Patent Publication Number: US-2020289794-A1

Title: Dual hub introducer sheath

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims priority to U.S. Provisional Application No. 62/817,901, filed Mar. 13, 2019, the contents of which are fully incorporated herein by reference. 
    
    
     BACKGROUND 
     Currently, percutaneous mechanical support devices are leveraged for a variety of clinical indications. Such support devices may comprise, but are not limited to, an Impella® pump, an Extracorporeal Membrane Oxygenation (ECMO) pump, and a balloon pump. The Impella® pump may further comprise an Impella2.5® pump, an Impella5.0® pump, an Impella CP® pump and an Impella LD® pump, all of which are by Abiomed, Inc. of Danvers, Mass. Most often they are inserted into a patient percutaneously through a single access point (e.g., radial access, femoral access, axillary access) while other procedures, such as, for example, percutaneous coronary intervention (PCI) are performed through a second access point, such as a contralateral femoral or radial access point. The use of multiple devices on a patient at the same time therefore often requires multiple access sites which presents several challenges. 
     BRIEF SUMMARY 
     The present technology relates to systems and methods for percutaneously delivering a first medical device and a second medical device to a patient. 
     In one aspect, the disclosure describes an introducer system comprising: an introducer sheath having a longitudinal axis and a lumen formed therein; and a hub coupled to a proximal end of the introducer sheath. The hub comprises: a first arm having a first lumen and a first hemostasis valve, the first lumen and the first hemostasis valve configured for the passage of a first medical device; a second arm coupled to the first arm and having a second lumen and a second hemostasis valve, the second lumen and the second hemostasis valve configured for the passage of a second medical device; and a connection port coupled to the introducer sheath and to the first arm and the second arm, such that the first lumen and the second lumen are in communication with the lumen of the introducer sheath to allow the passage of at least one of the first medical device and the second medical device through the introducer sheath for delivery to a patient. In some aspects, the first arm is arranged parallel to the longitudinal axis of the introducer sheath. In some aspects, the second arm is configured to branch off the first arm at an angle of no more than 90°. In some aspects, the first arm and the second arm are arranged in a Y-shaped configuration with respect to the introducer sheath. In some aspects, the second arm is located proximal to the connection port. In some aspects, the first arm and the second arm each has a proximal end and a distal end, and the distal end of the first arm is positioned distal of the proximal end of the second arm. In some aspects, the second lumen merges with the first lumen within the hub. In some aspects, the introducer sheath comprises a single lumen for the passage of the first and second medical devices. In some aspects, the first lumen and the second lumen are maintained as separate lumens within the hub. In some aspects, the introducer sheath comprises a dual lumen sheath such that the first lumen is in communication with one of the lumens of the dual lumen sheath, and the second lumen is in communication with the other lumen of the dual lumen sheath. In some aspects, the introducer sheath is an expandable sheath. In some aspects, the introducer sheath is a peel-away sheath. In addition, the hub may further comprise tabs to enable separation of the hub and the peel-away sheath. In some aspects, the first and second hemostasis valves are configured to seal the respective first and second lumens. In some aspects, the first and second hemostasis valves are each configured to be penetrable by the first or second medical device. In some aspects, the hub further comprises at least one suture ring. In some aspects, the first arm and the second arm each comprise at least one side-port. In addition, the side-port may comprise an irrigation port configured to be supplied with an irrigation fluid. In some aspects, at least one of the first arm and the second arm comprises a locking mechanism configured to prevent axial movement of one or both of the first medical device and the second medical device within the introducer sheath after delivery to the patient. In some aspects, the locking mechanism comprises at least one of: a Tuohy-Borst adaptor, an inflatable balloon, and a locking lever arm. In some aspects, the locking mechanism is biased in a state that is configured to prevent axial movement of one or both of the first medical device and the second medical device within the introducer sheath. In some aspects, the introducer sheath comprises at least one of: a polyether block amide; a polyethylene material; a polytetrafluoroethylene (PTFE) material; a high-density polyethylene (HDPE) material; a medium-density polyethylene (MDPE) material; or a low-density polyethylene (LDPE) material. In some aspects, the hub comprises at least one of: ethylene-vinyl acetate (EVA); styrene-butadiene copolymer (SBC); styrene ethylene butylene styrene (SEBS); a high-density polyethylene (HDPE) material; a medium-density polyethylene (MDPE) material; a low-density polyethylene (LDPE) material; polyether ether ketone (PEEK); a polyether block amide; an elastomer; synthetic rubber; or a polyethylene, polyurethane, or polycarbonate material with an elastic modulus of about 40 ksi. In some aspects, the first medical device is a mechanical circulatory support device, and the second medical device is a coronary reperfusion therapy device for providing the patient with percutaneous coronary intervention (PCI). In some aspects, the coronary reperfusion therapy device is a stent. In some aspects, the stent is configured for insertion through the second arm and introducer sheath by a catheter. In some aspects, the mechanical circulatory support device comprises at least one of: a blood pump; a transvalvular axial-flow (TV)-pump; an intra-aortic balloon pump; or an extracorporeal membrane oxygenation (ECMO) pump. In some aspects, the mechanical circulatory support device is a rotary blood pump having a cannula and a rotor and rotor housing. In some aspects, the first arm and the introducer sheath are configured to allow passage of the cannula of the rotary blood pump. In some aspects, the first arm and the introducer sheath are configured to allow passage of the rotor and rotor housing of the rotary blood pump. In some aspects, the hub comprises up to five second arms, each second arm configured with a hemostasis valve and a lumen in communication with the introducer sheath for the passage of the second medical device from a respective second arm into the introducer sheath. In some aspects, the second arms are arranged in a radially symmetric manner about the first arm. In some aspects, the hub comprises two second arms. In some aspects, the introducer system may further comprise at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostasis valve, the third lumen and third hemostasis valve configured for the passage of a third medical device. 
     In another aspect, the disclosure describes a method comprising: inserting a first medical device into a first arm of an introducer hub, the first arm having a first lumen for the passage of the first medical device therethrough; inserting a second medical device into a second arm attached to the first arm, the second arm having a second lumen for the passage of the second medical device therethrough; providing the first medical device and the second medical device to an introducer sheath via a connector port of an introducer hub, the connector port coupled to a proximal end of the introducer sheath; and delivering the first medical device and the second medical device to a patient from a distal end of the introducer sheath. In some aspects, the method further comprises inserting the first and second medical devices into a lumen formed within the introducer sheath for delivery to the patient. In some aspects, the method further comprises inserting the first medical device into a first lumen formed within the introducer sheath for delivery to the patient, and inserting the second medical device into a second lumen formed within the introducer sheath for delivery to the patient, the first lumen isolated from the second lumen. In some aspects, the method further comprises attaching the introducer hub to the patient via a suture ring. In some aspects, the method further comprises providing one or both of the first lumen and the second lumen with an irrigation fluid via a side-port positioned on each of the first and second arms. In some aspects, the method further comprises activating a locking mechanism to prevent axial movement of one or both of the first medical device and the second medical device within the introducer sheath. In some aspects, the locking mechanism comprises at least one of: a Tuohy-Borst adaptor, an inflatable balloon, and a locking lever arm. In some aspects, the locking mechanism is biased in a state that prevents axial movement of one or both of the first medical device and the second medical device within the introducer sheath. In some aspects, the method further comprises inserting a third medical device into a third arm attached to the first arm, the third arm having a third lumen for the passage of the third medical device therethrough for delivery to the patient. In some aspects, the method further comprises supporting the patient&#39;s heart that has sustained myocardial infarction. In some aspects, the method further comprises: inserting the first medical device through the first arm and through the introducer sheath into the patient&#39;s left ventricle; operating the first medical device for a support period of greater than 30 minutes at a rate of at least 2.5 L/min of blood flow; inserting the second medical device through the second arm and through the introducer sheath into a coronary vessel of the patient; and operating the second medical device after the support period has elapsed. In some aspects, the first device comprises a mechanical circulatory support device. In some aspects, the mechanical circulatory support device comprises at least one of: a blood pump, a transvalvular axial-flow (TV)-pump, an intra-aortic balloon pump, or an extracorporeal membrane oxygenation (ECMO) pump. In some aspects, the second device comprises a coronary reperfusion therapy device for providing the patient with percutaneous coronary intervention (PCI). In some aspects, the mechanical circulatory support device is operated to pump blood from the patient&#39;s left ventricle into the patient&#39;s aorta during the support period. In some aspects, the second medical device is inserted through the second arm after the first medical device is positioned across the patient&#39;s aortic valve and is unloading the patient&#39;s left ventricle. In some aspects, the second medical device is inserted through the introducer sheath at least 15 minutes after the first medical device begins unloading the patient&#39;s left ventricle. In some aspects, the first medical device is positioned with a distal tip located within the patient&#39;s left ventricle and pumps blood from the patient&#39;s left ventricle into the patient&#39;s aorta. In some aspects, the introducer hub comprises up to five second arms, each second arm configured with a hemostasis valve and a lumen in communication with the introducer sheath for the passage of the second medical device from a respective second arm into the introducer sheath. In some aspects, the second arms are arranged in a radially symmetric manner about the first arm. In some aspects, the introducer hub comprises two second arms. In some aspects, the introducer hub further comprises at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostasis valve, the third lumen and third hemostasis valve configured for the passage of a third medical device. 
     In another aspect, the disclosure describes an introducer hub comprising: a first arm having a first lumen and a first hemostasis valve, the first lumen and first hemostasis valve configured for the passage of a first medical device; a second arm coupled to the first arm and having a second lumen and a second hemostasis valve, the second lumen and second hemostasis valve configured for the passage of a second medical device; and a connection port coupled to an introducer sheath and to the first arm and the second arm, such that the first lumen and the second lumen are in communication with the lumen of the introducer sheath to allow the passage of at least one of the first medical device and the second medical device through the introducer sheath for delivery to a patient. In some aspects, the first arm is arranged parallel to a longitudinal axis of the introducer sheath. In some aspects, the second arm is configured to branch off the first arm at an angle of no more than 90°. In some aspects, the first arm and the second arm are arranged in a Y-shaped configuration with respect to the introducer sheath. In some aspects, the second arm is located proximal to the connection port. In some aspects, the first arm and the second arm each has a proximal end and a distal end, and the distal end of the first arm is positioned distal of the proximal end of the second arm. In some aspects, the second lumen merges with the first lumen. In some aspects, the introducer sheath comprises a single lumen for the passage of the first and second medical devices. In some aspects, the first lumen and the second lumen are maintained as separate lumens. In some aspects, the introducer sheath comprises a dual lumen sheath such that the first lumen is in communication with one of the lumens of the dual lumen sheath, and the second lumen is in communication with the other lumen of the dual lumen sheath. In some aspects, the introducer sheath is an expandable sheath. In some aspects, the introducer sheath is a peel-away sheath. In some aspects, the introducer hub further comprises tabs to enable separation of the introducer hub and the peel-away sheath. In some aspects, the first and second hemostasis valves are configured to seal the respective first and second lumens. In some aspects, the first and second hemostasis valves are each configured to be penetrable by the first or second medical device. In some aspects, the introducer hub further comprises at least one suture ring. In some aspects, the first arm and the second arm each comprise at least one side-port. In some aspects, the side-port comprises an irrigation port configured to be supplied with an irrigation fluid. In some aspects, at least one of the first arm and the second arm comprises a locking mechanism configured to prevent axial movement of one or both of the first medical device and the second medical device within the introducer sheath after delivery to the patient. In some aspects, the locking mechanism comprises at least one of: a Tuohy-Borst adaptor, an inflatable balloon, and a locking lever arm. In some aspects, the locking mechanism is biased in a state that is configured to prevent axial movement of one or both of the first medical device and the second medical device within the introducer sheath. In some aspects, the introducer hub comprises up to five second arms, each second arm configured with a hemostasis valve and a lumen in communication with the introducer sheath for the passage of the second medical device from a respective second arm into the introducer sheath. In some aspects, the second arms are arranged in a radially symmetric manner about the first arm. In some aspects, the introducer hub comprises two second arms. In some aspects, the introducer hub further comprises at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostasis valve, the third lumen and the third hemostasis valve configured for the passage of a third medical device. In some aspects, the introducer hub comprises at least one of: ethylene-vinyl acetate (EVA); styrene-butadiene copolymer (SBC); styrene ethylene butylene styrene (SEBS); a high-density polyethylene (HDPE) material; a medium-density polyethylene (HDPE) material; a low-density polyethylene (LDPE) material; polyether ether ketone (PEEK); a polyether block amide; an elastomer; synthetic rubber; or a polyethylene, polyurethane, or polycarbonate material with an elastic modulus of about 40 ksi. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing and other objects and advantages will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which: 
         FIG. 1  shows an illustrative cross section of a dual hub introducer sheath system used for delivering a first medical device and second medical device into an arteriotomy of a patient, according to aspects of the disclosure; 
         FIG. 2  shows a dual hub introducer sheath system with a dilator for insertion into the arteriotomy of the patient, according to aspects of the disclosure; 
         FIG. 3  shows a detailed view of the dual hub introducer sheath system of  FIG. 2 ; 
         FIG. 4  shows a detailed view of the dual hub introducer sheath system of  FIG. 2  with an occulder sealing a lumen in a side arm; 
         FIG. 5A  shows an illustrative locking mechanism, in an open state, used in a dual hub introducer sheath system according to aspects of the disclosure; 
         FIG. 5B  shows the locking mechanism of  FIG. 5A  in a locked state; 
         FIG. 6  shows an illustrative flowchart of a method of using a dual hub introducer sheath system according to aspects of the disclosure; and 
         FIG. 7  shows an illustrative flowchart of a method of using a dual hub introducer sheath system for unloading the left ventricle of the heart according to aspects of the disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     To provide an overall understanding of the systems, devices and methods described herein, certain illustrative examples will be described. Although the examples and features described herein are specifically described for use in connection with dual hub introducer sheath for use in intravascular procedures involving catheter based ventricular assist devices, it will be understood that all the components and other features outlined below may be combined with one another in any suitable manner and may be adapted and applied to other types of procedures requiring a dual hub introducer sheath. 
     As mentioned above, while it is possible to use multiple devices on a patient at the same time using multiple access sites, this can be challenging for a variety of reasons. Firstly, the patient may not have two anatomically available access sites for the PCI procedural devices, in which, for example, two 6-7 Fr sheaths may be used to facilitate procedures such as ballooning and stenting. In addition, peripheral artery disease, vessel lumen size (too small), scar tissue from previous procedures, and other diseases may complicate gaining access to a percutaneous site for larger devices, e.g., mechanical support devices. Using multiple access sites may also increase the likelihood of encountering vascular access complications, which can correlate to increased mortality, added hospital costs, etc. Further, multiple access sites requires more procedural time since access needs to be gained more than once, and can lead to increased procedural costs due to requiring multiple vascular closure devices, additional introducers, etc. There is thus a significant need for reducing the complexity of procedures requiring the operation of multiple devices on a patient. 
     The systems, devices and methods described herein relate to a dual hub introducer sheath which enables a single access site for multiple devices. For purposes of illustration herein, but not by way of limitation, the devices are described as a mechanical assist device (such as, for example, an Impella device) and a device for the PCI procedure. However, one skilled in the art will understand that the present disclosure is not limited to any particular kind of percutaneously inserted device. In fact, the disclosure contemplates that, in some aspects of the technology, the multiple devices can be two of the same device. Until recently, such single access for multiple devices has not been apparently possible because physicians were unaware of the ability to fit both the PCI device and the Impella device through a single sheath without increasing the overall diameter of the sheath. 
     Successful insertion of PCI devices through the same access sheath as the Impella device to perform both PCI and Impella support in a single access site has recently been reported (M. L. Esposito et al., “Left Ventricular Unloading Before Reperfusion Promotes Functional Recovery After Acute Myocardial Infarction,” Journal of the American College of Cardiology, Elsevier, vol. 72, no. 5, May 2018). However, using the current solutions leads to issues with hemostasis from the introducer valve and pump migration into and out of the ventricle as PCI devices are exchanged and manipulated. These adverse effects arise because conventional introducer valves are simply not designed to be accessed by dual devices. 
     The devices and methods described herein relate to a dual hub introducer sheath having a longitudinal axis and a lumen formed therein. The sheath also comprises a hub coupled to a proximal end of the introducer sheath. The hub comprises a first arm having a first lumen and a first hemostasis valve, the first lumen and hemostasis valve configured for the passage of a first medical device. The hub also comprises a second arm coupled to the first arm and having a second lumen and a second hemostasis valve, the second lumen and hemostasis valve configured for the passage of a second medical device. Further, the hub comprises a connection port coupled to the introducer sheath and to the first arm and the second arm, such that the first lumen and the second lumen are in communication with the lumen of the introducer sheath to allow the passage of at least one of the first medical device and second medical device through the introducer sheath for delivery to the patient. 
     The dual hub introducer sheath of the present disclosure allows for both the PCI and Impella device to be inserted through it while maintaining appropriate and acceptable hemostasis. By leveraging a bifurcated hub, two separate valves can be implemented which are specifically designed to meet insertion force and leakage requirements for either the Impella device or the PCI device, noting that these requirements and designs are quite different. Additionally, the dual hub introducer sheath of the present disclosure has a locking mechanism isolated to an arm of the hub intended for the Impella device which the physician can activate to hold the Impella in place preventing it from advancing or retracting as the PCI procedure is performed. 
       FIG. 1  shows a dual hub introducer sheath delivery system  100  for percutaneously delivering a first medical device and a second medical device to a patient. System  100  comprises introducer sheath  110  that extends between a proximal end  112  and a distal end (not shown) along a longitudinal axis (not shown). Sheath  110  further comprises a lumen  115  that extends between the proximal end  112  and distal end for the passage of the first medical device and the second medical device. While  FIG. 1  depicts a sheath  110  having a single lumen  115 , in some aspects of the technology, sheath  110  may comprise two distinct lumens throughout the length of the sheath, for example. In other aspects of the technology, sheath  110  may comprise any number of distinct lumens. System  100  further comprises a hub  120  coupled to the proximal end  112  of the sheath  110 . 
     Hub  120  comprises a first arm  130  having a proximal end  132  and a distal end  134 , the first arm  130  defining a first lumen  135 . A first valve  138  is provided at the proximal end  132  of the first arm  130  to seal the first lumen  135  from the ambient. The first valve  138  is penetrable by the first medical device  140 . Hub  120  further comprises a second arm  150  attached to the first arm  130 . As with the first arm  130 , second arm  150  defines a second lumen  155  and comprises a proximal end  152  and a distal end  154 . A second valve  158  is provided at the proximal end  152  of the second arm  150  to seal the second lumen  155  from the ambient. The second valve  158  is penetrable by the second medical device  160 . In some aspects of the technology, the first valve  138  and the second valve  158  may comprise hemostasis valves (also referred to as “hemostatic” valves), such as, for example the valve described in U.S. Pat. No. 10,576,258 entitled “Hemostatic Valve for Medical Device Introducer,” the entire contents of which are hereby incorporated by reference herein. While  FIG. 1  shows a hub  120  comprising one second arm  150 , it will be understood that the hub  120  may comprise any number of second arms arranged relative to the first arm  130 . 
     The hub  120  further comprises a connection port  170  which connects to the first lumen  135  and the second lumen  155 . The connection port  170  of the hub  120  is coupled to the proximal end  112  of the sheath  110  such that the first medical device  140  and the second medical device  160  may traverse the sheath  110  to be delivered to a patient when the sheath  110  is inserted in the patient. In some aspects of the technology, such coupling may be a friction fit, for example, in which the proximal end  112  of the sheath  110  is dimensioned such that a friction fit between the outer surface of the sheath  110  and the inner surface of the connection port  170  prevents the proximal end  112  of the sheath  110  from detaching from the hub  120 . In other aspects of the technology, the coupling may be brought about by an external thread on the outer surface of the proximal end  112  of the sheath  110  which interacts with a complementary thread on the inner surface of the connection port  170 , for example. In further aspects of the technology. the sheath  110  may be coupled to the connection port  170  in any manner that enables the first lumen  135  and the second lumen  155  to be fluidically connected to the lumen  115  of the sheath  110  via the connection port  170  of the hub  120 . In some aspects of the technology, the hub  120  may be overmolded and press fit or compressed onto the proximal end  112  of the sheath  110 . 
     In some aspects of the technology, the hub  120  may be fabricated such that the first lumen  135  and the second lumen  155  merge within the hub  120  before transitioning into the connection port  170 , as shown in  FIG. 1 . In such cases, the hub  120  may be coupled to a single lumen sheath, such as sheath  110  in  FIG. 1 , where the lumen  115  of the sheath  110  is in fluid communication with the first lumen  135  and the second lumen  155  via the connection port  170  of the hub  120 . Thus, when the first medical device  140  is inserted into the first arm  130  and the second medical device  160  is inserted into the second arm  150  of the hub  120 , the medical devices share the same lumen  115  of the sheath  110  when traversing the sheath  110  for delivery to the patient. In other aspects of the technology, the hub  120  may be fabricated such that the first lumen  135  and the second lumen  155  are maintained as separate lumens throughout the hub  120 . In such cases, the hub  120  may be coupled to a dual lumen sheath such that the first medical device  140  and the second medical device  160  are separated at all times while traversing the length of the sheath  110  for delivery into an arteriotomy of the patient. 
     As shown in  FIG. 1  the second arm  150  may be arranged such that it branches off the first arm  130  at an angle relative to the first arm  130 , and the first arm  130  may be axially aligned with the longitudinal axis of the sheath  110 . In some aspects of the technology, this angle is not larger than 90°. In such cases, when the first medical device  140  is inserted into the first arm  130 , it is maintained in a substantially straight shape within the hub  120  without having to bend or kink; and when the second device  160  is inserted into the second arm  150 , the arrangement of the second arm  150  relative to the first arm  130  causes the second device  160  to bend such that it aligns with the first device  140  before exiting the hub  120  via the connector port  170  and traversing the lumen  115  of the sheath  110 . 
     In some aspects of the technology, the first arm  130  and the second arm  150  may be arranged such that they form a Y-shaped configuration with respect to the longitudinal axis of the introducer sheath  110 . In such cases, both the first medical device  140  and the second medical device  160  may bend within the hub  120  such that they are aligned with the longitudinal axis of the sheath  110  as they exit the connector port  170  and traverse the lumen  115  of the sheath  110 . 
       FIG. 2  shows the configuration of a dual hub introducer sheath system  200  according to aspects of the technology. Sheath system  200  is similar to sheath system  100  in that it comprises a sheath  210  having a proximal end  212  and a distal end  214  with a lumen extending between the proximal end  212  and the distal end  214  for the passage of at least one medical device, such as the first medical device  140  and the second medical device  160  of  FIG. 1 , for delivery to an arteriotomy of a patient. The proximal end  212  of the sheath  210  is coupled to a connector port  270  of a hub  220 . The hub  220  comprises a first arm  230  having a proximal end  232  and a distal end  234 , and a second arm  250  attached to the first arm  230  and having a proximal end  252  and a distal end  254 . The first arm  230  forms a first lumen  235  which is sealed from the ambient by a first valve  238 . Similarly, the second arm  250  forms a second lumen  255  which is sealed from the ambient by a second valve  258 . The first valve  238  and the second valve  258  may comprise a hemostasis valve, and may be penetrable by the first and second medical devices, as has been described in relation to  FIG. 1 . In some aspects of the technology, the second lumen  255  fluidically connects to the first lumen  235  within the hub  220 , as shown in  FIG. 2 . In other aspects of the technology, the first lumen  235  and the second lumen  255  may be maintained as separate lumens within the hub  220 . In some aspects of the technology, the first valve  238  and the second valve  258  may be inserted into position by a snap cap to secure their position within the hub  220 . 
     As shown in  FIG. 2  (and the enlargement  300  in  FIGS. 3 and 4 ) the first arm  230  further comprises a first side port  236  that is in fluid connection with the first lumen  235 . Similarly, the second arm  250  comprises a second side port  256  that is in fluid communication with the second lumen  255 . Side port  236  and side port  256  may each serve as an irrigation port through which irrigation fluid can be injected to free the lumens  235 ,  255  within the hub  220  of any thrombus that may have formed during treatment of the patient. In other aspects of the technology, the side ports  236 ,  256  may serve as inflation ports connected to inflatable balloons within the hub  220  that may be inflated with an inflation fluid to expand the balloons so as to anchor or lock the positions of the first medical device  140  and the second medical device  160  relative to the respective arms through which they are inserted. In such cases, the inflated balloon may compress the medical device against its respective arm so as to prevent axial movement of the medical device within the sheath once the device is deployed in the patient. Such locking mechanisms for securing the position of a medical first device to prevent axial motion during insertion or manipulation of a second medical device using internal sheath balloons are known to those skilled in the art. For example, various locking mechanisms for securing the position of a first medical device to prevent axial motion during insertion or manipulation of a second medical device using internal sheath balloons are described in U.S. Provisional Patent Application No. 62/797,527, the entire contents of which are hereby incorporated by reference herein. Other locking mechanisms will be detailed in the foregoing sections. While only one side port is shown on each arm in  FIGS. 2 and 3 , any number of side ports may be used on each arm within the scope of the present disclosure. 
     As discussed above, the second arm  250  may be arranged on the first arm  230  and configured to branch off the first arm  230  at an angle of no more than 90° with respect to the longitudinal axis of the sheath  210 . Additionally, in some aspects of the technology, the distal end  254  of the second arm  250  may be positioned proximal to the connector port  270 , and the proximal end  232  of the first arm  230  may be positioned distal to the connector port  270 . In this manner the proximal end  252  of the second arm  250  may be sufficiently spaced apart from the proximal end  232  of the first arm  230  to allow the first and second medical devices to interact with the respective arms  230 ,  250  without having to abut each other. 
     As seen in  FIGS. 2 and 3 , the hub  220  may optionally include a suture ring  225  to aid with the attachment of the hub  220  to the patient after the first and second medical devices have been inserted in the patient. In certain aspects of the technology, the suture ring  225  may be positioned proximal to the connector port  270  as the profile of the hub  220  in this location may be smaller than at locations proximal to either the first arm  230  or the second arm  250 . In other aspects of the technology, the suture ring  225  may be located at any location along the body of hub  220 . While only one suture ring is shown in  FIGS. 2 and 3 , it will be understood that any number of suture rings may be present to aid in securing the hub  220  to the patient. 
     In order to insert the introducer sheath  210  into the patient, a dilator  280  may be used in connection with the dual hub  220 .  FIGS. 2 and 3  also show a dilator  280  that has been inserted into the first arm  230  of the hub  220 . The dilator  280  comprises a proximal end  282  and a distal end  284 . The length of the dilator is such that the distal end  284  extends beyond the distal end  214  of the sheath  210  when the dilator  280  is fully inserted into the  210 . As previously mentioned, while the first arm  230  and the second arm  250  may assume any configuration relative to the longitudinal axis of the sheath  210  (e.g., a Y-shaped configuration), where insertion of the introducer sheath  210  into the patient requires a dilator  280 , the first arm  230  may be axially aligned with the longitudinal axis of the sheath  210 . With this arrangement of the first arm  230 , the dilator does not need to bend when being inserted in to the hub  220 , which may allow for a greater force to be applied when inserting the sheath  210  into the patient. Once inserted, proximal end  282  of the dilator  280  may connect to the proximal end  232  of the first arm  230 . This may be accomplished by any suitable type of connection, such as through a press fit or a twist connection. 
     In some aspects of the technology, an occluder  490  may be inserted into the lumen  255  of the second arm  250 , as shown in  FIG. 4 . Such an occluder  490  may be inserted to prevent any backflow of fluid when the sheath  210  is inserted into the patient. This may be helpful in cases where sheath  210  needs to be repositioned after the medical devices have been removed from the first arm  230  and the second arm  250 . In such situations, due to their prior use, the respective seals  238 ,  258  may not be able to seal the lumens  235 ,  255  from the ambient completely due to wear and tear. As with the dilator  280 , the occluder  490  may connect to the proximal end  252  of the second arm  250  by any suitable type of connection, such as through a press fit or a twist connection. 
     As mentioned in the foregoing, the first medical device  140  and the second medical device  160  may be axially constrained by a locking mechanism. In some aspects of the technology, a locking mechanism may be configured so that some action must be taken in order to lock and/or unlock it. In some aspects of the technology, a locking mechanism may have a bias. For example, in some aspects of the technology, a locking mechanism may be biased in an unlocked state such that it does not restrict movement of the medical device unless an action is taken to lock the locking mechanism. Conversely, in some aspects of the technology, a locking mechanism may be biased in a locked state such that it restricts movement of the medical device unless an action is taken to unlock the locking mechanism. In some aspects of the technology, the locking mechanism may comprise an internal balloon located within the first lumen  235  or the second lumen  255 , the internal balloon being inflated by a side arm  236 ,  256 , as previously described. In some aspects of the technology, the locking mechanism may also comprise a locking lever arm as shown in  FIGS. 5A and 5B .  FIG. 5A  shows the cross section of a hub  510  similar to hubs  220  and  120  as described in the foregoing. Hub  510  is shown with a first medical device  520  traversing therethrough, although it will be appreciated that the hub  510  may be allow the passage of a plurality of medical devices. Hub  510  also comprises a lever arm  530  which may be a separate component which is positioned within the hub body. The lever arm  530  may be configured to have a semicircular shape as shown in  FIGS. 5A and 5B , however any shape of arm may be used that is suitable to secure the medical device  520  and prevent axial motion thereof. 
     The lever arm  530  may be pivotally connected to the hub  510  at a point  532  as shown in  FIG. 5A . In the unlocked position, the lever arm  530  resides within the hub body. The lever arm may comprise an actuating mechanism such as a handle or tab (not shown) that is accessible from the exterior of the hub  510 . The lever arm  530  comprises a notch or catch  538  that is configured to fit around the external periphery of the medical device  520  when the lever arm  530  is in the locked position. In this position, as shown in  FIG. 5B , the notch  538  pinches the medical device  520  to increase axial friction. In some aspects of the technology, the notch  538  may bend the medical device  520  when the lever arm  530  is in the locked position. In some aspects of the technology, the lever arm  530  may be located at the respective hemostasis valves  238 ,  258 . Additionally, to secure the lever arm in the locked position, the end  534  of the lever arm  530  may be configured with a recess on its distal surface that engages with a protrusion  536  located within the hub body. The side profiles of end  534  and protrusion  536  are shown in  FIG. 5A . Similarly,  FIG. 5B  shows end  534  in engagement with protrusion  536 . In some aspects of the technology, the lever arm  530  may be overmolded with a high friction material such as a low-durometer polyurethane or a silicone. 
     In addition to, or as an alternative to, the locking mechanisms described in the foregoing, the dual hub of the present disclosure may also comprise a Tuohy Borst mechanism built into the first or second arms of the hub body. Such a mechanism comprises a silicone slug that reduces in inner diameter onto the first and/or second medical device traversing the respective arm, thereby securing the position of the medical device. 
     As noted above, in some aspects of the technology, the sheath  210  may comprise a dual lumen sheath. In such a case, when the dual lumen sheath is coupled to the hub  220 , the first lumen  235  of the hub  220  may be in fluid communication with one of the lumens of the dual lumen sheath, and the second lumen  255  of the hub  220  may be communication with the other lumen of the dual lumen sheath. 
     In some aspects of the technology, the sheath  210  may comprise an expandable sheath. Expandable sheaths are well known to those skilled in the art and are not described in detail herein. For example, various expandable sheaths are described in U.S. Provisional Patent Application No. 62/797,527, which has been incorporated by reference herein. 
     In some aspects of the technology, the sheath  210  may comprise a peel-away sheath. Peel-away sheaths are also well known to those skilled in the art and are not described in detail herein. For example, various peel-away sheaths are described in U.S. Provisional Patent Application No. 62/777,598, the entire contents of which are hereby incorporated by reference herein. Peel-away sheaths may comprise one or more lines of weakness that are formed within the sheath body and extend longitudinally along the sheath to allow the sheath to be pulled apart as needed during treatment of the patient. 
     In some aspects of the technology, the hub  220  may comprise tabs that enable the hub  220  itself to be separated when it is no longer needed, e.g., when one or more of the medical devices are positioned within the patient. 
     In some aspects of the technology, the sheath  210  may be extruded and/or laminated. In some aspects of the technology, the introducer sheath  110 ,  210  may comprise at least one of: a polyether block amide (such as PEBAX® or PebaSlix®); a polyethylene material; a polytetrafluoroethylene (PTFE) material; a high-density polyethylene (HDPE) material; a medium-density polyethylene (MDPE) material; or a low-density polyethylene (LDPE) material. 
     Further, as described above, in some aspects of the technology, the hub  120 ,  220  may be formed by overmolding. In some aspects of the technology, the hub  120 ,  220  may comprise at least one of: ethylene-vinyl acetate (EVA); styrene-butadiene copolymer (SBC); styrene ethylene butylene styrene (SEBS); a high-density polyethylene (HDPE) material; a medium-density polyethylene (MDPE) material; a low-density polyethylene (LDPE) material; polyether ether ketone (PEEK); a polyether block amide (such as PEBAX® or PebaSlix®); an elastomer; synthetic rubber; a polyethylene, polyurethane, or polycarbonate material with an elastic modulus of about 40 ksi; a crack-resistant material; or a material with a low coefficient of friction. 
     As mentioned in the foregoing description, the dual hub introducer sheath of the present disclosure is designed to facilitate the traversal of catheter-based medical devices (such as the first medical device and the second medical device) within the lumen of an introducer sheath. In some aspects of the technology, the first medical device is a mechanical circulatory support device, and the second medical device is a coronary reperfusion therapy device for providing the patient with percutaneous coronary intervention (PCI). These PCI procedures may involve the use of a coronary stent delivered into the distal left anterior descending artery (LAD). Examples of such coronary stents include, but are not limited to, the Promus PREMIER™ and the REBEL™ bare-metal Platinum Chromium Coronary Stents, and the SYNERGY™ Bioabsorbable Polymer Stent, all by Boston Scientific, Marlborough, Mass. In some aspects of the technology, the mechanical circulatory support device may comprise a rotary blood pump having a cannula, a rotor, and rotor housing. Examples of such blood pumps include, but are not limited to, an Impella® pump, an Extracorporeal Membrane Oxygenation (ECMO) pump, and a balloon pump. The Impella® pump may further comprise an Impella 2.5® pump, an Impella 5.0® pump, an Impella CP® pump, or an Impella LD® pump, all of which are by Abiomed, Inc. of Danvers, Mass. 
     In some aspects of the technology, the first medical device and the second medical device may be used with the dual hub introducer sheath as described in the foregoing in procedures where PCI and percutaneous ventricular assist devices are used in unison, such as, for example, the method of left ventricular unloading in treating myocardial infarction as described in U.S. patent application Ser. No. 16/244,998, the entire contents of which are hereby incorporated by reference herein. 
       FIG. 6  illustrates an exemplary method  600  of using a dual hub introducer sheath, such as any of the introducer sheaths as described in the foregoing description, according to aspects of the technology. The method  600  will be described in relation to the exemplary systems depicted in  FIGS. 1-5  above. Prior to using the dual hub introducer sheath, the sheath  210  is positioned into the arteriotomy of the patient (not indicated in  FIG. 6 ). Prior to insertion of the sheath  210  into the patient, a connector port of the hub, such as connector port  270  of the hub  220  as described above, is coupled to a proximal end of an introducer sheath, such as end  212  of sheath  210  as described above. In some aspects of the technology, a dilator may be inserted into the lumen of the sheath before insertion into the patient, such as dilator  280  shown in  FIGS. 2 and 3 . The dilator assists with positioning the sheath in regions of the patient&#39;s body which are difficult to penetrate with the sheath alone. Once inserted, the dilator is removed from the lumen of the sheath. 
     In step  610 , the first medical device  140  is inserted into a first arm  230  of the dual hub  220 . Here, the first medical device  140  is pushed through the first hemostasis valve  238  and traverses the hub  220  towards the connector port  270 . As with the first medical device  140 , in step  620 , the second medical device  160  is pushed through the second hemostasis valve  258  in the second arm  250 , after which it also traverses hub  220  toward connector port  270 . In step  630 , the first and second medical devices are provided to the lumen of the sheath  210  via the connector port  270  of the hub  220 . In step  640 , the first and second medical devices are delivered into an arteriotomy of the patient by pushing the devices along the length of sheath  210  until they exit the distal end  214  of the sheath  210 . 
     Once in position in the patient&#39;s arteriotomy, the medical devices can be used as desired to treat the patient. In some aspects of the technology, the dual hub introducer sheath may be used to unload the left ventricle of the patient, as shown in the exemplary method  700  of  FIG. 7 . In such cases, the first medical device  140  may be a mechanical circulatory support device, and the second medical device  160  may be a coronary reperfusion therapy device for providing the patient with percutaneous coronary intervention (PCI). With respect to  FIG. 7 , in step  710 , after the first medical device  140  has emerged from the distal end  214  of the sheath  210 , it is advanced into position in the left ventricle of the heart. The first medical device  140  may then be locked in position via a locking mechanism located on the first arm  230  of the hub  220 . As already discussed, such locking mechanisms may include any one of: a Tuohy-Borst adaptor, an inflatable balloon, and a locking lever arm. In step  720 , the mechanical circulatory device is operated within the left ventricle for a support period in excess of 30 minutes. In some aspects of the technology, the mechanical circulatory device may be operated at 2.5 L/min of blood flow. In step  730 , the second medical device  160  is positioned into a coronary vessel of the patient. The second medical device  160  may then also be locked in position via a locking mechanism located on the second arm  250  of the hub  220  as previously discussed. In step  740 , after the support period has passed, reperfusion therapy is applied to the coronary vessel via a PCI device, as described above. The reperfusion therapy may be performed in parallel with operation of the mechanical circulatory device, or after operation of the mechanical circulatory device. 
     In some aspects of the technology, the various steps discussed above with respect to methods  600  and  700  of  FIGS. 6 and 7  may be performed in a different order and/or concurrently with each other. Furthermore, if desired, one or more of the above described steps may be optional or may be combined. 
     The foregoing description is merely intended to be illustrative of the principles of the technology. As such, the devices and methods described herein can be practiced by other than the described implementations, which are presented for purposes of illustration and not of limitation. It is to be understood that the systems, devices and methods disclosed herein, while described with respect to certain procedures, may be applied in any context where access to an arteriotomy of a patient is desired without creating multiple access sites in the vasculature of the patient. In addition, the disclosed features may be implemented in any combination or subcombination (including multiple dependent combinations and subcombinations) with one or more other features described herein. The various features described or illustrated above, including any components thereof, may also be combined or integrated into other systems. Finally, certain features may be omitted or not implemented without departing from the spirit of the technology.