VASCULAR OCCLUSION AND DRUG DELIVERY DEVICES, SYSTEMS, AND METHODS

• US 20130338638A1
• Filed: 06/10/2013
• Published: 12/19/2013
• Est. Priority Date: 06/15/2012
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Duncan, Jeffrey B., Paget, Douglas S., Radspinner, Rachel, Shaw, Edward E., Vonesh, Michael J.
• Granted Patent: US 9,878,132 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00884 enhancing wound closure
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16

Abstract

Embodiments of the present disclosure comprise occlusion and drug delivery devices and methods. One aspect of the disclosure comprises a drug delivery device comprising an inner expansion member and an outer drug delivery component. Another aspect of the disclosure comprises bioabsorbable, lumen-occluding implants.

Claims

1. A vascular delivery device comprising:

an inner expandable member; and

an outer drug delivery component comprising a drug infusible layer and being associated with the inner expandable member,

wherein the inner expandable member and the outer drug delivery component are evertable.

2. The vascular delivery device of claim 1, wherein the outer drug delivery component is configured to deliver a therapeutic agent upon pressurizing the inner expandable member to a pressure threshold less than 20 psi above an ambient pressure.

3. The vascular delivery device of claim 1, wherein the drug infusible layer comprises an infusion lumen and a ventilation lumen, and wherein the therapeutic agent at least partially infuses the drug infusible layer before a portion of the therapeutic agent exits the ventilation lumen.

4. The vascular delivery device of claim 1, wherein the drug infusible layer comprises a wicking material.

5. The vascular delivery device of claim 1, wherein the drug infusible layer comprises an open pore, highly nodal membrane of PTFE.

6. The vascular delivery device of claim 1, wherein the drug infusible layer comprises an infusion path defined by at least one seam.

7. The vascular delivery device of claim 1, wherein the outer drug delivery component further comprises an outer barrier comprising a polymeric film, wherein the outer barrier is mounted around the drug infusible layer and configured to weep a therapeutic agent upon pressurizing the inner expandable member to a pressure threshold less than 20 psi above an ambient pressure.

8. The vascular delivery device of claim 1, wherein the inner expandable member comprises a substantially impermeable, tubular form and is not in fluid communication with the outer drug delivery component.

9. The vascular delivery device of claim 1, wherein the inner expandable member and the outer drug delivery component have a retracted position and an extended position.

10. The vascular delivery device of claim 1, wherein a proximal end of the inner expandable member is coupled to a distal portion of an elongate member.

11. The vascular delivery device of claim 1 further comprising a tethering device.

12. The vascular delivery device of claim 2, wherein the pressure threshold is less than 5 psi above the ambient pressure.

13. A method of delivering a therapeutic agent comprising:

infusing a drug delivery component comprising an inner drug infusible layer with a therapeutic agent;

pressurizing an expandable member and thereby everting and extending the drug delivery component and the expandable member through a lumen of a vessel; and

pressurizing the expandable member to a pressure threshold less than 20 psi above an ambient pressure to deliver the therapeutic agent to a surrounding tissue.

14. The method of claim 13 further comprising the step of closing an infusion port and a ventilation port after an amount of the therapeutic agent exits through the ventilation port, wherein the infusion port is in fluid communication with the inner drug infusible layer through an infusion lumen and the ventilation port is in fluid communication with the inner drug infusible layer through a ventilation lumen, and wherein the therapeutic agent at least partially infuses the inner drug infusible layer before a portion of the therapeutic agent exits the ventilation lumen.

15. The method of claim 13 further comprising the step of securing a proximal end of a tethering device, wherein a distal end of the tethering device is coupled to a distal end of the expandable member.

16. The method of claim 13, wherein the inner drug infusible layer comprises an open pore, highly nodal membrane of PTFE.

17. The method of claim 13, wherein the inner drug infusible layer comprises a wicking material.

18. The method of claim 13, wherein the drug delivery component comprises a fluoropolymer outer barrier mounted around the drug delivery component and configured to weep the therapeutic agent upon pressurizing the expandable member an amount less than 5 psi above the ambient pressure.

19. The method of claim 13, wherein the expandable member comprises a substantially impermeable tubular form, wherein the expandable member is not in fluid communication with the drug delivery component.

20. The method of claim 13, wherein a proximal end of the expandable member is coupled to a distal portion of an elongate member.