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Publication Number

US-9198783-B2

Patent

Publication Date

2015-12-01

Expiration Date


Abstract

Delivery systems for a polymeric tubular implant, kits that include such delivery systems, and methods of treating patients by implanting tubular implants using the delivery systems. The delivery systems include an inner shaft, an expandable member slidably disposed about the inner shaft and configured to receive the tubular implant, and a tubular outer shaft disposed about the inner shaft.

Core Innovation

The delivery system and methods load and implant self-expanding polymeric tubular implants. A mesh or woven expandable member applies gradual, substantially uniform radial compression as an outer shaft advances, while an optional second expandable member supports the implant from within. The implant is retained in a compressed configuration between catheter components and is released from the delivery catheter for implantation in the body.

The delivery system controls implant release by reducing stent jumping and mitigating the effects of stress relaxation during storage. Loading the implant shortly before implantation limits stress relaxation of the self-expanding polymeric structure. This configuration maintains the implant between inner and outer catheter members until deployment within a patient.

Claims Coverage

The three independent claims are claims 1, 16, and 21, defining three inventive features directed to catheter configurations and methods for compressing, delivering, and releasing a tubular implant.

Catheter with first and second expandable members

Independent claims 1 and 21 recite an inner shaft, a slidably disposed first expandable member, a second expandable member affixed to the inner shaft and configured for partial placement inside the implant, and a slidably disposed tubular outer shaft, wherein the second expandable member is not a balloon and both expandable members comprise mesh material, woven material, or both.

Implant retained in a compressed configuration

Independent claims 1 and 21 recite moving the tubular implant from its unstressed configuration to a compressed configuration in which it is removably disposed between the inner shaft and tubular outer shaft and between the first and second expandable members for delivery and implantation in a patient.

Delivery device with a compressible cushion

Independent claim 16 recites a compressible cushion on the inner shaft, a first mesh or woven expandable member, a non-balloon second expandable member, and a tubular outer shaft, wherein the implant is compressed and loaded between the inner shaft and outer shaft followed by exposure of the implant so it can relax away from the inner tubular member.

Together, these inventive features provide paired expandable members, compressible cushion elements, and shaft components to load, retain, and release a compressed tubular implant in a patient.

Stated Advantages

The mesh or woven expandable member applies gradual, substantially uniform radial compression.

The optional second expandable member improves release control and reduces stent jumping.

End-user loading shortly before implantation can limit stress relaxation during storage.

Documented Applications

Treating a patient by delivering and implanting a tubular implant within the body using a delivery catheter or delivery device.

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