FIELD

[0001] The present disclosures relate to catheters, particularly those used for aspiration and effective for the delivery and staging of life-essential neurovascular therapies.

BACKGROUND OF THE DISCLOSURES

[0002] Catheter systems and micro-catheters are known and subject to constant evolution to deliver therapies and remove undesired obstruction and thrombi.

OBJECTS AND SUMMARY OF THE INVENTION

[0003] Briefly stated, improved catheter systems leverage PTFE tubes and liners with gaps and spaces for flexure to enable navigation through tortuous and highly constrained neurovascular spaces without tissue insult and injury, unlike prior art attempts.

[0004] According to embodiments, methods for manufacture include wrapping and counter wrapping of films, including PTFE. The teachings of the instant disclosure provide improved catheter systems, comprising, in combination, at least a PTFE tube constructed of films of PTFE wrapped and counter-wrapped without extrusion, a coil wound over the at least a PTFE tube, a braid on top of the coil, marker bands located at a distal end, and Chronoprene™ jacket covering the assembly.

[0005] According to embodiments, there are disclosed methods for manufacture of specialized catheters, comprising, wrapping films of PTFE and counter-wrapping, without extrusion, to create assemblies having gaps and spaces and concomitant improved and increased flexibility.

[0006] According to embodiments, there are disclosed liner inclusive catheters with shrink tubes. Processes for making catheters for aspiration and small tortuous vessels, comprise, in combination, providing a liner of WPTFE, coil winding over the WPTFE liner, laying down a braid on top of the coil, including a marker band on a distal tip, and, application of a cover jacket.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Various preferred embodiments are described herein with references to the drawings in which merely illustrative views are offered for consideration, whereby: [0008] Fig la shows an exemplary coil subassembly being a wrapped PTFE liner with incorporated NITINOL wire; Fig. lb showing a cross-sectional view; and Fig. 1c showing detail of the subject coil assembly, according to the instant teachings.

[0009] Fig 2 shows an exemplary braid subassembly, being a wire braid pattern and construction, according to the instant teachings.

[0010] Fig 3 illustrates, for example, an exemplary catheter subassembly being a coating according to the instant teachings, with detail shown on and an end and cross sectional view.

[0011] Fig 4 shows a cartooned schematic of an exemplary catheter packaged assembly;

[0012] Fig 5 shows the balance of the elements of a kit, according to the instant teachings;

[0013] Fig 6 is a table showing wrapped v. extruded PTFE in terms of bend stiffness; and,

[0014] Fig 7 shows the unexpectedly flexible resulting catheter as part of a system with the instant disclosure. The present inventor has discovered that unexpected properties emerge when PTFE is wrapped, as opposed to extruded, for use within catheters. As further described herein, more robust properties can be achieved without the sacrifice of flexibility, and the ability to be navigated into the neurovasculature is decidedly enhanced this way.

DETAILED DESCRIPTION OF THE INVENTIONS

[0015] The present inventor has discovered that unexpected properties emerge when PTFE is wrapped, as opposed to extruded, for use within catheters. Referring now to Fig. 7, the inherent flexibility of the instant invention is shown within the context of this invention, namely it can be used to navigate tortuous anatomy and in fact remain integral with circular and obtuse flexure used to deliver it. As further described herein, more robust properties can be achieved without the sacrifice of flexibility, and the ability to be navigated into the neurovasculature is decidedly enhanced this way.

[0016] Referring now to Figures 1 through 5 in particular, the process for manufacturing of the instant invention can be readily understood. Fig. 1 shows an illustrative but not limiting embodiment of a coil subassembly being a wrapped PTFE liner , which then has a coil wind over, and (see Fig. 2) braid placed on top of coil, then (Fig. 3) marker band 3 attached distally while a Chronoprene™ type of over-jacket is attached. Fig 4 shows an exemplary, but not limiting, embodiment of the catheter packaged assembly having of each said previously recited features incorporated therein. Namely, each piece of catheter sub assembly shown in Fig. 1, Fig. 2, and Fig 3 has been disposed within the shown catheter packaged assembly. Artisans understand this further comprises; a 6Fr hub combined with 6Fr strain relief, between at least about 122 cm and 144 cm as working length.

[0017] Figures 4 and 5 illustrate exemplary, but not limiting embodiments described above and claimed below, of subject catheter packaged assembly kit; this version is shown with 6 Fr hub and strain relief proximal end while distal end terminates marker band appliance, as expanded detail is shown for example below proximal end of the figure. Distal end has the same at least about.0710 Min. ID (inner diameter) and approximately .0865 OD (outer diameter)

[0018] Those skilled in the art understand kits to include (even though not shown) packaging with product cards, catheter pouches, catheter vials, and IFU (Instructions for Use, etc.) along with pre-packaged introducers and indicators.

[0019] Likewise, Figure 5 shows a detailed view of exemplary, but not limiting, dimensions of catheter hand to tip (distal end) and catheter hand to end of WPTFE ranging, again merely for example, from 0.0710 mm to 0.0865 mm maximum outer diameter (OD). This example is but one version of the instant teachings. In terms of flexibility, unexpectedly, the data from Figure 6 shows enhanced flexibility, as shown also in Figure 7.

[0020] Referring now to Fig. 6, a three-point bend stiffness (gF) test shows that instead of extruding PTFE (as is generally known and done in the prior art) unexpectedly better results came from film wrapping and counter wrapping. This in entirely unexpected based upon data that has been reviewed from known catheter systems

[0021] Resultory spaces and grooves enable flexibility beyond what is contemplated or expected. This is optimal for tortuous vessels in the brain.

[0022] Referring now to Fig. 7, an example at approximately 0.72 ID (6 Fr) is shown with a complete 360° turn and return to original form.

[0023] It is respectfully proposed that the spaces and grooves enable said flexibility. Since cerebral and related neurovascular vessels are small, tortuous and fragile this invention solves long standing needs.

[0024] Catheters for aspiration from procedures, including delivery of liquid embolics, are made better this way, and do not delaminate or tear.

[0025] Similarly, use of a liner of cross-linked polyolefin provides ostensive benefits and improvements over the prior art (namely, for example, Sophia® and Sophia PLUS™ brands of catheters from TERUMO/Microvention and/or Titan® brands of catheters). [0026] The present invention uses WPTFE shrink tubes and creates a temperature stable (matt- free) ultra-thin aspiration catheter.

[0027] Corresponding reference characters indicate corresponding components throughout the several views of the drawings. Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity, and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments of the present invention.

[0028] While several embodiments of the present disclosure have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the functions and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the present disclosure. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present disclosure is/are used.

[0029] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the disclosure described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the disclosure may be practiced otherwise than as specifically described and claimed. The present disclosure is directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure.

[0030] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms. [0031] The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.” The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified, unless clearly indicated to the contrary.

[0032] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0033] The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.

[0034] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar throughout this specification may, but do not necessarily, all refer to the same embodiment.

[0035] Furthermore, the described features, structures, or characteristics of the invention may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to provide a thorough understanding of embodiments of the invention. One skilled in the relevant art will recognize, however, that the invention may be practiced without one or more of the specific details, or with other methods, components, materials, and so forth. In other instances, well-known structures, materials, and so forth. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the invention. [0036] Specific embodiments disclosed herein may be further limited in the claims using consisting of or consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of’ excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of’ limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the invention so claimed are inherently or expressly described and enabled herein.

[0037] As one skilled in the art would recognize as necessary or best-suited for performance of the methods of the invention, a computer system or machines of the invention include one or more processors (e.g., a central processing unit (CPU) a graphics processing unit (GPU) or both), a main memory and a static memory, which communicate with each other via a bus.

[0038] A processor may be provided by one or more processors including, for example, one or more of a single core or multi-core processor (e.g., AMD Phenom II X2, Intel Core Duo, AMD Phenom II X4, Intel Core i5, Intel Core I & Extreme Edition 980X, or Intel Xeon E7-2820).

[0039] An VO mechanism may include a video display unit (e.g., a liquid crystal display (LCD) or a cathode ray tube (CRT)), an alphanumeric input device (e.g., a keyboard), a cursor control device (e.g., a mouse), a disk drive unit, a signal generation device (e.g., a speaker), an accelerometer, a microphone, a cellular radio frequency antenna, and a network interface device (e.g., a network interface card (NIC), Wi-Fi card, cellular modem, data jack, Ethernet port, modem jack, HDMI port, mini-HDMI port, USB port), touchscreen (e.g., CRT, LCD, LED, AMOLED, Super AMOLED), pointing device, trackpad, light (e.g., LED), light/image projection device, or a combination thereof.

[0040] Memory according to the invention refers to a non-transitory memory which is provided by one or more tangible devices which preferably include one or more machine-readable medium on which is stored one or more sets of instructions (e.g., software) embodying any one or more of the methodologies or functions described herein. The software may also reside, completely or at least partially, within the main memory, processor, or both during execution thereof by a computer within system, the main memory and the processor also constituting machine-readable media. The software may further be transmitted or received over a network via the network interface device.

[0041] While the machine-readable medium can in an exemplary embodiment be a single medium, the term “machine-readable medium” should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions. The term “machine-readable medium” shall also be taken to include any medium that is capable of storing, encoding or carrying a set of instructions for execution by the machine and that cause the machine to perform any one or more of the methodologies of the present invention. Memory may be, for example, one or more of a hard disk drive, solid state drive (SSD), an optical disc, flash memory, zip disk, tape drive, “cloud” storage location, or a combination thereof. In certain embodiments, a device of the invention includes a tangible, non-transitory computer readable medium for memory. Exemplary devices for use as memory include semiconductor memory devices, (e.g., EPROM, EEPROM, solid state drive (SSD), and flash memory devices e.g., SD, micro SD, SDXC, SDIO, SDHC cards); magnetic disks, (e.g., internal hard disks or removable disks); and optical disks (e.g., CD and DVD disks).

[0042] Furthermore, numerous references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are individually incorporated herein by reference in their entirety.

[0043] In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.