US-12623061-B2 - Support catheters and associated loading components

US12623061B2US 12623061 B2US12623061 B2US 12623061B2US-12623061-B2

Abstract

Split support catheters, loading tools, and methods of use are disclosed. A support catheter can include an elongate tubular member and a push member. The tubular member can comprise a longitudinal slit configured to accommodate the exchange of various interventional devices into and out of the lumen defined by the tubular member. A loading tool can comprise a body member, a rod member, or both and can facilitate loading of the support catheter onto one or more interventional devices during a medical procedure. The support catheters can provide intravascular support to various interventional devices and can advantageously be inserted and removed without first removing an interventional device having its distal end at or near a target site within a patient's vasculature.

Inventors

Jason Galdonik
Mark W. I. Webster
Christopher E. Buller
Joshua Brenizer
Daniel Jindra

Assignees

Teleflex Life Sciences Llc

Dates

Publication Date: 20260512
Application Date: 20220215

Claims (12)

1 . A guide extension catheter for use with a guide catheter, comprising: an elongate tube member having a longitudinal slit, a lumen, and an outer diameter smaller than a lumen of the guide catheter, the elongate tube member further having or coupled with an angled proximal port; and a push member eccentrically coupled relative to an axis of the elongate tube member and extending proximal of the elongate tube member for slidably positioning the elongate tube member within and partially beyond a distal end of the guide catheter, wherein the longitudinal slit includes a straight portion and at least one slanted or curved portion relative to the axis of the elongate tube member, the at least one slanted or curved portion located distal to the straight portion.
2 . The guide extension catheter of claim 1 , wherein the outer diameter of the elongate tube member tapers distally, such that the outer diameter is smaller at a distal portion of the elongate tube member than at a proximal portion of the elongate tube member.
3 . The guide extension catheter of claim 2 , wherein the distal portion of the elongate tube member comprises a flexible, tapered distal tip configured to fold proximally into the lumen of the elongate tube member.
4 . The guide extension catheter of claim 1 , wherein a width of the longitudinal slit varies along a length of the elongate tube member.
5 . The guide extension catheter of claim 1 , wherein the push member comprises a flattened portion embedded in at least a portion of the elongate tube member.
6 . The guide extension catheter of claim 5 , wherein the flattened portion of the push member extends substantially an entire length of the elongate tube member.
7 . The guide extension catheter of claim 1 , wherein a distal portion of the elongate tube member is curved.
8 . The guide extension catheter of claim 1 , wherein the longitudinal slit is configured to accommodate an exchange of an interventional device into and out of the lumen of the elongate tube member.
9 . The guide extension catheter of claim 1 , wherein the at least one slanted or curved portion spans a length of 0.25 centimeters to 3 centimeters, inclusive.
10 . The guide extension catheter of claim 1 , wherein the elongate tube member comprises a frame defined by a longitudinal spine and a plurality of prongs extending from the longitudinal spine.
11 . The guide extension catheter of claim 1 , wherein the angled proximal port is defined by a slanted wall, a collar, or a concave track extending from the push member to a fully cylindrical portion of the elongate tube member.
12 . The guide extension catheter of claim 1 , wherein the push member is coupled to the elongate tube member at a location opposite a location of the longitudinal slit.

Description

CLAIM OF PRIORITY This non-provisional patent document claims the benefit of priority under 35 U.S.C. § 119(e) to Galdonik et al., U.S. Provisional Patent Application Ser. No. 63/149,510, entitled “EXPANDABLE SPLIT SUPPORT CATHETER AND LOADING TOOL DESIGNS, METHODS FOR MANUFACTURE AND METHODS FOR USE” and filed on Feb. 15, 2021, which is herein incorporated by reference in its entirety. TECHNICAL FIELD This patent document relates to medical devices. More particularly, but not by way of limitation, the patent document relates to support catheters with attributes configured to support other interventional devices within a patient's vasculature. Accessory devices configured to assemble support catheters with various interventional devices are also disclosed. BACKGROUND A guide catheter can back out and withdraw from a vessel's ostium or branch when an interventional device, such as a guidewire, balloon catheter, stent or stent catheter, is passed therethrough and advanced beyond the guide catheter's distal end. This backing out of the guide catheter can cause the operating physician to lose the ability to further advance the interventional device distally. The interventional device itself may also be unable to access or cross a treatment site, such as a lesion, due to lack of backup support. Devices configured to prevent guide catheter withdrawal and provide additional anchoring support for interventional devices must be selected by an operating physician before a medical procedure is initiated to avoid the need to remove one or more devices from a patient's vasculature during the procedure. Overview The present inventors recognize that the need to provide increased backup support to interventional devices, such as guide catheters, during interventional procedures can be unpredictable. The present inventors also recognize that, once advanced down a blood vessel during an interventional procedure, support catheters can increase procedural success by “anchoring” an interventional device in the vessel, thereby making it less likely to back out or dislodge from a target site as another interventional device, e.g., balloon or stent delivery system, is advanced. The present inventors also recognize that support catheters can reduce friction between interventional devices and the surrounding vessel walls, making it less likely that the interventional devices catch on calcified and diseased upstream vessel wall tissue. The present inventors recognize that support catheters are increasingly used in chronic total occlusion (CTO) and percutaneous coronary intervention (PCI) procedures to increase guide support, and also to provide a target for retrograde wire re-entry. Another useful role for support catheters recognized by the present inventors is to facilitate selective delivery of contrast (e.g., to a desired branch vessel), thereby improving angiographic imaging, with a reduction in contrast volume. The present inventors recognize that currently commercialized support catheters may consist of a proximal handle, a flexible distal tubular structure, and a push rod connecting the handle to the tube. The distal tubular structure can include a radiopaque element(s) so that it can be visualized, such as a round platinum-iridium (Pt—Ir) marker band. The distal tube is typically a fully round tube, and the wall may consist of an inner lubricious layer (such as a PTFE liner), a support material (such as stainless steel braid), and a polymeric outer layer (such as Nylon, Pebax®, or the like). The present inventors further recognize that some preexisting support catheters have an approximately 5F outer diameter configured to be advanced through a 6F guide catheter, where F is an abbreviation for the French catheter scale (a unit of measure catheter diameter (1F=⅓ mm)). Also on the market are 4F, 6F, and 7F support catheters. Generally, a 4F catheter has an internal diameter greater than or equal to 0.050 inches. Generally, a 5F catheter has an internal diameter greater than or equal to 0.059 inches, a 6F catheter has an internal diameter greater than or equal to 0.070 inches, and a 7F catheter has an internal diameter greater than or equal to 0.078 inches. It is to be appreciated that, because the wall thickness of the support catheter's tubular member can vary, and because of the need for some amount of space between the support catheter's tubular member and the guide catheter's inner wall, the support catheter's tubular member's inner diameter, when the tube does not have a device such as an interventional cardiology device inserted into it, may vary, and may be smaller than the inner diameter of a guide catheter of corresponding size. For example, while a standard 5F guide catheter may have an inner diameter of 0.059 inches or more, a 5F support catheter of the present invention in its resting state (without anything inserted into or through it) may have an inner diameter of about any of 0.052 inches or less, 0.053 inches,