Polymeric inner liners for use with catheters or other medical devices, where the polymeric inner liner tubing can have regions of customized properties created by slot type patterns in the liner.
Medical catheters allow physicians to apply a variety of different therapies within the body of a patient. Many catheters access remote regions of the human body for delivering diagnostic or therapeutic tools and/or agents to those sites. Alternatively, the catheter can comprise a shaft or support for a therapeutic working end (e.g., balloon, filter retriever, electrode, etc.). Some catheters, including but not limited to catheters for neurovascular use, are intended to be advanced from a main artery (e.g., a femoral or radial artery) through tortuous anatomy into a small cerebral vessel. As such, the catheter must be configured with varying structural traits due to the varying regions of the anatomy through which the catheter passes. Many times, the vascular pathways wind back upon themselves in a multi-looped path making it difficult for catheter design to meet the requirements demanded by the tortuous anatomy. For example, catheters must be fairly stiff at their proximal end to allow the pushing and manipulation of the catheter as it progresses through the body, and yet must be sufficiently flexible at the distal end to allow passage of the catheter tip through the loops and smaller blood vessels. Regardless, the catheter does not cause significant trauma to the blood vessel or to the surrounding tissue.
Additionally, many interventional catheters use a low friction liner on the innermost surface of the catheter to allow for the smooth passage of other interventional devices or biologic agents through the catheter. PTFE liners are one of the most lubricious and durable low-friction liners available. While PTFE offers a smooth, durable, and low friction surface, it is relatively stiff and imparts a significant added stiffness to the overall catheter construction. Often the added stiffness creates challenges and problems for the catheter in terms of reduced bendability and reduced navigability, especially at the distal end of the catheter, which needs to encounter more aggressive anatomical curvature. Previously, attempts were made to “soften” the inner liner using mechanical manipulations (i.e., axial or biaxial stretching, fatiguing, expanding, etc., but without significant effect. PTFE is extremely durable and practically inert from a polymer chemistry perspective, and attempts to soften the PTFE through chemical changes or polymer chemistry changes have not been successful. Designers must choose whether to utilize a PTFE liner that runs continuously through the distal region of the catheter (i.e., runs from proximal shaft to distal tip) and accept the limitations of reduced navigation and reduced ability to access distal anatomic territories. Alternatively, designers must terminate the PTFE liner proximal to the distal tip and replace it with something more flexible that permits easier navigation. Currently, most of the currently available neuro-interventional access catheters utilize PTFE liners that run from the proximal shaft in the distal direction and terminate around 10 cm to 20 cm from the distal tip of the catheter; in this location, the PTFE liner usually “transitions” to a new liner, often made of polyolefin, ePTFE, or another softer polymeric material. This new polymer is softer than the PTFE and thus allows for better bending ability and improved navigability. However, this softer liner is also less durable and has a less favorable frictional surface. Therefore, interventional devices being delivered through the ID of the catheter (i.e., metal stents, coils, etc.) can damage the liner during both delivery and retrieval back through the catheter, causing damage to the entire catheter shaft and resulting in the catheter failing and needing replacement during a procedure. Additionally, the transition of the two materials is not a polymeric fusing, the way other catheter transitions would be, because PTFE is a thermoset material and therefore does not melt and reflow the way conventional thermoplastics do. Therefore, the transition region can sometimes delaminate and cause further negative issues and events.
As shown in
In many cases, catheters must be advanced through tortuous anatomy with a decreasing vessel diameter. In such cases, the diameter of the catheter is significantly reduced such that the structural properties of the inner liner 14 adversely affect the flexibility of the catheter. Some manufacturers address these adverse issues by simply terminating the inner liner 14 prior to the distal end of the catheter. However, such designs produce catheters with reduced lubricity at the distal section, which can cause other adverse effects when trying to use the catheter to perform procedures at the distal end.
Therefore, there remains a need for a catheter having improved inner liners.
The present disclosure includes catheters and similar medical devices having inner liners where the polymeric inner liner tubing can have regions of customized properties created by slot-type patterns in the inner liner catheter. Variations of the devices can include constructions having a catheter shaft having an axial length, the catheter shaft including an inner liner, a reinforcement structure that is exterior to the inner liner, and a tubular outer layer extending over the reinforcement structure, and the inner liner includes at least one spiral slot pattern included of a plurality of slots between a plurality of interruptions where a wall of the inner liner remains intact, wherein each slot of the plurality of slots has a length measured between each adjacent interruption.
Variations of the devices herein include catheter constructions wherein the plurality of slots includes a first pattern of slots, each having a first length and a second pattern of slots, each having a second length, where the first length and second length are different. In some variations, a pitch of the at least one spiral slot pattern varies over an axial length of the inner liner.
In some aspects, the devices herein include catheter constructions with a catheter shaft having an axial length, the catheter shaft including an inner liner, a reinforcement structure that is exterior to the inner liner, and a tubular outer layer extending over the reinforcement structure; and wherein the inner liner includes a plurality of regions extending sequentially lengthwise along the inner liner having a plurality of slots, each of the plurality of regions having a number of slots of the plurality of slots extending spirally about the inner liner; and the plurality of regions including at least a first-end region and a second-end region on opposite ends of the plurality of regions, wherein the number of slots in the first-end region is greater than the number of slots in each of a remainder of the plurality of regions such that the first-end region includes a first stiffness, wherein the number of slots in the second-end region is less than the number of slots in each of the remainder of the plurality of regions such that the second-end region includes a second stiffness, wherein the first stiffness less than the second stiffness.
In additional variations, the inner liner includes a plurality of regions extending sequentially lengthwise along the inner liner having a plurality of slots, each of the plurality of regions having a number of slots of the plurality of slots extending spirally about the inner liner; and the plurality of regions including at least a first-end region and a second-end region on opposite ends of the plurality of regions, wherein the number of slots in the first-end region is greater than the number of slots in each of the remainder of the plurality of regions such that the first-end region includes a first stiffness, wherein the number of slots in the second-end region is less than the number of slots in each of the remainder of the plurality of regions such that the second-end region includes a second stiffness, wherein the first stiffness less than the second stiffness.
In some aspects, catheter constructions can include the plurality of regions having an intermediate region between the first-end region and second-end region, where the number of slots in the intermediate region is greater than the number of slots in the second-end region and less than the number of slots in the first-end region, such that an intermediate stiffness of the intermediate region is less than the first stiffness and greater than the second stiffness.
Variations of the devices described herein relate to a catheter construction, wherein the plurality of regions includes a plurality of intermediate regions sequentially located between the first-end region and second-end region, where the number of slots in each of the plurality of intermediate regions decreases from the first-end region to the second-end region, such that a stiffness of each of the plurality of intermediate regions increases towards the second-end region.
In additional variations, a pitch of the number of slots in the first-end region increases in a direction away from the second-end region, such that the first stiffness of the first-end region decreases as a pitch decreases.
The slots can extend partially or fully through a wall of the inner liner.
The present disclosure also includes catheter constructions having a catheter shaft having an axial length, the catheter shaft including an outer layer and an inner liner located coaxially within the outer layer, the inner liner having a lumen extending therethrough, a proximal end, and a distal end; and wherein the inner liner includes one or more slots extending helically along the inner liner, where a depth of the one or more slots varies along an axial length of the catheter shaft.
The one or more slots can include a plurality of slots between a plurality of interruptions where a wall of the inner liner remains intact, wherein each slot has a depth that extends from the wall of the inner liner towards the lumen of the inner liner in a radial direction.
In some variations, the depth of the one or more slots improves preferential bending of the inner liner. In additional variations, the depth of the one or more slots gradually increases from the proximal end of the inner liner to the distal end of the inner liner.
In some aspects, the techniques described herein relate to a catheter construction, wherein the inner liner includes a plurality of regions extending sequentially lengthwise along the inner liner, wherein a number of slots in each of the plurality of regions vary.
Variations of the devices include a catheter construction, wherein the plurality of regions includes a first region and a second region, wherein the depth of the one or more slots in the first region is greater than the depth of the one or more slots in the second region.
Variations of the devices can include slots where the depth of the one or more slots in a first region of the inner liner extends from a surface of the inner liner through to the lumen. Additionally, in a second region, the depth of the one or more slots decreases such that the depth extends from the surface of the inner liner and partially through a wall of the inner liner.
The devices described herein can include a reinforcement structure exterior to the inner liner and within the outer layer extending over the reinforcement structure.
In some aspects, the techniques described herein relate to a catheter construction, wherein the inner liner includes a first radial side and a second radial side opposite to the first radial side, the inner liner further including a first segment and a second segment, wherein at the first segment the depth of the one or more slots at the first radial side is less than the depth of the one or more slots on the second radial side.
In some aspects, the techniques described herein relate to a liner for use with a medical tubing, the liner including a liner body extending along an axial length and including a lumen extending therethrough a proximal end and a distal end; and wherein the liner body includes one or more slots extending helically along the liner body, where a depth of the one or more slots vary along the axial length.
In some aspects, the techniques described herein relate to a liner, wherein the one or more slots include a plurality of slots between a plurality of interruptions where a wall of the liner body remains intact, wherein each slot has a depth that extends from the wall of the liner body towards the lumen of the liner body in a radial direction.
The devices of the present disclosure allow for a considerable number of combinations and permutations of different variations of liners and catheters, as well as a combination of aspects of those structures as well. It is contemplated that any of the requirements and elements described herein can be combined with any independent claim where the requirements of the independent claims would not contradict the various elements.
The catheter configuration discussed herein can be used in a variety of devices where different regions are selected for customized properties. The configurations described herein can be incorporated into various medical devices or can be used as catheter shafts. Furthermore, in some variations, the construction features of the present disclosure are not limited to in-dwelling medical devices and can be used for any device requiring tubing.
As shown, in one variation of the device, the tubular construction or shaft of the catheter 100 extends from a hub 101 and can be formed by the improved outer polymeric layer 103, discussed below, that overlays a braid 20, coil or other support structure commonly used with catheters. The braid 20 is positioned about a tubular inner liner 14 (commonly constructed from PTFE, but other materials are within the scope of this disclosure). As shown in
Traditional catheter designs include the use of a lubricious liner within the catheter (see, e.g., liner 14 in
Laser cut patterns can be formed with a single spiral pattern or multiple spiral patterns adjacent to one another. In the example shown in
Turning to the specifics of
To further illustrate the concept of altering the depth in the circumferentially extending slot,
As for other details of the present invention, materials and manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts that are commonly or logically employed. In addition, though the invention has been described in reference to several examples, optionally incorporating various features, the invention is not to be limited to that which is described or indicated as contemplated with respect to each variation of the invention.
Various changes may be made to the invention described, and equivalents (whether recited herein or not included for the sake of some brevity) may be substituted without departing from the true spirit and scope of the invention. Also, any optional feature of the inventive variations may be set forth and claimed independently or in combination with any one or more of the features described herein. Accordingly, the invention contemplates combinations of various aspects of the embodiments or combinations of the embodiments themselves, where possible. Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural references unless the context clearly dictates otherwise.
It is important to note that where possible, aspects of the various described embodiments, or the embodiments themselves can be combined. Where such combinations are intended to be within the scope of this disclosure.
This application is a non-provisional application of U.S. Provisional application 63/369,833 filed on Jul. 29, 2022, the entirety of which is incorporated by reference.
Number | Date | Country | |
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63369833 | Jul 2022 | US |