OCCLUSION DEVICE

• US 20150257763A1
• Filed: 03/12/2015
• Published: 09/17/2015
• Est. Priority Date: 03/12/2014
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Sherman, Sara M., Blum, Kevin
• Granted Patent: US 9,668,742 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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 2017/00893 pharmaceutically effective

Abstract

An occlusion device for placement within a body vessel may include a wire constructed support structure having a covering applied thereto. The covering includes a mixture of PET and ultra-high molecular weight polyethylene (UHMWPE). The covering is applied to the support structure via an electrospinning process to produce a non-woven fiber covering having increase strain capabilities relative to an electrospun PET covering without UHMWPE. The device has a nominal state that is radially expanded and a delivery state that is radially compressed and longitudinally extended for disposal within a low-profile delivery sheath. The covering increased strain capability allows for the device to have relative large diameter in the nominal state while still being capable of low-profile delivery. This occlusion device can provide faster occlusive capability when deployed and does not rely on delayed embolization. The covering extends across the vessel upon deployment to provide instant occlusion.

Claims

1. A medical device for placement within a body vessel for providing vessel occlusion, the device comprising:

a support structure having proximal and distal ends and defining a longitudinal axis therebetween, wherein the support structure is biased toward a nominal state having a radial expanded and longitudinally shortened configuration and extendable from the nominal position to a lengthened state having a radially reduced and longitudinally lengthened configuration;

at least one layer of nonwoven electrospun fibers attached to and encapsulating the support structure; and

wherein the electrospun fibers comprise a mixture of Polyethylene Terephthalate (PET) solution and Ultra High Molecular Weight Polyethylene (UHMWPE) micro-particles.

2. The medical device of claim 1, wherein the mixture comprises approximately 5% UHMPE microparticles and 95% PET solution.

3. The medical device of claim 2, wherein the PET solution includes approximately 15% PET solids and 85% 50:

50 trifluoroacetic acid and dichloromethane.

4. The medical device of claim 1, wherein the microparticles are approximately 30 micron micro-particles.

5. The medical device of claim 1, wherein the at least one layer comprises a first layer and a second layer.

6. The medical device of claim 5, wherein the first layer has a thickness of about 30-60 microns and the second layer has a thickness of about 30-60 microns.

7. The medical device of claim 5 further comprising a coating of TiO2/SiO2 sol-gel applied to at least one of the first and second layers.

8. The medical device of claim 7, wherein the coating is disposed between the first and second layers.

9. The medical device of claim 7, wherein the coating has a ratio of approximately 9:

1 TiO2;

SiO2.

10. The medical device of claim 7, wherein the coating is disposed on an outermost surface of the device.

11. The medical device of claim 1, wherein the support structure comprises a first mesh and a second mesh, and an intermediate portion disposed therebetween, wherein the intermediate portion has a smaller diameter than the proximal and distal portions in both the nominal and lengthened states, wherein each of the first mesh and second mesh comprise a plurality of wires.

12. The medical device of claim 1 further comprising PET fibers tied around the electrospun fibers at both the proximal and distal ends.

13. The medical device of claim 1, wherein the support structure and attached covering can withstand approximately double the strain of the support structure with an alternative covering of electrospun fibers having no UHMWPE.

14. A method for coating a support structure with a non-woven electrospun material, the method comprising:

attaching a support structure to a conductive mandrel;

rotating the mandrel;

applying a mixture of ultra high molecular weight polyethylene (UHMWPE) microparticles and Polyethylene Terephthalate (PET) solution to the support structure by electrospinning; and

coating the support structure with non-woven electrospun fibers produced by electrospinning the mixture to produce at least one layer of non-woven electrospun fibers.

15. The method of claim 15, wherein the at least one layer comprises a first layer and second layer, and the first layer and second layer are provided in a first coating step and a second coating step.

19. The method of claim 15, further comprising tying PET fibers around proximal and distal ends of the at least one layer.

16. The method of claim 16, further comprising applying a TiO2/SiO2 solution to at least one of the first layer and the second layer, wherein the applying step is performed between the first and second coating steps.

17. The method of claim 16, further comprising applying a TiO2/SiO2 solution to at least one of the first layer and the second layer, wherein the applying step is performed after the first and second coating steps.

18. The method of claim 16, wherein the first coating step includes translating the support structure relative to the mandrel over 2-3 passes and the second coating step includes translating the support structure relative to the mandrel over 3-4 passes.

20. The method of claim 21, wherein the mixture includes about 4%-10% UHMWPE microparticles in suspension and the remainder comprises the PET solution.