneurysms with the use of commercially known coated arterial endoprostheses. In this way, the use of the endoprosthesis, object of this invention, together with other commercially available arterial stents, will increase the possibility of treatment of arterial aneurysms through a minimally invasive technique.
  • the stents cited by Myers (US005925075A), Hagaman (WO201 / , Lau (US005876432A), James (EP1923020A2), Dierking (GB2476451), Stelter (US2004 / 0260383A1), Greenberg (WO2004 / 002370A1), among other coated endoprostheses available on the Medical Product Market.
  • the differential of the present invention is in the possibility of allowing a precise positioning and coupling of the commercially available arterial endoprostheses.
  • the possibility of a precise positioning provides a greater efficiency of the sealing of the coupled union, thus minimizing any possibility of leakage between the connections and thus providing efficient maintenance of the vital branches of the aorta.
  • the use of the device object of this invention in conjunction with commercially available devices will allow the treatment by any minimally invasive technique of any type of existing aortic artery aneurysm, including aneurysms in regions which have vital branches of the aortic arch, passing through the thoracic region the abdominal region.
  • the straight endoprosthesis is comprised of a cylindrical, straight or conical body, comprising a film coating of polymeric material, of the polyester type, PTFE or the like, with a support structure made of nitinol, stainless steel, chromium molybdenum, biocompatible polymer or similar biocompatible material. It is characterized by presenting an internal segment, made of material similar to that of the body, positioned in a section of the body and connected, by suture, glue or similar means of union, to the inner cylindrical surface of the endoprosthesis body.
  • the inner segment has the geometric shape of a disk or a cone; has two, three, four, five or more openings of equal or different sizes and shapes. All openings are radiopaque in their contour. These openings allow connection of coated arterial endoprostheses, with different sizes and shapes, available in the market of medical products.
  • the inner segments, in the form of disks may be positioned parallel to each other and in transverse sections perpendicular to the axis of the cylindrical body of the endoprosthesis.
  • the inner segments, in the form of disks may be positioned parallel to each other and in transverse sections inclined to the axis of the cylindrical body of the endoprosthesis.
  • the inner segments, in the form of disks may be positioned inclined to each other and in transverse sections inclined to the axis of the cylindrical body of the stent.
  • the inner segment may be circular, elliptical or conical to better fit the connection of commercial endoprostheses in specific regions.
  • the inner segment, elliptical or conical can increase the sealing contact region thereby offering a more efficient sealing.
  • Internal segments positioned in transverse sections inclined to the axis of the cylindrical body of the endoprosthesis also allow a better compaction of the material of the arterial endoprosthesis within the delivery system, thereby facilitating minimally invasive endovascular procedure.
  • the straight stent graft, object of this invention may have a conical segment, with or without metal structure, concentric with the straight cylindrical body, positioned inside the straight cylindrical body.
  • the conical segment will serve to support the other commercial endoprostheses when connected to the endoprosthesis object of this invention.
  • the lower part of the conical segment may have a metal ring so as to support the other connected stents.
  • the lower part of the conical segment also has radiopaque marking to facilitate its visualization during the connection procedure of the other coated commercial endoprostheses.
  • Figure 1 is a three-dimensional view of the stent () and shows the cylindrical liner (2), the support structure (3) and the inner segment (5) in a plane perpendicular to the axis of the cylindrical liner (2);
  • Figure 2 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and the inner segment (5) in a plane perpendicular to the axis of the cylindrical liner (2);
  • Figure 3 is an exploded view of the endoprosthesis (1) and shows the cylindrical shell (2), the support structure (3), the conical segment (4) and a pair of inner segments (5) in planes perpendicular to the axis of the cylindrical coating (2);
  • Figure 4 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and a set of three internal segments (5) in planes perpendicular to the axis of the cylindrical casing (2);
  • Figure 5 is a three-dimensional view of the stent (1) and shows the cylindrical liner (2), the support structure (3) and the inner segment (5) in a plane inclined to the axis of the cylindrical liner (2);
  • Figure 6 is an exploded view of the stent (1) and shows the cylindrical shell (2), the support structure (3), the conical segment (4) and the inner segment (5) in a plane inclined to the axis of the cylindrical shell (2);
  • Figure 7 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and an inner segment pair (5), parallel to each other and in planes inclined to the axis of the cylindrical coating (2);
  • Figure 8 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and a set of three inner segments (5), parallel to each other and in inclined planes> to the axis of the cylindrical coating (2);
  • Figure 9 is a top view of the inner segment 5, in the geometric shape of a disk, with a larger aperture 19 and four smaller apertures 15, 16, 17, and 18.
  • Figure 10 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and the inner segment (5) with the geometric shape of a concentric cone to the axis of the cylindrical coating (2); shows the apertures (51, 52, 53, 54 and 55) in the conical wall of the inner segment (5).
  • Figure 11 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and a pair of inner segments (5) of the geometrical shape (5) shows the apertures (51, 52, 53, 54 and 55) in the conical wall of the inner segment (5).
  • Figure 12 is a schematic view of the endoprosthesis (1), with the aperture (19) already positioned above the thoracoabdominal aneurysm (7) and shows a delivery system (8) on a guidewire (9) in the femoral artery (10).
  • Figure 13 is a schematic view of the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7) and shows the guidewires (11, 12, 13 and 14) already passed by access of the axillary arteries.
  • Figure 14 is a schematic view of the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7) and shows the guidewires (11, 12, 13 and 14) already passed by access of the axillary arteries connecting respectively to the (20), right renal (21), superior mesenteric (22) and celiac trunk artery (23).
  • Figure 15 is a schematic view of the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7) and shows the coated commercial endoprostheses (24, 25, 26 and 27) already placed in the visceral branches.
  • FIG 16Erro! Reference source not found is a schematic view of the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7) and shows the coated commercial endoprostheses (24, 25, 26 and 27) placed in the visceral branches; and shows the bifurcated commercial endoprosthesis (28) positioned in the opening (19) of the stent (1) and the iliac coated commercial endoprosthesis (29) connected to the bifurcated commercial stent (28).
  • Figure 17 is a schematic view of the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30).
  • Figure 18 is a schematic view of the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30).
  • the guide wires (31, 32 and 33) are already positioned in the openings (34, 35 and 36) respectively of the endoprosthesis (1).
  • Figure 19 is a schematic view of the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30) and shows, by wrapping the guidewires (31, 32 and 33), the coated commercial endoprostheses (38, 39 and 40).
  • Figure 20 is a schematic endoprosthesis view (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30), the coated commercial endoprostheses (38, 39 and 40) already positioned in the endoprosthesis (1) openings and in the access arteries.
  • Figure 21 is a schematic view of the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30), the coated commercial endoprostheses (38, 39 and 40) already positioned in the endoprosthesis (1) openings and access arteries.
  • the commercial straight stent (37) is already positioned in the largest opening of the stent (1).
  • the stent (1) the subject of this invention, which may be fabricated from a cylindrical coating (2) of biocompatible polymeric material (PTFE, polyester or the like) with or without a support structure (3) of biocompatible material (stainless steel, polymer, nitinol, chrome molybdenum steel or similar material).
  • a support structure (3) of biocompatible material stainless steel, polymer, nitinol, chrome molybdenum steel or similar material.
  • a stent-shaped support structure 3 there is shown in Figures 1 to 4 a stent-shaped support structure 3, but this structure may have a differentiated or minimized configuration depending on the dimensions of the diameter, length and location of the stent graft specific.
  • the diameter of the stent (1) is defined by the cylindrical shell (2) and the support structure (3), where applicable; the diameter of the stent () can vary from 20 to 60mm.
  • the length of the stent graft object of this invention may range from 10 to 200mm.
  • the endoprosthesis (1) may have an internal conical segment (4) of length sufficiently equal to the length of the cylindrical coating (2). When the endoprosthesis (1) presents internal conical segment (4), the larger diameter of the conical segment (4) can also vary from 20 to 60mm. The smaller diameter of the conical segment (4) may vary from 19 to 59mm.
  • the lower part of the internal conical segment (4) has radiopaque marking for positioning orientation during the surgical procedure.
  • the stent (1) has an inner segment (5) connected to the body (2) by suture, glue or any similar attachment means.
  • the inner segment 5 has the geometric shape of a disk, as shown in Figures 2 to 9, or the shape of a cone as shown in Figures 10 and 11.
  • the inner segment 5 may have two, three, four, five or more openings 15, 16, 16, 17, 18 and 19 where commercial endoprostheses of different diameters and lengths will be connected.
  • the openings (15, 16, 16, 17, 18 and 19) of the inner segment (5) may have different shapes and sizes.
  • the apertures 41, 42, 43, 44 and 45 are distributed on the conical surface of the inner segment 5. All openings, regardless of the shape of the internal segment (5), have radiopaque marking for connection orientation during the surgical procedure.
  • the connection of the conical segment 4 to the cylindrical casing 2 or to the internal segment 5 may be made by suturing, glueing or any similar attachment means.
  • the endoprosthesis 1 may have a plurality of inner segments 5, as shown in Figures 3 to 8.
  • the inner segments 5 may be positioned parallel to each other and in transverse sections perpendicular to the axis of the cylindrical body of the endoprosthesis as shown in Figures 3 and 4.
  • the inner segments 5 may be positioned parallel to each other and in transverse sections inclined to the axis of the cylindrical body of the stent 1, as shown in Figures 7 and 8.
  • the inner segments 5) may be positioned inclined to each other and in transverse sections inclined to the axis of the cylindrical body of the stent (1).
  • the distances between the inner segments (5), where the commercial endoprostheses are connected may range from 0 to 50mm, depending on the total length of the stent (1) object of this invention.
  • the distance between the elliptical inner segments (5) can range from 0 to 50mm being measured in a line perpendicular to the internal segments, when these internal segments are parallel to each other. If the inclined elliptical inner segments (5) are not parallel to each other, the distance measurement is taken from the closest points between the inner segments (5).
  • the internal segment (5) is conical, its height may vary from 1 mm to the total length of the straight stent. If the configuration has several conical inner segments (5), the distance between them may vary from 0 to 50mm.
  • Figures 12 to 21 show applications of the endoprosthesis (1), object of this report, for different procedures of endovascular treatment of aneurysms or aortic dissection; in particular where the incidence of aneurysms occurs in regions where there are vital lateral branches in the aortic artery (subclavian arteries, carotid arteries and visceral arteries).
  • Figure 12 shows the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7). Placement is done by means of a delivery system (8) concentric with a guidewire (9) and through the femoral artery (10). The guidewire (9) is positioned through the opening (19) of the stent (1).
  • Figure 13 shows the endoprosthesis (1) already positioned above the thoraco-abdominal aneurysm (7) with the guidewires (11, 12, 13 and 14) already passed through the axillary arteries.
  • the guide wire 11 and 12 pass separately through two openings 15 and 16 of the inner segment 5 of the stent 1 and are directed to the left and right renal arteries respectively.
  • the guidewire 13 is positioned by axillary access and is directed to the superior mesenteric artery passing through the aperture 17 of the inner segment 5 of the stent 1.
  • the guidewire 14 is placed by axillary access and is directed to the celiac trunk artery passing through the aperture 8 of the inner segment 5 of the stent 1.
  • Figure 14 shows the endoprosthesis (1) already positioned above the thoraco-abdominal aneurysm (7) with the guidewires (11, 12, 13 and 14) already passed by access of the axillary arteries connecting respectively to the left renal visceral branches (20), right renal (21), superior mesenteric (22) and celiac trunk artery (23).
  • a coated commercial endoprosthesis (24, 25, 26 and 27) is placed through the same accesses on each positioned guide, for example: Viabahn of the company Gore.
  • a bifurcated (28) or straight commercial endoprosthesis is placed by the guidewire (9) positioned in the opening (19) of the inner segment (5) of the stent (1).
  • Figure 15 shows the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm with the commercial coated endoprostheses (24, 25, 26 and 27), for example: Viabahn of the Gore company already placed in the visceral branches.
  • the commercial bifurcated stent (28) is positioned in the aperture (19) of the inner segment (5) of the stent (1).
  • Figure 16 shows the stent graft () positioned above the thoracoabdominal aneurysm with the coated commercial endoprostheses (24, 25, 26 and 27) for example: Viabahn of the Gore company placed in the visceral branches.
  • the commercial bifurcated stent (28) positioned in the opening (19) of the internal segment (5) of the stent (1) and the iliac coated commercial endoprosthesis (29) connected to the bifurcated commercial stent graft (28).
  • Figure 17 shows the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30).
  • the endoprosthesis is positioned by minimally invasive technique with the aid of the guidewire (9) which is positioned in the larger aperture (19) of the inner segment (5) of the stent (1).
  • Figure 18 shows the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30).
  • the guidewires 31, 32 and 33 are already positioned in the openings 34, 35 and 36 respectively of the inner segment 5 of the stent (1).
  • the guidewires (31 and 33) are positioned through the brachial or axillary arteries.
  • the guidewire (32) is positioned from the left carotid artery.
  • Figure 19 shows the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30).
  • the coated commercial endoprostheses 38, 39 and 40 respectively in the apertures (34, 35 and 36) of the internal segment (5) of the stent (1).
  • the 20 shows the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30), the coated commercial endoprostheses (38, 39 and 40) already positioned in the apertures of the internal segment (5) of the endoprosthesis ( l) and access arteries.
  • the commercial straight stent (37) is positioned in the largest opening of the inner segment (5) of the stent (1).
  • Figure 21 shows the stent (L) already positioned in the ascending thoracic aorta released above the aortic arch aneurysms (30), the stent "coated commercial (38, 39, 40) already positioned in the openings of the inner segment (5) of the stent (1) and the access arteries.
  • the commercial straight stent (37) is already positioned in the largest opening of the internal segment (5) of the stent (1).

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  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

An endoprosthesis for a modular endovascular treatment system comprises an endoprosthesis (1), composed of a straight cylinder body with a polymeric-material-film coating, with a support structure made from a biocompatible material, which includes internal segments (5), of polymeric material, with the edge fastened to the inner cylindrical wall of the body of the endoprosthesis (1), and said internal segments (5), in disc or cone form, have a plurality of apertures of identical or different sizes and forms, all the apertures having radiopaque marking around the contour thereof, and said apertures allowing the connection of arterial endoprostheses already known in the prior art.

Description

ELEMENTOS ESTRUTURAIS CONECTORES DE  STRUCTURAL ELEMENTS CONNECTORS OF
STENTS REVESTIDOS  STENTS COATED
Compreende uma endoprótese, composta por um corpo reto ou cónico de filme de material polimérico, com estrutura de suporte feita com material biocompatível que contém um segmento interno, de material polimérico, com a borda fixada na parede cilíndrica ou cónica interna do corpo da endoprótese, e esse segmento interno possui uma pluralidade de aberturas, de iguais ou diferentes tamanhos e formas, sendo que todas as aberturas possuem marcação radiopaca em seu contorno. Estas aberturas permitem a conexão de endopróteses arteriais já conhecidas, no atual estado da técnica. It comprises an endoprosthesis composed of a straight or conical film body of polymeric material with a support structure made of biocompatible material containing an inner segment of polymeric material with the edge fixed to the inner cylindrical or conical wall of the endoprosthesis body, and this inner segment has a plurality of apertures, of equal or different sizes and shapes, all apertures having radiopaque marking in their contour. These openings allow the connection of already known arterial endoprostheses, in the present state of the art.
O tratamento endovascular de aneurismas ou dissecção de aorta é realizado através do implante de uma endoprótese (dispositivo minimamente invasivo constituído por um stent metálico revestido - stent graft) que tem por finalidade excluir o saco aneurismático ou região de dissecção e restabelecer o fluxo sanguíneo normal. No entanto, a incidência de aneurismas em regiões onde existem ramificações laterais vitais na artéria aorta (artérias subclávias, carótidas e artérias viscerais) dificulta o implante de endopróteses convencionais, já que as ramificações vitais não podem ser obstruídas pois causariam isquemia nos órgãos ou regiões irrigadas pelo ramo.  Endovascular treatment of aneurysms or aortic dissection is performed through the implantation of an endoprosthesis (a minimally invasive device consisting of a stent graft) to exclude the aneurysmal sac or dissection region and restore normal blood flow. However, the incidence of aneurysms in regions where there are vital lateral branches in the aorta artery (subclavian arteries, carotid arteries and visceral arteries) complicates the implantation of conventional endoprostheses, since vital branches can not be obstructed since they would cause ischemia in organs or irrigated regions by branch.
Esforços têm sido feitos para superar essas limitações incorporando fenestrações (orifícios) ou ramos nas endopróteses durante o processo de fabricação - ver Anderson (2004) e Stanley et al. (2001 ). Apesar de apresentar resultados satisfatórios, estes dispositivos exigem um elevado grau de customização, levando em consideração a anatomia de cada paciente, o que aumenta significativamente o custo de produção destes dispositivos e o tempo de espera do paciente. Efforts have been made to overcome these limitations by incorporating fenestrations (orifices) or branches into endoprostheses during the manufacturing process - see Anderson (2004) and Stanley et al. (2001). Despite the satisfactory results, these devices require a high degree of customization, taking into account the anatomy of each patient, which significantly increases the cost of producing these devices and the patient's waiting time.
Uma alternativa para os casos de aneurismas em regiões onde existem ramificações laterais vitais é a fenestração in-situ com posterior colocação de uma endoprótese ramo. A fenestração in-situ torna o procedimento comercialmente viável porque supera a necessidade de customização das endopróteses. A adaptação dos furos e da endopróteses-ramo são parte do próprio procedimento cirúrgico, o que permite estender a abrangência do tratamento endovascular a casos que hoje em dia não podem ser tratados pela técnica minimamente invasiva, implicando em menores riscos para o paciente e redução de custos para o sistema de saúde.  An alternative for cases of aneurysms in regions where there are vital lateral branches is in-situ fenestration with posterior placement of a branch endoprosthesis. In-situ fenestration makes the procedure commercially feasible because it overcomes the need for customization of endoprostheses. The adaptation of the holes and the branch endoprostheses are part of the surgical procedure itself, which allows extending the scope of the endovascular treatment to cases that today can not be treated by the minimally invasive technique, implying lower risks for the patient and reduction of costs to the health system.
Iniciativas nesse sentido foram realizadas com sucesso no tratamento da aorta torácica - McWilliams (2004) e Numan (2008). Nestes casos, a fenestração é feita via artéria subclávia, o que facilita o posicionamento do dispositivo de fenestração. A fenestração é iniciada pela realização de um furo por meio de agulha que em seguida é dilatado por um cateter balão. A força que deve ser aplicada para dilatar o furo é considerável prejudicando o controle do processo. Adicionalmente, o processo de dilatação do furo pode produzir a ruptura do revestimento {graft), comprometendo a integridade da endoprótese.  Initiatives in this direction were successfully performed in the treatment of the thoracic aorta - McWilliams (2004) and Numan (2008). In these cases, the fenestration is done via the subclavian artery, which facilitates the positioning of the fenestration device. The fenestration is initiated by perforating a hole through a needle which is then dilated by a balloon catheter. The force that must be applied to dilate the hole is considerable, hampering process control. In addition, the hole dilation process can produce the graft rupture, compromising the integrity of the stent.
Alguns trabalhos empregaram ondas de radiofrequência para produzir furos de maneira controlada em endopróteses - Bruszewski and Macaulay (2007) e Wallace and Sthaler (2009). Estes dispositivos empregam um aparato eletrônico com dois eletrodos que concentram as ondas de radiofrequência em um dos poios, sendo, portanto, capazes de produzir furos em revestimentos com aplicação de pouca força. No entanto, além de um sistema que permita ajustar a posição do eletrodo no local exato onde se deseja realizar a fenestração, estes dispositivos necessitam também de um controle eletrônico adequado para não lesionar os tecidos vivos adjacentes ao furo com uma sobrecarga de energia. Adicionalmente estes dispositivos necessitam uma fonte de radiofrequência, além de dois eletrodos separados que devem ser posicionados de maneira adequada para que se obtenha o resultado desejado. Some studies have used radiofrequency waves to produce holes in a controlled manner in endoprostheses - Bruszewski and Macaulay (2007) and Wallace and Sthaler (2009). These devices employ an electronic apparatus with two electrodes that concentrate the radiofrequency waves in one of the wells and are therefore able to produce holes in coatings with low force application. However, in addition to a position of the electrode in the exact place where the fenestration is desired, these devices also need an adequate electronic control so as not to injure the living tissues adjacent to the hole with an overload of energy. In addition, these devices require a radiofrequency source, in addition to two separate electrodes that must be properly positioned to achieve the desired result.
Iniciativas para resolver o tratamento tanto de aneurismas do arco aórtico quanto aneurismas tóraco-abdominais também foram feitas por Chuter (2005), cuja solução busca construir endopróteses já ramificadas sem necessidade de customização. Conforme demonstrado por Chuter (2005) a endoprótese possui pequenos ramos pré-definidos que são prolongados com outras endopróteses para a manutenção das ramificações vitais da artéria aorta.  Initiatives to resolve the treatment of both aortic arch aneurysms and thoraco-abdominal aneurysms were also performed by Chuter (2005), whose solution seeks to build already branched endoprostheses without the need for customization. As demonstrated by Chuter (2005), the endoprosthesis has small pre-defined branches that are prolonged with other endoprostheses for the maintenance of the vital branches of the aorta.
Outra solução para a manutenção dos ramos vitais da artéria aorta é descrita por Kasirajan (201 1 ) através do tratamento de um aneurisma aórtico tóraco-abdominal usando inúmeras endopróteses comerciais (uso off-the-shelf). Kasirajan utiliza uma técnica inovadora usando endopróteses arteriais simplesmente conectadas ou conectadas em paralelo, ou seja, conectando uma ou duas endopróteses em paralelo dentro de outra endoprótese arterial reta ou bifurcada. Os documentos relacionados abaixo descrevem o atual estado da técnica:  Another solution for the maintenance of vital branches of the aortic artery is described by Kasirajan (201 1) through the treatment of a thoracoabdominal aortic aneurysm using numerous commercial endoprostheses (off-the-shelf use). Kasirajan uses an innovative technique using arterial stents simply connected or connected in parallel, ie, connecting one or two endoprostheses in parallel inside another straight or bifurcated arterial endoprosthesis. The documents listed below describe the current state of the art:
• Anderson, J. L, "Fenestrated and branch aortic stent grafts", Endovascular Today, April, 2004, pp. 40-46.  • Anderson, J. L, "Fenestrated and branch aortic stent grafts", Endovascular Today, April, 2004, pp. 40-46.
• Stanley, B.M.; Semmens, J.B.; Lawrence-Brown, M.M.D.; Goodman, M.A.and Hartley, D. E., "Fenestration in endovascular grafts for aortic aneurysm repair: new horizons for preserving blood flow in branch vessels", J. Endovasc. Ther.,• Stanley, BM; Semmens, JB; Lawrence-Brown, MMD; Goodman, MA Hartley, DE, "Fenestration in endovascular grafts for aortic aneurysm repair: new horizons for preserving blood flow in branch vessels, J. Endovasc. Ther.,
2001 , v. 8, pp. 16-24. 2001, v. 8, pp. 16-24.
• McWilliams, R.G.; Murphy, M.; Hartley, D.; Lawrence-Brown, M.M.D. and Harris, P.L, n situ stent-graft fenestration to preserve the left subclavian artery", J. Endovasc. Ther., 2004, v. 1 1 , pp. 170-174  • McWilliams, R.G .; Murphy, M .; Hartley, D .; Lawrence-Brown, M.M.D. and Harris, P.L, n situ stent-graft fenestration to preserve the left subclavian artery, J. Endovasc. Ther., 2004, v. 11, pp. 170-174
• Numan, F.; Arbatli, H.; Bruszewski, W. and Cikirikcioglu, M. " Total endovascular aortic arch reconstruction via fenestration in situ with cerebral circulatory support: an acute experimental study", Interact CardioVasc Thorac Surg, 2008, V. 7, PP. 535-538.  • Numan, F .; Arbatli, H .; Bruszewski, W. and Cikirikcioglu, M. "Total endovascular aortic arch reconstruction via fenestration in situ with cerebral circulatory support: an experimental experimental study", Interact CardioVasc Thorac Surg, 2008, v. 7, PP. 535-538.
· Bruszewski, W. G. and Macaulay, W., "Cutting radio frequency catheter for creating fenestrations in graft cloth", 2007, patent, EP 1 920 724 A1 • Bruszewski, W. G. and Macaulay, W., "Cutting radio frequency catheter for creating fenestrations in graft cloth", 2007, patent, EP 1 920 724 A1
• Wallace, D.T. and Sthaler, G.J., Ίη-situ graft fenestration", 2009, patent, US2009/0228020 A1  • Wallace, D.T. and Sthaler, G.J., Ίη-situ graft fenestration ", 2009, patent, US2009 / 0228020 A1
• Chuter, Timothy, A. , M., "Modular Stent-Graft for Endovascular Repair of Aortic Arch Aneurysms and Dissections" ', 2005, patent, WO 2005/027784 A2• Chuter, Timothy, A. M., "Modular Endovascular Stent-Graft for Aortic Arch Repair of Aneurysms and dissections"', 2005, patent WO 2005/027784 A2
• Kasirajan, Karthikeshwar, "Tandem Endografts for Type II TAAAs", 201 1 , vol.10, n.5, pp.30-34. • Kasirajan, Karthikeshwar, "Tandem Endografts for Type II TAAAs", 201 1, vol.10, n.5, pp.30-34.
• Myers, David J. et al. , "Intraluminal Stent Graft", 1999, patent, US005925075A. • Myers, David J. et al. , "Intraluminal Stent Graft", 1999, patent, US005925075A.
• Hagaman, Logan, Hartman, Cody L, "Bifurcated Highly Conformable Medicai Device Branch Access", 2009, patent, WO201 1/044459A2. • Hagaman, Logan, Hartman, Cody L, "Bifurcated Highly Conformable Medical Device Branch Access", 2009, patent, WO201 1 / 044459A2.
• Armstrong, Joseph R. , et al., "Covered Endoprosthesis and Delivery System", • Armstrong, Joseph R., et al., "Covered Endoprosthesis and Delivery System",
2002, patent, US2002/0198588A1. 2002, patent, US2002 / 0198588A1.
• Thornton, Troy, et al., "Kink-Resistant Bifurcated Prosthesis", 2002, patent, US2002/0165603A1 . • Lau, Lilip, et al., "Self-Expandable Helical Intravascular Stent and Stent-Graft", 1999, patent, US005876432A. • Thornton, Troy, et al., "Kink-Resistant Bifurcated Prosthesis", 2002, patent, US2002 / 0165603A1. • Lau, Lilip, et al., "Self-Expandable Helical Intravascular Stent and Stent-Graft", 1999, patent, US005876432A.
• James, Mitchell W., "Stent-Graft with anchoring pins", 2008, patent, EP1923020A2.  • James, Mitchell W., "Stent-Graft with anchoring pins", 2008, patent, EP1923020A2.
· Dierking, William K., et al., "Ascending Aorta Stent Graft", 201 1 , patent, GB2476451 . Dierking, William K., et al., "Ascending Aorta Stent Graft," 201, patent, GB2476451.
• Stelter, Wolf, et al., "Endovascular Stent Graft", 2004, patent, US2004/0260383A1 .  • Stelter, Wolf, et al., "Endovascular Stent Graft", 2004, patent, US2004 / 0260383A1.
• Greenberg, Roy K., et al., "Thoracic Aortic Aneurysm Stent Graft", 2004, patent, WO2004/002370A1.  • Greenberg, Roy K., et al., "Thoracic Aortic Aneurysm Stent Graft", 2004, patent, WO2004 / 002370A1.
A ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, descrita neste relatório, compreende uma endoprótese arterial reta ou cónica que permite a conexão ou acoplamento, seguro e eficiente, de outras endopróteses arteriais revestidas, com diferentes diâmetros e comprimentos, comercialmente disponíveis. A endoprótese, objeto dessa invenção, é um dispositivo que permitirá tanto o tratamento de aneurismas do arco aórtico quanto de aneurismas tóraco-abdominais com o uso de endopróteses arteriais revestidas, já conhecidas comercialmente. Dessa forma o uso da endoprótese, objeto dessa invenção, em conjunto com , demais endopróteses arteriais, comercialmente disponíveis, ampliará a possibilidade de tratamento de aneurismas arteriais através de técnica minimamente invasiva. Entre as possíveis endopróteses arteriais comerciais que podem ser usadas com o dispositivo objeto dessa invenção pode-se destacar as endopróteses citadas por Myers (US005925075A), Hagaman (WO201 1/044459A2), Armstrong (US2002/0198588A1 ), Thornton (US2002/0165603A1 ), Lau (US005876432A), James (EP1923020A2), Dierking (GB2476451 ), Stelter (US2004/0260383A1 ), Greenberg (WO2004/002370A1 ), entre outras endopróteses revestidas, disponíveis no Mercado de produtos médicos. ENDOPASCULAR MODULAR ENDOPROTETIC SYSTEM, described in this report, comprises a straight or conical arterial endoprosthesis that allows the secure and efficient coupling or coupling of other coated arterial endoprostheses with different diameters and lengths, commercially available. The stent graft, the subject of this invention, is a device which will enable both the treatment of aortic arch aneurysms and thoracic-abdominal aneurysms with the use of commercially known coated arterial endoprostheses. In this way, the use of the endoprosthesis, object of this invention, together with other commercially available arterial stents, will increase the possibility of treatment of arterial aneurysms through a minimally invasive technique. Among the possible commercial arterial endoprostheses that may be used with the device object of this invention may be noted the stents cited by Myers (US005925075A), Hagaman (WO201 / , Lau (US005876432A), James (EP1923020A2), Dierking (GB2476451), Stelter (US2004 / 0260383A1), Greenberg (WO2004 / 002370A1), among other coated endoprostheses available on the Medical Product Market.
O diferencial do presente invento está na possibilidade de permitir um preciso posicionamento e acoplamento das endopróteses arteriais comercialmente disponíveis. A possibilidade de um preciso posicionamento proporciona uma maior eficiência do selamento da união acoplada, minimizando dessa forma qualquer possibilidade de vazamento entre as conexões e proporcionando assim a manutenção eficiente dos ramos vitais da artéria aorta.  The differential of the present invention is in the possibility of allowing a precise positioning and coupling of the commercially available arterial endoprostheses. The possibility of a precise positioning provides a greater efficiency of the sealing of the coupled union, thus minimizing any possibility of leakage between the connections and thus providing efficient maintenance of the vital branches of the aorta.
O uso do dispositivo objeto dessa invenção em conjunto com dispositivos comercialmente disponíveis permitirá o tratamento, através de técnica minimamente invasiva, de qualquer tipo de aneurisma da artéria aorta existente, incluindo aneurismas nas regiões que apresentam ramificações vitais do arco aórtico, passando pela região torácica até a região abdominal.  The use of the device object of this invention in conjunction with commercially available devices will allow the treatment by any minimally invasive technique of any type of existing aortic artery aneurysm, including aneurysms in regions which have vital branches of the aortic arch, passing through the thoracic region the abdominal region.
A endoprótese reta, objeto desta invenção, é composta por um corpo cilíndrico, reto ou cónico, que compreende um revestimento de filme de material polimérico, do tipo poliéster, PTFE ou material similar, com estrutura de suporte feita em nitinol, aço inoxidável, aço cromo molibdênio, polímero biocompatível ou material biocompatível similar. Caracteriza-se por apresentar um segmento interno, feito em material similar ao do corpo, posicionado em uma seção do corpo e conectado, por sutura, cola ou meio similar de união, na superfície cilíndrica interna do corpo da endoprótese. O segmento interno possui a forma geométrica de um disco ou de um cone; possui duas, três, quatro, cinco ou mais aberturas de iguais ou diferentes tamanhos e formas. Todas as aberturas possuem marcação radiopaca em seu contorno. Estas aberturas permitem a conexão de endoproteses arteriais revestidas, com diferentes tamanhos e formas, disponíveis no Mercado de produtos médicos. The straight endoprosthesis, the subject of this invention, is comprised of a cylindrical, straight or conical body, comprising a film coating of polymeric material, of the polyester type, PTFE or the like, with a support structure made of nitinol, stainless steel, chromium molybdenum, biocompatible polymer or similar biocompatible material. It is characterized by presenting an internal segment, made of material similar to that of the body, positioned in a section of the body and connected, by suture, glue or similar means of union, to the inner cylindrical surface of the endoprosthesis body. The inner segment has the geometric shape of a disk or a cone; has two, three, four, five or more openings of equal or different sizes and shapes. All openings are radiopaque in their contour. These openings allow connection of coated arterial endoprostheses, with different sizes and shapes, available in the market of medical products.
Caracteriza-se ainda por apresentar uma pluralidade de segmentos intenos. O uso de segmentos internos duplo, triplo ou múltiplo tem o objetivo de aumentar a eficiência de vedação na conexão das endoproteses de diferentes diâmetros; evita dessa forma problemas de vazamentos nas conexões o que poderia diminuir a eficiência do dispositivo no isolamento da região do aneurisma ou dissecção da aorta.  It is further characterized in that it has a plurality of intentional segments. The use of double, triple or multiple internal segments has the objective of increasing the sealing efficiency in the connection of endoprothesis of different diameters; thus avoiding leakage problems in the connections which could decrease the efficiency of the device in the isolation of the aneurysm region or dissection of the aorta.
Os segmentos internos, na forma de discos, podem estar posicionados paralelos entre si e em seções transversais perpendiculares ao eixo do corpo cilíndrico da endoprótese. Os segmentos internos, na forma de discos, podem estar posicionados paralelos entre si e em seções transversais inclinadas ao eixo do corpo cilíndrico da endoprótese. Os segmentos internos, na forma de discos, podem estar posicionados inclinados entre si e em seções transversais inclinadas ao eixo do corpo cilíndrico da endoprótese. O segmento interno pode ser circular, elíptico ou cónico para melhor adequar a conexão das endoproteses comerciais em regiões específicas. O segmento interno, de forma elíptica ou cónica, pode aumentar a região de contato de selamento oferecendo dessa forma um selamento mais eficiente. Segmentos internos posicionados em seções transversais inclinadas ao eixo do corpo cilíndrico da endoprótese permitem também uma melhor compactação do material da endoprótese arterial no interior do sistema de entrega, facilitando dessa forma o procedimento endovascular minimamente invasivo.  The inner segments, in the form of disks, may be positioned parallel to each other and in transverse sections perpendicular to the axis of the cylindrical body of the endoprosthesis. The inner segments, in the form of disks, may be positioned parallel to each other and in transverse sections inclined to the axis of the cylindrical body of the endoprosthesis. The inner segments, in the form of disks, may be positioned inclined to each other and in transverse sections inclined to the axis of the cylindrical body of the stent. The inner segment may be circular, elliptical or conical to better fit the connection of commercial endoprostheses in specific regions. The inner segment, elliptical or conical, can increase the sealing contact region thereby offering a more efficient sealing. Internal segments positioned in transverse sections inclined to the axis of the cylindrical body of the endoprosthesis also allow a better compaction of the material of the arterial endoprosthesis within the delivery system, thereby facilitating minimally invasive endovascular procedure.
A endoprótese reta, objeto desta invenção, poderá ter um segmento cónico, com ou sem estrutura metálica, concêntrico com o corpo cilíndrico reto, posicionado no interior do corpo cilíndrico reto. O segmento cónico servirá para apoiar as demais endopróteses comerciais quando conectadas à endoprótese objeto dessa invenção. A parte inferior do segmento cónico poderá apresentar um anel metálico de maneira a dar suporte às demais endopróteses conectadas. A parte inferior do segmento cónico também apresenta marcação radiopaca para facilitar a sua visualização durante o procedimento de conexão das outras endopróteses comerciais revestidas. The straight stent graft, object of this invention, may have a conical segment, with or without metal structure, concentric with the straight cylindrical body, positioned inside the straight cylindrical body. The conical segment will serve to support the other commercial endoprostheses when connected to the endoprosthesis object of this invention. The lower part of the conical segment may have a metal ring so as to support the other connected stents. The lower part of the conical segment also has radiopaque marking to facilitate its visualization during the connection procedure of the other coated commercial endoprostheses.
A figura 1 é uma vista tridimensional da endoprótese( ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3) e o segmento interno (5) em plano perpendicular ao eixo do revestimento cilíndrico(2);  Figure 1 is a three-dimensional view of the stent () and shows the cylindrical liner (2), the support structure (3) and the inner segment (5) in a plane perpendicular to the axis of the cylindrical liner (2);
A figura 2 é uma vista explodida da endoprótese(l ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3), o segmento cônico(4) e o segmento interno(5) em plano perpendicular ao eixo do revestimento cilíndrico(2);  Figure 2 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and the inner segment (5) in a plane perpendicular to the axis of the cylindrical liner (2);
A figura 3 é uma vista explodida da endoprótese(l ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3), o segmento cônico(4) e um par de segmentos internos(5) em planos perpendiculares ao eixo do revestimento cilíndrico(2);  Figure 3 is an exploded view of the endoprosthesis (1) and shows the cylindrical shell (2), the support structure (3), the conical segment (4) and a pair of inner segments (5) in planes perpendicular to the axis of the cylindrical coating (2);
A figura 4 é uma vista explodida da endoprótese(l ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3), o segmento cônico(4) e um conjunto de três segmentos internos(5) em planos perpendiculares ao eixo do revestimento cilíndrico(2);  Figure 4 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and a set of three internal segments (5) in planes perpendicular to the axis of the cylindrical casing (2);
A figura 5 é uma vista tridimensional da endoprótese(l ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3) e o segmento interno(5) em plano inclinado ao eixo do revestimento cilíndrico(2); A figura 6 é uma vista explodida da endoprótese(l ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3), o segmento cônico(4) e o segmento interno(5) em plano inclinado ao eixo do revestimento cilíndrico(2); Figure 5 is a three-dimensional view of the stent (1) and shows the cylindrical liner (2), the support structure (3) and the inner segment (5) in a plane inclined to the axis of the cylindrical liner (2); Figure 6 is an exploded view of the stent (1) and shows the cylindrical shell (2), the support structure (3), the conical segment (4) and the inner segment (5) in a plane inclined to the axis of the cylindrical shell (2);
A figura 7 é uma vista explodida da endoprótese(l ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3), o segmento cônico(4) e um par de segmento interno(5), paralelos entre si e em planos inclinados ao eixo do revestimento cilíndrico(2);  Figure 7 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and an inner segment pair (5), parallel to each other and in planes inclined to the axis of the cylindrical coating (2);
A figura 8 é uma vista explodida da endoprótese(l) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3), o segmento cônico(4) e um conjunto de três segmentos internos(5), paralelos entre si e em planos inclinados > ao eixo do revestimento cilíndrico(2);  Figure 8 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and a set of three inner segments (5), parallel to each other and in inclined planes> to the axis of the cylindrical coating (2);
A figura 9 é uma vista superior do segmento interno(5), com a forma geométrica de um disco, com uma abertura(19) maior e quatro aberturas (15, 16, 17, e 18) menores.  Figure 9 is a top view of the inner segment 5, in the geometric shape of a disk, with a larger aperture 19 and four smaller apertures 15, 16, 17, and 18.
A figura 10 é uma vista explodida da endoprótese(l ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3), o segmento cônico(4) e o segmento interno(5) com a forma geométrica de um cone concêntrico ao eixo do revestimento cilíndrico(2); mostra as aberturas (51 , 52, 53, 54 e 55) na parede cónica do segmento interno(5).  Figure 10 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and the inner segment (5) with the geometric shape of a concentric cone to the axis of the cylindrical coating (2); shows the apertures (51, 52, 53, 54 and 55) in the conical wall of the inner segment (5).
A figura 1 1 é uma vista explodida da endoprótese(l ) e mostra o revestimento cilíndrico(2), a estrutura de suporte(3), o segmento cônico(4) e um par de segmentos internos(5), com a forma geométrica de cone, concêntrico ao eixo do revestimento ci(índrico(2); mostra as aberturas (51 , 52, 53, 54 e 55) na parede cónica do segmento interno(5). A figura 12 é uma vista esquemática da endoprótese(l ), com a abertura(19), já posicionada acima do aneurisma tóraco-abdominal(7) e mostra um sistema de entrega(8) sobre um fio guia(9) na artéria femoral(10). Figure 11 is an exploded view of the endoprosthesis (1) and shows the cylindrical liner (2), the support structure (3), the conical segment (4) and a pair of inner segments (5) of the geometrical shape (5) shows the apertures (51, 52, 53, 54 and 55) in the conical wall of the inner segment (5). Figure 12 is a schematic view of the endoprosthesis (1), with the aperture (19) already positioned above the thoracoabdominal aneurysm (7) and shows a delivery system (8) on a guidewire (9) in the femoral artery (10).
A Figura 13 é uma vista esquemática da endoprótese(l ) já posicionada acima do aneurisma tóraco-abdominal(7) e mostra os fios guias (1 1 , 12, 13 e 14) já passados por acesso das artérias axilares.  Figure 13 is a schematic view of the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7) and shows the guidewires (11, 12, 13 and 14) already passed by access of the axillary arteries.
A figura 14 é uma vista esquemática da endoprótese(l) já posicionada acima do aneurisma tóraco-abdominal(7) e mostra os fios guias (1 1 , 12, 13 e 14) já passados por acesso das artérias axilares conectando-se respectivamente aos ramos viscerais renal esquerda(20), renal direita(21 ), mesentérica superior(22) e artéria do tronco celíaco(23).  Figure 14 is a schematic view of the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7) and shows the guidewires (11, 12, 13 and 14) already passed by access of the axillary arteries connecting respectively to the (20), right renal (21), superior mesenteric (22) and celiac trunk artery (23).
A figura 15 é uma vista esquemática da endoprótese(l ) já posicionada acima do aneurisma tóraco-abdominal(7) e mostra as endopróteses comerciais revestidas (24, 25, 26 e 27) já colocadas nos ramos viscerais.  Figure 15 is a schematic view of the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7) and shows the coated commercial endoprostheses (24, 25, 26 and 27) already placed in the visceral branches.
A figura 16Erro! Fonte de referência não encontrada, é uma vista esquemática da endoprótese(l ) já posicionada acima do aneurisma tóraco- abdominal(7) e mostra as endopróteses comerciais revestidas (24, 25, 26 e 27) colocadas nos ramos viscerais; e mostra a endoprótese comercial bifurcada(28) posicionada na abertura(19) da endoprótese(l ) e a endoprótese comercial revestida ilíaca(29) conectada à endoprótese comercial bifurcada(28).  Figure 16Erro! Reference source not found is a schematic view of the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7) and shows the coated commercial endoprostheses (24, 25, 26 and 27) placed in the visceral branches; and shows the bifurcated commercial endoprosthesis (28) positioned in the opening (19) of the stent (1) and the iliac coated commercial endoprosthesis (29) connected to the bifurcated commercial stent (28).
A figura 17 é uma vista esquemática da endoprótese(l ) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30).  Figure 17 is a schematic view of the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30).
A figura 18 é uma vista esquemática da endoprótese(l ) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30). Os fios guias (31 , 32 e 33) estão já posicionados nas aberturas (34, 35 e 36) respectivamente da endoprótese(1 ). Figure 18 is a schematic view of the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30). The guide wires (31, 32 and 33) are already positioned in the openings (34, 35 and 36) respectively of the endoprosthesis (1).
A figura 19 é uma vista esquemática da endoprótese(l ) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30) e mostra, envolvendo os fios guias (31 , 32 e 33), as endopróteses comerciais revestidas (38, 39 e 40).  Figure 19 is a schematic view of the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30) and shows, by wrapping the guidewires (31, 32 and 33), the coated commercial endoprostheses (38, 39 and 40).
A figura 20 é uma vista esquemática endoprótese(l) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30), as endopróteses comerciais revestidas (38, 39 e 40) já posicionadas nas aberturas da endoprótese(l ) e nas artérias de acesso.  Figure 20 is a schematic endoprosthesis view (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30), the coated commercial endoprostheses (38, 39 and 40) already positioned in the endoprosthesis (1) openings and in the access arteries.
A figura 21 é uma vista esquemática da endoprótese(l ) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30), as endopróteses comerciais revestidas (38, 39 e 40) já posicionadas nas aberturas da endoprótese(l ) e nas artérias de acesso. A endoprótese reta comercial(37) já posicionada na abertura maior da endoprótese(l ).  Figure 21 is a schematic view of the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30), the coated commercial endoprostheses (38, 39 and 40) already positioned in the endoprosthesis (1) openings and access arteries. The commercial straight stent (37) is already positioned in the largest opening of the stent (1).
A endoprótese(l ), objeto dessa invenção, que pode ser fabricada a partir de um revestimento cilíndrico(2) de material polimérico biocompatível (PTFE, poliéster ou similar) com ou sem estrutura de suporte(3) de material biocompatível (aço inoxidável, polímero, nitinol, aço cromo molibdênio ou material similar). Para fins de ilustração é representada nas figuras 1 a 4, uma estrutura de suporte(3) em forma de stent "2", porém essa estrutura pode ter configuração diferenciada ou minimizada dependendo das dimensões de diâmetro, comprimento e do local de colocação da endoprótese específica.  The stent (1), the subject of this invention, which may be fabricated from a cylindrical coating (2) of biocompatible polymeric material (PTFE, polyester or the like) with or without a support structure (3) of biocompatible material (stainless steel, polymer, nitinol, chrome molybdenum steel or similar material). For purposes of illustration, there is shown in Figures 1 to 4 a stent-shaped support structure 3, but this structure may have a differentiated or minimized configuration depending on the dimensions of the diameter, length and location of the stent graft specific.
O diâmetro da endoprótese(l ) é definido pelo revestimento cilíndrico(2) e pela estrutura de suporte(3), quando aplicável; o diâmetro da endoprótese( ) pode variar de 20 a 60mm. O comprimento da endoprótese objeto dessa invenção poderá variar de 10 a 200mm. A endoprótese(l ) pode apresentar um segmento cônico(4) interno de comprimento suficientemente igual ao comprimento do revestimento cilíndrico(2). Quando a endoprótese(l ) apresentar segmento cônico(4) interno, o diâmetro maior do segmento cônico(4) poderá variar igualmente de 20 a 60mm. O diâmetro menor do segmento cônico(4) poderá variar de 19 a 59mm. A parte inferior do segmento cônico(4) interno apresenta marcação radiopaca para orientação de posicionamento durante o procedimento cirúrgico. The diameter of the stent (1) is defined by the cylindrical shell (2) and the support structure (3), where applicable; the diameter of the stent () can vary from 20 to 60mm. The length of the stent graft object of this invention may range from 10 to 200mm. The endoprosthesis (1) may have an internal conical segment (4) of length sufficiently equal to the length of the cylindrical coating (2). When the endoprosthesis (1) presents internal conical segment (4), the larger diameter of the conical segment (4) can also vary from 20 to 60mm. The smaller diameter of the conical segment (4) may vary from 19 to 59mm. The lower part of the internal conical segment (4) has radiopaque marking for positioning orientation during the surgical procedure.
A endoprótese(l ) apresenta um segmento interno(5) conectado ao corpo(2) através de sutura, cola ou qualquer meio de união similar. O segmento interno(5) possui a forma geométrica de um disco, como mostrado nas figuras 2 a 9, ou a forma de um cone como mostrado nas figuras 10 e 1 1 . O segmento interno(5) pode apresentar dois, três, quatro, cinco ou mais aberturas(15, 16, 16, 17, 18 e 19) onde serão conectadas endopróteses comerciais de diferentes diâmetros e comprimentos. As aberturas(15, 16, 16, 17, 18 e 19) do segmento interno (5) poderão ter formas e tamanhos diferentes. No caso em que o segmento interno(5) é cónico, como mostrado nas figuras 10 e 1 1 , as aberturas (41 , 42, 43, 44 e 45) estão distribuídas na superfície cónica do segmento interno(5). Todas as aberturas, independente da forma do segmento interno(5), possuem marcação radiopaca para orientação na conexão, durante o procedimento cirúrgico.  The stent (1) has an inner segment (5) connected to the body (2) by suture, glue or any similar attachment means. The inner segment 5 has the geometric shape of a disk, as shown in Figures 2 to 9, or the shape of a cone as shown in Figures 10 and 11. The inner segment 5 may have two, three, four, five or more openings 15, 16, 16, 17, 18 and 19 where commercial endoprostheses of different diameters and lengths will be connected. The openings (15, 16, 16, 17, 18 and 19) of the inner segment (5) may have different shapes and sizes. In the case where the internal segment 5 is conical, as shown in Figures 10 and 11, the apertures 41, 42, 43, 44 and 45 are distributed on the conical surface of the inner segment 5. All openings, regardless of the shape of the internal segment (5), have radiopaque marking for connection orientation during the surgical procedure.
A conexão do segmento cônico(4) ao revestimento cilíndrico(2) ou ao segmento interno(5) pode ser feita através de sutura, cola ou qualquer meio de união similar. A endoprotese(l ) pode apresentar uma pluralidade de segmentos internos(5), conforme mostrado nas figuras 3 a 8. Os segmentos internos(5) podem estar posicionados paralelos entre si e em seções transversais perpendiculares ao eixo do corpo cilíndrico da endoprótese(l ), conforme mostrado nas figuras 3 e 4. Os segmentos internos(5) podem estar posicionados paralelos entre si e em seções transversais inclinadas ao eixo do corpo cilíndrico da endoprótese(l ), conforme mostrado nas figuras 7 e 8. Os segmentos internos(5) podem estar posicionados inclinados entre si e em seções transversais inclinadas ao eixo do corpo cilíndrico da endoprótese(l). The connection of the conical segment 4 to the cylindrical casing 2 or to the internal segment 5 may be made by suturing, glueing or any similar attachment means. The endoprosthesis 1 may have a plurality of inner segments 5, as shown in Figures 3 to 8. The inner segments 5 may be positioned parallel to each other and in transverse sections perpendicular to the axis of the cylindrical body of the endoprosthesis as shown in Figures 3 and 4. The inner segments 5 may be positioned parallel to each other and in transverse sections inclined to the axis of the cylindrical body of the stent 1, as shown in Figures 7 and 8. The inner segments 5) may be positioned inclined to each other and in transverse sections inclined to the axis of the cylindrical body of the stent (1).
As distâncias entre os segmentos internos(5), onde são conectadas as endopróteses comerciais, poderão variar de 0 a 50mm, dependendo do comprimento total da endoprótese(l ) objeto dessa invenção. Quando os segmentos internos(5), onde são conectadas as endopróteses comerciais, forem elípticos, inclinados em relação ao eixo do corpo cilíndrico, a distância entre os segmentos internos(5) elípticos pode variar de 0 a 50mm sendo medida em uma reta perpendicular aos segmentos internos, quando esse segmentos internos são paralelos entre si. Caso os segmentos internos(5) elípticos, inclinados, não sejam paralelos entre si, a medição da distância se dá a partir dos pontos mais próximos entre os segmentos internos(5). Caso o segmento interno(5) seja cónico, sua altura pode variar de 1 mm até o comprimento total da endoprótese reta. Caso a configuração tenha vários segmentos internos(5) cónicos, a distância entre eles pode variar de 0 a 50mm.  The distances between the inner segments (5), where the commercial endoprostheses are connected, may range from 0 to 50mm, depending on the total length of the stent (1) object of this invention. When the internal segments (5), where the commercial endoprostheses are connected, are elliptical, inclined relative to the axis of the cylindrical body, the distance between the elliptical inner segments (5) can range from 0 to 50mm being measured in a line perpendicular to the internal segments, when these internal segments are parallel to each other. If the inclined elliptical inner segments (5) are not parallel to each other, the distance measurement is taken from the closest points between the inner segments (5). If the internal segment (5) is conical, its height may vary from 1 mm to the total length of the straight stent. If the configuration has several conical inner segments (5), the distance between them may vary from 0 to 50mm.
As figura 12 a 21 mostram aplicações da endoprotese(l ), objeto deste relatório, para distintos procedimentos de tratamento endovascular de aneurismas ou dissecção de aorta; em especial quando a incidência de aneurismas ocorre em regiões onde existem ramificações laterais vitais na artéria aorta (artérias subclávias, carótidas e artérias viscerais). Figures 12 to 21 show applications of the endoprosthesis (1), object of this report, for different procedures of endovascular treatment of aneurysms or aortic dissection; in particular where the incidence of aneurysms occurs in regions where there are vital lateral branches in the aortic artery (subclavian arteries, carotid arteries and visceral arteries).
A figura 12 mostra a endoprótese(l ) já posicionada acima do aneurisma tóraco-abdominal(7). A colocação é feita por meio de um sistema de entrega(8) concêntrico a um fio guia(9) e através da artéria femoral(10). O fio guia(9) fica posicionado transpassando a abertura(19) da endoprótese(1 ).  Figure 12 shows the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm (7). Placement is done by means of a delivery system (8) concentric with a guidewire (9) and through the femoral artery (10). The guidewire (9) is positioned through the opening (19) of the stent (1).
A figura 13 mostra a endoprótese(l ) já posicionada acima do aneurisma tóraco-abdominal(7) com os fios guias (1 1 , 12, 13 e 14) já passados por acesso das artérias axilares. O fio guia (1 1 e 12) passam separadamente por duas aberturas (15 e 16) do segmento interno(5) da endoprótese(l ) e são direcionados às artérias renais esquerda e direita respectivamente. O fio guia(13) é colocado por acesso axilar e é direcionado para artéria mesentérica superior passando pela abertura(17) do segmento interno(5) da endoprótese(l ). O fio guia(14) é colocado por acesso axilar e é direcionado para artéria do tronco celíaco passando pela abertura( 8) do segmento interno(5) da endoprótese(l ).  Figure 13 shows the endoprosthesis (1) already positioned above the thoraco-abdominal aneurysm (7) with the guidewires (11, 12, 13 and 14) already passed through the axillary arteries. The guide wire 11 and 12 pass separately through two openings 15 and 16 of the inner segment 5 of the stent 1 and are directed to the left and right renal arteries respectively. The guidewire 13 is positioned by axillary access and is directed to the superior mesenteric artery passing through the aperture 17 of the inner segment 5 of the stent 1. The guidewire 14 is placed by axillary access and is directed to the celiac trunk artery passing through the aperture 8 of the inner segment 5 of the stent 1.
A figura 14 mostra a endoprótese(l ) já posicionada acima do aneurisma tóraco-abdominal(7) com os fios guias(1 1 , 12, 13 e 14) já passados por acesso das artérias axilares conectando-se respectivamente aos ramos viscerais renal esquerda(20), renal direita(21 ), mesentérica superior(22) e artéria do tronco celíaco(23). Pelos mesmos acessos sobre cada guia posicionada é colocada uma endoprótese comercial revestida (24, 25, 26 e 27), por exemplo:Viabahn da empresa Gore. Pelo fio guia(9), posicionado na abertura(19) do segmento intemo(5) da endoprótese(l ) é colocada uma endoprótese comercial bifurcada(28) ou reta. A figura 15 mostra a endoprótese(l ) já posicionada acima do aneurisma tóraco-abdominal com as endopróteses comerciais revestidas (24, 25, 26 e 27), por exemplo: Viabahn da empresa Gore já colocadas nos ramos viscerais. A endoprótese comercial bifurcada(28) é posicionada na abertura(19) do segmento interno(5) da endoprótese(l ). Figure 14 shows the endoprosthesis (1) already positioned above the thoraco-abdominal aneurysm (7) with the guidewires (11, 12, 13 and 14) already passed by access of the axillary arteries connecting respectively to the left renal visceral branches (20), right renal (21), superior mesenteric (22) and celiac trunk artery (23). A coated commercial endoprosthesis (24, 25, 26 and 27) is placed through the same accesses on each positioned guide, for example: Viabahn of the company Gore. A bifurcated (28) or straight commercial endoprosthesis is placed by the guidewire (9) positioned in the opening (19) of the inner segment (5) of the stent (1). Figure 15 shows the endoprosthesis (1) already positioned above the thoracoabdominal aneurysm with the commercial coated endoprostheses (24, 25, 26 and 27), for example: Viabahn of the Gore company already placed in the visceral branches. The commercial bifurcated stent (28) is positioned in the aperture (19) of the inner segment (5) of the stent (1).
A figura 16 mostra a endoprótese( ) posicionada acima do aneurisma tóraco-abdominal com as endopróteses comerciais revestidas (24, 25, 26 e 27) por exemplo: Viabahn da empresa Gore colocadas nos ramos viscerais. A endoprótese comercial bifurcada(28) posicionada na abertura(19) do segmento interno(5) da endoprótese(l ) e a endoprótese comercial revestidas ilíacas(29) conectada à endoprótese comercial bifurcada(28).  Figure 16 shows the stent graft () positioned above the thoracoabdominal aneurysm with the coated commercial endoprostheses (24, 25, 26 and 27) for example: Viabahn of the Gore company placed in the visceral branches. The commercial bifurcated stent (28) positioned in the opening (19) of the internal segment (5) of the stent (1) and the iliac coated commercial endoprosthesis (29) connected to the bifurcated commercial stent graft (28).
A figura 17 mostra a endoprótese(l ) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30). A endoprótese é posicionada por técnica minimamente invasiva com auxílio do fio guia(9) que fica posicionado na abertura maior(19) do segmento interno(5) da endoprótese(l ).  Figure 17 shows the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30). The endoprosthesis is positioned by minimally invasive technique with the aid of the guidewire (9) which is positioned in the larger aperture (19) of the inner segment (5) of the stent (1).
A figura 18 mostra a endoprótese(l ) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30). Os fios guias (31 , 32 e 33) estão já posicionados nas aberturas (34, 35 e 36) respectivamente do segmento interno(5) da endoprótese(l). Os fios guias (31 e 33) são posicionados através das artérias braquiais ou axilares. O fio guia(32) é posicionado a partir da artéria carótida esquerda.  Figure 18 shows the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30). The guidewires 31, 32 and 33 are already positioned in the openings 34, 35 and 36 respectively of the inner segment 5 of the stent (1). The guidewires (31 and 33) are positioned through the brachial or axillary arteries. The guidewire (32) is positioned from the left carotid artery.
A figura 19 mostra a endoprótese(l ) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30). Sobre os fios guias (31 , 32 e 33) são posicionadas as endopróteses comerciais revestidas (38, 39 e 40) respectivamente nas aberturas (34, 35 e 36) do segmento interno(5) da endoprótese(l). Figure 19 shows the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30). On the guidewires (31, 32 and 33) are positioned the coated commercial endoprostheses (38, 39 and 40) respectively in the apertures (34, 35 and 36) of the internal segment (5) of the stent (1).
A figura 20 mostra a endoprótese(l ) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30), as endopróteses comerciais revestidas (38, 39 e 40) já posicionadas nas aberturas do segmento interno(5) da endoprótese(l) e nas artérias de acesso. A endoprótese reta comercial (37) é posicionada na abertura maior do segmento interno(5) da endoprótese(l).  20 shows the endoprosthesis (1) already positioned in the ascending thoracic aorta released above the aortic arch aneurysm (30), the coated commercial endoprostheses (38, 39 and 40) already positioned in the apertures of the internal segment (5) of the endoprosthesis ( l) and access arteries. The commercial straight stent (37) is positioned in the largest opening of the inner segment (5) of the stent (1).
A figura 21 mostra a endoprótese(l) já posicionada na aorta torácica ascendente liberada acima do aneurisma do arco aórtico(30), as endopróteses" comerciais revestidas (38, 39 e 40) já posicionadas nas aberturas do segmento interno(5) da endoprótese(l) e nas artérias de acesso. A endoprótese reta comercial(37) já posicionada na abertura maior do segmento interno(5) da endoprótese(l). Figure 21 shows the stent (L) already positioned in the ascending thoracic aorta released above the aortic arch aneurysms (30), the stent "coated commercial (38, 39, 40) already positioned in the openings of the inner segment (5) of the stent (1) and the access arteries. The commercial straight stent (37) is already positioned in the largest opening of the internal segment (5) of the stent (1).
Os materiais empregados na fabricação da endoprotese(l ) e o processo de fabricação são conhecidos no atual estado da técnica e não são aqui reivindicados.  Materials used in the manufacture of the endoprosthesis (1) and the manufacturing process are known in the state of the art and are not claimed herein.

Claims

REIVINDICAÇÕES
1. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR compreende uma endoprótese(l ) arterial reta que permite a conexão ou acoplamento, em seu corpo, de outras endopróteses arteriais revestidas, com diferentes diâmetros e comprimentos, caracterizada por apresentar segmento interno(5), feito em material similar ao do corpo da endoprótese(l ), posicionado em uma seção do corpo e conectado na superfície cilíndrica interna do corpo da endoprótese(l ) e o segmento interno(5) possuir uma pluralidade de aberturas(15, 16, 17, 18, 19, 51 , 52, 53, 54 e 55) de iguais ou diferentes tamanhos e formas.  1. ENDOPROTETIC FOR MODULAR ENDOVASCULAR TREATMENT SYSTEM comprises a straight arterial stent (L) which allows the connection or coupling of other coated arterial endoprostheses with different diameters and lengths, characterized in that the internal segment (5) is made in a material similar to that of the endoprosthesis body 1, positioned in a section of the body and connected to the inner cylindrical surface of the endoprosthesis body 1 and the inner segment 5 has a plurality of apertures 15, 16, 17, 18, 19, 51, 52, 53, 54 and 55) of equal or different sizes and shapes.
2. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 , caracterizado pela conexão do segmento interno(5) na superfície cilíndrica interna do corpo da endoprótese(l ), ser por sutura, cola ou meio similar de união;  ENDOPASCULAR MODULAR ENDOPROTETIC SYSTEM, according to claim 1, characterized in that the connection of the internal segment (5) on the internal cylindrical surface of the endoprosthesis body (1), is by suture, glue or similar means of attachment;
3. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 , caracterizado pelo segmento interno(5) possuir forma de um disco circular; ENDOPASCULAR MODULAR SYSTEM OF ENDOVASCULAR TREATMENT, according to claim 1, characterized in that the internal segment (5) is in the form of a circular disc;
4. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 e 3, caracterizado pela endoprotese(l ) possuir uma pluralidade de segmentos internos(5) de forma circular e os segmentos internos(5) estarem posicionados paralelos entre si e em seções transversais perpendiculares ao eixo do corpo cilíndrico da endoprótese( );  ENDOPASCULAR MODULAR SYSTEM OF ENDOVASCULAR TREATMENT SYSTEM according to claim 1 and 3, characterized in that the endoprosthesis (1) has a plurality of inner segments (5) of circular shape and the inner segments (5) are positioned parallel to one another and in transverse sections perpendicular to the axis of the cylindrical body of the stent ();
5. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 4, caracterizado pelas distâncias entre os segmentos internos(5), onde são conectadas as endoproteses comerciais, variar de 0 a 50mm ENDOPROTSE FOR MODULAR ENDOVASCULAR TREATMENT SYSTEM, according to claim 4, characterized in that distances between the inner segments (5), where the commercial endoprostheses are connected, vary from 0 to 50mm
6. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 , caracterizado pelo segmento interno(5) possuir forma de um disco elíptico;  A ENDOVASCULAR MODULAR TREATMENT SYSTEM ENDOPROTE, according to claim 1, characterized in that the internal segment (5) is in the form of an elliptical disc;
7. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 e 6, caracterizado pela endoprotese(l ) possuir uma pluralidade de segmentos internos(5) de forma elíptica e os segmentos internos(5) estarem posicionados paralelos entre si e em seções transversais inclinadas em relação ao eixo do corpo cilíndrico da endoprótese(l);  ENDOPASCULAR MODULAR SYSTEM OF ENDOVASCULAR TREATMENT SYSTEM according to claim 1 and 6, characterized in that the endoprosthesis (1) has a plurality of elliptical inner segments (5) and the inner segments (5) are positioned parallel to one another and in transverse sections inclined with respect to the axis of the cylindrical body of the stent (1);
8. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 e 6, caracterizado pela endoprotese(l ) possuir uma pluralidade de segmentos internos(5) de forma elíptica e os segmentos internos(5) estarem posicionados inclinados entre si e em seções transversais inclinadas em relação ao eixo do corpo cilíndrico da endoprótese(l );  ENDOPASCULAR MODULAR SYSTEM OF ENDOVASCULAR TREATMENT SYSTEM according to claim 1 and 6, characterized in that the endoprosthesis (1) has a plurality of inner segments (5) of elliptical shape and the inner segments (5) are positioned inclined to one another and in transverse sections inclined with respect to the axis of the cylindrical body of the stent (1);
9. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 , caracterizado pelo segmento interno(5) possuir forma cónica; e sua altura variar de 1 mm até o comprimento total da endoprótese(l ).  ENDOPASCULAR MODULAR ENDOPROTECTAL TREATMENT SYSTEM according to claim 1, characterized in that the internal segment (5) is conical in shape; and its height varies from 1 mm to the total length of the stent (l).
10. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 e 9, caracterizado pela endoprotese(l ) possuir uma pluralidade de segmentos internos(5) de forma cónica e os segmentos internos(5) estarem alinhados axialmente entre si e a base dos cones estarem em seções transversais perpendicular ao eixo do corpo cilíndrico da endoprótese(l ); e a distancia entre os cones variar de 1 a 50 mm;ENDOPASCULAR MODULAR SYSTEM OF ENDOVASCULAR TREATMENT SYSTEM according to claim 1 and 9, characterized in that the endoprosthesis (1) has a plurality of conical shaped segments (5) and the inner segments (5) are axially aligned with one another and The base of the cones are in transverse sections perpendicular to the axis of the cylindrical body of the stent (1); and the distance between the cones varies from 1 to 50 mm;
11. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 , caracterizado pelas aberturas(15, 16, 17, 18, 19, 51 , 52, 53, 54 e 55), do segmento interno(5), possuírem marcação radiopaca em seu contorno perimetral; The endovascular device according to claim 1, characterized in that the apertures (15, 16, 17, 18, 19, 51, 52, 53, 54 and 55) of the inner segment (5) radiopaque marking in its perimetral contour;
12. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 1 , caracterizado pela endoprótese(l) ter um segmento cônico(4), com ou sem estrutura metálica, concêntrico com o corpo cilíndrico reto, e posicionado no interior do corpo cilíndrico reto;  ENDOPASCULAR MODULAR ENDOPROTETIC SYSTEM, according to claim 1, characterized in that the endoprosthesis (1) has a conical segment (4), with or without metal structure, concentric with the cylindrical straight body, and positioned inside the body cylindrical straight;
13. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 12, caracterizado pelo segmento cônico(4), com ou sem estrutura metálica e posicionado no interior do corpo cilíndrico reto, possuir um anel metálico na base de menor diâmetro;  ENDOPASCULAR MODULAR ENDOPROTETIC TREATMENT SYSTEM according to claim 12, characterized in that the conical segment (4), with or without metal structure and positioned inside the straight cylindrical body, has a metal ring in the base of smaller diameter;
14. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 12, caracterizado pelo segmento cônico(4), com ou sem estrutura metálica e posicionado no interior do corpo cilíndrico reto, possuir marcação radiopaca na periferia da base de menor diâmetro;  ENDOPASCULAR MODULAR ENDOPROTETIC SYSTEM, according to claim 12, characterized in that the conical segment (4), with or without metal structure and positioned inside the straight cylindrical body, has radiopaque marking at the periphery of the base of smaller diameter;
15. ENDOPROTESE PARA SISTEMA MODULAR DE TRATAMENTO ENDOVASCULAR, de acordo com a reivindicação 12, caracterizado pelo segmento cônico(4) ter um comprimento suficientemente igual ao comprimento da endoprótese(l ) e poder variar de 10 a 200mm, e o diâmetro maior do segmento cônico(4) poder variar, igual à endoprótese(l ), de 20 a 60mm.  A ENDOVASCULAR MODULAR TREATMENT SYSTEM ENDOPROTE according to claim 12, characterized in that the conical segment (4) has a length sufficiently equal to the length of the stent (1) and can vary from 10 to 200mm, and the largest diameter of the segment conical (4) can vary, similar to the stent (l), from 20 to 60mm.
PCT/BR2011/000351 2011-09-21 2011-09-21 Coated stent-connector structural elements WO2013040663A1 (en)

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