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CN-122028871-A - Restraint arrangement for stent grafts loaded onto a delivery system

CN122028871ACN 122028871 ACN122028871 ACN 122028871ACN-122028871-A

Abstract

A constraining arrangement for a stent graft loaded onto a delivery device. The stent graft has a graft body defining an elongate lumen and a positionable region. At least one apposition release wire releasably secures the graft body to the guidewire cannula along the length of the guidewire cannula. The suture is circumferentially threaded through and around the graft body such that a plurality of inner suture portions are formed. The confinement ring is formed by a first one of the inner suture portions. The plurality of reduced loops are formed by other ones of the inner suture portions. At least one apposition release wire passes through each of the plurality of reduction rings and the constraining ring and releases each of the reduction rings and the constraining ring upon retraction of the apposition release wire, thereby allowing the stent graft to expand and release from the guidewire cannula.

Inventors

  • C.JIN
  • DUECK WILHELM
  • KOLBEL TILO

Assignees

  • 库克医药技术有限责任公司

Dates

Publication Date
20260512
Application Date
20240906
Priority Date
20230908

Claims (14)

  1. 1. A constraining arrangement for a stent graft loaded onto a delivery device in combination with a stent graft, the stent graft having a graft body defining an elongate lumen, and a positionable region, the delivery device having a sleeve passing through the elongate lumen and the sleeve being disposed about a guidewire cannula, the constraining arrangement comprising: At least one apposition release wire releasably securing the graft body relative to the guidewire cannula along a length of the guidewire cannula; a suture circumferentially threaded through and stitched around the graft body such that a plurality of outer suture portions and a plurality of inner suture portions are formed; a constraining ring formed from a first one of the inner suture portions surrounding the guidewire cannula and constraining the positionable region in close juxtaposition with the sleeve, and A plurality of reduced loops formed by other ones of the inner suture portions, the plurality of reduced loops extending radially inward from the graft body, Wherein the at least one apposition release wire passes through each of the plurality of reduction rings and the confinement ring, an Wherein retraction of the at least one apposition release wire releases each of the plurality of reduction rings and the constraining ring, thereby allowing the stent graft to expand and release from the guidewire cannula.
  2. 2. The constraining arrangement of claim 1, wherein the at least one apposition release wire penetrates the graft body from the exterior of the graft body into the interior of the graft body and then returns from the interior of the graft body to the exterior of the graft body, thereby providing a linear attachment zone within the interior of the graft body, and wherein the constraining ring constrains the positionable region of the stent graft to the sleeve.
  3. 3. The restraint arrangement of claim 2, wherein the at least one apposition release wire comprises an apposition release wire proximal end that is located within the sleeve when in a loading position and is located outside the sleeve when in a deployed position.
  4. 4. A restraint arrangement according to claim 3, wherein the restraint ring engages the apposition release wire at a location proximal to the location at which the plurality of reduction rings engage the apposition release wire.
  5. 5. The constraining arrangement of claim 3, wherein the constraining ring engages the apposition release wire at a location distal to where the plurality of narrowing rings engage the apposition release wire.
  6. 6. The constraining arrangement of claim 1, further comprising at least one proximal release wire releasably securing a portion of the positionable region to the guidewire cannula.
  7. 7. The constraint arrangement of claim 6 further comprising a proximal bracket attached to the graft body, Wherein the at least one proximal release wire passes through the proximal end of the proximal stent.
  8. 8. The constraining arrangement of claim 1, wherein the apposition release wire repeatedly penetrates the graft body from the interior of the graft body to the exterior of the graft body around the guide wire cannula and then returns from the exterior of the graft body to the interior of the graft body to repeatedly encircle the guide wire cannula along the longitudinal length of the stent graft to fix the stent graft relative to the guide wire cannula.
  9. 9. A stent graft and delivery device assembly, the assembly comprising: a guidewire cannula for sliding over a guidewire; A sleeve disposed about the guidewire cannula; A tip located at a proximal end of the guidewire cannula; A handle at a distal end of the guidewire cannula; a pusher disposed about the guidewire cannula and extending proximally from the handle; a stent graft receiving area located between the tip and the pusher; A stent graft having a graft body defining an elongate lumen, and a positionable region, the stent graft being positioned at the stent graft receiving region; a suture circumferentially threaded through and stitched around the graft body such that a plurality of outer suture portions and a plurality of inner suture portions are formed; a constraining ring formed from a first inner suture portion of the plurality of inner suture portions, the constraining ring surrounding and constraining the guidewire cannula in close juxtaposition with the positionable region; a plurality of reduced loops formed by other ones of the plurality of inner suture portions, the plurality of reduced loops extending radially inward from the graft body; A apposition release wire releasably securing the graft body to the guidewire cannula along a length of the guidewire cannula, the apposition release wire passing through each of the plurality of reduction rings and the constraining ring, and The multifunctional wire drawing mechanism is positioned on the handle, Wherein the apposition release wire is operably connected to the multi-function wiredrawing mechanism such that the multi-function wiredrawing mechanism is actuatable to release each of the plurality of reduction rings and the constraining ring to allow the stent graft to expand and release from the guidewire cannula.
  10. 10. The stent graft and delivery device assembly of claim 9, further comprising: At least one proximal release wire releasably securing a portion of the positionable region to the guidewire cannula, Wherein the multi-function wire drawing mechanism is actuatable to release the at least one proximal release wire.
  11. 11. The stent graft and delivery device assembly of claim 10, wherein the apposition release wire penetrates the graft body from the exterior of the graft body into the interior of the graft body and then returns from the interior of the graft body to the exterior of the graft body, thereby providing a linear attachment zone within the interior of the graft body, wherein the constraining ring constrains the positionable region of the stent graft to the sleeve.
  12. 12. The stent graft and delivery device assembly of claim 11, wherein the apposition release wire comprises an apposition release wire proximal end that is located within the guidewire cannula when in a loading position and is located outside the guidewire cannula when in a deployed position.
  13. 13. The stent graft and delivery device assembly of claim 12, wherein the constraining ring engages the apposition release wire at a location proximal to where the plurality of narrowing rings engage the apposition release wire.
  14. 14. The stent graft and delivery device assembly of claim 12, wherein the constraining ring engages the apposition release wire at a location distal to where the plurality of reducing rings engage the apposition release wire.

Description

Restraint arrangement for stent grafts loaded onto a delivery system Cross Reference to Related Applications The present application claims priority from U.S. provisional application No. 63/581,548 filed on 8 of 9 of 2023, which provisional application is hereby incorporated by reference in its entirety. Technical Field The present disclosure relates to medical devices, and more particularly to stent grafts mountable to deployment devices for intravascular introduction. Background The present disclosure will be discussed in particular with respect to stent grafts for placement into the aorta for treatment of aneurysms. However, the present disclosure is not so limited and may be applied to stent grafts for placement in any lumen of a human or animal body. Accurate positioning of stent grafts is important for a number of reasons, including the need to avoid occlusion of the branch artery in many cases. However, positioning is complicated because the diameter of the stent graft is typically deliberately made larger than when placed to allow for an accurate seal against the vessel wall. Once released from the delivery device, the stent graft with the self-expanding stent will occupy a position against the vessel wall. Many cases of aneurysm repair require accurate placement of the stent graft relative to certain anatomical features (e.g., fenestration or scalloping). In many cases, accurate rotational positioning is also important. In the case where the stent graft is to be deployed in a curved portion of a blood vessel, such as the aortic arch, it is also important that the stent graft conform to an interior portion of the curved portion of the aorta, for example. It is an object of the present disclosure to provide a stent graft system that allows for accurate placement, repositioning and conformation. Throughout this specification, the term "distal" with respect to a portion of the aorta, deployment device or prosthesis is the end of the aorta, deployment device or prosthesis facing away from the heart in the direction of blood flow, while the term "proximal" means the portion of the aorta, deployment device or prosthesis closer to the heart. Similar terms, such as caudal and cephalad, should be understood when applied to other blood vessels. Disclosure of Invention A constraining arrangement for a stent graft loaded onto a delivery device in combination with a stent graft. The stent graft has a graft body defining an elongate lumen and a positionable region. At least one apposition release wire releasably secures the graft body to the guidewire cannula along the length of the guidewire cannula. The first suture is circumferentially threaded through and sutured around the graft body such that a plurality of outer suture portions and a plurality of inner suture portions are formed. The constraining ring is formed from a first one of the inner suture portions and surrounds the guidewire cannula to constrain the positionable region in close juxtaposition with the guidewire cannula. A plurality of reduced loops are formed from other ones of the inner suture portions, the reduced loops extending radially inward from the graft body. At least one apposition release wire passes through each of the plurality of reduction rings and the constraining ring and releases each of the reduction rings and the constraining ring upon retraction of the apposition release wire, thereby allowing the stent graft to expand and release from the guidewire cannula. The apposition release wire may be helical, wavy or vortex-shaped. Apposition release filaments may be woven into and out of the implant. The first suture may be attached at a distal apex of the proximal-most inner stent. The present invention may be practiced according to the claims without some or all of these specific details. For the sake of clarity, technical material that is known in the technical fields related to the invention has not been described in detail so that the invention is not unnecessarily obscured. Drawings The invention has been generally described above, but for the purpose of aiding understanding, reference will now be made to the accompanying drawings which illustrate preferred embodiments of the invention. FIG. 1A is a side view of a stent graft; FIG. 1B is a side view of a portion of a stent graft and delivery device assembly; FIG. 2A is a stylized end view of the proximal interior of the stent graft shown in FIG. 1B; FIG. 2B is a close-up diagrammatic view of the proximal interior of the stent graft shown in FIG. 2A; FIG. 3 is a view similar to the view of FIG. 2B, but showing an alternative suture arrangement; FIG. 4 is a close-up view of the proximal portion of the stent graft and delivery device assembly of FIGS. 1B, 2A and 2B; Fig. 5 and 6 are diagrammatic views showing deployment of the stent graft and delivery device assembly of fig. 1B, 2A and 2B under the aortic arch of a patient; fig. 7A is a side view of an alternative stent graft; fig.