US-12622795-B1 - Tapered sleeve

US12622795B1US 12622795 B1US12622795 B1US 12622795B1US-12622795-B1

Abstract

The present disclosure describes methods of making a sleeve comprising a conical frustum having first and second end profiles and a lumen there through for covering and constraining an expandable device, and apparatuses, systems, and assemblies comprising an expandable device and a sleeve having a frustoconical shape when the expandable device is at least partially expanded. The present disclosure further describes methods for deploying an expandable device in a patient comprising releasing a releasable seam disposed on a sleeve and everting the sleeve while retracting it from the expandable device.

Inventors

Matthew G. Sondreaal

Assignees

W. L. GORE & ASSOCIATES, INC.

Dates

Publication Date: 20260512
Application Date: 20240123

Claims (16)

1 . An endoprosthesis delivery system comprising: an endoprosthesis defining a longitudinal length; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including: a sleeve member configured to constrain the endoprosthesis in a delivery configuration and an intermediate deployment configuration and to release the endoprosthesis when in an everted configuration, the sleeve member configured to at least partially evert from the intermediate deployment configuration to the everted configuration, wherein the sleeve member surrounds the endoprosthesis along the longitudinal length when in the delivery configuration and the intermediate deployment configuration; and a coupling member removably coupled to the sleeve member along at least a portion of a longitudinal length of the sleeve member, wherein the coupling member maintains the sleeve member in the delivery configuration when coupled to the sleeve member and wherein the sleeve member is free to expand to the intermediate deployment configuration when the coupling member is actuated, wherein the sleeve member is without a seam in the intermediate deployment configuration.
2 . The endoprosthesis delivery system of claim 1 , wherein endoprosthesis is free to transition to a deployed configuration when the sleeve member is everted and not surrounding the endoprosthesis.
3 . The endoprosthesis delivery system of claim 1 , wherein coupling member is woven through the sleeve member to define a seam.
4 . The endoprosthesis delivery system of claim 3 , further comprising at least one remote pull line tether coupled to the second end and operable to evert the sleeve member when actuated.
5 . The endoprosthesis delivery system of claim 1 , wherein the sleeve member includes a first end, a body, and a second end, wherein the second end is configured to be actuated to everted over the body and the first end.
6 . The endoprosthesis delivery system of claim 1 , wherein the sleeve member is configured to transition from the delivery configuration to the intermediate deployment configuration when the coupling member is actuated and at least partially decoupled from the sleeve member.
7 . The endoprosthesis delivery system of claim 1 , wherein the sleeve member includes a tapered profile in the intermediate configuration such that the inner portion of the sleeve member has a first diameter at a first longitudinal position and a second diameter at a second longitudinal position, wherein the first diameter is greater than the second diameter.
8 . The endoprosthesis delivery system of claim 7 , wherein the tapered profile includes a frustoconical shape.
9 . An endoprosthesis delivery system comprising an endoprosthesis; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including: a sleeve member defining a lumen extending longitudinally through the sleeve member, wherein the sleeve member is configured to at least partially evert; a deployment line removably coupled to sleeve member along at least a portion of a longitudinal length of the sleeve member, wherein the deployment line is coupled to the sleeve member at a first circumferential position of the sleeve member and a second circumferential position of the sleeve member such that the first and second circumferential positions are adjacent each other when the deployment line is coupled to the sleeve member and the first and second circumferential positions are spaced from each other when the deployment line is removed; and a remote pull line extending from the sleeve member and configured to evert the sleeve member when actuated, wherein the sleeve member includes a first seam and a second seam, wherein the first seam is permanent and the the second seam is releasable via the deployment line.
10 . The endoprosthesis delivery system of claim 9 , wherein the sleeve member includes a delivery configuration, an intermediate deployment configuration, and a full deployment configuration.
11 . The endoprosthesis delivery system of claim 10 , wherein the sleeve member is operable to transition from the delivery configuration to the intermediate deployment configuration when the deployment line is actuated and decoupled from the sleeve member.
12 . The endoprosthesis delivery system of claim 11 , wherein the sleeve member is operable to transition from the intermediate deployment configuration to the full deployment configuration when the remote pull line is actuated to evert the sleeve member.
13 . The endoprosthesis delivery system of claim 10 , wherein the sleeve member includes a tapered profile in the intermediate deployment configuration such that the sleeve member has a first diameter at a first longitudinal position and a second diameter at a second longitudinal position, wherein the first diameter is greater than the second diameter.
14 . The endoprosthesis delivery system of claim 13 , wherein the tapered profile includes a frustoconical shape.
15 . The endoprosthesis delivery system of claim 9 , wherein the deployment line is woven through the sleeve member to define the second seam is releasable via the deployment line.
16 . An endoprosthesis delivery system comprising: an endoprosthesis defining a longitudinal length; and an endoprosthesis constraining sleeve configured to constrain the endoprosthesis, the endoprosthesis constraining sleeve including: a sleeve member configured to constrain the endoprosthesis in a delivery configuration and an intermediate deployment configuration and to release the endoprosthesis when in an everted configuration, the sleeve member configured to at least partially evert from the intermediate deployment configuration to the everted configuration, wherein the sleeve member surrounds the endoprosthesis along the longitudinal length when in the delivery configuration and the intermediate deployment configuration; and a coupling member removably coupled to the sleeve member along at least a portion of a longitudinal length of the sleeve member, wherein the coupling member maintains the sleeve member in the delivery configuration when coupled to the sleeve member and wherein the sleeve member is free to expand to the intermediate deployment configuration when the coupling member is actuated, wherein the sleeve member includes a first seam and a second seam, and wherein the first seam is permanent and the second seam is releasable via the coupling member.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. application Ser. No. 16/935,682, filed Jul. 22, 2020, which is a continuation of U.S. application Ser. No. 15/704,505, filed Sep. 14, 2017, now U.S. Pat. No. 10,751,205, issued Aug. 25, 2020, which is a continuation of U.S. application Ser. No. 14/183,303, filed Feb. 18, 2014, now U.S. Pat. No. 9,763,819, issued Sep. 19, 2017, which claims priority to U.S. Provisional Application No. 61/772,984, filed Mar. 5, 2013, all of which are herein incorporated by reference in their entireties. FIELD The present disclosure relates generally to the remote orientation and deployment of implantable medical devices and, more particularly, to implantable expandable devices surrounded by constraining sleeves. BACKGROUND Medical devices are frequently used to treat the anatomy of patients. Such devices can be permanently or semi-permanently implanted in the anatomy to provide treatment to the patient. Frequently, these devices, including stents, grafts, stent-grafts, filters, valves, occluders, markers, mapping devices, therapeutic agent delivery devices, prostheses, pumps, bandages, and other endoluminal and implantable devices, are inserted into the body at an insertion point and delivered to a treatment site using a catheter. Common types of expandable devices include stents and stent-grafts. Expandable devices such as stents or stent-grafts are used in a variety of places in the human body to repair aneurysms and to support various anatomical lumens, such as blood vessels, respiratory ducts, gastrointestinal ducts, and the like. Expandable devices can have a reduced diameter when in a collapsed configuration, and can be designed to spontaneously dilate (i.e., elastically recover), or be balloon-expanded, from their collapse configuration, through one or more intermediate configurations, up to a maximum functional configuration. Expandable devices can be constrained in the collapsed configuration with a sleeve to facilitate transport to the treatment site. The endoluminal delivery and deployment of expandable devices pose potential issues. First, the expandable device itself must be radially compacted to a suitable delivery configuration to allow insertion into the vasculature, constrained and mounted onto a delivery device such as a catheter. Subsequently, the constraint must be removed in order to allow the expandable device to expand or be expanded to its functional configuration and achieve the desired therapeutic outcome. A variety of ways of constraining and deploying an expandable device are known in the art. For example, an expandable device can be constrained by one or more sleeves with deployment comprising the removal of the one or more sleeves. As such, there is an ongoing need to improve the endoluminal delivery and deployment of expandable devices such as stents and stent-grafts. New devices, assemblies and methods of deployment that can improve the use of sleeve-constrained expandable implants would be useful and desirable. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure. The drawings incorporated in and constituting a part of this specification illustrate embodiments of the disclosure, and together with the description, serve to explain the principles of the disclosure, wherein like numerals denote like elements and wherein: FIG. 1A illustrates a partial cutaway side view of an embodiment of an assembly comprising an expandable device constrained in a collapsed configuration in accordance with the present disclosure; FIG. 1B illustrates side views of embodiments of an expanded device and a sleeve in accordance with the present disclosure; FIG. 2 illustrates a perspective view of an embodiment of a sleeve in accordance with the present disclosure; FIG. 3 illustrates an unwrapped sheet of material usable to form an embodiment of a sleeve in accordance with the present disclosure; and FIGS. 4A, 4B and 4C illustrate side views of an embodiment of an expandable device being deployed in accordance with the present disclosure. DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and systems configured to perform the intended functions. Stated differently, other methods and systems can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not all drawn to scale, but can be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting. With that said, and as will be described in more detail herein, various embodiments of the present disclosure generally comprise sleeves comprising a conical frustum usable for constraining expandable devices, assemblies