Stents having protruding drug-delivery features and associated systems and methods

• US 10,258,487 B2
• Filed: 03/27/2017
• Issued: 04/16/2019
• Est. Priority Date: 10/12/2015
• Status: Active Grant

• Current Assignee: ReFlow Medical Inc.
• Original Assignee: ReFlow Medical Inc.
• Inventors: Fulkerson, John, Rizk, Isa, Mustapha, Jihad Ali, Jimenez, Jr., Teodoro S.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/470,688
• Publication Number:
  US 20170196717A1
• Time in Patent Office: 750 Days
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/44 Radioisotopes, radionuclides
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Expandable elements having drug-delivery features and associated systems and methods are disclosed herein. In one embodiment, a drug-eluting stent includes a radially expandable cylindrical frame having a plurality of struts. The frame is transformable between a low-profile delivery state and an expanded deployed state. A plurality of drug-delivery features are carried by one of the struts and configured to deliver a drug to a treatment site within the patient or piercing through the tissue wall to break the constricting of the vessel wall inwardly. When the frame is in the expanded state within a body lumen of the patient, the drug-delivery features extend radially outwardly away from the strut and are configured to engage and, in some arrangements, pass through a wall of the body lumen.

Claims

1. An expandable element for treating a human patient, the expandable element comprising:

a radially expandable cylindrical frame having struts, a proximal end, a distal end, and a lumen between the proximal end and the distal end and providing a fluid pathway along a longitudinal axis of the frame, wherein the frame is transformable between a deployed state having a deployed diameter and a constrained low-profile delivery state having a smaller, delivery diameter for delivery to a treatment site within a body lumen of the patient; and

a plurality of protruding features carried by and integrally formed with the struts,

wherein, when the frame is in the constrained low-profile delivery state, the protruding features do not extend radially outwardly away from the frame, and

wherein, as the frame is released or deployed from the constrained low-profile delivery state at the treatment site within the body lumen—

the frame transforms to the deployed state and the deployed diameter, and

the protruding features, moving with the frame, are released to engage tissue of the body lumen such that a first portion of each protruding feature extends from the frame in a direction substantially parallel to the longitudinal axis of the frame and a second portion of each protruding feature forms a terminal end of the protruding feature that extends radially outwardly away from the frame and is positioned entirely distal to the first portion,

wherein the frame is collapsible from the deployed state to the delivery state to be retracted within a catheter and withdrawn from the body lumen of the patient.

2. The expandable element of claim 1 wherein, when the frame is in the deployed state within the body lumen, the protruding features are configured to pierce the first portion of the body lumen and extend into a second portion of the body lumen.

3. The expandable element of claim 2 wherein the second portion of the body lumen is a media, an adventitia, an internal elastic lamina (IEL), an external elastic lamina (EEL), or a combination thereof.

4. The expandable element of claim 1 wherein the first portion of the body lumen is an occlusion, an intima, or a combination thereof.

5. The expandable element of claim 2 wherein the protruding features are configured to extend into a third portion proximal to the body lumen.

6. The expandable element of claim 5 wherein the third portion is fascia, a different body lumen, or a combination thereof.

7. The expandable element of claim 1 wherein the plurality of protruding features comprise a first set of protruding features carried by a first strut and a second set of protruding features carried by a second, different strut.

8. The expandable element of claim 1 wherein the protruding features comprise a first set of protruding features and a second set of protruding features carried by a first strut.

9. The expandable element of claim 1 wherein the protruding features comprise a first set of protruding features, a second set of protruding features, and a third set of protruding features, and wherein the first, second, and third sets are carried by a first strut, a second different strut, a third different strut, respectively.

10. The expandable element of claim 1 wherein the protruding features carry a drug for delivery to the patient.

11. The expandable element of claim 1 wherein the protruding features further comprise a first set of protruding features configured to deliver a first drug to the patient and a second set of protruding features configured to deliver a second drug to the patient, and wherein the first drug and the second drug are different.

12. The expandable element of claim 1 wherein the protruding features comprise reservoirs integrally formed therein.

13. The expandable element of claim 1 wherein the expandable element is configured to be thermally activated and wherein, when thermally activated, the expandable element is configured to deliver thermal treatment to the body lumen.

14. The expandable element of claim 1 wherein the expandable element is self-expanding.

15. The expandable element of claim 1 wherein the expandable element, the protruding features, a portion of the protruding features, a portion of each of the features, or a combination thereof are biodegradable.

16. The expandable element of claim 1 wherein, when the frame is in the deployed state within the body lumen, the expandable element is configured to allow one or more substances to flow through the expandable element.

17. The expandable element of claim 1 wherein, when the frame is in the deployed state within the body lumen, the expandable element does not limit a rate of fluid flowing through the body lumen.

18. The expandable element of claim 1 wherein the expandable element is configured for post-dilation, for preparation of the body lumen, for rotation when force is applied, or a combination thereof.

19. The expandable element of claim 1, further comprising a material positioned over at least a portion of the radially expandable cylindrical frame.

20. The expandable element of claim 1 wherein the frame and the integrally formed protruding features comprise a single unitary structure.

21. The expandable element of claim 1 wherein, when the frame is in the deployed state within the body lumen, the protruding features extend perpendicularly away from a longitudinal axis of the cylindrical frame.

22. The expandable element of claim 1, further comprising a longitudinal member secured to the frame and configured to withdraw the frame from the body lumen after delivery of a drug to the treatment site via the protruding features.

23. The expandable element of claim 1 wherein the protruding features are connected to each other only via the frame.

24. The expandable element of claim 1 wherein the second portion of each protruding portion forms a terminal end and the second portion is connected to the frame only via the first portion.

25. The expandable element of claim 1 wherein the struts are connected to each other to form a circumferential ring that extends continuously about the longitudinal axis.

26. An expandable stent for treating a human patient, the expandable stent comprising:

a radially expandable cylindrical frame having struts, a proximal end, a distal end, and a lumen between the proximal end and the distal end and providing a fluid pathway along a longitudinal axis of the frame, wherein the frame is transformable between a deployed state having a deployed diameter and a constrained low-profile delivery state having a smaller, delivery diameter for delivery to a treatment site within a body lumen of the patient;

a plurality of protruding features carried by and integrally formed with the struts, wherein—

when the frame is in the delivery state, the protruding features are substantially parallel to the longitudinal axis of the frame, and

when the frame is in the deployed state, a first portion of each of the protruding features extends from the frame in a direction substantially parallel to the longitudinal axis of the frame and a second portion of each of the protruding features forms a terminal end of the protruding feature that extends perpendicularly away from the longitudinal axis of the frame to engage tissue of the body lumen and is positioned entirely distal to the first portion; and

a longitudinal member coupled to the frame and configured to withdraw the frame in the deployed state from the body lumen,

wherein the frame and the protruding features are integrally formed of a metal or metal alloy,

wherein the frame and the protruding features are (a) configured to be held in the delivery state by radial compression, and (b) further configured such that, when released from radial compression, the frame self-expands to the deployed diameter,

wherein the frame is collapsible from the deployed state to the delivery state to be retracted within a catheter and withdrawn from the body lumen of the patient.

27. The stent of claim 26 wherein the longitudinal member passes from the frame into a catheter, and wherein the catheter is configured to receive the stent in a collapsed state therein.

28. The stent of claim 26 wherein the frame and the protruding features are formed from nitinol.

29. The stent of claim 26 wherein the stent, in the deployed state, is open at distal and proximal ends thereof and defines a stent inner lumen through the stent, and further wherein the stent, in the deployed state, does not limit a rate of fluid flowing through the body lumen.

30. The stent of claim 29 wherein, in the deployed state, the frame comprises an open lattice wall structure through which a wall of the body lumen is exposed to the stent inner lumen.

31. The stent of claim 26 wherein the protruding features are configured to pierce a first portion of the body lumen and extend into a second portion of the body lumen.

32. The stent of claim 26 wherein the protruding features carry a drug for delivery to the patient.