PEDIATRIC APPLICATION OF BIOABSORBABLE POLYMER STENTS IN INFANTS AND CHILDREN WITH CONGENITAL HEART DEFECTS

• US 20130138206A1
• Filed: 11/30/2011
• Published: 05/30/2013
• 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: Cheong, Wai-Fung, Sudhir, Krishnankutty, Giddings, Virginia
• Granted Patent: US 9,408,952 B2
• Time in Patent Office: Days
• US Class Current: 623/1.38
• 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 congenital heart defect in a human patient comprising:

identifying one or more segments that are narrowed in one or more peripheral branches of the pulmonary artery of a human child;

deploying one or more bioabsorbable polymer scaffolds in one or more of the narrowed segments,

wherein the deployed bioabsorbable scaffolds provide support at the segments at an increased diameter to allow increased blood flow which facilitates development of the lungs of the human patient for a period of at least 6 months,

wherein the deployed scaffolds eventually completely absorb away.

2. The method of claim 1, wherein the one or more scaffolds maintain a radial strength of at least 200 mmHg for at least 6 months.

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

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

5. The method of claim 1, further comprising implanting an additional bioabsorbable scaffold at the site of deployment of at least one of the scaffolds 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 pulmonary branch.

6. The method of claim 1, further comprising performing surgical repair in the heart 1 to 2 years after deployment of the scaffolds.

7. A method of treating a congenital heart defect in a human patient comprising:

identifying a human child having abnormalities associated with Tetralogy of the Fallot, wherein the abnormalities include pulmonary stenosis and at least two additional abnormalities from the group consisting of ventricular septal defect, right ventricular hypertrophy and overriding of the aorta;

deploying a bioabsorbable polymer scaffold in the pulmonary artery of the patient,

wherein the deployed bioabsorbable scaffold provides support at an increased diameter to allow increased blood flow into the lung of the patient,

wherein the increased blood flow facilitates development of the lungs;

performing surgical repair of at least one of the additional abnormalities at some time after deployment,

wherein the scaffold is completely absorbed after providing the support for a period of time.

8. The method of claim 7, wherein the scaffold maintains a radial strength of at least 200 mmHg for at least 6 months.

9. The method of claim 7, 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.

10. The method of claim 7, 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.

11. The method of claim 7, further comprising implanting an additional bioabsorbable scaffold at the implant site of the scaffold after the scaffold 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 pulmonary artery.

12. A method of treating a congenital heart defect in a human patient comprising:

identifying a newborn human patient having a complex congenital cardiac malformation; and

deploying a bioabsorbable polymer scaffold in the ductus arteriosis of the patient to maintain patency of the ductus arteriosis,

wherein the patency of the ductus arteriosis allows blood flow to the lungs and the body until the complex congenital cardiac malformation is repaired, and

wherein the scaffold is completely absorbed from the segment after providing the patency for a period of time.

13. The method of claim 12, further comprising performing surgical repair of the complex congenital cardiac malformation prior to complete resorption of the scaffold.

14. The method of claim 12, wherein the scaffold maintains a radial strength of at least 200 mmHg for at least 6 months.

15. The method of claim 12, 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 an increased diameter.

16. The method of claim 12, 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 stent a target diameter that maintains the patency of the ductus arteriosis.

17. The method of claim 12, further comprising implanting an additional bioabsorbable scaffold in the ductus arteriosis after the scaffold initially implanted has partially or completely absorbed.

18. A method of treating a coarcation of the aorta in a human patient comprising:

identifying a narrowed segment in the aorta of a human child, 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 scaffold provides support at the segment at an increased diameter,

wherein the deployed scaffold eventually completely absorbs away.

19. The method of claim 18, wherein the narrowed segment is proximal to the ductus arteriosus.

20. The method of claim 18, wherein narrowed segment is at the insertion of the ductus arteriosus.

21. The method of claim 18, wherein the narrowing segment is distal to the insertion of the ductus arteriosus.

22. The method of claim 18, wherein the scaffold maintains a radial strength of at least 200 mmHg for at least 6 months.

23. The method of claim 18, 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.

24. The method of claim 18, 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.

25. The method of claim 18, further comprising implanting an additional bioabsorbable 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.

26. The method of claim 18, wherein the scaffold comprises an antiproliferative agent to reduce hyperplasia and stenosis in the segment.