System and method for endoluminal device treatment

Abstract

To provide a suitable system.SOLUTION: Various concepts relate to a treatment system for a medical device delivered into a patient in medical procedures. The treatment system may include a proximal valve configured to receive an endoluminal device, an optional distal valve configured to receive the endoluminal device, and a treatment chamber configured to receive a portion of the endoluminal device.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] Field The present disclosure generally relates to introducer systems and methods for the treatment of devices introduced into a patient's body, and more specifically, to systems and methods for intraluminal device treatment.

Background Art

[0002] Background Intraluminal devices are generally delivered into a patient's body (e.g., the patient's vasculature) using an introducer system. The introducer system typically includes a valve or similar feature for stopping backflow of body fluid (e.g., blood) into the introducer while allowing the intraluminal device to pass through the introducer and into the patient's body. In various examples, a clinician or other user of the intraluminal device may also desire to perform one or more treatments with the intraluminal device.

[0003] Particularly advantageous introducer systems include those sold under the trade name GORE® DrySeal Flex Introducer Sheaths by W.L. Gore & Associates, Inc. The GORE® DrySeal Flex Introducer Sheaths are intended to be inserted into the vascular system to provide a conduit for inserting an intravascular device while minimizing blood loss associated with the insertion of the intravascular device. The GORE® system includes an introducer sheath with a GORE® DrySeal Valve attached thereto, a twist-style locking dilator, and a syringe. The introducer sheath is a composite tube comprising a hydrophilic-coated Pebax® outer tube reinforced with a flat stainless steel wire and a PTFE liner with a tapered tip. The introducer sheath is attached to the GORE® DrySeal Valve. The GORE® DrySeal Valve includes an outer silicone tube and an inner film tube. The region between the silicone tube and the film tube can be pressurized by injecting a saline solution into that region using a syringe. Additional examples of similar systems can be found in U.S. Patent No. 10,155,104, "Valve Assembly for Medical Procedures," filed by W.L. Gore & Associates, Inc. SUMMARY OF THE INVENTION

[0004] Abstract Various examples relate to systems for treating intraluminal devices, as well as methods for treating such devices, whether those methods use existing device technology in an improved manner or use an improved system. Most examples are provided in the context of intraluminal devices, more specifically implantable devices delivered via the vasculature, but the principles and examples of the present disclosure are intended to be broadly applicable to any device treated as part of an introduction into the body using an introducer system. It will also be apparent that various advantages can be achieved using the systems and methods described herein, including removal of trapped air, pre-wetting or pre-dosing of one or more portions of the intraluminal device, and other procedures that can be performed to facilitate improved clinical outcomes.

[0005] According to one example ("Example 1"), a treatment system for an intraluminal device includes a proximal valve, optionally a distal valve, and a treatment chamber. The proximal valve can be configured to receive the intraluminal device, and the proximal valve includes a proximal seal mechanism operable between a sealed state and a non-sealed state to seal around the intraluminal device. When present, the distal valve can be configured to receive the intraluminal device, and the distal valve includes a distal seal mechanism operable between a sealed state and a non-sealed state around the intraluminal device. The treatment chamber can be configured to receive a portion of the intraluminal device, such as a portion extending between the proximal valve and the distal valve. The treatment chamber is fluidly coupled to the proximal valve to define a treatment space. The treatment chamber is optionally coupled between the proximal valve and the distal valve to define a treatment space between the proximal valve and the distal valve.

[0006] In addition to Example 1, according to another example ("Example 2"), one or both of the proximal seal mechanism and the distal seal mechanism include an outer tube, an inner tube, and a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube, and the pressurizable space is pressurizable to conform the inner tube around the intraluminal device to form a seal around the intraluminal device.

[0007] In addition to Example 2, according to another example (``Example 3''), the inner tube is formed of a compliant material.

[0008] In addition to Example 3, according to another example (``Example 4''), the compliant material includes one or more of ePTFE (expanded polytetrafluoroethylene), silk, and poly(paraphenylene terephthalamide).

[0009] In addition to any one of Examples 2 to 4, according to another example (``Example 5''), the outer tube is formed of an elastomeric material.

[0010] In addition to Example 5, according to another example (``Example 6''), the elastomeric material includes silicone.

[0011] In addition to any of the preceding examples, according to another example (``Example 7''), the system further includes an introducer sheath extending distally from the distal valve.

[0012] In addition to any of the preceding examples, according to another example (``Example 8''), the treatment chamber has a proximal portion adjacent to the proximal valve and a distal portion adjacent to the distal valve, and the treatment system further includes a proximal treatment port in fluid communication with the proximal portion of the treatment chamber and a distal treatment port in fluid communication with the distal portion of the treatment chamber.

[0013] In addition to Example 8, according to another example (``Example 9''), each of the proximal treatment port and the distal treatment port includes a valve for fluidly sealing and unsealing a proximal treatment portion and a distal treatment portion, respectively.

[0014] In addition to any of the previous examples, according to another example (Example 10), the intraluminal device is a transcatheter delivery system including a catheter and an implantable device maintained in a compacted delivery diameter or state, and further, the treatment chamber is configured to receive an implantable device in a compacted delivery diameter or state.

[0015] In addition to any of the previous examples, according to another example (Example 11), the intraluminal device is a transcatheter delivery system including a catheter and an implantable device maintained in a compacted delivery diameter or state by a delivery catheter, and further, the treatment chamber is configured to receive an implantable device with an intermediate partially expanded diameter larger than the compacted delivery diameter.

[0016] According to another example (Example 12), a method of treating an intraluminal device for introduction into a patient's body includes disposing the intraluminal device within a treatment system, where the treatment system includes a proximal valve, a distal valve, and a treatment chamber defining a treatment space between the proximal valve and the distal valve, and the intraluminal device includes a first portion extending through the proximal valve, a second portion extending through the distal valve, and a treatment portion extending through the treatment space of the treatment chamber. The method also includes closing the proximal valve and the distal valve to seal the proximal valve against the first portion of the intraluminal device and the distal valve against the second portion of the intraluminal device. And the method includes delivering a treatment medium to the treatment space to expose the treatment portion of the intraluminal device to the treatment medium.

[0017] In addition to Example 12, according to another example (Example 13), the treatment portion of the intraluminal device includes an implantable device maintained by a delivery catheter.

[0018] In addition to Example 12 or 13, according to another example ("Example 14"), the treatment portion of the intraluminal device includes the proximal portion of the implantable device, and the distal portion of the intraluminal device extends from the distal valve.

[0019] In addition to any one of Examples 12 to 14, according to another example ("Example 15"), the treatment medium is selected from one or more of a saline solution, carbon dioxide, a perfluorocarbon solution, methylene blue, and combinations thereof.

[0020] In addition to any one of Examples 12 to 15, according to another example ("Example 16"), when the treatment medium is delivered to the treatment space, air is pushed out from the treatment portion of the intraluminal device.

[0021] In addition to any one of Examples 12 to 16, according to another example ("Example 17"), the method further includes delivering the treatment medium into the treatment space through at least one of a proximal treatment port in fluid communication with the proximal portion of the treatment chamber and a distal treatment port in fluid communication with the distal portion of the treatment chamber.

[0022] In addition to any one of Examples 12 to 17, according to another example ("Example 18"), the treatment medium exits the treatment chamber through a distal treatment port in fluid communication with the distal portion of the treatment chamber.

[0023] In addition to any one of Examples 12 to 18, according to another example ("Example 19"), the intraluminal device includes a sleeve that maintains the implantable device in a compacted delivery state. Further, the distal valve is closed on the sleeve, and the treatment medium exits the distal valve through one or more gaps between the sleeve and the implantable device and enters the treatment chamber.

[0024] In addition to any one of Examples 12 to 19, according to another example (Example 20), the treatment system includes an introducer sheath, and the method further includes inserting the introducer sheath into a body cavity of a patient.

[0025] In addition to Example 20, according to another example (Example 21), the treatment medium is delivered to the treatment space with the introducer sheath inserted into the body cavity of the patient.

[0026] According to another example (Example 22), a method of treating an intraluminal device for introduction into a patient's body includes disposing the intraluminal device in a treatment system, where the treatment system includes a valve and a treatment chamber extending from the valve, and the intraluminal device includes a first portion extending through the valve and a treatment portion extending into a treatment space of the treatment chamber. The method also includes closing the valve to seal the valve against the first portion of the intraluminal device and sealing the treatment chamber. The method can also include delivering a treatment medium to the treatment space within the treatment chamber to expose the treatment portion of the intraluminal device to the treatment medium.

[0027] In addition to Example 22, according to another example (Example 23), the treatment chamber is sealed with a cap member extending distally from the valve.

[0028] In addition to Example 22, according to another example (Example 24), the treatment chamber is manually sealed with a cap member.

[0029] In addition to Example 24, according to another example (Example 25), the treatment chamber is digitally sealed by a user of the treatment system.

[0030] In addition to any one of Examples 22 to 25, according to another example (Example 26), the intraluminal device includes a sleeve that maintains the implantable device in a compacted delivery state, and further, the valve is closed on the sleeve, and the treatment medium exits the treatment chamber through the valve through one or more gaps between the sleeve and the implantable device.

[0031] According to another example (Example 27), a treatment system for an intraluminal device includes a proximal valve and a treatment chamber. The proximal valve can be configured to receive the intraluminal device, and the proximal valve includes a proximal sealing mechanism operable between a sealed state and an unsealed state to seal around the intraluminal device. The treatment chamber can be configured to receive a portion of the intraluminal device, and the treatment chamber is fluidly coupled to the proximal valve. The treatment chamber can have a proximal portion fluidly coupled to the proximal valve and a distal portion sealed in a liquid-tight or other manner (e.g., using a removable sealing mechanism such as a permanent or removable cap member).

[0032] In addition to Example 27, according to another example (Example 28), the distal portion of the treatment chamber is sealed by a cap member extending distally from the valve.

[0033] In addition to Example 27, according to another example (Example 29), the distal portion of the treatment chamber is sealed by a clamp member.

[0034] In addition to Example 27, according to another example (Example 30), the distal portion of the treatment chamber is sealed by a plug.

[0035] In addition to any one of Examples 27 to 30, according to another example (Example 31), the intraluminal device is received in the treatment chamber, the intraluminal device includes a sleeve that maintains the implantable device in a compacted delivery state, and further, the proximal valve is closed on the sleeve, and a pressurized treatment medium is present in the treatment chamber.

[0036] In addition to Example 27 or 31, according to another example ("Example 32"), the treatment system further includes a distal valve including a distal sealing mechanism operable between a sealed state and a non-sealed state to seal around the intraluminal device, and an introducer sheath removably coupled to the distal valve.

[0037] In addition to Example 32, according to another example ("Example 33"), the introducer sheath includes a hemostatic valve removably coupled to the distal valve.

[0038] In addition to any of the preceding examples, according to another example ("Example 34"), the treatment chamber (e.g., distal sheath) is configured to be length-adjustable, and the treatment chamber includes one or more of the following: one or more removable sections (e.g., releasably or breakably coupled), one or more longitudinally divisible features, a longitudinally compressible configuration (e.g., defining or including a plurality of wrinkles, folds or pleats similar to an accordion bellows), and / or a configuration that extends or contracts in length when a torsional force is applied to the treatment chamber (e.g., the treatment chamber includes a helical wrap or layered assembly that can be twisted while sealed to cause relative movement of the helical wrap or layers to shorten or extend the length of the treatment chamber).

[0039] The above examples are merely examples and should not be read as limiting or narrowing any scope of the concepts of the invention provided by the present disclosure. Although multiple examples are disclosed, further other embodiments will be apparent to those skilled in the art from the following detailed description which illustrates exemplary examples. Accordingly, the drawings and the detailed description are to be considered as essentially non-limiting and essentially exemplary. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Brief Description of the Drawings The accompanying drawings are included to provide a further understanding of the present disclosure, are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the principles of the present disclosure.

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[0059] One of ordinary skill in the art will readily understand that the various aspects of the present disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated in order to illustrate the various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

Mode for Carrying Out the Invention

[0060] Detailed Description Definitions and Terms The present disclosure is not intended to be read in a limiting manner. For example, the terms used in this application should be read broadly in relation to the meanings that terms in the art ascribe to such terms.

[0061] Regarding the term of inaccuracy, the terms "about" and "approximately" can be used interchangeably to refer to a measurement value that includes the stated measurement value and also includes measurement values reasonably close to the stated measurement value. A measurement value reasonably close to the stated measurement value deviates from the stated measurement value by a reasonably small amount that would be understood and readily confirmed by a person of ordinary skill in the relevant art. Such a deviation can be due to, for example, measurement error or small adjustments made to optimize performance. If it is determined that a person of ordinary skill cannot readily confirm such values of reasonably small differences, the terms "about" and "approximately" can be understood to mean ±10% of the stated value.

[0062] Description of various embodiments Before, during, or after introducing a luminal device into a patient's body, a treatment system with features that facilitate the treatment of the luminal device, as well as various examples of methods for treating a luminal device, are provided. In various examples, a treatment medium is applied to a luminal device, particularly an implantable device of the luminal device, to remove trapped air or otherwise pretreat the implantable device to reduce the risk of embolism or other harmful effects. In particular, saline solutions have been found to be effective treatment media, and carbon dioxide has also been found to be an effective treatment medium. Trapped carbon dioxide that has replaced trapped air is generally preferred because it shows small "bubbles" when the carbon dioxide is released into the bloodstream, thus reducing the physiological impact. Some examples of features and advantages have been described above, but according to the present disclosure, additional or alternative features and advantages are conceivable.

[0063] Figure 1A shows a treatment system 100 configured as an introducer system or integrated with an introducer system, according to several examples. As shown, the treatment system 100 includes a proximal valve 200A, a distal valve 200B, a treatment chamber 300 (which can also be called a garage conduit), and a distal sheath 400. Generally, the treatment system 100 includes a lumen 101 (Figure 3), which continuously extends throughout the entire length of the treatment system 100 and includes the proximal valve 200A, the treatment chamber 300, the distal valve 200B, and the distal sheath 400 configured to facilitate the introduction of an intraluminal device into the body cavity. Thus, using the treatment system 100, an intraluminal device can be introduced into a patient's body (not shown) by passing the intraluminal device through the lumen 101 from a location outside the patient's body to a location inside the patient's body. The treatment system 100 can be used with various intraluminal devices such as those shown in Figures 1B and 6 - 9. In various examples, the treatment system 100 is used to treat an intraluminal device (e.g., flush air from a part of the intraluminal device) with a treatment medium (e.g., carbon dioxide, saline solution, perfluorocarbon solution, methylene blue, etc.).

[0064] Figure 1B shows an optional dilator 500 that can be used in combination with the treatment system 100 to access one or more body cavities of a patient. During use, the dilator 500 is received through the lumen 101 of the treatment system 100 and utilized in relation to the treatment system 100 to gain access to the patient's body (e.g., vascular system, airway, biliary tract, gastrointestinal tract, cardiac space, etc.). The various valves of the treatment system 100 help prevent retrograde bleeding through the treatment system 100 during the dilation procedure using the dilator 500. As shown, the dilator 500 includes a dilator tip 502, a dilator body 504, and a hub end 506. The hub end 506 is configured to connect to the proximal portion of the treatment system 100 and can also help prevent the retraction of the dilator 500 when inserting the dilator 500 into the patient's body.

[0065] FIG. 3 is an enlarged partial cross-sectional view of the proximal portion of the treatment system 100 showing various features of the assembled proximal valve 200A. FIG. 4 is an isometric view of the same portion of the treatment system 100 as FIG. 3, but in a disassembled state. FIG. 5 is an end view of the treatment system 100 showing the pressurized and sealed proximal valve 200A according to several examples.

[0066] The proximal valve 200A is generally configured to receive an intraluminal device (e.g., an expander, an intravascular delivery system, a balloon catheter, a percutaneous delivery system, etc.) and provide a fluid seal around the outer surface of the intraluminal device to prevent unwanted (e.g., blood and / or treatment media) backflow around the intraluminal device and back through the lumen 101 of the treatment system 100. Further, the proximal valve 200A is configured to fully close or close and seal itself in a closed or sealed state (e.g., as shown in FIG. 5) when no intraluminal device is present. Again, this prevents unwanted (e.g., blood and / or treatment media) backflow through the proximal valve 200A. Suitable examples of the design, materials, and methods for making the proximal valve 200A, as well as the distal valve 200B (similar to the proximal valve 200A) and the distal sheath 400, can be found in U.S. Patent No. 10,155,104 entitled "Valve Assembly for Medical Treatment," although various designs, materials, and methods for making such valves are contemplated.

[0067] As can be seen in FIG. 3, the proximal valve 200A has a lumen 201A that extends the length of the proximal valve 200A. As previously referenced, the lumen 201A of the proximal valve 200A forms part of the lumen 101 of the treatment system 100. The proximal valve 200A includes a proximal seal mechanism 202A that is operable between a sealed state and a non-sealed state to open, close, or expand a portion of the lumen 201A. The proximal seal mechanism 202A includes an outer tube 204A, an inner tube 206A, a pressurizable space 208A (FIG. 3) formed between the inner surface of the outer tube 204A and the outer surface of the inner tube 206A, and a fill port 210A. As is apparent from the figure, note that the pressurizable space 208A is generally sealed, except for the access provided by the fill port 210A, according to various examples. As shown, the proximal seal mechanism 202A also includes a rear ring 218A and a front ring 220A that are fixed in a facing manner at opposite ends of the outer tube 204A. The rings generally assist in supporting, sealing, and coupling the proximal seal mechanism 202A to the remainder of the proximal valve 200A.

[0068] The proximal valve 200A also includes a rear fitting 224A attached to the rear ring 218A and a front fitting 226A attached to the front ring 220A (e.g., via complementary threads, adhesives, snap fits, fasteners, and / or other mechanisms). The rear and front fittings 224A, 226A can help to fix various portions of the proximal valve 200A together in a sealing manner and can also provide a mechanism or method for fixing the proximal valve 200A to other components of the treatment system 100, such as the treatment chamber 300. The rear fitting 224A can also be configured to be coupled to one or more portions of an intraluminal device, such as the hub end 506 (FIG. 1B).

[0069] In addition to the filling port 210A, the proximal valve 200A also has a treatment port 230A (also referred to as a flush port) that is in fluid communication with the lumen 201A of the proximal valve 200A at a distal position of the proximal seal mechanism 202A. As will be described later, the treatment port 230A can be used to deliver a treatment medium into the treatment chamber 300.

[0070] In some embodiments, the outer tube 204A has a relaxed hourglass shape, although a straight cylinder and other shapes are contemplated. The outer tube 204A has elastic properties (e.g., is formed from an elastomeric material) and can expand (physically expand) when the pressurizable space 208A is pressurized, radially outwardly deflecting from the hourglass shape to a more cylindrical state and potentially a more bulbous outwardly convex shape. In some examples, the outer tube 305A is formed from a silicone material (e.g., using insert molding techniques), although a variety of materials are contemplated, including any of a variety of elastomeric materials or materials having elastic properties. For example, the outer tube 204A can be composed of any elastomer, latex, or polycarbonate having desirable mechanical and biocompatible properties.

[0071] The expansion characteristics of the outer tube 204A can provide a visual indication that the pressurizable space 208A has been positively pressurized and thus the proximal valve 200A has been closed. In some examples, when the proximal seal mechanism 202A is positively pressurized and closed, the hourglass shape of the outer tube 204A expands to indicate a desired positive pressure within the pressurizable space 208A (e.g., a pressure sufficient to adequately prevent backflow through the proximal seal mechanism 202A).

[0072] The inner tube 206A can be constructed from a thin and strong drapeable material such as, for example, ePTFE, fabric, silk, or Kevlar® brand fibers. Such materials can be used, as appropriate, in a single-layer or multi-layer structure. As shown, the inner tube 206A can have an hourglass shape in a relaxed state. The shape of the inner tube 206A can be varied as desired, including wall thickness, length, width, diameter, and other characteristics.

[0073] In use, inner tube 206A is thin and compliant, such that when the pressurizable space 208A is positively pressurized, inner tube 206A flexes inwardly and drapes, conforming tightly to the outer periphery of the intraluminal device received through proximal valve 200A to form a seal. When no intraluminal device is present, inner tube 206A flexes inwardly such that the inner surface of inner tube 206A engages itself to form a seal.

[0074] As shown, fill port 210A includes coupling feature 211A associated with front ring 220A and passageway 212A formed through outer tube 204A and entering pressurizable space 208A. Coupling feature 211A is optionally configured to be attached to a syringe (e.g., coupling feature 211A can be configured as a luer fitting with a valve). Regardless of the particular pathway, fill port 210A provides means for pressurizing (or depressurizing) pressurizable space 208A. In particular, fill port 210A is in fluid communication with pressurizable space 208A.

[0075] Fill port 210A can be configured to couple to any of a variety of positive or negative pressure sources (fluids or gases), including a syringe (not shown). For reference, pressurizable space 208A can be filled with any suitable one or more materials. For example, in certain applications, a saline solution may be preferred, but pressurizable space 208A can be positively pressurized with one or more of air, silicone, water, saline solution, low volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foams, elastomeric spheres, crosslinked silicone gels, and combinations thereof.

[0076] Anyway, a pressure source can be used to deliver (positively pressurize) a suitable material (e.g., a salt solution) to the pressurizable space 208A, respectively, or to remove the material from the pressurizable space 208A (create a negative pressure or depressurize), causing the closing or opening of each of the proximal seal mechanisms 202A. In particular, according to various embodiments, when the pressurizable space 208A is positively pressurized using the filling port 210A, the inner tube 206A collapses inwardly (e.g., around itself or around a device received through the inner tube 206A) to form a seal. FIG. 5 shows an end view of the treatment system 100 in which the inner tube 206A of the proximal valve 200A is crushed under positive pressure conditions and engaged with itself.

[0077] The front fitting 226A is fixed to the front ring 220A and to the proximal portion of the treatment chamber 300 (e.g., via complementary threading as shown in FIG. 3), thus assisting in fluidly coupling the proximal valve 200A to the treatment chamber 300. The front fitting 226A or a portion thereof may be formed of a transparent material (e.g., a transparent or translucent polymer) that allows a user of the treatment system 100 to visually confirm that a device (or a portion thereof) inserted through the treatment system 100 is passing through the proximal valve 200A, particularly beyond the proximal seal mechanism 202A.

[0078] As shown, the treatment port 230A communicates with the lumen 201A at a distal position of the proximal seal mechanism 202A. The treatment port 230A includes a coupling feature 232A (e.g., a valved luer fitting for sealing and unsealing the treatment port 230A) and a passage 234A (e.g., at a position distal to the proximal seal mechanism 202A as shown) to the lumen 201A of the proximal valve 200A through the front fitting 226A. Regardless of the specific path, the treatment port 230A provides means for carrying treatment media to and / or from the lumen 201A of the proximal valve 200A (and to and / or from the proximal portion of the treatment chamber 300) as described below.

[0079] As shown in one or more of FIGS. 1A, 3, and 4, the treatment chamber 300 has a lumen 301 that forms part of the lumen 101 of the treatment system 100. The treatment chamber 300 includes a proximal coupling 310, a distal coupling 312, and a body 314 that extends between the proximal coupling 310 and the distal coupling 312. The proximal coupling 310 is configured to fix the treatment chamber 300 to the proximal valve 200A in a seal-like manner (e.g., via complementary threads), and the distal coupling 312 is similarly configured to fix the treatment chamber 300 to the distal valve 200B in a seal-like manner (e.g., via complementary threads). The body 314 is optionally hollow and tubular in configuration and sized (e.g., appropriate cross-section and length) to receive a desired portion of the intraluminal device disposed between the proximal valve 200A and the distal valve 200B. In particular, the treatment chamber 300 is fluidly coupled between the proximal valve 200A and the distal valve 200B to define a treatment space within the lumen 301 between the proximal valve 200A and the distal valve 200B. The treatment chamber 300 can be relatively rigid or relatively flexible, as desired. In some examples, the treatment chamber 300 or a portion thereof is partially or fully transparent to enable observation of the intraluminal device received within the treatment chamber 300.

[0080] As shown in FIG. 1A, the distal valve 200B can, according to various examples, be substantially similar in shape and function to the proximal valve 200A. Accordingly, the features of the distal valve 200B can be described collectively with the features of the proximal valve 200A. As shown in FIG. 1A, the proximal valve 200A and the distal valve 200B are substantially similar (although the distal valve 200B has a modified rear fitting 224B that is substantially similar to the front fitting 226A of the proximal valve 200A). Accordingly, when referring to the features of the distal valve 200B that correspond to the features of the proximal valve 200A, the same reference numbers are used for each, except that "B" comes instead of "A" for the corresponding features of the distal valve 200B.

[0081] According to some embodiments, similar to the proximal valve 200A, the distal valve 200B also has a lumen (not shown) that forms part of the lumen 101 of the treatment system 100. The distal valve 200B is also configured to receive an intraluminal device within the lumen of the distal valve 200B. And the distal valve 200B is also structured and operates similar to the proximal seal mechanism 202A, is operable between a sealed state and an unsealed state, and includes a distal seal mechanism 202B that opens, closes, or expands a portion of the lumen of the distal valve 200B.

[0082] The distal seal mechanism 202B includes an outer tube 204B, an inner tube (not shown), a pressurizable space (not shown) formed between the inner surface of the outer tube 204B and the outer surface of the inner tube, and a filling port 210B. The pressurizable space is generally sealed, except for the access provided by the filling port 210B, similar to various examples of the proximal seal mechanism 202A. As shown, the distal seal mechanism 202B also includes a rear ring 218A and a front ring 220B that are fixed opposite each other at both ends of the outer tube 204B. The rings 218A, 218B generally assist in supporting, sealing, and coupling the distal seal mechanism 202B to the rest of the distal valve 200B.

[0083] As shown, the distal valve 200B also includes a rear fitting 224B attached to the rear ring 218B and a front fitting 226B attached to the front ring 220B (e.g., via complementary threads, adhesives, snap fits, fasteners, and / or other mechanisms). The rear and front fittings 224B, 226B can help secure the various parts of the distal valve 200B together. As shown, the rear fitting 224B is effectively a mirror image of the front fitting 226B (and front fitting 226A). The rear fitting 224B provides a mechanism or method for securing the proximal valve 200A to the treatment chamber 300 in a manner similar to the front fitting 226A of the proximal valve 200A (e.g., via their respective complementary threads). Next, the front fitting 226B of the distal valve 200B is configured to be coupled to the distal sheath 400 (e.g., via their respective complementary threads).

[0084] In addition to the fill port 210B for actuating the distal seal mechanism 202B, the distal valve 200B also optionally has a treatment port 230B (also referred to as a flush port) that is in fluid communication with the lumen 201A of the proximal valve 200A at a proximal location of the distal seal mechanism 202B. The treatment port 230B includes a coupling feature 232B associated with the rear fitting 224B (e.g., a valved luer fitting for sealing and unsealing the treatment port 230A) and a passage (not shown) that passes through the rear fitting 224B and into the lumen of the distal valve 200B (e.g., at a proximal location of the distal seal mechanism 202B as shown). Regardless of the specific path, the treatment port 230B provides means for carrying treatment media into and / or out of the lumen of the distal valve 200B (and into and / or out of the distal portion of the treatment chamber 300). For example, as shown by the direction of the arrow in FIG. 10, the treatment media enters the lumen from the first treatment port 230A, passes through the lumen through the treatment chamber 300, and exits the lumen through the second treatment port 230B.

[0085] Furthermore, as shown, the distal valve 200B further includes a treatment port 240B (also described as a flush port) distal to the distal seal mechanism 202B that is in fluid communication with the lumen of the distal valve 200B. The treatment port 240B includes coupling features 242B associated with the front fitting 226B (e.g., a valved luer fitting for sealing and unsealing the treatment port 230A) and a passage (not shown) that passes through the front fitting 226B (e.g., at the distal position of the distal seal mechanism 202B as shown) and into the lumen of the distal valve 200B. Regardless of the particular path, the treatment port 240B provides means for carrying treatment media into and / or out of the lumen of the distal valve 200B (and into and / or out of the distal sheath 400).

[0086] As shown in FIG. 1A, the distal sheath 400 is coupled to the front fitting 226B of the distal valve 200B (e.g., via complementary threads on the two components). The distal sheath 400 is substantially tubular and has a lumen (not shown) that forms part of the lumen 101 of the treatment system 100. The distal sheath 400 can be formed from a variety of materials, but in some examples is formed from fluorinated ethylene propylene (FEP), high density polyethylene, and / or other suitable materials. The distal sheath 400 can be configured with an outer diameter in a range of various sizes, but in some examples is sized from 12Fr to 26Fr. The distal sheath 400 can optionally have any of a variety of lengths and can be configured to be inserted into a patient's body cavity (e.g., the vasculature) to assist in the introduction of an intraluminal device into the patient (not shown).

[0087] Figure 2A shows a treatment system 100 of another embodiment according to several examples. As shown, the distal valve 200B includes a filling port connector 250 and a treatment port connector 260. The filling port connector 250 fluidly connects the filling port 210B to the pressurizable space 208A to provide means for pressurizing (or depressurizing) the pressurizable space 208A. The treatment port connector 260 fluidly connects the treatment port 240B to the lumen of the distal valve 200B to provide means for transporting treatment media into and / or out of the lumen.

[0088] As shown, the filling port connector 250 of the distal valve 200B includes a rear fitting 224B attached to a rear ring 218B in which the filling port 210B is disposed. The filling port connector 250 also includes an outer tube 204B connected to a front ring 220B. The treatment port connector 260 includes a rear ring 218C that connects to the front ring 220B of the filling port connector 250. The treatment port connector 260 also includes an outer tube 204C and includes a front ring 220C that connects to a front fitting 226B in which the treatment port 240B is disposed. The connection can be achieved via, for example, complementary threads, adhesives, snap fits, fasteners, and / or other mechanisms.

[0089] The filling port connector 250 and the treatment port connector 260 can be formed separately and then connected or joined together to form the distal valve 200B. Further, other connectors can be attached between the filling port connector 250 and the treatment port connector 260, or more specifically, between the front ring 220B of the filling port connector 250 and the rear ring 218C of the treatment port connector 260. In some examples, an additional port connector 270, an additional port 210D, a rear ring 218D, a front ring 220D, an outer tube 204D, and a coupling feature 211D associated with the rear ring 218D as shown in FIG. 2B are implemented to introduce additional fluid into the treatment system 100. In such an embodiment, the rear ring 218D is connected to the front ring 220B and the front ring 220D is connected to the rear ring 218C. Any number of such additional port connectors 270 can be implemented in the distal valve 200B when appropriate.

[0090] By including one or more additional port connectors, it becomes possible to introduce different treatment media at different times for a more flexible treatment. For example, if a second treatment media is to be introduced at a specific time after the first treatment media, the first treatment media can be introduced via the first treatment port (e.g., 210B) and then, when the time comes to introduce the second treatment media, this can be done using the second treatment port (e.g., 210D). The two treatment media can be any of the foregoing examples such as a saline solution, carbon dioxide, a perfluorocarbon solution, methylene blue, etc. Each coupling feature can be attached to a syringe or other delivery device containing a different treatment media. In some examples, having multiple treatment ports can help eliminate the need to switch different delivery devices when changing from one treatment media to another.

[0091] Treatment system 100 can be utilized with various types of intraluminal devices, including the examples shown in FIGS. 6 - 9, all of which are generically referred to by reference numeral 600 (except for the expander 500 shown in FIG. 1B. The expander 500 is also an intraluminal device).

[0092] FIG. 6 shows an intraluminal device 600 in the form of a transcatheter delivery system that includes a catheter and an implantable device maintained in a delivery diameter or state compacted by a delivery catheter. The implantable device defines a treatment portion or a part of the intraluminal device 600 where the treatment is performed. In particular, the intraluminal device 600 of FIG. 6 includes an artificial valve 610V (e.g., an artificial heart valve) maintained in a radially compacted state by a delivery catheter 620V. As shown, the delivery catheter 620V employs a fiber restraint delivery system as described in U.S. Patent Application No. 16 / 129,657, titled "Transcatheter Deployment System and Related Methods," filed on September 12, 2018. The artificial valve 610V can transition between a fully compacted delivery diameter or state, a partially compacted treatment diameter (e.g., as shown in FIG. 6), and a fully expanded and deployed diameter using a delivery catheter 620V that tightens and loosens a restraint body 630V releasably coupled to the artificial valve 610V.

[0093] FIG. 7A shows an intraluminal device 600 in the form of a transcatheter delivery system that includes a catheter and an implantable device maintained in a compacted delivery diameter or state by a delivery catheter. The implantable device is included in a treatment portion, or a part of the intraluminal device 600 where treatment is performed. In particular, the intraluminal device 600 of FIG. 7A includes a septal occluder 610S (e.g., atrial septal occluder) maintained in a state compacted in the diametric direction by a delivery catheter 620S. As shown, the delivery catheter 620S employs a sheath or tube restraint delivery system as described in U.S. Patent No. 8,956,389, entitled "Sealing Device and Delivery System." The septal occluder 610S can be transitioned between a fully compacted delivery diameter or state, a partially compacted treatment diameter, and a fully expanded and deployed diameter (e.g., as shown in FIG. 7A) using a delivery catheter 620S that extends and retracts the septal occluder 610S from the sheath or using a tube 630S associated with the delivery catheter 620S.

[0094] FIG. 7B shows an intraluminal device 600 in the form of a transcatheter delivery system that includes a catheter and an implantable device maintained in a delivery diameter or state compacted by a delivery catheter. The implantable device is included in a treatment portion, or a part of the intraluminal device 600 where the treatment is performed. In particular, the intraluminal device 600 of FIG. 7B includes an occluder 610L (e.g., a left atrial appendage occluder) maintained by a delivery catheter 620L. As shown, the delivery catheter 620L employs a sheath or tube restraint delivery system as described in PCT Publication No. WO2016 / 183495 of the invention entitled "Device and Method for Occlusion of the Atrial Appendage". The occluder 610L can be transitioned between a fully compacted delivery diameter or state, a partially compacted treatment diameter, and a fully expanded and deployed diameter (e.g., as shown in FIG. 7B) using a delivery catheter 620L that extends and contracts the occluder 610L from the sheath, or a tube 630L associated with the delivery catheter 620L.

[0095] Figures 8 and 9 show an intraluminal device 600 in the form of a transcatheter delivery system that includes a catheter and an implantable device maintained in a delivery diameter or state compacted by a delivery catheter. The implantable device defines a treatment portion or a part of the intraluminal device 600 where the treatment is performed. In particular, the intraluminal device 600 of FIGS. 8 and 9 includes an endoprosthesis 610E (e.g., a stent graft) maintained in a state compacted in the diameter direction by a delivery catheter 620E. As shown, the delivery catheter 620E employs a retention sleeve restraint delivery system as described in U.S. Patent No. 9,592,143, titled "Sleeve for Expandable Medical Devices." The endoprosthesis 610E can be transitioned between a fully compacted delivery diameter or state (e.g., as shown in FIGS. 8 and 9) and a fully expanded and deployed diameter using the delivery catheter 620E that releases a retention sleeve 630E to deploy the endoprosthesis 610E carried by the delivery catheter 620E.

[0096] As will be described in more detail, some methods of treating an intraluminal device for introduction into a patient's body include placing the intraluminal device within a treatment system 100, closing proximal valve 200A and distal valve 200B to seal proximal valve 200A against a first portion of the intraluminal device and distal valve 200B against a second portion of the intraluminal device, and delivering a treatment medium to a treatment space to expose a part of the intraluminal device being treated or the treatment portion of the intraluminal device to the treatment medium.

[0097] In some examples, the treatment portion of the intraluminal device includes an implantable device maintained by a delivery catheter. The treatment portion of the intraluminal device can include the proximal portion of the implantable device, and the distal portion of the intraluminal device extends from the distal valve. In various examples, when delivering a treatment medium to the treatment space, air is pushed out from the treatment portion of the intraluminal device. In particular, when delivering the treatment medium to the treatment space through at least one of a proximal treatment portion in fluid communication with the proximal portion of the treatment chamber and a distal treatment portion in fluid communication with the distal portion of the treatment chamber, air trapped from a part of the intraluminal device (e.g., an implantable device) is pushed out.

[0098] In some examples, the treatment medium exits the treatment chamber 300 through a treatment port 230B that is in fluid communication with the distal portion of the treatment chamber 300. The intraluminal device can include a retention sleeve that maintains the implantable device in a compacted delivery state, and the distal valve can be closed on the sleeve, such that the treatment medium exits the treatment chamber 300 from the distal valve 200B through one or more gaps between the sleeve and the implantable device. Some methods also include inserting an introducer sheath into the patient's body cavity before, during, or after intraluminal device treatment.

[0099] FIG. 10 is an enlarged partial view of a related luminal device received by a treatment system according to a method of treating a portion of the treatment system of FIG. 1A and a luminal device, according to some embodiments. The luminal device 600, which includes an implantable device 610 carried by a delivery catheter 620, is generally represented by a dashed box to show the relative positions of the components in a schematic manner. In other words, the relative positions of the generalized components of the luminal device 600 are superimposed on the treatment system 100 for visualization purposes. In some examples, the delivery catheter 620 has a longitudinally collapsible configuration. For example, a portion of the delivery catheter 620 can include a plurality of wrinkles, folds, or pleats similar to an accordion bellows such that when a longitudinal force is applied, the pleats collapse to shorten the length of the delivery catheter 620. In some examples, the delivery catheter 620 can be separable by breaking or splitting. In some examples, a row of apertures or perforations can be formed along at least a portion of the length of the delivery catheter 620 such that when sufficient radial force is applied to the delivery catheter 620, the surface of the delivery catheter 620 is torn, disengaging the delivery catheter 620 from the luminal device 600.

[0100] In some examples, the distal sheath 400 is inserted into the patient's body, e.g., the patient's vasculature, with the aid of the dilator 500. The dilator 500 is detached from the treatment system 100, and the intraluminal device 600 is advanced into the treatment system 100. The implantable device 610 is positioned within the treatment chamber 300 between the proximal seal mechanism 202A and the distal seal mechanism 202B. The proximal valve 200A is pressurized and closed to form a seal around the intraluminal device 600, and the distal seal mechanism is pressurized and closed to form a seal. In this manner, the implantable device 610 (e.g., a stent graft or prosthetic valve) is positioned within the sealed treatment space between the proximal valve 200A and the distal valve 200B. In an example where a portion of the treatment system 100 (e.g., a portion of the proximal valve 200A and the distal valve 200B, and / or the treatment chamber 300) is transparent, the user can visually confirm proper positioning. It should be noted that the distal sheath 400 is placed within the patient's body only in some embodiments prior to device treatment, and in other embodiments, the treatment is performed prior to insertion of the treatment system 100.

[0101] Regardless, with both the proximal valve 200A in a closed or sealed state around the intraluminal device 600, particularly the delivery catheter 620, and the distal valve 200B in a closed or sealed state, the treatment medium is delivered to the treatment space of the treatment chamber 300 using the treatment ports 230A, 230B. For example, a pressure source (e.g., a pressure reservoir such as a syringe or pressurized gas source) is attached to each of the treatment ports 230A, 230B, and the treatment medium (e.g., saline solution, carbon dioxide, perfluorocarbon solution, methylene blue, etc.) is delivered into the treatment chamber 300. The treatment medium can be "pushed" into the treatment chamber 300 via positive pressure through the treatment port 230A and "pulled" into the treatment chamber 300 via negative pressure through the treatment port 230B, and vice versa. Alternatively, only positive or negative pressure can be applied through one of the treatment ports 230A, 230B to introduce the treatment medium into the treatment chamber 300.

[0102] The implantable device 610 can be treated in a partially or fully expanded state if the treatment chamber 300 is of an appropriate size (e.g., a sufficient diameter) and the user so desires. Treating the implantable device 610 in a partially or fully expanded state may be advantageous (assuming that the delivery catheter 620 and associated retention mechanism can reverse the expansion or that reverse expansion is not required). This is because more of the device surface is accessible during device treatment, which can speed up and improve the treatment effect.

[0103] In some examples, when the implantable device 610 is treated as desired (e.g., flushed with air, moistened or treated in other ways), the treatment port 240B (FIG. 1A) can be opened and blood can be drawn into the distal sheath 400 (e.g., by attaching a syringe and applying negative pressure through the treatment port 240B). When the distal sheath 400 is filled with blood, the distal valve 200B can be opened or released to fill the treatment chamber 300 and associated treatment space with blood. Next, the implantable device 610 can be tracked to a desired location within the body by advancing the implantable device 610 through and out of the distal sheath 400 of the treatment system 100 (e.g., by tracking the implantable device 610 over a guide wire).

[0104] FIG. 11A is an enlarged partial view of a portion of the treatment system of FIG. 1A, and the intraluminal device 600 is in a treatment position adjusted relative to the position shown in FIG. 10 by other means of treating the intraluminal device 600.

[0105] In the example of FIG. 11A, the procedure will typically be performed before inserting the distal sheath 400 into the patient's body. In some examples, the distal end of the distal sheath 400 may be trimmed (e.g., pre-cut) or may be of full length. As shown in FIG. 11A, the distal sheath 400 is shortened or trimmed, but such trimming is not required. Further, the distal end of the distal sheath 400 is generally capped with the cap member 410 shown in FIG. 11A or sealed in some other way. The cap member 410 can be a threaded dead head cap, a plug, or other instrument, or the end can be manually sealed with the user's thumb functioning as the cap member 410.

[0106] In some examples, the cap member 410 can be replaced with a clamp, plug or other sealing member. For example, a hose clamp or any other suitable vascular clamp (e.g., a "Kelly" clamp) can be used to pinch the distal end of the distal sheath 400 (e.g., the distal sheath 400 is formed from a flexible tubing material). In any case, the seal at the distal end can be temporary or permanent as appropriate. In some examples, the distal ends 414 of the tubes 412 can be joined together (e.g., at least partially flattened, sealed and closed to form a "duckbill" configuration as shown in FIG. 11B). In some examples, the distal ends of the tubes can be heated and / or then closed, crushed or sealed together in any suitable configuration to form a seal at the distal ends of the tubes.

[0107] In the example of FIG. 11C, the cap member 410 includes a frangible seal 416 at the distal end of the cap member 410. The frangible seal 416 is manually broken, torn, or punctured by pressing the intraluminal device 600 or other instrument against the frangible seal 416. The frangible seal 416 can be a membrane or film (e.g., a self-healing membrane) made of a polymeric material. Including the seal can help ensure that the implantable device 610 does not come into contact with the environment (e.g., ambient air) after the procedure in the treatment chamber. In particular, before breaking the frangible seal 416, the distal sheath 400 can be coupled to an introducer sheath, valve, or other device for direct insertion into the patient.

[0108] As shown, the intraluminal device 600 is advanced into the treatment chamber 300, the implantable device 610 is positioned at the distal valve 200B, and either end or end portion of the implantable device 610 is at either end of the distal seal mechanism 202B. In an example where a portion of the treatment system 100 (e.g., a portion of the proximal valve 200A and distal valve 200B, and / or the treatment chamber 300) is transparent, the user can visually confirm the proper positioning of the implantable device 610.

[0109] In the example of FIG. 11A, the treatment space extends within the distal sheath 400 and includes the capped distal sheath 400. Thus, it can be said that the distal sheath 400 acts as an alternative or additional treatment chamber. When each of the proximal valve 200A and the distal valve 200B is pressurized and closed to form a seal around the intraluminal device 600, the treatment medium is delivered to the treatment space of the distal sheath 400 using the treatment port 240B, as indicated by the solid arrow "A". For example, a pressure source (e.g., a pressurized gas source or a pressure reservoir such as a syringe) is attached to the treatment port 240B, and a treatment medium (e.g., carbon dioxide, saline solution, perfluorocarbon solution, methylene blue, etc.) is delivered into the distal sheath 400. When sufficient backpressure is applied, the pressurized treatment medium passes through the creases, wrinkles or gaps that exist in the implantable device 610 or between the implantable device and a holding mechanism (e.g., not shown, such as a holding sleeve). Next, the pressurized treatment medium passes through the closed distal valve 200B and "passes" through the gap and enters the processing chamber 300 and exits from one or both of the treatment ports 230A, 230B as desired, as indicated by the dashed arrows "B" and "C".

[0110] Such a process can be particularly advantageous for pushing trapped air out of the implantable device 610 and / or from the creases, wrinkles or gaps that exist between the implantable device 610 and any associated holding mechanism (e.g., not shown, such as a holding sleeve). It is less likely that the treatment medium simply passes around the implantable device 610 and the holding mechanism. Instead, it can be particularly useful that the distal valve 200B is closed at the outer periphery of the implantable device 610 and any associated holding mechanism (not shown) when the air-trapping gaps, creases, wrinkles and spaces are passed through.

[0111] It should be understood that retrograde flow of the treatment medium can also be effectively applied in the situation of FIG. 11A. In other words, positive pressure can be applied through one or both of the treatment ports 230A, 230B, and the treatment medium is pushed from the treatment chamber 300, through the implantable device 610, across the closed distal valve 200B, into the capped distal sheath 400, and out through the treatment port 240B. Alternatively, the cap member 410 can be omitted, and the treatment medium can simply pass from the end of the distal sheath 400 as desired. In the example described in connection with FIG. 11A, the implantable device 610 is generally treated in a fully compacted state, although not necessarily in all cases when the distal valve 200B is sealed on the implantable device 610.

[0112] In various examples, when the implantable device 610 is treated as desired (e.g., flushed with air, moistened, or treated in other ways), the treatment system 100 can be introduced into the patient's body, and the delivery of the implantable device 610 can proceed in a manner similar to that described above.

[0113] FIG. 12A is a partial enlarged view of another treatment system 100 that can be a delivery system according to some embodiments, and a related intraluminal device 600 received by the treatment system 100 according to a method of treating the intraluminal device 600. As shown in FIG. 12A, the proximal valve 200A is omitted from the treatment system 100, and a single valve 200 that is substantially similar to the proximal valve 200A and the distal valve 200B is selected. Thus, the valve 200 includes generally the same features as the features of the proximal valve 200A and / or the distal valve 200B, and the features of the valve 200 are referred to by the same reference numbers as the features of the proximal valve 200A and the distal valve 200B, except that "A" or "B" does not follow these reference numbers.

[0114] A single valve is used, and the method can be similar to that described above with reference to FIG. 11A according to various examples. As shown in FIG. 12A, the distal sheath 400 functions as a treatment chamber, or may be referred to as a treatment chamber.

[0115] In the example of FIG. 12A, the treatment is typically performed, although not in all cases, before inserting the distal sheath 400 into the patient's body. In some examples, the distal end of the distal sheath 400 may be trimmed (e.g., pre-cut) or may be of full length. As shown in FIG. 12A, the distal sheath 400 is shortened or trimmed. Further, the distal end of the distal sheath 400 is generally capped or sealed in some other way with the cap member 410 shown in FIG. 12A. The cap member 410 can be a threaded dead head cap, a plug, or some other instrument such as the user's thumb, and is generally shown in FIG. 12A. In each of the above examples, when using the user's finger or thumb to seal the distal sheath 400 (also described as the treatment chamber), it may be referred to as digitally sealing the distal sheath 400 (or treatment chamber). In some examples, the cap member 410 can be replaced with a clamp, a plug, or some other sealing member. For example, a hose clamp or any other suitable vascular clamp (e.g., a "Cooley" clamp) can be used to pinch the distal end of the distal sheath 400 (e.g., the distal sheath 400 is formed from a flexible tubing material). Anyway, the seal at the distal end can be temporary or permanent as appropriate. In some examples, the distal ends 414 of the tubes 412 can be joined together (e.g., at least partially flattened, sealed, and closed to form a "duckbill" configuration as shown in FIG. 11B). In some examples, the distal end of the tube can be heated and then sealed, crushed, or sealed together in any suitable configuration to form a seal at the distal end of the tube.

[0116] As shown, the intraluminal device 600 is advanced into the seal mechanism 202 of the valve 200, and either end of the implantable device 610 is at either end of the seal mechanism 202. In an example where a portion of the treatment system 100 (such as a portion of the valve 200 like the front fitting 226) is transparent, the user can visually confirm the proper positioning of the implantable device 610.

[0117] As shown, the distal portion of the implantable device 610 is disposed within the treatment space defined by the distal sheath 400. Thus, in the example of FIG. 12A, the treatment space extends and includes the capped distal sheath 400. When the valve 200 is pressurized and closed to form a seal around the intraluminal device 600, the treatment medium is delivered through the treatment port 240 to the treatment space as defined by the distal sheath 400 that functions as a treatment chamber. For example, a pressure source (such as a pressurized gas source or a pressure reservoir like a syringe) is attached to the treatment port 240, and the treatment medium (such as carbon dioxide, saline solution, perfluorocarbon solution, methylene blue, etc.) is delivered to the distal sheath 400 that functions as a treatment chamber. When sufficient backpressure is applied, the pressurized treatment medium is forced through creases, wrinkles, or gaps that exist within the implantable device 610 or between the implantable device and any associated retention mechanism (such as, although not shown, a retention sleeve). Next, the pressurized treatment medium passes through the gap "through" the closed valve 200 and exits from the other end of the implantable device 610 and / or the associated retention mechanism (such as, although not shown, a retention sleeve disposed around the implantable device 610). The direction of the flow of the pressurized treatment medium is indicated by the arrows in FIG. 12A.

[0118] The treatment medium has a low tendency to simply pass around the implantable device 610 and the retention mechanism. Instead, when passing through gaps, folds, wrinkles, and spaces where air may be trapped, it can be particularly useful for the valve 200 to close at the outer periphery of the implantable device 610 and any associated retention mechanism.

[0119] In various examples, when the implantable device 610 is treated as desired (e.g., air flushing, wetting, or other methods), the treatment system 100 is introduced into the patient's body, and the delivery of the implantable device 610 can proceed in a manner similar to that described above.

[0120] FIG. 12B shows additional or alternative features of the treatment system 100 according to FIG. 12A, particularly potential modifications of the distal sheath 400, according to various examples. As shown in FIG. 12B, the distal sheath 400 functions as a treatment chamber and may also be referred to as a treatment chamber. As shown, the distal sheath 400 can include a plurality of sections, such as a first section 400A, a second section 400B, and a third section 400C. Each section of the distal sheath 400 can be configured to be removably coupled to another section and / or the valve 200. In this way, the user of the treatment system 100 can use one or more of the first section 400A, the second section 400B, and the third section 400C as desired and select the length of the distal sheath 400. Coupling mechanisms, such as male and female threaded ends, can be used between sections, such as the distal end 414A of the first section 400A and / or the distal end 414B of the second section 414B. Although three sections are shown, fewer (e.g., two) or more (e.g., three, more than four, or any number as needed) can be implemented to achieve the desired degree of adjustability.

[0121] As a further feature, as shown in FIG. 12C, the sections can have a "separable" connection therebetween (e.g., a scribe line or weakened area between the sections), such that one or more of the sections are configured to be manually removed. Alternatively, the sections can simply be cut using scissors or a knife and then optionally capped or clamped. FIG. 12C shows additional or alternative features of the treatment system 100 according to FIG. 12A, particularly potential modifications of the distal sheath 400, according to various examples. As shown in FIG. 12C, the distal sheath 400 functions as a treatment chamber and may also be referred to as a treatment chamber. As shown, the distal sheath 400 can include a plurality of sections such as a first section 400A, a second section 400B, and a third section 400C. Each section of the distal sheath 400 can be removably coupled to another section and / or the valve 200 by a breakable connection (e.g., a cut or other weakened portion) that can separate the respective first section 400A, second section 400B, and third section 400C. In this way, a user of the treatment system 100 can remove one or more of the third section 400C and the second section 400B, as desired, to select the length of the distal sheath 400. Although three sections are shown, fewer (e.g., two) or more (e.g., three, more than four, or any number as desired) can be implemented to achieve the desired degree of adjustability.

[0122] As a further feature, as shown in FIG. 12D, the distal sheath 400 can include one or more longitudinally divisible features 411 in the form of a longitudinal score line, a frangible section, or a weakened area to enable the distal sheath to be torn, cut, separated, or otherwise removed (e.g., from around a luminal device 600 (not shown)). During use, an operator (not shown) can cut, tear, or otherwise divide the distal sheath 400 along the longitudinally divisible feature 411 to separate and optionally remove the distal sheath 400. Although relatively straight longitudinally divisible features are shown, helically oriented features are also contemplated.

[0123] As a further feature, as shown in FIG. 12E, the distal sheath 400 can have a threaded or other removable coupling feature and can be provided as part of a kit with various distal sheaths (not shown) of different lengths. In such an example, a user (not shown) can simply select a distal sheath 400 of the desired length and removably attach the distal sheath 400 to the valve 200.

[0124] As a further feature, as shown in FIG. 12F, the distal sheath 400 can be collapsible longitudinally (e.g., like an accordion) to shorten or extend the length of the distal sheath 400. For reference, FIG. 12F shows the distal sheath 400 in a dashed extended state and a solid line longitudinally collapsed state with accordion wrinkles or folds 411a. In some examples, the distal sheath 400 is length adjustable at any of a variety of desired lengths by longitudinally compressing or extending the distal sheath 400.

[0125] As a further feature, as shown in FIG. 12G, the distal sheath 400 can be longitudinally collapsible (e.g., like a helically wound member) by twisting the distal sheath 400 to shorten its overall length. In some examples, the distal sheath 400 includes a helical wrap or layered assembly that can be twisted while it is sealed to cause relative movement of the helical wrap or layer 411B to shorten or extend the length of the distal sheath 400. In some examples, the distal sheath 400 is length-adjustable to any of a variety of desired lengths by longitudinally compressing or stretching the distal sheath 400 by twisting the distal sheath 400 in an appropriate direction.

[0126] FIGS. 13 - 24 illustrate examples of treatment sequences of an intraluminal device using the treatment system of FIG. 12A according to some embodiments. As shown in FIG. 13, an inflation media source (IMS) and a treatment media source (TMS) are each coupled to a filling port 210 and a treatment port 240 of a valve 200, respectively. The inflation media source (IMS) can be a syringe filled with an inflation media (e.g., a saline solution) for pressurizing and depressurizing the valve 200 to open and close the valve 200. The treatment media source (TMS) can optionally be a syringe filled with any of the treatment media described above.

[0127] FIG. 14 shows a container 1000 (e.g., a packing tray in which an intraluminal device 600 is maintained in a sterile environment before use) having a pocket 1010 that can deliver a treatment media (e.g., a sterile liquid). As shown, a sterile saline solution is being delivered to the pocket 1010 as part of the treatment sequence.

[0128] FIG. 15 shows an intraluminal device 600 (e.g., in the form of a catheter-based delivery system including a catheter and an implantable device maintained in a compacted delivery diameter or state by a delivery catheter) immediately prior to being introduced into the valve 200 of the treatment system 100.

[0129] Figure 16 shows the intraluminal device 600 introduced into the valve 200 with a portion of the implantable device 610 within the distal sheath 400 and a portion protruding from the valve 200, such that the implantable device 610 extends partially from the valve 200. The valve 200 is pressurized using an inflation media source (IMS) (Figure 13) to transition the valve 200 to a pressurized closed state, such that the valve 200 closes over the implantable device 610.

[0130] Figure 17 shows a treatment media source (TMS) coupled to the treatment port 240 and ready to be pressurized (e.g., manually, by the user pushing a syringe plunger). Figure 18 shows the treatment media source (TMS) pressurized and the distal sheath 400 open at the distal end 414. As shown, the distal sheath 400 is being purged with treatment media passing through the distal end 414. The intraluminal device 600 can also be purged at this stage, and the treatment media passes through the lumen (not shown) of the intraluminal device 600.

[0131] Figure 19 shows the intraluminal device 600 operating to seal or otherwise close the lumen of the intraluminal device 600 (e.g., by closing the handle portion valve (e.g., a luer fitting) shown in Figure 19).

[0132] Figure 20 shows the distal sheath 400 sealed (e.g., by the user placing a thumb on the distal end 414), the treatment media source (TMS) pressurized to push treatment media into the distal sheath 400, and then through the implantable device 610 and through the valve 200 (e.g., between the outer sleeve of the implantable device 610 and the body of the implantable device 610) to treat the implantable device 610 (e.g., flush air from the implantable device 610). In this step, some treatment media can pass through the implantable device 610 proximal to the valve 200. Figure 21 is an enlarged view around the valve 200 for additional visualization.

[0133] FIG. 22 shows the lumen of the flushed intraluminal device 600. For example, the handle portion valve can be opened, the treatment media source (TMS) can be pressurized, and the treatment media can pass through the intraluminal device 600 to flush the lumen of the intraluminal device 600.

[0134] FIG. 23 shows that the valve 200 is open (e.g., by depressurizing the valve 200 using the fill port 210) and the intraluminal device 600 has been removed from the treatment system 100. FIG. 24 shows the intraluminal device 600, particularly the implantable device 610, which is then disposed within a pocket 1010 that receives a treatment media (e.g., a sterilizing liquid). In this optional step, the currently processed implantable device 610 is substantially prevented from reabsorbing air. In other words, the effectiveness of the treatment (e.g., the flush) is substantially preserved by placing the implantable device 610 within a treatment media such as a sterilizing saline solution.

[0135] Various features are specifically described in connection with some examples and not in connection with other examples. However, it is not intended to exclude combinations of features between the examples. Instead, such combinations are specifically contemplated and form part of the present disclosure. The inventive concepts of the present disclosure have been described generally and with respect to specific embodiments. It will be apparent to those skilled in the art that various changes and modifications can be made in the embodiments without departing from the scope of the present disclosure. Accordingly, the embodiments are intended to cover the changes and modifications of the present invention so long as they fall within the scope of the appended claims and their equivalents. (Aspect) (Aspect 1) A proximal valve configured to receive an intraluminal device, the proximal valve including a proximal seal mechanism operable between a sealed state and an unsealed state to seal around the intraluminal device. A distal valve configured to receive an intraluminal device, the distal valve including a distal sealing mechanism operable between a sealed state and a non-sealed state around the intraluminal device, and, A treatment chamber configured to receive a portion of the intraluminal device extending between the proximal valve and the distal valve, the treatment chamber being fluidly coupled between the proximal valve and the distal valve to define a treatment space between the proximal valve and the distal valve, A treatment system for an intraluminal device, including. (Aspect 2) One or both of the proximal sealing mechanism and the distal sealing mechanism includes an outer tube, an inner tube, and a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube, and the pressurizable space is pressurizable to conform the inner tube around the intraluminal device to form a seal around the intraluminal device, the system according to Aspect 1. (Aspect 3) The inner tube is formed of a compliant material, the system according to Aspect 2. (Aspect 4) The compliant material includes one or more of ePTFE (expanded polytetrafluoroethylene), silk, and polyparaphenylene terephthalamide, the system according to Aspect 3. (Aspect 5) The outer tube is formed of an elastomeric material, the system according to any one of Aspects 2 to 4. (Aspect 6) The elastomeric material includes silicone, the system according to Aspect 5. (Aspect 7) The system according to any one of the preceding aspects, further including an introducer sheath extending distally from the distal valve. (Aspect 8) The treatment chamber has a proximal portion adjacent to the proximal valve and a distal portion adjacent to the distal valve, and the treatment system further includes a proximal treatment port in fluid communication with the proximal portion of the treatment chamber and a distal treatment port in fluid communication with the distal portion of the treatment chamber. The system according to any one of the preceding aspects. (Aspect 9) Each of the proximal treatment port and the distal treatment port includes a valve for fluidly sealing and unsealing the proximal treatment portion and the distal treatment portion, respectively. The system according to aspect 8. (Aspect 10) The intraluminal device includes a catheter and an implantable device maintained in a compacted delivery diameter or state. The system is a transcatheter delivery system, and further, the treatment chamber is configured to receive an implantable device in a compacted delivery diameter or state. The system according to any one of the preceding aspects. (Aspect 11) The intraluminal device includes a catheter and an implantable device maintained in a compacted delivery diameter or state by a delivery catheter. The system is a transcatheter delivery system, and further, the treatment chamber is configured to receive an implantable device with an intermediate partially expanded diameter larger than the compacted delivery diameter. The system according to any one of the preceding aspects. (Aspect 12) A method of treating an intraluminal device for introduction into a patient's body, the method comprising: placing the intraluminal device within a treatment system, where the treatment system includes a proximal valve, a distal valve, and a treatment chamber defining a treatment space between the proximal valve and the distal valve, and the intraluminal device includes a first portion extending through the proximal valve, a second portion extending through the distal valve, and a treatment portion extending through the treatment space of the treatment chamber. Closing the proximal valve and the distal valve to seal the proximal valve against the first portion of the intraluminal device and the distal valve against the second portion of the intraluminal device, and Delivering a treatment medium to the treatment space to expose the treatment portion of the intraluminal device to the treatment medium, A method comprising. (Aspect 13) The method according to aspect 12, wherein the treatment portion of the intraluminal device comprises an implantable device maintained by a delivery catheter. (Aspect 14) The method according to aspect 12, wherein the treatment portion of the intraluminal device comprises a proximal portion of the implantable device, and the distal portion of the intraluminal device extends from the distal valve. (Aspect 15) The method according to any one of aspects 12 to 14, wherein the treatment medium is selected from one or more of a saline solution, carbon dioxide, a perfluorocarbon solution, methylene blue, and combinations thereof. (Aspect 16) The method according to any one of aspects 12 to 15, wherein when the treatment medium is delivered to the treatment space, air is pushed out from the treatment portion of the intraluminal device. (Aspect 17) The method according to any one of aspects 12 to 16, further comprising delivering the treatment medium to the treatment space through at least one of a proximal treatment portion in fluid communication with the proximal portion of the treatment chamber and a distal treatment portion in fluid communication with the distal portion of the treatment chamber. (Aspect 18) The method according to any one of aspects 12 to 17, wherein the treatment medium exits the treatment chamber through a distal treatment port in fluid communication with the distal portion of the treatment chamber. (Aspect 19) The intraluminal device includes a sleeve that maintains the implantable device in a compacted delivery state, and further, the distal valve is closed on the sleeve, and the treatment medium exits the treatment chamber from the distal valve through one or more gaps between the sleeve and the implantable device, according to any one of aspects 12 to 17. (Aspect 20) The treatment system includes an introducer sheath, and the method further includes inserting the introducer sheath into a body cavity of a patient, according to any one of aspects 12 to 19. (Aspect 21) The treatment medium is delivered to the treatment space with the introducer sheath inserted into the body cavity of the patient, according to aspect 20. (Aspect 22) A method of treating an intraluminal device for introduction into a patient's body, the method comprising: placing the intraluminal device within a treatment system, where the treatment system includes a valve and a treatment chamber extending from the valve, and the intraluminal device includes a first portion extending through the valve and a treatment portion extending within a treatment space of the treatment chamber; closing the valve to seal the valve against the first portion of the intraluminal device; sealing the treatment chamber; and delivering a treatment medium to a treatment space within the treatment chamber to expose the treatment portion of the intraluminal device to the treatment medium. A method comprising the above steps. (Aspect 23) The treatment chamber is sealed with a cap member, according to aspect 22. (Aspect 24) The method according to aspect 22 further includes adjusting the length of the treatment chamber. (Aspect 25) The treatment chamber is digitally sealed by a user, according to aspect 24. (Aspect 26) The intraluminal device according to any one of aspects 22 to 25, wherein the intraluminal device includes a sleeve that maintains the implantable device in a compacted delivery state, the valve is closed on the sleeve, and the treatment medium exits the treatment chamber through the valve through one or more gaps between the sleeve and the implantable device.

Claims

1. A proximal valve configured to receive an intraluminal device, the proximal valve including a proximal sealing mechanism operable between a sealed state and a non-sealed state, A distal valve configured to receive an intraluminal device, the distal valve including a distal sealing mechanism operable between a sealed state and a non-sealed state, and, A treatment chamber configured to receive a portion of the intraluminal device extending between the proximal valve and the distal valve, the treatment chamber being fluidly coupled between the proximal valve and the distal valve to define a treatment space between the proximal valve and the distal valve, Including, the intraluminal device includes a sleeve that maintains at least a portion of the intraluminal device in a compacted delivery state, and the sleeve extends through the distal valve in the sealed state, a treatment system for the intraluminal device.

2. One or both of the proximal sealing mechanism and the distal sealing mechanism includes an outer tube, an inner tube, and a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube, and the pressurizable space is configured to pressurize the inner tube to conform around the intraluminal device and form a seal around the intraluminal device, The system of claim 1.

3. The inner tube is formed of a compliant material, The system of claim 2.

4. The compliant material includes one or more of ePTFE (expanded polytetrafluoroethylene), silk, and polyparaphenylene terephthalamide, The system of claim 3.

5. The outer tube is formed of an elastomeric material, The system of any one of claims 2 to 4.

6. The elastomeric material includes silicone, The system of claim 5.

7. Further including an introducer sheath extending distally from the distal valve, The system of any one of claims 1 to 6.

8. The treatment chamber has a proximal portion adjacent to the proximal valve and a distal portion adjacent to the distal valve, the treatment system further including a proximal treatment port in fluid communication with the proximal portion of the treatment chamber, and a distal treatment port in fluid communication with the distal portion of the treatment chamber, The system of any one of claims 1 to 7.

9. The system according to claim 8, wherein each of the proximal placement port and the distal placement port includes a valve for fluidly sealing and unsealing the proximal placement portion and the distal placement portion, respectively.

10. The intraluminal device is a transcatheter delivery system including a catheter and an implantable device maintained in a compacted delivery diameter or state, and further, the treatment chamber is configured to receive an implantable device in a compacted delivery diameter or state. The system according to any one of claims 1 to 9.

11. The intraluminal device is a transcatheter delivery system including a catheter and an implantable device maintained in a compacted delivery diameter or state by a delivery catheter, and further, the treatment chamber is configured to receive an implantable device with an intermediate partially expanded diameter larger than the compacted delivery diameter. The system according to any one of claims 1 to 10.

12. The system according to claim 10 or 11, wherein the intraluminal device is held in a compacted delivery state by a holding sleeve, and the intraluminal device is received in the treatment chamber in the compacted delivery state.

13. The system according to claim 12, wherein the distal valve is closed on the holding sleeve, so that the treatment medium flows through one or more gaps between the holding sleeve and the implantable device and through the distal valve.

14. The system according to claim 1, further including a sheath extending from the treatment chamber.

15. The treatment system defines a length including the proximal valve, the distal valve, the sheath, and the treatment chamber, and the treatment system further has a lumen extending along the length of the treatment system. The system according to claim 14.

16. In the system according to claim 1, at least a part of the treatment medium can exit the treatment space through one or more gaps between the sleeve and the portion of the intraluminal device.

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