Access Equipment Hub

Abstract

For example, an access device may be provided that includes a hub configured to improve blood flow within the lumen to prevent clot formation while also avoiding hemolysis. The hub may have a removably attachable second arm, a protrusion / recess in the lumen of the hub or system, and / or a plug or plug-like object may be used to prevent flow from entering some areas of the lumen in the hub. These hubs may be used as part of an access device that may have, for example, a modular form.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 297,516, filed January 7, 2022, No. 63 / 328,184, filed April 6, 2022, and No. 63 / 344,408, filed May 20, 2022, the contents of each of which are incorporated by reference in their entirety into this specification.

[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's body and to promote blood circulation through extracorporeal devices. [Background technology]

[0003] background

[0003] Extracorporeal Membrane Oxygenation (ECMO) involves the use of mechanical circulatory devices in patients experiencing cardiogenic shock or other forms of hemodynamic compromise. Ventricular assist devices (VADs) and catheter-based VADs (e.g., intravascular blood pumps) can be used to unload the heart (e.g., the left ventricle).

[0004]

[0004] Access devices, which generally include a cannula attached to a hub, 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 a guidewire, a balloon catheter, or an intravascular blood pump (e.g., a catheter-based heart pump) into the vasculature of the human body. These access devices may 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] In accordance with a first aspect of the present disclosure, a hub may be provided that improves fluid flow within the hub, minimizing the risk of thrombus formation and hemolysis.

[0006]

[0006] In some embodiments, the hub may include a first arm having a first lumen extending from a proximal end to a distal end, the distal end configured to be operably coupled to a cannula. In some embodiments, the first lumen may be non-linear, such that a central axis of the first lumen at the distal end forms an angle with a central axis of the first lumen at the proximal end. In some embodiments, the first arm may be configured to be operably coupled to a second arm, the second arm may include a second lumen extending therethrough. In some embodiments, the second arm may be coupled to the hub and may be removably coupled to the hub. In some embodiments, the hub may include a protrusion, a recess, or both in the first lumen, a protrusion, a recess, or both in the second lumen, or a combination thereof.

[0007]

[0007] In some embodiments, a plug may be used, where the hub may be configured to removably receive the plug through the proximal end of the first lumen, such that at least a portion of the first lumen is blocked (e.g., fluid cannot enter the blocked portion). The plug may be configured to be removably inserted into the proximal end of the first lumen. In some embodiments, the plug may include collagen. In some embodiments, a plug analog may be used. For example, in some embodiments, one or more dilators may be used, where the dilators are configured to extend from the proximal end of the first lumen to less than the full length of the first lumen. In some embodiments, the one or more dilators may be configured to fill at least a portion of the space in the first lumen at or near the proximal end of the first lumen. In some embodiments, the plug may be configured to be removably inserted into the proximal end of the second lumen.

[0008] In some embodiments, the plug can include a slit through which a medical device can be inserted into the first lumen. In various embodiments, the medical device can be, for example, a guidewire, a balloon catheter, or a catheter-based heart pump. In some embodiments, one or more dilators can be configured to extend through the slit.

[0009] In some embodiments, a hemostasis valve may be disposed in the first arm. In some embodiments, the hemostasis valve may be positioned adjacent to the plug.

[0010]

[0010] In some embodiments, the hub may include a third lumen operably connected to the first lumen, the second lumen, or both. The third lumen may be configured to connect, for example, to an external attachment, such as a distal crural irrigation cannula, a pressurized bag, or an infusion pump. In some embodiments, the third lumen is configured to allow fluid to pass through the hub into or out of the cannula. In some embodiments, the third lumen may be connected to a valve.

[0011] In some embodiments, the first arm may be perpendicular to the second arm. In some embodiments, the first arm may extend tangentially to the second arm. In some embodiments, the first lumen of the first arm may extend tangentially to the second lumen of the second arm. In some embodiments, the longitudinal axis of the first arm may be offset laterally from the longitudinal axis of the second arm. In some embodiments, the central axis of the distal portion of the first arm and the central axis of the second arm form an angle at the proximal end of the hub, where the angle is between 15 and 30 degrees.

[0012] In some embodiments, the cap can be coupled to a proximal end of the first arm. In some embodiments, an O-ring and a silicone valve can be positioned between a portion of the cap and a portion of the first arm. In some embodiments, a second O-ring can be disposed between the silicone valve and the cap. In some embodiments, the cap can be a Tuohy Borst valve.

[0013]

[0013] According to a second aspect of the present disclosure, an access device may be provided that includes a hub. The access device may include a cannula and a hub of any of the embodiments as disclosed herein, the hub configured to be coupled to a proximal end of the cannula. In some embodiments, the cannula may be coupled to the hub by a threaded connection. In some embodiments, the wall thickness of the cannula may be 0.2 mm to 0.4 mm. In some embodiments, the cannula may be reinforced by wound wire, braided wire, or precision cut hypotube. In some embodiments, the cannula may include a low friction polymer coating, such as polytetrafluoroethylene (PTFE), on an inner surface of the joint lumen. In some embodiments, the cannula may use a thermoplastic polyurethane, nylon, or polyamide block polymer. In some embodiments, the cannula may use a radiopaque material. In some embodiments, the cannula may include a straight cannula. In some embodiments, the cannula may be configured to receive a dilator assembly.

[0014] In some embodiments, the access device can include a second arm configured to be removably coupled to the hub. The second arm can include a second arm having a second lumen extending therethrough, the second lumen configured to be operably coupled to the first lumen through an opening in the hub.

[0015]

[0015] In some embodiments, the access device can include a tubular extension. The tubular extension can be configured to be removably coupled to a proximal end of the cannula, and the hub is removably coupled to the proximal end of the tubular extension. In some embodiments, the tubular extension can also be configured to be removably coupled to a proximal end of the second arm.

[0016]

[0016] In some embodiments, the access device may include a clamp configured to allow a user to unclamp the second arm. In some embodiments, the access device may include an anchoring feature. In some embodiments, the anchoring feature may be a butterfly pad or a suture ring. In some embodiments, the anchoring feature may be axially stationary relative to the cannula. In some embodiments, the anchoring feature may be movably positioned along the cannula.

[0017]

[0017] In some embodiments, the access device may include one or more caps coupled to the proximal end of the hub. The one or more caps may include a Tuohy Borst valve. In some embodiments, the access device may include a silicone valve and at least an O-ring "sandwiched" between the hub and one of the caps, or between two caps, where compression deforms one or more O-rings to assist the barrier function of the silicone valve. In some embodiments, the deformed O-ring acts as a first barrier to resist the pressure of blood in the hub. In some embodiments, the deformed O-ring is proximal to the silicone valve and supports the silicone valve by deformation.

[0018] In some embodiments, the first arm can extend tangentially to the second arm. In some embodiments, the lumen of the first arm can extend tangentially to the second lumen of the second arm. In some embodiments, the first arm can extend perpendicular to the second arm.

[0019]

[0019] According to a third aspect of the disclosure, a method of using the hub and access device disclosed herein may be provided. The method may include providing an access device according to any of the embodiments disclosed herein and inserting a cannula of the access device into the patient's body. The method may then include inserting a medical device into the patient's body through the hub and / or oxygenating blood using an extracorporeal membrane oxygenation (ECMO) device operably coupled to the cannula through the second arm, the alternative connector subsystem, or both. In some embodiments, the medical device is inserted through the hemostasis valve, the first lumen, and the joint lumen. In some embodiments, the medical device is inserted through the hemostasis valve, the first lumen, the alternative connector subsystem, and the joint lumen. In some embodiments, the medical device may be an intravascular blood pump.

[0020] According to a fourth aspect of the present disclosure, a kit may be provided. The kit may include an access device according to any of the embodiments disclosed herein, an extracorporeal membrane oxygenation (ECMO) device configured to be operatively coupled to a cannula of the access device, and a medical device configured to be inserted through a hemostasis valve, a first lumen, and a joint lumen of the access device. In some embodiments, the medical device may be an intravascular pump. [Brief description of the drawings]

[0021] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] FIG. 2 is a cutaway view of one embodiment of an access device. [Diagram 2]

[0022] FIG. 2 is a cutaway view of one embodiment of a hub. [Diagram 3] FIG. 1 is a cutaway view of one embodiment of a hub. [Figure 4A] FIG. 1 is a cutaway view of one embodiment of a hub. [Figure 4B] FIG. 1 is a cutaway view of one embodiment of a hub. [Diagram 5] FIG. 1 is a cutaway view of one embodiment of a hub. [Figure 6] FIG. 1 is a cutaway view of one embodiment of a hub. [Figure 7]

[0023] 1 is a cutaway view of one embodiment of an access device configured as a modular system. [Figure 8A]

[0024] FIG. 2 is a cutaway view of one embodiment of a hub. [Figure 8B] FIG. 1 is a cutaway view of one embodiment of a hub. [Figure 9A]

[0025] 1A-1C are cutaway views of different embodiments of an access device configured as a modular system. [Figure 9B] 1 is a cutaway view of an embodiment of different configurations of an access device configured as a modular system. [Figure 9C] 1 is a cutaway view of an embodiment of different configurations of an access device configured as a modular system. [Figure 9D] 1 is a cutaway view of an embodiment of different configurations of an access device configured as a modular system. [Figure 10A]

[0026] 11A-11C are cutaway views of embodiments of different connection options for the hub. [Figure 10B] 4A-4D are cutaway views of embodiments of different connection options for the hub. [Figure 11]

[0027] 1 is a flow chart of one embodiment of a method. [Figure 12]

[0028] 1 is a schematic diagram of one embodiment of an access device inserted into a patient's body. [Figure 13]

[0029] FIG. 1 illustrates a perspective view of one embodiment of a hub. [Figure 14]

[0030] FIG. 14 is a side view of the hub of FIG. [Figure 15]

[0031] FIG. 14 is a top view of the hub of FIG. 13. [Figure 16]

[0032] FIG. 14 is a cross-sectional view of the hub of FIG. 13. [Figure 17]

[0033] FIG. 13 is a top view of a hub according to another embodiment. [Figure 18]

[0034] FIG. 1 is a diagram of one embodiment of a system. [Figure 19A]

[0035] FIG. 2 illustrates a side view of one embodiment of a hub. [Figure 19B]

[0036] FIG. 1 illustrates an exploded side view of one embodiment of a hub. [Figure 19C]

[0037] FIG. 19C is a side cross-sectional view of one embodiment of a valve in a hub, showing an uncompressed view with a single O-ring (19C). [Figure 19D] FIG. 19 is a side cross-sectional view of one embodiment of a valve in a hub showing a compression diagram with a single O-ring (19D). [Figure 19E] FIG. 19 is a side cross-sectional view of one embodiment of a valve in a hub showing a compression diagram with two O-rings (19E). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Detailed Description

[0038] Cardiogenic shock is the leading cause of death in patients with acute myocardial infarction (AMI) who arrive alive at the hospital. Cardiogenic shock results from cardiac dysfunction or failure, which prevents the heart from pumping enough blood to the body. In some cases, ventricular assist devices (VADS) and catheter-based VADS (such as intravascular blood pumps) can be used to mechanically unload the heart (e.g., the left ventricle).

[0023]

[0039] Extracorporeal membrane oxygenation (ECMO) allows for gas exchange of blood when the lungs are not working properly and may involve the use of a mechanical circulatory device 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 lead to increased left ventricular afterload.

[0024]

[0040] As described herein, in some cases, a patient may require both ECMO support and a VAD. In some cases, such support may be performed simultaneously, but in some cases, a patient may require ECMO support prior to and / or after VAD support. Traditionally, this has required multiple entry points, which may add additional time, complexity, and / or risk to a surgical procedure. As such, the inventors have recognized the benefit of an access device that can be used to facilitate the introduction of multiple medical devices.

[0025]

[0041] The inventors have also recognized the benefit of improving flow through the access device to minimize and / or prevent blood stagnation within the access device. In some embodiments, this may minimize the risk of clot formation within the access device. The inventors have also recognized the benefit of improving flow through the access device to minimize the risk of hemolysis due to turbulent flow.

[0026]

[0042] Referring now to FIG. 1, an access device 1 is shown in accordance with an embodiment of the present disclosure. As shown in this figure, in some embodiments, the access device 1 generally includes a first arm 30 that may allow for the insertion of one or more medical devices into the patient's body through the device, and a second arm 40 that may allow for the connection of a supporting external medical device (e.g., an ECMO machine) to the patient. As will be appreciated, in some embodiments, the second arm may also allow for the insertion of one or more medical devices. As will be further appreciated, a variety of medical devices may be used. For example, in some embodiments, a catheter-based medical device may be inserted into the patient's body.

[0027]

[0043] As described herein, the access device may allow for simultaneous ECMO support and insertion of a medical device, as well as tandem 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 attached within the patient's body through the access device while ECMO support is discontinued.

[0028]

[0044] In some embodiments, the access device 1 may include a hub 10 having a hub body 20 defining first and second arms 30, 40. In some embodiments, the hub 10 is coupled to a shared cannula 90 at a proximal end 91 of the cannula, the cannula defining a joint lumen 95 (sometimes referred to as a shared lumen). As will be appreciated, the cannula may be permanently attached to the access device or may be attachable to the access device (e.g., by a clinician). 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 for insertion into the patient's body.

[0029]

[0045] For purposes herein, a joint 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 and blood therethrough (e.g., from an ECMO circuit). In other embodiments, a joint 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. In such embodiments, the medical device may extend through the first lumen and the ECMO circuit may be operably connected to the second circuit. 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, the single lumen may be in communication with each of the two lumens.

[0030]

[0046] Although shown and described as being attached to a shared cannula, it will be understood that the access device may be attached to the patient in other suitable manners For example, in some embodiments, the access device may be connected to a graft and then attached to the patient.

[0031]

[0047] As shown in FIG. 1, the first arm 30 defines a first lumen 35 and the second arm 40 defines a second lumen 45. In some embodiments, the second lumen 45 may intersect with the first lumen 35. In some embodiments, the first arm may include a hemostatic valve 60 arranged to minimize and / or prevent blood leakage through the first arm. In some embodiments, the hemostatic valve may be located at a proximal end of the first arm. In some embodiments, the first arm may include more than one hemostatic valve, for example, two hemostatic valves (e.g., a first and a second hemostatic valve). In some embodiments, a medical device may be passed through the hemostatic valve 60, the first lumen, the joint lumen 95, and exit the distal end 92 of the cannula (into the patient's body). In some embodiments, the medical device inserted may be a guidewire, a balloon catheter, or a catheter-based heart pump. As will be appreciated, other catheter-based medical devices may also be insertable through the first arm. In some embodiments, the inserted medical device may be an intravascular heart pump. In some embodiments, a portion of each of multiple medical devices may be simultaneously present within the first lumen and the joint lumen of the access device.

[0032]

[0048] In some embodiments, an external medical device, such as an ECMO device (not shown), may be operably coupled to the proximal end 41 of the second arm, and blood may flow through the second lumen 45 and the joint lumen 95 to exit the cannula at the distal end 92 into the patient's body. In some embodiments, the access device may include a clamp configured to allow a user to unclamp the second arm, for example to control blood flowing into and out of the access device. In some embodiments, the clamp may be integral to the second arm, but the clamp may also be removably attached to the second arm. In some embodiments, the clamp may include a Roberts clamp, but in other embodiments, other suitable clamps may be used. 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 second arm may include a built-in valve (e.g., a stopcock) or clamping to control flow.

[0033]

[0049] In some embodiments, the hub 10 may also include a third arm 50 defining a third lumen 55. In some embodiments, the third lumen 55 may also intersect with the first lumen 35. As will be appreciated, the third lumen may be connected to the first lumen, the second lumen, or both. In some embodiments, the third lumen 55 may be configured to connect to an external attachment, such as a distal crural irrigation cannula, a pressure bag, or an infusion pump. In some embodiments, the third lumen 55 may be configured to allow fluid to pass through the hub 10 into or out of the cannula 90. In some embodiments, the third lumen 55 may be coupled to a tube 80. In some embodiments, the third lumen 55 may be directly or indirectly connected to a valve 85. In some embodiments, the valve 85 may be between the hub 10 and an external attachment (not shown). In some embodiments, the valve may be a three-way stopcock.

[0034]

[0050] According to some embodiments, the hub may be configured to reduce the risk of clot formation and turbulence to an acceptable level consistent with ISO standards. In some embodiments, as described herein, the hub may be optimized to minimize areas within the hub where blood may stagnate. In some embodiments, this may include optimizing the blood flow path and / or minimizing identified stagnation areas. In some embodiments, this may include at least partially plugging one or more areas where blood may stagnate. In other embodiments, as described herein, this may include configuring the hub such that blood flow may flush one or more portions of the hub (e.g., a portion of a lumen or a portion on one side of a hemostasis valve) as blood travels through the hub and / or one or more lumens into the patient's body.

[0035]

[0051] Referring to FIG. 2, in some embodiments of the hub 100, the first lumen can include a distal portion 121 and a proximal portion 125. In some embodiments, the central axis 126 of the proximal portion 125 can form a first arm angle 127 with the central axis 122 of the distal portion 121, where the first arm angle 127 can be between 15 degrees and 145 degrees. In some embodiments, the angle can be between 15 degrees and 30 degrees. In some embodiments, the central axis 136 of the second lumen 135 can form a second arm angle 137 with the central axis 122 of the distal portion 121, where the second arm angle 137 can be between 15 degrees and 145 degrees. In some embodiments, the second arm angle can be between 15 degrees and 30 degrees. In some embodiments, the second arm angle can be 30 degrees. In some embodiments, the second arm angle 137 can be greater than the first arm angle 127. In some embodiments, the second arm angle 137 may be less than the first arm angle 127 .

[0036]

[0052] 3, in some embodiments, the hub 101 may include one or more protrusions 141 extending inwardly from the inner surface 123 of the hub into the flow path (e.g., into the flow path of the first and / or second lumen). In other embodiments, the inner surface 123 of the hub may include one or more indentations 142 in the sidewall 124. In some embodiments, the hub may include one or more protrusions and one or more indentations on the inner surface. That is, the first and / or second arms may include indentations and protrusions on their respective inner surfaces. As will be appreciated, the first and second arms need not have the same number of protrusions and / or indentations on their inner surfaces.

[0037]

[0053] As will be further appreciated, the shape and / or size of the protrusions and depressions may be the same or different from protrusion to protrusion or depression to depression. For example, as shown in FIG. 3, the first arm includes two larger protrusions while the second arm includes two smaller protrusions. The second arm also has two larger depressions compared to the size of the depressions in the first arm. In some embodiments, the protrusions and / or depressions may be symmetrically positioned along the length of the first and / or second arms. In some embodiments, some or all of the protrusions and / or depressions may be asymmetrically positioned along the length of the first and / or second arms. In some embodiments, the protrusions and / or depressions may be configured to control the flow of fluid (e.g., blood) through the hub. Thus, the shape, size, number, and location of the depressions / protrusions may be selected to obtain a desired flow path of blood from the second arm (e.g., and ECMO circuit) into the distal region of the first arm and into the joint cannula.

[0038]

[0054] In some embodiments, blood may stagnate in portions of the lumen of the first arm. Thus, as shown in FIGS. 4A and 4B, in some embodiments, the hub 102 may include a plug 210 configured to plug at least a portion of the first lumen 225 to minimize and / or prevent such stagnation areas. In some embodiments, the plug 210 may be configured to prevent fluid from flowing back toward the proximal end portion 240 of the first arm as the fluid flows from the proximal end 231 of the second lumen 235 into the first arm 220 before flowing out the distal end 221 of the first lumen into the patient. In some embodiments, the proximal end portion 240 of the first arm may include one or more hemostatic valves, such as hemostatic valve 243. In some embodiments, the proximal end portion 240 may also include an end cap 241 and a foam member 242. As shown in this figure, the hemostatic valve may be sandwiched between the plug and the foam member. In some embodiments, the end cap, foam member, and hemostasis valve may be fixedly attached to one another and attachable to the first arm, as will be appreciated, such components may also be attached to one another in other suitable manners.

[0039]

[0055] In some embodiments, the plug 210 can be configured to fill some or all of the space extending from the proximal end portion 240 toward where the second lumen fully enters the first lumen. In some embodiments, the plug 210 can be configured to fill some or all of the space between the proximal end portion 240 and the point 239 where the central axis 232 of the second lumen 235 meets the central axis 222 of the distal portion 226 of the first lumen 225. In some embodiments, the plug 210 can have a surface 211 that is tangential to the inner surface of the second arm 230. In such embodiments, the plug can cooperate with the first and second arms to form a smooth flow path along which blood can travel.

[0040]

[0056] In some embodiments, the plug 210 may also block the third lumen 255 .

[0041]

[0057] 4B, the plug may include a slit 260 through which a medical instrument may pass (e.g., from the first arm into the joint lumen). In this regard, in such embodiments, the plug 210 may also perform the function of a hemostatic valve. In some embodiments, this may provide redundancy to the hemostatic valve 243 in the proximal end portion to minimize and / or prevent blood leakage from the first arm.

[0042]

[0058] In some embodiments, the plug may be removably attached to the hub, in some embodiments, the plug may be press-fit into the first arm, in some embodiments, the plug may be screwed into place and / or locked into place.

[0043]

[0059] In some embodiments, the plug may comprise a collagen material. In some embodiments, the collagen may be irreversibly hydrolyzed. In some embodiments, the plug may comprise an elastomeric material.

[0044]

[0060] 4B and 5, in some embodiments, instead of or in addition to a plug, one or more dilators 250, 251 may be used to prevent fluid from flowing back toward the proximal end portion 240 of the first arm when the fluid flows from the proximal end 231 of the second lumen 235 into the first arm 220 before exiting the distal end 221 of the first lumen. In some embodiments, such as the one shown in FIG. 4B, the dilator 250 may pass through a slit 260 in the plug 210 (and hemostasis valve 243) through which a medical device may otherwise be passed. In these embodiments, the dilator may eliminate some or all of the space in the first lumen 225 where blood may stagnate. In some embodiments, a single dilator may be used. In other embodiments (see, for example, FIG. 5), the first dilator 250 may be inserted first through the hemostasis valve 243, and then the second dilator 251 may be inserted into the first dilator. In some embodiments, the shape and size of the cap and / or proximal end portion can correspond to the shape and size of a portion of the dilator. In some embodiments, the dilator can include a key that is received in a recess in the proximal portion to determine proper insertion of the dilator into the hub. In some embodiments, the dilator is arranged to lock onto the first arm of the hub to maintain a seal through the dilator.

[0045]

[0061] 6, in some embodiments, a second plug 261 may be provided such that some or all of the second lumen 235 of the second arm may be occluded when the second arm is not operably coupled to an external medical device, such as an ECMO circuit. In such embodiments, the shape and / or size of the second plug may correspond to the shape and / or size of the second arm. Like the first plug of the first arm, the second plug 261 may be configured to be locked in place. In some embodiments, the second plug 261 may be screwed into place.

[0046]

[0062] 7, 8A-8B, and 9A-9D, the access device may be configured as a modular system, allowing the clinician to configure the access device according to the type and / or sequence of assistance the patient requires. In this regard, unused portions of the access device may be eliminated, which may also eliminate potential areas where blood may stagnate. In some embodiments, a kit may be provided that may include all of these modular components.

[0047]

[0063] Briefly, with reference to FIG. 8A , a wall 410 of a hub 400 of a hub subsystem can define a first arm 420 with a first lumen 425 disposed therein. In some embodiments, the wall 410 can define an opening 475 at which a second arm can be operably connected to the hub. For example, in some embodiments, the second arm can include a tubular body 431 with a second lumen 435 disposed therein that is attached to the hub. In some embodiments, at least a portion of an outer surface 432 of the tubular body 431 can be configured to be inserted into the opening 475. In some embodiments, the outer surface 432 of the tubular body 431 and at least a portion 470 of the wall 410 can form a press-fit seal. In some embodiments, a portion 470 of the wall 410 includes threads, ridges, or other features that enable the tubular body 431 to be secured in place. In some embodiments, the tubular body can include one or more keys or protrusions 437 on the outer surface 432. In some embodiments, the distal surface 438 of the protrusion 437 is configured to interact with the outer surface 471 of the hub 400. In some embodiments, the protrusion is configured to allow the second arm to be properly positioned within the opening 475 and / or first lumen 425. In some embodiments, the protrusion may also form a component in a locking mechanism for the second arm.

[0048]

[0064] In some embodiments, the hub may also include a third arm (see, e.g., FIG. 8A, third arm 450) provided with a third lumen (see, e.g., FIG. 8A, third lumen 455). In some embodiments, the third lumen operably connects to the first lumen 425. As shown in FIG. 7, the hub 310 may define a third lumen 314 coupled to a tube 318. In some embodiments, the third lumen 314 may be directly or indirectly connected to a valve 319. In some embodiments, the valve 319 may be between the hub 310 and an external attachment. In some embodiments, the valve may be a three-way stopcock.

[0049]

[0065] 8B, in some embodiments, a plug 480 may be provided to removably block opening 475 once the second arm is removed. In some embodiments, plug 480 may be completely removable from the hub. In some embodiments, the plug may be coupled to the hub at attachment point 481, but still allow the plug to be inserted into opening 475 and removed therefrom.

[0050]

[0066] Returning to FIG. 7 , the cannula may include a lumen extending from a proximal end 321 to a distal end 322. In some embodiments, an anchoring feature 329, such as a butterfly pad or a sewing ring, may be attached to the cannula for fixation. In some embodiments, the anchoring feature may be configured to be axially stationary relative to the cannula. In some embodiments, the anchoring feature may be rotatable about the cannula. In some embodiments, the anchoring feature may be movably positioned along the cannula 323.

[0051]

[0067] In some embodiments, the wall thickness 326 of the cannula may be between 0.2 mm and 0.4 mm. In some embodiments, the wall thickness may be substantially constant. In some embodiments, the wall thickness of one portion of the cannula may be thicker than the wall thickness of a different portion of the cannula (excluding any rounded or thinned ends of the cannula).

[0052]

[0068] In some embodiments, the cannula may include one or more layers 327, 328. In some embodiments, the cannula may include an inner layer 327 and an outer layer 328 (sometimes referred to as an outer jacket). In some embodiments, some or all of the cannula may be reinforced with wound wire, braided wire, or precision cut hypotube. In some embodiments, the outer jacket may include wound wire, braided wire, or precision cut hypotube. In some embodiments, the cannula may include a low friction polymer coating (e.g., polytetrafluoroethylene (PTFE)) on the inner surface of the joint lumen. In some embodiments, the inner layer may include a low friction polymer coating (e.g., polytetrafluoroethylene (PTFE)). In some embodiments, one or more of the layers forming the cannula may include a thermoplastic polyurethane, nylon, or polyamide block polymer.

[0053]

[0069] In some embodiments, the cannula may include a radiopaque material. In some embodiments, the radiopaque material is an elemental metal. 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 (e.g., polyurethane). In some embodiments, the radiopaque material is arranged in bands that are axially offset from one another along some or all of the length of the cannula.

[0054] In some embodiments, the modular system may include a tubular extension 360 for attaching the cannula to different hubs, as shown in Figure 7. As will be appreciated, in some embodiments, the hub may be directly attachable to the cannula.

[0055]

[0070] In some embodiments, the cannula may be configured to receive a dilator assembly.

[0056]

[0071] In some embodiments, the second arm 331 may be coupled (e.g., via the flexible tube 342) to the flexible tube 332, to the connector 341, and to an external medical device, such as an ECMO circuit. For example, the proximal end 343 of the flexible tube 342 may be configured to be removably coupled from the medical device (e.g., ECMO, heat exchanger, etc.) when used in one configuration, and from the hub 310 when used in a different configuration. In some embodiments, a clamp 362 may be used to control the flow of fluid through the flexible tube 332.

[0057]

[0072] In some embodiments, the attachment or connector 341 is configured to allow the alternative connector subsystem 340 to be removably coupled to the proximal end 333 of the second arm subsystem 330 when used in one configuration, and to be removably coupled to the proximal end 321 of the cannula subsystem 320 when used in a different configuration. In some embodiments, the attachment or connector 341 is configured to allow the alternative connector subsystem 340 to be removably coupled to or to the proximal end 361 of the tubular extension 360.

[0058]

[0073] The modular access device may be configured such that one or both arms are removably attachable to the hub. For example, as shown in FIG. 9A, in some embodiments of the modular access system 800, the second arm (e.g., connected to an ECMO circuit) may be removable from the hub 810, for example, after ECMO support is completed. In such embodiments, the first arm 811 may remain attached to the hub while the patient is under VAD support. In a similar manner, a 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, a clinician may initially 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 and second arms attached to the hub, regardless of what type of support is required by the patient.

[0059]

[0074] 9B-9D show an embodiment in which the tubular extension 860 may be used to attach different forms of modular access devices for patient support. For example, as shown in these figures, the tubular extension 860 may be attached to a cannula 820, which may be inserted into the patient's body at a single insertion site (not shown). In an embodiment in which only ECMO support is required (or is required initially), the clinician may attach only the connector 841 to the tubular extension for ECMO support (see FIG. 9B). Once ECMO support is completed, the connector may be removed and the clinician may attach a hub with a single arm (e.g., first arm 811) if / when only VAD support is required (see FIG. 9C). As will be appreciated, the clinician does not need to initially attach the connector 841 (e.g., ECMO connector) to the tubular extension. Instead, if only VAD support is required, the clinician may attach only the hub 810 with the first arm 811 to the tubular extension 860 (see FIG. 9C). 9D, an access device including both a first arm 811 and a second arm 812 may be attachable to a tubular extension 860 when simultaneous or tandem assistance is to be provided to a patient. As shown in this figure, in some embodiments, a connector 841 may be attached or operably coupled to the second arm 812 (e.g., directly or indirectly, e.g., via a flexible tube 842).

[0060]

[0075] In some embodiments, some components in the system, such as the hub, the second arm, the connector, and any plugs or extenders, may be configured to be removable and replaceable, hi some embodiments, one or more of the components may be removed, cleaned, and reassembled in place.

[0061]

[0076] In some embodiments, the hub can be configured to have a smooth connection for a cannula or other component. As shown in FIG. 10A, the portion of the hub that connects to a cannula or other component can include a barbed connection 601. As shown in FIG. 10B, the portion of the hub that connects to a cannula or other component can include a threaded connection 602.

[0062]

[0077] In some embodiments, the hub may be configured to allow a user to visualize flow and clot formation within the hub. For example, in some embodiments, the hub may be formed from or may include portions made from a permeable material. In some embodiments, one or more portions of the hub may include a transparent window that allows a user to view one or more portions of the first lumen. In some embodiments, one or more portions of the hub may include a transparent window that allows a user to view one or more portions of the second lumen.

[0063]

[0078] In some embodiments, the access device may include rigid and flexible materials. In some embodiments, rigid materials (e.g., HIPS, ABS, nylon, etc.) may be used for injection molded elements, while flexible materials (e.g., thermoplastic polyurethane) may be used for overmolded or insert molded elements. In some embodiments, flexible materials may be used to couple the cannula to the hub.

[0064]

[0079] According to another embodiment of the present disclosure, a method is provided for using the access device described above. Referring to FIG. 11, an embodiment of a method 700 may initially include providing 710 any embodiment of an access device or system as disclosed herein. The access device or system may be surgically attached to a patient, where at least a portion of a cannula is inserted 720 into the patient's body through a single insertion site.

[0065]

[0080] The method may then include an insertion step 730, where 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's body. In some embodiments, the insertion step 730 may include inserting the medical device through the hemostasis valve, the first lumen, and the joint lumen.

[0066]

[0081] The method may also include coupling 740 an external device, such as an ECMO device, to a second arm of the access device, after which the method may include oxygenating 750 the blood with the ECMO device, where the blood flows through the joint lumen and the second lumen of the access device. As will be appreciated, the inserting step 730 and the coupling step 740 may be completed in any order. In some embodiments, the coupling step 740 and the oxygenation step 750 may be completed prior to completion of the inserting step 730.

[0067]

[0082] The disclosed method may be visually illustrated in Figure 12, where one embodiment of a system 801 may include a modular access system 800 that may be shown inserted into a patient's body. At least a portion of a cannula 820 that may be coupled to a hub 810 has been passed through the surface of the patient's skin 802 at an insertion site 803 and into the patient's body.

[0068]

[0083] A medical device 898 (here, an intravascular blood pump) was inserted into the first arm 811 and then into the patient's body through the cannula 820. Specifically, the medical device 898 was inserted through the hemostasis valve 816, the first lumen 815, and the joint lumen 825.

[0069]

[0084] According to another embodiment of the present disclosure, a kit may be provided. The kit may include 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 joint 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 that allows the physician to access an artery or vein. In some embodiments, the kit may also include a guidewire that allows placement of the cannula in the vasculature. The kit may also include one or more dilators of successive sizes to sequentially dilate the vessel prior to insertion of the described device.

[0070]

[0085] The basic components of such a kit are shown in FIG. 12, including a first device (e.g., modular access system 800), an external medical device 899 (e.g., an ECMO device), and at least one medical device (e.g., medical device 898) configured to be inserted through a portion of the access device.

[0071]

[0086] In some embodiments, the kit may also include additional medical devices, such as one or more dilator assemblies and / or one or more needles.

[0072]

[0087] 13-15 show a hub 910 according to another embodiment of the present disclosure. As shown in these figures, the hub can include a first arm 930 that can enable ECMO support to the patient and a second arm 940 that can enable a medical device to be inserted through the hub and into the patient's body. As noted above, in some embodiments, the second arm can include one or more hemostasis valves.

[0073]

[0088] As shown at least in FIG. 14, in some embodiments, the first and second arms may extend substantially perpendicular to one another. As shown in FIG. 15, in such embodiments, the longitudinal axis X of the first arm may be laterally offset from the longitudinal axis Y of the second arm. As shown in FIGS. 15 and 16, in some embodiments, the first arm may be disposed tangentially to the second arm. In this regard, as shown in FIG. 16, the first lumen of the first arm 930 may be tangentially connected to the second lumen of the second arm 940. In some embodiments, this tangential relationship between the first and second arms may cause blood flow through the lumen into the hub to flush the first lumen before entering the shared lumen. In some embodiments, this may prevent blood from stagnating in the hub and may minimize clot formation.

[0074]

[0089] In some embodiments, for example, as shown in Figure 15, the hub may include a single blood flow inlet for blood to enter the hub. As disclosed herein, this may create a circulation flow that allows blood to flush the first lumen before entering the shared lumen. In other embodiments, as shown in Figure 17, the hub may include a first inlet 931 and a second inlet 932 for blood to enter the hub. In such embodiments, each of the first and second inlets may include an arm, such as those disclosed herein, with a lumen disposed therein.

[0075]

[0090] As in Figure 17, in some embodiments, each of the first inlet 931 and the second inlet 932 can have a tangential relationship to the second arm (not shown). As shown in Figure 17, in some embodiments, the first and second inputs can have first and second longitudinal axes X1, X2, respectively, that are laterally offset from the longitudinal axis Y of the second arm. In some embodiments, also as shown in Figure 17, the first and second longitudinal axes X1, X2 of the first and second inlets can be parallel and offset with respect to one another.

[0076]

[0091] Referring to FIG. 18, an embodiment of another access system 1100 is shown. As shown, a hub 810 may be operably coupled to a cannula 820. The cannula may include a reinforcing cage 1101 at a distal end. The cannula may also include a coupling 1102 at a proximal end for connecting to the hub. An anchoring feature 329 may be attached to the cannula, for example, to attach the access system to a patient. A tube 318 (e.g., a high flow side port) may be used to couple the hub and the valve 319. A flexible tube 842 (e.g., an irrigation tube) may be removably coupled to the hub (specifically the second lumen). A connector 841 (e.g., a 3 / 8″ barbed connector) may be coupled to the 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 the flow through the tube 1103.

[0077]

[0092] A dilator 1120 may be present, including a tubular member 1121 in a dilator handle 1122. In some embodiments, as disclosed herein, the tubular member may pass through the arms of the hub 200 and into a cannula while the dilator handle remains proximal to the hub 200. For example, in some embodiments, the tubular member of the dilator hub may be passed through a valve coupled to the proximal end of the hub and remain in the first arm and cannula. In some embodiments, a dilator may be used to facilitate insertion of a medical device into a patient's body (e.g., via the first arm).

[0078]

[0093] In some embodiments, the proximal end of the hub 810 may be coupled to one or more additional components, as shown in Figure 18. For example, the hub may include a Tuohy Borst valve 1080 coupled to the proximal end of the first arm. In such embodiments, the Tuohy Borst valve may serve as a redundant anti-leak feature.

[0079]

[0094] 19A , in some embodiments, the proximal end of the hub 200 may be coupled to a first cap 1210. In some embodiments, the Tuohy Borst valve 1080 may also be coupled to the first cap 1210. In some embodiments, a dust cap 1290 may be coupled to the first cap or the Tuohy Borst valve. For example, the dust cap may be removably attached to the Tuohy Borst valve unless / until a medical device can be inserted through the valve.

[0080]

[0095] In some embodiments, the valve may be formed from two or more components sandwiched between the hub and the first cap or Tuohy Borst valve, or between the first cap and the Tuohy Borst valve. In FIG. 19B, for example, the valve 1220 is shown using three components - a first O-ring 1221, a silicone valve 1222 (note that this may be replaced with any other suitable valve and may include two or more layers, e.g., polyurethane foam, etc.), and an optional second O-ring 1223. In some embodiments, the hemostatic valve may be proximal to the first O-ring. In some embodiments, the hemostatic valve may be distal to the first O-ring. In some embodiments, the hemostatic valve may be positioned between the first O-ring and the second O-ring. In FIG. 19B, the first cap 1210 and hub 200 are referred to as forming a "sandwich" outer element, however, it will be understood that a hub and Tuohy Borst valve, or a first cap and Tuohy Borst valve may also be used.

[0081]

[0096] In some embodiments, the first cap may be removably coupled to the hub. For example, first cap 1210 is shown as having a threaded portion 1211 that mates with a surface (e.g., inner surface 1201) of the hub. In some embodiments, the first cap may be permanently coupled to the hub. For example, the first cap may be glued or welded to the hub.

[0082]

[0097] Referring to FIG. 19C, in some embodiments, the silicone valve and first O-ring can be placed in the hub, with the first O-ring 1221 prevented from moving distally by a portion 1202 of the hub and prevented from moving proximally by the silicone valve 1222. Referring to FIG. 19D, when compressed (e.g., by a first cap being tightly fastened to the hub), the silicone valve pushes down on the O-ring, deforming it by pressing against the portion 1202 of the hub to hold it in place. This deformation allows the O-ring to act as a first barrier against the pressure of blood that may enter the hub. As shown in FIG. 19E, this same concept can also apply when there are two O-rings. The distal end 1212 of the first gap (shown here as having a concave shape) can push down on the second O-ring 1223, which deforms when pressurizing the silicone valve 1222 and compresses the first O-ring 1221 as described with respect to FIG. 19D. The deformation of the second O-ring may allow it to support the back of the silicone valve as it - and the first O-ring - act as a barrier against the pressure of blood in the hub.

[0083]

[0098] 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 herein which equivalents are intended to be encompassed by the following claims.

[0084]

[0099] The embodiments of the present disclosure will be described in detail with reference to the drawings, in which like reference numerals identify similar or identical elements. It is understood that the disclosed embodiments are merely examples of the present disclosure, which may be provided in various forms. Well-known functions or configurations are not described in detail to avoid obscuring the present disclosure with unnecessary details. Therefore, the specific structure and functional details disclosed herein are not to be construed as limitations, but merely as a basis for the claims, and as a representative basis for teaching those skilled in the art to variously use the present disclosure in substantially any suitable detailed structure.

Claims

1. 1. A hub for an access device, said hub comprising: a first arm having a first lumen extending from a proximal end to a distal end, the distal end configured to be operably coupled to a cannula; Including, a central axis of the first lumen at the distal end forms an angle with the central axis of the first lumen at the proximal end; and A hub, wherein the first arm is configured to be operably coupled to a second arm, the second arm having a second lumen extending therethrough.

2. The hub of claim 1 , wherein the second arm is coupled to the hub.

3. The hub of claim 2 , wherein the second arm is removably coupled to the hub.

4. a protrusion, a depression, or both, within the first lumen; a protrusion, a depression, or both, within the second lumen; or The hub of claim 1, a combination thereof.

5. The hub of claim 1 , further comprising a plug configured to be removably inserted into the proximal end of the first lumen.

6. The hub of claim 1 , further comprising one or more dilators configured to extend from the proximal end of the first lumen less than the entire length of the first lumen.

7. The hub of claim 1 , further comprising a plug configured to be removably inserted into the proximal end of the second lumen.

8. 1. A hub for an access device, said hub comprising: a first arm having a first lumen extending from a proximal end to a distal end, the distal end configured to be operably coupled to a cannula; Including, the first arm is configured to be operably coupled to a second arm having a second lumen extending therethrough; and a protrusion, a depression, or both, within the first lumen; a protrusion, a depression, or both, within the second lumen; or The combination of these is the hub.

9. A hub for access devices, a first arm having a first lumen extending from a proximal end to a distal end, the distal end configured to be operably coupled to a cannula; a second arm operably coupled to the first arm, the second arm having a second lumen extending therefrom; and one or more dilators extending from the proximal end less than the entire length of the first lumen, the one or more dilators configured to fill at least a portion of the space within the first lumen at or near the proximal end of the first lumen. Including the hub.

10. The hub of claim 9, further comprising a plug configured to be inserted into the proximal end of the second lumen.

11. The hub of claim 10, wherein the plug includes a slit through which a medical device can be inserted into the first lumen.

12. 10. The hub of claim 9, wherein the hub further comprises a third lumen operably connected to the first lumen, the second lumen, or both.

13. 10. The hub of claim 1, 8, or 9, wherein the longitudinal axis of the first arm is laterally offset from the longitudinal axis of the second arm.

14. 10. The hub of claim 1, 8, or 9, wherein the central axis of the first lumen at the distal end forms a second arm angle with the central axis of the second lumen at the proximal end, the angle being between 15 and 30 degrees.

15. The hub of claim 1 , 8 or 9, further comprising a cap coupled to the proximal end of the first arm.

16. 16. The hub of claim 15, further comprising an O-ring and a silicone valve positioned between a portion of the cap and a portion of the first arm.

17. 17. The hub of claim 16, further comprising a second O-ring disposed between the silicone valve and the cap.

18. a cannula having a proximal end and a distal end, the cannula having a joint lumen; 10. The hub of claim 1, 8, or 9, configured to be operably coupled to the proximal end of the cannula. access equipment, including

19. 1. A method for using an access device, comprising: Providing an access device according to claim 18; inserting a cannula of the access device into a patient; inserting a medical device into the patient's body through the hub of the access device and / or oxygenating blood using an extracorporeal membrane oxygenation (ECMO) device operably coupled to the cannula through a second arm, an alternative connector subsystem, or both; A method comprising:

20. an access device according to claim 18; an extracorporeal membrane oxygenation (ECMO) machine configured to be operably coupled to a cannula of the access device; a medical device configured to be inserted through the hemostatic valve, the first lumen, and the joint lumen of the access device; Includes a kit.

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