Air release quantification and back bleed flushing technology and features for internal prosthetic organ delivery systems

Abstract

Techniques and features for reducing the potential release of air during the deployment of intraluminal devices (e.g., thoracic aortic stent grafts). Methods for quantifying the effectiveness of pre-treatment techniques and features for reducing such air are also described. Such air reduction helps reduce the risk of air embolism during device deployment (e.g., implants such as stent grafts), potentially mitigating the risk of adverse effects from such embolisms.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the benefit of U.S. Patent Application No. 18 / 637,257, filed Apr. 16, 2024, "Air Release Quantification and Back - bleed Flushing Techniques and Features for an Internal Organ Delivery System", which claims the benefit of Provisional Application No. 63 / 459,849, filed Apr. 17, 2023, "Air Release Quantification and Back - bleed Flushing Techniques and Features for an Internal Organ Delivery System", and for all purposes, the entire contents of these applications are incorporated herein by reference.

Background Art

[0002] Background Intraluminal devices are generally introduced 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 to prevent backflow of body fluid (e.g., blood) through the introducer and to permit insertion of the intraluminal device into the patient's body through the introducer. In various situations, a clinician or other user of the intraluminal device may also wish to perform one or more procedures on the intraluminal device.

[0003] A particularly advantageous introducer system is the one sold by WL Gore & Associates, Inc. under the trade name GORE® DrySeal Flex Introducer Sheath. The GORE® DrySeal Flex Introducer Sheath is intended to provide a conduit for insertion into the vascular system for inserting intravascular devices, while simultaneously minimizing blood loss associated with such insertion. The GORE® system includes an introducer sheath fitted with a GORE® DrySeal Valve, a twist-lock dilator, and a syringe. The introducer sheath is a composite tube consisting of a hydrophilic coated Pebax® outer tube reinforced with flat stainless steel wire and a PTFE liner with a tapered tip. The introducer sheath is fitted with a GORE® DrySeal Valve. The GORE® DrySeal 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 solution into that area using a syringe. Further examples of similar systems can be found in U.S. Patent No. 10,155,104, “Valve Assembly for Medical Procedures,” filed by WL Gore & Associates, Inc.

[0004] Some methods for pre-treating intraluminal devices prior to deployment and / or delivery of the device to a target site within the body include inserting an internal prosthesis delivery catheter for an internal prosthesis device (GORE® TAG® Conformable Thoracic Stent Graft) via a guidewire into a valve of an introducer sheath (GORE® DrySeal Sheath) and stopping when only the posterior end of the constrained internal prosthesis device is visible, thereby allowing blood to flow back through the constrained internal prosthesis device. [Overview of the Initiative]

[0005] Abstract The various techniques and features discussed herein relate to the reduction of air that may be released during the deployment of intraluminal devices (e.g., thoracic aortic stent graft devices). Methods for quantifying the effectiveness of pretreatment techniques and features for reducing such air are also discussed. Such air reduction helps to reduce the risk of air embolism during the deployment of devices (e.g., implants such as stent grafts), potentially reducing the risk of adverse effects caused by such embolisms.

[0006] According to one example ("Example 1"), the intraluminal device delivery system includes an intraluminal device, an implant having a first end and a second end, wherein the implant is comprised of a collapsed delivery configuration, the implant includes a delivery catheter including a body to which an intraluminal device is attached, the implant having one or more air-filled cavities defined by the collapsed implant, and a treatment system including a delivery sheath and a valve coupled to the delivery sheath, the valve being operable between a sealed configuration and an unsealed configuration, the implant protruding proximally from the valve at a protrusion distance of about 1 cm, the treatment system defining a blood pathway between the delivery sheath and the body of the catheter, the blood passing from the first end of the implant to the second end of the implant and into one or more cavities defined by the collapsed implant, and the valve being operable from an unsealed state in which blood bypasses the blood pathway to a sealed state in which blood is pushed along the blood pathway.

[0007] In one example ("Example 2"), in addition to Example 1, the implant protrudes 0.5 cm to 1.5 cm proximally from the valve.

[0008] According to one example ("Example 3"), in addition to Example 1 or 2, the implant includes an implant visual insertion marker corresponding to the protrusion distance.

[0009] According to one example ("Example 4"), in addition to Examples 1-3, the intraluminal device further includes a retaining sleeve for maintaining the implant in a collapsed delivery configuration.

[0010] According to one example ("Example 5"), in addition to Example 4, the retaining sleeve includes a sleeve insertion visual marker corresponding to the protrusion distance.

[0011] According to one example ("Example 6"), the intraluminal device delivery system includes an intraluminal device comprising a delivery catheter including a body to which an intraluminal device is attached, having an implant having a first end and a second end, wherein the implant is composed of a collapsed delivery configuration, and the implant has one or more air-filled voids defined by the collapsed implant; and a delivery sheath, and a seal between the delivery catheter and the delivery sheath, the seal located proximal to the implant corresponding to the protrusion distance between the seal and the implant. The treatment system includes a delivery sheath having a distal end configured to be exposed to blood pressure, the treatment system having one or more vents configured to vent to ambient air pressure, the one or more vents having openings located distal to the seal and proximal to the implant, thereby the treatment system defining a blood pathway between the delivery sheath and the body of the catheter, the blood passing from a first end of the implant to a second end of the implant and out through the one or more vents, and the blood being directed to one or more voids defined by the collapsed implant.

[0012] According to one example ("Example 7"), in addition to Example 6, the one or more vents have an outlet located distal to the seal.

[0013] According to one example ("Example 8"), in addition to Example 7, the one or more vents are formed within the delivery sheath.

[0014] According to one example ("Example 9"), in addition to Example 6, the one or more vents have an outlet located proximal to the seal.

[0015] According to one example ("Example 10"), in addition to Example 9, the outlet is located at the proximal end of the treatment system.

[0016] According to one example ("Example 11"), in addition to Example 9 or 10, the one or more vents are formed within the delivery catheter.

[0017] According to one example ("Example 12"), in addition to Examples 9-11, the one or more vents are formed as vent tubes, tubular lumenes or snorkels, providing a fluid conduit from the distal end to the seal, and to the proximal opening located toward the proximal end of the treatment system.

[0018] According to one example ("Example 13"), in addition to Examples 6-12, the implant includes an implant visual insertion marker corresponding to the projection distance.

[0019] According to one example ("Example 14"), in addition to Example 13, the implantable visual insertion marker includes radiographic material.

[0020] According to one example ("Example 15"), in addition to Examples 6-12, the delivery catheter includes a delivery catheter visual insertion marker corresponding to the protrusion distance.

[0021] According to one example ("Example 16"), an intraluminal device delivery system having a pre-selected projection distance of an intraluminal device from a delivery sheath of the system, the system includes an intraluminal device having an outer surface and configured to transition from a diametrically compressed delivery configuration to a diametrically expanded deployment configuration, wherein the implant includes a retaining sleeve that constrains the implant to a diametrically compressed delivery configuration, the implant having a proximal end, a distal end opposite the proximal end, and a length between the proximal end and the distal end, and a delivery sheath configured to introduce the intraluminal device into the body of a patient, wherein at least one of the implant and the retaining sleeve includes a visual insertion marking on its outer surface, and the system includes a delivery sheath configured to introduce the intraluminal device into the body of a patient, the visual insertion marking corresponding to the pre-selected projection distance of the intraluminal device from the delivery sheath.

[0022] According to one example ("Example 17"), in addition to Example 16, the visual insertion marking is visible to the naked eye.

[0023] According to one example ("Example 18"), in addition to Example 16 or 17, the visual insertion marking is aligned with the proximal end of the treatment system at the pre-selected projection distance.

[0024] According to one example ("Example 19"), an intraluminal device delivery system having a pre-selected protrusion distance of an intraluminal device from a seal of a delivery sheath of the system, the system includes an intraluminal device, comprising a delivery catheter including a body to which the implant is attached, the implant having a first end and a second end, wherein the implant is composed of a collapsed delivery configuration, the implant is defined by the collapsed implant and has one or more air-filled voids, and the system includes a delivery sheath and a seal between the delivery catheter and the delivery sheath at a position proximal to the implant, the seal including a seal corresponding to the protrusion distance between the seal and the implant, wherein at least one of the implant and the delivery catheter has a visual insertion marking on its outer surface corresponding to the pre-selected protrusion distance of the intraluminal device from the delivery sheath.

[0025] According to one example ("Example 20"), in addition to Example 19, the visual insertion marking is visible to the naked eye.

[0026] According to one example ("Example 21"), in addition to Example 19 or 20, the visual insertion marking is aligned with the proximal end of the treatment system at the pre-selected projection distance.

[0027] According to one example (Example 22), a method for pretreating an intraluminal device by back bleeding, the method comprising: disposing a treatment system within a patient's body cavity such that a distal portion of the treatment system is exposed to blood at blood pressure; inserting an intraluminal device comprising an implant and a delivery catheter in a diametrically compressed and collapsed state into the treatment system at a preselected protrusion distance, wherein the treatment system comprises a delivery sheath and a seal between the intraluminal device and the treatment system; and flowing blood along a blood path defined between a distal portion and a proximal portion of the treatment system, wherein the blood path extends through a first end of the implant to a second end of the implant and into one or more voids defined by the implant, whereby reducing the volume of entrained air within the one or more voids.

[0028] According to one example (Example 22), in addition to Example 21, the volume of the entrained air is reduced to 10 μL or less.

[0029] According to one example (Example 23), in addition to Example 21, the volume of the entrained air is reduced to 5 μL or less.

[0030] According to one example (Example 24), in addition to Example 21, the volume of the entrained air is reduced to 2 μL or less.

[0031] According to one example (Example 25), in addition to Examples 21-24, at least one of the implant, the delivery catheter, and the retention sleeve of the intraluminal device comprises a visual insertion marking on its outer surface corresponding to the preselected protrusion distance, and the method further comprises inserting the intraluminal device into the treatment system to the preselected protrusion distance using the visual insertion marking.

[0032] According to one example (Example 26), in addition to Example 25, the method comprises using the visual insertion marking with the naked eye.

[0033] According to one example ("Example 27"), in addition to Examples 21-26, flowing blood along the blood pathway includes observing two or three drops of blood from the blood pathway. [Brief explanation of the drawing]

[0034] Brief explanation of the drawing [Figure 1] Figure 1 shows several embodiments of the intraluminal device delivery system 10.

[0035] [Figure 2] Figure 2 shows a partial longitudinal section of a treatment system near a valve according to several embodiments.

[0036] [Figure 3] Figure 3 is an isometric view of the same parts as the treatment system in Figure 2, but in an exploded state, according to several embodiments of the treatment system.

[0037] [Figure 4] Figure 4 is an end view of a treatment system showing a pressurized and sealed valve according to several embodiments.

[0038] [Figure 5] Figure 5 shows intraluminal devices in the form of a transcatheter delivery system, according to several embodiments, which include a catheter and an implantable device maintained in a compressed delivery diameter or state by the delivery catheter. [Figure 6] Figure 6 shows intraluminal devices in the form of a transcatheter delivery system, according to several embodiments, which include a catheter and an implantable device maintained in a compressed delivery diameter or state by the delivery catheter.

[0039] [Figure 7]Figure 7 shows intraluminal devices in the form of a transcatheter delivery system, according to several embodiments, which include a catheter and an implantable device maintained in a compressed delivery diameter or state by the delivery catheter.

[0040] [Figure 8] Figure 8 shows intraluminal devices in the form of a transcatheter delivery system, according to several embodiments, which include a catheter and an implantable device maintained at a delivery diameter or state compressed by the delivery catheter.

[0041] [Figure 9] Figure 9 is an enlarged schematic cross-section and partial view of a part of the treatment system of Figure 1, which includes an intraluminal device at the treatment site, and illustrates several embodiments of a method for pre-treating the intraluminal device using the back bleed method.

[0042] [Figure 10] Figure 10 shows examples of treatment sequences for intraluminal devices using the treatment system of Figure 1, according to several embodiments. [Figure 11] Figure 11 shows examples of treatment sequences for intraluminal devices using the treatment system of Figure 1, according to several embodiments. [Figure 12] Figure 12 shows examples of treatment sequences for intraluminal devices using the treatment system of Figure 1, according to several embodiments.

[0043] [Figure 13] Figure 13 is a schematic cross-sectional view of another intraluminal device delivery system according to several embodiments.

[0044] [Figure 14] Figure 14 is a schematic cross-sectional view of yet another intraluminal device delivery system according to several embodiments.

[0045] [Figure 15]Figure 15 shows various features of air release tests (ART) according to several embodiments. [Figure 16] Figure 16 shows various features of air release tests (ART) according to several embodiments. [Figure 17] Figure 17 shows various features of air release tests (ART) according to several embodiments. [Figure 18] Figure 18 shows various features of air release tests (ART) according to several embodiments. [Figure 19] Figure 19 shows various features of air release tests (ART) according to several embodiments.

[0046] [Figure 20] Figure 20 shows data corresponding to various system examples based on several embodiments. [Figure 21] Figure 21 shows data corresponding to various system examples according to several embodiments. [Figure 22] Figure 22 shows data corresponding to various system examples according to several embodiments. [Figure 23] Figure 23 shows data corresponding to various system examples based on several embodiments. [Figure 24] Figure 24 shows data corresponding to various system examples according to several embodiments. [Figure 25] Figure 25 shows data corresponding to various system examples according to several embodiments.

[0047] The accompanying drawings are included to enhance the understanding of this disclosure, are incorporated into this specification, constitute part of it, illustrate embodiments, and help to explain the principles of this disclosure together with the description. Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of this disclosure, and in that respect, the drawings should not be construed as limiting. [Modes for carrying out the invention]

[0048] Detailed explanation Definitions and Terms This disclosure is not intended to be confined to any particular purpose. For example, terms used in this application should be interpreted broadly in relation to the meanings that parties in the art may assign to such terms.

[0049] With regard to imprecise terminology, the terms “about” and “approximately” may be used interchangeably to refer to measurements that include the stated measurement and measurements that are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates by a reasonably small amount from the stated measurement to the extent that it can be understood and readily verified by a person skilled in the art. Such deviations may result from, for example, measurement errors, differences in the calibration of measuring instruments and / or manufacturing equipment, human error in reading and / or setting of measurements, fine-tuning made to optimize performance and / or structural parameters to account for differences in measurements related to other components, specific implementation scenarios, improper adjustment and / or handling of an object by a person or machine, and / or similar. If it is determined that a person skilled in the art cannot readily verify the value of such a reasonably small difference, the terms “about” and “approximately” shall be understood to mean ±10% of the stated value.

[0050] Description of various embodiments The various techniques and features discussed herein relate to the reduction of air that may be released during the use of intraluminal devices (thoracic aortic stent graft devices). Methods for quantifying the effectiveness of pretreatment techniques and features for reducing such air are also discussed. Such air reduction helps to reduce the risk of air embolism during stent graft deployment and may reduce the risk of adverse effects caused by such embolisms.

[0051] Figure 1 shows an intraluminal device delivery system 10 in several embodiments. System 10 includes a treatment system 100 (sometimes referred to as an introducer system) which includes a valve 200, a delivery sheath 400, and an optional dilator 500. System 10 also includes an intraluminal device 600 (for example, in the form of a transcatheter delivery system which includes a catheter and an implantable device maintained at a delivery diameter or state compressed by the delivery catheter). The intraluminal device 600 includes an implant 610 or implantable device 610 delivered by a delivery catheter 620. The intraluminal device 600 also includes a retaining sleeve 630 for restraining the implant 610.

[0052] Figure 2 shows a longitudinal section of a portion of the treatment system 100 near the valve 200. Generally speaking, the treatment system 100 includes a lumen 101 that extends continuously along the entire length of the treatment system 100, including the valve and the delivery sheath 400, and is configured to facilitate the introduction of the intraluminal device into the body cavity.

[0053] The treatment system 100 can be used to introduce an intraluminal device into a patient's body (not shown) by passing the intraluminal device through the lumen 101 from an external location to an internal location within the patient's body. The treatment system 100 can be used with various intraluminal devices as shown in Figures 1 and 6-9. In various examples, the treatment system 100 is used to treat an intraluminal device using a back-bleed method (e.g., flushing or degassing one or more parts of the intraluminal device 600, such as an implant, using blood at arterial pressure) (e.g., flushing air from a part of the intraluminal device).

[0054] Figure 2 is a magnified partial dissection of the proximal portion of the treatment system 100, showing various features of the proximal valve 200 in its assembled state. Figure 3 is an isometric view of the same portion of the treatment system 100 as in Figure 2, but in a disassembled state. Figure 4 is an end view of the treatment system 100 showing the valve 200 in a pressurized and sealed state in several examples.

[0055] Valve 200 is generally configured to receive an intraluminal device (e.g., a dilator, intravascular delivery system, balloon catheter, percutaneous delivery system, etc.) and to provide a fluid seal around the outer surface of the intraluminal device to prevent undesirable backflow around the intraluminal device and undesirable backflow (e.g., backflow of blood and / or treatment medium) returning through the lumen 101 of the treatment system 100. Furthermore, when the intraluminal device is not present (e.g., as shown in Figure 4), valve 200 is configured to close completely or to close and seal itself, thus creating a closed or sealed state. Here again, this prevents undesirable backflow (e.g., backflow of blood and / or treatment medium) through the proximal valve 200. A good example of the design, materials and manufacturing method of the proximal valve 200 and delivery sheath 400 can be found in U.S. Patent No. 10,155,104, “Valve Assembly for Medical Treatment,” but various designs, materials and manufacturing methods of such valves are possible. As mentioned above, the valve 200 and delivery sheath 400 are compatible with the GORE® DrySeal Flex Introducer Sheath, available from WL Gore & Associates, Inc.

[0056] As shown in Figure 2, the valve 200 has a lumen 201 extending along the length of the valve 200. As previously stated, the lumen 201 of the valve 200 forms part of the lumen 101 of the treatment system 100. The valve 200 includes a sealing mechanism 202 that is operable between a sealed and an unsealed state in order to open, close or expand part of the lumen 201. The sealing mechanism 202 includes an outer tube 204, an inner tube 206, a pressurizable space 208 (Figure 2) formed between the inner surface of the outer tube 204 and the outer surface of the inner tube 206, and a filling port 210. As is evident from the figure, it should be noted that the pressurizable space 208 is largely sealed except for access provided by the filling port 210 in various examples. As shown in the figure, the sealing mechanism 202 also includes a rear ring 218 and a front ring 220 fixed in opposite directions toward both ends of the outer tube 204. These rings generally help to support, seal, and connect the sealing mechanism 202 to the rest of the valve.

[0057] The valve 200 also includes a rear fitting 224 attached to a rear ring 218 and a front fitting 226 attached to a front ring 220 (e.g., via complementary threads, adhesive, snap-fit, fasteners and / or other mechanisms). The rear fitting 224 and front fitting 226 help to secure various parts of the valve to each other in a sealed state and can also provide a mechanism or method for securing the valve to other components of the treatment system 100, such as a delivery sheath 300.

[0058] In addition to the filling port 210, the valve 200 also has a flush port 230 (also referred to as a flush port) distal to the sealing mechanism 202, which is in fluid communication with the lumen 201 of the valve. As will be described later, the flush port 230 may be used to deliver the treatment medium into the treatment chamber 300.

[0059] In some embodiments, the outer tube 204 has an hourglass shape in its relaxed state, but cylindrical and other shapes are also possible. The outer tube 204 has elastic properties (e.g., formed from an elastomer material) and can expand (physically expand) under pressure in the pressurizable space 208, bending radially outward from its hourglass shape to a more cylindrical state, and even a more bulbous, outwardly convex shape. In some examples, the outer tube 204 is formed from a silicone material (e.g., using insert molding techniques), but a variety of materials are possible, including various elastomer materials or materials with elastic properties. For example, the outer tube 204 may be composed of any elastomer, latex, or polycarbonate having desirable mechanical properties and biocompatibility.

[0060] The expansion characteristics of the outer tube 204 can provide a visual indication that the pressurizable space 208 has been brought to positive pressure and therefore the valve has been closed. In some examples, when the sealing mechanism 202 is brought to positive pressure and closed, the hourglass shape of the outer tube 204 expands, indicating the desired positive pressure in the pressurizable space 208 (e.g., a positive pressure sufficient to prevent backflow through the sealing mechanism 202).

[0061] The inner tube 206 can be made of any thin, strong, and draping material, such as ePTFE, fabric, silk, or Kevlar® brand fibers. Such materials can be used as a single-layer or multi-layer structure as appropriate. As shown in the figure, the inner tube 206 may have an hourglass shape when relaxed. The shape of the inner tube 206, including wall thickness, length, width, diameter, and other features, can be modified as desired.

[0062] During use, the inner tube 206 is thin and conformable, so when the pressurizable space 208 is pressurized, the inner tube 206 bends inward, draping over the outer circumference of the intraluminal device received through the valve, i.e., conforming to it and forming a seal. When the intraluminal device is not present, the inner tube 206 bends inward, thereby engaging the inner surfaces of the inner tube 206 together to form a seal.

[0063] As shown in the figure, the filling port 210 includes a coupling mechanism 211 associated with the front ring 220 and a path 212 formed through the outer tube 204 to the pressurizable space 208. The coupling mechanism 211 is configured to be attached to a syringe as needed (for example, the coupling mechanism 211 can be configured as a Luer fitting with a valve). Regardless of the specific path, the filling port 210 provides means for pressurizing (or depressurizing) the pressurizable space 208. In particular, the filling port 210 is in fluid communication with the pressurizable space 208.

[0064] The filling port 210 can be configured to connect to any of the following positive or negative pressure sources (fluid or gas), including a syringe (not shown). For reference, the pressurizable space 208 can be filled with any suitable material. For example, while saline solutions may be preferred in certain applications, the pressurizable space 208 can be positively pressurized with one or more of the following, or combinations thereof: air, silicone, water, saline solutions, low-volatility biocompatible liquids, glycerin, propylene glycol, polyethylene glycol, compressible foam, elastomer spheres, cross-linked silicone gels.

[0065] In any case, the sealing mechanism 202 can be closed or opened, respectively, by using a pressure source to deliver a suitable material (e.g., a salt solution) to the pressurizable space 208 (applying positive pressure) or to remove the material from the pressurizable space 208 (applying negative pressure or depressurizing). In particular, according to various embodiments, when the pressurizable space 208 is pressurized using the filling port 210, the inner tube 206 collapses inward (e.g., toward the inner tube 206 itself or around the device received through the inner tube 206) to form a seal. Figure 4 shows an end view of the treatment system 100 in which the inner tube 206 of the valve has collapsed and engaged with the inner tube 206 itself under positive pressure.

[0066] The forward fitting 226 is secured to the forward ring 220 and the proximal portion of the treatment chamber 300 (for example, via complementary threads as shown in Figure 2), thereby assisting fluid communication between the valve and the treatment chamber 300. The forward fitting 226 or a portion thereof can be formed using a transparent material (for example, a transparent or translucent polymer), so that the user of the treatment system 100 can visually confirm that the device (or a portion thereof) inserted into the treatment system 100 has passed through the valve and, in particular, beyond the sealing mechanism 202.

[0067] As shown in the figure, the flush port 230 communicates with the lumen 201 distal to the sealing mechanism 202. The flush port 230 includes a coupling mechanism 232 (e.g., a Luer fitting with a valve for sealing and unsealing the flush port 230) and a path 234 entering the lumen 201 of the valve 200 through a forward fitting 226 (e.g., distal to the sealing mechanism 202 as shown in the figure). Regardless of the specific path, the flush port 230 provides means for transporting the treatment medium into and / or outside the lumen 201 of the valve (and into or outside the proximal portion of the treatment chamber 300), as will be described later.

[0068] As shown in Figure 1, the delivery sheath 400 is connected to the forward fitting 226 of the valve 200 (for example, via complementary threads of two components). The delivery sheath 400 is substantially tubular and has a lumen (not shown) that forms part of the lumen 101 of the treatment system 100. The delivery sheath 400 can be formed from a variety of materials, but in some examples it is formed from fluorinated ethylene propylene (FEP), high-density polyethylene and / or other suitable materials. The outer diameter of the delivery sheath 400 can be configured in a range of sizes, but in some examples it is 12Fr to 26Fr. The delivery sheath 400 can have any of a variety of lengths as desired and can be inserted into a patient's body cavity (e.g., the vascular system) to assist in the introduction of an intraluminal device into the patient (not shown).

[0069] In some cases, a portion of the treatment system 100 (e.g., a portion of the valve 200 and / or delivery sheath 400) is transparent, thereby allowing the user to better or more easily visually confirm the proper placement of the intraluminal device 600 within the treatment system 100.

[0070] The optional dilator 500, when used in combination with the treatment system 100, allows access to one or more body cavities of a patient. When used, the dilator 500 is received through the lumen 101 of the treatment system 100 and, when used in combination with the treatment system 100, provides access to the patient's body cavities (e.g., blood vessels, airways, biliary tract, gastrointestinal tract, cardiac cavities, etc.). Various valves in the treatment system 100 help prevent back-bleeding through the treatment system 100 during dilation procedures using the dilator 500. As shown in the figure, 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 also helps prevent the dilator 500 from retracting when it is inserted into the patient's body.

[0071] Figures 6 and 7 show an intraluminal device 600 in the form of a transcatheter delivery system, which includes a catheter and an implantable device maintained in a compressed delivery diameter or state by the delivery catheter. The implantable device defines the flush portion, i.e., the portion of the intraluminal device 600 in which the procedure is performed. In particular, the intraluminal device 600 in Figures 8 and 9 includes an internal prosthesis 610E (e.g., a stent graft) maintained in a diametrically compressed state by the delivery catheter 620E. As shown, the delivery catheter 620E employs a retaining sleeve-restrained delivery system, such as that described in U.S. Patent No. 9,592,143, “Sleeve for Expandable Medical Devices”. The internal prosthesis 610E can be moved between a fully compressed delivery diameter or state (e.g., as shown in Figures 6 and 7) and a fully expanded deployed diameter using a delivery catheter 620E, which releases the retaining sleeve 630E, and the internal prosthesis 610E being transported by the delivery catheter 620E is deployed.

[0072] Figure 7 shows an intraluminal device 600 in the form of a transcatheter delivery system, comprising a catheter and an implantable device maintained in a compressed delivery diameter or state by the delivery catheter. The implantable device defines the flush portion, i.e., the portion of the intraluminal device 600 in which the procedure is performed. In particular, the intraluminal device 600 in Figure 7 includes an artificial valve 610V (e.g., an artificial heart valve) maintained in a diametrically compressed state by the delivery catheter 620V. As shown, the delivery catheter 620V employs a fiber-restricted delivery system as described in U.S. Provisional Application No. 16 / 129,657, filed September 12, 2018, with the invention title "Transcatheter Deployment System and Related Methods". The artificial valve 610V can be transitioned using the delivery catheter 620V between a fully compressed delivery diameter or state, a partially compressed treatment diameter (e.g., as shown in Figure 7), and a fully expanded deployment diameter. The delivery catheter 620V can tighten and loosen the restraint device 630V, which is releasably coupled to the artificial valve 610V.

[0073] Figure 8 shows an intraluminal device 600 in the form of a transcatheter delivery system, comprising a catheter and an implantable device maintained in a compressed delivery diameter or state by the delivery catheter. The implantable device is included in the flush portion, i.e., the portion of the intraluminal device 600 in which the procedure is performed. In particular, the intraluminal device 600 in Figure 8 includes a septal occluder 610S (e.g., an atrial septal occluder) maintained in a diametrically compressed state by the delivery catheter 620S. As shown in the figure, the delivery catheter 620S employs a sheath or tube-restrained delivery system, such as that described in U.S. Patent No. 8,956,389, "Sealing Devices and Delivery Systems." The septal occluder 610S can be transitioned between a fully compressed delivery diameter or state, a partially compressed treatment diameter, and a fully expanded deployment diameter (for example, as shown in Figure 8) using the delivery catheter 620S, which extends and retracts the septal occluder 610S from the sheath or tube 630S associated with the delivery catheter 620S.

[0074] In some cases, after the implantable device 610 has been treated as desired (e.g., by air flushing, blood wetting, or other treatment), the implantable device 610 can be tracked to a desired location within the body by advancing it through the delivery sheath 400 of the treatment system 100 and then withdrawing it (e.g., by tracking the implantable device 610 on a guidewire).

[0075] Figure 9 shows an enlarged schematic cross-section and partial view of part of the treatment system 100 of Figure 1, in which the intraluminal device 600 is in the treatment position according to several methods for pre-treating the intraluminal device 600 using the back-bleed method. The intraluminal device 600 can be, for example, a GORE® TAG® thoracic branch internal prosthesis aortic component ("TBE aortic component"), a GORE® TAG® thoracic branch internal prosthesis side branch (SB) component ("TBE side branch"), or a GORE® TAG® conformable thoracic stent graft ("CMDS") with an ACTIVE CONTROL system, available from WL Gore & Associates, Inc., headquartered in Newark, Delaware.

[0076] 600 includes an implant 610 (e.g., a stent graft), which is held in a diametrically compressed state by a releasable retaining sleeve 630 using a delivery catheter 620 to which the implant 610 is releasably coupled. As shown in the figure, the delivery sheath 400 is inserted into and received within a blood vessel V, such as an arterial vessel. The intraluminal device 600, in particular the implant 610 and the retaining sleeve 630, is partially translated within the delivery sheath 400 and extends to one side of the valve 200. The implantable device 610 and the retaining sleeve 630 are partially positioned within the valve 200, with the other portion protruding proximally from the valve 200 by a desired amount. In particular, the implantable device extends proximally posteriorly from across the sealing mechanism 202. In examples where part of the treatment system 100 (e.g., part of the valve 200 and / or delivery sheath 400) is transparent, the user can visually confirm the proper placement of the implant 610.

[0077] Valve 200 is pressurized and closed, forming a seal around the intraluminal device 600, particularly around the implant 610 and a portion of the retaining sleeve 630 within the sealing mechanism 202. As shown in the figure, the retaining sleeve 630 is open at its proximal end 632 and distal end 634, and the blood pathway P is defined to enter through the delivery sheath, through the open distal end 632, through the implant 610 (e.g., through the diametrically compressed body formed by the implant 610), and exit through the proximal end 632. In particular, pressurized blood (e.g., mean arterial pressure) is prevented from passing around the retaining sleeve 630, and is instead carried along the blood pathway P by blood pressure, eventually "back-bleeding" through the implant and being discharged from the implant 610 (e.g., outside the patient's body). The blood flow from the implant 610 can be relatively slow (drop by drop). In particular, the pressure difference between the internal blood pressure (e.g., mean arterial pressure) and the ambient external pressure at the posterior end of valve 200 causes the blood to flow along the blood pathway P.

[0078] The implant is compressed diametrically and collapses in itself, generally defining voids, or openings, in the space between the diametrically compressed portions of the implant 610 (schematically represented by dashed lines in Figure 9). As blood flows through these voids along the blood pathway P, any air trapped or taken into the implant 610 within these voids is pushed out of the device. This mechanism involves the absorption of air by the blood (e.g., hemoglobin) and / or the air being pushed out of the voids by fluid pressure and discharged from the proximal end of the implant 610. In other words, when sufficient back pressure (e.g., by mean arterial pressure, i.e., MAP) is applied, the blood passes through folds, creases, or gaps present within the implantable device 610 or between the implantable device and the retaining sleeve 630. The pressurized blood then "passes" through the gaps via the closed valve 200 and is discharged from the treatment system 100.

[0079] It can be particularly beneficial that the valve 200 is closed on the outer circumference of the implantable device 610 and associated retaining mechanism, in which case the treatment medium is less likely to simply pass around the implantable device 610 and retaining mechanism, and is instead forced to pass through gaps, folds or creases and spaces where air may be trapped. As shown in the figure, the implant 610 and retaining sleeve 630 protrude proximally from the valve 200 by a protrusion distance D. In some examples, the protrusion distance D is greater than 0 cm and less than 1 cm. In some examples, the protrusion distance D is about 1 cm. In some examples, the protrusion distance D is at least 1 cm. Surprisingly, it has been found that when the protrusion distance is greater than 0 cm (e.g., about 1 cm), it is particularly effective in reducing air trapped within the implant 610.

[0080] In some embodiments, the retaining sleeve 630 and / or implant 610 include a visual insertion marker 612 (Figure 1) (e.g., implant visual insertion marker 612 and / or retaining sleeve visual insertion marker 612) for the user to confirm that an appropriate protrusion distance D has been achieved. For example, the visual insertion marker 612 may be a visual band (e.g., ink, different material, or other marker) associated with the retaining sleeve 630, the implant 610, or both. In some examples, the retaining sleeve 630 is transparent or translucent, thereby allowing the visual insertion marker 612 to be associated with the implant 610 and visible through the retaining sleeve 630. The visual insertion marker 612 may include a visible circumferential band, symbol, text, or other indicator to guide the user about the appropriate insertion depth and corresponding protrusion distance D of the intraluminal device in the valve 200.

[0081] In various cases, once the implantable device 610 has been prepared as desired (e.g., by air flushing, wet-out, or other procedures), the treatment system 100 can be introduced into the patient's body, and the delivery of the implantable device 610 can proceed in a desired manner (e.g., by expansion and deployment from the delivery catheter 620).

[0082] Figures 11-13 show exemplary treatment sequences for intraluminal devices using the treatment system of Figure 1, according to several embodiments. As shown in Figure 10, the expansion medium source (IMS) and the flush medium source (TMS) are coupled to the filling port 210 and the flush port 240 of the valve 200, respectively. The expansion medium source (IMS) is a syringe filled with an expansion medium (e.g., a saline solution) that pressurizes and depressurizes the valve 200 to open and close the valve 200. The flush medium source (TMS) is optionally a flush medium (e.g., a saline solution) filled in a syringe.

[0083] Figure 11 shows a delivery sheath 400 inserted into the patient's body B to access a blood vessel (not shown). Figure 11 also shows an intraluminal device 600 (e.g., in the form of a transcatheter delivery system including a catheter and an implantable device maintained at a delivery diameter or state compressed by the delivery catheter) immediately before being introduced into a valve 200 of the treatment system 100.

[0084] Figure 12 shows a delivery sheath 400 inserted into the patient's body B to access a blood vessel (not shown). The intraluminal device 600 is introduced into the valve 200 with the implantable device 610 partially extending from the valve 200, with part of the implantable device 610 inside the delivery sheath 400 and part protruding from the valve 200. The valve 200 is pressurized using an expansion medium source (IMS) (Figure 12) and transitions to a pressurized closed state so that the valve 200 closes to cover the implantable device 610.

[0085] Figure 13 is a schematic cross-sectional view of another intraluminal device delivery system 10A according to several embodiments. System 10A includes a treatment system 100A which includes a seal 200A, a delivery sheath 400A, and an intraluminal device 600A (e.g., in the form of a transcatheter delivery system which includes a delivery catheter 620A and an implantable device 610A maintained on the delivery catheter 620A with a compressed delivery diameter or delivery state). The delivery sheath 400A and / or intraluminal device 600A (e.g., delivery catheter 620A) include a seal 200A which provides a hemostatic seal between the delivery sheath 400A and the intraluminal device 600A. The seal 200A can be, for example, an O-ring or other mechanism (e.g., an actuated inflatable seal). In other embodiments, the seal 200A is simply a sufficiently tight fit between the delivery catheter 620A and the delivery sheath 400A, providing sufficient resistance to blood flow and allowing blood to flow along the blood pathway P. As shown in the figure, the delivery sheath 400A also includes one or more vents 430A and a distal portion 440A that terminates at the distal end 450A.

[0086] As schematically shown in Figure 13, the implant 610A may include an implant visual insertion marker 612A (e.g., radioactive material) corresponding to the protrusion distance D. Additionally or alternatively, the delivery catheter 620A may include a delivery catheter visual insertion marker 612A corresponding to the protrusion distance D. During use, the visual insertion marker can be used to ensure that an appropriate insertion distance D is achieved.

[0087] Generally, the distal portion 440A is configured to be inserted into the patient's body (not shown), more specifically into the patient's vascular system (arterial vascular system). The implant 610A (which may be an internal prosthesis or one of the aforementioned implants) is generally constrained in a compressed state by the delivery sheath 400A, thereby defining folds, gaps, or other spaces that may contain air, as described above. The blood pathway P is defined to run from the open distal end 450A of the delivery sheath 400, through the space between the delivery sheath 400A and the implant 610A, through the air-containing gaps or openings, and then out through one or more vents 430A of the delivery sheath 400A. When in use, the distal portion 440A is long (and flexible) enough to be inserted into the vascular system with at least some protrusion from the body, and one or more vents 430A are located outside the body. In this way, the pressure difference between the internal blood pressure (e.g., mean arterial pressure) and the ambient external pressure causes the blood to flow along the blood pathway P. Similar to the method described above, the air contained within the implant 610A and / or between the implant 610A and the delivery sheath 400A can be substantially reduced or removed.

[0088] Figure 14 is a schematic cross-sectional view of yet another intraluminal device delivery system 10B according to several embodiments. System 10B includes a treatment system 100B which includes a seal 200B, a delivery sheath 400B, and an intraluminal device 600B (e.g., in the form of a transcatheter delivery system which includes a delivery catheter 620B and an implantable device 610B maintained on the delivery catheter 620B at a compressed delivery diameter or delivery state). The delivery sheath 400B and / or intraluminal device 600B (e.g., delivery catheter 620B) include a seal 200B for providing a hemostatic seal between the delivery sheath 400B and the intraluminal device 600B. The seal 200B may be, for example, an O-ring or other mechanism (e.g., an actuated inflatable seal). In other embodiments, the seal 200B is simply provided by a sufficiently tight fit between the delivery catheter 620B and the delivery sheath 400B, providing sufficient blood flow resistance for blood to flow along the blood pathway P.

[0089] As shown, the delivery catheter 620B and / or sheath 400B include one or more vents 430B. One or more vents 430B may be in the form of a vent tube, lumen or snorkel and provide a fluid conduit from the front of the seal 200B to a proximal opening 452B located on the proximal end side of the treatment system 100B. This proximal opening 452B should be located on the treatment system 100B in a position that can be outside the user's body, thereby providing the aforementioned pressure difference between ambient pressure and blood pressure and allowing blood flow along the blood pathway P. Similarly, the delivery sheath 400B includes a distal portion 440B on the distal side of the seal 200B and terminates at a distal end 450B.

[0090] As schematically shown in Figure 14, the implant 610B optionally includes an implant visual insertion marker 612B (e.g., radiographic material) corresponding to the protrusion distance D. Additionally or alternatively, the delivery catheter 620B optionally includes a delivery catheter visual insertion marker 612B corresponding to the protrusion distance D. During use, the visual insertion marker can be used to ensure that an appropriate insertion distance D is achieved.

[0091] Generally, the distal portion 440B is configured to be inserted into the patient's body (not shown), more specifically into the patient's vascular system (arterial vascular system). The implant 610B (which may be an internal prosthesis or one of the aforementioned implants) is generally constrained in a compressed state by the delivery sheath 400B, thereby defining other spaces that may contain folds, gaps, or air, as described above. The blood pathway P is defined to exit from the open distal end 450B of the delivery sheath 400, through the air-filled gap or opening between the delivery sheath 400B and the implant 610B, and then through one or more vents 430B of the delivery catheter 620B and / or the delivery sheath 400B. When in use, the distal portion 440B is made long (and flexible) enough to be inserted into the vascular system, and the entire treatment system 100 is configured to be inserted into the patient's body (not shown) with one or more vents 430B located outside the body. Again, in this manner, the pressure difference between the internal blood pressure (e.g., mean arterial pressure) and the ambient external pressure causes the blood to flow along the blood pathway P. Similar to the method described above, the air contained within the implant 610B and / or between the implant 610B and the delivery sheath 400B can be substantially reduced or removed.

[0092] As described in more detail, several methods for pre-treating intraluminal devices for introduction into a patient's body include the use of back-bleed techniques. Several methods for pre-treating intraluminal devices by back-bleed include positioning the treatment system within the patient's body cavity such that the distal portion of the treatment system is exposed to blood at blood pressure, and inserting the intraluminal device, including the implant and delivery catheter, in a diametrically compressed and collapsed state, into the treatment system at a pre-selected protrusion distance. The treatment system includes a delivery sheath and a seal between the intraluminal device and the treatment system (e.g., a hemostatic seal provided by a valve, O-ring, seal, or other mechanism). Blood can flow along a defined blood pathway between the distal portion of the treatment system and the proximal portion of the treatment system (e.g., utilizing the pressure difference between blood pressure and ambient or environmental pressure). The blood pathway extends from the first end of the implant to the second end of the implant and into one or more voids defined by the implant, thereby reducing the amount of air trapped in one or more void spaces.

[0093] The volume of mixed air can be reduced to 10 μL or less, 5 μL or less, 2 μL or less, or any other value as desired. At least one of the intraluminal device implant, delivery catheter, and retaining sleeve may include a visual insertion marking on its outer surface corresponding to a pre-selected protrusion distance, and this method includes inserting the intraluminal device into the treatment system to a pre-selected protrusion distance using the visual insertion marking. Some embodiments include using the visual insertion marking with the naked eye. In some examples, the back-bleed method includes observing 2-3 drops of blood from the blood pathway. In some examples, the method includes back-bleeding the implant for, for example, 5 seconds, 10 seconds, 15 seconds, 30 seconds, 1 minute, or 5 minutes. In some methods, the blood pressure corresponds to the mean arterial pressure (MAP), for example, 67 mmHg or greater than 67 mmHg.

[0094] Air release test method The following describes specific methods and equipment, but please understand that other methods or equipment deemed appropriate by those skilled in the art may be used instead.

[0095] the purpose The purpose of the Air Release Test (ART) is to quantify the amount of air released during the deployment of intraluminal devices using both non-backbleed and backbleed methods.

[0096] device 2.5ml, 10ml, and 60ml syringes

[0097] Hamilton 50μL, Model 1705 TLLX, Instrument Syringe

[0098] Bubble characteristic evaluation jig

[0099] 0.035-inch guide wire

[0100] Pressure fluid chamber

[0101] Blood analogs

[0102] Air-powered water bath

[0103] Test setup Figure 15 shows a bubble characterization (ABC) fixture in which a vertical glass funnel and sampling syringe are mounted in an outer container attached to the top of the fixture. This system is connected via tubing to a pressure fluid chamber on the left, which is at an appropriate height to simulate blood pressure (e.g., mean aortic pressure). The test setup includes the following steps:

[0104] Process 1.1 The bubble characterization (ABC) fixture is prepared by placing it in the outer container and attaching a vertical glass funnel to the top of the fixture. Ensure that the pressure fluid chamber attached to the fixture is set to a height where the pressure gauge indicates a suitable blood pressure (67 mmHg) for the test.

[0105] Process 1.2 Install a pump in the bucket containing the blood analog and ensure that the blood analog can be delivered through the tubing into the pressurized fluid chamber.

[0106] Process 1.3 Ensure that the tube is connected between the pressure fluid chamber and the ABC fixture.

[0107] Process 1.4 Inflate all Gore DrySeal Valves connected to the fixture with 2.5 mL of water.

[0108] Process 1.5 Once the ABC fixture is filled with blood analogs, close and secure the plastic lid of the ABC fixture, and continue filling the rest of the fixture with blood analogs.

[0109] Process 1.6 Ensure that the funnel stopper on the vertical glass funnel is open.

[0110] Process 1.7 Maintain the system at a steady flow rate for several hours, or until no more bubbles are visible in the vertical glass funnel.

[0111] Catheter flush Catheter flushing includes: step 2.1 flushing the catheter of each device according to the flushing procedure in the Instructions for Use (IFU), step 2.2 recording the performed catheter flushing procedure (e.g., IFU number and revision number), and step 2.3 proceeding to the desired device flushing procedure below.

[0112] Device flushing The device may or may not be pre-treated (e.g., flushed) as part of the test protocol. One pre-treatment method is the use of a GORE® DrySeal Sheath Valve. Figure 16 shows an intraluminal device (test article) inserted into the pre-treated device (approximately 1 cm exposed from the back of the GORE® DrySeal Sheath Valve, allowing fluid to seep out from the exposed portion of the intraluminal device. Two to three visible drops of fluid seep out from the exposed portion of the intraluminal device). A device flushing method, including the use of a GORE® DrySeal Sheath Valve, includes the following steps:

[0113] 3.1. Ensure that the fluid chamber of the test apparatus is filled with a blood analog to a level corresponding to the appropriate blood pressure (e.g., mean aortic pressure, i.e., MAP) (tolerance ±5 mmHg). Record the pressure at the valve flush port with a blood pressure monitor.

[0114] 3.2a. No back bleed. Fully insert the test specimen into the GORE® DrySeal Sheath Valve. Proceed to the following device insertion steps.

[0115] 3.2b. Back bleed is performed. Insert the test specimen into the valve, exposing approximately 1 cm of the component to be flushed (crushed stent graft). Wait until fluid (blood analog) begins to seep out from the exposed portion of the component. Complete back bleed when fluid consistently seeps out from the exposed portion of the component (2-3 drops of fluid). Verify that the protrusion distance D is approximately 1 cm using the GORE® DrySeal Sheath Valve. Proceed to the following device insertion procedure.

[0116] Device insertion and deployment Figure 17 shows the deployment of the device after pretreatment in a vertical glass funnel. The insertion and deployment of the device includes the following steps:

[0117] 4.1. By purging the air present from the measuring syringe and stopcock, confirm that air has been purged from the entire bubble characteristic evaluation fixture system.

[0118] 4.2 Ensure the funnel stopper on the vertical glass funnel is open. Insert the appropriate guide wire into the valve.

[0119] 4.3 The test specimen is passed through the valve on the guide wire and advanced into the ABC fixture until the entire flushed component (crushed device) is visible within the vertical glass funnel.

[0120] 4.4 Complete the device deployment procedure according to the relevant section of the related test item documentation.

[0121] Air collection and measurement Figure 18 shows a glass syringe attached to a 2.5 mL collection syringe via a Luer coupler. Figure 19 shows an image of the air volume within the glass syringe. The assembly is inverted so that the glass syringe is on top to allow the air to move. When the flushed (or unflushed) device is unfolded, the air bubbles rise and collect at the bottom of the collection syringe. The air collection and measurement protocol includes the following steps.

[0122] 5.1 Rotate the funnel stopper to bring any trapped air bubbles along the end to the surface and collect them below the collection syringe.

[0123] 5.2 Use a plunger to draw the air bubbles into the collection syringe.

[0124] 5.3 Remove the collection syringe and transfer the contents to a water bath to allow air to be transferred.

[0125] 5.4 Immerse the syringe containing the collected device air volume in a water bath and connect it to a lure coupler.

[0126] 5.5 Without releasing the collected air volume, gently press down the 2.5 mL syringe and confirm that no air remains in the coupler.

[0127] 5.6 Attach the 50 μL glass syringe to the Luer coupler.

[0128] 5.7 Turn this syringe assembly upside down in water so that the glass syringe is facing upwards.

[0129] 5.8 Gently tap the assembly of the 2.5 mL collection syringe until all air bubbles are removed from the plunger, then collect the air volume using the Luer coupler.

[0130] 5.9 Use a glass plunger to draw all the air volume into a 50 μL glass syringe.

[0131] 5.10 Record the total volume of air inside the glass syringe.

[0132] Consideration of the testing method As a clinically relevant and potentially worst-case (e.g., low-pressure) scenario for the air release quantitative test, a blood pressure (e.g., mean aortic pressure) of 67 mmHg can be used in the test. To replicate the clinical setting, simulate physiological aortic pressure using a pressurization system. Where applicable, the GORE® DrySeal Valve can be used according to the device's instructions for use. Fill the fluid column, mount it on an extendable tripod, and set it to a height of approximately 67 mmHg (e.g., starting with the GORE® DrySeal Valve into which the device is introduced). Deploy the device using a vertical glass funnel to allow the air to float upwards for collection with a syringe.

[0133] A suitable blood analog is prepared so that its viscosity at 25°C matches that of blood at 37°C, mimicking the viscosity of blood in vivo. Blood analog testing can be completed at ambient temperature. The geometry of the deployment model or the temperature of the blood analog should not affect the amount of air released during device deployment. Therefore, any representative deployment model and blood analog at ambient temperature are acceptable. Viscosity testing should be performed to confirm that the solution matches the hematocrit value.

[0134] Data Analysis Upon completion of deployment, the total volume of released air should be reported for each device size and flashing method group. For each device size, the mean, standard deviation, maximum, and minimum values ​​can be reported for each flashing method group. The volume of released air can be quantified and compared among the flashing method groups. [Examples]

[0135] example Example 1 Test item GORE® TAG® Thoracic Branch Internal Prosthesis Aortic Component ("TBE Aortic Component") is available from WL Gore & Associates, Inc. (Headquarters: Newark, Delaware).

[0136] GORE® TAG® Thoracic Branch Internal Prosthesis (SB) Components ("TBE Branch") are available from WL Gore & Associates, Inc. (Headquarters: Newark, Delaware).

[0137] The GORE® TAG® Conformable Chest Stent Graft with Active Control System ("CMDS") is available from WL Gore & Associates, Inc. (headquartered in Newark, Delaware).

[0138] Table 1 shows the test items by product and sample size. [Table 1]

[0139] All samples were sterile standard devices and were evaluated to ensure they were free from defects that could affect the properties being assessed.

[0140] Figure 20 shows a graph of the air volume (μL) of the devices tested using the air release test method described above for the test items specified in Table 1. The devices were tested using back-bleed and back-bleed-free flushing techniques and MAP 67 mmHg, and the GORE® dry seal introducer sheath valve was inflated with 2.5 mL of water. In all back-bleed data, the protrusion distance D was approximately 1 cm.

[0141] To evaluate the potential air in untreated devices that have not passed through the GORE® DrySeal Introducer Sheath Valve, tests were conducted without using mean arterial pressure (MAP) or DrySeal Valve technology / backbleed. It was shown that in the absence of such interactions (i.e., simply unfolding the test material), the volume of air trapped within the device is generally in the range of 100–1,020 μL.

[0142] The backbleed-free test was performed using a GORE® DrySeal Sheath Valve inflated with 2.5 mL of saline solution at a MAP of 67 mmHg. The internal prosthesis passed through the GORE® DrySeal Sheath Valve without waiting for backbleed. In such cases, the total volume of air trapped within the device was measured to an average of 15.983 μL (e.g., decreased from the average range of 100–1,020 μL). Figure 21 shows the data for this test in graphical form. In the backbleed-free test, the volume of trapped air was reduced by 95.0% compared to a unit taken directly from manufacturing (322 μL - 15.983 μL) / 322 μL.

[0143] The backbleed test was performed using a GORE® DrySeal Introducer Sheath Valve inflated with 2.5 mL of saline solution at MAP 67 mmHg, incorporating backbleed (a residence time sufficient for only 2-3 drops of backbleed). The volume of air trapped inside the device decreased to an average of 1.720 μL. This represents a 99.5% reduction compared to a unit taken out of production (322 μL - 1.720 μL) / 322 μL, and an 89.2% reduction compared to a DrySeal Sheath Valve inflated with 2.5 mL of saline solution at MAP 67 mmHg without backbleed (15.983 μL - 1.720 μL) / 15.983 μL. Figure 22 shows the data for this test in graph format.

[0144] Example 2 Figures 25–27 show additional data for various test items tested according to the air release test method and the back-bleed test or no-back-bleed test using blood analogs. Figure 23 shows data for various configurations of the Conformable GORE® TAG® Thoracic Internal Prosthesis ("CTAG") available from WL Gore & Associates, Inc., headquartered in Newark, Delaware. Figure 26 shows data for various configurations of the GORE® TAG® Thoracic Branch Internal Prosthesis Aortic Component ("TBE Aortic Component") (datasets O, P, and Q) and the GORE® TAG® Thoracic Branch Internal Prosthesis Side Branch (SB) Component ("TBE Side Branch") (datasets R and S, and T and U) available from WL Gore & Associates, Inc., headquartered in Newark, Delaware. Figure 27 shows data for various configurations of the GORE® Ascending Stent Graft ("ASG") manufactured by WL Gore & Associates, Inc. The various variables and data are described in the sections on the test method and Example 1 above. In particular, Example 2 includes some data at higher mean arterial pressures (MAPs) than those performed in Example 1. For reference, datasets containing MAP "0" (e.g., dataset A in Figure 23) correspond to data acquired without using the GORE® DrySeal Introducer Sheath Valve, or "as-manufactured" measurements without insertion and MAP exposure. For all backbleed data, the protrusion distance D was approximately 1 cm.

[0145] Figure 23 shows comparative data for datasets A, E, F, and L. As shown, a completely untreated device (e.g., as manufactured) has an average initial air content of approximately 322 μL (dataset A). Using the back bleed method and air release test method for MAPs at 67 mmHg (dataset E), 90 mmHg (dataset F), and 93-94 mmHg (dataset L), the average residual air content decreased to less than 5 μL, and to less than 2 μL (1.8 μL) at 67 mmHg.

Claims

1. An implant having a first end and a second end, A delivery catheter including a main body to which an intraluminal device is attached, Intraluminal devices, including, Delivery sheath and, A treatment system including a valve coupled to the delivery sheath, An intraluminal device delivery system including, The implant consists of a collapsed delivery configuration, and the implant has one or more air-filled voids defined by the collapsed implant. An intraluminal device delivery system wherein the valve is operable between a sealed configuration and an unsealed configuration, the implant protrudes proximally from the valve at a protrusion distance of approximately 1 cm, the treatment system defines a blood pathway between the delivery sheath and the body of the catheter, the blood passes from a first end of the implant to a second end of the implant and into one or more voids defined by the collapsed implant, and the valve is operable from an unsealed state in which blood bypasses the blood pathway to a sealed state in which blood is pushed along the blood pathway.

2. The system according to claim 1, wherein the implant protrudes 0.5 cm to 1.5 cm proximally from the valve.

3. The system according to claim 1 or 2, wherein the implant includes an implant visual insertion marker corresponding to the protrusion distance.

4. The system according to any one of claims 1 to 3, wherein the intraluminal device further includes a retaining sleeve for maintaining the implant in a collapsed delivery configuration.

5. The system according to claim 4, wherein the retaining sleeve includes a sleeve insertion visual marker corresponding to the protrusion distance.

6. An implant having a first end and a second end, A delivery catheter including a main body to which an intraluminal device is attached, Intraluminal devices, including, Delivery sheath and, A seal between the delivery catheter and the delivery sheath, the seal located proximal to the implant corresponding to the protrusion distance between the seal and the implant, Treatment systems, An intraluminal device delivery system including, The implant consists of a collapsed delivery configuration, and the implant has one or more air-filled voids defined by the collapsed implant. An intraluminal device delivery system wherein the delivery sheath has a distal end configured to be exposed to blood pressure, the treatment system has one or more vents configured to vent to ambient air pressure, the one or more vents having openings located distal to the seal and proximal to the implant, thereby the treatment system defines a blood pathway between the delivery sheath and the body of the catheter, the blood passing from a first end of the implant to a second end of the implant and out through the one or more vents, and the blood is directed to one or more voids defined by the collapsed implant.

7. The system according to claim 6, wherein one or more vents have an outlet located distal to the seal.

8. The system according to claim 7, wherein one or more ventilation holes are formed within the delivery sheath.

9. The system according to claim 6, wherein the one or more vents have an outlet located near the seal.

10. The system according to claim 9, wherein the outlet is located at the proximal end of the treatment system.

11. The system according to claim 9 or 10, wherein one or more ventilation holes are formed within the delivery catheter.

12. The system according to any one of claims 9 to 11, wherein one or more vents are formed as vent tubes, lumens or snorkels, providing a fluid conduit from distal to seal to a proximal opening positioned toward the proximal end of the treatment system.

13. The system according to any one of claims 6 to 12, wherein the implant includes an implant visual insertion marker corresponding to the protrusion distance.

14. The system according to claim 13, comprising the implantable visual insertion marker and radiographic material.

15. The system according to any one of claims 6 to 12, wherein the delivery catheter includes a visual insertion marker for the delivery catheter corresponding to the protrusion distance.

16. An intraluminal device delivery system having a pre-selected protrusion distance of an intraluminal device from a delivery sheath of the system, wherein the system is An implant having an outer surface and configured to transition from a delivery configuration that is compressed in the diametrical direction to a deployment configuration that is expanded in the diametrical direction, An intraluminal device comprising a retaining sleeve that restrains the implant in a delivery configuration compressed in the diametrical direction, and A treatment system comprising a delivery sheath configured to introduce the intraluminal device into the patient's body, Includes, The implant has a proximal end, a distal end opposite to the proximal end, and a length between the proximal end and the distal end. At least one of the implant and the retaining sleeve includes a visual insertion marking on its outer surface, An intraluminal device delivery system in which the visual insertion markings correspond to a pre-selected protrusion distance of the intraluminal device from the delivery sheath.

17. The system according to claim 16, wherein the visually inserted marking is visible to the naked eye.

18. The system according to claim 16 or 17, wherein the visual insertion marking is aligned with the proximal end of the treatment system at the pre-selected protrusion distance.

19. An intraluminal device delivery system having a pre-selected protrusion distance of the intraluminal device relative to the seal of the system's delivery sheath, wherein the system is An implant having a first end and a second end, A delivery catheter including a main body to which the aforementioned implant is attached, Intraluminal devices, including, Delivery sheath and, A seal between the delivery catheter and the delivery sheath at a position proximal to the implant, wherein the seal comprises a protruding distance between the seal and the implant, Treatment systems, Includes, The implant consists of a collapsed delivery structure, and the implant is defined by the collapsed implant and has one or more air-filled voids. An intraluminal device delivery system comprising, on the outer surface of at least one of the implant and the delivery catheter, a visual insertion marking corresponding to the pre-selected protrusion distance of the intraluminal device from the delivery sheath.

20. The system according to claim 19, wherein the visual insertion marking is visible to the naked eye.

21. The system according to claim 19 or 20, wherein the visual insertion marking is aligned with the proximal end of the treatment system at the pre-selected projection distance.

22. A method for pre-treating an intraluminal device by back bleeding, wherein the method is Position the treatment system within the patient's body cavity so that the distal portion of the treatment system is exposed to blood due to blood pressure. Inserting an intraluminal device, including an implant and delivery catheter, which are compressed and collapsed in the diametrical direction, into the treatment system at a pre-selected protrusion distance, and To flow blood along a defined blood pathway between the distal part and the proximal part of the treatment system, A method including, The treatment system includes a delivery sheath and a seal between the intraluminal device and the treatment system. A method wherein the blood pathway extends from the first end of the implant to the second end of the implant and into one or more voids defined by the implant, thereby reducing the volume of air trapped in the one or more voids.

23. The method according to claim 21, wherein the volume of the mixed air is reduced to 10 μL or less.

24. The method according to claim 21, wherein the volume of the mixed air is reduced to 5 μL or less.

25. The method according to claim 21, wherein the volume of the mixed air is reduced to 2 μL or less.

26. The method according to any one of claims 21 to 25, wherein at least one of the implant of the intraluminal device, the delivery catheter, and the retaining sleeve includes a visual insertion marking on its outer surface corresponding to the pre-selected protrusion distance, and the method further comprises inserting the intraluminal device into the treatment system to the pre-selected protrusion distance using the visual insertion marking.

27. The method according to claim 26, further comprising using visual insertion marking with the naked eye.

28. The method according to any one of claims 21 to 27, wherein flowing blood along the blood pathway includes observing two to three drops of blood from the blood pathway.

Images