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EP-4734857-A1 - SELF-ADJUSTING TISSUE LUMEN STENTS

EP4734857A1EP 4734857 A1EP4734857 A1EP 4734857A1EP-4734857-A1

Abstract

The present disclosure provides medical devices (400) such as self-expanding stents or tissue lumen stents with an overlapping layer. The medical devices can have a coating or cover disposed over all or a portion of the medical device. The overlapping layer define a doubled back portion at an end of the medical device that includes an elongate section (414) to provide dynamic movement of the end of the medical device relative to a central portion (408) of the medical device.

Inventors

  • FOLAN, Martyn G.

Assignees

  • Boston Scientific Scimed, Inc.

Dates

Publication Date
20260506
Application Date
20240627

Claims (15)

  1. 1. A medical device, comprising: an elongate tubular body comprising a first end portion and a second end portion opposite the first end portion, the elongate tubular body having a constrained configuration and an unconstrained configuration; the first end portion, in the unconstrained configuration comprising a retention member, an elongate section distal to the retention member, and a doubled back portion extending from the elongate section over the retention member towards the second end portion.
  2. 2. The medical device of claim 1, the elongate tubular body comprising a central portion disposed between the first end portion and the second end portion, the second end portion comprising a second retention member.
  3. 3. The medical device of claim 2, the second end portion comprising a second doubled back portion extending from the retention member towards the first end portion.
  4. 4. The medical device of claim 3, the second end portion comprising a second elongate section distal to the second retention member, wherein the second doubled back portion extends from the second elongate section over the second retention member towards the central portion.
  5. 5. The medical device of any one of claims 1 to 4, the second end portion comprising a straight end portion.
  6. 6. The medical device of any one of claims 1 to 5, the second end portion comprising a tapered end portion, the elongate tubular body comprising a central portion disposed between the first end portion and the tapered end portion.
  7. 7. The medical device of any one of claims 1 to 6, wherein the doubled back portion comprises a radial inner wall defining a lumen of the elongate tubular body and a radial outer wall extending over an outer perimeter of the inner wall.
  8. 8. The medical device of any one of claims 1 to 7, the elongate tubular body comprising a covering disposed over at least a portion of the elongate tubular body.
  9. 9. The medical device of any one of claims 1 to 8, wherein the elongate tubular body in the unconstrained configuration is configured to facilitate fluid flow without leakage between the first end portion and the second end portion.
  10. 10. The medical device of any one of claims 1 to 9, wherein the medical device is a self-expanding stent.
  11. 11. The medical device of any one of claims 1 to 10, wherein the elongate tubular body comprises a mesh, one or more braided wires, or woven filament.
  12. 12. The medical device of any one of claims 1 to 11, wherein the elongate tubular body comprises a polymer, a metal, a shape memory material, or Nitinol.
  13. 13. A medical device for placement in an anastomosis, comprising: an elongate tubular body comprising a first end portion and a second end portion opposite the first end portion, the elongate tubular body having a constrained configuration and an unconstrained configuration; the first end portion, in the unconstrained configuration comprising a retention member, an elongate section distal to the retention member, and a doubled back portion extending from the elongate section over the retention member towards the second end portion, wherein the elongate section is configured to provide dynamic movement of the retention member relative to the second end portion.
  14. 14. The medical device of claim 13, the elongate tubular body comprising a central portion disposed between the first end portion and the second end portion, the second end portion comprising a second retention member and a second doubled back portion extending from the retention member towards the first end portion.
  15. 15. The medical device of claim 14, the second end portion comprising a second elongate section distal to the second retention member, wherein the second doubled back portion extends from the second elongate section over the second retention member towards the central portion, and wherein the second elongate section is configured to provide dynamic movement of the second retention member relative to the first end portion.

Description

SELF-ADJUSTING TISSUE LUMEN STENTS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/510,783 filed on June 28, 2023, the disclosure of which is incorporated herein by reference. FIELD [0002] This application relates generally to medical methods and devices. More specifically, the present disclosure relates to lumen stents and methods for their use in maintained lumen patency with medical procedures. BACKGROUND [0003] Tissue lumen stents are often used in medical procedures to maintain lumen patency. Typically, the tissue lumen stent has a body with upstream and downstream ends and a central region therebetween. Medical procedures can be provided, which include (a) accessing a biliary system of a patient with an endoscope, and (b) deploying, within the biliary system of the patient, a tissue lumen stent such that the tissue lumen stent contacts a lumen in the biliary system of the patient, such as, for example, the common bile duct, the pancreatic duct, and the hepatic duct. BRIEF SUMMARY [0004] Various embodiments described herein provide a tissue lumen stent with overlapping layers, at least one of which may comprise a coating or cover. Doubled back medical device designs are contemplated which combine benefits of covered stent drainage capabilities and uncovered stent retentive strength to promote tissue in-growth. [0005] In some cases, when the stent is in the foreshortened configuration, the upstream flange structure has a larger maximum lateral dimension, axial width and/or axial radius than that of the downstream flange structure and may include an inclined portion having an axial length at least as long as a maximum diameter of the saddle region when the body is in the foreshortened configuration. On the other hand, some embodiments arc characterized by a downstream flange structure that has a larger maximum lateral dimension, axial width and/or axial radius than that of the upstream flange structure. Alternatively, or additionally, the upstream flange structure can include a distal-most opening having a diameter larger than a maximum internal diameter of the saddle region when the body is in the foreshortened configuration. In certain embodiments, the body includes a covered mesh, and in some cases, may comprise both covered and uncovered mesh, while some embodiments include a covering or membrane over at least the cylindrical saddle portion of the stent and, optionally, one or both upstream and downstream flange structures. [0006] Some embodiments of the disclosure can be implemented as a medical device. The medical device can comprise an elongate tubular body comprising a first end portion and a second end portion opposite the first end portion, the elongate tubular body having a constrained configuration and an unconstrained configuration; the first end portion, in the unconstrained configuration comprising a retention member, an elongate section distal to the retention member, and a doubled back portion extending from the elongate section over the retention member towards the second end portion. [0007] In further embodiments of the medical device, the elongate tubular body can comprise a central portion disposed between the first end portion and the second end portion, the second end portion comprising a second retention member. [0008] In further embodiments of the medical device, the second end portion can comprise a second doubled back portion extending from the retention member towards the first end portion. [0009] In further embodiments of the medical device, the second end portion can comprise a second elongate section distal to the second retention member, wherein the second doubled back portion extends from the second elongate section over the second retention member towards the central portion. [0010] In further embodiments of the medical device, the second end portion can comprise a straight end portion. [0011] In further embodiments of the medical device, the second end portion can comprise a tapered end portion, the elongate tubular body comprising a central portion disposed between the first end portion and the tapered end portion. [0012] In further embodiments of the medical device, the doubled back portion comprises a radial inner wall defining a lumen of the elongate tubular body and a radial outer wall extending over an outer perimeter of the inner wall. [0013] In further embodiments of the medical device, the elongate tubular body can comprise a covering disposed over at least a portion of the elongate tubular body. [0014] In further embodiments of the medical device, the elongate tubular body in the unconstrained configuration is configured to facilitate fluid flow without leakage between the first end portion and the second end portion. [0015] In further embodiments of the medical device, the medical device is a selfexpanding stent. [0016] In further embodiments of the medical device, the