Pediatric application of bioabsorbable polymer stents in infants and children with congenital heart defects

• US 9,408,952 B2
• Filed: 11/30/2011
• Issued: 08/09/2016
• Est. Priority Date: 11/30/2011
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Sudhir, Krishnankutty, Cheong, Wai-Fung, Giddings, Virginia
• Primary Examiner(s): Prebilic, Paul
• Application Number:
  US13/308,256
• Publication Number:
  US 20130138206A1
• Time in Patent Office: 1,714 Days
• Field of Search: 623/1.38
• 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 2/82 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth
• CPC Class Codes: A61F 2250/009 for single use, e.g. having means for preventing re-use
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• 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

Abstract

Methods of treating congenital heart defects in infants and children with bioabsorbable polymer stents are described. The treatments reduce or eliminate the adverse affects of congenital heart defects or may be palliative.

Claims

1. A method of treating a coarctation of the aorta in a human patient comprising:

identifying a narrowed segment in the aorta of a human child who is born with a coarctation of the aorta, wherein the aorta narrows in an area where the ductus arteriosus inserts in the aorta;

deploying a bioabsorbable polymer scaffold at the narrowed segment;

wherein the deployed bioabsorbable polymer scaffold provides support at the segment at an increased diameter;

wherein the deployed bioabsorbable polymer scaffold eventually completely absorbs away;

wherein the bioabsorbable polymer scaffold comprises poly(L-lactide) (PLLA), wherein the PLLA has an initial molecular weight (Mn(0)) of at least 60 kDa, 60 to 66 kDa, 66 to 80 kDa, 80 to 120 kDa, or greater than 120 kDa and an initial L-lactide monomer content within the range less than 0.02 wt %, 0.02 wt % to 0.2 wt %, or 0.02 wt % to 1 wt %;

or the bioabsorbable polymer scaffold comprises, poly(L-lactide) (PLLA) or poly(L-lactide-co-glycolide) (PLLGA), in combination with a lower modulus polymer selected from the group consisting of polycaprolactone (PCL), poly(trimethylene carbonate) (PTMC), polydioxanone (PDO), poly(4-hydroxy butyrate) (PHB), poly(butylene succinate) (PBS), poly(L-lactide)-co-polycaprolactone (PLLA-co-PCL), poly(L-lactide)-b-polycaprolactone (PLLA-b-PCL), and blends and copolymers thereof;

wherein the deployed bioabsorbable polymer scaffold maintains a radial strength of at least 200 mm Hg for at least 6 months.

2. The method of claim 1, wherein the narrowed segment is proximal to the ductus arteriosus.

3. The method of claim 1, wherein the narrowed segment is at the insertion of the ductus arteriosus.

4. The method of claim 1, wherein the narrowed segment is distal to the insertion of the ductus arteriosus.

5. The method of claim 1, wherein prior to deployment, the scaffold is constrained at a reduced diameter by a sheath and is deployed by removing the sheath and allowing the scaffold to self-expand to the increased diameter.

6. The method of claim 1, wherein prior to deployment, the scaffold is constrained at a reduced diameter around a balloon and is deployed by expanding the balloon which expands the scaffold to the increased diameter.

7. The method of claim 1, further comprising implanting an additional bioabsorbable polymer scaffold at the site of deployment of the scaffold after it has partially or completely absorbed, wherein the additional scaffold is deployed at a greater diameter than the absorbed scaffold to accommodate for growth in the aorta.

8. The method of claim 1, wherein the scaffold comprises an antiproliferative agent to reduce hyperplasia and stenosis in the segment.

9. The method of claim 1, wherein the bioabsorbable polymer scaffold comprises poly(L-lactide) (PLLA), wherein the PLLA has an initial molecular weight (Mn(0)) of 60 to 66 kDa, 66 to 80 kDa, or 80 to 120 kDa, and an initial L-lactide monomer content within the range less than 0.02 wt %, 0.02 wt % to 0.2 wt %, or 0.02 wt % to 1 wt %.

10. The method of claim 1, wherein the bioabsorbable polymer scaffold comprises, poly(L-lactide) (PLLA) or poly(L-lactide-co-glycolide) (PLLGA), in combination with a low modulus polymer selected from the group consisting of polycaprolactone (PCL), poly(trimethylene carbonate) (PTMC), polydioxanone (PDO), poly(4-hydroxy butyrate) (PHB), poly(butylene succinate) (PBS), poly(L-lactide)-co-polycaprolactone (PLLA-co-PCL), poly(L-lactide)-b-polycaprolactone (PLLA-b-PCL), and blends and copolymers thereof.