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BR-112021017546-B1 - Vascular implant for implantation in a patient's blood vessel and method for manufacturing it.

BR112021017546B1BR 112021017546 B1BR112021017546 B1BR 112021017546B1BR-112021017546-B1

Abstract

VASCULAR IMPLANT FOR IMPLANTATION INTO A PATIENT'S BLOOD VESSEL AND METHOD FOR MANUFACTURING THEREOF. The present invention relates to a vascular implant for implantation into a patient's blood vessel, the vascular implant comprising a hollow cylindrical main body with a proximal end and a distal end, a main body lumen and a longitudinal axis and at least one hollow cylindrical side body branching from the main body and comprising a side body lumen, the side body lumen being in fluid communication with the main body lumen, wherein the hollow cylindrical main body and the at least one hollow cylindrical side body are formed in a single piece from a single flat sheet of graft material.

Inventors

  • Lisa BOHNE

Assignees

  • JOTEC GMBH

Dates

Publication Date
20260310
Application Date
20200304
Priority Date
20190306

Claims (16)

  1. 1. Vascular implant (1) for implantation into a patient's blood vessel, the vascular implant comprising a hollow cylindrical main body (10) with a proximal end (11) and a distal end (12), a main body lumen (13) and a longitudinal axis (14) and a hollow cylindrical side body (20) branching from the main body (10) and comprising a side body lumen (23), the side body lumen (23) being in fluid communication with the main body lumen (13), wherein the hollow cylindrical main body (10) and the hollow cylindrical side body (20) are formed in a single piece from a single flat sheet of graft material (30), characterized in that the vascular implant (1) further comprises a dart (34) extending from the distal end of the side body opening in the main body (51) along a portion of the proximal end of the lateral body (52).
  2. 2. Vascular implant (1), according to claim 1, characterized in that the dart (34) is formed by folding a portion of the graft material in the distal part of the branching region in the main tube with the dart pointing towards each side of the lateral tube in a proximal direction, the folds being fastened by stitching.
  3. 3. Vascular implant (1), according to claim 1, characterized in that the dart (34) is formed by incisions in the graft material sheet at the distal end of the lateral arm dissection in the main portion substantially parallel to the longitudinal axis of the main body, the incisions being connected when forming the tubular limbs from the graft material sheet.
  4. 4. Vascular implant (1), according to any one of claims 1 to 3, characterized in that the single flat sheet (30) comprises a main portion (31) having a width corresponding to the circumference of the main body (10) and two mirrored arm portions (32, 32') extending from the main portion on both sides having a width corresponding to half the circumference of the lateral body (20).
  5. 5. Vascular implant (1), according to claim 4, characterized in that the main portion is partially divided to form a common main portion (31') and two main portion legs (311, 311').
  6. 6. Vascular implant (1), according to claim 4 or 5, characterized in that two mirrored arm portions (32, 32') additionally comprise secondary lateral arm portions (33, 33') extending from the arm portions (32, 32').
  7. 7. Vascular implant (1), according to any one of claims 1 to 6, characterized in that the edges of the flat sheet (A, A', B, B', C, C') are joined to each other by welding, gluing, stitching or sewing to form the hollow cylindrical main body (10) and a hollow cylindrical side body (20).
  8. 8. Vascular implant (1), according to any one of claims 1 to 7, characterized in that the flat sheet of graft material is woven, braided, knitted, electrospun or pulverized.
  9. 9. Vascular implant (1), according to any one of claims 1 to 8, characterized in that the flat sheet of graft material is made from one or more polymers or copolymers thereof selected from Polyurethane, Polyether, Polyester, Polyamide, Polyethylene Terephthalate, Polytetrafluoroethylene or Expanded Polytetrafluoroethylene.
  10. 10. Vascular implant (1), according to any one of claims 1 to 9, characterized in that the vascular implant has one or more secondary lateral bodies (70) branching out from a lateral body (20).
  11. 11. Vascular implant (1), according to any one of claims 1 to 10, characterized in that the longitudinal axis (24) of a lateral body (20) branching off from the main body (10) is configured at an angle α relative to the longitudinal axis (14) of the main body.
  12. 12. Vascular implant (1), according to any one of claims 1 to 11, characterized in that it further comprises one or more stent rings (60) arranged successively along the longitudinal axis of a portion of the main body (10) and optionally of a portion of any of the side bodies (20), the stent rings (60) being transformable from a compressed state to a self-expanding state.
  13. 13. Vascular implant (1), according to claim 12, wherein the stent rings (60) are one-piece stent springs (61) arranged successively along the longitudinal axis (14) of the main body (10) and circumferentially meandrically, respectively, in a manner perpendicular to the longitudinal axis (14), the stent springs (61) being connected to the graft material (40) of the main body, the stent springs being connected to each other only by means of the graft material, and wherein the circumferentially meandrically stent springs have pointed arches (601) that alternately turn towards the proximal end and the distal end of the main body and parallel to its longitudinal axis, characterized in that, in the self-expanded state, the longitudinal axis (24) of a lateral body (20) branching from the main body (10) is configured at an angle α with respect to the longitudinal axis (14) of the main body, the angle being stabilized by a pointed arch (602) of a stent spring of the main body which projects angularly in a pre-formed manner with respect to the longitudinal axis of the main body in the self-expanded state.
  14. 14. Vascular implant (1), according to claim 13, characterized in that the dart (34) extends from the distal end of the lateral body opening in the main body (51) to a position adjacent to a leg (603) of the pointed arch (602) of the stent spring that projects angularly relative to the longitudinal axis of the main body.
  15. 15. Method for manufacturing the vascular implant (1), as defined in any one of claims 1 to 14, the method characterized in that it comprises the steps of (i) providing a flat sheet of graft material (30), and (ii) joining the edges (A, A', B, B', C, C') of the flat sheet to each other by welding, gluing, stitching or sewing to form the hollow cylindrical main body (10) and a hollow cylindrical side body (20), wherein the dart (34) is formed by folding a portion of the graft material (30) at the distal part of the branching region in the main tube with the dart pointing towards each side of the side tube in a proximal direction, the folds being fastened by stitching, or wherein the dart (34) is formed by incisions in the sheet of graft material at the distal end of the dissection of the side arm in the main portion substantially parallel to the longitudinal axis of the main body, the incisions being joined when forming the tubular limbs from the leaf of grafting material.
  16. 16. Vascular implant (1), according to claim 13, characterized in that the stent coils (61) are connected to the graft material (40) of the main body and to either of the side bodies.

Description

Description TECHNICAL FIELD [0001] This invention relates to a vascular implant for implantation in a patient's branched blood vessel to restore the vessel's unblocking. BACKGROUND OF THE INVENTION [0002] The present invention relates to a vascular implant for implantation in a patient's blood vessel, the vascular implant comprising a hollow cylindrical main body with a proximal end and a distal end, a main body lumen and a longitudinal axis and at least one hollow cylindrical side body branching off from the main body and comprising a side body lumen, the side body lumen being in fluid communication with the main body lumen. [0003] Such so-called branched vascular implants are known in the state of the art. Such vascular implants, which are also referred to as endovascular grafts, are implanted for the treatment of aneurysms, occlusions, or other damage to arteries. An aneurysm is understood to be the enlargement or bulging of an arterial blood vessel as a result of congenital or acquired changes in the wall. The bulging may affect the vessel wall as a whole or, as in the case of a so-called false aneurysm or dissection, blood may flow from the lumen of the artery between the layers of the vessel wall and may tear them. Failure to treat an aneurysm, occlusion, or other damage may lead to rupture of the artery at an advanced stage, with the consequence that the patient bleeds internally. [0004] For the treatment of aneurysms, occlusions or other damage, the vessel in question is therefore interconnected and/or stabilized by implanting a graft, in order to prevent rupture of the vessel. [0005] Such a graft may be applied to the vessel alone or the graft may be supported by a metal stent or stent coils arranged successively within or outside the graft. Such a construction is referred to as a stent graft. [0006] The graft or stent graft is introduced into the blood vessel by endoluminal techniques employing suitable delivery devices in order to restore the unobstructed blood vessel caused by the aneurysm. [0007] At the site of the vessel where such a vascular implant is to be inserted, blood vessels often branch laterally, which is why, by introducing the vascular implant at such branching points in the vessel, there is a risk that these lateral vessels will be cut off from the blood supply by the vascular implant in the main vessel or by the implant material, which may be impermeable to blood. Therefore, in these regions, vascular implants often have openings, also known as "fenestrations," in the graft material in order to direct the blood flowing through the vascular implant through these openings and also, generally, through lateral branches of the vascular implant, whose lateral branches are separately supplied in these openings and are being introduced into the lateral vessels, also into the lateral vessels that branch off from the vessel. In this way, it is ensured that the regions of the body that are supplied by the lateral vessel are also supplied with blood. [0008] In many cases, vascular implants or grafts/stent grafts to be introduced into such branching regions not only have fenestrations, but also lateral branches that branch out from the main body of the vascular implant, these branches being released into the aneurysmal sac above the branching vessel and serving, for example, as a landing zone for a supplementary stent graft, which is implanted in the lateral branch and the branching vessel in order to interconnect the aneurysm. In this way, it is additionally ensured that the lateral vessels are also supplied with blood. [0009] Critical regions in the human vascular system are, for example, the aortic bifurcation region and also the branching of the iliac arteries into the external and internal iliac arteries. With each of the branches, it is normally necessary to ensure the supply of the branching vessels if the aorta or the iliac arteries have to be treated in that region, for example, because of an aneurysm. [0010] Vascular implants comprising side branches that are currently known and available in the state of the art are normally made by attaching the side branches between stent coils as represented, for example, in document US6645242B. Alternatively, as, for example, disclosed in document EP0709066A1, a side arm graft tube is sutured into a hole of a main graft tube. [0011] One disadvantage of vascular implants with side branches known in the state of the art is that these vascular implants with side branches typically have an accumulation of material in the branching region, such as, for example, a nitinol ring in the side branch, through which the side branch is opened after expansion, or such as, for example, cloth rings sewn in an additional manner to the implant material, which, in turn, require larger insertion systems and, in narrow vessels, can lead to difficult handling of these vascular implants. Ring-forming sutures perpendicular to the blood flow can also cause turbulence in