Systems and methods for endoluminal device handling

Abstract

The present invention relates to a processing system for a medical device delivered into a patient's body during a medical procedure. The processing system can include a proximal valve configured to receive an intraluminal device, an optional distal valve configured to receive the intraluminal device, and a processing chamber configured to receive a portion of the intraluminal device.

Description

[0001] This application is a continuation-in-part of the patent application with the application number 202080021156.1, the title of which is “Systems and methods for endoluminal device handling”, which application with the application number 202080021156.1 is the national phase entry into China of the international patent application PCT / US2020 / 014107. TECHNICAL FIELD

[0002] The present disclosure relates generally to introduction systems and methods for handling devices introduced into a patient, and more particularly to systems and methods for endoluminal device handling. BACKGROUND

[0003] Endoluminal devices are often delivered into a patient (e.g., into a blood vessel of a patient) using an introducer system. Introducer systems typically include a valve or similar feature to prevent the backflow of bodily fluids (such as blood) into the introducer while allowing the endoluminal device to pass through the introducer and into the patient. In various instances, a clinician or other user of the endoluminal device can also wish to perform one or more procedures on the endoluminal device.

[0004] Particularly advantageous introducer systems include those sold by W. L. Gore & Associates, Inc. under the trade names DrySeal Flex Introducer Sheath. The DrySeal Flex Introducer Sheath is designed to be inserted into a blood vessel to provide a conduit for the insertion of an intravascular device while minimizing blood loss associated with such insertion. The system includes an introducer sheath with a dry-seal valve, a twist-to-lock dilator, and a syringe. The introducer sheath is a composite tube consisting of a flat stainless steel wire reinforced hydrophilic coating outer tube and a PTFE inner liner with a tapered leading tip. The introducer sheath is attached to the dry-seal valve. The dry-seal valve includes an outer silicone tube and an inner film tube. The area between the silicone tube and the film tube can be pressurized by injecting saline into the area using the syringe. Additional examples of similar systems can be found in U.S. Patent 10155104, “Valve assembly for medical procedures,” filed by W. L. Gore & Associates, Inc. SUMMARY

[0005] Various examples relate to systems for processing intraluminal devices and methods for processing such devices, whether the methods are using existing device technology with improved methods or using improved systems. While most examples are provided in the context of intraluminal devices, and more specifically implantable devices delivered through a blood vessel, the principles and examples of the present disclosure are intended to be broadly applicable to any device considered a component introduced into the body using a introducer system. It will also be apparent that various advantages can be realized using the systems and methods described herein, including removal of entrained air, pre-wetting or pre-dosing of one or more portions of the intraluminal device, and other treatments that can be implemented to facilitate improved clinical outcomes.

[0006] According to one example ("Example 1"), a processing system for an intraluminal device includes a proximal valve, optionally a distal valve, and a processing chamber. The proximal valve can be configured to receive the intraluminal device, the proximal valve including a proximal sealing mechanism actuatable between a sealed state and an unsealed state to seal around the intraluminal device. If present, the distal valve can be configured to receive the intraluminal device, the distal valve including a distal sealing mechanism actuatable between a sealed state and an unsealed state around the intraluminal device. The processing 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 processing chamber is fluidly coupled to the proximal valve to define a processing space. The processing chamber is optionally coupled between the proximal valve and the distal valve to define the processing space between the proximal valve and the distal valve.

[0007] According to another example ("Example 2") further to Example 1, 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 actuatable to cause the inner tube to conform around the intraluminal device to form a seal around the intraluminal device.

[0008] According to another example ("Example 3") further to Example 2, the inner tube is formed of a conformable material.

[0009] According to another example ("Example 4") further to Example 3, the conformable material includes one or more of ePTFE (expanded polytetrafluoroethylene), silk, and poly-paraphenylene (poly-terephthalic acid butylene / poly-para-phenylene).

[0010] According to another example ("Example 5") further to any of Examples 2-4, the outer tube is formed of an elastomeric material.

[0011] According to yet another example further to Example 5 ("Example 6"), the elastomeric material comprises silicone gel (silicone).

[0012] According to yet another example further to any of the preceding examples ("Example 7"), the system further comprises an introducer sheath extending distally from the distal valve.

[0013] According to yet another example further to any of the preceding examples ("Example 8"), the treatment chamber has a proximal portion adjacent the proximal valve, a distal portion adjacent the distal valve, the treatment system further comprising 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.

[0014] According to yet another example further to Example 8 ("Example 9"), each of the proximal treatment port and the distal treatment port comprises a valve for fluidly sealing and unsealing the proximal treatment portion and the distal treatment portion, respectively.

[0015] According to yet another example further to any of the preceding examples ("Example 10"), the endoluminal device is a catheter-delivered system comprising a catheter and an implantable device held in a compact delivery diameter or state, and wherein the treatment chamber is configured to receive the implantable device in the compact delivery diameter or state.

[0016] According to yet another example further to any of the preceding examples ("Example 11"), the endoluminal device is a catheter-delivered system comprising a catheter and an implantable device held by the delivery catheter in a compact delivery diameter or state, and wherein the treatment chamber is configured to receive the implantable device in an intermediate partially expanded diameter that is greater than the compact delivery diameter.

[0017] According to another example ("Example 12"), a method of treating an endoluminal device for introduction into a patient comprises positioning the endoluminal device into a treatment system comprising a proximal valve, a distal valve, and a treatment chamber (treatment chamber) defining a treatment space (treatment space) between the proximal valve and the distal valve, the endoluminal device comprising 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 further comprises closing the proximal valve and the distal valve to seal the proximal valve against the first portion of the endoluminal device and to seal the distal valve against the second portion of the endoluminal device. And, the method further comprises delivering a treatment medium into the treatment space to expose the treatment portion of the endoluminal device to the treatment medium.

[0018] According to yet another example further to Example 12 ("Example 13"), the treatment portion (treatment portion) of the endoluminal device comprises an implantable device held by a delivery catheter.

[0019] According to yet another example further to any of examples 12 or 13 (“Example 14”), the treatment portion of the endoluminal device comprises a proximal portion of the implantable device, and the distal portion of the endoluminal device extends from the distal valve.

[0020] According to yet another example further to any of examples 12 to 14 (“Example 15”), the treatment medium is selected from one or more of saline, carbon dioxide, perfluorocarbon solution, methylene blue, and combinations thereof.

[0021] According to yet another example further to any of examples 12 to 15 (“Example 16”), the delivery of the treatment medium into the treatment space forces air out of the treatment portion of the endoluminal device.

[0022] According to yet another example further to any of examples 12 to 16 (“Example 17”), the method further comprises delivering the treatment medium into the treatment space through at least one of a proximal treatment portion in fluid communication with a proximal portion of the treatment chamber and a distal treatment portion in fluid communication with a distal portion of the treatment chamber.

[0023] According to yet another example further to any of examples 12 to 17 (“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.

[0024] According to yet another example further to any of examples 12 to 18 (“Example 19”), the endoluminal device comprises a sleeve holding the implantable device in a compact delivery state, and wherein 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.

[0025] According to yet another example further to any of examples 12 to 19 (“Example 20”), the treatment system comprises an introducer sheath, and the method further comprises inserting the introducer sheath into a body lumen of the patient.

[0026] According to yet another example further to example 20 (“Example 21”), the treatment medium is delivered into the treatment space while the introducer sheath is inserted into the body lumen of the patient.

[0027] According to another example ("Example 22"), a method of processing an endoluminal device for introduction into a patient includes positioning the endoluminal device into a processing system, the processing system including a valve and a processing chamber extending from the valve, and the endoluminal device including a first portion extending through the valve and a processing portion extending into a processing space of the processing chamber. The method further includes closing the valve to seal the valve against the first portion of the endoluminal device, and sealing the processing chamber. The method can further include delivering a processing medium into the processing space within the processing chamber to expose the processing portion of the endoluminal device to the processing medium.

[0028] According to yet another example ("Example 23") further to Example 22, the processing chamber is sealed with a cover member extending distally from the valve.

[0029] According to yet another example ("Example 24") further to Example 22, the processing chamber is manually sealed with a cover member.

[0030] According to yet another example ("Example 25") further to Example 24, the processing chamber is digitally sealed by a user of the processing system.

[0031] According to yet another example ("Example 26") further to any of Examples 22-25, the endoluminal device includes a sleeve holding an implantable device in a compact delivery state, and wherein the distal valve is closed over the sleeve, and the processing medium (treatment medium) exits the processing chamber (treatment chamber) via the valve through one or more gaps between the sleeve and the implantable device.

[0032] According to another example ("Example 27"), a processing system for an endoluminal device includes a proximal valve and a processing chamber. The proximal valve can be configured to receive the endoluminal device, the proximal valve including a proximal sealing mechanism actuatable between a sealed state and an unsealed state to seal around the endoluminal device. The processing chamber can be configured to receive a portion of the endoluminal device, the processing chamber fluidly coupled to the proximal valve. The processing chamber can have a proximal portion fluidly coupled to the proximal valve and a distal portion that is fluidly tight or otherwise sealed (e.g., permanently sealed or sealed using a removable sealing mechanism, such as a removable cover member).

[0033] According to yet another example ("Example 28") further to Example 27, the distal portion of the processing chamber is sealed with a cover member extending distally from the valve.

[0034] According to yet another example ("Example 29") further to Example 27, the distal portion of the processing chamber is sealed by a clamp member (clamping member).

[0035] According to yet another example further to Example 27 ("Example 30"), the distal portion of the treatment chamber is sealed by a plug (stopper).

[0036] According to yet another example further to any of Examples 27-30 ("Example 31"), the intraluminal device is received in the treatment chamber, the intraluminal device includes a sleeve holding the implantable device in a compact delivery state, and wherein the proximal valve is closed on the sleeve and there is pressurized treatment media in the treatment chamber.

[0037] According to yet another example further to any of Examples 27-31 ("Example 32"), the treatment system further includes a distal valve including a distal sealing mechanism actuatable between a sealed state and an unsealed state to seal around the intraluminal device, and an introducer sheath removably coupled to the distal valve.

[0038] According to yet another example further to Example 32 ("Example 33"), the introducer sheath includes a hemostasis valve removably coupled to the distal valve.

[0039] According to yet another example further to any of the preceding examples ("Example 34"), the treatment chamber (e.g., a distal sheath) is configured to be adjustable in length, the treatment chamber including one or more of: one or more removable segments (e.g., releasably or disconnectably coupled), one or more longitudinally splittable features, a longitudinally compressible configuration (e.g., to define or otherwise include a plurality of folds, pleats, or corrugations similar to a concertina bellows), and / or a configuration that lengthens or retracts in length upon imparting a twisting force to the treatment chamber (e.g., where the treatment chamber includes a helical wrap or layered assembly that can be twisted while sealed, causing relative movement of the helical wrap or layered assembly to reduce or extend the length of the treatment chamber).

[0040] The foregoing examples are merely examples rather than limitations and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by the present disclosure. While a number of examples have been disclosed, still other examples will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature. BRIEF DESCRIPTION OF DRAWINGS

[0041] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments and serve to explain the principles of the present disclosure.

[0042] Figure 1AA processing system according to some embodiments is shown.

[0043] Figure 1B The illustration shows a combination of some embodiments and, for example, Figure 1A The expander tool used in the processing system shown.

[0044] Figure 2A A processing system according to some embodiments is shown.

[0045] Figure 2B It is shown that, according to some embodiments, it is possible to Figure 2A Additional port connectors implemented in the processing system.

[0046] Figure 3 According to some embodiments Figure 1A A cross-sectional view of the proximal valve of the processing system.

[0047] Figure 4 It is in a decomposed state according to some embodiments. Figure 3 Axonometric view of the proximal valve.

[0048] Figure 5 It is in a pressurized off state according to some embodiments. Figure 3 End view of the proximal valve;

[0049] Figure 6 An intraluminal device for use in association with a delivery system according to some embodiments is shown, the intraluminal device being in the form of an implantable prosthetic valve held on a delivery catheter.

[0050] Figure 7A and 7B An intraluminal device for use in association with a delivery system according to some embodiments is shown, the intraluminal device being in the form of an implantable prosthetic occluder held on a delivery catheter.

[0051] Figure 8 An intraluminal device for use in association with a delivery system according to some embodiments is shown, the intraluminal device being in the form of an implantable, built-in prosthesis held in a compact state on the delivery catheter by a retaining sleeve.

[0052] Figure 9 According to some embodiments Figure 8 The isometric view of the built-in prosthesis, with the help of examples, shows the details of the additional retaining sleeve and the built-in prosthesis.

[0053] Figure 10 According to some embodiments Figure 1A A close-up partial view of a part of the processing system and an associated intracavitary device received by the processing system according to the method of processing intracavitary devices.

[0054] Figure 11A is a close-up partial view of a portion of a tube implemented in a processing system according to some embodiments. Figure 1A is a close-up partial view of a portion of a processing system and an associated in-cavity device received by the processing system according to another method of processing in-cavity devices.

[0055] Figure 11B is a close-up partial view of a portion of a tube implemented in a processing system according to some embodiments. Figure 1A is a close-up partial view of a portion of a processing system and an associated in-cavity device received by the processing system according to another method of processing in-cavity devices.

[0056] Figure 11C is a close-up partial view of a portion of a processing system and an associated in-cavity device received by the processing system according to another method of processing in-cavity devices. Figure 11A is a close-up partial view of a portion of a processing system and an associated in-cavity device received by the processing system according to another method of processing in-cavity devices.

[0057] Figure 12A is a close-up partial view of a portion of a processing system and an associated in-cavity device received by the processing system according to another method of processing in-cavity devices.

[0058] Figures 12B to 12G is a close-up partial view of a portion of a processing system and an associated in-cavity device received by the processing system according to another method of processing in-cavity devices.

[0059] Figures 13 to 24 shows an exemplary processing sequence for an in-cavity device according to some embodiments.

[0060] Those skilled in the art will readily understand that aspects of the present application can be implemented by any number of methods and devices constructed to perform the intended functions. It should also be noted that the figures referred to in this disclosure are not necessarily drawn to scale, but can be enlarged to illustrate various aspects of the disclosure, and in this regard, the figures should not be construed as limiting. DETAILED DESCRIPTION

[0061] Definitions and Terminology

[0062] The present disclosure is not intended to be read in a limiting fashion. For example, the terms used in this application should be read broadly, in the context of the meaning ascribed to such terms by those skilled in the art.

[0063] With respect to imprecise terms, the terms "about" and "approximately" are used interchangeably to refer to a measurement that includes the stated measurement and also includes any measurement that is reasonably close to the stated measurement. As understood and readily determined by one of ordinary skill in the relevant art, a measurement that is reasonably close to the stated measurement deviates from the stated measurement by an amount that is quite small. For example, such a deviation can be attributable to measurement error or a slight adjustment made for optimization of performance. If it is determined that one of ordinary skill in the relevant art would not readily determine the value of such a reasonably small deviation, the terms "about" and "approximately" can be understood to be plus or minus 10% of the stated value.

[0064] Description of Various Embodiments

[0065] Various examples are provided of treatment systems that facilitate the handling of endovascular devices before, during, or after their introduction into a patient, as well as methods for handling endovascular devices. In these various examples, treatment media are applied to endovascular devices, particularly implantable devices, to remove entrained air or otherwise pretreat the implantable device to reduce the risk of embolism or other adverse effects. Normal saline has been primarily found to be an effective treatment media, and carbon dioxide has also been found to be an effective treatment media. Entrained carbon dioxide, which displaces previously entrained air, is generally preferred because it exhibits smaller “bubbles” when released into the bloodstream and thus exhibits less physiological impact. While examples of some features and advantages have been described above, additional or alternative features and advantages are contemplated according to this disclosure.

[0066] Figure 1A A processing system 100 configured as an introduction system or integrated with an introduction system according to some examples is shown. As shown, the processing system 100 includes a proximal valve 200A, a distal valve 200B, a processing chamber 300 (also referred to as a storage conduit), and a distal sheath 400. Generally, the processing system 100 includes an inner cavity 101 ( Figure 3 The lumen extends continuously along the entire length of the treatment system 100, including through a proximal valve 200A, a treatment chamber 300, a distal valve 200B, and a distal sheath 400, the distal sheath being configured to facilitate the introduction of an intracavitary device into a body cavity. Therefore, the treatment system 100 can be used to introduce an intracavitary device (not shown) into a patient by passing the intracavitary device through the lumen 101 from a location outside the patient to a location inside the patient. The treatment system 100 can be used with various intracavitary devices, such as… Figure 1B and 6 The devices shown in Figures 9 to 9. In various examples, the processing system 100 is used to process the intracavitary device (e.g., to flush air from a portion of the intracavitary device) using a processing medium (e.g., carbon dioxide, saline, perfluorocarbon solution, methylene blue, or other media).

[0067] Figure 1BAn optional dilator 500 is shown that can be used in conjunction with the treatment system 100 to access one or more body lumens of a patient. In use, the dilator 500 is received through the lumen 101 of the treatment system 100 and used in association with the treatment system 100 to access (access) a body (e.g., vasculature (vessel), airway, biliary tract, gastrointestinal tract, cardiac space, or other) of a patient. During a dilatation procedure using the dilator 500, various valves of the treatment system 100 assist in preventing backflow of blood (exudation) through the treatment system 100. 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 with the proximal end portion of the treatment system 100 and can also assist in preventing retraction of the dilator 500 when inserted into the patient.

[0068] Figure 3 is an enlarged partial cutaway view of the proximal portion of the treatment system 100 showing various features of the proximal valve 200A in an assembled state. Figure 4 is an isometric view of the same portion of the treatment system 100, but with the proximal valve in a disassembled state. Figure 3 is an end view of the treatment system 100 according to some examples showing the proximal valve 200A in a pressurized and sealed state. Figure 5

[0069] The proximal valve 200A is generally configured to receive an endoluminal device (e.g., a dilator, an intravascular delivery system, a balloon catheter, a percutaneous delivery system, etc.) and provide a fluid seal around an outer surface of the endoluminal device to prevent unwanted backflow (e.g., of blood and / or treatment media) around the endoluminal device and through the lumen 101 of the treatment system 100. In addition, the proximal valve 200A is configured to close completely when there is no endoluminal device, or to seal itself into a closed or sealed state (e.g., as shown) without an endoluminal device. Again, this prevents unwanted backflow (e.g., of blood and / or treatment media) through the proximal valve 200A. Suitable examples of the design, materials, and methods of fabrication of 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 10155104 entitled “Valve Assembly for Medical Procedures,” although various designs, materials, and methods of fabricating such valves are contemplated. Figure 5

[0070] As shown in Figure 3 ​​As can be seen, the proximal valve 200A has an inner lumen 201A that extends the length of the proximal valve 200A. As previously described, the inner lumen 201A of the proximal valve 200A forms a portion of the inner lumen 101 of the processing system 100. The proximal valve 200A includes a proximal sealing mechanism 202A that is actuatable between a sealed state and an unsealed state to open and close or expand a portion of the inner lumen 201A. The proximal sealing mechanism 202A includes an outer tube 204A, an inner tube 206A, a pressurizable space 208A Figure 3 ), formed between an inner surface of the outer tube 204A and an outer surface of the inner tube 206A, and a fill port 210A. Although apparent from the figures, it should be noted that, according to various examples, the pressurizable space 208A is typically sealed apart from (sealed off from) a passageway provided by the fill port 210A. As shown, the proximal sealing mechanism 202A also includes a rear ring 218A and a front ring 220A that are fixed in opposite directions toward either end of the outer tube 204A. These rings generally assist in coupling, supporting, and sealing the proximal sealing mechanism 202A with the rest of the proximal valve 200A.

[0071] 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, snaps, fasteners, and / or other mechanisms). The rear fitting 224A and the front fitting 226A can help to fixedly secure the various portions of the proximal valve 200A together in a sealed manner, and can also provide a mechanism or means by which the proximal valve 200A is secured to other components of the processing system 100, such as the processing chamber 300. The rear fitting 224A can also be configured to be coupled to one or more portions of an in-cavity device, such as the hub end 506 Figure 1B ).

[0072] In addition to the fill port 210A, the proximal valve 200A has a process port 230A (also described as a flush port) that is in fluid communication with the inner lumen 201A of the proximal valve 200A at a location that is distal of the proximal sealing mechanism 202A. The process port 230A can be utilized to deliver a process medium into the processing chamber 300, as described subsequently.

[0073] In some embodiments, the outer tube 204A has an hourglass shape in a relaxed state, although straight cylinders and other shapes are also contemplated. The outer tube 204A can have elastic properties (e.g., be formed of an elastic material) and expand (physically distend) when the pressurizable space 208A is pressurized to deflect radially outward from the hourglass shape into a more cylindrical state, and possibly a more bulbous, outwardly convex shape. In some examples, the outer tube 305A is formed of a silicone material (e.g., using insert molding techniques), although various materials are contemplated, including any of a variety of elastic or elastically- behaving materials. For example, the outer tube 204A can be composed of any elastomer, latex, or polycarbonate having the desired mechanical and biocompatible properties.

[0074] The distending properties of the outer tube 204A can provide a visual indication that the pressurizable space 208A has been positively pressurized and, thus, that the proximal valve 200A has been closed. In some examples, when the proximal sealing mechanism 202A is positively pressurized and closed, the hourglass shape of the outer tube 204A becomes distended to indicate the ideal positive pressure in the pressurizable space 208A (e.g., a pressure that will sufficiently prevent backflow through the proximal sealing mechanism 202A).

[0075] The inner tube 206A can be composed of any thin, strong, drapable material, such as ePTFE, fabric, silk, or cardiac fiber. Such materials can be used suitably as a single layer construction or a multi-layer construction. 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 features.

[0076] In use, the inner tube 206A is thin and conformable, and, thus, once the pressurizable space 208A is positively pressurized, the inner tube 206A deflects inward and drapes or closely conforms to the outer perimeter of an endoluminal device received through the proximal valve 200A to form a seal. When no endoluminal device is present, the inner tube 206A deflects inward such that the inner surface of the inner tube 206A engages itself to form a seal.

[0077] As shown, the fill port 210A includes a coupling feature 211 A associated with the front ring 220A and a passage 212A formed through the outer tube 204A into the pressurizable space 208A. The coupling feature 211 A is optionally configured to attach to a syringe (e.g., the coupling feature 211 A can be configured as a valved luer fitting). Regardless of the specific pathway, the fill port 210A provides a means for pressurizing (or depressurizing) the pressurizable space 208A. In particular, the fill port 210A is in fluid communication with the pressurizable space 208A.

[0078] Filling port 210A can be configured to couple to any of a variety of positive or negative pressure sources (fluid or gas), including a syringe (not shown). By way of reference, pressurizable space 208A can be filled with any suitable material. For example, while saline can be preferred in certain applications, pressurizable space 208A can be positively pressurized with one or more of the following: air, silicone, water, saline (solution), low volatility biocompatible liquids, glycerol, propylene glycol, polyethylene glycol, compressible foam, elastomeric spheres, cross-linked silicone gel, and combinations thereof.

[0079] Regardless, a pressure source can be used to deliver a suitable material (e.g., saline) into pressurizable space 208A (positive pressure) or remove material from pressurizable space 208A (negative pressure, or decompression), respectively, resulting in the closing or opening of proximal sealing mechanism 202A, respectively. In particular, according to various embodiments, upon positive pressurization of pressurizable space 208A using filling port 210A, inner tube 206A collapses inward (e.g., against itself or around a device received through inner tube 206A) to form a seal. Figure 5 An end view of processing system 100 is shown, with inner tube 206A of proximal valve 200A collapsed and engaged with itself under positive pressure conditions.

[0080] Front fitting 226A is secured to front ring 220A and a proximal portion of processing chamber 300 (e.g., as shown, via complementary threads), and thus assists in the fluidic coupling of proximal valve 200A with processing chamber 300. Front fitting 226A, or portions thereof, can be formed of a transparent material (e.g., a transparent or translucent polymer), which can allow a user of processing system 100 to visually confirm that a device (or portions thereof) inserted through processing system 100 has passed proximal valve 200A, and in particular, beyond proximal sealing mechanism 202A. Figure 3

[0081] As shown, processing port 230A communicates with inner lumen 201A at a location distal of proximal sealing mechanism 202A. Processing port 230A includes a coupling feature 232A (e.g., a valved luer fitting for sealing and unsealing processing port 230A) and a passageway 234A (e.g., as shown, at a location distal of proximal sealing mechanism 202A) into inner lumen 201A of proximal valve 200A through front fitting 226A. Regardless of the particular pathway, processing port 230A provides a means for delivering processing media into and / or out of inner lumen 201A of proximal valve 200A (and into or out of a proximal portion of processing chamber 300), as described subsequently.

[0082] As Figure 1A , 3 ​As shown in one or more of FIGS. 1-4, the process chamber 300 has an inner cavity 301 that forms a portion of the inner cavity 101 of the processing system 100. The process chamber 300 includes a proximal coupling 310, a distal coupling 312, and a body 314 extending between the proximal coupling 310 and the distal coupling 312. The proximal coupling 310 is configured to secure the process chamber 300 to the proximal valve 200A in a sealed manner (e.g., via complementary threads), and the distal coupling 312 is likewise configured to secure the process chamber 300 to the distal valve 200B in a sealed manner (e.g., via complementary threads). The body 314 is optionally hollow and tubular in configuration and sized (e.g., appropriately cross-sectioned and lengthed) to receive a desired portion of an in-cavity device positioned between the proximal valve 200A and the distal valve 200B. In particular, the process chamber 300 is fluidically coupled between the proximal valve 200A and the distal valve 200B to define a process space in the inner cavity 301 between the proximal valve 200A and the distal valve 200B. The process chamber 300 can be relatively rigid or relatively flexible as desired. In some examples, the process chamber 300 or portions thereof are partially or fully transparent to allow for viewing of an in-cavity device received in the process chamber 300.

[0083] As shown in FIG. 1, according to various examples, the distal valve 200B can be substantially similar in form and function to the proximal valve 200A. As such, features of the distal valve 200B can be described uniformly with features of the proximal valve 200A. As shown in FIG. 2, the proximal valve 200A and the distal valve 200B are substantially similar (though the distal valve 200B has a modified rear fitting 224B that is substantially similar to the front fitting 226A of the proximal valve 200A). Thus, when a feature of the distal valve 200B corresponds to a feature of the proximal valve 200A, the same reference number is used for each feature, except that the corresponding feature of the distal valve 200B is not followed by an "A" but by a "B". Figure 1A Figure 1A As shown in FIG. 2, the proximal valve 200A and the distal valve 200B are substantially similar (though the distal valve 200B has a modified rear fitting 224B that is substantially similar to the front fitting 226A of the proximal valve 200A). Thus, when a feature of the distal valve 200B corresponds to a feature of the proximal valve 200A, the same reference number is used for each feature, except that the corresponding feature of the distal valve 200B is not followed by an "A" but by a "B".

[0084] According to some embodiments, similar to the proximal valve 200A, the distal valve 200B also has an inner cavity (not shown) that forms a portion of the inner cavity 101 of the processing system 100. The distal valve 200B is also configured to receive an in-cavity device within the cavity of the distal valve 200B. Moreover, the distal valve 200B also includes a distal sealing mechanism 202B that is configured and operable similar to the proximal sealing mechanism 202A and actuatable between a sealed state and an unsealed state to open and close or expand a portion of the inner cavity of the distal valve 200B.

[0085] ​The distal seal mechanism 202B includes an outer tube 204B, an inner tube (not shown), a pressurizable space (not shown) formed between an inner surface of the outer tube 204B and an outer surface of the inner tube, and a fill port 210B. The pressurizable space is generally sealed apart from (sealed off from) a passageway provided by the fill port 210B, similar to the 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 in opposite directions toward either end of the outer tube 204B. These rings 218A, 218B generally assist in coupling, supporting, and sealing the proximal seal mechanism 202B with the rest of the proximal valve 200B.

[0086] 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, adhesive, a snap, fasteners, and / or other mechanisms). The rear fitting 224B and the front fitting 226B can help secure various portions of the distal valve 200B together. As shown, the rear fitting 224B is effectively a mirror image of the front fitting 226B (and the front fitting 226A). The rear fitting 224B provides a mechanism or way for securing the proximal valve 200A to the process chamber 300 in a similar manner as the front fitting 226A of the proximal valve 200A (e.g., via complementary threads on the respective fittings). The front fitting 226B of the distal valve 200B, in turn, is configured to couple to the distal shield 400 (e.g., via complementary threads on the respective fittings).

[0087] In addition to actuating the fill port 210B of the distal seal mechanism 202B, the distal valve 200B also optionally has a process port 230B (also described as a purge port) that is in fluid communication with the inner lumen 201A of the proximal valve 200A at a location proximal of the distal seal mechanism 202B. The process port 230B includes a coupling feature 232A associated with the rear fitting 224B (e.g., a valved luer fitting for sealing and unsealing the process port 224B) and a passageway into the inner lumen of the distal valve 200B through the rear fitting 224B (e.g., as shown, at a location proximal of the distal seal mechanism 202B). Regardless of the specific path, the process port 230B provides a means (way) for passing a process medium into and / or out of the inner lumen of the distal valve 200B (and into and / or out of a distal portion of the process chamber 300). For example, as shown by the arrow directions in FIG. 2, process medium enters the inner lumen from the first process port 230A, passes through the inner lumen through the process chamber 300, and exits the inner lumen from the second process port 230B. Figure 10

[0088] ​Furthermore, as shown, the distal valve 200B also includes a processing port 240B (also described as a flushing port) located distal to the distal sealing mechanism 202B, which is in fluid communication with the interior of the distal valve 200B. The processing port 240B includes a connection feature 242B associated with the front fitting 226B (e.g., a valved Luer fitting for sealing and unsealing the processing port 230A) and a passage (not shown) through the front fitting 226B into the interior of the distal valve 200B (e.g., at a location distal to the distal sealing mechanism 202B, as shown). Regardless of the specific path, the processing port 240B provides a means (pathway) for conveying processing media into and / or out of the interior of the distal valve 200B (and into and / or out of the distal sheath 400).

[0089] like Figure 1A As shown, 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 an inner lumen (not shown) that forms part of the inner lumen 101 of the treatment system 100. The distal sheath 400 can be formed of various materials, but in some examples it is formed of fluorinated ethylene propylene (FEP), high-density polyethylene, and / or any other suitable material. The distal sheath 400 can be configured with an outer diameter ranging from a variety of sizes, but in some examples its size is from 12 Fr (French, French unit) to 26 Fr. The distal sheath 400 can have various lengths as desired and can be configured to be inserted into a patient's body cavity (e.g., a vascular system (blood vessel)) to assist in the introduction of an endovascular device into the patient (not shown).

[0090] Figure 2A Another embodiment of the processing system 100 according to some examples is shown. As shown, the distal valve 200B includes a fill port connection 250 and a processing port connection 260. The fill port connection 250 fluidly connects the fill port 210B to a pressurizable space 208A to provide a means (path / device) for pressurizing (or depressurizing) the pressurizable space 208A. The processing port connection 260 fluidly connects the processing port 240B to the interior cavity of the distal valve 200B to provide a means for delivering processing media into and / or out of the interior cavity.

[0091] As shown in the figure, the fill port connector 250 of the distal valve 200B includes a rear fitting 224B attached to a rear ring 218B, where the fill port 210B is located. The fill port connector 250 also includes an outer tube 204B connected to a front ring 220B. The processing port connector 260 includes a rear ring 218C connected to the front ring 220B of the fill port connector 250. The processing port connector 260 also includes an outer tube 204C and a front ring 220C connected to a front fitting 226B where the processing port 240B is located. For example, the connection can be achieved via complementary threads, adhesives, snap-fits, fasteners, and / or other mechanisms.

[0092] The fill port connector 250 and the process port connector 260 can be formed separately and then connected or coupled together to form the distal valve 200B. Additionally, other connectors can be attached between the fill port connector 250 and the process port connector 260, or more specifically between the front ring 220B of the fill port connector 250 and the rear ring 218C of the process port connector 260. In some examples, an additional port connector 270 may be implemented, such as… Figure 2B As shown, this additional port connection has an additional port 210D, a rear ring 218D, a front ring 220D, an outer tube 204D, and a connection feature 211D associated with the rear ring 218D to introduce additional fluid into the processing 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 connections 270 can be implemented in the distal valve 200B, wherever appropriate.

[0093] Including one or more additional port connections allows for the introduction of different processing media at different times, making the process more flexible. For example, if a second processing media is to be introduced at a time after the first processing media, the first processing media can be introduced via the first processing port (e.g., 210B), and when the time comes to introduce the second processing media, it can be done using the second processing port (e.g., 210D). The two processing media can be any of those in the previous examples, such as saline, carbon dioxide, perfluorocarbon solution, (methylene) blue, or others. Each connection feature can be attached to a syringe or other delivery device containing different processing media. In some examples, having more than one processing port helps avoid switching between different delivery devices when changing from one processing media to another.

[0094] The processing system 100 can be used with various types of intracavitary devices, including Figures 6 to 9 The examples shown are all collectively referred to by reference numeral 600 (except for...). Figure 1B The expander 500 shown is also an intracavitary device.

[0095] Figure 6 An endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device held in a compact delivery diameter or state by the delivery catheter. The implantable device defines a treatment portion of the endoluminal device 600 or a portion thereof for which treatment is to be performed. Specifically, Figure 6 The endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device held in a compact delivery diameter or state by the delivery catheter. The implantable device defines a treatment portion of the endoluminal device 600 or a portion thereof for which treatment is to be performed. Specifically, Figure 6 The endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device held in a compact delivery diameter or state by the delivery catheter. The implantable device defines a treatment portion of the endoluminal device 600 or a portion thereof for which treatment is to be performed. Specifically,

[0096] Figure 7A An endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device held in a compact delivery diameter or state by the delivery catheter. The implantable device defines a treatment portion of the endoluminal device 600 or a portion thereof for which treatment is to be performed. Specifically, Figure 7A The endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device held in a compact delivery diameter or state by the delivery catheter. The implantable device defines a treatment portion of the endoluminal device 600 or a portion thereof for which treatment is to be performed. Specifically, Figure 7A The endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device held in a compact delivery diameter or state by the delivery catheter. The implantable device defines a treatment portion of the endoluminal device 600 or a portion thereof for which treatment is to be performed. Specifically,

[0097] Figure 7BEndoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device that is maintained in a compact delivery diameter or state by the delivery catheter. The implantable device includes or will have a portion of the treatment performed in the treatment portion of endoluminal device 600. Specifically, Figure 7B Endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device that is maintained in a compact delivery diameter or state by the delivery catheter. The implantable device includes or will have a portion of the treatment performed in the treatment portion of endoluminal device 600. Specifically, Figure 7B Endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device that is maintained in a compact delivery diameter or state by the delivery catheter. The implantable device includes or will have a portion of the treatment performed in the treatment portion of endoluminal device 600. Specifically,

[0098] Figure 8 and 9 Endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device that is maintained in a compact delivery diameter or state by the delivery catheter. The implantable device includes or will have a portion of the treatment performed in the treatment portion of endoluminal device 600. Specifically, Figure 8 and 9 Endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device that is maintained in a compact delivery diameter or state by the delivery catheter. The implantable device includes or will have a portion of the treatment performed in the treatment portion of endoluminal device 600. Specifically, Figure 8 and 9 Endoluminal device 600 in the form of a transcatheter delivery system is shown, which includes a catheter and an implantable device that is maintained in a compact delivery diameter or state by the delivery catheter. The implantable device includes or will have a portion of the treatment performed in the treatment portion of endoluminal device 600. Specifically, 9

[0099] As described in further detail, some methods of processing an endoluminal device for introduction into a patient include positioning the endoluminal device into the processing system 100; closing the proximal valve 200A and the distal valve 200B to seal the proximal valve 200A against a first portion of the endoluminal device and to seal the distal valve 200B against a second portion of the endoluminal device; and delivering a processing medium into the processing space to expose a portion of the endoluminal device to be processed or a processed portion of the endoluminal device to the processing medium.

[0100] In some examples, the processed portion of the endoluminal device includes an implantable device held by the delivery catheter. The processed portion of the endoluminal device can include a proximal portion of the implantable device, with a distal portion of the endoluminal device extending from the distal valve. In different examples, delivering the processing medium into the processing space forces air out of the processed portion of the endoluminal device. In particular, delivering the processing medium into the processing space through at least one of a proximal processing portion in fluid communication with a proximal portion of the processing chamber and a distal processing portion in fluid communication with a distal portion of the processing chamber forces entrained air out of a portion of the endoluminal device (e.g., the implantable device).

[0101] In some examples, the processing medium exits the processing chamber 300 through a processing port 230B in fluid communication with a distal portion of the processing chamber 300. The endoluminal device can include a holding sleeve holding the implantable device in a compact delivery state, and the distal valve can be closed over the sleeve such that the processing medium exits the processing chamber 300 through one or more gaps between the sleeve and the implantable device from the distal valve 200B. Some methods further include inserting an introducer sheath into a body lumen of the patient before, during, or after processing of the endoluminal device.

[0102] Figure 10 is in accordance with some embodiments Figure 1AFIG. 6 is a close-up partial view of a portion of the processing system of FIG. 1 and an associated endoluminal device, in accordance with a method of processing an endoluminal device by the processing system. The endoluminal device 600, including the implantable device 610 carried by the delivery catheter 620, is generally represented by a dashed box, to show the location of the respective components in a schematic manner. In other words, for visualization purposes, the relative locations of the generalized components of the endoluminal device 600 are superimposed on the processing system 100. 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 folds, creases, or pleats similar to the bellows of an accordion, 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 separated by breaking or splitting (cleaving). In some examples, a row of holes or perforations can be formed along at least a portion of the length of the delivery catheter 620, such that when a sufficient radial force is applied to the delivery catheter 620, the surface of the delivery catheter 620 can be torn, causing the delivery catheter 620 to detach (break away) from the endoluminal device.

[0103] In some examples, the distal sheath 400 is inserted into the patient, for example into the patient's vasculature (blood vessels) with the assistance of the dilator 500. The dilator 500 is removed from the processing system 100, and the endoluminal device 600 is translated into the processing system 100 with the implantable device 610 positioned in the processing chamber 300 between the proximal and distal sealing mechanisms 202A, 202B, with the proximal valve 200A pressurized and closed to form a seal around the endoluminal device 600, and the distal sealing mechanism pressurized and closed to form a seal. In this manner, the implantable device 610 (e.g., a stent graft or prosthetic valve) is located in the sealed processing space between the proximal and distal valves 200A, 200B. In examples in which portions of the processing system 100 are transparent (e.g., portions of the proximal and distal valves 200A, 200B and / or the processing chamber 300), the user can visually confirm correct positioning. It should be noted that the distal sheath 400 is in the patient prior to device processing in only some embodiments, and in other embodiments, the processing is performed prior to insertion into the processing system 100.

[0104] Regardless, with the proximal valve 200A in a closed or sealed state about the endoluminal device 600, specifically the delivery catheter 620, and the distal valve 200B in a closed or sealed state, a treatment medium is delivered into 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 a pressurized gas source) is attached to each of the treatment ports 230A, 230B, and a treatment medium (e.g., saline, carbon dioxide, perfluorocarbon solution, (sub) methylene blue, or other) is delivered into the treatment chamber 300. The treatment medium can be "pushed" into the treatment chamber 300 via the treatment port 230A by positive pressure and "pulled" into the treatment chamber 300 via the treatment port 230B by negative pressure, or vice versa. Alternatively, instead, positive or negative pressure is applied through only one of the treatment ports 230A, 230B to introduce the treatment medium into the treatment chamber 300.

[0105] If the treatment chamber 300 is of a suitable size (e.g., has a sufficient diameter), and if the user so desires, the implantable device 610 can be treated in a partially or fully expanded state. Treating the implantable device 610 in a partially or fully expanded state can be advantageous (assuming the delivery catheter 620 and associated retention mechanism is capable of reverse expansion, or does not require reverse expansion) because more device surface area can be accessed during device treatment, which can speed up and enhance treatment efficacy.

[0106] In some examples, once the implantable device 610 is treated (e.g., flushed by air, wetted, or otherwise treated) as desired, the treatment port 240B Figure 1A ) can be opened, and blood can be introduced into the distal sheath 400 (e.g., by attaching a syringe and applying negative pressure through the treatment port 240B). Once 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. The implantable device 610 can then be tracked to a desired location in 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 guidewire).

[0107] Figure 11A is a close-up partial view of a portion of the treatment system of Figure 1A in which the endoluminal device 600 is shown in an adjusted treatment position relative to Figure 10 .

[0108] In Figure 11AIn some examples, the treatment is more typically performed before the distal sheath 400 is inserted into the patient. In some examples, the distal end of the distal sheath 400 may be truncated (e.g., pre-cut) or may be full-length. Figure 11A As shown, the distal sheath 400 is shortened or truncated, but such truncation is not necessary. Furthermore, the distal end of the distal sheath 400 utilizes... Figure 11A The cover member 410 shown in the general diagram is covered or otherwise sealed. The cover member 410 may be a threaded, headed cap, plug, or other implementation, or its end may be manually sealed by the user's thumb.

[0109] In some examples, the cap member 410 may be replaced by a clamp, plug, or other sealing member. For example, a hose clamp or any other suitable vascular clamp (e.g., a "Cooley" clamp) may be used to clamp the distal end of the distal sheath 400 (e.g., the distal sheath 400 is formed of a flexible tubing material). In any case, the seal at the distal end may be temporary or permanent, depending on the circumstances. In some examples, the distal ends 414 of the tube 412 may be joined together (e.g., at least partially flattened to form a seal such as...). Figure 11B The "duckbill" construction shown is used to seal the closure. In some examples, the distal end of the tube may be heated and / or subsequently closed, crushed (crushed), or sealed together with any suitable construction to form a seal (part) in the distal end of the tube.

[0110] exist Figure 11C In the example, at the distal end of the cover member 410, the cover member 410 includes a detachable seal 416. The detachable seal 416 can be manually disconnected, torn, or punctured by pushing the intracavitary device 600 or other instrument against it. The detachable seal 416 can be a diaphragm or membrane made of a polymeric material (e.g., a self-healing diaphragm). Including the seal helps ensure that the implantable device 610 does not come into contact with the environment (e.g., ambient air) after treatment in the treatment chamber. Specifically, the distal sheath 400 can be attached to an insertion sheath, valve, or other device for direct insertion into the patient before disconnecting the detachable seal 416.

[0111] As shown in the figure, the intracavitary device 600 is translated into the processing chamber 300, wherein the implantable device 610 is located in the distal valve 200B, and either end or any end portion of the implantable device 610 is located on either end of the distal sealing mechanism 202B. In examples where parts of the processing system 100 are transparent (e.g., parts of the proximal valve 200A and distal valve 200B and / or the processing chamber 300), the user can visually confirm the correct positioning of the implantable device 610.

[0112] exist Figure 11A In the example, the processing space extends into the distal sheath 400 to include a covered distal sheath 400. Therefore, the distal sheath 400 can be considered as acting as an alternative or additional processing chamber. With each of the proximal valves 200A and distal valves 200B pressurized and closed to form a seal around the intracavitary device 600, processing media are delivered into the processing space of the distal sheath 400 using processing port 240B, as indicated by solid arrow “A”. For example, a pressure source (e.g., a pressure reservoir, such as a pressurized gas source or syringe) is attached to processing port 240B, and processing media (e.g., carbon dioxide, saline, perfluorocarbon solution, methylene blue, or others) are delivered into the distal sheath 400. When sufficient back pressure is applied, the pressurized processing media is forced through any folds, creases, or gaps present in the implantable device 610, or similar features present between the implantable device and any associated retention mechanism (e.g., not shown, but such as a retention sleeve). Then, the pressurized processing medium “passes” through the gap, through the closed distal valve 200B, into the processing chamber 300, and exits from one or both processing ports 230A, 230B as desired, as indicated by the dashed arrows “B” and “C”.

[0113] Such a process is particularly advantageous for forcing any entrained air out of folds, creases, or gaps in the implantable device 610, or from similar features present between the implantable device and any associated retaining mechanism (e.g., not shown, but such as a retaining sleeve). Particularly helpful is the closure of the distal valve 200B around the periphery of the implantable device 610 and any associated retaining mechanism (not shown), as the processing medium is unlikely to simply bypass the implantable device 610 and the retaining mechanism, but is instead forced through gaps, folds, creases, and spaces where air may be entrained (and trapped).

[0114] It should be understood that, in Figure 11A In this scenario, reverse flow of the treatment medium can also be effectively applied. To reiterate, positive pressure can be applied through one or both treatment ports 230A, 230B, forcing the treatment medium out of the treatment chamber 300, across the closed distal valve 200B, through the implantable device 610, into the covered distal sheath 400, and out of the treatment port 240B (or, the covered member 410 can be omitted, and the treatment medium can simply pass through the end of the distal sheath 400 as desired). In conjunction with Figure 11A In the associated examples, since the distal valve 200B is sealed onto the implantable device 610, the implantable device 610 is typically handled in a fully compact state, but this is not necessarily the case in all cases.

[0115] In various examples, once the implantable device 610 is processed as desired (e.g., by air flushing, wetting, or otherwise), the treatment system 100 can be introduced into the patient, and delivery of the implantable device 610 can be performed in a manner similar to that previously described.

[0116] Figure 12A is a close-up, partial view of another treatment system 100 that can be part of a delivery system according to some embodiments, and an associated endoluminal device 600 that is received by the treatment system 100 according to the method of treating the endoluminal device 600. As Figure 12A shown, the proximal valve 200A is omitted from the treatment system 100, and a single valve 200 is employed that is substantially similar to the proximal valve 200A and the distal valve 200B. Thus, the valve 200 includes substantially the same features as the proximal valve 200A and / or the distal valve 200B, and the features of the valve 200 are referred to by the same reference numerals as the proximal valve 200A and the distal valve 200B, except that these reference numerals are not followed by an "A" or a "B."

[0117] While a single valve is employed, according to different examples, the method can be similar to that described above with reference to Figure 11A As Figure 12A shown, the distal sheath 400 is used as a treatment chamber, and can be referred to alternatively as a treatment chamber.

[0118] In Figure 12A examples, the treatment is more typically performed prior to insertion of the distal sheath 400 into the patient, but this is not the case in all instances. In some examples, the distal end of the distal sheath 400 can be truncated (e.g., pre-cut), or can be full-length. As Figure 12A shown, the distal sheath 400 is shortened or truncated. In addition, the distal end of the distal sheath 400 is capped or otherwise sealed with a cap member 410 that is generally shown in Figure 12A The cap member 410 can be a threaded, a head-sealed cap, a plug, or other implementation such as a user's thumb, and is generally described in Figure 12Aindicated. In each of the previously described cases, the distal sheath 400 (also described as the treatment chamber) can be referred to as being sealed digitally (in a digital manner) when sealed with a user's finger or thumb. In some examples, the cover 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 "Cooley" clamp) can be employed to clamp the distal end of the distal sheath 400 (e.g., the distal sheath 400 is formed of a flexible tubing material). Regardless, the seal at the distal end can be temporary or permanent, as the case can be. In some examples, the distal ends 414 of the tubes 412 can be brought together (e.g., at least partially flattened to form a "duckbill" configuration as Figure 11B indicated, and sealed shut). In some examples, the distal ends of the tubes can be heated and / or subsequently closed, crushed, or sealed together in any suitable configuration to form a seal in the distal ends of the tubes.

[0119] As shown, the intraluminal device 600 is translated into the sealing mechanism 202 of the valve 200 with either end of the implantable device 610 on either end of the sealing mechanism 202. In examples where portions of the treatment system 100 are transparent (e.g., portions of the valve 200, such as the front fitting 226), a user can visually confirm proper positioning of the implantable device 610.

[0120] As shown, a distal portion of the implantable device 610 is positioned within a treatment space defined by the distal sheath 400. Thus, in Figure 12A examples, the treatment space extends to include the distal sheath 400 with the cover. With the valve 200 pressurized and closed to form a seal around the intraluminal device 600, a treatment medium is delivered into the treatment space defined by the distal sheath 400 with the treatment port 240 acting as a treatment chamber. For example, a pressure source (e.g., a pressure reservoir, such as a pressurized gas source or a syringe) is attached to the treatment port 240 and a treatment medium (e.g., carbon dioxide, saline, perfluorocarbon solution, methylene blue, or other) is delivered into the distal sheath 400 acting as a treatment chamber. When sufficient back pressure is applied, the pressurized treatment medium forces its way through any folds, creases, or gaps present in the implantable device 610, or the like present between the implantable device and any associated holding mechanism (e.g., not shown, but such as a holding sleeve). The pressurized treatment medium then "passes" through the gap ("passes" through the gap of the closed valve 200) and out the other end of the implantable device 610 and / or associated holding mechanism (e.g., not shown, but such as a holding sleeve positioned around the implantable device 610). The direction of flow of the pressurized treatment medium is indicated by the arrows in Figure 12A .

[0121] It is particularly helpful that the valve 200 closes (closes) around the outer perimeter of the implantable device 610 and any associated retention mechanism, as it is less likely that the treatment medium will simply bypass the implantable device 610 and any retention mechanism, but instead be forced through gaps, folds, creases, and spaces that can entrain air (which can become trapped therein).

[0122] In various examples, once the implantable device 610 is treated as desired (e.g., flushed by air, wetted, or otherwise treated), the treatment system 100 can be introduced into the patient, and delivery of the implantable device 610 can be performed in a manner similar to that previously described.

[0123] Figure 12B Additional or alternative features of the treatment system 100 according to various examples are shown according to Figure 12A and, in particular, potential modifications to the distal sheath 400. As Figure 12B shown, the distal sheath 400 functions as a treatment chamber, and can be alternatively referred to as a treatment chamber. As shown, the distal sheath 400 can include a plurality of segments, such as a first segment 400A, a second segment 400B, and a third segment 400C. Each segment of the distal sheath 400 can be configured to be removably coupled to another segment and / or the valve 200. In this manner, a user of the treatment system 100 can select a length of the distal sheath 400 using one or more of the first segment 400A, the second segment 400B, and the third segment 400C as desired. Between segments, such as at the distal end 414A of the first segment 400A and / or the distal end 414B of the second segment 414B, coupling mechanisms such as external and internal threads can be employed. Although three segments are shown, fewer (such as two) or more (such as more than 3, 4, or more, or any desired number) segments can be implemented to achieve a desired degree of adjustability.

[0124] As a further feature, as Figure 12C shown, the segments can have a “breakaway” (break) coupling therebetween (e.g., a score or weakened area between the segments, such that one or more of the segments are configured to be manually removed. In addition, the segments can also simply be snipped open with scissors or a knife, and then capped or clamped as appropriate. Figure 12C Additional or alternative features of the treatment system 100 according to various examples are shown according to Figure 12A and, in particular, potential modifications to the distal sheath 400. As Figure 12CAs shown, the distal sheath 400 serves as a processing chamber and is alternatively referred to as such. As illustrated, the distal sheath 400 may include multiple segments, such as a first segment 400A, a second segment 400B, and a third segment 400C. Each segment of the distal sheath 400 may be configured to be removably connected to another segment and / or valve 200 at a fragile (breakable) connection (e.g., a notch or other weakened portion), at which the respective first segment 400A, second segment 400B, and third segment 400C can be disengaged. In this way, a user of the processing system 100 can select the length of the distal sheath 400 according to the desired removal of one or more of the third segment 400C and the second segment 400B. Although three segments are shown, fewer (e.g., two) or more (e.g., more than three, four, or any desired number) segments may be implemented to achieve the desired degree of adjustability.

[0125] As a further feature, such as Figure 12D As shown, the distal sheath 400 may include one or more longitudinally separable (splittable) features 411 in the form of longitudinal score lines, fragile (breakable) sections, or weakened areas to allow the distal sheath to be torn, cut, separated, or otherwise removed (e.g., removed from around the cavity device 600 (not shown)). In use, an operator (not shown) may cut, tear, or otherwise split the distal sheath 400 along the longitudinally separable (splittable) features 411 to separate and optionally remove the distal sheath 400. While relatively straight longitudinally separable features are shown in the figure, helically oriented features are also conceivable.

[0126] As a further feature, such as Figure 12E As shown, the distal sheath 400 may have features such as threading or other removable connections, and may be supplied as a kit with distal sheaths (not shown) of various lengths. In this case, the user (not shown) can simply select the desired length of the distal sheath 400 and removably attach the distal sheath 400 to the valve 200.

[0127] As a further feature, such as Figure 12F As shown, the distal sheath 400 can collapse longitudinally (e.g., in an accordion-like manner) to reduce or lengthen the length of the distal sheath 400. For reference, Figure 12F The distal sheath 400 in its extended state is shown in dashed lines, while the distal sheath with accordion-like pleats or folds 411a in its longitudinally collapsed state is shown in solid lines. In some examples, the length of the distal sheath 400 can be adjusted by longitudinally compressing or extending the distal sheath 400 to any of a variety of desired lengths.

[0128] As a further feature, such as Figure 12GAs shown, the distal sheath 400 can be longitudinally collapsed by twisting the distal sheath 400 to cause a reduction in overall length (e.g., in a manner that spirally winds the member). In some examples, the distal sheath 400 includes a helical wrap or layered assembly that can be twisted to cause relative movement of the helical wrap or layers 41 IB to reduce or lengthen the length of the distal sheath 400 while sealed. In some examples, the distal sheath 400 can be adjusted in length by either longitudinally compressing or extending to any of a variety of desired lengths by twisting the distal sheath 400 in the appropriate direction.

[0129] Figures 13 to 24 An exemplary processing sequence for an endoluminal device using a processing system of Figure 12A Figure 13 As shown, an inflation medium source (IMS) and a treatment medium source (TMS) are coupled to the fill port 210 and the treatment port 240 of the valve 200, respectively. The inflation medium source (IMS) can be a syringe filled with an inflation medium (e.g., saline) for pressurizing and depressurizing the valve 200 to open and close the valve 200. The treatment medium source (TMS) can optionally be a syringe filled with any of the treatment media previously described.

[0130] Figure 14 A container 1000 (e.g., a packaging tray that maintains the endoluminal device 600 in a sterile environment prior to use) is shown having a recess 1010 into which a treatment medium (e.g., a sterile liquid) can be delivered. As shown, as part of the processing sequence, sterile saline is delivered into the recess 1010.

[0131] Figure 15 An endoluminal device 600 is shown just prior to being introduced into the valve 200 of the processing system 100 (e.g., in the form of a transcatheter delivery system including a catheter and an implantable device held in a compact delivery diameter or state by the delivery catheter).

[0132] Figure 16 An endoluminal device 600 is shown being introduced into the valve 200, with the implantable device 610 partially extending from the valve 200 such that a portion of the implantable device 610 is in the distal sheath 400 and a portion protrudes from the valve 200. The valve 200 is pressurized (using the inflation medium source (IMS)) to transition the valve 200 to a pressurized closed state such that the valve 200 closes on the implantable device 610. Figure 13

[0133] Figure 17 ​​A treatment media source (TMS) is shown coupled to the treatment port 240 and ready to be pressurized (e.g., manually by a user pressing a syringe plunger). Figure 18 A treatment media source (TMS) is shown pressurized and the distal sheath 400 is open at the distal end 414. As shown, the distal sheath 400 is being cleaned by treatment media passing over the distal end 414. The intraluminal device 600 can also be cleaned at this stage, with treatment media passing through the intraluminal device's 600 internal lumen (not shown).

[0134] Figure 19 The intraluminal device 600 is shown operating to seal or otherwise close the intraluminal device's 600 internal lumen (e.g., by closing a valve (e.g., a luer fitting) of the handle portion shown in FIG. 6B). Figure 19

[0135] Figure 20 The distal sheath 400 is shown sealed (e.g., a user places a thumb over the distal end 414) and the treatment media source (TMS) is pressurized to force treatment media into the distal sheath 400, then through the valve 200 and through the implantable device 610 (e.g., between the implantable device's 610 outer sleeve and the implantable device's 610 body) to treat the implantable device 610 (e.g., to flush air out of the implantable device 610). In this step, some of the treatment media can come out proximal of the valve 200 through the implantable device 610. Figure 21 is a close-up view of the valve 200 for further observation.

[0136] Figure 22 The intraluminal device 600 is shown being flushed. For example, the valve of the handle portion can be opened, the treatment media source (TMS) is pressurized, and treatment media can pass through the intraluminal device 600 to flush the intraluminal device's 600 internal lumen.

[0137] Figure 23 The valve 200 is shown opened (e.g., by depressurizing the valve 200 using the fill port 210) and the intraluminal device 600 is removed from the treatment system 100. Figure 24 The intraluminal device 600, and specifically the implantable device 610, is shown subsequently placed in the pocket 1010, with treatment media (e.g., sterile liquid) received into the pocket. In this optional step, the now treated implantable device 610 is substantially prevented from resorbing air. In other words, by placing the implantable device 610 in treatment media (e.g., sterile saline), the efficacy of the treatment (e.g., flushing) is substantially preserved.

[0138] ​Various features associated with some examples, but not others, have been particularly described. However, this is not intended to exclude from the examples features that are associated with other examples. On the contrary, such combinations are contemplated and form part of the disclosure. The inventive concept has been described with a certain degree of particularity with reference to particular embodiments. It will be understood by those skilled in the art that various modifications and changes can be made to the embodiments without departing from the scope of the disclosure. It is intended that the embodiments cover the modifications and changes as long as they come within the scope of the appended claims and their equivalents.

Claims

1. A method of processing an endoluminal device for introduction into a patient, the method comprising: positioning the endoluminal device into a processing system, the processing system comprising a valve and a processing chamber extending from the valve, the endoluminal device comprising a first portion extending through the valve and a processing portion extending into a processing space of the processing chamber, the first portion extending through the valve such that a sleeve maintaining at least a portion of the endoluminal device in a compact delivery state extends through a portion of the valve and into the processing chamber; closing the valve to seal the valve against the first portion of the endoluminal device; digitally sealing the processing chamber by a finger or thumb of a user; and delivering a processing medium into the processing space of the processing chamber to expose the processing portion of the endoluminal device to the processing medium.

2. The method of claim 1, wherein, Further comprising adjusting a length of the processing chamber.

3. The method of claim 1 or 2, wherein, The valve closes over the sleeve and the processing medium exits the processing chamber from the valve through one or more gaps between the sleeve and the implantable device.

4. A processing system for an endoluminal device, comprising: a proximal valve configured to receive the endoluminal device, the proximal valve comprising a proximal sealing mechanism actuatable between a sealed state and an unsealed state to seal around the endoluminal device; and a processing chamber configurable to receive a portion of the endoluminal device, the processing chamber fluidly coupled to the proximal valve such that a sleeve maintaining at least a portion of the endoluminal device in a compact delivery state extends through a portion of the proximal valve and into the processing chamber, the processing chamber having a proximal portion fluidly coupled to the proximal valve and a distal portion that is fluid tight or sealed in one of the following: a cover member extending distally from the proximal valve, a clamp member, or a plug.

5. The processing system of claim 4, wherein, The endoluminal device is received in the processing chamber, the proximal valve is closed over the sleeve, and there is a pressurized processing medium within the processing chamber.

6. The processing system of claim 4 or 5, wherein, The processing system further comprises a distal valve comprising a distal sealing mechanism actuatable between a sealed state and an unsealed state to seal around the endoluminal device, and an introducer sheath removably coupled to the distal valve.

7. The processing system of claim 6, wherein, The introducer sheath comprises a hemostasis valve removably coupled to the distal valve.

8. The processing system of claim 4 or 5, wherein, The processing chamber is configured to be adjustable in length, the processing chamber comprising one or more of the following: one or more removable segments, one or more longitudinally splittable features, a longitudinally compressible configuration, and / or a configuration that lengthens or retracts in length when a twisting force is imparted to the processing chamber.

9. The processing system of claim 4 or 5, wherein, The endoluminal device is partially inserted through the proximal sealing mechanism of the proximal valve such that either end of the endoluminal device is on either end of the proximal sealing mechanism.

10. The processing system of claim 4, wherein, A portion of the processing medium is configured to flow out of the processing system and past the proximal valve when the proximal valve is sealed.

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