WO2025250773A1

WO2025250773A1 - Protective enclosures for inserting and containing intravascular membrane oxygenation catheters

Info

Publication number: WO2025250773A1
Application number: PCT/US2025/031390
Authority: WO
Inventors: Galen Robertson; Tobias Straube; Stewart Farling; Marc DESHUSSES; Bruce Klitzman
Original assignee: Vq Biomedical Inc
Current assignee: Vq Biomedical Inc
Priority date: 2024-05-29
Filing date: 2025-05-29
Publication date: 2025-12-04
Anticipated expiration: 2026-11-29

Abstract

Systems and devices described herein disclose a protective enclosure (730) for containing one or more devices. The protective enclosure can include a proximal hub (732), a distal hub (734), and a hollow body (716) configured to transition from an unexpanded state to an expanded state in which the hollow body is configured to receive an instrument inserted through the proximal hub. The protective enclosure can receive a blood oxygenation catheter (710).

Description

PROTECTIVE ENCLOSURES FOR INSERTING AND CONTAINING INTRAVASCULAR MEMBRANE OXYGENATION CATHETERS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/653,004, filed May 29, 2024, and titled “Protective Enclosure for Inserting and Containing Intravascular Membrane Oxygenation Catheter,” the disclosure of which is incorporated herein by reference.

TECHNICAL FIELD

[0002] The present disclosure generally relates to systems, devices, and methods for deploying and containing oxygenation devices.

BACKGROUND

[0003] Acute respiratory failure with inadequate oxygenation and/or ventilation is a common reason for intensive care unit (ICU) admission in children and adults. One potential option is an oxygenation catheter, such as the catheter disclosed in U.S. Patent No. 11,771,883, titled “Intravascular Membrane Oxygenator Catheter with Oscillating Hollow Fiber Membranes, issued on October 3, 2023 (“the ‘883 Patent”), the disclosure of which is incorporated herein by reference. However, it may be desirable to have systems and devices for deploying and containing such catheters during use, e.g., to reduce injury or damage to vessel walls due to movement of the hollow fiber membranes of the oxygenation catheter.

BRIEF SUMMARY OF THE DISCLOSURE

[0004] Protective enclosure for inserting and containing intravascular membrane oxygenation catheters, and systems, devices, and methods thereof are described herein.

[0005] The present disclosure describes a protective enclosure with a relatively flexible construction and small diameter which can be easily inserted into a patient’s vasculature and then expanded once properly positioned. A relatively larger diameter oxygenation catheter consisting of multiple hollow fiber membranes may be inserted into the protective enclosure after it is placed in the patient’s vasculature. The oxygenation catheter (such as the catheter disclosed in the ‘883 Patent) can include a series of hollow fiber membranes (HFMs), which allow the safe diffusion of oxygen into the blood without creating bubbles. The oxygenation catheter rotates about its length in order to achieve oxygen diffusion (e.g., at maximum levels), and the protective enclosure provides a stable and non-moving structure which can protect the patient’s skin and vasculature during the rotational motion of the HFMs. A separable protective enclosure can also ensure that the relatively larger diameter and less flexible oxygenation catheter can be easily placed by a clinician without concern for the catheter ending up in an undesirable location or damaging the vasculature while being inserted. In addition, the protective enclosure can ensure that the vessel walls are not damaged by hollow fiber membrane oscillations during use.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1A is a schematic diagram of an intravascular oxygenation membrane catheter, according to some embodiments.

[0007] FIG. IB is a schematic diagram of an intravascular protective enclosure, according to some embodiments.

[0008] FIG. 1C is a schematic diagram of the intravascular oxygenation membrane catheter of FIG. 1 A mated to the protective enclosure of FIG. IB.

[0009] FIG. 2 shows a protective enclosure in an insertion configuration with an enclosure sheath, according to an embodiment.

[0010] FIG. 3A shows a protective enclosure with multiple segments in an insertion configuration with an enclosure sheath, according to an embodiment.

[0011] FIG. 3B shows a protective enclosure with multiple expanded segments in a deployed configuration, according to an embodiment.

[0012] FIG. 4 is a cross-sectional view of obturator, according to embodiments.

[0013] FIG. 5 A shows a protective enclosure containing an obturator with a balloon expansion mechanism in an insertion position, according to embodiments.

[0014] FIG. 5B shows a protective enclosure containing an obturator with a balloon expansion mechanism in a deployed position, according to embodiments.

[0015] FIG. 6A shows a transverse view of a balloon expansion mechanism while deflated (insertion position), according to embodiments.

[0016] FIG. 6B shows a transverse view of the balloon expansion mechanism of FIG. 6A while fully inflated (deployed position). [0017] FIG. 7A is a view of a protective enclosure in an insertion configuration with an obturator present, according to embodiments.

[0018] FIG. 7B is a view of a protective enclosure in a deployed configuration with an obturator present, according to embodiments.

[0019] FIG. 8 is a view of a protective enclosure in a deployed configuration with a deployed HFM catheter inside, according to embodiments.

[0020] FIG. 9 is a view of belt-based portable system for providing intravascular oxygenation, according to embodiments.

[0021] FIG. 10 is a view of wheeled cart-based portable system for providing intravascular oxygenation, according to embodiments.

[0022] FIG. 11 is a schematic of a single unified control for an oxygenation system, according to embodiments.

[0023] FIGS. 12A-12F depict a sequence for placement of a catheter and a protective enclosure within a patient vasculature, according to embodiments.

[0024] FIG. 13 is a flow chart of a method for placing a catheter and an protective enclosure within a patient vasculature, according to embodiments.

DETAILED DESCRIPTION

[0025] A separable protective enclosure that can enclose an oxygenation catheter, and its embodiments are described herein. The protective enclosure can include a protective enclosure proximal hub, proximal port, an expandable protective tube, a protective enclosure distal hub, an expansion mechanism, and a removable sheath. The oxygenation catheter can include an oxygen and torque delivery shaft, a proximal cap, a series of a hollow fiber membranes (HFMs) (which can contact venous blood and diffuse oxygen into the bloodstream), and a distal hub. The protective enclosure is a flexible and unmoving structure, which is designed to protect the vessel walls from damage or irritation from contacting the rotating or vibrating HFMs of the catheter. The entire system is designed to be placed safely into a patient’s venous system, and then be safely removed.

[0026] Typically, an oxygenation catheter can be inserted into a target blood vessel or body lumen (e.g., the inferior vena cava (IVC), the superior vena cava (SVC), or a right atrium) of a patient that may have acute or chronic lung disease. The HFMs can be configured to move (e.g., oscillate (intermittently or continuously), rotate (intermittently or continuously), vibrate (intermittently or continuously), etc.) to increase a velocity of the blood flowing through the target vessel which, in turn, causes an influx of oxygen into the bloodstream. This influx of oxygen can give rest to ailing lungs as the lungs heal from an underlying disease. Oscillating HFMs may provide other benefits, such as reducing or limiting bubble formation in the blood, disrupting boundary layer formation along the vessel of interest, etc. Further examples of suitable oxygenation catheters are described in U.S. Patent No. 11,771,883, incorporated above by reference. However, HFMs oscillating in close proximity to the wall / lining of the vessel can pose a risk of contact between the wall and the HFMs. With the HFMs oscillating at high rates, contact with the lining can risk damage to the vessel of interest. Therefore, a protective mechanism may need to be utilized to shield the HFMs from the lining but to allow blood flow therethrough to permit the oxygenation of the blood. One example of a protective mechanism can be a wire loom or a cage, which can be configured to protect the surrounding vessels and prevent them from contacting rotating fibers of an oxygenation device. Examples of a wire loom or cage are described in U.S. Patent Application No. 11/408,576, published as U.S. Patent Application No. 2006/0264810, filed April 21, 2006, and titled “Percutaneous respiratory assist catheter incorporating a spinning fiber bundle,” the disclosure of which is incorporated herein by reference. However, these wire looms or cages are attached to the oxygenation devices, thereby making it difficult to place these devices within the patient vasculature. Additionally, replacement of the oxygenation devices would require removal of the entire device, including the protective wire loom or cage.

[0027] Systems, devices, and methods described herein provide a protective enclosure that can separably receive an oxygenation catheter, which can address drawbacks of existing systems. The protective enclosure can include a protective enclosure proximal hub, which can provide four functions: providing a seal against blood leakage; providing a rigid attachment so that a port remains in a stable and consistent orientation on the patient’s skin; allowing for free rotation of the oxygenation catheter with minimal friction; and providing a releasable mechanical lock release so that the oxygenation catheter can remain in the same axial location relative to the protective tube until unlocked. Additionally, protective enclosures described herein can be configured to receive replacement oxygenation catheters or other devices. For example, protective enclosures described herein can decouple (e.g., via the releasable mechanical lock release) from the oxygenation catheter such that the oxygenation catheter can be removed from the patient venous system and another instrument (e.g., another oxygenation catheter, an extracorporeal membrane oxygenation (ECMO) cannula) can be inserted into the patient venous system. In turn, the subsequent instrument may be detachably coupled to and/or enclosed by the protective enclosures described herein. To that end, protective enclosures described herein may first be deployed within the patient venous system, e.g., prior to or without an instrument disposed therein. An instrument such as an oxygenation catheter can then be inserted and deployed within the protective enclosure. In this manner, systems, devices, and methods described herein can provide an access path for introducing a subsequent device (e.g., the oxygenation catheter) therein, while minimizing damage to patient anatomy such as the heart.

Overview of System

[0028] Schematics of the systems described herein are depicted in FIGS. 1 A-1C. FIG. 1 A is a schematic illustration of a catheter including HFMs, which can be referred to as a HFM catheter or an oxygenation catheter, according to embodiments. FIG. IB is a schematic illustration of a protective enclosure. FIG. 1C is a schematic illustration of the HFM catheter 110 inserted into the protective enclosure 130.

[0029] FIG. 1 A shows features of the HFM or oxygenation catheter 110. The schematic shows a gas inlet 120 and a flexible torque transmitting shaft 122 entering on a left side of the schematic (e.g., a proximal side of the HFM catheter 110. These connections originate from a system controller (not shown), which can provide gases and motion control to the HFM catheter 110. The gas inlet 120 and the torque line 122 can interface with a proximal hub 112 of the HFM catheter 110. In some embodiments, the proximal hub 112 provides a locking mechanism 118 that is configured to couple to a protective enclosure (e.g., protective enclosure 130) during use. In some embodiments, the locking mechanism 118is configured to interact with a mating element or feature in a proximal hub 132 of the protective enclosure, e.g., to couple with the protective enclosure. The HFM catheter proximal hub 112 is also coupled to the HFMs 116, which provide oxygen to the bloodstream. The HFMs 116 can connect to a distal hub 114 of the HFM catheter 110. In some embodiments, the HFM catheter 110 can include a center shaft that also extends between the proximal hub 112 and the distal hub 114.

[0030] FIG. IB shows features of the protective enclosure 130, which may include a proximal hub 132, a protective tube 136 (e.g., hollow body or expandable body), and a distal hub 134. In some embodiments, at least the protective tube 136 and the distal hub 134 are disposable within a body lumen of a patient. In some embodiments, the proximal hub 132, the protective tube 136, and the distal hub 134 are disposable within the body lumen of the patient. The protective enclosure proximal hub 132 can be configured to receive the HFM catheter proximal hub 112 or other devices while preventing blood loss from the protective enclosure 130, with or without an inserted device. The protective enclosure proximal hub 132 can provide a protective enclosure locking mechanism 138 (also referred to herein as “latching mechanism”) that interfaces with (e.g., detachably couples to) the HFM catheter proximal hub 112, or other devices. The locking mechanism 138 can be configured to maintain or secure the inserted device within the protective enclosure 130. In some embodiments, the locking mechanism 138 is disposed on or in the proximal hub 132. Alternatively, the locking mechanism 138 may be disposed on or in the distal hub 134.

[0031] The distal end of the protective enclosure proximal hub 132 can connect to the protective tube 136. The protective tube 136 can be a hollow or expandable body disposed between the proximal hub 132 and the distal hub 134. The protective tube 136 can provide vessel protection when deployed (e.g., expanded) in the vasculature, while minimally impeding blood flow. The right end of the schematic shows the distal hub 134 of the protective enclosure 130. The protective enclosure distal hub 134 can provide an axial anchor point for the HFM catheter distal hub 114 and/or other devices. The protective enclosure distal hub 134 can provide a termination point for the protective tube 136 and a docking point that can align or center the inserted devices axially within the protective enclosure 130.

[0032] FIG. 1C shows the HFM catheter 110 inserted into the protective enclosure 130 and presents the operational view of the HFM catheter 110 and protective enclosure 130 combined. The protective tube 136 can be configured to transition from an unexpanded state to an expanded state. In the expanded state, the protective tube 136 can be configured to receive an instrument (e.g., the HFM catheter 110) inserted into the protective enclosure 130 via the proximal hub 132. The protective enclosure 130 can lock the HFM catheter 110 into position (e.g., via one or more mating features, via the locking mechanism 138, etc.) and can align or center the HFM catheter 110 within the walls of the expandable protective tube 136. For example, the locking mechanism 138 can be configured to maintain an axial position of the HFM catheter 110 or other instrument within the protective tube 136 (e.g., when the locking mechanism 138 is coupled to the HFM catheter 110 or other instrument). Further, the locking mechanism 138 (e.g., when coupled to the HFM catheter 110) can be configured to enable rotational movement of the HFM catheter 110 and/or the HFMs 116 about a longitudinal axis of the protective tube 136 while preventing axial movement of the HFM catheter 110 relative to the protective tube 136. The HFMs 116, after the HFM catheter 110 has been received and deployed within the protective enclosure 130, can be free to move within the protective enclosure 130. In some embodiments, the HFMs 116 are configured to transition to a deployed, expanded state within the protective tube 136 when the HFM catheter 110 is positioned within the protective tube 136 and is engaged with a mating element (e.g., the locking mechanism 138).

[0033] Further, the protective tube 136 can be configured to be permeable such that blood can permeate into an interior of the protective tube 136 when the protective tube 136 is in the expanded position, thus enabling blood flow to the HFMs 116 disposed therein. The protective enclosure 130 shields the vessel walls from contact with the HFMs 116 during their movement. In particular, the protective tube 136 can be configured to space or separate the HFM catheter 110 or other instrument from the vessel walls to protect the vessel from movements of the HFM catheter 110 (e.g., movement of the HFMs 116) or other instrument. In some embodiments, the protective tube 136 can exert a force on the vessel wall in a radial direction towards the vessel well when the protective tube 136 is in the expanded position. This radial force can shape, reshape, or otherwise dilate the vessel wall to be, for example, more round. As such, the protective tube 136 can, in the expanded position, create more space / room within the vessel for the HFMs 116 to move. In some embodiments, a misshapen, narrow, and/or ovular cross- sectional vessel may limit or prevent oscillation and, thus, oxygenation capabilities of the HFMs 116. Further, the protective tube 136 can remain stationary relative to the body lumen when the HFMs 116 move, rotate, or oscillate. In such manner, the protective enclosure 130 can be configured to reduce or minimize damage or injury to the vessel wall. In some embodiments, the protective tube 136 can be configured to have sections with different cross- sectional areas and/or diameters. For example, the protective tube 136 can have a first section that is narrower, e.g., for positioning within a blood vessel (e.g., jugular vein or femoral vein) or a narrower portion of anatomy, and a second section that can expand to a wider diameter, e.g., for providing at least a predetermined area for the HFM catheter 110 and/or the HFMs 116 to expand therein, e.g., to ensure greater efficacy of oxygenation and/or other gas transfer/delivery. The wider diameter section can be disposed in, for example, the inferior jugular vein, the superior jugular vein, and/or the right atrium. As described above, in some embodiments, the wider diameter section can also exert a radial force that can shape the anatomy (e.g., to be more circular), to provide further space for the HFM catheter to expand therein.

[0034] While oxygenation catheters are described herein, it can be appreciated that catheters including HFMs can be configured to deliver other types of gases, including, for example, anesthetic gases or agents, and/or remove agents from the bloodstream. In some embodiments, an instrument configured to deliver anesthesia gases or drugs to the blood stream can be inserted and deployed within the protective enclosure. In some embodiments, an instrument configured to remove or flush carbon dioxide from the blood stream can be inserted and deployed within the protective enclosure.

Protective Enclosure in Insertion Configuration

[0035] FIG. 2 depicts an example of a protective enclosure 230, in a collapsed or insertion configuration, according to embodiments. The protective enclosure 230 can be structurally and/or functionally similar to other protective enclosures described herein, including, for example, protective enclosure 130. As depicted in FIG. 2, the protective enclosure 230 can be in an insertion configuration, whereby the protective enclosure 230 has been constricted to a smaller diameter (e.g., by a sheath 228) and is ready for insertion into the vasculature.

[0036] In one embodiment, the protective enclosure 230 can include a proximal hub 232, an expandable protective tube or hollow body 236, and a distal hub 234. The protective enclosure, when in its insertion configuration can be at its minimum diameter, e.g., to make insertion as minimally invasive as possible. In some embodiments, the protective enclosure 230 can be collapsed closely against an obturator that is disposed within the protective enclosure (e.g., an obturator 450, as depicted in FIG. 4).

[0037] The proximal hub 232 can include an outer housing 205, with a channel that can extend into the central channel 226. The outer housing 205 allows for a variety of devices to be placed into and removed from the protective enclosure 230. In some embodiments, the protective enclosure 230 can include a hub valve 211, which is configured to provide a liquid tight seal, e.g., when no instrument is located within the protective enclosure 230 and/or when an instrument is placed inside the protective enclosure 230. In some embodiments, the protective enclosure 230 can include one or more hub valve(s) 211. For example, a first hub valve can be configured to provide a seal when an instrument is placed inside the protective enclosure 230, and a second hub valve can be configured to provide a seal when no instrument is located within the protective enclosure 230. In some embodiments the first hub valve may be an annular valve, and the second hub valve may be a cross slit or duckbill valve. The hub valve 211 may be disposed in the proximal hub 232. Instruments placed inside the protective enclosure can include, for example, an obturator (e.g., obturator 450), an HFM catheter (e.g., HFM catheter 110), an ECMO cannula, a central venous line, or one or more other instruments. As such, the hub valve 211 can be configured to open to enable an instrument to be inserted through the proximal hub 232 and into the protective tube 236. In one embodiment, the hub valve 211 is an iris valve. In other embodiments, the hub valve 211 can include a duckbill valve, a cross slit valve, a flapper valve, or a combination of two or more valves. The hub valve 211 is configured to ensure that blood does not leak out of the vein when the protective enclosure is placed inside the patient’s vein. As such, the hub valve 211 can be configured to prevent blood loss from the body lumen when (i) the protective tube 236 and the distal hub 234 are disposed within the body lumen and/or (ii) the instrument is removed from the protective tube 236.

[0038] The outer housing 205 may be constructed of polycarbonate, nylon, or a wide variety of other biocompatible plastics. Optionally, in some embodiments, the proximal hub 232 may contain one or more central lines 212. The one or more central lines 212 can terminate at different lengths within the protective enclosure. For example, a line 216 may terminate at the vena cava - atrial junction when the protective enclosure 230 is disposed in the vasculature of a patient. Other central lines 218 may terminate farther down into the inferior vena cava of the patient, when the protective enclosure 230 is disposed in the vasculature of the patient. Alternate versions of the central line may terminate close to the outer housing. The central lines 212 may be used to prime the protective enclosure prior to insertion and/or a dedicated priming line may be included.

[0039] In some embodiments, the proximal hub 232 can also receive a deployment cable 239. The deployment cable 239 can include deployment cable markings 237 that indicate the amount of the linear deployment distance made by the distal hub 234. As the protective enclosure 230 is deployed, the deployment cable 239 moves and the number of marks show the accumulated movement of the protective enclosure 230 relative to a static length reference 240 on the proximal hub 232. The deployment cable 239 thus conveys the distance moved by the distal hub 234. The linear distance moved by the distal hub 234 is a measure the distal hub 234 position and the amount of expansion of the expandable protective tube 236. Once the desired deployment distance is met, the length lock 231 is set to hold the deployment cable 239 and the protective enclosure expandable protective tube 236 at that desired deployment. In some embodiments, the protective enclosure 230 can be deployed by inserting an obturator (e.g., obturator 450, as described below), latching the obturator into the distal hub 234, and pulling back on the obturator. The protective enclosure 230 could also be deployed by the other mechanisms described below.

[0040] The proximal hub 232 can include a latching mechanism or locking mechanism 238 that provides a mating feature for inserted devices, such as the HFM catheter 110, to lock into the proximal hub 232. The latching mechanism 238 (e.g., structurally and/or functionally similar to the locking mechanism 138) in the proximal hub 232 can provide a visual, audible, tactile, or other reference to indicate that a device has been inserted properly into the protective enclosure 230, that the device has been coupled to the locking mechanism 238, etc. In some embodiments, the locking mechanism 238 can engage an inserted device but be configured to allow for axial movement of the inserted device, e.g., for changing an axial position or location of the inserted device. For example, the locking mechanism 238 can include or be configured to interface with one or more grooves, teeth, or features (e.g., similar to a ratcheting system) that are spaced apart from one another on the proximal hub 232 (or the distal hub 234) of the protective tube 236 and/or a portion of the HFM catheter 110 to set an axial position of the catheter. In particular, the locking mechanism 238 can be configured to selectively engage with one of a plurality of teeth or grooves disposed on the catheter 110, to set an axial position of the catheter. The catheter 110 can be pushed or retracted to overcome the selectively engagement to reposition or change the axial position of the catheter. This can enable an operator of the inserted device to further refine or adjust a position of the inserted device. In some embodiments, a separate length lock 231 (further described below) can engage the inserted device to clamp or otherwise secure (e.g., by a friction fit or other mechanical engagement) the inserted device in place (e.g., thereby preventing additional axial movement of the inserted device). The length lock 231 can further be configured to be released, e.g., to allow an operative to adjust an axial position of the catheter 110, before relocking the length lock 231 to secure the catheter 110 in place. As such, the latching mechanism 238 and/or the length lock 231 can ensure the device inserted into the protective enclosure 230 stays in the inserted position and cannot be removed until a device lock release is released. In some embodiments, the lock release can be a finger grip 213, which can be actuated to unlock the inserted device (e.g., HFM catheter) from the protective enclosure 230. In use, the inserted device may be configured to rotate about a longitudinal axis of the inserted device when the locking mechanism 238 is engaged with the inserted device and/or when the length lock 231 is engaged with the inserted device, e.g., to allow for diffusion of oxygen or other gases via oscillation, rotation, or other movement of the HFMs.

[0041] The proximal hub 232 of the protective enclosure is connected to the expandable protective tube 236. The expandable protective tube 236 may be constructed of nitinol, a composite mesh, and/or other biocompatible materials that maintain shape when deployed, yet are compliant to provide flexibility for body movement, breathing, and size changes in the anatomy. The expandable protective tube 236 constrains the placement of devices inserted into the protective enclosure 230 and provides a protective barrier between the inserted devices and the vessel walls, thereby reducing or minimizing damage to the vessel walls due to insertion or movement of the devices. The protective enclosure 230 can maintain the insertion depth and position of inserted devices, while preventing blood loss at the insertion site and minimizing restriction of blood flow in the vessel.

[0042] The protective tube 236 is configured to connect to the distal hub 234 at the distal end of the protective enclosure 230. The distal hub 234 of the protective enclosure 230 can include a locking mechanism 220, a guidewire channel 224, and a proximity sensor 222. The centering locking mechanism 220 provides a mechanism for the distal end of the distal hub 234 or other devices (e.g., obturator, oxygenation catheter) inserted therein, to connect and be locked into the center axis of the protective enclosure 230. The centering locking mechanism 220 provides a bearing point for the HFM catheter 210, to rotate, ungulate, vibrate or make any additional or alternative desired movement while maintaining lateral and axial position within the protective enclosure 230 and vasculature.

[0043] The guidewire channel 224 can provide an exit port for fluid to escape during saline flushing of the protective enclosure 230 prior to insertion. The guidewire channel 224 can provide a port for a guidewire to pass through the distal hub 234. The guidewire can be inserted into the vasculature via a superior approach (e.g., through a jugular vein) or an inferior approach (e.g., through a femoral vein). Once the guidewire is in position (e.g., as determined through fluoroscopy or ultrasound imaging), a dilator (or a series of successively larger dilators) can be placed over the guidewire and advanced down the guidewire to increase a diameter of the incision site. The dilator can then be removed, leaving the guidewire in place. Then, the protective enclosure 230 can be threaded onto the guidewire and advanced over the guidewire, through the patient’s vasculature, to the desired location (which, in some embodiments, may be monitored under fluoroscopy or ultrasound imaging). Further details of the process of placing a protective enclosure 230 within a patient vasculature is described with reference to FIGS. 12A-13.

[0044] Once the protective enclosure 230 is in position (e.g., positioned at a target site or predetermined location in the vasculature or heart), the tear away enclosure sheath 228 (also referred to herein as “tear away sheath” or “sheath”) can be removed. As described above, the tear away sheath 228 can be configured to cover the protective enclosure 230 to constrain a diameter of the protective enclosure 230. When the protective enclosure 230 is covered by the sheath 228, the protective enclosure 230 may be configured to be advanced to a predetermined location with the vasculature. In other words, the protective enclosure 230 may be constrained by the sheath 228 during insertion and placement of the protective enclosure 230 in the vasculature. The protective enclosure tube 236 can then be expanded to deploy it (e.g., via expandable mechanisms, as described below) and the protective enclosure 230 can then be attached to a patient support (e.g., a patient support 809, as described in connection with at least FIG. 9). In some embodiments, the expandable protective tube 236 of the protective enclosure 230 can be configured to self-expand in response to removal of the tear away sheath 228. For example, the expandable protective tube 236 can be configured to expand to a memory set diameter after the sheath 228 has been removed.

[0045] The distal hub 234 of the protective enclosure 230 may include the proximity sensor 222 (also referred to herein as “sensor”) to provide feedback that an inserted device such as a HFM catheter has engaged properly into the distal hub 234, has been disposed in a predetermined position within the protective enclosure 230, etc. The sensor 222 may provide engagement status haptically, electronically, audibly, visually, tactilely or a combination of feedback types. The feedback provided may include performance data such as, for example, axial or longitudinal motion rate of change of the HFM catheter, motion velocity of the HFM catheter, blood saturation measure, blood flow, and/or other measures.

[0046] The tear away enclosure sheath 228 can retain the protective enclosure 230 in a constricted state, such as for the insertion configuration described above. The tear away enclosure sheath 228 may be implemented with a tear-away feature to facilitate removal of the tear away enclosure sheath 228 from the protective enclosure 230 when no longer needed (e.g., after placement of the protective enclosure 230 at the target site). The tear away enclosure sheath 228 can maintain the protective enclosure 230 in the insertion configuration during insertion into the vasculature, provide a low friction surface to ease insertion, and/or facilitate priming the protective enclosure 230. The distal end of the tear away enclosure sheath 228 is open to provide a pathway for priming solution to escape, which can provide an indication of when the protective enclosure 230 is primed. The tear away enclosure sheath 228 opening also provides a pathway for the guidewire.

Protective Enclosure With Multiple Segments

[0047] In some embodiments, a protective enclosure may have two, three, or multiple constricted diameters. The multiple constricted diameters can be configured to contact an instrument or device inserted within the protective enclosure, such as, for example, the HFM catheter 110. FIGS. 3A and 3B depict a protective enclosure 330 with multiple segments 336a, 336b. FIG. 3A depicts the protective enclosure 330 in an insertion configuration, and FIG. 3B depicts the protective enclosure 330 in an expanded or operational configuration. The protective enclosure 330 in the insertion configuration has multiple segments 336a, 336b with a first constricted diameter 354a (e.g., a centrally located constricted diameter 354a) and a second constricted diameter 354b (e.g., a proximally located constricted diameter 354b). The constricted diameter sections 354a, 354b do not expand, e.g., similar to the proximal and distal hubs. The constricted diameter 354a can act as a centering mechanism on the HFM catheter 110 or other devices inserted into the protective enclosure 330. In some embodiments, such inserted devices may also have multiple segments, therefore making the protective enclosure 330 more suitable for use with such devices. Further, the multiple segments of the protective enclosure 330 can have different diameters (e.g., a diameter of the first segment 336a can be different than a diameter of the second segment 336b). In some embodiments, the constricted diameter 354b protrudes from a body of the patient when the protective enclosure 330 is at least partially positioned within the body lumen. In such embodiments, the proximal hub 332 may be positioned outside of the patient while the constricted diameter 354b is positioned within an entrance (e.g., insertion point or site on the skin) and the other components (e.g., the first segment 336a, the constricted diameter 354a, the second segment 336b, the distal hub 334, etc.) are disposed within the patient. FIG. 3B shows the protective enclosure 330 expanded in a multipoint operational configuration.

[0048] The protective enclosure 330 can be structurally and/or functionally similar to other protective enclosures described herein, including, for example, protective enclosures 130, 230, and therefore can include components that are structurally and/or functionally similar to those other protective enclosures. For example, the protective enclosure 330 can include a hub valve

311 (e.g., structurally and/or functionally similar to hub valve 211), a locking mechanism 338 (e.g., structurally and/or functionally similar to locking mechanism 138, 238), a central line

312 (e.g., structurally and/or functionally similar to central line 212), a proximal hub 332 (e.g., structurally and/or functionally similar to proximal hub 232), a distal hub 334 (e.g., structurally and/or functionally similar to distal hub 234), an outer housing 305 (e.g., structurally and/or functionally similar to outer housing 205), a central channel 326 (e.g., structurally and/or functionally similar to central channel 226), an expandable protective tube 336 (e.g., structurally and/or functionally similar to expandable protective tube 236), a guidewire channel 324 (e.g., structurally and/or functionally similar to guidewire channel 224), and a centering locking mechanism 320 (e.g., structurally and/or functionally similar to centering locking mechanism 220). In some embodiments, the protective enclosure 330 can optionally include a sensor 307, such as, for example, a sensor to measure oxygen levels or other physiological parameters. The sensor 307 can be located along or near the protective tube 336 to make measurements within the venous blood flowing past. [0049] In some embodiments, the diameter of a protective enclosure (or specifically, the protective tube), such as any of the protective enclosures described herein, may be constricted at points along its axis to accommodate narrowing points or portions within the anatomy of the vessel or to interface with organs connected to the vessel, such as, for example, the atrium, renal veins, or hepatic veins. For example, a proximal region of the protective enclosure (or specifically, the protective tube) may be constricted or limited in diameter relative to other expandable portions of the protective enclosure to accommodate regions of the protective enclosure that may be located within a smaller vein or body lumen, e.g., the jugular vein or femoral vein.

Obturator

[0050] An obturator 450, as depicted in FIG. 4, can be placed in the central lumen / passage of a protective enclosure (e.g., protective enclosure 130) prior to insertion of the protective enclosure into the vasculature of the patient. When fully seated into the protective enclosure, the obturator distal end 460 may extend beyond the proximal hub of the protective enclosure (e.g., proximal hub 132). The obturator 450 has a central channel 454 which allows a guidewire to pass through the central channel 454 while it is inside the protective enclosure.

[0051] In some embodiments, the obturator 450 can also include at least one priming lumen 453 passing through the obturator 450, which can be connected to a standard Luer lock fitting on the proximal end 462 and at least one outlet hole on the proximal end 462 of the obturator 450. The proximal end Luer lock may be connected to a syringe filled with flushing fluid, such as sterile saline. When the syringe plunger is depressed, sterile saline passes through the obturator priming lumen 453, exiting at least one opening near the distal hub of the protective enclosure (e.g., distal hub 134). The priming fluid is then forced between the obturator 450 and the expandable tube of the protective enclosure, from the distal end up to the proximal end, including the protective enclosure proximal hub, pushing all air out of the system.

[0052] In some embodiments, the obturator distal end 460 can physically connect to the distal end of the protective enclosure. In one embodiment, the obturator 450 has at least one barb 456 which protrudes from the distal end of the obturator 450. This barb 456 can be spring loaded such that it can be depressed while the obturator 450 is advancing and expands fully once it reaches the distal hub of the protective enclosure. Once the barb 456 has expanded in the distal hub of the protective enclosure, the obturator distal end 460 and the distal end of the protective enclosure are locked together. The barb 456 can be retracted by pulling a release wire or string, which subsequently retracts the barbs 456 and allows the obturator 450 to be separated from the protective enclosure, e.g., when desired by the clinician. In another embodiment, the obturator distal end 460 can be connected to the distal hub by a magnet 458. In some embodiments, a sensor (e.g., sensor 222) may be present in the distal hub of the protective enclosure, which can be configured to detect the presence of a properly seated obturator 450 or HFM catheter (e.g., HFM catheter 110).

Expansion Mechanisms for Protective Enclosure

[0053] FIGS. 5A, 5B, 6A and 6B show one embodiment where a protective enclosure is expanded as a result of an expanding balloon, which is integrated into a balloon obturator, according to embodiments.

[0054] FIGS. 7A and 7B show one embodiment where the protective enclosure is expanded as a result of mechanical expansion, according to embodiments. The following sections describe the operation of each of these embodiments.

Mechanical Expansion

[0055] In some embodiments, it may be necessary to mechanically expand or deploy the protective enclosures described herein. FIGS. 7 A and 7B depict an example of an obturator that is used to mechanically expand a protective sheath. As shown, after inserting the protective enclosure 630 into the vasculature and/or the protective tear away enclosure sheath (e.g., the sheath 228) has been removed, the protective enclosure 630 may still be in the insertion configuration, as shown in FIG. 7A. The obturator distal end 660 can be latched into the distal hub 634. For example, the distal hub 634 can include grasping elements configured to engage with a distal portion of an instrument (e.g., the obturator distal end 660, a distal end of the HFM catheter 110, etc.). In some embodiments, the distal hub 634 defines a cavity configured to receive the distal end of the instrument, wherein the grasping elements are disposed within the cavity. The obturator distal end 660 can include grasping barb(s) (e.g., the grasping barb(s) 356 or the grasping barbs 456) (as described above), to latch into corresponding mating / grasping features in the distal hub 634. To deploy the protective enclosure 630, as shown in FIG. 7B, the proximal end (e.g., the proximal end 462) of the obturator 650 can be pulled back from the proximal hub 632. The pulling action can force the protective enclosure expandable protective tube 636 to open. The pulling force can be limited, for example, by an internal spring within the obturator 650. If the maximum force is exceeded, the spring can release, limiting the pulling force and informing the clinician to pull less. Markings (e.g., length reference 240) on the deployment cable 639 can be used to indicate how much the expandable protective tube 636 diameter has increased. Once the desired diameter is reached, the length lock (e.g., the length lock 231) on the proximal hub 632 can be latched and the expandable protective tube 636 can be held in the set diameter. The release cable on the obturator 650 can be pulled to release the obturator 650 from the protective enclosure 630. Pulling the release cable retracts the grasping features in the distal hub of the obturator 650, which can, in turn, free the obturator 650 from the distal hub 634 and allowing the obturator 650 to be removed from the protective enclosure 630.

[0056] To remove the protective enclosure 630 from the patient’s vasculature in this embodiment, the obturator 650 can be inserted into the protective enclosure 630. The obturator 650 is advanced into the protective enclosure 630 until it contacts the distal hub 634. At this point, the obturator 650 can latch into the distal hub 634 and the proximity sensor (e.g., the proximity sensor 222) can show / indicate a positive connection. The protective enclosure length lock (e.g., the length lock 231) can be released. Continuing to advance the obturator 650 can collapse the protective enclosure expandable protective tube 636. The markings on the deployment cable 639 can indicate when the protective enclosure expandable protective tube 636 is completely restored to the insertion configuration (FIG. 7A) and can be removed from the patient.

[0057] In one embodiment the protective enclosure 630 is provided with the obturator 650 preinstalled. After insertion into the vasculature of the patient, the protective enclosure 630 can be released from the insertion configuration (FIG. 7A) to the expanded configuration (FIG. 7B) when the obturator 650 is moved from the insertion configuration, or removed from the protective enclosure 630. As provided, when the obturator 650 is fully extended into the protective enclosure 630, the obturator 650 can stretch the protective enclosure 630 into the insertion configuration (FIG. 7A). The insertion configuration can create the smallest diameter for the expandable protective tube 636, and is in the insertion configuration for the protective enclosure 630 into the vasculature. The force provided by the obturator 650 can stretch the expandable protective tube 636 to contract the walls of the expandable protective tube 636.

[0058] The expandable protective tube 636 can include laser cut nitinol or braided nitinol. In some embodiments, the expandable protective tube 636 is fabricated from self-expanding shape memory alloy, spring steel, biocompatible woven fabrics, woven metals, or woven plastics. The woven material may be pushed out for the central line 612 of the protective enclosure 630 by the memory shape metals or plastics, or internal springs when the tension of the obturator 650 is released. When in the insertion configuration, the obturator 650 can be held in place in the protective enclosure 630 by a latch 617 in the proximal hub 632. This latch may also be referred to as the configuration latch 617. Releasing the configuration latch 617 can allow the obturator 650 to be moved to an operational position in the protective enclosure 630 or to be fully removed. By either moving the obturator 650 to the operational position or fully extracting the obturator 650 from the protective enclosure 630, the stretching force can be removed from the protective enclosure 630 distal end and the protective tube 636 is allowed to expand to the deployed configuration (FIG. 7B). The expandable protective tube 636 can expand to the maximum diameter allowed by the vasculature. Once the protective enclosure 630 is deployed, the obturator 650 may not be required for the protective enclosure 630 to maintain the deployed configuration and the obturator 650 can be removed. Other devices can now be inserted into the protective enclosure 630.

[0059] To remove the protective enclosure 630 in this embodiment, the obturator 650 can be inserted into the protective enclosure 630 until the obturator 650 indicator shows it is aligned with the insertion configuration (FIG. 7A) and the configuration latch 617 is able to latch. In this position, the obturator 650 can provide sufficient force to the distal end of the protective enclosure 630 to extend the protective enclosure 630 to the insertion configuration. Once in the insertion configuration, the protective enclosure 630 and obturator 650 can be removed.

[0060] In one embodiment the protective enclosure 630 is provided with an obturator 650 that can operate by rotation. After insertion in the vasculature, the protective enclosure 630 can be expanded by rotation of the obturator 650. The protective enclosure 630 is provided in the insertion configuration (FIG. 7A). Once the protective enclosure 630 and obturator 650 are inserted into the vasculature, the obturator 650 can be unlatched from the protective enclosure 630 by pressing the configuration latch 617 and rotating the latch to the deployed position. In this embodiment, the expandable protective tube 636 can coil around a long axis of the expandable protective tube 636. Rotating the protective enclosure 630 can uncoil the expandable protective tube 636 thus allowing the expandable protective tube 636 to expand to the deployed configuration. When the protective enclosure 630 is in the deployed configuration state of FIG. 7A, the expanded expandable protective tube 636 is in a relaxed or natural state (e.g., based on expandable protective tube 136 being biased to expand). The deployed state can be naturally formed / achieved by the expandable protective tube 636 when no rotational force is applied. Once the protective enclosure 630 is in the deployed configuration, the obturator 650 may be moved to the operational position or removed to be replaced with other devices.

[0061] To remove the protective enclosure 630 in this embodiment, the obturator 650 can be inserted into the protective enclosure 630. A mark on the obturator 650 can be aligned to the deployed position mark on the proximal hub 632. The obturator 650 can be rotated back and forth to engage the obturator 650 with the centering locking mechanism 620 of the protective enclosure 630. The user can receive feedback that the tab engagement is true. The feedback can be haptic, visual, audible or combination of indicators. Once engaged, the obturator 650 can be rotated in the insertion direction until the obturator 650 aligns with the insertion latch position and the configuration latch 617 engages. The expandable protective tube 636 can be coiled back into the insertion configuration (FIG. 7 A) and ready for removal.

[0062] In one embodiment, the protective enclosure 630 does not require other devices to deploy and constrict the expandable protective tube 636. In this embodiment, the protective enclosure 630 can provide a two-piece proximal hub. The external proximal hub piece can be stationary, and the internal hub piece can be allowed to move and rotate as needed. The internal hub piece can have two latching positions for deployed and constricted. The protective enclosure 630 can be provided in the insertion configuration. After the protective enclosure 630 is inserted into the vasculature, the external hub can be attached to a patient support (e.g., the patient support 809, as described in connection with at least FIG. 9). The configuration latch 617 can be disengaged, which allows the inner hub piece to rotate relative to the outer hub. The inner hub piece can be rotated to cause the protective enclosure 630 to move to the deployed position. When the protective enclosure 630 is completely deployed, the inner hub piece can be latched into the deployed position. A secondary safety latch can also be locked into place (e.g., similar to a medicine bottle or by dropping an attached pin into locking holes). As part of the protective enclosure 630 for this embodiment, shaft(s) can extend from the inner hub piece to the distal end of the protective enclosure 630. The shaft(s) can rotate the distal end when the inner hub piece in the proximal end is rotated. As the shaft(s) rotate, the shaft(s) can uncoil the protective tube 636, which is coiled in the long direction of the protective enclosure 630. The shafts can be formed to move away from the center of the protective enclosure 630 to avoid contact with inserted instruments.

[0063] To remove the protective enclosure 630 in this embodiment, the secondary lock can be pressed coincident with the configuration latch 617. The inner hub latch can be rotated to the insertion configuration, thereby collapsing the expandable protective tube 636, allowing the protective enclosure 630 to be removed.

Balloon Expansion

[0064] Balloons or other expandable structures can also be used to expand of deploy a protective sheath. In FIGS. 5A, 5B, 6A and 6B, an embodiment is implemented with the protective enclosure 530 (e.g., structurally and/or functionally similar to the protective enclosure 130, the protective enclosure 230, the protective enclosure 330, and/or the protective enclosure 630) expanded by an expansion balloon obturator 550 (e.g., structurally and/or functionally similar to the obturator 350, the obturator 450, and/or the obturator 650) is shown. A balloon can be attached to the expansion balloon obturator 550 and inserted into the protective enclosure 530, ready to expand the expandable protective tube 536 (e.g., structurally and/or functionally similar to the expandable protective tube 136, the expandable protective tube 236, the expandable protective tube 336, and/or the expandable protective tube 636). The protective enclosure expansion mechanism may also be comprised of one balloon or several balloons 563 to minimize blood flow restriction. In all balloon configurations, the clinician can connect a syringe to the priming lumen (e.g., the priming lumen 453) to purge the device with a purging solution to remove air. In the provided configuration of FIG. 5 A, the balloon(s) is in the collapsed, uninflated state. An inflation tube 503, terminated with a Luer lock, can be provided in the proximal end of the protective enclosure 530 to inflate the balloon(s). A obturator central channel 554 (e.g., structurally and/or functionally similar to the central channel 454) runs through the center of the balloon(s) to provide a pathway 552 for a guidewire 570. The guidewire 570 can be provided as part of the kit. Once the guidewire 570 is placed and the incision site has been prepared for insertion of the protective enclosure 530, the distal hub 534 can be slid over the guidewire 570 (e.g., such that the guidewire slides through the guidewire channel 524 of the distal hub 534) and the protective enclosure 530 can be inserted into the vasculature. Once the protective enclosure 530 is in place, the protective enclosure 530 is attached to a patient support (e.g., the patient support 809, as described in connection with at least FIG. 9).

[0065] The balloon(s) 563 can then be inflated by connecting the prescribed syringe to the inflation tube 503 and inflating the balloon(s) 563 with saline or a similar fluid. Inflating the balloon(s) 563 can force the protective tube 536 open. Each balloon can expand the expandable protective tube 536 based on the volume of saline ejected into the balloon 563 from the syringe. A limit valve may be used to prevent exceeding the maximum pressure. Once the balloon 563 is inflated to the desired diameter, the volume from the syringe can be removed, which can deflate the balloon(s) 563. The balloon assembly can then be removed by unlatching the assembly from a protective enclosure locking mechanism 538 (e.g., structurally and/or functionally similar to the protective enclosure locking mechanism 138, 238, 338) and removing the balloon obturator 550. A hub valve 511 (e.g., structurally and/or functionally similar to the hub valve 211 and/or the hub valve 311) in the protective enclosure 530, a previously discussed, prevents blood loss while the balloon obturator 550 is extracted (e.g., when no device is in the protective enclosure 530, when a device is entering the protective enclosure 530, etc.). In this embodiment, there may be multiple balloons arranged radially around the central channel, in a manner such that when the balloons 563 are fully inflated there is still a path for blood to return to the heart through empty channels.

[0066] An alternate embodiment is implemented with the protective enclosure 530 contained in a tear away enclosure sheath (e.g., the sheath 228). The protective enclosure 530 can first be primed with a saline solution to eliminate air in the protective enclosure 530. A guidewire 570 can be inserted into the vasculature to define the insertion path for the protective enclosure 530. The protective enclosure 530 can then be slid over the guidewire 570 and inserted into the vasculature of the patient. Once the protective enclosure 530 is on the guidewire 570, the tear away enclosure sheath (e.g., the sheath 228) containing the protective enclosure 530 can be removed, such as by tearing the tear away enclosure sheath along a parting line to ease removal. Removing the tear away enclosure sheath allows the protective tube 536 to expand to the extent of, or near the vessel walls.

[0067] To remove the protective enclosure 530 in this embodiment, a length lock (e.g., the length lock 231) can be pressed in the proximal hub 532. Pressing the length lock can release the deployment cable (e.g., the deployment cable 639) in the proximal hub 532 allowing the expandable protective tube 536 to relax as it exits the vasculature and reduces the diameter of the protective enclosure 530.

[0068] Sensors in the proximal hub of a HFM catheter (e.g., the proximal hub 112 of the HFM catheter 11) or the proximal hub 532 of the protective enclosure 530 can indicate the configuration position. The controller can alarm if the HFM catheter (e.g., the HFM catheter 110) is not in the correct position for the present device operation.

Oxygenation Catheter

[0069] Turning to FIG. 8, an HFM Catheter 710 (e.g., structurally and/or functionally similar to the HFM catheter 110) is deployed within a protective enclosure 730 (e.g., structurally and/or functionally similar to the protective enclosure 130, 230, 330, 530, 630). The HFM catheter 710 described herein may include components that are structurally and/or functionally similar to oxygenation catheters described in the ’883 Patent, incorporated above by reference. However, catheters as described herein include components and/or functions that are necessary for such catheters to be able to interoperate with the protective enclosures, such as protective enclosure 730. Those modifications can include: a locking mechanism or element 718 (e.g., the locking mechanism 118) to lock HFM catheter 710 within the protective enclosure 730; a lock release optionally implemented as a finger grip 713 (e.g., structurally and/or functionally similar to the finger grip 213) to unlock the HFM catheter 710 from the protective enclosure 730; a sensor or sensing mechanism in the HFM catheter distal hub (e.g., the distal hub 114) to confirm engagement with the distal hub 734; and/or a sensor (e.g., structurally and/or functionally similar to the sensor 307) to take measurements, including physiological parameters such as SpCh, temperature, or blood flow characteristics.

[0070] The HFM catheter 710 shown in FIG. 8 includes a proximal hub 712 (e.g., structurally and/or functionally similar to the proximal hub 112), HFMs 716 (diffusion fibers) (e.g., structurally and/or functionally similar to the HFMs 116), and a distal hub 714 (e.g., structurally and/or functionally similar to the distal hub 714). A sheath (e.g., structurally and/or functionally similar to sheath 228) configured to contain the protective enclosure 730 can facilitate insertion of the protective enclosure 730 into the vasculature and/or facilitate priming of the protective enclosure 730. A sheath may also cover tubing or other connections connecting the HRM catheter 710 to an oxygen source (e.g., via an oxygen inlet) and/or to a torque drive.

[0071] The locking mechanism in the proximal hub 712 can be configured to latch to a locking mechanism of the proximal hub 732 (e.g., structurally and/or functionally similar to the locking mechanism 138 or other protective enclosure locking mechanisms described herein) when the HFM catheter 710 is inserted into the protective enclosure 730. In some embodiments, the locking mechanism 118 can be a latching mechanism that includes a spring or otherwise be spring loaded. Such a spring may be configured to apply a force to push the latching mechanism into engagement with a portion of the HFM catheter 710 or other instrument. For example, as the HFM catheter 710 is inserted, the latching tabs of the proximal hub 712 (also referred to herein as “catheter tabs”) can contact the mating latching tabs on the proximal hub 732 (also referred to herein as “enclosure tabs”). The catheter tabs and/or the enclosure tabs can be designed with or include a ramped face. When the catheter tabs touch the enclosure tabs, and the ramped faces are adjacent to each other, the force applied on the ramped faces can compress the spring. Further, lowering the catheter tabs can allow the catheter tabs to pass the enclosure tabs during insertion. Once the catheter tabs and the enclosure tabs have passed each other, the spring can expand, thereby pushing one or both of the enclosure tabs into the locked position. In the locked position, the enclosure tabs can make planar contact with the catheter tabs and maintain this longitudinal position, keeping the HFM catheter 710 positioned within the protective enclosure 730 (e.g., until the release mechanism is activated). Latching the HFM catheter 710 into the protective enclosure 730 can deploy the HFMs 716. For example, when positioning the HFM catheter 710 in the protective enclosure 730, the distal hub 714 of the HFM catheter 710 can push against the distal hub 734 of the protective enclosure 730, and a proximal portion of the HFM catheter 710 can lock to a locking mechanism of the protective enclosure 730, thus constricting the HFM catheter 710 and reducing a distance between proximal and distal ends of the HFMs 716, allowing the HFMs 716 to deploy (e.g., bow or extend radially outward). Alternatively, the HFMs 716 can be deployed when a protective sheath covering the HFMs 716 is removed. Or alternatively, the HFMs 716 can deploy by rotating the HFM catheter 710 while latched in the protective enclosure 730. Or alternatively, the HFMs 716 can be configured to self-expand once disposed within the expanded space of the protective enclosure 730 (specifically, for example, the expanded space of the protective tube of the protective enclosure 730).When in the non-deployed or insertion state, the HFMs 716 of the HFM catheter 710 can be held taught between the proximal hub 712 and the distal hub 714 of the HFM catheter 110. For example, the HFMs 716 can extend substantially parallel to a longitudinal axis of the HFM catheter 110. While the locking mechanisms described above are implemented as latching elements, it can be appreciated that other locking mechanisms can be used, including, for example, other mechanical locking mechanisms, magnetic locking mechanisms, etc.

[0072] To unlatch or decouple the HFM catheter 710 from the protective enclosure 730, the lock release element (e.g., structurally and/or functionally similar to other lock releases described herein) can be released or pulled back. In FIG. 8, this lock release element is implemented as finger grip 713; however, other lock release elements can be used, such as, for example, other components that can be actuated by a user (e.g., a button, a lever, a string, a cord, etc.). Pulling the finger grip 713 in an axial direction away from the distal hub 734 can release the catheter tab, overpowering the spring force, and allow the catheter tabs and the enclosure tabs to clear each other (e.g., to move relative to one another). The HFM catheter 710 can then be removed from the protective enclosure 730. In some embodiments, a second HFM catheter can be inserted into the protective enclosure 730, e.g., in the case where the first HFM catheter needs to be replaced. In some embodiments, a different device (e.g., a ECMO cannula) can be inserted into the protective enclosure 730. In some embodiments, an additional device may not be inserted into the protective enclosure 730; however, the protective enclosure 730 may remain within the patient vasculature, e.g., to provide infusion port access (via infusion port 721).

[0073] When in the latched or locked position, the HFM catheter 710 may be limited or prevented from moving axially in the protective enclosure 730. However, the HFM catheter 710 may be free to move rotationally, e.g., by any amount and/or continuously. In some embodiments, the protective enclosure 730 and/or the HFM catheter 710 include roller bearings or bushings to facilitate the rotation of the HFM catheter 710 when the HFM catheter 710 is positioned within the protective enclosure 730.

[0074] In some embodiments, the proximal hub 712 of the HFM catheter 710 can have an infusion port 721 configured to allow infusion of fluids, blood products, or medications into the vein. This is an additional port outside the central lines, which may be present in the protective enclosure.

[0075] Latching the HFM catheter 710 in the distal hub 734 can be an alternate embodiment of the protective enclosure locking mechanism (e.g., the protective enclosure locking mechanism 138). In this embodiment, the HFM catheter 710 and protective enclosure 730 latching tabs and springs can be positioned in the distal hubs 714, 734. The tabs can operate as previously described. A cable or string lock release can connect the catheter tab in the distal hub 714 to a lock release in the proximal hub 712. Pulling the finger grip 713, can release the HFM catheter 710 as previously described. When in the latched position, the HFM catheter 710 may be limited or prevented from moving axially in the protective enclosure 730. However, the HFM catheter 710 may be free to move rotationally any amount and continuously.

Portable System

[0076] As shown in FIG. 9, in one embodiment the HFM catheter 810 (e.g., structurally and/or functionally similar to the HFM catheter 110, 810) and protective enclosure 830 (e.g., structurally and/or functionally similar to the protective enclosure 130, 230, 330, 530, 630, 730) are connected via a flexible shaft to a system control unit 890 which is connected to a belt 823, which can be worn around the waist of a mobile patient (i.e., during walking or transport). Also connected to the belt 823 can be a battery pack 819 and pressurized oxygen cannister and regulator 827. An M2 or M4 oxygen cannister or other small oxygen canisters may be small enough to be belt worn and provide less than about 15 minutes of oxygen supply. Additionally, the system control unit 890 may have at least two power connection(s) and at least two oxygen connect! on(s). Having at least two oxygen connections can allow the clinician or patient to connect to both a large wall oxygen source and small wearable oxygen tank at the same time. The system control unit 890 may prioritize oxygen from the wall or large oxygen supply and only switch to the small or portable connection when the wall connection no longer supplied oxygen. In the same manner, the system control unit 890 can have at least two power connections and may prioritize power from a wall plug, but automatically switch to the belt battery 819 in the event the wall is unplugged. The system control unit 890 may also have an additional internal battery which can provide power in the event of a power loss or interruption. Both the oxygen and power configurations may allow continuous supply of oxygen and power while connecting and discounting to the portable supplies. Different embodiments of the belt 823 can be worn around the waist, over the shoulder, or as a backpack.

[0077] An alternate embodiment of a portable system could be based on a wheeled cart, as shown in FIG. 10. In this embodiment a system control unit 90 (e.g., structurally and/or functionally similar to the system control unit 890), a larger portable oxygen tank 927, and an external battery 919 (e.g., structurally and/or functionally similar to the battery 819) can be fixed to a small, wheeled cart with a handle. The patient or clinician can push the wheeled cart without any connections to a wall. An oxygen concentrator may be used in place of an oxygen cannister in either of these embodiments.

Single Unified Control

[0078] The diffusion of oxygen from the HFM catheter (e.g., HFM catheter 110, 710, or any of the other HFM catheters described herein) into the bloodstream is controlled by multiple variables, including but not limited to: the oxygen pressure inside the HFMs (e.g., structurally and/or functionally similar to the HFMs 116), the oxygen flow rate through the HFMs and the oscillation of the HFMs, and the percent oxygen in the gas passing through the HFMs (%FiO2). The oscillation of the HFMs may consist of micro-oscillations and macro-oscillations, as described in more detailed in the incorporated ’883 Patent. A system control unit 1000 (FIG. 11), controls the value of at least three variables, and may control additional variables. Increasing oxygen pressure inside the HFMs increases the diffusion of oxygen. Increasing the oxygen flow rate through the HFMs increases the diffusion of oxygen. Increasing the magnitude of oscillations (micro and/or macro) increases the diffusion of oxygen.

[0079] In one embodiment the system control unit has a single input control 1010 (such as a dial or other single input device) that can be configured to be manipulated to control a pressure of gas within the HFMs, an oscillation of the HFMs, and a concentration of oxygen within the gas. For example, the single input control 1010 can control the flow of oxygen. Further, an electronic controller inside the system control unit 1000 can modify necessary variables to smoothly adjust the amount of oxygen diffused into the bloodstream of the Patient P from a maximum value (100%) to a minimum value (0%). Having zero % oxygen delivery is valuable to determine if the patient is ready to have supplemental oxygen removed, and they can remain stable and oxygenate themselves, once the HFM catheter is removed. Adjusting a single dial is valuable to clinicians who need to respond to varying oxygenation saturation values, without extensive training on the function of the device.

[0080] In one embodiment, the maximum oxygen delivery (100%) would result from the single input control 1010 being set (e.g., dial being turned) to the maximum position. In this configuration the Fi02% would be at 100%, the oxygen delivery pressure would be at a maximum (e.g., 50 psi), oscillations would be at the maximum rate, and oxygen flow rate would be maximized. In some embodiments, the electronic controller 1015 can be configured to control the oscillation of the HFMs by controlling an angular speed of the oscillation. Alternatively, the electronic controller 1015 can be configured to control the oscillation of the HFMs by controlling an amplitude of the oscillations. When the single input control is decreased below the maximum setting, one example control algorithm would include the electronic controller 1015 in the system control unit 1000 initially decreasing the amplitude of oscillations, while keeping all other parameters the same. Once the oscillations were reduced to a pre-determined level the next parameter to be decreased could be the oxygen pressure inside the HFMs. Further decreases in oxygen delivery pressure commanded by the single input control 1010 would result in further decreases in oscillation amplitude. Once the oxygen delivery reaches a lower desired value (in one illustrative example this may be 50% oxygen delivery) the system would begin to decrease the FiO2%, along with further decreases in the other parameters. At 0% oxygen delivery the system may maintain a minimal level of oscillations or no oscillations, with a minimal flow rate and pressure, and may have an FiO2% of 20%. In other embodiments, the sequence in which parameters are changed could be different, e.g., the first parameter to be decreased to reduce oxygen delivery below 100% could be oxygen delivery pressure or FiO2%, the second parameter could be oscillation magnitude, etc.

[0081] In one embodiment the system follows the same algorithm every time. In this embodiment, when the single input control is at a given setting (52%, 75%, etc.) the system control unit always commands the same outputs for all variables (i.e. the oxygen pressure inside the HFMs 116, the oxygen flow rate through the HFMs 116 and the oscillation of the HFMs 116, and the percent oxygen in the air passing through the HFMs 116 (%FiC>2)). In other embodiments, a given setting could be achieved by commanding different outputs for different variables, which may be selected based on other inputs to the system other than the user input. [0082] The system control unit 1000 includes a single input control 1010 to modify oxygen delivery through a HFM catheter. The system control unit has connections to allow gaseous oxygen and power to be delivered. The system control unit may also have a “room air” gaseous air supply, or other medical gasses supplied. The gas supply would pass into a gas control inlet. This inlet is controlled electronically by an electronic controller 815. The inlet may consist of one or more of the following components: a pressure regulator; a mass flow controller; a mixer; a compressor; and a pressure sensor. The pressure regulator may be used to decrease the supply side gas pressure to a lower pressure. The mass flow controller may be used to control the mass of gas flowing through the inlet. The compressor may be used to increase the pressure of the gas above what is provided by the external gas supply. The pressure sensor may be used to monitor the pressure in the gas line.

[0083] A pressurized gas line carries the gases from the gas control inlet 1018 to the HFM catheter (e.g., HFM catheter 110, 710, or any of the other HFM catheters described herein). The HFM catheter diffuses the oxygen (e.g., by oscillating the plurality of HFMs 116) and/or other gases into the bloodstream of the Patient P. The electronic controller 1015 can control the pressure of the gases within the plurality of the HFMs by controlling a flow rate of the gas. The electronic controller 1015 may be operatively coupled to the gas control outlet 1020 such that the electronic controller 1015 can control a flow restriction (e.g., to control a flow rate of the gas being exhausted from the HFM catheter to the gas control outlet 1020). The exhaust gases from the HFM catheter can exit the HFM catheter, flow through a second pressurized gas line and enter the gas control outlet 1020 (e.g., based on an instruction or command from the electronic controller 1015). The gas control outlet 1020 can include one or more of the following components: a pressure sensor; a flow restriction which is controllable to control a flow of the gas being exhausted from the HFM catheter; and/or a mass flow controller. The flow restriction which is controllable may have a larger or smaller opening, the size of which can be dictated by the electronic controller 1015. The electronic controller 1015 can adjust the flow restriction to have a smaller opening. In some embodiments, the smaller opening may be used when a higher pressure is desired in the HFM catheter, with a lower mass flow rate. Alternatively, the electronic controller 1015 can adjust the flow restriction to have a larger opening. In some embodiments, the larger opening may be used when a lower pressure and higher flow rate is desired. However, the electronic controller 1015 can be configured to control the pressure within the HFMs and the flow rate of the gas independently from one another. For example, the electronic controller 1015 can control the pressure of the gas delivered to the HFM catheter while keeping the flow rate constant (e.g., by changing the size of the flow restriction). In other words, the electronic controller 1015 can control the amount of gas being exhausted via the gas control outlet 1020, which can impact the pressure within the catheter, while keeping the flow rate constant. A mass flow controller may perform a similar function. Controlling a specific mass flow rate in the outlet 1020, which is lower than the mass flow rate in the inlet 1018 can control the pressure and diffusion occurring in the HFMs. The gas control outlet 1020 may vent the exiting gas either into the system control unit 1000 and then into the surrounding air, or into a pressurized gas line which vents to the outside. In an alternate embodiment, the outlet 1020 may vent directly to an anesthesia gas scavenger.

[0084] The system control unit 1000 may also contain a plug for an external power source, an internal power supply 1030, an electronic controller 1015, and user input. In some embodiments the system control unit 1000 can also include a motor 1025 or other drive unit, and a motor shaft which can transmit oscillations or other movements to the HFM catheter. In some embodiments the system control unit 1000 contains other user interface elements such as a power switch, display(s), and other switches. The display(s) may show data such as the amount of oxygen or other gases being diffused into the Patient P’s bloodstream, patient vital signs, femoral and or venous blood oxygenation saturation, and other data.

[0085] The internal power supply 1030 may include multiple components, including, but not limited to, an AC to DC converter, a backup battery, a power supply, and a power management system. The electronic controller 1015 may include a microcontroller, FPGA or mechanical control.

[0086] The motor shaft is connected to the HFM catheter through a flexible shaft. The shaft may include at least two components: a flexible torque transmitting shaft and a gas inlet line. In some embodiments, there may be an additional gas outlet line which connects to the gas control outlet 1020. In some embodiments, there may be connections for multiple catheters on one control unit 1000.

[0087] In some embodiments, there may be a connection for room air and a separate connection for oxygen. The room air and oxygen may be mixed and varied from 20% oxygen (room air) to 100% oxygen. This mixture may also be part of the single input control algorithm. At 100% oxygen delivery the gas delivered can be 100% oxygen.

[0088] In some embodiments, the single dial unified control input 1010 (also referred to herein as “dial”) is rotatable by a user. When rotated, the dial 1010 can be configured to send a signal to the electronic controller 1015 that causes the electronic controller 1015 to modify at least one of the pressure of the gas within the HFMs, the oscillation of the HFMs, or the concentration of the oxygen within the gas. In some embodiments, when the dial 1010 is rotated from a first position to a second position, the electronic controller 1015 is configured to modify the oscillation of the plurality of HFMs while maintaining a pressure of the gas and the concentration of the oxygen at set levels. Further, the electronic controller 1015 may be configured to modify the pressure of the gas while maintaining the oscillation of the HFMs at a predetermined level and the concentration of the oxygen at the set level when the dial 1010 is further rotated from the second position to a third position. When the dial 1010 is further rotated from the third position to a fourth position, the electronic controller 1015 can be configured to modify the concentration of the oxygen while maintaining the oscillation of the HFMs at the predetermined level and the pressure of the gas at a predetermined level.

[0089] A chart below shows one embodiment of the control algorithm. In this table the single dial unified control input 1010 is moved or rotated from 0 (e.g., a first position) to 10 (e.g., a second position), which can deliver 0% or 100% supplemental oxygen respectively through the HFMs to the patient. In this chart several different relevant parameters are shown, along with how each of the parameters may change. This is one embodiment of a control algorithm, and other embodiments be used to accomplish the same change in oxygenation delivery from 0% to 100%. In the table below 02% can indicate the percent of the gas flowing through the fiber that is oxygen gas. As the 02% decreases below 100%, the remaining gas is may be replaced with nitrogen. This may be accomplished by mixing a pure oxygen input with a “room air” input. This chart shows illustrative values at 5 different delivery set points. The parameters listed can be varied linearly or through other non-linear variations.

[0090] A second chart shows an additional embodiment of the control algorithm with different inputs to create the same output.

Closed Loop Control

[0091] In an alternate embodiment the single input control 1010 may not be operated by a clinician but is instead operated by an algorithm. This algorithm may preferably use the patient’s femoral oxygen saturation percentage as an input. The algorithm can set the oxygen delivery between 0% and 100% as necessary to establish and maintain the patient’s desired oxygen saturation percentage. The oxygen saturation data can be collected from a variety of sources including an external pulse oximeter on the patient or a sensor 1016. In some embodiments, the sensor 1016 is an internal femoral oxygen saturation sensor or an internal venous oxygen saturation sensor. These oxygen saturation sensors may be an existing sensor that are present on another device separate from the HFM device but communicate with the system control unit by either wired or wireless communication. For example, the sensor 1016 can be configured to measure one or more physiological parameters of a patient, e.g., a blood oxygenation saturation level within the patient vasculature (e.g., in an artery), and the controller 1015 can be configured to control at least one of the pressure of the gas, the oscillation or rotation of the HFMs, and/or the concentration of oxygen within the gas based on a signal from the sensor 1016. Venous oxygenation sensors may also be integrated into either the protective enclosure (e.g., the protective enclosure 130, 730, or any of the other protective enclosures described herein) or the HFM catheter (e.g., the HFM catheter 110, 710, or any of the other HFM catheters described herein). If integrated into the HFM catheter or protective tube of the protective enclosure, these sensors can be placed at the proximal end, the distal end, or in the middle of the catheter or protective enclosure. Methods

Methods for use - Insertion Process

[0092] Prior to the methods described in connection with FIGS. 12A-13, the following sequence may occur or otherwise be executed (e.g., by a technician, clinician, or other user): (1) remove the protective enclosure 130, obturator 350 and catheter from sterile packaging; (2) place obturator/balloon inside of protective enclosure 130 (e.g., the protective enclosure may be pre-placed); (3) consider whether a lock is in place; (4) consider whether the lock wire has any compressive strength; (5) determine whether the proximity sensor (e.g., the proximity sensor 222) indicates a lock; (6) prime system by connecting a syringe to each central line 212 access port and prime each line; (7) prime system by connect the syringe to the obturator 350 and prime space between the obturator 350 and the enclosure sheath; (8) prime system by connecting the syringe to the HFM catheter 110 and prime space between the fibers and the sheath; (9) connect HFM catheter 110 and protective enclosure 130 to system control unit; (10) run system diagnostics on the HFM catheter 110 and the protective enclosure 130; (11) perform a pressure check on the HFM catheter 110; (12) determine whether the proximal sensor is working on the protective tube 136; (13) determine whether the protective tube 136 is at full extension; (14) remove guide wire from packaging.

[0093] FIGS. 12A-12F depict schematic views of a sequence of placing a catheter and a protective enclosure within a patient vasculature, according to embodiments. FIG. 13 is a flow chart of a method 1300 for placing a catheter and an protective enclosure within a patient vasculature, according to embodiments. For example, the method 1300 can be implemented to execute the sequence of FIGS. 12A-12F. For illustrative purposes, the method 1300 of FIG. 13 is described in connection with FIGS. 12A-12F.

[0094] At 1302, a guidewire is advanced into a body lumen of a patient (e.g., the patient vasculature). As shown in FIG. 12A, the guidewire 1170 is advanced into the IVC of the patient. In some embodiments, the insertion site may be in the SVC, the jugular vein, the femoral vein, the right atrium of the heart, or other vasculature. In some embodiments, the guidewire 1170 is a 0.035 inch j-tip guidewire. Alternatively, the guidewire 1170 may be a straight tip guidewire. In some embodiments, proper placement of guidewire 1170 is confirmed via appropriate medical imaging, including fluoroscopy, ultrasound, or other methods. In some embodiments, the guidewire 1170 gains access to the body lumen via a micropuncture kit. For example, an access path may be formed via the femoral view or the jugular view of the patient. [0095] At 1304, the body lumen may be dilated via a serial dilator. As shown in FIG. 12B, the body lumen may be dilated via a dilator 1172. In some embodiments, the body lumen is dilated to expand access in the skin and the vein. In some embodiments, the dilator 1172 can dilate the venotomy to 15-20 Fr.

[0096] At 1306, a protective enclosure is advanced over the guidewire into the body lumen, the protective enclosure surrounded by a sheath. As shown in FIG. 12C, the protective enclosure 1130 is advanced over the guidewire 1170 and into a location within the body lumen, the protective enclosure 1130 being surrounded by the sheath 1174. In some embodiments, proper placement of the protective enclosure 1130 and the sheath 1174 can be confirmed via medical imaging. In some embodiments, the protective enclosure 1130 in the sheath 1174 is 15-20 Fr. At 1308, the guidewire can be removed. As shown in FIG. 12, the guidewire 1170 can be removed.

[0097] At 1310, an expandable body of the protective enclosure can be expanded by removing the sheath. As shown in FIG. 12D, an expandable body of the protective enclosure 1130 can be expanded (e.g., allowed to self-expand, deployed, etc.) by removing (e.g., retracting, peeling away, etc.) the sheath 1174. In some embodiments, the sheath 1174 is removed by pulling back on an exposed tab, until the sheath 1174 is fully removed. The expandable body of the protective enclosure 1130 may be configured to expand until fully deployed. In some embodiments, the protective enclosure 1130 may be locked in the deployed position. As shown in FIG. 12E, the protective enclosure 1130 may be dilated by the dilator 1178 to a size of about 25 Fr ID.

[0098] At 1312, an oxygenation catheter may be advanced into the body lumen through the protective enclosure. As shown in FIG. 12F, the HFM catheter 1110 may be advanced into the body lumen through the protective enclosure 1130. Further, the HFM catheter 1110 may be advanced through a proximal hub of the protective enclosure 1130 into the expandable body of the protective enclosure 1130. In some embodiments, a sheath of the HFM catheter 1110 is removed. In some embodiments, a clinician can confirm proper seating by observing / assessing the proximity sensor (e.g., the proximity sensor 222) for an affirmative indication. In some embodiments, the method 1300 can further include locking, using a locking mechanism (e.g., the locking mechanism 220) of the protective enclosure 1130, the HFM catheter 1110 to the protective enclosure 1130 such that the HFM catheter 1110 is axially maintained within the protective enclosure 1130 while the plurality of HFMs oscillate within the protective enclosure 1130. At 1314, the oxygenation catheter may be deployed. For example, the HFM catheter 1110 may be deployed (e.g., the HFMs may be enabled to expand, move, oscillate, etc.). Optionally, at 1316, the oxygenation catheter may be removed. For example, the HFM catheter 1110 may be removed (e.g., from the protective enclosure 1130, from the vessel, etc.).

[0099] Subsequent to or intermediately with the methods described in connection with FIGS. 12A-13, the following sequence may occur or otherwise be executed (e.g., by a technician, clinician, or other user): (1) deploy the HFM fibers on the HFM catheter 1110; (2) confirm device properly placed via system control unit; (3) command system control unit to run preoperation checks; (4) confirm proximity sensor (e.g., the proximity sensor 222) is reading appropriately; (5) confirm the HFM fibers are in position; (6) confirm that rotation of HFMs can occur without excessive resistance; (7) confirm that gas flow is nominal; (8) assess other checks as needed; (9) activate system to operate by initiating oxygen flow and HFM rotation. In some embodiments, the HFMs may be deployed (e.g., rotated) in response to advancing the HFM catheter 1110 into the expandable body of the protective enclosure 1130.

Methods for use - Removal Process

[0100] Subsequent to the methods of insertion described above, the following sequence may occur or otherwise be executed (e.g., by a technician, clinician, or other user): (1) pull back on the hub of the HFM catheter 110 while pushing forward on the hub of the protective enclosure 1130 to release the HFM catheter 1110; (2) place HFM catheter 1110 removal sheath into valve; (3) remove HFM catheter 1110; (4) optionally place an ECMO cannula into the protective enclosure 1130 instead of or in place of the HFM catheter 1110; (5) release a length lock (e.g., the length lock 231) on the protective enclosure 1130; (6) insert an obturator (e.g., the obturator 350) into the protective sheath; (7) place retraction sheath over sides to protect incision; (8) remove the protective enclosure 1130; (9) suture vein closed.

Claims

1. An apparatus, comprising: a proximal hub; a distal hub; a hollow body disposed between the proximal hub and the distal hub, the hollow body configured to transition from an unexpanded state to an expanded state in which the hollow body is configured to receive an instrument inserted through the proximal hub, the hollow body and the distal hub being disposable within a body lumen of a patient, the hollow body in the expanded state being configured to space the instrument from a wall of the body lumen to protect the body lumen from movements of the instrument; and a locking mechanism configured to detachably couple to the instrument, the locking mechanism, when coupled to the instrument, being configured to maintain an axial position of the instrument within the expandable hollow body.

2. The apparatus of claim 1, wherein the hollow body includes laser cut nitinol or braided ni tinol.

3. The apparatus of claim 1, wherein the locking mechanism is disposed on the proximal hub.

4. The apparatus of claim 1, wherein the locking mechanism includes a mating feature configured to latch onto a portion of the instrument.

5. The apparatus of claim 1, wherein the locking mechanism, when coupled to the instrument, is configured to enable rotational movement of the instrument about a longitudinal axis of the hollow body while preventing axial movement of the instrument relative to the hollow body.

6. The apparatus of claim 1, wherein the locking mechanism, when coupled to the instrument, is configured to provide a visual, audible, or tactile reference to indicate that the instrument has been coupled to the locking mechanism.

7. The apparatus of claim 1, further including a sensor, the sensor being configured to provide feedback that the instrument has been disposed in a predetermined position within the hollow body.

8. The apparatus of claim 1, wherein the locking mechanism includes a spring that is configured to apply a force to push the locking mechanism into engagement with a portion of the instrument.

9. The apparatus of claim 1, wherein the distal hub defines a cavity configured to receive a distal end of the instrument, the distal hub including grasping elements configured to engage with a distal portion of the instrument.

10. The apparatus of claim 1, further comprising a valve disposed in the proximal hub, the valve configured to prevent blood loss from the body lumen when the expandable body and the distal hub are disposed within the body lumen and the instrument is removed from the hollow body.

11. The apparatus of claim 10, wherein the valve is configured to open to enable the instrument to be inserted through the proximal hub and into the hollow body.

12. The apparatus of claim 1, wherein the hollow body in the expanded state is configured to be permeable such that blood can permeate into an interior of the hollow body.

13. The apparatus of claim 1, wherein the hollow body in the expanded state is configured to receive a blood oxygenation catheter and to allow the blood oxygenation catheter to oscillate within the hollow body while the hollow body remains stationary relative to the body lumen.

14. The apparatus of claim 1, wherein the hollow body in the expanded state includes a proximal segment that has a constricted diameter configured to accommodate a narrowing portion of a vasculature of the patient.

15. The apparatus of claim 1, further comprising an infusion port configured to allow infusion of a fluid into the hollow body.

16. A system, comprising: an enclosure including a proximal hub, a distal hub, and an expandable body disposed between the proximal hub and the distal hub; and a catheter configured to be inserted through the proximal hub of the enclosure and positioned within the expandable body, the catheter including a distal portion configured to engage with at least one mating element positioned in at the proximal hub or the distal hub, the catheter including a plurality of hollow fiber membranes (HFMs), the plurality of HFMs, when the catheter is positioned within the expandable body, being configured to be rotated relative to the enclosure while being maintained axially such that the plurality of HFMs can be configured to cause diffusion of oxygen into blood within a blood vessel.

17. The system of claim 16, wherein the expandable body is configured to space a wall of the blood vessel from the catheter to prevent forces generated by the plurality of HFMs while the HFMs are rotated within the expandable body from damaging the wall of the blood vessel.

18. The system of claim 16, wherein the expandable body is configured to expand or reshape a cross-sectional area of the blood vessel to provide at least a predetermined area for the plurality of HFMs to expand within the expandable body.

19. The system of claim 16, wherein the enclosure further includes at least one valve positioned at the proximal hub, the valve being configured to prevent leakage of blood out of the blood vessel via the proximal hub of the enclosure.

20. The system of claim 16, wherein the enclosure further includes a locking mechanism configured to lock to a portion of the catheter to maintain the catheter axially within the enclosure.

21. The system of claim 20, wherein the locking mechanism includes a mating feature configured to latch onto the portion of the catheter.

22. The system of claim 20, wherein the locking mechanism, when locked to the portion of the catheter, is configured to maintain the catheter axially within the enclosure while enabling rotational movement of the plurality of HFMs.

23. The system of claim 16, wherein the plurality of HFMs, when the catheter is positioned within the expandable body and is engaged with the mating element, are configured to transition to a deployed, expanded state within the expandable body.

24. The system of claim 16, further comprising a sheath configured to cover the enclosure, the enclosure, when covered by the sheath, being configured to be advanced within the blood vessel to a predetermined location within the blood vessel, the sheath configured to be removed from the enclosure after the enclosure is at the predetermined location to enable the expandable body to expand within the blood vessel.

25. A system, comprising: a catheter including a plurality of hollow fiber membranes (HFMs), the catheter configured to be deployed within an enclosure that is disposed within a blood vessel of a patient, the plurality of HFMs being coupled to a drive unit that is configured to oscillate the plurality of HFMs within the enclosure when the catheter is deployed with the enclosure, the plurality of HFMs further being coupled to a gas source and being configured to receive gas containing oxygen from the gas source and to deliver the oxygen into the blood vessel, and a controller operatively coupled to the catheter, the drive unit, and the gas source, the controller including a single input device configured to be manipulated to control a pressure of the gas within the plurality of HFMs, an oscillation of the plurality of HFMs, and a concentration of oxygen within the gas.

26. The system of claim 25, wherein the controller is configured to control the oscillation of the plurality of HFMs by controlling an amplitude of the oscillations.

27. The system of claim 25, wherein the controller is configured to control the oscillation of the plurality of HFMs by controlling an angular speed of the oscillation.

28. The system of claim 25, wherein the controller is configured to control the pressure of the gas within the plurality of HFMs by controlling a flow rate of the gas.

29. The system of claim 25, wherein the input device is a dial that is rotatable by a user, the dial when rotated configured to send a signal to the controller that causes the controller to modify at least one of the pressure of the gas within the plurality of HFMs, the oscillation of the plurality of HFMs, or the concentration of oxygen within the gas.

30. The system of claim 29, wherein, when the dial is rotated from a first position to a second position, the controller is configured to modify the oscillation of the plurality of HFMs while maintaining the pressure of the gas and the concentration of the oxygen at set levels.

31. The system of claim 30, wherein, when the dial is rotated further from the second position to a third position, the controller is configured to modify the pressure of the gas while maintaining the oscillation of the plurality of HFMs at a predetermined level and the concentration of the oxygen at the set level.

32. The system of claim 31, wherein, when the dial is rotated further from the third position to a fourth position, the controller is configured to modify the concentration of the oxygen while maintaining the oscillation of the plurality of the HFMs at the predetermined level and the pressure of the gas at a predetermined level.

33. The system of claim 25, further comprising a gas control outlet coupled to the catheter, the gas control outlet including a flow restriction that is controllable to control a flow of the gas diffusing from the catheter into blood flowing through the blood vessel.

34. The system of claim 33, wherein the controller is operatively coupled to the gas control outlet, the controller further being configured to control the flow restriction to control a flow rate of the gas diffusing from the catheter into blood flowing through the blood vessel.

35. The system of claim 25, wherein the controller is operatively coupled to a sensor configured to detect a parameter of blood in the blood vessel, the controller configured to control at least one of the pressure of the gas within the plurality of HFMs, the oscillation of the plurality of HFMs, or the concentration of oxygen within the gas based on a signal from the sensor.

36. A method, comprising: advancing an enclosure to a location within a body lumen of a patient, the enclosure including a proximal hub, a distal hub, and an expandable body disposed between the proximal hub and the distal hub; expanding, after advancing the enclosure to the location within the body lumen, the expandable body of the enclosure; advancing a catheter including a plurality of hollow fiber membranes (HFMs) through the proximal hub of the enclosure and into the expandable body; and subsequent to advancing the catheter into the expandable body, deploying the plurality of HFMs within the expandable body.

37. The method of claim 36, wherein expanding the expandable body of the enclosure includes removing a sheath disposed over the enclosure to allow the expandable body to selfexpand within the body lumen.

38. The method of claim 36, further comprising locking, using a locking mechanism of the enclosure, the catheter to the enclosure such that the catheter is axially maintained within the enclosure while the plurality of HFMs can oscillate within the enclosure.

39. The method of claim 36, further comprising: delivering gas containing oxygen to the plurality of HFMs; and oscillating the plurality of HFMs while delivering the gas containing the oxygen to cause diffusion of the oxygen into blood within the body lumen.

40. The method of claim 36, wherein the body lumen includes a portion of at least one of inferior vena cava, superior vena cava, or right atrium of a heart.

41. The method of claim 36, further comprising, prior to advancing the enclosure to the location within the body lumen, forming an access path via a femoral vein or a jugular vein of the patient.