Delivery device and method of delivery
Inventors
Longo, Michael • Evans, Douglas • Harrison, William James
Assignees
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Publication Number
US-10898356-B2
Publication Date
2021-01-26
Expiration Date
Abstract
A delivery device can provide sequential delivery of a plurality of intraluminal devices or tacks held in a compressed state on the delivery device. Delivery platforms on the delivery device can hold a tack in a compressed position and have a unique shape, such as a non-constant outer diameter, an hourglass shape, a tapered proximal half, ridges, dimples, etc. This unique shape can be positioned between annular pusher bands that may also be radiopaque markers. In some embodiments, the unique shape is provided by a sleeve of flexible material with the unique shape surrounding a harder inner shaft. Further, the annular pusher bands can be made of wire or sections of material to increase flexibility while remaining radiopacity. A tack deployment method can include alignment of radiopaque markers on the outer sheath and the tack to be deployed prior to deployment.
Core Innovation
The invention relates to a delivery device for sequential deployment of a plurality of compressed intraluminal devices using multiple delivery platforms. Each intraluminal device is held in a compressed state by a delivery platform that includes a recessed delivery platform surrounding an inner shaft, defined by circumferential raised shoulders and adjacent sleeve and inner shaft features configured to accept and hold the intraluminal device.
An outer sheath positioned on and slidable over the inner shaft and the delivery platform moves between a pre-deployment position and a deployment position. In the pre-deployment position the outer sheath covers every recessed delivery platform, and in the deployment position the outer sheath exposes at least one recessed delivery platform, supporting staged exposure and one-by-one deployment using different recessed delivery platforms and associated spacing between them.
The delivery device uses a sleeve surrounding at least a portion of the inner shaft, the sleeve having a non-constant outer diameter with a first cylindrical section and a second cylindrical section. The second cylindrical section has an outer diameter larger than the first cylindrical section and smaller than the raised shoulders and/or annular bands, and the sleeve is formed of a material different from the inner shaft. Radiopaque markers aligned between an outer sheath marker and a marker on the intraluminal device may be used for deployment alignment, and radiopaque elements may be included in raised shoulders, including radiopaque helical coils.
Claims Coverage
The independent claims cover three inventive features. They address recessed delivery platform geometry, an outer sheath that covers or exposes the recessed delivery platform(s), and a non-constant outer diameter sleeve of different material than the inner shaft that supports controlled deployment and prevents longitudinal movement or premature deployment.
Recessed delivery platform defined by raised shoulders and sleeve/shaft edges
A delivery device includes an inner shaft; at least two raised shoulders fixed to and circumferentially surrounding the inner shaft, including at least one proximal raised shoulder and at least one distal raised shoulder; and a sleeve surrounding at least a portion of the inner shaft, the sleeve having a non-constant outer diameter comprising a first cylindrical section and a second cylindrical section with an outer diameter larger than the first cylindrical section and smaller than the raised shoulders, wherein the sleeve extends between and contacts at least one distal edge of the proximal raised shoulder and the proximal edge of a distal raised shoulder, and wherein the distal edge of the proximal raised shoulder, the proximal edge of a distal raised shoulder, and at least one of the inner shaft and the sleeve form at least one recessed delivery platform surrounding the inner shaft and configured to accept and hold an intraluminal device.
Outer sheath pre-deployment and deployment exposing recessed delivery platform(s)
A delivery device includes an outer sheath positioned on and slidable over the inner shaft, the raised shoulders, and the recessed delivery platform(s), wherein the outer sheath has a pre-deployment position covering every recessed delivery platform and a deployment position exposing at least one recessed delivery platform.
Non-constant outer diameter sleeve and prevention of longitudinal movement or premature deployment
A delivery device includes a sleeve distinct from and surrounding at least a portion of the inner shaft, the sleeve extending between and contacting pair(s) of raised annular bands and having a non-constant outer diameter comprising a first cylindrical section and a second cylindrical section with an outer diameter greater than the first cylindrical section and less than the pair of raised annular bands; and an outer sheath positioned on and slidable over the inner shaft and the delivery platform(s), wherein the outer sheath has a pre-deployment position covering every recessed delivery platform and a deployment position exposing at least one recessed delivery platform, and wherein the sleeve surrounding at least a portion of the inner shaft is configured to prevent at least one of longitudinal movement and premature deployment of a self-expanding intraluminal device as the outer sheath is moved from the pre-deployment position to the deployment position.
Across the independent claims, the delivery device is characterized by recessed delivery platform(s) defined by circumferential raised shoulders and sleeve/shaft edges, a sleeve with a non-constant outer diameter that differs from the inner shaft and/or contacts raised annular bands, and an outer sheath that moves between pre-deployment and deployment positions exposing recessed delivery platform(s). The claims also emphasize controlled exposure and retention of self-expanding intraluminal devices while preventing longitudinal movement or premature deployment.
Stated Advantages
Reduces risk of distal "shooting"/jumping during deployment (watermelon seeding).
Supports controlled deployment of multiple intraluminal devices one-by-one with controlled spacing between tacks.
Documented Applications
Treating atherosclerotic occlusive disease after balloon angioplasty.
Treating tissue dissection, including vessel flaps, after balloon angioplasty.
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