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EP-4736820-A2 - LUMEN APPOSING STENT TO DELIVER TARGETED THERAPY

EP4736820A2EP 4736820 A2EP4736820 A2EP 4736820A2EP-4736820-A2

Abstract

A system for delivering a functional and/or therapeutic agent may comprise a stent comprising a lumen extending longitudinally therethrough being configured to shift between a first configuration and a second configuration and a functional and/or therapeutic agent. When in the second configuration, the stent may define a first retention member, a second retention member, and a saddle region extending therebetween. When the stent is positioned within a body lumen, the first retention member, the second retention member, the saddle region and a portion of a tissue wall of the body lumen may define a volume which is configured to retain the functional and/or therapeutic agent therein.

Inventors

  • WALSH, KEVIN
  • FLEURY, SEAN P.
  • CALLAGHAN, DAVID
  • RICHARDS, Laura Emily
  • FAVREAU, John Thomas
  • SCUTTI, JAMES J.

Assignees

  • Boston Scientific Scimed, Inc.

Dates

Publication Date
20260506
Application Date
20220518

Claims (13)

  1. A system for delivering a functional and/or therapeutic agent, comprising: (i) a stent (110, 210, 310) comprising a lumen (211, 311) extending longitudinally therethrough, wherein the stent (110, 210, 310) is configured to shift between a first configuration and a second configuration; and (ii) a functional and/or therapeutic agent (150); wherein in the second configuration, the stent (110, 210, 310) defines a first retention member (220, 320), a second retention member (240, 340), and a saddle region (230, 330) extending therebetween; and when the stent (110, 210, 310) is positioned within a body lumen, the first retention member (220, 320), the second retention member (240, 340), the saddle region (230, 330), and a portion of a tissue wall of the body lumen define a volume (313) configured to retain the functional and/or therapeutic agent (150) therein.
  2. The system of claim 1, wherein the functional and/or therapeutic agent (150) is in a gel or liquid form.
  3. The system of claim 1 or claim 2, wherein the functional and/or therapeutic agent (150) comprises an agent selected from the group consisting of: an adhesive agent, a healing agent,
  4. The system of any one of claims 1 to 3, wherein the first retention member (220, 320) and the second retention member (240, 340) are configured to space the portion of the tissue wall away from the saddle region (230, 330).
  5. The system of any one of claims 1 to 4, further comprising a fluid delivery device (160) configured to inject the functional and/or therapeutic agent (150).
  6. The system of claim 5, wherein the fluid delivery device (160) is configured to inject the functional and/or therapeutic agent (150) through the portion of the tissue wall and into the volume (313) defined by the stent (110, 210, 310) and the tissue wall.
  7. The system of claim 5 or 6, wherein the fluid delivery device (160) is configured to extend through a wall of the stent (110, 210, 310), in particular through one of the first retention member (220, 320) or the second retention member (240, 340), to inject the functional and/or therapeutic agent (150) into the volume (313).
  8. The system of any one of claims 1 to 7, further comprising: (i) an inner member (102), wherein the stent (110, 210, 310) is disposed about the inner member; and (ii) a first sheath (104) disposed over the stent (110, 210, 310); wherein the first sheath (104) is proximally longitudinally retractable with respect to the inner member (102), or the inner member (102) is distally longitudinally extendable with respect to the first sheath (104), or both, such that the stent (110, 210, 310) is released from within the first sheath (104) to transition from the first configuration to the second configuration.
  9. The system of claim 8, further comprising a cutting element (108) disposed at a distal end (102d) of the inner member (102).
  10. The system of claim 8 or 9, further comprising a second sheath (106) disposed over the first sheath (104), wherein the functional and/or therapeutic agent (150) is disposed in a space (107) between the first sheath (104) and the second sheath (106), and wherein the system is configured to dispose the agent (150) on a surface of the stent (110, 210, 310) upon retraction of the second sheath (106).
  11. The system of claim 10, wherein the system is configured to dispose the functional and/or therapeutic agent (150) upon application of pressure from a proximal end (100p) of the system into the space (107).
  12. The system of claim 10 or 11, wherein the functional and/or therapeutic agent (150) comprises a first functional and/or therapeutic agent component (152) and a second functional and/or therapeutic agent component (154), the first component and the second component being configured to react with each other.
  13. The system of claim 12, wherein the first functional and/or therapeutic agent component (152) is disposed in the space (107) between the first sheath (104) and the second sheath (106), and the second functional and/or therapeutic agent component (154) is disposed over the stent (110, 210, 310) when the stent is in the first configuration within the first sheath (104).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority of U.S. Provisional Application No. 63/190,491, filed May 19, 2021, the entire disclosure of which is hereby incorporated by reference herein for all purposes. FIELD The present disclosure relates generally to the field of medical devices, systems, and methods for operatively delivering a functional and/or therapeutic agent to a body, such as to body tissue. More particularly, the present disclosure relates to medical devices, systems, and methods utilizing a device as a scaffold on which a functional and/or therapeutic agent may be deposited and delivered to a body, such as in situ. BACKGROUND Various implantable devices are used for a number of treatment protocols and procedures. For instance, stents, such as self-expanding metal stents (SEMS), may be used within an anatomical area (e.g., body lumen, passage, vessel, duct, etc.) to enable fluid communication from one area to another, such as through a body lumen, or from one anatomical structure (e.g., body lumen or cavity or organ) to another anatomical structure (e.g., body lumen or cavity or organ). Stents, such as lumen apposing stents, may be used to increase and improve access to different anatomical regions, such as within the gastrointestinal (GI) tract. Current uses of lumen apposing stents include drainage of pancreatic pseudocysts and antegrade access to the gallbladder. Stents may also be used to hold body tissues in apposition. One challenged faced when using stents is that various forces (e.g., as a result of the patient's natural motion or involuntary movements within the body, such as peristaltic movements along the GI tract) may increase a risk for migration of the stent. Migration of an implanted stent may result in fluid leakage, discomfort for the patient, and/or an additional procedure to replace the stent. Different devices, systems, and methods for reducing or preventing migration of a deployed stent thus would be welcome in the industry. Moreover, expansion of uses of stents, such as for closure of full thickness resections, by addressing various challenges presented by such procedures, would also be welcome in the industry. Finally, different secure and efficient mechanisms for applying agents or substances to the target / deployment site of the stent during or after deployment would be welcome in the industry as well. SUMMARY This summary of the disclosure is given to aid understanding, and one of skill in the art will understand that each of the various aspects and features of the disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, or the like in this summary. In accordance with an aspect of the present disclosure, a system for maintaining a flow path in tissue is provided with a first sheath, a stent disposed within the first sheath, and a second sheath disposed about the first sheath. In some embodiments, the stent is configured to transition between a first configuration and a second configuration. In some embodiments, a functional and/or therapeutic agent is disposed between the first sheath and the second sheath. In some embodiments, the functional and/or therapeutic agent includes an agent selected from the group including of: an adhesive agent, a healing agent, a therapeutic agent. In some embodiments, the stent is disposed about an inner member; and the first sheath is proximally longitudinally retractable with respect to the inner member, the inner member is distally longitudinally extendable with respect to the first sheath, or both, such that the stent is released from within the first sheath to transition to the second configuration. In some embodiments, the first functional and/or therapeutic agent component is disposed between the first sheath and the second sheath, and the second functional and/or therapeutic agent component is disposed over the stent when disposed within the first sheath. In accordance with another aspect of the present disclosure, a system is disclosed as having a stent including a lumen extending longitudinally therethrough, the stent configured to shift between a first configuration and a second configuration; and a functional and/or therapeutic agent. In some embodiments, in the second configuration, the stent defines a first retention member, a second retention member, and a saddle region extending therebetween, and when the stent is positioned within a body lumen in the second configuration, the first retention member, the second retention member, the saddle region, and the tissue wall of the lumen define a volume configured to retain the functional and/or therapeutic agent therein. In some embodiments, the first retention member and the second retention member are c