WO2018032358A1 - Endoprosthesis having graft portion and stent graft portion - Google Patents

Endoprosthesis having graft portion and stent graft portion Download PDF

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Publication number
WO2018032358A1
WO2018032358A1 PCT/CN2016/095539 CN2016095539W WO2018032358A1 WO 2018032358 A1 WO2018032358 A1 WO 2018032358A1 CN 2016095539 W CN2016095539 W CN 2016095539W WO 2018032358 A1 WO2018032358 A1 WO 2018032358A1
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WO
WIPO (PCT)
Prior art keywords
graft
branch
endoprosthesis
stent
stent graft
Prior art date
Application number
PCT/CN2016/095539
Other languages
French (fr)
Inventor
Xiaoming Bian
Frank Zheng
Original Assignee
Dalian Corvivo Medical, Co. Ltd
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 Dalian Corvivo Medical, Co. Ltd filed Critical Dalian Corvivo Medical, Co. Ltd
Priority to PCT/CN2016/095539 priority Critical patent/WO2018032358A1/en
Priority to CN201621063737.9U priority patent/CN206934208U/en
Priority to CN201610833060.0A priority patent/CN107753148A/en
Publication of WO2018032358A1 publication Critical patent/WO2018032358A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • 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
    • A61F2/02—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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • the present invention relates to an endoprosthesis and, in particular, to an endoprosthesis having a graft portion and a stent graft portion.
  • United States Patent Application Publication No. 2006/0074484 which was published on April 6, 2016 in the name of Huber, discloses an endoprosthesis that may be placed in the aortic arch.
  • the endoprosthesis may include arms that extend into the brachiocephalic artery (innominate artery), left common carotid artery, and left subclavian artery, respectively.
  • an endoprosthesis comprising a graft portion and a stent graft portion.
  • the graft portion has a graft trunk with a first graft branch and a second graft branch.
  • the first graft branch and the second graft branch are each in fluid communication with the graft trunk and extend outwardly from the graft trunk.
  • the stent graft portion has a main stent graft and a stent graft branch extending from the main stent graft.
  • the stent graft branch is in fluid communication with the main stent graft and extends outwardly from the main stent graft.
  • the graft portion and the stent graft portion are in fluid communication and define a lumen of the endoprosthesis.
  • the graft portion has a circumferential wall and the stent graft portion has a circumferential wall.
  • the circumferential wall of the graft portion and the circumferential wall of the stent graft portion may be unitary.
  • the stent graft portion may further include a self-expandable mesh.
  • the first graft branch may be configured to fit into an innominate artery.
  • There may be a ring for sealing the first graft branch against the innominate artery.
  • the first graft branch may be magnetic and the ring may be magnetic, to magnetically engage the first graft branch and seal the first graft branch against the innominate artery.
  • the second graft branch may be configured to fit into a left common carotid artery.
  • the second graft branch may be magnetic and the ring may be magnetic, to magnetically engage the secondgraft branch and seal the second graft branch against the left common carotid artery.
  • the stent graft branch may be configured to fit into a subclavian artery.
  • the endoprosthesis may be movable between a contracted configuration and an expanded configuration. The endoprosthesis may be biased to the expanded configuration.
  • an endoprosthesis comprising a graft portion and a stent graft portion.
  • the graft portion has a graft trunk with a first graft branch, a second graft branch, and a third graft branch.
  • the first graft branch, the second graft branch, and the third graft branch are each in fluid communication with the graft trunk and extend outwardly from the graft trunk.
  • Thestent graft portion is in fluid communication with the graft portion.
  • the graft portion and the stent graft portion define a lumen of the endoprosthesis.
  • the graft portion has a circumferential wall and the stent graft portion has a circumferential wall.
  • the circumferential wall of the graft portion and the circumferential wall of the stent graft portion may be unitary.
  • the stent graft portion may further include a self-expandable mesh.
  • Figure 1 is a perspective, partially cut away, view of a firstendoprosthesis having a graft portion and a stent graft portion;
  • Figure 1A is a sectional view taken along line A-A of Figure 1;
  • Figure 1B is a sectional view taken along line B-B of Figure 1;
  • Figure 2 is an elevation view of a ring used with the first endoprosthesis
  • Figure 3 is a partially cut away and partially sectional view showing the first endoprosthesis being introduced into an aortic arch during a first procedure
  • Figure 4 is another partially cut away and partially sectional view showing the first endoprosthesis being introduced into the aortic arch during the first procedure;
  • Figure 5 is a partially cut away and partially sectional view showing the first endoprosthesis positioned in the aortic arch during the first procedure;
  • Figure 5A is a sectional view taken along line A-A of Figure 5;
  • Figure 5B is a sectional view taken along line B-B of Figure 5;
  • Figure 6 is a partially cut away and partially sectional view showing the first endoprosthesis being introduced into an aortic arch during a second procedure
  • Figure 7 is another partially cut away and partially sectional view showing the first endoprosthesis being introduced into the aortic arch during the second procedure;
  • Figure 8 is a partially cut away and partially sectional view showing the first endoprosthesis positioned in the aortic arch during the second procedure;
  • Figure 9 is another partially cut away and partially sectional view showing the first endoprosthesis positioned in the aortic arch during the second procedure;
  • Figure 10 is a perspective, partially cut away, view of the second endoprosthesis having a graft portion and a stent graft portion;
  • Figure 11 is a perspective, partially cut away, view of a second endoprosthesis being used to replace an aortic arch
  • Figure 12 is a perspective, partially cut away, view of a third endoprosthesis having a graft portion and a stent graft portion;
  • Figure 13 is a perspective, partially cut away, view of the third endoprosthesis being used to replace an aortic arch.
  • the endoprosthesis 10 comprises a graft portion 20 and a stent graft portion 30.
  • the graft portion 20 includes a graft trunk 22 with a first graft branch 24 and a second graft branch 26 each extending radially outward from the graft trunk 22.
  • the first graft branch 24 and the second graft branch 26 are each in fluid communication with the graft trunk 22.
  • the graft trunk 22 is formed of a suitable synthetic material such as Dacron® or Gortex® which defines a circumferential wall 28 of the graft trunk 22 as shown in Figure 1A.
  • the first graft branch 24 and the second graft branch 26 are likewise formed of a suitable synthetic material and may have magnetic elements and/or magnetic properties.
  • the stent graft portion 30 includes a main stent graft 32 and a stent graft branch 34 extending radially outward from the main stent graft 32.
  • the stentgraft branch 34 is in fluid communication with themain stent graft 32.
  • the stent graft portion 30 includes aninner self-expandablemesh 36, wire mesh in this example, and a circumferential wall 38 which is formed of a suitable synthetic material such as Dacron® or Gortex®as shown in Figure 1B.
  • the circumferential wall 28 of the graft trunk 22 and the circumferential wall 38 of the main stent graft 32 are unitary, in this example, and define a lumen 40 of the endoprosthesis.
  • a lumen 42 of the first graft branch 24 and a lumen 44 of the second graft branch 26 are each in fluid communication with the lumen 40.
  • a lumen 46 of the stent graft branch 34 is likewise in fluid communication with the lumen 40.
  • the self-expandable mesh 36 of the stent graft portion 30 is a self-expanding wire mesh which is biased to an expanded configuration as shown in Figure 1.
  • the endoprosthesis 10 is accordingly biased to an expanded configuration.
  • Figure 2 shows a ring 50 for use with the endoprosthesis 10.
  • the ring 50 is an open ended ring formed of a soft magnetic material 52.
  • the ring 50 has a resilient core 54 which renders the ring 50 pliable. This allows the ring 50 to be used to magnetically engage the first graft branch 24 and the second graft branch 26to seal an annulus between the first graft branch 24 and a corresponding native vessel branch as well as an annulus between the second graft branch 26 and a corresponding native vessel branch without anastomosis.
  • the endoprosthesis 10 is initially provided to a surgeon in a contracted configuration as shown in Figure 3.
  • the endoprosthesis 10 is retained in the contracted state by a sheath 60.
  • the endoprosthesis 10 and sheath 60 may be introduced into a patient during a first procedure using guidewires and, in this example, a plurality of guidewires 62, 64 and 66 are used to introduce the endoprosthesis 10 and sheath 60 into the aortic arch 70.
  • a first guidewire 62 is used to guide the first graft branch 24 into the innominate artery 72.
  • a second guide wire 64 is used to guide the second graft branch 26 into the left common carotid artery 74.
  • a third guidewire 66 is used to guide the stent graft branch 34 into the subclavian artery 76. This results in the graft portion 20 of the endoprosthesis 10 being disposed substantially within the aortic arch 70 and the stent graft portion 30 of the endoprosthesis being disposed substantially within the descending aorta 78.
  • a ring 50 may be used to seal the first graft branch 24 against the innominate artery 72.
  • a ring 50 may likewise be used to seal the second graft branch 26 against the left common carotid artery 74.
  • the circumferential wall 28 of the graft trunk 22 and the circumferential wall 38 of the main stent graft 32 each push against the aortic wall as shown in Figures 5A and 5B. This allows for repair of the aortic arch.
  • the endoprosthesis 10 and sheath 60 may alternatively be introduced into a patient, during a second procedure,after the innominate artery 72 and left common carotid artery 74 have been cut as shown in Figure 6.
  • the first guidewire 62 is used to guide the first graft branch 24 into the innominate artery 72.
  • the second guide wire 64 is used to guide the second graft branch 26 into the left common carotid artery 74.
  • the third guidewire 66 is used to guide the stent graft branch 34 into the subclavian artery 76. This results in the graft portion 20 of the endoprosthesis 10 being disposed substantially within the aortic arch 70 and the stent graft portion 30 of the endoprosthesis being substantially disposed within the descending aorta 78.
  • a ring 50 may be used to seal the first graft branch 24 against the innominate artery 72.
  • a ring 50 may likewise be used to seal the second graft branch 26 against the left common carotid artery 74.
  • Thefirst graft branch 24 may then be connected to the distal part of theinnominate artery 72 and the second graft branch 26 may be connected to the distal part of the left common carotid artery 74, as shown in Figure 9.
  • sutures 80 are used to connect the first graft branch 24 to the distal part of the innominate artery 72 and sutures 82 are used to connect the second graft branch 26 to the distal part of the left common carotid artery 74. This allows for repair of the innominate artery, the left common carotid artery and the aortic arch.
  • the endoprosthesis 110 comprises a graft portion 120 and a stent graft portion 130.
  • the graft portion 120 includes a graft trunk 122 with a first graft branch 124 and a second graft branch 126 each extending radially outward from the graft trunk 122.
  • the first graft branch 124 and the second graft branch 126 are each in fluid communication with the graft trunk 122.
  • the graft trunk 122 is formed of a suitable synthetic material such as Dacron® or Gortex® which defines a circumferential wall 128 of the graft trunk 122.
  • the stent graft portion 130 includes a main stent graft132 and a stent graft branch134 extending radially outward from the main stent graft 132.
  • the stent graft branch134 is in fluid communication with the main stent graft 132.
  • the stent graft portion 130 includes aninner self-expandable mesh 136, wire mesh in this example, and a circumferential wall 138 which is formed of a suitable synthetic material such as Dacron® or Gortex®.
  • the circumferential wall 128 of the graft trunk 122 and the circumferential wall 138 of the main stent graft132 are unitary, in this example, and define a lumen 140 of the endoprosthesis.
  • a lumen 142 of the first graft branch 124 and a lumen 144 of the second graft branch 126 are each in fluid communication with the lumen 140.
  • a lumen 146 of the stent graft branch 134 is likewise in fluid communication with the lumen 140.
  • the self-expandable mesh 136 of the stent graft portion 130 is a self-expanding wire mesh which is biased to an expanded configuration as shown in Figure 10.
  • the endoprosthesis110 is accordingly biased to an expanded configuration.
  • the endoprosthesis 110 further includes a collar 148 which extends about the graft trunk 122 adjacent to the stent graft portion 130.
  • the endoprosthesis110 may be used in aortic arch replacement as shown in Figure 11.
  • the first graft branch 124 may be connected to the distal part of the innominate artery 172 and the second graft branch 126 may be connected to the distal part of the left common carotid artery 174.
  • sutures 180 are used to connect the first graft branch 124 to the distal part of the innominate artery 172 and sutures182 are used to connect the second graft branch 126 to the distal part of the left common carotid artery 174.
  • the stent graft branch 134 is disposed substantially within the subclavian artery 176 and the main stent graft 132 is disposed substantially within the descending aorta 178.
  • the collar 148 of the endoprosthesis110 may be connected to the aorticarch 170.
  • sutures 184 and 186 are used to connect the graft trunk 122 to the aorticarch 170.
  • the graft trunk 122 may be connected by sutures 188 to the ascending aorta 190.
  • the endoprosthesis 210 comprises a graft portion 220 and a stent graft portion 230.
  • the graft portion 220 includes a graft trunk 222 with a first graft branch 224, a second graft branch 226, and a third graft branch 227each extending radially outward from the graft trunk 222.
  • the first graft branch 224, the second graft branch 226, and the third graft branch 227 are each in fluid communication with the graft trunk 222.
  • the graft trunk 222 is formed of a suitable synthetic material such as Dacron® or Gortex® which defines a circumferential wall 228 of the graft trunk 222.
  • the stent graft portion 230 is a main stent graft 232 which includes aninner self-expandable mesh 236, wire mesh in this example, and a circumferential wall 238 which is formed of a suitable synthetic material such as Dacron® or Gortex®.
  • the circumferential wall 228 of the graft trunk 222 and the circumferential wall 238 of the main stent graft 232 are unitary, in this example, and define a lumen 240 of the endoprosthesis.
  • a lumen 242 of the first graft branch 224, a lumen 244 of the second graft branch 226, and a lumen 246 of the third graft branch 227 are each in fluid communication with the lumen 240.
  • the self-expandable mesh 236 of the stent graft portion 230 is a self-expanding wire mesh which is biased to an expanded configuration as shown in Figure 12.
  • the endoprosthesis210 is accordingly biased to an expanded configuration.
  • the endoprosthesis 210 further includes a collar 248 which extends about the graft trunk 222 adjacent to the stent graft portion 230.
  • the endoprosthesis210 may be used in aortic arch replacement as shown in Figure 13.
  • the first graft branch 224 may be connected to the distal part of the innominate artery 272
  • the second graft branch 226 may be connected to the distal part of the left common carotid artery 274
  • the third graft branch 227 may be connected to the distal part of the subclavian artery 276.
  • sutures 280 are used to connect the first graft branch 224 to the distal part of the innominate artery 272
  • sutures 282 are used to connect the second graft branch 226 to the distal part of the left common carotid artery 27
  • sutures 283 are used to connect the third graft branch 227 to the distal part of the subclavian artery 276.
  • the main stent graft 232 is disposed substantially within the descending aorta 278.
  • the collar 248 of the endoprosthesis210 may be connected to the descending aorta 278.
  • sutures 284 and 286 are used to connect the collar 248 to the descending aorta 278. This seals a space between the main stent graft 232 to the descending aorta 278.
  • the graft trunk 222 may connected by sutures 288 to the ascending aorta 290.

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

Abstract

An endoprosthesis(10) comprises a graft portion(20) and a stent graft portion(30). The graft portion(20) has a graft trunk(22) with a first graft branch(24) and a second graft branch(26). The first graft branch(24) and the second graft branch(26) are each in fluid communication with the graft trunk(22) and extend outwardly from the graft trunk(22). The stent graft portion(30) has a main stent graft(32) and a stent graft branch(34) extending from the main stent graft(32). The stent graft branch(34) is in fluid communication with the main stent graft(32) and extends outwardly from the main stent graft(32). The graft portion(20) and the stent graft portion(30) are in fluid communication and define a lumen(40) of the endoprosthesis(10).

Description

ENDOPROSTHESIS HAVING A GRAFT PORTION AND A STENT GRAFT PORTION
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates to an endoprosthesis and, in particular, to an endoprosthesis having a graft portion and a stent graft portion.
Description of the Related Art
United States Patent Application Publication No. 2006/0074484, which was published on April 6, 2016 in the name of Huber, discloses an endoprosthesis that may be placed in the aortic arch. The endoprosthesis may include arms that extend into the brachiocephalic artery (innominate artery), left common carotid artery, and left subclavian artery, respectively.
SUMMARY OF THE INVENTION
There is provided an endoprosthesis comprising a graft portion and a stent graft portion. The graft portion has a graft trunk with a first graft branch and a second graft branch. The first graft branch and the second graft branch are each in fluid communication with the graft trunk and extend outwardly from the graft trunk. The stent graft portion has a main stent graft and a stent graft branch extending from the main stent graft. The stent graft branch is in fluid communication with the main stent graft and extends outwardly from the main stent graft. The graft portion and the stent graft portion are in fluid communication and define a lumen of the endoprosthesis.
The graft portion has a circumferential wall and the stent graft portion has a circumferential wall. The circumferential wall of the graft portion and the circumferential wall of the stent graft portion may be unitary. The stent graft portion may further include a self-expandable mesh. The first graft branch may be configured to fit into an innominate artery. There may be a ring for sealing the first graft branch against the innominate artery. The first graft branch may be magnetic and the ring may be magnetic, to magnetically engage the first graft branch and seal the first graft branch against the innominate artery. The second graft branch may be configured to fit into a left common carotid artery. There may be a ring for sealing the second graft branch against the left common carotid artery. The second graft branch may be magnetic and the ring may be magnetic, to magnetically engage the secondgraft branch and seal the second graft branch against the left common carotid artery.The stent graft branch may be configured to fit into a subclavian artery.The endoprosthesismay be movable between a contracted configuration and an expanded configuration. The endoprosthesis may be biased to the expanded configuration. There may be a collar extending about the graft portion.
There is also provided an endoprosthesis comprising a graft portion and a stent graft portion. The graft portion has a graft trunk with a first graft branch, a second graft branch, and a third graft branch. The first graft branch, the second graft branch, and the third graft branch are each in fluid communication with the graft trunk and extend outwardly from the graft trunk. Thestent graft portion is in fluid communication with the graft portion. The graft portion and the stent graft portion define a lumen of the endoprosthesis.The graft portion has a circumferential wall and the stent graft portion has a circumferential wall. The circumferential wall of the graft portion and the circumferential wall of the stent graft portion may be unitary. The stent graft portion may further include a self-expandable mesh. There may be a collar extending about the graft portion.
BRIEF DESCRIPTIONS OF DRAWINGS
The invention will be more readily understood from the following description of the embodiments thereof given, by way of example only, with reference to the accompanying drawings, in which:
Figure 1 is a perspective, partially cut away, view of a firstendoprosthesis having a graft portion and a stent graft portion;
Figure 1A is a sectional view taken along line A-A of Figure 1;
Figure 1B is a sectional view taken along line B-B of Figure 1;
Figure 2 is an elevation view of a ring used with the first endoprosthesis;
Figure 3 is a partially cut away and partially sectional view showing the first endoprosthesis being introduced into an aortic arch during a first procedure;
Figure 4 is another partially cut away and partially sectional view showing the first endoprosthesis being introduced into the aortic arch during the first procedure;
Figure 5 is a partially cut away and partially sectional view showing the first endoprosthesis positioned in the aortic arch during the first procedure;
Figure 5A is a sectional view taken along line A-A of Figure 5;
Figure 5B is a sectional view taken along line B-B of Figure 5;
Figure 6 is a partially cut away and partially sectional view showing the first endoprosthesis being introduced into an aortic arch during a second procedure;
Figure 7 is another partially cut away and partially sectional view showing the first endoprosthesis being introduced into the aortic arch during the second procedure;
Figure 8 is a partially cut away and partially sectional view showing the first endoprosthesis positioned in the aortic arch during the second procedure;
Figure 9 is another partially cut away and partially sectional view showing the first endoprosthesis positioned in the aortic arch during the second procedure;
Figure 10 is a perspective, partially cut away, view of the second endoprosthesis having a graft portion and a stent graft portion;
Figure 11 is a perspective, partially cut away, view of a second endoprosthesis being used to replace an aortic arch;
Figure 12 is a perspective, partially cut away, view of a third endoprosthesis having a graft portion and a stent graft portion; and
Figure 13 is a perspective, partially cut away, view of the third endoprosthesis being used to replace an aortic arch.
DESCRIPTIONS OF THE PREFERRED EMBODIMENTS
Referring to the drawings and first to Figure 1, a first endoprosthesis 10 is shown. The endoprosthesis 10 comprises a graft portion 20 and a stent graft portion 30. The graft portion 20 includes a graft trunk 22 with a first graft branch 24 and a second graft branch 26 each extending radially outward from the graft trunk 22. The first graft branch 24 and the second graft branch 26 are each in fluid communication with the graft trunk 22. In this example, the graft trunk 22 is formed of a suitable synthetic material such as Dacron® or Gortex® which defines a circumferential wall 28 of the graft trunk 22 as shown in Figure 1A. The first graft branch 24 and the second graft branch 26 are likewise formed of a suitable synthetic material and may have magnetic elements and/or magnetic properties. The stent graft portion 30 includes a main stent graft 32 and a stent graft branch 34 extending radially outward from the main stent graft 32. The stentgraft branch 34 is in fluid communication with themain stent graft 32. In this example, the stent graft portion 30 includes aninner self-expandablemesh 36, wire mesh in this example, and a circumferential wall 38 which is formed of a suitable synthetic material such as Dacron® or Gortex®as shown in Figure 1B.
The circumferential wall 28 of the graft trunk 22 and the circumferential wall 38 of the main stent graft 32 are unitary, in this example, and define a lumen 40 of the endoprosthesis. A lumen 42 of the first graft branch 24 and a lumen 44 of the second graft branch 26 are each in fluid communication with the lumen 40. A lumen 46 of the stent graft branch 34 is likewise in fluid communication with the lumen 40. The self-expandable mesh 36 of the stent graft portion 30 is a self-expanding wire mesh which is biased to an expanded configuration as shown in Figure 1. The endoprosthesis 10 is accordingly biased to an expanded configuration.
Figure 2 shows a ring 50 for use with the endoprosthesis 10. In this example, the ring 50 is an open ended ring formed of a soft magnetic material 52. The ring 50 has a resilient core 54 which renders the ring 50 pliable. This allows the ring 50 to be used to magnetically engage the first graft branch 24 and the second graft branch 26to seal an annulus between the first graft branch 24 and a corresponding native vessel branch as well as an annulus between the second graft branch 26 and a corresponding native vessel branch without anastomosis.
The endoprosthesis 10 is initially provided to a surgeon in a contracted configuration as shown in Figure 3. The endoprosthesis 10 is retained in the contracted state by a sheath 60. The endoprosthesis 10 and sheath 60 may be introduced into a patient during a first procedure using guidewires and, in this example, a plurality of guidewires 62, 64 and 66 are used to introduce the endoprosthesis 10 and sheath 60 into the aortic arch 70. A first guidewire 62 is used to guide the first graft branch 24 into the innominate artery 72. A second guide wire 64 is used to guide the second graft branch 26 into the left common carotid artery 74. A third guidewire 66 is used to guide the stent graft branch 34 into the subclavian artery 76. This results in the graft portion 20 of the endoprosthesis 10 being disposed substantially within the aortic arch 70 and the stent graft portion 30 of the endoprosthesis being disposed substantially within the descending aorta 78.
Referring now to Figures 4 and 5, once the endoprosthesis 10 is positioned in the aortic arch, the sheath 60 is removed and the endoprosthesis 10 expands to the expanded configuration. A ring 50 may be used to seal the first graft branch 24 against the innominate artery 72. A ring 50 may likewise be used to seal the second graft branch 26 against the left common carotid artery 74. The circumferential wall 28 of the graft trunk 22 and the circumferential wall 38 of the main stent graft 32 each push against the aortic wall as shown in Figures 5A and 5B. This allows for repair of the aortic arch.
The endoprosthesis 10 and sheath 60 may alternatively be introduced into a patient, during a second procedure,after the innominate artery 72 and left common carotid artery 74 have been cut as shown in Figure 6. The first guidewire 62 is used to guide the first graft branch 24 into the innominate artery 72. The second guide wire 64 is used to guide the second graft branch 26 into the left common carotid artery 74. The third guidewire 66 is used to guide the stent graft branch 34 into the subclavian artery 76. This results in the graft portion 20 of the endoprosthesis 10 being disposed substantially within the aortic arch 70 and the stent graft portion 30 of the endoprosthesis being substantially disposed within the descending aorta 78.
Once the endoprosthesis 10 is positioned in the aortic arch 70, as shown in Figures 7 and 8, the sheath 60 is removed and the endoprosthesis 10 expands to the expanded configuration. A ring 50 may be used to seal the first graft branch 24 against the innominate artery 72. A ring 50 may likewise be used to seal the second graft branch 26 against the left common carotid artery 74. Thefirst graft branch 24 may then be connected to the distal part of theinnominate artery 72 and the second graft branch 26 may be connected to the distal part of the left common carotid artery 74, as shown in Figure 9. In this example, sutures 80 are used to connect the first graft branch 24 to the distal part of the innominate artery 72 and sutures 82 are used to connect the second graft branch 26 to the distal part of the left common carotid artery 74. This allows for repair of the innominate artery, the left common carotid artery and the aortic arch.
Referring now to Figure 10, a second endoprosthesis110 is shown. The endoprosthesis 110 comprises a graft portion 120 and a stent graft portion 130. The graft portion 120 includes a graft trunk 122 with a first graft branch 124 and a second graft branch 126 each extending radially outward from the graft trunk 122. The first graft branch 124 and the second graft branch 126 are each in fluid communication with the graft trunk 122.The graft trunk 122 is formed of a suitable synthetic material such as Dacron® or Gortex® which defines a circumferential wall 128 of the graft trunk 122. The stent graft portion 130 includes a main stent graft132 and a stent graft branch134 extending radially outward from the main stent graft 132. The stent graft branch134 is in fluid communication with the main stent graft 132. In this example, the stent graft portion 130 includes aninner self-expandable mesh 136, wire mesh in this example, and a circumferential wall 138 which is formed of a suitable synthetic material such as Dacron® or Gortex®.
The circumferential wall 128 of the graft trunk 122 and the circumferential wall 138 of the main stent graft132 are unitary, in this example, and define a lumen 140 of the endoprosthesis. A lumen 142 of the first graft branch 124 and a lumen 144 of the second graft branch 126 are each in fluid communication with the lumen 140. A lumen 146 of the stent graft branch 134 is likewise in fluid communication with the lumen 140. The self-expandable mesh 136 of the stent graft portion 130 is a self-expanding wire mesh which is biased to an expanded configuration as shown in Figure 10. The endoprosthesis110 is accordingly biased to an expanded configuration. In this example, the endoprosthesis 110 further includes a collar 148 which extends about the graft trunk 122 adjacent to the stent graft portion 130.
The endoprosthesis110 may be used in aortic arch replacement as shown in Figure 11. The first graft branch 124 may be connected to the distal part of the innominate artery 172 and the second graft branch 126 may be connected to the distal part of the left common carotid artery 174. In this example, sutures 180 are used to connect the first graft branch 124 to the distal part of the innominate artery 172 and sutures182 are used to connect the second graft branch 126 to the distal part of the left common carotid artery 174.The stent graft branch 134 is disposed substantially within the subclavian artery 176 and the main stent graft 132 is disposed substantially within the descending aorta 178. The collar 148 of the endoprosthesis110 may be connected to the aorticarch 170. In this example, sutures 184 and 186 are used to connect the graft trunk 122 to the aorticarch 170. The graft trunk 122 may be connected by sutures 188 to the ascending aorta 190.
Referring now to Figure 12, a third endoprosthesis210 is shown. The endoprosthesis 210 comprises a graft portion 220 and a stent graft portion 230. The graft portion 220 includes a graft trunk 222 with a first graft branch 224, a second graft branch 226, and a third graft branch 227each extending radially outward from the graft trunk 222. The first graft branch 224, the second graft branch 226, and the third graft branch 227 are each in fluid communication with the graft trunk 222. The graft trunk 222 is formed of a suitable synthetic material such as Dacron® or Gortex® which defines a circumferential wall 228 of the graft trunk 222. The stent graft portion 230 is a main stent graft 232 which includes aninner self-expandable mesh 236, wire mesh in this example, and a circumferential wall 238 which is formed of a suitable synthetic material such as Dacron® or Gortex®.
The circumferential wall 228 of the graft trunk 222 and the circumferential wall 238 of the main stent graft 232 are unitary, in this example, and define a lumen 240 of the endoprosthesis. A lumen 242 of the first graft branch 224, a lumen 244 of the second graft branch 226, and a lumen 246 of the third graft branch 227 are each in fluid communication with the lumen 240.The self-expandable mesh 236 of the stent graft portion 230 is a self-expanding wire mesh which is biased to an expanded configuration as shown in Figure 12. The endoprosthesis210 is accordingly biased to an expanded configuration. In this example, the endoprosthesis 210 further includes a collar 248 which extends about the graft trunk 222 adjacent to the stent graft portion 230.
The endoprosthesis210 may be used in aortic arch replacement as shown in Figure 13. The first graft branch 224 may be connected to the distal part of the innominate artery 272, the second graft branch 226 may be connected to the distal part of the left common carotid artery 274, and the third graft branch 227 may be connected to the distal part of the subclavian artery 276. In this example, sutures 280 are used to connect the first graft branch 224 to the distal part of the innominate artery 272, sutures 282 are used to connect the second graft branch 226 to the distal part of the left common carotid artery 274, and sutures 283 are used to connect the third graft branch 227 to the distal part of the subclavian artery 276. The main stent graft 232 is disposed substantially within the descending aorta 278. The collar 248 of the endoprosthesis210 may be connected to the descending aorta 278. In this example, sutures 284 and 286 are used to connect the collar 248 to the descending aorta 278. This seals a space between the main stent graft 232 to the descending aorta 278. The graft trunk 222 may connected by sutures 288 to the ascending aorta 290.
It will be understood by a person skilled in the art that many of the details provided above are by way of example only, and are not intended to limit the scope of the invention which is to be determined with reference to the following claims.

Claims (19)

  1. An endoprosthesis comprising:
    a graft portion having a graft trunk with a first graft branch and a second graft branch, the first graft branch and the second graft branch each being in fluid communication with the graft trunk and extending outwardly from the graft trunk; and
    a stent graft portion having a main stent graft and a stent graft branch extending from the main stent graft, the stent graft branch being in fluid communication with the main stent graft and extending outwardly from the main stent graft, wherein the graft portion and the stent graft portion are in fluid communication and define a lumen of the endoprosthesis.
  2. The endoprosthesis as claimed in claim 1 wherein the graft portion has a circumferential wall and the stent graft portion has a circumferential wall, and the circumferential wall of the graft portion and the circumferential wall of the stent graft portion are unitary.
  3. The endoprosthesis as claimed in claim 2 wherein the stent graft portion further includes a self-expandable mesh.
  4. The endoprosthesis as claimed in claim 1 wherein the first graft branch is configured to fit into an innominate artery.
  5. The endoprosthesis as claimed in claim 4 further including a ring for sealing the first graft branch against the innominate artery.
  6. The endoprosthesis as claimed in claim 1 wherein the first graft branch is magnetic and is configured to fit into an innominate artery.
  7. The endoprosthesis as claimed in claim 6 further including a magnetic ring for magnetically engaging the first graft branch to seal the first graft branch against the innominate artery.
  8. The endoprosthesis as claimed in claim 1 wherein the second graft branch is configured to fit into a left common carotid artery.
  9. The endoprosthesis as claimed in claim 8 further including a ring for sealing the second graft branch against the left common carotid artery.
  10. The endoprosthesis as claimed in claim 1 wherein the second graft branch is magnetic and is configured to fit into aleft common carotid artery.
  11. The endoprosthesis as claimed in claim 10 further including a magnetic ring for magnetically engaging the second graft branch to seal the second graft branch against the left common carotid artery.
  12. The endoprosthesis as claimed in claim 1 wherein the stent graft branch is configured to fit into a subclavian artery.
  13. The endoprosthesis as claimed in claim 1 wherein the endoprosthesis is movable between a contracted configuration and an expanded configuration.
  14. The endoprosthesis as claimed in claim 13 wherein the endoprosthesis is biased to the expanded configuration.
  15. The endoprosthesis as claimed in claim 1 further including a collar extending about the graft portion.
  16. An endoprosthesis comprising:
    a graft portion having a graft trunk with a first graft branch, a second graft branch, and a third graft branch, the first graft branch, the second graft branch, and the third graft branch each being in fluid communication with the graft trunk and extending outwardly from the graft trunk; and
    a stent graft portion in fluid communication with the graft portion, wherein the graft portion and the stent graft portion define a lumen of the endoprosthesis.
  17. The endoprosthesis as claimed in claim 16 wherein the graft portion has a circumferential wall and the stent graft portion has a circumferential wall, and the circumferential wall of the graft portion and the circumferential wall of the stent graft portion are unitary.
  18. The endoprosthesis as claimed in claim 17 wherein the stent graft portion further includes a self-expandable mesh.
  19. The endoprosthesis as claimed in claim 16 further including a collar extending about the graft portion.
PCT/CN2016/095539 2016-08-16 2016-08-16 Endoprosthesis having graft portion and stent graft portion WO2018032358A1 (en)

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CN201621063737.9U CN206934208U (en) 2016-08-16 2016-09-19 Built-in prothesis with artificial blood vessel part and overlay film frame part
CN201610833060.0A CN107753148A (en) 2016-08-16 2016-09-19 Built-in prothesis with artificial blood vessel part and overlay film frame part

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