URETHRAL PATENCY IMPLANT

• US 20160242894A1
• Filed: 02/18/2016
• Published: 08/25/2016
• Est. Priority Date: 02/20/2015
• Status: Abandoned Application

• Current Assignee: Scaffold Medical AG
• Original Assignee: Scaffold Medical AG
• Inventors: Davis, H. Richard
• Application Number:
  US15/047,305
• Publication Number:
  US 20160242894A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/047 Urethrae
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A urethral scaffold is provided for expanding a portion of the urethra that extends through the prostate. The scaffold is expandable and has a plurality of undulating circumferential members disposed between a proximal end and a distal end of the scaffold. A central section of the scaffold has a width that exceeds the width at the distal end of the scaffold. The scaffold is made of a material that reacts with urine or with tissue surrounding the urethra to reduce the volume of the scaffold such that the scaffold can self-explant without an interventional procedure.

Claims

1. A scaffold for expanding a portion of a urethra that extends through a prostate, the scaffold comprising:

an elongate body having a proximal end, a distal end, an outer surface, and an inner surface,

the elongate body comprising a plurality of undulating circumferential members disposed between the proximal end and the distal end, the undulating circumferential members being spaced apart along a longitudinal axis of the scaffold and being connected to at least one adjacent undulating circumferential member by at least one axial connector;

the elongate body having a collapsed state and an expanded state, the collapsed state configured to enable the elongate body to be delivered into the urethra and to enable the elongate body to be navigated to a position within the portion of the urethra that extends through the prostate, the expanded state configured such that the undulating circumferential members provide the elongate body with sufficient radial strength to maintain open the portion of the urethra that extends through the prostate,

the elongate body having a width defined in a plane transverse to the longitudinal axis at a distal-end, the elongate body having a width defined in a plane transverse to the longitudinal axis at a central section located between the distal end and the proximal end, the width at the central section exceeding the width at the distal end, and

wherein the elongate body comprises a material that reacts with urine or with the tissue surrounding the urethra to reduce the volume of the elongate body such that the scaffold can be removed from the urethra after a prescribed period without requiring an interventional procedure.

2. The scaffold of claim 1, wherein at least one of the undulating members comprise a proximal apex, a distal apex, and an elongate member extending between the proximal apex and the distal apex, the elongate member comprising a necked down region.

3. The scaffold of claim 2, wherein the necked down region comprises a strut width that is less than a strut width of at least one of the proximal apex and the distal apex.

4. The scaffold of claim 2, wherein the necked down region comprises a strut thickness that is less than a strut thickness of at least one of the proximal apex and the distal apex.

5. The scaffold of claim 2, wherein the necked down region comprises at least one aperture formed through the elongate body from the inner surface to the outer surface.

6. The scaffold of claim 5, wherein the necked down region comprises a plurality of apertures formed therethrough.

7. The scaffold of claim 1, wherein the material comprises magnesium.

8. The scaffold of claim 1, wherein the material comprises magnesium configured to react with urine to cause the elongate body to fracture within 30 days when exposed to urine.

23. The scaffold of claim 1, wherein the material is selected from the group consisting of iron, zinc, PLLA, PLGA, and compounds that can be plastically deformed to trigger a degradation of the compound in vivo.

9. A scaffold for expanding the urethra, comprising:

an elongate body having a proximal end, a distal end, an outer surface, and an inner surface,

the elongate body being disposed along a longitudinal axis of the scaffold between the proximal end and the distal end, the elongate body having a collapsed state and an expanded state, the elongate body having sufficient radial strength to maintain a lumen thereof open when disposed in the urethra,

the outer surface of elongate body having a width defined in a plane transverse to the longitudinal axis at a distal-end, the outer surface of elongate body having a width defined in a plane transverse to the longitudinal axis at a central section located between the distal end and the proximal end, the width at the central section exceeding the width at the distal end,

wherein the elongate body comprises a removal configuration in which the scaffold will self-explant after a prescribed period.

10. The scaffold of claim 9, further comprising a material enabling the scaffold to be removed from the urethra after a prescribed period by interaction with urine in the urethra, with tissues disposed around the urethra or after a shortened period upon exposure to an external agent.

11. The scaffold of claim 10, wherein the material comprises magnesium.

12. The scaffold of claim 9, wherein the elongate body comprises an inner layer comparing a first material that is reactive with urine or the tissue surrounding the urethra and an outer layer comprising a second material that is less reactive with urine or with the tissue surrounding the urethra than the first material.

13. The scaffold of claim 12, wherein the first material comprises magnesium and the second material comprises an absorbable polymer.

14. The scaffold of claim 9, wherein the outer layer completely encapsulates the inner layer.

15. The scaffold of claim 9, wherein the elongate body has at least one necked down region configured to cause the scaffold to fracture into at least two segments, the segments being sized to pass out of the urethra with urine flow.

16. The scaffold of claim 15, wherein the necked down region is disposed between the central section and the distal end.

17. The scaffold of claim 15, wherein a first necked down region is disposed between the central section and the distal end and a second necked down region is disposed between the central section and the proximal end.

18. A scaffold for expanding a urethra through a narrows formed in the urethra, comprising:

an elongate body having a proximal end, a distal end, an outer surface to be expanded into contact with the urethra, and an inner surface configured to surround a lumen for urine flow,

the elongate body having an expanded state configured with sufficient radial strength to maintain the lumen open when disposed in the narrows of the urethra, wherein at least a portion of the elongate body is configured to be eroded by urine.

19. The scaffold of claim 18, wherein the elongate body has a first width defined in a plane transverse to the longitudinal axis at a distal end and a second width defined in a plane transverse to the longitudinal axis at a central section located between the distal end and the proximal end, the second width being greater than the first width.

20. The scaffold of claim 18, wherein the elongate body comprises a material including magnesium, the material configured to be eroded by urine.

21. The scaffold of claim 20, wherein the material including magnesium is disposed in an inner portion surrounded by an outer portion, the outer portion being eroded by urine at a lower rate than the material configured to be eroded by urine.

22. The scaffold of claim 21, wherein the outer portion is configured to be modified by a subsequent intervention to expose the inner portion to urine.