BIODEGRADABLE SUPPORTING DEVICE

• US 20160262915A1
• Filed: 05/25/2016
• Published: 09/15/2016
• Est. Priority Date: 03/09/2012
• Status: Active Grant

• Current Assignee: Q3 Medical Devices Limited (Boill Holding Group Co., Ltd.)
• Original Assignee: Q3 Medical Devices Limited (Boill Holding Group Co., Ltd.)
• Inventors: MANGIARDI, Eric K.
• Granted Patent: US 11,051,958 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/844 folded prior to deployment
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0009 using materials or accessories for preventing galvanic or electrolytic corrosion
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00041 : Magnesium or Mg-based alloys
• CPC Class Codes: A61F 2310/00065 : Manganese or Mn-based alloys
• CPC Class Codes: A61K 2300/00 : Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/337 : having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/436 : the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• 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 2300/64 : Animal cells
• CPC Class Codes: A61L 2400/12 : Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2420/02 : Methods for coating medical devices
• CPC Class Codes: A61L 2420/04 : Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
• CPC Class Codes: A61L 2420/08 : Coatings comprising two or more layers
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/022 : Metals or alloys
• CPC Class Codes: A61L 31/088 : Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 9/04 : Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: B82Y 5/00 : Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Abstract

A biodegradable in vivo supporting device is disclosed. In one embodiment, a coated stent device includes a biodegradable metal alloy scaffold made from a magnesium alloy, iron alloy, zinc alloy, or combination thereof, and the metal scaffold comprises a plurality of metal struts. The metal struts are at least partially covered with a biodegradable polymer coating. A method for making and a method for using a biodegradable in vivo supporting device are also disclosed.

Claims

1. A biodegradable in vivo supporting device, comprising:

a biodegradable metal alloy scaffold comprising a plurality of metal struts; and

a biodegradable polymer coating at least partially covering the metal struts.

2. The device of claim 1, wherein the metal struts have an average cross-sectional thickness between 100-200 μ

m, the polymer coating has a thickness between 10-100 μ

m.

3. The device of claim 1, wherein the biodegradable metal alloy scaffold comprises a magnesium alloy, an iron alloy, a zinc alloy, or combination thereof.

4. The device of claim 3, wherein the alloy further comprises one or more metals selected from the group consisting of manganese, magnesium, neodymium, cerium, iron, zinc, palladium, cobalt, aluminum, tungsten, boron, carbon, sulfur, silicon, lithium, zirconium, calcium, and yttrium.

5. The device of claim 1, wherein the metal alloy further comprises at least one rare earth metal and a majority of the metal alloy comprises magnesium.

6. The device of claim 5, wherein the rare earth metal is neodymium or cerium.

7. The device of claim 1, wherein the biodegradable metal scaffold is made from a magnesium alloy having at least 96 wt. % of magnesium, at least 1 wt. % of manganese, and at least 0.5 wt. % of a rare earth metal.

8. The device of claim 7, wherein the biodegradable metal scaffold is made from a magnesium alloy having a magnesium content of 96-97.9 wt. %, a manganese content of 1.6-2 wt. %, and rare earth metal content of 0.5-2 wt. %.

9. The device of claim 7, wherein the biodegradable metal scaffold is made from a magnesium alloy having a magnesium content of 97.45 wt. %, a manganese content of 1.8 wt. %, and a neodymium content of 0.75 wt. %.

10. The device of claim 1, wherein the biodegradable metal scaffold is an expandable scaffold.

11. The device of claim 1, wherein the metal scaffold is less than 60% w/w or less than 60% v/v of the device.

12. The device of claim 1, wherein the biodegradable polymer coating is permeable to body fluid.

13. The device of claim 1, wherein the biodegradable polymer comprises PLLA, PLGA, or a combination thereof.

14. The device of claim 1, wherein the biodegradable polymer coating has one or more holes allowing direct contact between the metal struts and body fluids when the stent device is placed inside a body lumen.

15. The device of claim 1, wherein the biodegradable polymer coating comprises an anti-proliferative agent selected from the group consisting of paclitaxel, sirolimus, docetaxel, biolimus A9, zotarolimus, everolimus, myolimus, novolimus, pimecrolimus, tacrolimus, ridaforolimus, temsirolimus and combination thereof.

16. The device of claim 1, further comprising an additional coating between the metal alloy scaffold and the biodegradable coating that delays the degradation time of the metal alloy scaffold.

17. The device of claim 16, wherein the additional coating is a nano-coating of iron.

18. A biodegradable in vivo supporting device, comprising:

a biodegradable metal alloy scaffold made from a magnesium alloy, an iron alloy, a zinc alloy, or combination thereof, the metal scaffold comprising a plurality of metal struts;

a biodegradable polymer coating at least partially covering the metal struts,

wherein the metal struts have an average cross-sectional thickness between 100-200 μ

m, the polymer coating has a thickness between 10-100 μ

m.

19. A biodegradable in vivo supporting device, comprising:

a biodegradable metal alloy scaffold made from a magnesium alloy having a magnesium content of 97.45 wt. %, a manganese content of 1.8 wt. %, and a neodymium or cerium content of 0.75 wt. %, the metal scaffold comprising a plurality of metal struts;

a biodegradable polymer coating at least partially covering the metal struts,

wherein the metal struts have an average cross-sectional thickness between 100-200 μ

m, the polymer coating has a thickness between 10-100 μ

m.

20. A method for treating a condition in a subject with a biodegradable in vivo supporting device, comprising:

establishing an entry portal into a body lumen in a subject in need of such treatment; and

delivering said supporting device to a target location through said body lumen; and

deploying said supporting device at the target location,

wherein said biodegradable in vivo supporting device comprises a biodegradable metal alloy scaffold comprising a plurality of metal struts and a biodegradable polymer coating at least partially covering the metal struts.

21. The method of claim 20, wherein said body lumen is a blood vessel.

22. The method of claim 21, wherein said blood vessel is a cardiac blood vessel.

23. The method of claim 22, wherein the metal struts have an average cross-sectional thickness between 100-200 μ

m, the polymer coating has a thickness between 10-100 μ

m.

24. A kit for placement of a biodegradable in vivo supporting device, comprising:

a biodegradable in vivo supporting device comprising a biodegradable metal alloy scaffold comprising a plurality of metal struts and a biodegradable polymer coating at least partially covering the metal struts, and

a guide wire.