Access Device

Abstract

The present disclosure relates to an access device including a cannula with a mating lumen extending therethrough and a hub coupled to a proximal end of the cannula. The hub includes at least two arms. The first arm may have a first lumen and a first hemostatic valve, the first lumen operably connected to the mating lumen, the first lumen and the first hemostatic valve configured for passage of a medical device, and the second arm is coupled to the first arm and may have a second lumen, the second lumen operably connected to the mating lumen, the second arm configured to be operably coupled to an external medical device, such as an extracorporeal membrane oxygenation (ECMO) device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 297,506, filed January 7, 2022, U.S. Provisional Patent Application No. 63 / 313,791, filed February 25, 2022, and U.S. Provisional Patent Application No. 63 / 344,300, filed May 20, 2022, the entirety of each of which is incorporated herein by reference.

[0002] Technical Field

[0002] The present disclosure relates to surgical access devices, and more particularly, to access devices that can be used to facilitate the introduction of medical devices into a patient and to promote blood circulation through extracorporeal devices. [Background technology]

[0003] background

[0003] Extracorporeal membrane oxygenation (ECMO) involves the use of mechanical circulatory devices for patients experiencing cardiogenic shock or other forms of hemodynamic compromise. Ventricular assist devices (VADs) and catheter-based devices (such as intravascular blood pumps) may be used to relieve stress on the heart (e.g., the left ventricle).

[0004]

[0004] Access devices are commonly used in surgical procedures to facilitate the introduction of medical instruments into the body's natural biological vessels, cavities, and the like. These access devices include, for example, devices that facilitate the introduction of guidewires, balloon catheters, or other catheter-based medical devices into the vasculature of the human body. These access devices can also be used to facilitate extracorporeal circulation of blood, such as when utilizing extracorporeal membrane oxygenation (ECMO) devices (including, for example, veno-arterial ECMO (VA-ECMO) or veno-venous ECMO (VV-ECMO) devices). Summary of the Invention [Means for solving the problem]

[0005] overview

[0005] According to a first aspect of the present disclosure, an access device can be provided to allow insertion of two or more medical devices into a patient through the device. The access device can include a hub configured to be coupled to a proximal end of a cannula having a proximal end, a distal end, and a mating lumen passing through the cannula. The access device can also include a second arm coupled to the first arm, where the hub can have a first arm and a second arm. The first arm can have a first lumen operably connected to the mating lumen and a first hemostatic valve configured for passage of a medical device. The second arm can be operably connected to the mating lumen and can be configured to be operably coupled to an extracorporeal membrane oxygenation (ECMO) device. In some embodiments, the cannula can be coupled to the hub by a threaded or barbed connection. In some embodiments, the medical device can be a guidewire, a guide catheter, a balloon catheter, or a catheter-type heart pump.

[0006] In some embodiments, the cannula may be a junction cannula that may comprise multiple sections. In some embodiments, the junction cannula may comprise a first junction cannula section having a proximal end coupled to the hub and a second junction cannula section having a proximal end coupled to a distal end of the first junction cannula section. In some embodiments, the first junction cannula section, the second junction cannula section, or both may be semi-rigid.

[0007] In some embodiments, the second arm can be configured to be operably coupled to the ECMO device via an additional cannula. In some embodiments, the additional cannula can be a flexible cannula.

[0008] In some embodiments, a first angle formed between a central axis of the first arm and a central axis of the second arm can be less than 90 degrees. In some embodiments, a second angle formed between a central axis of the first lumen and a central axis of the second lumen can be less than 90 degrees. In some embodiments, the first angle, the second angle, or both can be between 30 degrees and 60 degrees.

[0009] In some embodiments, the first lumen and the second lumen connect to form a junction.

[0010]

[0010] In some embodiments, the access device may also include a clamp configured to allow a user to clamp and block the second arm.

[0011]

[0011] In some embodiments, the access device may also include a fixation feature, such as a butterfly pad or a suture ring. In some embodiments, the fixation feature may be configured to be axially fixed relative to the cannula. In some embodiments, the fixation feature may be movably positioned along the cannula.

[0012] In some embodiments, the junction lumen may have an inner diameter ID where 3mm≦ID≦36mm. In some embodiments, the junction lumen may have an inner diameter ID that is ≦6.5mm. In some embodiments, the junction lumen may have an inner diameter ID where 5mm≦ID≦6.5mm.

[0013] In some embodiments, the cannula may have a wall thickness of 0.2 mm to 0.4 mm. In some embodiments, some or all of the cannula may be reinforced with coiled wire, braided wire, or precision cut hypotubes. In some embodiments, the cannula may include a low friction polymer coating (such as polytetrafluoroethylene (PTFE)) on the inner surface of the joint lumen. In some embodiments, the cannula may include thermoplastic polyurethane, nylon, or polyamide block polymer. In some embodiments, the cannula may include a radiopaque material.

[0014] In some embodiments, the cannula may include a straight cannula. As will be appreciated, in other embodiments, at least a portion of the cannula may be bent and / or curved. In some embodiments, the bends and / or curves may be located at predetermined distances along the length of the catheter.

[0015]

[0015] In some embodiments, the cannula may have one or more lumens within a distal portion of the cannula, and each of the one or more lumens may extend from an outer surface of the cannula through a side wall of the cannula to a juncture lumen.

[0016] In some embodiments, the cannula may be configured to receive a dilator assembly. In some embodiments, the dilator assembly may be threaded through the arm (e.g., to provide ECMO support or through the first arm or the second arm for passage of a medical device). In some embodiments, the hub may include a third lumen operably connected to the first lumen, the second lumen, or both. In some embodiments, this third lumen may be configured to allow fluid to flow through the hub to or from the cannula. In some embodiments, this third lumen may be configured to connect to an external accessory, such as a distal limb perfusion cannula, a pressurized bag, or an infusion pump. In some embodiments, this third lumen may be connected to a valve. The valve may be located between the hub and the external accessory.

[0017]

[0017] According to a second aspect of the present disclosure, a method of using the access device described above is provided. The method includes preparing any embodiment of the access device according to the first aspect of the present disclosure, inserting a medical device into a first arm of the access device and into a patient, and then oxygenating blood using an extracorporeal membrane oxygenation (ECMO) device connected to a second arm of the access device, where the blood flows through a junction lumen and a second lumen of the access device. In some embodiments, the inserting step can include inserting the medical device through the first hemostatic valve, the first lumen, and the junction lumen. In some embodiments, the medical device can be an intravascular blood pump.

[0018]

[0018] According to a third aspect of the present disclosure, a kit may be provided. The kit may comprise or consist of any embodiment of the access device according to the first aspect of the present disclosure, an extracorporeal membrane oxygenation (ECMO) device configured to be coupled to the second arm of the single access device, and at least one medical device configured to be inserted through the first hemostatic valve, the first lumen, and the junction lumen of the access device. In some embodiments, the medical device may be an intravascular pump. In some embodiments, the kit may also include a needle to allow a physician to access an artery or vein. In some embodiments, the kit may also include a guidewire to allow placement of a cannula in the vasculature. The kit may also include one or more dilators of sequential sizes to sequentially dilate the blood vessel prior to insertion of the device. [Brief description of the drawings]

[0019] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1A] FIG. 1 is a cutaway view of an embodiment of an access device connected to an ECMO device. [Figure 1B]

[0020] FIG. 2 is a cross-sectional view of a cannula according to one embodiment. [Figure 1C]

[0021] 1 is a cutaway view of an embodiment of an access device according to some embodiments. [Figure 2A]

[0022] 1 is a cutaway view of an embodiment of a cannula of an access device. [Figure 2B] FIG. 13 is a cutaway view of an embodiment of a cannula of an access device. [Figure 2C] FIG. 13 is a cutaway view of an embodiment of a cannula of an access device. [Diagram 3]

[0023] FIG. 13 is a cutaway view of an embodiment of a docking cannula comprising two or more sections. [Figure 4A]

[0024] FIG. 13 is a cutaway view of an embodiment of a hub. [Figure 4B]

[0025] 1A-1C are cutaway views of embodiments of different connection options for the hub. [Figure 4C] 4A-4C are cutaway views of embodiments of different connection options for the hub. [Figure 4D]

[0026] 13 is a cutaway view of an embodiment of an access device according to another embodiment. [Figure 4E] FIG. 13 is a cutaway view of an embodiment of an access device according to another embodiment. [Figure 4F]

[0027] FIG. 13 is a cutaway view of an embodiment of a hub. [Figure 4G]

[0028] FIG. 1 is a cutaway view of an embodiment of a hub connected to an ECMO device. [Figure 5A]

[0029] 11A-11C are schematic diagrams of embodiments of different lumen configurations within the hub. [Figure 5B] 11A-11C are schematic diagrams of embodiments of different lumen configurations within the hub. [Figure 6]

[0030] 1 is a flow chart of a method embodiment. [Figure 7]

[0031] 1 is a schematic diagram of an embodiment of an access device inserted into a patient. [Figure 8]

[0032] 1 illustrates a cutaway view of a modular access device according to some embodiments. [Figure 9A]

[0033] 1 illustrates an embodiment of a modular access device. [Figure 9B] 1 illustrates an embodiment of a modular access device. [Figure 9C] 1 illustrates an embodiment of a modular access device. [Figure 10]

[0034] 1 illustrates an access device according to one embodiment. [Figure 11]

[0035] 1 illustrates an embodiment of a modular access device according to one embodiment. [Figure 12A]

[0036] 1 shows an access device having an inflatable valve. [Figure 12B]

[0037] 1 illustrates different configurations of an inflatable valve. [Figure 12C] 1 illustrates different configurations of an inflatable valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Detailed Description

[0038] Cardiogenic shock is the leading cause of death in patients with acute myocardial infarction (AMI) who survive to be admitted to the hospital. Cardiogenic shock occurs due to cardiac dysfunction or failure, which prevents the heart from pumping enough blood to the body. In some cases, a ventricular assist device (VADS) or catheter-based VADS (such as an intravascular blood pump) may be used to mechanically relieve the load on the heart (e.g., the left ventricle).

[0021]

[0039] Extracorporeal membrane oxygenation (ECMO) allows for gas exchange of blood when the lungs do not function properly and may involve the use of mechanical circulation devices for patients with oxygenation problems. In some cases, ECMO may be used for patients with oxygenation problems due to cardiogenic shock or other forms of hemodynamic compromise. In some cases, the use of such devices may increase left ventricular afterload.

[0022]

[0040] As described herein, in some cases, a patient may require both ECMO support and a VAD. In some cases, such support may occur simultaneously, but in some cases, a patient may require ECMO support prior to VAD support. Traditionally, this requires multiple entry points, which may add additional time, complexity, and / or risk to a surgical procedure. Thus, the inventors have recognized that the benefits of an access device that can be used to facilitate the introduction of a medical device and / or to promote circulation of blood through an extracorporeal device would be useful and desirable.

[0023]

[0041] Referring to FIG. 1A, an access device 1 according to an embodiment of the present invention is shown. As shown in this figure, in some embodiments, the access device includes a first arm 210 and a second arm 220 configured to allow one or more medical devices to be inserted into a patient through the device. A variety of medical devices may be utilized. For example, in some embodiments, a catheter-based medical device may be inserted into a patient. Further, in some embodiments, one arm may be used to insert one or more medical devices while the other arm may allow, for example, ECMO support. As will be appreciated, in some embodiments, the access device may allow multiple medical devices to be inserted into a patient through the device. As described herein, the access device may allow simultaneous ECMO support and insertion of a medical device, as well as two-stage ECMO support and insertion of a medical device (e.g., insertion before and / or after completion of ECMO support). The device may also allow a medical device (e.g., a VAD) to remain in place in the patient through the access device while ECMO support is discontinued.

[0024]

[0042] In some embodiments, the access devices may be connected to a shared cannula 100 having a proximal end 101 and a distal end 102. As will be appreciated, the cannula may be permanently attached to the access device in some embodiments, or may be attachable (e.g., by a clinician) to the access device in other embodiments. In embodiments in which the cannula is attachable to the access device, the cannula may be configured to be fixedly attached to the access device.

[0025]

[0043] In some embodiments, the shared cannula may include a junction lumen 105 (sometimes referred to as a shared lumen) therethrough. For purposes herein, a junction lumen may include a single lumen extending along the length of the shared cannula that may be used to pass one or more medical devices through the shared cannula as well as blood (e.g., from an ECMO circuit) through the shared cannula. In other embodiments, a junction lumen may include two or more lumens extending along the length of the shared cannula. For example, in some embodiments, the cannula may include two parallel lumens extending along the length of the shared cannula (see, e.g., a cross-sectional view of an embodiment of a shared cannula in FIG. 1B, showing two lumens passing through at least a portion of the shared cannula). In such an embodiment, a medical device may extend through the first lumen and an ECMO circuit may be connected to the second lumen. In another embodiment, the shared cannula may include a first portion with a single lumen and a second portion with two or more lumens (e.g., two parallel lumens). In such embodiments, a single lumen may communicate with each of the parallel lumens.

[0026]

[0044] Although the access devices are shown and described as being attached to a shared cannula, it will be understood that they may be attached to the patient in other suitable manners, for example, in some embodiments, the access devices may be connected to an implant that is subsequently attached to the patient.

[0027]

[0045] 1A, the access device can include a hub 200 configured to be coupled to the proximal end 101 of the cannula. As shown in this figure, the hub includes a first arm 210 and a second arm 220, where the second arm is coupled to the first arm.

[0028]

[0046] The first arm 210 may have a first lumen 215 operably connected to the cannula (e.g., the junction lumen 105). The proximal end of the first arm may include a first hemostatic valve 216 configured for passage of a medical device. In some embodiments, the hemostatic valve may be configured to minimize and / or prevent blood leakage from the first arm. In some embodiments, the inserted medical device may be a guidewire, a balloon catheter, or a catheter-type heart pump. In some embodiments, the inserted medical device may be an intravascular heart pump. As will be appreciated, other catheter-type medical devices may also be insertable through the first arm. As will be further appreciated, in embodiments where the cannula includes two or more lumens extending therethrough, the first lumen 215 may be connected to a corresponding first lumen of the cannula (see, e.g., first lumen 125 of FIG. 1B).

[0029]

[0047] In some embodiments, a portion of each of the multiple medical devices can be simultaneously present within the first lumen and the mating lumen of the access device. In some embodiments, the access device (e.g., the first arm) can include one or more features for retaining the position of the medical device relative to the access device when the medical device is in the patient. For example, the access device can include one or more locking features for locking the placement of the medical device when the medical device is in the patient. As will be appreciated, the locking features can be configured to disengage to allow removal of the medical device.

[0030]

[0048] Although the first arm is shown as having only a single hemostatic valve, in other embodiments, the first arm may include two or more hemostatic valves. For example, as shown in FIG. 1C, the first arm may include a first hemostatic valve 245 and a second hemostatic valve 246. In such embodiments, the second hemostatic valve 246 may provide redundancy to minimize and / or prevent bleeding from the first arm (e.g., when one or more medical devices are inserted through the first arm).

[0031]

[0049] The valves may be oriented in different directions, however, in some embodiments, both hemostasis valves may be oriented in the same direction. In embodiments having only a single hemostasis valve, the valve may be oriented like the valve shown in FIG. 1A or may be inverted and oriented in the opposite direction.

[0032]

[0050] The second arm 220 may be operably connected to the junction lumen 105 and may be configured to be operably coupled (e.g., through one or more additional connectors 310, cannula 311, etc.) to an external device 400 (such as an extracorporeal membrane oxygenation (ECMO) device). Similar to above, in embodiments in which the cannula includes two or more lumens extending therethrough, the lumen 205 of the second arm may be connected to a second lumen of the cannula (see, e.g., second lumen 126 in FIG. 1B).

[0033]

[0051] In some embodiments, the access device 1 may also include a clamp 320 configured to allow a user to clamp and block the second arm. In some embodiments, the clamp 320 may be integral with the second arm. In some embodiments, the clamp 320 may be removably attached to the second arm. In some embodiments, the clamp may include a Roberts clamp, although other suitable clamps may be used in other embodiments. It will be appreciated that the second arm may include other arrangements for controlling blood flow through the second arm. For example, in some embodiments, the access device may include an internal valve (e.g., a stopcock) or clamp to control flow.

[0034]

[0052] In some embodiments, the access device may also include a fixation feature 330, such as a butterfly pad, a suturing pad, or a suturing ring. In some embodiments, the fixation feature may be configured to be axially fixed relative to the cannula. In some embodiments, the fixation feature may be rotatable about the cannula. In some embodiments, the fixation feature may be movably positioned along the shared cannula 100.

[0035]

[0053] In some embodiments, the shared cannula 100 may have one or more side openings 106 at a distal portion of the cannula (e.g., closer to the distal end 102 of the cannula than the proximal end 101), each of which may extend from the outer surface 107 of the cannula through the side wall 108 of the cannula to the junction lumen 105. In some embodiments, such side openings may provide an alternate path for blood flow through the cannula, such as if the junction lumen becomes occluded (e.g., the cannula is pressed up against a vessel wall). In some embodiments, the side openings may be 2-4 mm in size, e.g., 3 mm. In some embodiments, there may be 2, 4, 6, 8, 10, 12, or more side openings along the length of the tip. For example, in an exemplary embodiment, there may be six openings along the distal portion of the cannula.

[0036]

[0054] In some embodiments, the distal portion of the cannula may be reinforced, which may provide stability to the distal portion of the tip (e.g., to reduce the possibility of changes in the cannula diameter and / or to aid in the insertion of a medical device).

[0037]

[0055] In some embodiments, the cannula may have a single stiffness, while in other embodiments, the stiffness of the cannula may vary along the length of the cannula, for example, in some embodiments, the cannula may have a stiff section near the proximal end and a soft section near the distal end.

[0038]

[0056] 2A-2C, it can be seen that the shared cannula 100 can have different configurations. For example, in some embodiments, the cannula can include or consist of straight cannulas 110, 120. In some embodiments, the straight cannula 110 defines a junction lumen 114 having an inner diameter 117 that is substantially constant all along the central axis 113 of the junction lumen from the proximal end 111 to the distal end 112. In other embodiments, the straight cannula 120 does not have a substantially constant inner diameter. For example, as seen in FIG. 2B, the straight cannula 120 can be somewhat trapezoidal with straight sidewalls but defining a junction lumen 123 in which the inner diameter 117 at the proximal end 121 is greater than the inner diameter 118 at the distal end 122.

[0039]

[0057] In some embodiments, the cannula may include or consist of a curved cannula 130 (see FIG. 2), which forms a junction lumen 133 that may be formed to have at least one predetermined radius of curvature. In some embodiments, the cannula may include a bent portion. As will be appreciated, the cannula may have other suitable configurations in other embodiments.

[0040]

[0058] In some embodiments, the juncture lumens 105, 114, 123, 133 have an average inner diameter ID where 3 mm < ID < 36 mm. In some embodiments, the juncture lumens can have an average inner diameter ID that is < 6.5 mm. In some embodiments, the juncture lumens have an average inner diameter ID where 5 mm < ID < 6.5 mm. In some embodiments, the cannulas can be formed with different outer diameters (e.g., 16.5 Fr, 17.5 Fr, 19 Fr, and / or 21 Fr).

[0041]

[0059] In some embodiments, the cannula may have a wall thickness 119 of 0.2 mm to 0.4 mm. In some embodiments, the wall thickness may be substantially constant. In some embodiments, the wall thickness in one portion of the cannula may be thicker than the wall thickness in a different portion of the cannula (excluding any rounded or thinned ends of the cannula).

[0042]

[0060] In some embodiments, the cannula may include one or more layers. In some embodiments, the cannula may include an inner layer 116 and an outer layer 115 (sometimes referred to as a "jacket"). In some embodiments, some or all of the cannula may be reinforced with coiled wire, braided wire, or precision cut hypotube. In some embodiments, the outer layer 115 may include coiled wire, braided wire, or precision cut hypotube. In such embodiments, the cannula may be reinforced (e.g., with Nitinol or stainless steel). In some embodiments, the cannula may include a low friction polymer coating (such as polytetrafluoroethylene (PTFE) or HDPE) on the inner surface of the interface lumen. In some embodiments, the inner layer 116 may include a low friction polymer coating (such as polytetrafluoroethylene (PTFE)). In some embodiments, one or more of the layers forming the cannula may include thermoplastic polyurethane, nylon, or polyamide block polymer. In some embodiments, the outer layer may include a hydrophilic coating.

[0043]

[0061] In some embodiments, the cannula may include a tapered extension, in some embodiments, the extension may be thermoformed onto the reinforced body, in some embodiments, this may allow for modular connection of the cannula to a barbed connector or the like, as described herein.

[0044]

[0062] In some embodiments, the cannula may include a radiopaque material. In some embodiments, the radiopaque material is a metallic element. In some embodiments, the radiopaque material is tungsten, silver, tantalum, or tin. In some embodiments, the radiopaque material is tungsten powder. In some embodiments, the radiopaque material may be combined with a polymer, such as polyurethane. In some embodiments, the radiopaque material is arranged in bands that are axially offset from one another over some or all of the length of the cannula.

[0045]

[0063] In some embodiments, the cannula may be configured to receive a dilator assembly.

[0046]

[0064] As seen in FIG. 3, in some embodiments, the cannula 150 may include multiple sections. In some embodiments, the cannula 150 may include a first cannula section 151 having a proximal end 153 coupled to the hub 200 and a second cannula section 152 having a proximal end 155 coupled to a distal end 154 of the first cannula section 151. In some embodiments, the distal end 156 of the second cannula section 152 may not be coupled to any other mating cannula section. In some embodiments, the distal end 156 of the second cannula section 152 may be coupled to an additional cannula section (not shown). In some embodiments, the first cannula section 151, the second cannula section 152, or both, may be semi-rigid. As will be appreciated, while the cannula is shown as having two connecting portions, it will be understood that in some embodiments, the cannula may include three or more connecting portions. As will be further appreciated, the cannula sections may be fixedly joined together prior to use of the cannula by a clinician, hi other embodiments, the first cannula portion and the second cannula portion may be part of a kit and may be attached to one another by a clinician.

[0047]

[0065] In some embodiments, the first cannula section is configured to have a stiffness greater than a stiffness of the second cannula section.

[0048]

[0066] In some embodiments, the first cannula section is configured to be a straight cannula. In some embodiments, the second cannula section is a straight cannula. In some embodiments, the second cannula section is a curved cannula.

[0049]

[0067] 4A-4C, the shared cannula 100 may be coupled to a distal end 201 of a hub 200. In some embodiments, as shown in FIG. 4A, a distal portion 219 of a first arm 210 of the hub may be configured to be coupled to a cannula. In other embodiments, a proximal portion 229 of a second arm 220 of the hub may be configured to be coupled to a cannula. As seen in FIG. 4A, the distal portion 219 of the first arm or the proximal portion 229 of the second arm may be substantially smooth. As seen in FIG. 4B, these portions (e.g., the distal portion 219 and the proximal portion 229) may have one or more barbs 241 to allow for coupling a cannula to the hub via a barbed connection. As seen in FIG. 4C, these portions (the distal portion 219 and the proximal portion 229) may have one or more threads 242 to allow for coupling a cannula to the hub via a threaded connection.

[0050]

[0068] 4A, in some embodiments, the first arm and first lumen can be coaxial and the second arm and second lumen can be coaxial. In such embodiments, the angle 213 at the proximal end formed between (a) the central axis 211 of the distal portion of the first lumen 215 and (b) the central axis 221 of the second lumen 225 is less than 90 degrees. In some embodiments, this angle 213 can be between 15 and 30 degrees. In some embodiments, this angle 213 can be 30 degrees.

[0051]

[0069] In some embodiments, the first lumen is straight. In some embodiments, the first lumen is curved, such as at the junction of the first lumen with the second lumen. In some embodiments, an angle 295 formed between (a) a central axis 290 of a distal portion of the first lumen and (b) a central axis 291 of a proximal portion of the first lumen is greater than 0 degrees and less than 90 degrees. For example, the angle 295 can be 15 degrees in some embodiments (see FIG. 4D), while in other embodiments, the angle 295 can be 30 degrees (see FIG. 4E).

[0052]

[0070] Referring again to FIG. 4F, in some embodiments, the hub 202 can be configured such that the first arm and the first lumen are not coaxial and / or the second arm and the second lumen are not coaxial. FIG. 4F shows a non-limiting example in which the hub 202 is configured such that the first arm and the first lumen are coaxial, but the second arm and the second lumen are not coaxial. In some embodiments, the first angle 224 formed between the central axis 211 of the first arm and the central axis 222 of the second arm 220 can be less than 90 degrees. In some embodiments, the second angle 214 formed between the central axis 211 of the first lumen 215 and the central axis 221 of the second lumen 225 can be less than 90 degrees. In some embodiments, the first angle 224, the second angle 214, or both, can be between 30 degrees and 60 degrees.

[0053]

[0071] 4A and 4G, in some embodiments, the second arm 220 of the hub 203 may be configured to be operably coupled to an external device 400 (e.g., an ECMO device) via one or more additional cannulas 311, 312 and one or more connectors 310. As seen in FIG. 4G, in some embodiments, a proximal end of the second arm 220 may be connected to a distal end of the additional cannula 312. The proximal end of the additional cannula 312 may be connected to a connector 310, which may be connected to the one or more additional cannulas 311 prior to connection with the external device 400 (e.g., an ECMO device).

[0054]

[0072] In some embodiments, each additional cannula 311, 312 may be a separately flexible cannula, hi some embodiments, all additional cannulas 311, 312 may be flexible cannulas.

[0055]

[0073] 5A and 5B, the first and second lumens can be connected in various configurations 501, 502. In some non-limiting embodiments, the lumens can have a configuration 501 such that the first and second lumens connect to form a junction 510, with proximal portions of the first and second lumens 215, 225 extending proximally from the junction and a distal portion of the third lumen 520 (distal to the junction of the first and second lumens) extending distally toward the distal end of the hub. In such embodiments, the central axis of the distal portion of the third lumen (not shown) may not be coaxial with the central axis of either the first or proximal portions of the second lumen. In some non-limiting embodiments, the lumens can have a configuration 502 such that the second lumen 225 intersects with the first lumen 215 as the first lumen extends distally toward the distal end of the hub.

[0056]

[0074] 1A , in some embodiments, the hub 200 may include a third lumen 235 operably connected to the first lumen 215, the second lumen 225, or both. In some embodiments, the third lumen 235 may be configured to connect to an external accessory, such as a distal limb perfusion cannula, a pressurized bag, or an infusion pump.

[0057]

[0075] In some embodiments, the third lumen 235 may be configured to allow fluid to flow in or out of the shared cannula 100 through the hub 200. In some embodiments, the third lumen 235 may be coupled to a tube 340. In some embodiments, the third lumen 235 may be directly or indirectly connected to a valve 350. In some embodiments, the valve 350 may be disposed between the hub 200 and an external accessory. In some embodiments, the valve may be a three-way stopcock.

[0058]

[0076] According to other embodiments, there is provided a method of using the access device described above. With reference to Figure 6, an embodiment of a method 600 may first include providing 610 any embodiment of an access device as described herein. The access device is surgically attached to a patient and at least a portion of a cannula is inserted 620 into the patient through a single insertion site.

[0059]

[0077] The method may then include an insertion step 630 in which a medical device (such as an intravascular blood pump) may be inserted into the first arm of the access device and then through the cannula into the patient. In some embodiments, the insertion step 630 may include inserting the medical device through the first hemostatic valve, the first lumen, and the interface lumen.

[0060]

[0078] The method may also include coupling 640 the ECMO device to a second arm of the access device, after which the method includes oxygenating 650 the blood with the ECMO device, where the blood flows through the junction lumen and the second lumen of the access device. As will be appreciated, the inserting step 630 and coupling 640 may be completed in any order. In some embodiments, coupling 640 and oxygenating 650 may be completed before the inserting step 630 is completed.

[0061]

[0079] The method of the present disclosure can be visually seen in Figure 7, which shows an embodiment of a system 700 including an access device 1 inserted into a patient, where at least a portion of a shared cannula 100, coupled to a hub 200, is passed through the surface of the patient's skin 710 at an insertion site 711 and into the patient.

[0062]

[0080] A medical device 750 (here, an intravascular blood pump) is inserted into the patient through the first arm 210 of the access device 1 and through the shared cannula 100. Specifically, the medical device 750 is inserted through the first hemostatic valve 216, the first lumen 215, and the junction lumen 105.

[0063]

[0081] In some embodiments, a portion of the cannula may be arranged to be removable, e.g., peeled away, such as after insertion of a medical device. For example, in an exemplary embodiment, an intravascular blood pump may be installed (e.g., via the first arm) after the patient is on ECMO support. After installation of the blood pump, the cannula may be removed from the patient, with only the blood pump remaining in the patient. In such embodiments, the access device may be attachable to a repositioning unit (not shown), which may be attachable to the patient at or near the insertion site.

[0064]

[0082] According to another embodiment of the present disclosure, a kit may be provided. The kit may comprise or consist of any embodiment of the access device according to the first aspect of the present disclosure, an external medical device, such as an extracorporeal membrane oxygenation (ECMO) device configured to be coupled to the second arm of the single access device, and at least one medical device configured to be inserted through the first hemostatic valve, the first lumen, and the junction lumen of the access device. In some embodiments, the medical device may be an intravascular pump. The kit may also include a cannula attached to the access device. In some embodiments, the kit may also include a needle to allow the physician to access an artery or vein. In some embodiments, the kit may also include a guidewire to allow placement of the cannula in the vasculature. The kit may also include one or more dilators of sequential sizes to sequentially dilate the blood vessel prior to insertion of the device.

[0065]

[0083] The basic components of such a kit can be seen in Figure 7, which includes the access device 1, an external medical device 400 (such as an ECMO device), and at least one medical device 750 configured to be inserted through a portion of the access device. In some embodiments, the kit may also include additional medical devices, such as one or more dilator assemblies and / or one or more needles.

[0066]

[0084] According to yet another embodiment, the access device may be configured as a modular access system. For example, in such an embodiment, the clinician may configure the access device depending on the type (and order) of support the patient needs. In a first embodiment, the access device 8 may be configured such that one or both arms are removably attached to the hub. For example, as shown in FIG. 8, in some embodiments, the second arm (e.g., connected to an ECMO circuit) may be removable from the hub, such as after ECMO support is completed. In such an embodiment, the first arm 810 may remain attached to the hub while the patient is receiving VAD support. Similarly, the clinician may begin using the hub with only the first arm attached when VAD support is required, and then attach the second arm if / when ECMO support is required. In other embodiments, the clinician may first attach only the second arm to the hub when only ECMO support is required, and then attach the first arm to the hub if / when VAD support is required. As will be appreciated in view of the above, a clinician may still decide to leave both the first arm and the second arm attached to the hub regardless of what type of support is required by the patient.

[0067]

[0085] 9A-9C show an embodiment in which the tubular extension 850 can be used to attach different configurations of modular access devices for patient support. For example, as shown in these figures, the tubular extension 850 can be attached to a cannula 800 that can be inserted into a patient at a single insertion site (not shown). In an embodiment in which only ECMO support is required (or is required initially), the clinician can attach only the connector 852 to the tubular extension for ECMO support (see FIG. 9A). Once ECMO support is completed, the connector can be removed and the clinician can attach a hub with only a single arm (e.g., the first arm 810) if / when VAD support is required (see FIG. 9B). As will be appreciated, the clinician does not need to first attach the connector 852 for ECMO support to the tubular extension. Instead, if only VAD support is required, the clinician can attach only the hub with the first arm to the tubular extension 850 (see FIG. 9B). 9C, an access device with both a first arm 810 and a second arm 812 may be attachable to a tubular connector if simultaneous or two-level support is to be provided to the patient. As shown in this figure, a connector 852 may be attached to the second arm 812 in some embodiments.

[0068]

[0086] In still other embodiments, the device may include additional leak prevention features. For example, the hub may, in some embodiments, include an external leak prevention device (e.g., disposed on the outside of the hub). In some embodiments, as shown in FIG. 10, the leak prevention feature may include a Tuohy Borst valve 1080. The leak prevention feature may also include an annular valve design with a mechanism that tightens a seal around a catheter of a medical device (not shown) that may pass through the annular valve. The leak prevention feature may further generally include a seal with an automatic or user-activated mechanism to seal around the catheter of such a medical device to prevent leakage. As will be appreciated, other suitable valves and / or seals may be used to form the external leak prevention feature.

[0069]

[0087] In some embodiments, the seal or valve may be configured to help secure the catheter of the medical device and / or other parts or accessories of the medical device (e.g., a repositioning sheath) from moving in and out of the hub and / or in and out of the shared cannula 100. The leak prevention feature may also include one or more locking features for locking the medical device and / or other parts or accessories of the medical device (e.g., a dilator) to the leak prevention feature. In some embodiments, the locking feature and / or the hub may include features for a sterilization sleeve. In some embodiments, the medical device may include a catheter-type pump, such as a heart pump, and the design of the leak prevention feature may include considerations of ease of use, ease of guidewire insertion, ease of pump insertion, ease of insertion of other accessories, ease of establishing a seal, leak prevention effectiveness, and pump position retention effectiveness.

[0070]

[0088] 10 includes only one hemostasis valve, it will be understood that anti-leak features may be added to hubs having two (or more) hemostasis valves. Anti-leak features may also be added to access devices having configurations different than that shown in FIG.

[0071]

[0089] In some embodiments, the device may include a cannula with a bifurcation and a valve system. With reference to FIG. 12A, in some embodiments, the valve system may include an inflatable valve system. The valve system may also include a passive valve system. In some embodiments, the valve system may be configured to reduce flow turbulence. In FIG. 12A, an inflatable valve 1300 can be seen disposed within a lumen of the hub 200. As shown, the valve is disposed within the third lumen 520 (e.g., the junction lumen), but as will be appreciated, may be disposed in other locations within the hub, including the first lumen 215 or the second lumen 225. As shown, the medical device 1310 may be threaded through the hemostatic valve 216 and through the inflatable valve 1300. The valve may be inflated in any known manner. For example, in some embodiments, the valve may be inflated by providing saline through a port 1301 coupled to an interior volume of the space within the inflatable valve. The valve may have multiple configurations. For example, as seen in Figure 12B, in the contracted configuration, the lumen in which the valve is disposed may not be substantially occluded. With reference to Figure 12C, in the inflated configuration, the lumen in which the valve is disposed may be completely blocked or may be configured to hold one or more medical devices in place and / or to prevent flow through the valve except through the medical device in place. As will be appreciated, although the hub is shown as having a hemostatic valve and an inflatable valve, in other embodiments, the hub may only include an inflatable valve for blocking the third (e.g., joining) lumen and for allowing passage of a medical device into the patient (e.g., through the first lumen and the third lumen).

[0072]

[0090] In other embodiments, the device may include an internal bladder, which may be configured to act like a flap that may push a medical device, such as a mechanical circulation device (e.g., a sheath or cannula), to the side under antegrade blood flow so that blood flow does not interfere with the medical device (e.g., where clotting or hemolysis is a concern).

[0073]

[0091] Referring to FIG. 11, an embodiment of another access system 1100 can be seen. As shown, a hub 200 may be operably coupled to a cannula 100. The cannula may include a reinforcing cage 1101 at a distal end. The cannula may also include a fitting 1102 at a proximal end for connection to the hub. A fixation feature 330 may be attached to the cannula, such as for attaching the access system to a patient. A tube 340 (e.g., a high flow side port) may be used to couple the hub and a valve 350 (e.g., via a third arm). A flexible tube 1103 (e.g., an irrigation tube) may be removably coupled to the hub (e.g., via a second arm). A connector 310 (such as a 3 / 8 inch barb connector) may be coupled to a proximal end of the tube 1103. A tube cap 1104 may be coupled to the connector. A clamp 1130 may be used, for example, to control flow through the flexible tube 1103.

[0074]

[0092] There may be a dilator 1120 including a tubular member 1121 coupled to and attached to a dilator handle 1122. As disclosed herein, in some embodiments, the tubular member passes through an arm (e.g., a first arm) of the hub 200 and into a cannula, while the dilator handle remains proximal to the hub 200. For example, in some embodiments, the dilator tubular member 1121 may pass through a Touhy Borst valve 1080 coupled to the proximal end of the hub 200, into the first arm, and then into the cannula. In some embodiments, the dilator may be used to facilitate insertion of a medical device into a patient (e.g., via the first arm).

[0075]

[0093] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described below which equivalents are intended to be encompassed by the following claims.

[0076]

[0094] The embodiments of the present disclosure will be described in detail with reference to the figures, in which similar reference numbers identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. Well-known functions or structures are not described in detail to avoid obscuring the present disclosure in unnecessary details. Therefore, the specific structure and functional details disclosed herein should not be interpreted as limiting, but merely as a basis for the claims, and as a representative basis for teaching those skilled in the art to use the present disclosure in various ways in virtually any appropriately detailed structure.

Claims

1. 1. An access device, comprising: a hub configured to couple to a proximal end of the cannula having a proximal end, a distal end, and a mating lumen extending therethrough, the hub comprising: a first arm having a first lumen and a first hemostatic valve, the first lumen operably connected to the junction lumen, the first lumen and the first hemostatic valve configured for passage of an internally positionable medical device; a second arm coupled to the first arm, the second arm having a second lumen operably connected to the junction lumen, the second arm configured to be operably coupled to an external medical device; An access device comprising:

2. The access device of claim 1 , wherein the external medical device comprises an extracorporeal membrane oxygenation (ECMO) device.

3. The access device of claim 1 , wherein the cannula is coupled to the hub by a threaded or barbed connection.

4. The cannula is a junction cannula, the junction cannula comprising: a first junction cannula section having a proximal end and a distal end, the proximal end of the first junction cannula section being coupled to the hub; a second junction cannula section having a proximal end and a distal end, the proximal end of the second junction cannula section coupled to the distal end of the first junction cannula section; The access device of claim 1 , comprising:

5. The access device of claim 4 , wherein the first mating cannula section, the second mating cannula section, or both are semi-rigid.

6. The access device of claim 1 , wherein the second arm is configured to be operably coupled to an external medical device via an additional cannula.

7. The access device of claim 6 , wherein the additional cannula is a flexible cannula.

8. The access device of claim 1 , wherein the docking lumen has an inner diameter ID, where 3 mm≦ID≦36 mm.

9. The access device of claim 1 , wherein a first angle formed between a central axis of the first arm and a central axis of the second arm is less than 90 degrees.

10. The access device of claim 1 , wherein a second angle formed between a central axis of the first lumen and a central axis of the second lumen is less than 90 degrees.

11. The access device of claim 1 , wherein the first lumen and the second lumen connect to form a junction.

12. a clamp configured to allow a user to clamp the second arm into isolation; comprising a fixation feature; The access device of claim 1 .

13. The access device of claim 12 , wherein the fixation feature is movably positioned along the cannula.

14. The cannula comprises: having a wall thickness of 0.2 mm to 0.4 mm; Reinforced with coiled wire, braided wire, or precision-cut hypotubing The access device of claim 1 , including a low-friction polymer coating on an inner surface of the dorsal lumen.

15. The cannula comprises: thermoplastic polyurethane, nylon, or polyamide block polymer; comprising a radiopaque material; a straight cannula; further comprising at least one lumen within the distal portion of the cannula, the at least one lumen extending from an outer surface of the cannula through a wall of the cannula to the junction lumen; The access device of claim 1 , configured to receive a dilator assembly.

16. The access device of claim 1 , wherein the hub further comprises a third lumen operably connected to the first lumen, the second lumen, or both.

17. the third lumen is configured to allow fluid to flow through the hub to or from the cannula; The access device of claim 16 , configured to connect to an external accessory and connected to a valve.

18. further comprising a second hemostatic valve positioned within the first arm. further comprising an inflatable valve disposed within the first lumen, the second lumen, or the joint lumen. The access device of claim 1 .

19. 1. A method of using a single access device, comprising: Providing an access device according to claim 1; connecting the hub of the access device to the cannula; inserting a medical device into the first arm of the single access device and into a patient; connecting an external medical device to the single access device via an additional cannula; A method comprising:

20. A kit comprising: The access device of claim 1; an external medical device configured to be coupled to the second arm of the access device; and a medical device configured to be inserted through the first hemostatic valve, the first lumen, and the joint lumen; A kit comprising:

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