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EP-4734887-A1 - APPARATUSES AND METHODS FOR EXPANDABLE BRANCHING STENT PROSTHESES

EP4734887A1EP 4734887 A1EP4734887 A1EP 4734887A1EP-4734887-A1

Abstract

Expandable branching stent prostheses and methods of deployment for the same are discussed herein. A deployment system includes an expandable branching stent prosthesis having a trunk portion, a first branching portion, and a second branching portion. The deployment system also includes a first balloon disposed within the first branching portion and the trunk portion, the first balloon being configured to inflate to deploy the first branching portion and the trunk portion of the expandable branching stent prosthesis. The deployment system also includes a second balloon disposed within the second branching portion and configured to inflate to deploy the second branching portion of the expandable branching stent prosthesis.

Inventors

  • ADAMS, MICHAEL
  • HISLOP, JOANNE
  • WIERSDORF, Jason
  • MEDINA, YUMA

Assignees

  • MERIT MEDICAL SYSTEMS, INC.

Dates

Publication Date
20260506
Application Date
20240625

Claims (20)

  1. 1. A deployment system for deployment of a device to a branching implant site having a trunk, a first branch, and a second branch, the deployment system comprising: an expandable branching stent prosthesis having a trunk portion, a first branching portion, and a second branching portion; a first balloon disposed within the first branching portion and the trunk portion, the first balloon being configured to inflate to deploy the first branching portion and the trunk portion of the expandable branching stent prosthesis; a first catheter coupled to the first balloon and having a first inflation lumen, and the first catheter configured to selectively inflate the first balloon; a second balloon disposed within the second branching portion and configured to inflate to deploy the second branching portion of the expandable branching stent prosthesis; and a second catheter coupled to the second balloon and having a second inflation lumen, the second catheter configured to selectively inflate the second balloon.
  2. 2. The deployment system of claim 1 , further comprising a floss wire passing through the first branching portion and out the second branching portion of the expandable branching stent prosthesis, the floss wire having a distal end disposed outside of the second branching portion of the expandable branching stent prosthesis.
  3. 3. The deployment system of any one of claims 1-2, wherein the second catheter is disposed outside the first balloon.
  4. 4. The deployment system of any one of claims 2-3, wherein the second catheter includes: the second inflation lumen and an additional inflation lumen in fluid communication with the second balloon and configured to selectively inflate the second balloon; and a wire lumen having the floss wire extending therethrough.
  5. 5. The deployment system of any one of claims 2-4, wherein the floss wire extends through the second balloon.
  6. 6. The deployment system of any one of claims 2-5, wherein the distal end of the floss wire terminates in a catch.
  7. 7. The deployment system of any one of claims 1-6, wherein, when inflated, the first balloon includes: a first balloon portion having a first diameter or a first lateral width and disposed in the first branching portion; and a trunk balloon portion having a trunk diameter or a trunk lateral width greater than the first diameter or the first lateral width of first balloon portion, with the trunk balloon portion being disposed in the trunk portion of the expandable branching stent prosthesis.
  8. 8 The deployment system of claim 7, wherein, when inflated the second balloon has a second diameter or a second lateral width that is less than the trunk diameter or the trunk lateral width of the trunk balloon portion of the first balloon.
  9. 9. The system of any one of claims 1-8, further comprising a catheter sleeve configured to surround the expandable branching stent prosthesis, the first balloon, the second balloon, the first catheter, and the second catheter during the delivery.
  10. 10. The deployment system of any one of claims 1-9, wherein the branching implant site is within a vascular system.
  11. 11. The deployment system of any one of claims 1-10, wherein the first inflation lumen and the second inflation lumen are fluidly coupled such that the first balloon and the second balloon are configured to inflate and/or deflate substantially simultaneously.
  12. 12. The deployment system of any one of claims 1-10, wherein the first inflation lumen and the second inflation lumen are not fluidly coupled such that the first balloon and the second balloon are configured to selectively inflate and/or deflate substantially simultaneously or at different times.
  13. 13. The deployment system of any one of claims 1-12, wherein the first catheter and the second catheter are selectively connectable and disconnectable effective to allow the first balloon and the second balloon to be removed from the branching implant site together when the first balloon and the second balloon are connected and removed separately when the first balloon and the second balloon are disconnected.
  14. 14. A method comprising: delivering, to a branching implant site comprising a trunk, a first branch, and a second branch, a deployment system via the first branch, the deployment system comprising: an expandable branching stent prosthesis having a trunk portion, a first branching portion, and a second branching portion; a first balloon disposed within the first branching portion and the trunk portion of the expandable branching stent prosthesis; a second balloon disposed within the second branching portion; and a floss wire passing through the first branching portion and out the second branching portion of the expandable branching stent prosthesis, the floss wire having a distal end disposed outside of the second branching portion of the expandable branching stent prosthesis; delivering a distal end of a snare wire to the branching implant site via the second branch, the snare wire extending back through the second branch; connecting the distal end of the floss wire and the distal end of the snare wire together at the branching implant site; using one or more of the floss wire and the snare wire to seat the first branching portion of the expandable branching stent prosthesis along the first branch of the branching implant site and the second branching portion of the expandable branching stent prosthesis along the second branch of the branching implant site; inflating the first balloon to expand the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis for deployment; and inflating the second balloon to expand the second branching portion of the expandable branching stent prosthesis for deployment.
  15. 15. The method of claim 14, further comprising, after inflating the first balloon and the second balloon, pulling the snare wire to bring the distal end of the floss wire through the second branch and out of an access incision of the second branch.
  16. 16. The method of any one of claims 14-15, wherein: inflating the first balloon to expand the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis for deployment includes: inflating the first balloon with a first catheter coupled to the first balloon and having a first inflation lumen in fluid communication with the first balloon to expand the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis for deployment; and inflating the second balloon to expand the second branching portion of the expandable branching stent prosthesis for deployment includes: inflating the second balloon with a second catheter coupled to the second balloon and having a second inflation lumen to expand the second branching portion of the expandable branching stent prosthesis for deployment.
  17. 17. The method of claim 16, wherein the second catheter is disposed outside the first balloon.
  18. 18. The method of any one of claims 16-17, wherein the second catheter includes: the second inflation lumen and an additional inflation lumen in fluid communication with the second balloon and configured to selectively inflate the second balloon; and a wire lumen having the floss wire extending therethrough until the floss wire is pulled through the second branch and out of the access incision of the second branch
  19. 19. The method of any one of claims 16-18, wherein the floss wire extends through the second balloon until the floss wire is pulled through the second branch and out of the access incision of the second branch.
  20. 20. The method of any one of claims 16-18, further comprising: deflating the first balloon and the second balloon; and after pulling the snare wire to bring the distal end of the floss wire through the second branch, removing the deployment system from the branching implant site by pulling the first catheter and/orthe second cathetersuch that the second balloon is pulled from the second branch, over a bifurcation between the second branch and the first branch, and through the first branch.

Description

APPARATUSES AND METHODS FOR EXPANDABLE BRANCHING STENT PROSTHESES RELATED APPLICATIONS [0001] This application claims priority to United States Provisional Application No. 63/511 , 139, filed on June 29, 2023 and titled, “Apparatuses and Methods for Expandable Branching Stent Prosthesis,” and to United States Utility Application No. 18/753,791 , filed on June 25, 2024 and titled, “Apparatuses and Methods for Expandable Branching Stent Prosthesis,” both of which are hereby incorporated by reference in their entireties. TECHNICAL FIELD [0002] The present application relates to medical devices including stent prostheses, deployment devices, and methods of using the same. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0003] The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. The drawings depict only typical embodiments, which embodiments will be described with additional specificity and detail in connection with the drawings in which: [0004] FIG. 1 illustrates a perspective view of an expandable branching stent prosthesis, according to embodiments herein. [0005] FIG. 2 illustrates a deployed expandable branching stent prosthesis, according to embodiments herein. [0006] FIG. 3 illustrates a deployment system configured for use with an expandable branching stent prosthesis, according to embodiments herein. [0007] FIG. 4 illustrates a cross-sectional view of a catheter of the deployment system of FIG. 3. [0008] FIG 5 illustrates a first deployment stage for a deployment system used to deploy an expandable branching stent prosthesis at a branching implant site, according to embodiments herein. [0009] FIG. 6A illustrates a subsequent deployment stage for the deployment system, according to embodiments herein. [0010] FIG. 6B illustrates another subsequent deployment stage for the deployment system, according to embodiments herein. [0011] FIG. 7 illustrates a method according to embodiments disclosed herein. DETAILED DESCRIPTION [0012] Delivery catheter systems may be configured to deliver one or more medical appliances or systems to a location within a patient’s body and deploy the medical appliance or system within the patient’s body. For example, such a delivery catheter system may be configured to be advanced from an insertion site at the outside of an anatomical system to a treatment location within the anatomical system For example, a delivery catheter system may be configured to be advanced through bends, turns, or other structures within the anatomy of the vasculature [0013] A stent prosthesis may be disposed within a portion of the delivery catheter system (e.g., as or as part of a medical appliance or system) such that a practitioner may deploy the stent prosthesis from a distal end of the delivery catheter system through manipulation of one or more components of a handle assembly of the delivery catheter system. [0014] Stent prostheses may be deployed in various body lumens for a variety of purposes. Stent prostheses may be deployed, for example, in the arterial system for a variety of therapeutic purposes including the treatment of occlusions within the lumens of that anatomical system. It will be appreciated that the current disclosure may be applicable to stent prostheses designed for the central venous system, peripheral vascular system, abdominal aortic aneurism treatment, bronchial system, esophageal system, biliary system, or any other system of the human body. Further, the present disclosure may equally be applicable to other prosthesis such as grafts. [0015] Accordingly, it will be understood that while specific examples recited herein may refer to deployment of cardiovascular stent prostheses within a cardiovascular system, analogous concepts and devices may be used in/with various other anatomical systems of the body, including for placement and deployment of medical appliances in the gastrointestinal tract (including, for example, within the esophagus, intestines, stomach, small bowel, colon, and biliary duct); the respiratory system (including, for example, within the trachea, bronchial tubes, lungs, nasal passages, and sinuses); or any other location within the body, both within bodily lumens (for example, the ureter, the urethra, etc.) and within other bodily structures. [0016] The phrases “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to or in communication with each other even though they are not in direct contact with each other. For example, two components may be coupled to or in communication with each other through an intermediate component. [0017] The directional terms “proximal” and “distal” are used herein to refer to opposite locations relative to a medical device in use by a pra