Tubular implants with controlled biodegradation

Patent metadata

Field	Value
Publication number	US-12016764-B2
Application number	US-201816956524-A
Country	US
Kind code	B2
Filing date	Dec 21, 2018
Priority date	Dec 22, 2017
Publication date	Jun 25, 2024
Grant date	Jun 25, 2024

Abstract

Implantable medical devices have zones of high in vivo stability that are adjacent to zones of relatively low in vivo stability, so that when these medical devices are implanted into a host, the zones of low in vivo stability degrade first and allow the formation of independent segments of relatively intact high in vivo stability bands that are sufficiently small that they may pass from the host in a non-harmful manner.

First claim

What is claimed is:

1. A bioabsorbable implantable medical device comprising a generally tubular structure, the generally tubular structure comprising a monofilament in a shape of a coil, the coil comprising a sidewall enclosing a lumen where a longitudinal axis runs along a length of the lumen from a distal end to a proximal end of the structure, the monofilament coil consisting essentially of a bioabsorbable polymer, the coil comprising a plurality of bands that each encircle the longitudinal axis and have a distal side and a proximal side, the plurality of bands comprising relatively high in vivo stability bands that are separated by relatively low in vivo stability bands, and where the medical device is a graduated implant such that a proximal end of the medical device or portion thereof degrades more rapidly than does a distal end of the medical device due to a gradient in the properties of the low in vivo stability bands.

2. The medical device of claim 1 wherein the plurality of bands has at least three bands of relatively high in vivo stability and also has at least four bands of relatively low in vivo stability.

3. The medical device of claim 1 wherein the plurality of bands comprises alternating bands of relatively high in vivo stability and relatively low in vivo stability.

4. The medical device of claim 1 wherein the plurality of bands comprises at least two bands of relatively high in vivo stability that are separated by one band of relatively low in vivo stability, and where the band of relatively low in vivo stability degrades at least twice as quickly in vivo as compared to the at least one band of relatively high in vivo stability.

5. The medical device of claim 1 wherein the plurality of bands comprises a band of relatively low in vivo stability located on each side of one band of relatively high in vivo stability, and the two bands of relatively low in vivo stability have non-identical in vivo stabilities.

6. The medical device of claim 1 wherein the plurality of bands comprises a first band of relatively low in vivo stability that is located on a distal side of a first band of relatively high in vivo stability, and a second band of relatively low in vivo stability is located on a proximal side of the first band of relatively high in vivo stability, and the first band of relatively low in vivo stability has greater in vivo stability than does the second band of relatively low in vivo stability.

7. The medical device of claim 1 wherein the plurality of bands comprises a plurality of high in vivo stability bands that have essentially identical relatively high in vivo stability.

8. The medical device of claim 1 wherein the plurality of bands comprises a plurality of relatively low in vivo stability bands extending from a distal end to a proximal end of the structure and separated by bands of relatively high in vivo stability, wherein the in vivo stability of the plurality of relatively low in vivo stability bands increases from the distal end to the proximal end of the structure.

9. The medical device of claim 1 wherein the tubular structure comprises a mesh tube.

10. The medical device of claim 1 wherein the sidewall comprises a monofilament coil encircling the lumen, a mesh that overlays the monofilament coil, and a coating deposited on the coil and the mesh.

11. The medical device of claim 1 further comprising a kidney-retaining structure at the proximal end of the device and a bladder-retaining structure at the distal end of the device.

12. The medical device of claim 1 further comprising a kidney-retaining structure in a form of a curl at the proximal end of the device and a bladder-retaining structure in a form of a curl at the distal end of the device.

13. The medical device of claim 1 which is a ureteral stent.

14. The medical device of claim 1 further comprising a coating on the exterior surface of the device, wherein the coating has an average thickness.

15. The medical device of claim 1 further comprising a coating on the exterior surface of device, wherein the coating has non-uniform thickness across the entire device.

16. The medical device of claim 1 further comprising a coating on the exterior surface of the device, wherein the proximal end of the device comprises more coating compared to the distal end of the device.

17. The medical device of claim 1 which is a ureteral stent having a kidney-retaining structure at the proximal end of the device and a bladder-retaining structure at the distal end of the device, the device comprising a coating on the exterior surface of the device, wherein the proximal end of the device comprises more coating compared to the distal end of the device.

18. The medical device of claim 1 not including a containment layer which restricts the movement of the high in vivo stability bands that separate from the medical device during in vivo degradation.

19. The medical device of claim 1 wherein the bioabsorbable polymer is a poly(alpha-hydroxy acid) polymer or copolymer comprising the polymerization product of a monomer selected from glycolic acid or glycolide, lactic acid or lactide, hydroxybutyric acid, beta-hydroxypropionic acid, delta-valerolactone, and ε-caprolactone.

20. A method of preparing a medical device comprising: exposing a coil of a bioabsorbable medical device comprising a generally tubular structure with a lumen running down the middle of the generally tubular structure within a side wall of the generally tubular structure, the generally tubular structure comprising a monofilament in a shape of the coil, the coil comprising a sidewall enclosing a lumen where a longitudinal axis runs along a length of the lumen from a distal end to a proximal end of the structure, the monofilament coil consisting essentially of a bioabsorbable polymer, to ex vivo degradation condition to create low in vivo stability (LIVS) bands from the exposed bands, and not exposing bands that are adjacent to the exposed bands of the coil to the same degradation conditions, thereby creating high in vivo stability (HIVS) bands that are adjacent to the LIVS bands, and where the medical device is a graduated implant such that a proximal end of the medical device or portion thereof degrades more rapidly than does a distal end of the medical device due to a gradient in the properties of the low in vivo stability bands.

21. A medical device prepared by a method comprising the method of claim 20 .

Assignees

• Poly Med Inc

Inventors

• Cartledge Jennifer
• Clinkscales Kenneth W
• Elvington Elizabeth
• Hyde James
• Johns Brad
• Taylor Michael Scott

Classifications

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• A61F2230/0091

  helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section · CPC title

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2210/0004

  bioabsorbable · CPC title

• A61F2002/048

  Ureters · CPC title