Multi-layer braided structures for occluding vascular defects

• US 9,445,798 B2
• Filed: 01/17/2014
• Issued: 09/20/2016
• Est. Priority Date: 03/19/2004
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Amplatz, Kurt, Glimsdale, Matt, Santer, Jana, Wise, Derek, Oslund, John, Anderson, Kent, Adams, Daniel O.
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/157,682
• Publication Number:
  US 20140135827A1
• Time in Patent Office: 977 Days
• Field of Search: 606/151, 606/157, 606/191, 606/194, 606/198, 606/200, 606/213, 606/215, 623/1.2
• 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 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: D04C 1/02 made from particular materials
• CPC Class Codes: D10B 2401/046 Shape recovering or form memory
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A collapsible medical device and associated methods of occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from plural layers of a heat-treatable metal fabric. Each of the fabric layers is formed from a plurality of metal strands and the assembly is heat-treated within a mold in order to substantially set a desired shape of the device. By incorporating plural layers in the thus-formed medical device, the ability of the device to rapidly occlude an abnormal opening in a body organ is significantly improved.

Claims

1. A medical device for occluding a patent ductus arteriosus, the medical device comprising:

at least two layers of generally concentrically oriented tubular metal fabric having an expanded preset configuration comprising proximal and distal ends,

wherein the medical device comprises in the expanded preset configuration a proximal disk-shaped portion at the proximal end and a distal disk-shaped portion at the distal end and a central cylindrical portion disposed therebetween, each of the proximal and distal disk-shaped portions having a maximum cross-sectional dimension larger than the central cylindrical portion;

wherein the medical device in the expanded preset configuration further comprises a reduced diameter segment coupled to either of the proximal or distal disk-shaped portions and the central cylindrical portion, the reduced diameter segment having a maximum cross-sectional dimension smaller than both the proximal and distal disk-shaped portions and the central cylindrical portion.

2. The medical device of claim 1, further comprising in the expanded preset configuration a pair of reduced diameter segments, each reduced diameter segment coupled to one of the proximal or distal disk-shaped portions and the central cylindrical portion.

3. The medical device of claim 2, wherein each of the reduced diameter segments has a maximum cross-sectional dimension smaller than both the proximal and distal disk-shaped portions and the central cylindrical portion such that the proximal and distal disk-shaped portions and the central cylindrical portion are configured to pivot about an axis of the patent ductus arteriosus.

4. The medical device of claim 1, wherein the proximal and distal disk-shaped portions are mirror images of one another.

5. The medical device of claim 1, wherein each layer of tubular metal fabric comprises a plurality of braided metal strands.

6. The medical device of claim 5, wherein the metal strands comprise a material selected from the group consisting of stainless steel, nickel based, cobalt based, nickel-titanium, shape memory, and super-elastic materials.

7. The medical device of claim 6, wherein the medical device is configured to be constrained within a catheter having an outer diameter of about 4-5 French for percutaneous delivery.

8. The medical device of claim 1, wherein the medical device is configured to be constrained within a catheter having an outer diameter of about 4-7 French for percutaneous delivery.

9. The medical device of claim 1, wherein at least one of the proximal and distal ends are secured by a clamp.

10. The medical device of claim 9, wherein the clamp comprises a material selected from the group consisting of platinum-iridium and stainless steel.

11. A delivery system for delivering a medical device for occluding a patent ductus arteriosus, the delivery system comprising:

a delivery device coupled to the medical device according to claim 1; and

a catheter configured to overlie the delivery device and constrain the medical device therein, wherein the medical device is configured to be deployed from the catheter, and wherein the delivery device and catheter are configured to be delivered to the patent ductus arteriosus and to deploy the medical device at least partially within the patent ductus arteriosus.

12. The delivery system of claim 11, wherein the proximal and distal disk-shaped portions are configured to be positioned outside of the patent ductus arteriosus and the central cylindrical portion is configured to be positioned within a cavity defined by the patent ductus arteriosus.

13. The delivery system of claim 11, wherein the catheter has an outer diameter of about 5 French.

14. The delivery system of claim 11, wherein the catheter has an outer diameter of about 4 French.

15. The delivery system of claim 11, wherein the delivery device and catheter are configured to be delivered to the patent ductus arteriosus over a guidewire.

16. The delivery system of claim 11, wherein the catheter and delivery device are configured such that the medical device may be deployed from the catheter in response to displacement of the catheter with respect to the delivery device.

17. A method for occluding a patent ductus arteriosus, the method comprising:

providing a medical device according to claim 1;

collapsing the medical device from the preset expanded configuration to a collapsed configuration;

positioning the collapsed medical device in a catheter;

delivering the medical device within the catheter to the patent ductus arteriosus; and

deploying the medical device from the catheter at least partially within the patent ductus arteriosus such that the medical device returns to the preset expanded configuration.

18. The method of claim 17, wherein deploying comprises deploying the medical device such that the proximal and distal disk-shaped portions are positioned outside the patent ductus arteriosus and the central cylindrical portion is positioned within a cavity defined within the patent ductus arteriosus.

19. The method of claim 17, wherein deploying comprises detaching a delivery system positioned within the catheter and coupled to the medical device.

20. The method of claim 17, wherein delivering comprises delivering the medical device over a guide wire.