Growth stent for congenital narrowings

• US 10,702,407 B1
• Filed: 06/14/2019
• Issued: 07/07/2020
• Est. Priority Date: 02/28/2019
• Status: Active Grant

• Current Assignee: Renata Medical, Inc.
• Original Assignee: Renata Medical, Inc.
• Inventors: Armer, Dustin, Abbott, Eason
• Primary Examiner(s): Preston, Rebecca S
• Application Number:
  US16/441,201
• Time in Patent Office: 389 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth

Abstract

A growth stent and methods for making and using the same. The growth stent may be delivered to treat early stage congenital lesions, while expanding to adult vessel diameters. In selected embodiments, the growth stent can comprise a frame and may have a covering on some portion to prevent blood flow through a wall of the frame. The growth stent advantageously can maintain radial strength across an entire range of diameters necessary to treat a narrowed lesion from birth and childhood through adulthood as the vessels grow over the lifetime of a patient.

Claims

1. A catheter insertable and re-expandable growth stent for implantation in a neonate patient, comprising:

an elongated stent frame with a plurality of frame struts each extending continuously from a proximal end region of said stent frame to a distal end region of said stent frame and having a uniform strut width, adjacent frame struts defining intermediate frame cells and intersecting to form respective strut junctions by which said elongated stent frame expands via a delivery catheter from an initial state for facilitating insertion via the delivery catheter into a selected vessel of the neonate patient to a first stable expanded state configured to support the selected vessel at implantation, said stent frame in the first expanded state defining an internal channel with a first cross-section,

wherein said stent frame is configured to be re-expanded via subsequent introduction of a dilation catheter from the first expanded state to a second stable expanded state as the patient grows, said stent frame in the second expanded state continuing to support the selected vessel and defining the internal channel with a second cross-section being larger than the first cross-section.

2. The growth stent of claim 1, wherein said stent frame in the initial state has a small implantation size for facilitating insertion into the neonate patient.

3. The growth stent of claim 2, wherein the implantation size is less than 8 French.

4. The growth stent of claim 2, wherein the first cross-section is less than 10 millimeters.

5. The growth stent of claim 1, wherein said stent frame is configured to be re-expanded to the second expanded state after the neonate patient grows to become a child.

6. The growth stent of claim 5, wherein the second cross-section is between 10 millimeters and 15 millimeters, inclusive.

7. The growth stent of claim 1, wherein said stent frame is configured to further expand from the second expanded state to a third stable expanded state as the patient further grows, said stent frame in the third expanded state continuing to support the selected vessel and defining the internal channel with a third cross-section being larger than the second cross-section.

8. The growth stent of claim 7, wherein said stent frame is configured to be expanded to the third expanded state after the patient grows to become an adult.

9. The growth stent of claim 7, wherein the third cross-section is between 18 millimeters and 24 millimeters, inclusive.

10. The growth stent of claim 1, wherein said stent frame is provided with a tubular shape.

11. The growth stent of claim 1, wherein a strut junction between selected frame struts having a junction width that is sufficiently small for facilitating insertion of said stent frame in the initial state and that is sufficiently large for supporting expansion of said stent frame to the first and second expanded states while maintaining strength for supporting the selected vessel.

12. The growth stent of claim 1, wherein the internal channel extends between opposite end regions of said stent frame, at least one of the end regions being flared radially outwardly for facilitating an engagement between said stent frame and the selected vessel.

13. The growth stent of claim 1, wherein the internal channel extends between opposite end regions of said stent frame, at least one of the end regions being flared radially inwardly or being dulled for reducing risk of an aneurism in the selected vessel.

14. The growth stent of claim 1, wherein said stent frame includes a fluid-impermeable covering for preventing leaks due to ingrowth of the selected vessel as the patient grows.

15. The growth stent of claim 1, wherein said elongated stent frame is made of stainless steel, cobalt chromium, a polymer or a combination thereof.

16. The growth stent of claim 1, wherein the intermediate frame cells are enclosed by the adjacent frame struts.

17. The growth stent of claim 1, wherein two selected pairs of the adjacent frame struts intersect to define one of the intermediate frame cells and to form a plurality of the strut junctions.

18. The growth stent of claim 1, wherein two pairs of the adjacent frame struts intersect to define one of the intermediate frame cells and to form a plurality of the strut junctions.

19. A catheter insertable and re-expandable growth stent for implantation in a neonate patient, comprising:

an elongated stent frame with a plurality of frame struts each extending continuously from a proximal end region of said stent frame to a distal end region of said stent frame and having a uniform strut width, adjacent frame struts defining intermediate frame cells and intersecting to form respective strut junctions by which said elongated stent frame expands via a delivery catheter from an initial state for facilitating insertion via the delivery catheter into a selected vessel of the neonate patient to a first stable expanded state configured to support the selected vessel at implantation, said stent frame in the first expanded state defining an internal channel with a first cross-section,

wherein said stent frame is configured to be re-expanded via subsequent introduction of a dilation catheter from the first expanded state to a second stable expanded state as the patient grows into a teenage patient, said stent frame in the second expanded state being configured to continue to support the selected-vessel and defining the internal channel with a second cross-section being larger than the first cross-section, and

wherein said stent frame is further configured to be re-expanded via subsequent introduction of a second dilation catheter from the second expanded state to a third stable expanded state as the teenage patient further grows into an adult patient, said stent frame in the third expanded state being configured to continue to support the selected vessel and defining the internal channel with a third cross-section being larger than the second cross-section.

20. The growth stent of claim 19, wherein said stent frame in the initial state has an implantation size that is less than 8 French.

21. The growth stent of claim 19, wherein said elongated stent frame is made of stainless steel, cobalt chromium, a polymer or a combination thereof.

22. The growth stent of claim 19, wherein the intermediate frame cells are enclosed by the adjacent frame struts.

23. The growth stent of claim 19, wherein two selected pairs of the adjacent frame struts intersect to define one of the intermediate frame cells and to form a plurality of the strut junctions.

24. The growth stent of claim 19, wherein two pairs of the adjacent frame struts intersect to define one of the intermediate frame cells and to form a plurality of the strut junctions.

25. The growth stent of claim 19, wherein the first cross-section is less than 8 millimeters.

26. The growth stent of claim 19, wherein the second cross-section is 15 millimeters.

27. The growth stent of claim 19, wherein the third cross-section is between 18 millimeters and 24 millimeters, inclusive.