Dual Hub Introducer Sheath

Abstract

An introducer system for percutaneously delivering first and second medical devices to a patient is provided. The system may include an introducer sheath having a longitudinal axis and a lumen formed therein. The system may also include a hub coupled to a proximal end of the sheath. The hub may include a first arm having a first lumen for passage of the first medical device and a first hemostatic valve. The hub may also include a second arm coupled to the first arm and having a second lumen for passage of the second medical device and a second hemostatic valve. Furthermore, the hub may include connection ports such that the first and second lumens communicate with lumens of the introducer sheath for passage of at least one of the first and second medical devices through the introducer sheath for delivery to the patient. TIFF2022525109000002.tif158128

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 817,901, filed March 13, 2019, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] background Currently, percutaneous mechanical support devices are utilized for a variety of clinical indications. Such support devices may include, but are not limited to, Impella® pumps, extracorporeal membrane oxygenation (ECMO) pumps, and balloon pumps. Impella® pumps may also include the Impella 2.5® pump, Impella 5.0® pump, Impella CP® pump, and Impella LD® pump, all from Abiomed, Inc., Danvers, MA. In most cases, they are inserted percutaneously into a patient through a single access point (e.g., radial, femoral, or axillary access), although other procedures, such as percutaneous coronary intervention (PCI), are performed through a second access point, such as a contralateral femoral or radial access point. Therefore, using multiple devices on a patient simultaneously often requires multiple access sites, which presents multiple challenges. Summary of the Invention

[0003] overview The present technology relates to systems and methods for percutaneously delivering a first medical device and a second medical device to a patient.

[0004] In one aspect, the present 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 hemostatic valve configured to allow passage of a first medical device; a second arm coupled to the first arm and having a second lumen and a second hemostatic valve configured to allow passage of a second medical device; and a connection port coupled to the introducer sheath and coupled to the first arm and the second arm such that the first lumen and the second lumen communicate with a lumen of the introducer sheath to allow passage of at least one of the first and second medical devices through the introducer sheath for delivery to a patient. In some aspects, the first arm is disposed parallel to the longitudinal axis of the introducer sheath. In some aspects, the second arm is configured to branch off from the first arm at an angle of 90° or less. In some aspects, the first arm and the second arm are arranged in a Y-shaped configuration relative 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 have a proximal end and a distal end, and the distal end of the first arm is positioned distal to 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 includes a single lumen for 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 includes a dual lumen sheath such that the first lumen communicates with one lumen of the dual lumen sheath and the second lumen communicates 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.Additionally, the hub may further include a tab to enable separation of the hub and the peel-away sheath. In some aspects, the first and second hemostatic valves are configured to seal the first and second lumens, respectively. In some aspects, the first and second hemostatic valves are configured to be penetrable by the first or second medical device, respectively. In some aspects, the hub further includes at least one suture ring. In some aspects, the first arm and the second arm each include at least one side port. Additionally, the side port may include an irrigation port configured to receive irrigation fluid. In some aspects, at least one of the first arm and the second arm includes a locking mechanism configured to prevent axial movement of one or both of the first and second medical devices within the introducer sheath after delivery to the patient. In some aspects, the locking mechanism includes at least one of a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. In some aspects, the locking mechanism is biased to a state configured to prevent axial movement of one or both of the first and second medical devices within the introducer sheath. In some aspects, the introducer sheath comprises at least one of polyether block amide; polyethylene material; polytetrafluoroethylene (PTFE) material; high-density polyethylene (HDPE) material; medium-density polyethylene (MDPE) material; or 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); high-density polyethylene (HDPE) material; medium-density polyethylene (MDPE) material; low-density polyethylene (LDPE) material; polyether ether ketone (PEEK); polyether block amide; elastomer; synthetic rubber; or a polyethylene material, polyurethane material, or polycarbonate material having a modulus of elasticity 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 percutaneous coronary intervention (PCI) to a patient. In some aspects, the coronary reperfusion therapy device is a stent. In some aspects, the stent is configured to be inserted by a catheter through the second arm and the introducer sheath. In some aspects, the mechanical circulatory support device includes 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, a rotor, and a rotor housing. In some aspects, the first arm and the introducer sheath are configured to allow passage of a cannula of the rotary blood pump. In some aspects, the first arm and the introducer sheath are configured to allow passage of a rotor and a rotor housing of the rotary blood pump. In some aspects, the hub includes up to five second arms, each configured with a hemostatic valve and a lumen in communication with the introducer sheath to allow passage of a second medical device from the respective second arm into the introducer sheath. In some aspects, the second arms are arranged in a radially symmetrical manner about the first arm. In some aspects, the hub includes two second arms. In some aspects, the introducer system may further include at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostatic valve configured to allow passage of a third medical device.

[0005] In another aspect, the present disclosure describes a method that includes inserting a first medical device into a first arm of an introducer hub, the first arm having a first lumen for passage of the first medical device; inserting a second medical device into a second arm attached to the first arm, the second arm having a second lumen for passage of the second medical device; providing the first and second medical devices into an introducer sheath via a connector port of the introducer hub, the connector port coupled to a proximal end of the introducer sheath; and delivering the first and second medical devices from a distal end of the introducer sheath to a patient. In some aspects, the method further includes inserting the first and second medical devices into lumens formed in the introducer sheath for delivery to the patient. In some aspects, the method further includes inserting a first medical device into a first lumen formed in the introducer sheath for delivery to the patient and inserting a second medical device into a second lumen formed in the introducer sheath for delivery to the patient, the first lumen being isolated from the second lumen. In some aspects, the method further includes attaching the introducer hub to the patient via a sewing ring. In some aspects, the method further includes providing irrigation fluid to one or both of the first lumen and the second lumen through side ports positioned on each of the first and second arms. In some aspects, the method further includes 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 includes at least one of a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. In some aspects, the locking mechanism is biased to a state that prevents one or both of the first and second medical devices from moving axially within the introducer sheath.In some aspects, the method further includes inserting a third medical device into a third arm attached to the first arm, the third arm having a third lumen through which the third medical device passes, for delivery to the patient. In some aspects, the method further includes assisting the heart of a patient with a persistent myocardial infarction. In some aspects, the method further includes inserting a first medical device through the first arm and through an introducer sheath into the patient's left ventricle; operating the first medical device at a blood flow rate of at least 2.5 L / min for an assist time of more than 30 minutes; inserting a second medical device through the second arm and through the introducer sheath into the patient's coronary vessels; and operating the second medical device after the assist time has elapsed. In some aspects, the first device includes a mechanical circulatory assist device. In some aspects, the mechanical circulatory assist device includes at least one of a blood pump, a transvalve axial flow (TV) pump, an intra-aortic balloon pump, or an extracorporeal membrane oxygenation (ECMO) pump. In some aspects, the second device includes a coronary reperfusion therapy device for providing percutaneous coronary intervention (PCI) to the patient. In some aspects, the mechanical circulatory assist device is activated to pump blood from the patient's left ventricle into the patient's aorta during an assist period. In some aspects, the second medical device is inserted through the second arm after the first medical device has been positioned across the patient's aortic valve and unloaded the patient'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's left ventricle. In some aspects, the first medical device is positioned with its distal tip located within the patient's left ventricle and pumps blood from the patient's left ventricle into the patient's aorta. In some aspects, the introducer hub has up to five second arms, each configured with a hemostatic valve and a lumen communicating with the introducer sheath to allow passage of a second medical device from the respective second arm into the introducer sheath.In some aspects, the second arms are arranged in a radially symmetric manner around 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 hemostatic valve configured to allow passage of a third medical device.

[0006] In another aspect, the present disclosure describes an introducer hub comprising: a first arm having a first lumen and a first hemostatic valve, the first lumen and the first hemostatic valve configured to allow passage of a first medical device; a second arm connected to the first arm and having a second lumen and a second hemostatic valve, the second arm having a second lumen and a second hemostatic valve configured to allow passage of a second medical device; and a connection port connected to the introducer sheath and connected to the first arm and the second arm such that the first lumen and the second lumen communicate with a lumen of the introducer sheath to allow 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 disposed parallel to the longitudinal axis of the introducer sheath. In some aspects, the second arm is configured to branch off from the first arm at an angle of 90° or less. In some aspects, the first arm and the second arm are disposed in a Y-shaped configuration relative 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 have a proximal end and a distal end, and the distal end of the first arm is positioned distal to the proximal end of the second arm. In some aspects, the second lumen is coupled to the first lumen. In some aspects, the introducer sheath includes a single lumen for 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 includes a dual lumen sheath such that the first lumen communicates with one lumen of the dual lumen sheath and the second lumen communicates 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 a tab to allow separation of the introducer hub and the peel-away sheath.In some aspects, the first and second hemostatic valves are configured to seal the first and second lumens, respectively. In some aspects, the first and second hemostatic valves are configured to be penetrable by the first or second medical device, respectively. 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 includes an irrigation port configured to receive 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 and second medical devices within the introducer sheath after delivery to the patient. In some aspects, the locking mechanism includes at least one of a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. In some aspects, the locking mechanism is biased to a state configured to prevent axial movement of one or both of the first and second medical devices within the introducer sheath. In some aspects, the introducer hub includes up to five second arms, each configured with a hemostatic valve and a lumen in communication with the introducer sheath to allow passage of a second medical device from the respective second arm into the introducer sheath. In some aspects, the second arms are arranged in a radially symmetrical manner about the first arm. In some aspects, the introducer hub includes two second arms. In some aspects, the introducer hub further includes at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostatic valve configured to allow 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); high density polyethylene (HDPE) material; medium density polyethylene (MDPE) material; low density polyethylene (LDPE) material; polyether ether ketone (PEEK); polyether block amide; elastomer; synthetic rubber; or a polyethylene material, polyurethane material, or polycarbonate material having a modulus of elasticity of about 40 ksi. [The present invention 1001] an introducer sheath having a longitudinal axis and a lumen formed therein; and a hub coupled to a proximal end of the introducer sheath, a first arm having a first lumen and a first hemostatic valve, the first lumen and the first hemostatic valve configured to allow a first medical device to pass therethrough; a second arm coupled to the first arm and having a second lumen and a second hemostatic valve, the second lumen and the second hemostatic valve configured to allow a second medical device to pass therethrough; a connection port coupled to the introducer sheath and coupled to the first arm and the second arm such that the first lumen and the second lumen communicate with a lumen of the introducer sheath to allow passage of at least one of the first medical device and the second medical device through the introducer sheath for delivery to a patient; The hub comprises: An introducer system comprising: [The present invention 1002] The introducer system of the present invention 1001, wherein the first arm is positioned parallel to the longitudinal axis of the introducer sheath. [The present invention 1003] Any of the aforementioned introducer systems of the present invention, wherein the second arm is configured to branch off from the first arm at an angle of less than 90 degrees. [The present invention 1004] The introducer system of either invention 1001 or 1003, wherein the first arm and second arm are arranged in a Y-configuration relative to the introducer sheath. [The present invention 1005] Any of the aforementioned introducer systems of the present invention, wherein the second arm is located proximal to the connection port. [The present invention 1006] Any of the introducer systems of the present invention, wherein the first arm and the second arm each have a proximal end and a distal end, and the distal end of the first arm is positioned distal to the proximal end of the second arm. [The present invention 1007] Any of the aforementioned introducer systems of the present invention, wherein the second lumen joins the first lumen within the hub. [The present invention 1008] The introducer system of the present invention 1007, wherein the introducer sheath comprises a single lumen for passage of the first and second medical devices. [The present invention 1009] Any of the aforementioned introducer systems of the present invention, wherein the first and second lumens are maintained as separate lumens within the hub. [The present invention 1010] The introducer system of the present invention, wherein the introducer sheath comprises a dual lumen sheath such that the first lumen communicates with one lumen of the dual lumen sheath and the second lumen communicates with the other lumen of the dual lumen sheath. [The present invention 1011] Any of the aforementioned introducer systems of the present invention, wherein the introducer sheath is an expandable sheath. [The present invention 1012] Any of the introducer systems of the present invention, wherein the introducer sheath is a peel-away sheath. [The present invention 1013] The introducer system of the present invention 1012, wherein the hub further comprises a tab for enabling separation of the hub and the peel-away sheath. [The present invention 1014] Any of the aforementioned introducer systems of the present invention, wherein the first and second hemostatic valves are configured to seal the first and second lumens, respectively. [The present invention 1015] The introducer system of the present invention 1014, wherein the first and second hemostatic valves are configured to be penetrable by a first or second medical device, respectively. [The present invention 1016] Any of the aforementioned introducer systems of the present invention, wherein the hub further comprises at least one sewing ring. [The present invention 1017] Any of the aforementioned introducer systems of the present invention, wherein the first arm and the second arm each include at least one side port. [The present invention 1018] The introducer system of the present invention 1017, wherein the side port includes an irrigation port configured to receive irrigation fluid. [The present invention 1019] Any of the above introducer systems of the present invention, wherein at least one of the first arm and the second arm comprises a locking mechanism configured to prevent one or both of the first medical device and the second medical device from moving axially within the introducer sheath after delivery to the patient. [The present invention 1020] The introducer system of the present invention 1019, wherein the locking mechanism includes at least one of a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. [The present invention 1021] An introducer system of any of the present inventions 1019 to 1020, wherein the locking mechanism is biased to a state configured to prevent one or both of the first medical device and the second medical device from moving axially within the introducer sheath. [The present invention 1022] Any of the above introducer systems of the present invention, wherein 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. [The present invention 1023] Any of the above introducer systems of the present invention, wherein the hub comprises at least one of ethylene vinyl acetate (EVA); styrene-butadiene copolymer (SBC); styrene ethylene butylene styrene (SEBS); high density polyethylene (HDPE) material; medium density polyethylene (MDPE) material; low density polyethylene (LDPE) material; polyether ether ketone (PEEK); polyether block amide; elastomer; synthetic rubber; or a polyethylene material, polyurethane material, or polycarbonate material having a modulus of elasticity of about 40 ksi. [The present invention 1024] Any of the above introducer systems of the present invention, wherein the first medical device is a mechanical circulatory support device and the second medical device is a coronary reperfusion therapy device for providing percutaneous coronary intervention (PCI) to a patient. [The present invention 1025] The introducer system of the present invention 1024, wherein the coronary reperfusion therapy device is a stent. [The present invention 1026] The introducer system of the present invention 1025, wherein the stent is configured to be inserted by a catheter through the second arm and the introducer sheath. [The present invention 1027] The introducer system of any of claims 1024 to 1026, wherein the mechanical circulatory assist 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. [The present invention 1028] An introducer system according to any one of claims 1024 to 1026, wherein the mechanical circulatory assist device is a rotary blood pump having a cannula, a rotor, and a rotor housing. [The present invention 1029] The introducer system of the present invention 1028, wherein the first arm and the introducer sheath are configured to allow passage of a cannula of a rotary blood pump. [The present invention 1030] An introducer system according to the present invention 1029, wherein the first arm and the introducer sheath are configured to allow passage through a rotor and rotor housing of a rotary blood pump. [The present invention 1031] Any of the above-mentioned introducer systems of the present invention, wherein the hub has up to five second arms, each second arm being configured with a hemostatic valve and a lumen communicating with the introducer sheath to allow a second medical device to pass from the respective second arm into the introducer sheath. [The present invention 1032] The introducer system of the present invention 1031, wherein the second arm is arranged in a radially symmetrical manner around the first arm. [The present invention 1033] The introducer system of any one of inventions 1031 to 1032, wherein the hub has two second arms. [The present invention 1034] at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostatic valve configured to allow passage of a third medical device therethrough; Any of the introducer systems of the present invention further comprising: [This invention 1035] inserting a first medical device into a first arm of an introducer hub, the first arm having a first lumen for passage of the first medical device; inserting a second medical device into a second arm attached to the first arm, the second arm having a second lumen for passage of the second medical device; providing the first medical device and the second medical device to the introducer sheath via a connector port of an introducer hub coupled to a proximal end of the introducer sheath; and delivering the first medical device and the second medical device from the distal end of the introducer sheath into the patient. A method comprising: [The present invention 1036] Inserting first and second medical devices into lumens formed in the introducer sheath for delivery to the patient. The method of the present invention 1035, comprising: [This invention 1037] inserting a first medical device into a first lumen formed in an introducer sheath for delivery to a patient, and inserting a second medical device into a second lumen formed in the introducer sheath for delivery to the patient, the first lumen being isolated from the second lumen; The method of the present invention 1035, comprising: [The present invention 1038] Any of the methods of claims 1035 to 1037, comprising attaching an introducer hub to a patient via a sewing ring. [This invention 1039] Any of the methods of 1035-1038, including providing irrigation fluid to one or both of the first lumen and the second lumen via side ports positioned on each of the first and second arms. [The present invention 1040] The method of any of claims 1035-1039, comprising 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. [This invention 1041] The method of claim 1040, wherein the locking mechanism includes at least one of a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. [The present invention 1042] The method of claim 1041, wherein the locking mechanism is biased to a state that prevents one or both of the first medical device and the second medical device from moving axially within the introducer sheath. [This invention 1043] inserting a third medical device into a third arm attached to the first arm, the third arm having a third lumen for passage of the third medical device therethrough, for delivery to the patient. Any of the methods of claims 1035 to 1042 of the present invention, comprising: [This invention 1044] 1044. The method of any one of claims 1035 to 1043, comprising providing cardiac assistance to a patient with persistent myocardial infarction. [This invention 1045] inserting a first medical device through the first arm and through the introducer sheath into the left ventricle of the patient; operating the first medical device at a blood flow rate of at least 2.5 L / min for a support period of more than 30 minutes; inserting a second medical device through the second arm and through the introducer sheath into the patient's coronary vessel; and activating the second medical device after the auxiliary time has elapsed. The method of the present invention 1044, comprising: [The present invention 1046] The method of any one of claims 1035 to 1045, wherein the first device comprises a mechanical circulatory assist device. [This invention 1047] 1046. The method of claim 1046, wherein the mechanical circulatory assist 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. [This invention 1048] The method of any of claims 1035 to 1047, wherein the second device comprises a coronary reperfusion therapy device for providing percutaneous coronary intervention (PCI) to the patient. [This invention 1049] The method of any of claims 1046-1048, wherein the mechanical circulatory assist device is activated to pump blood from the patient's left ventricle into the patient's aorta during the assist period. [The present invention 1050] Any of the methods of claims 1044-1049, wherein after the first medical device is positioned across the patient's aortic valve and unloads the patient's left ventricle, a second medical device is inserted through the second arm. [This invention 1051] The method of any of claims 1045-1050, wherein the second medical device is inserted through the introducer sheath at least 15 minutes after the first medical device begins unloading the patient's left ventricle. [This invention 1052] The method of any of claims 1044-1051, wherein a first medical device is positioned with a distal tip located within the patient's left ventricle and pumps blood from the patient's left ventricle into the patient's aorta. [This invention 1053] Any of the methods of inventions 1035 to 1052, wherein the introducer hub has up to five second arms, each second arm configured with a hemostatic valve and a lumen communicating with the introducer sheath to allow a second medical device to pass from the respective second arm into the introducer sheath. [This invention 1054] The method of claim 1053, wherein the second arm is disposed in a radially symmetric manner about the first arm. [This invention 1055] The method of any one of claims 1053 to 1054, wherein the introducer hub has two second arms. [This invention 1056] Any of the methods of inventions 1035 to 1054, wherein the introducer hub further comprises at least one third arm connected to the first arm, each third arm having a third lumen configured to allow a third medical device to pass therethrough and a third hemostatic valve. [This invention 1057] a first arm having a first lumen and a first hemostatic valve, the first lumen and the first hemostatic valve configured to allow a first medical device to pass therethrough; a second arm coupled to the first arm and having a second lumen and a second hemostatic valve, the second lumen and the second hemostatic valve configured to allow a second medical device to pass therethrough; a connection port coupled to the introducer sheath and coupled to the first arm and the second arm such that the first lumen and the second lumen communicate with lumens of the introducer sheath to allow passage of at least one of the first medical device and the second medical device through the introducer sheath for delivery to a patient; An introducer hub comprising: [This invention 1058] The introducer hub of the present invention 1057, wherein the first arm is disposed parallel to the longitudinal axis of the introducer sheath. [This invention 1059] An introducer hub according to any one of claims 1057 to 1058, wherein the second arm is configured to branch off from the first arm at an angle of 90° or less. [The present invention 1060] The introducer hub of either invention 1057 or 1059, wherein the first arm and second arm are arranged in a Y-configuration relative to the introducer sheath. [This invention 1061] An introducer hub according to any one of 1057 to 1060 of the present inventions, wherein the second arm is located proximal to the connection port. [This invention 1062] An introducer hub of any of the present inventions 1057 to 1061, wherein the first arm and the second arm each have a proximal end and a distal end, and the distal end of the first arm is positioned distal to the proximal end of the second arm. [This invention 1063] An introducer hub according to any one of 1057 to 1062, wherein the second lumen is connected to the first lumen. [This invention 1064] The introducer hub of any one of claims 1057 to 1063, wherein the introducer sheath has a single lumen for passing the first and second medical devices. [This invention 1065] An introducer hub according to any one of 1057 to 1064, wherein the first lumen and the second lumen are maintained as separate lumens. [The present invention 1066] An introducer hub according to any one of claims 1057 to 1065, wherein the introducer sheath includes a dual lumen sheath such that the first lumen communicates with one of the lumens of the dual lumen sheath and the second lumen communicates with the other lumen of the dual lumen sheath. [This invention 1067] An introducer hub according to any one of claims 1057 to 1066, wherein the introducer sheath is an expandable sheath. [The present invention 1068] An introducer hub according to any one of the present inventions 1057 to 1067, wherein the introducer sheath is a peel-away sheath. [The present invention 1069] The introducer hub of the present invention 1068 further comprising a tab for allowing separation of the introducer hub and the peel away sheath. [The present invention 1070] The introducer hub of any of claims 1057 to 1069, wherein first and second hemostatic valves are configured to seal the first and second lumens, respectively. [This invention 1071] The introducer hub of the present invention 1070, wherein the first and second hemostatic valves are configured to be penetrable by a first or second medical device, respectively. [This invention 1072] The introducer hub of any one of claims 1057 to 1071, further comprising at least one sewing ring. [This invention 1073] The introducer hub of any one of claims 1057 to 1072, wherein the first arm and the second arm each have at least one side port. [This invention 1074] The introducer hub of the present invention 1073, wherein the side port includes an irrigation port configured to receive irrigation fluid. [This invention 1075] An introducer hub of any of inventions 1057 to 1074, wherein at least one of the first arm and the second arm has a locking mechanism configured to prevent one or both of the first medical device and the second medical device from moving axially within the introducer sheath after delivery to the patient. [This invention 1076] The introducer hub of the present invention 1075, wherein the locking mechanism includes at least one of a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. [This invention 1077] The introducer hub of any of the present inventions 1075 to 1076, wherein the locking mechanism is biased to a state configured to prevent one or both of the first medical device and the second medical device from moving axially within the introducer sheath. [This invention 1078] An introducer hub of any of the present inventions 1057 to 1077, wherein the introducer hub has up to five second arms, each second arm being configured with a hemostatic valve and a lumen connected to the introducer sheath so that a second medical device can pass from the respective second arm into the introducer sheath. [This invention 1079] The introducer hub of the present invention 1078, wherein the second arms are arranged in a radially symmetrical manner around the first arm. [The present invention 1080] An introducer hub according to any one of 1078 to 1079 of the present inventions, which has two second arms. [This invention 1081] at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostatic valve configured to allow passage of a third medical device therethrough; The introducer hub of any one of the present inventions 1057 to 1080, further comprising: [This invention 1082] The introducer hub of any of inventions 1057 to 1081 comprises at least one of ethylene vinyl acetate (EVA); styrene-butadiene copolymer (SBC); styrene ethylene butylene styrene (SEBS); high density polyethylene (HDPE) material; medium density polyethylene (MDPE) material; low density polyethylene (LDPE) material; polyether ether ketone (PEEK); polyether block amide; elastomer; synthetic rubber; or a polyethylene material, polyurethane material, or polycarbonate material having an elastic modulus of about 40 ksi. [Brief explanation of the drawings]

[0007] These and other objects and advantages will become apparent from the following detailed description considered in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout.

[0008] [Figure 1] 1 is an exemplary cross-sectional view of a dual hub introducer sheath system used to deliver a first medical device and a second medical device into an arteriotomy of a patient according to aspects of the present disclosure. [Figure 2] 1 illustrates a dual hub introducer sheath system with a dilator for insertion into an arteriotomy of a patient according to aspects of the present disclosure. [Figure 3] 3 shows a detailed view of the dual hub introducer sheath system of FIG. 2. [Figure 4] 3 shows a detailed view of the dual hub introducer sheath system of FIG. 2 with an obturator sealing the lumen in the side arm. [Figure 5] Figure 5A shows an exemplary locking mechanism used in a dual hub introducer sheath system according to aspects of the present disclosure in an open state, and Figure 5B shows the locking mechanism of Figure 5A in a locked state. [Figure 6] 1 illustrates an exemplary flow chart of a method of using a dual hub introducer sheath system according to aspects of the present disclosure. [Figure 7] 1 shows an exemplary flowchart of a method of using a dual-hub introducer sheath system to unload the left ventricle according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0009] Detailed Description Certain exemplary embodiments will be described so that the systems, devices, and methods described herein can be fully understood. While the embodiments and features described herein are particularly described for use in connection with a dual-hub introducer sheath for use in intravascular procedures involving catheter-based ventricular assist devices, it will be understood that all 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.

[0010] As mentioned above, while multiple access sites allow for the use of multiple devices simultaneously on a patient, this can be challenging for a variety of reasons. First, for devices for PCI procedures, where two 6-7 Fr sheaths are used to facilitate procedures such as balloon and stent procedures, patients may not have two anatomically available access sites. In addition, peripheral arterial disease, small vessel lumen size, scar tissue from previous procedures, and other conditions can make it difficult to gain percutaneous access suitable for larger devices, such as mechanically assisted devices. Using multiple access sites also increases the likelihood of encountering vascular access complications, which can correlate with increased mortality and hospital costs. Furthermore, multiple access sites require more than one access attempt, resulting in longer procedure times and potentially increased procedure costs due to the need for multiple vascular closure devices, additional introducers, etc. Therefore, there is a significant need to reduce the complexity of procedures that require the activation of multiple devices on a patient.

[0011] The systems, devices, and methods described herein relate to a dual-hub introducer sheath that allows for a single access site for multiple devices. For purposes of illustration herein, and not by way of limitation, the devices are described as mechanically-assisted devices (such as Impella devices) and devices for PCI procedures. However, those skilled in the art will understand that the present disclosure is not limited to any particular type of percutaneously inserted device. In fact, the present disclosure contemplates that in some aspects of the technology, the multiple devices may be two of the same device. Until recently, such single access for multiple devices was not clearly possible; this was because physicians were unaware of the possibility of being able to fit both PCI and Impella devices through a single sheath without increasing the overall diameter of the sheath.

[0012] Successful insertion of a PCI device through the same access sheath as an Impella device to perform both PCI and Impella support at a single access site has recently been reported (ML 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 current solutions leads to challenges with hemostasis from the introducer valve and pump migration in and out of the ventricle as the PCI device is exchanged and manipulated. These adverse effects occur because conventional introducer valves are not designed for dual-device access.

[0013] 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 includes a hub coupled to a proximal end of the introducer sheath. The hub includes a first arm having a first lumen configured to pass a first medical device and a first hemostatic valve. The hub also includes a second arm coupled to the first arm and having a second lumen configured to pass a second medical device and a second hemostatic valve. The hub further includes connection ports coupled to the introducer sheath and the first and second arms such that the first and second lumens communicate with the introducer sheath lumens to enable passage of at least one of the first and second medical devices through the introducer sheath for delivery to a patient.

[0014] The dual-hub introducer sheath of the present disclosure allows for the insertion of both PCI and Impella devices therethrough while maintaining adequate and acceptable hemostasis. By utilizing a bifurcated hub, two separate valves can be implemented that are specifically designed to meet the insertion force and leakage requirements for either Impella or PCI devices, keeping in mind that these requirements and designs are quite different; Additionally, the dual-hub introducer sheath of the present disclosure has a locking mechanism that is limited to only the arm of the hub intended for the Impella device; the locking mechanism can be activated by the physician to hold the Impella in place and prevent its advancement or retraction while the PCI procedure is being performed.

[0015] FIG. 1 illustrates a dual-hub introducer sheath delivery system 100 for percutaneously delivering a first medical device and a second medical device to a patient. The system 100 includes an introducer sheath 110 extending along a longitudinal axis (not shown) between a proximal end 112 and a distal end (not shown). The sheath 110 further includes a lumen 115 extending between the proximal end 112 and the distal end to allow passage of the first medical device and the second medical device. While FIG. 1 depicts the sheath 110 having a single lumen 115, in some aspects of the present technology, the sheath 110 may include two separate lumens, for example, throughout the length of the sheath. In other aspects of the present technology, the sheath 110 may include any number of separate lumens. The system 100 further includes a hub 120 coupled to the proximal end 112 of the sheath 110.

[0016] Hub 120 comprises a first arm 130 having a proximal end 132 and a distal end 134 and defining a first lumen 135. A first valve 138 is provided at the proximal end 132 of first arm 130 to seal first lumen 135 from the surrounding environment. First valve 138 is penetrable by a first medical device 140. Hub 120 further comprises a second arm 150 attached to first arm 130. Like first arm 130, second arm 150 defines a second lumen 155 and has a proximal end 152 and a distal end 154. A second valve 158 is provided at the proximal end 152 of second arm 150 to seal second lumen 155 from the surrounding environment. Second valve 158 is penetrable by a second medical device 160. In some aspects of the present technology, first valve 138 and second valve 158 may comprise hemostasis valves (also referred to as "hemostatic" valves), such as those described in U.S. Pat. No. 10,576,258, entitled "Hemostatic Valve for Medical Device Introducer," the entire contents of which are incorporated herein by reference. Although FIG. 1 shows hub 120 with one second arm 150, it will be understood that hub 120 may include any number of second arms disposed relative to first arm 130.

[0017] Hub 120 further comprises a connection port 170 that connects to first lumen 135 and second lumen 155. Connection port 170 of hub 120 is coupled to proximal end 112 of sheath 110 such that first medical device 140 and second medical device 160 can be passed through sheath 110 and delivered to the patient when sheath 110 is inserted into the patient. In some aspects of the present technology, such coupling may be, for example, a friction fit, where proximal end 112 of sheath 110 is dimensioned such that the friction fit between the outer surface of sheath 110 and the inner surface of connection port 170 prevents proximal end 112 of sheath 110 from becoming dislodged from hub 120. In other aspects of the present technology, coupling may be provided by, for example, male threads on the outer surface of proximal end 112 of sheath 110 that interact with complementary threads on the inner surface of connection port 170. In further aspects of the present technology, sheath 110 may be coupled to connection port 170 in any manner that allows first lumen 135 and second lumen 155 to fluidly connect to lumen 115 of sheath 110 via connection port 170 of hub 120. In some aspects of the present technology, hub 120 may be overmolded and press-fit or compressed onto proximal end 112 of sheath 110.

[0018] In some aspects of the present technology, hub 120 may be fabricated such that first lumen 135 and second lumen 155 are joined within hub 120 before transitioning into connection port 170, as shown in FIG. 1. In such a case, hub 120 may be coupled to a single lumen sheath, such as sheath 110 in FIG. 1, where lumen 115 of sheath 110 is in fluid communication with first lumen 135 and second lumen 155 via connection port 170 of hub 120. Thus, when first medical device 140 is inserted into first arm 130 and second medical device 160 is inserted into second arm 150 of hub 120, the medical devices share the same lumen 115 of sheath 110 as they pass through sheath 110 for delivery to a patient. In other aspects of the present technology, hub 120 may be fabricated such that first lumen 135 and second lumen 155 are maintained as separate lumens throughout hub 120. In such a case, the hub 120 may be coupled to the dual lumen sheath so that the first medical device 140 and the second medical device 160 remain separated throughout their passage through the length of the sheath 110 for delivery into the patient's arteriotomy.

[0019] As shown in FIG. 1 , the second arm 150 may be positioned to branch off from 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 present technology, this angle is 90° or less. In such cases, the first medical device 140, when inserted into the first arm 130, is maintained in a substantially straight shape within the hub 120 without bending or kinking; and the positioning of the second arm 150 relative to the first arm 130 causes the second device 160, when inserted into the second arm 150, to bend into alignment with the first device 140 before exiting the hub 120 via the connector port 170 and passing through the lumen 115 of the sheath 110.

[0020] In some aspects of the present technology, first arm 130 and second arm 150 may be arranged to form a Y-shaped configuration with respect to the longitudinal axis of introducer sheath 110. In such a case, both first medical device 140 and second medical device 160 may be bent within hub 120 so as to be aligned with the longitudinal axis of sheath 110 as they exit connector port 170 and pass through lumen 115 of sheath 110.

[0021] 2 illustrates a configuration of a dual hub introducer sheath system 200 in accordance with aspects of the present technology. Sheath system 200 is similar to sheath system 100 in that sheath system 200 includes 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 to allow passage of at least one medical device for delivery to an arteriotomy in a patient, such as first medical device 140 and second medical device 160 of FIG. 1 . The proximal end 212 of sheath 210 is coupled to a connector port 270 of a hub 220. Hub 220 includes a first arm 230 having a proximal end 232 and a distal end 234, and a second arm 250 attached to first arm 230 and having a proximal end 252 and a distal end 254. First arm 230 defines a first lumen 235 that is sealed from the surrounding environment by a first valve 238. Similarly, second arm 250 defines a second lumen 255 that is sealed from the surrounding environment by a second valve 258. As described in connection with FIG. 1 , first valve 238 and second valve 258 may comprise hemostatic valves and may be penetrable by first and second medical devices. In some aspects of the present technology, second lumen 255 fluidly connects to first lumen 235 within hub 220, as shown in FIG. 2 . In other aspects of the present technology, first lumen 235 and second lumen 255 may be maintained as separate lumens within hub 220. In some aspects of the present technology, first valve 238 and second valve 258 may be inserted into position with snap caps to securely secure their positions within hub 220.

[0022] As shown in FIG. 2 (and enlarged view 300 in FIGS. 3 and 4), first arm 230 further includes a first side port 236 in fluid communication with first lumen 235. Similarly, second arm 250 includes a second side port 256 in fluid communication with second lumen 255. Side port 236 and side port 256 may each serve as irrigation ports through which irrigation fluid may be injected to clear lumens 235, 255 in hub 220 of blood clots that may form during patient treatment. In another aspect of the present technology, side ports 236, 256 may serve as inflation ports connected to inflatable balloons in hub 220; the inflatable balloons may be inflated with inflation fluid to stretch the balloons to anchor or lock the position of first medical device 140 and second medical device 160 relative to their respective arms into which they are inserted. In such cases, the inflated balloons may press the medical device against its respective arm to prevent axial movement of the device within the sheath once the medical device is positioned within the patient. Such locking mechanisms using internal sheath balloons to securely fix the position of a first medical device to prevent axial movement during insertion or manipulation of a second medical device are known to those skilled in the art. For example, various locking mechanisms using internal sheath balloons to securely fix the position of a first medical device to prevent axial movement during insertion or manipulation of a second medical device are described in U.S. Provisional Patent Application No. 62 / 797,527, the entire contents of which are incorporated herein by reference. Other locking mechanisms are described in detail in the preceding sections. While only one side port is shown on each arm in Figures 2 and 3, any number of side ports may be used on each arm within the scope of this disclosure.

[0023] As described above, second arm 250 may be disposed on first arm 230 and may be configured to branch off from first arm 230 at an angle of 90° or less relative to the longitudinal axis of sheath 210. Additionally, in some aspects of the present technology, distal end 254 of second arm 250 may be positioned proximal to connector port 270, and proximal end 232 of first arm 230 may be positioned distal to connector port 270. In this manner, proximal end 252 of second arm 250 may be sufficiently spaced from proximal end 232 of first arm 230 so that first and second medical devices can interact with the respective arms 230, 250 without contacting each other.

[0024] As seen in Figures 2 and 3, hub 220 may optionally include a sewing ring 225 to aid in attaching hub 220 to the patient after the first and second medical devices have been inserted into the patient. In certain aspects of the present technology, sewing ring 225 may be positioned proximal to connector port 270 because the profile of hub 220 may be smaller at this location than at locations proximal to either first arm 230 or second arm 250. In other aspects of the present technology, sewing ring 225 may be located anywhere along the body of hub 220. While only one sewing ring is shown in Figures 2 and 3, it will be understood that any number of sewing rings may be present to help secure hub 220 to the patient.

[0025] A dilator 280 may be used in conjunction with the dual hub 220 to insert the introducer sheath 210 into a patient. Figures 2 and 3 also show the dilator 280 inserted into the first arm 230 of the hub 220. The dilator 280 has 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 sheath 210. As previously mentioned, the first arm 230 and the second arm 250 may be in any configuration relative to the longitudinal axis of the sheath 210 (e.g., a Y-shaped configuration), but if the dilator 280 is required for insertion of the introducer sheath 210 into a patient, the first arm 230 may be axially aligned with the longitudinal axis of the sheath 210. With the first arm 230 in this position, the dilator does not need to bend during insertion into the hub 220, potentially allowing for greater force to be applied when inserting the sheath 210 into the patient. Once inserted, the proximal end 282 of the dilator 280 may connect to the proximal end 232 of the first arm 230. This may be achieved by any suitable type of connection, such as a press-fit or twist connection.

[0026] In some aspects of the present 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 backflow of fluids when the sheath 210 is inserted into a patient. This may be helpful in cases where the sheath 210 needs to be repositioned after medical devices are removed from the first and second arms 230 and 250. In such situations, prior use may cause the respective seals 238, 258 to become worn and not completely seal the lumens 235, 255 from the surrounding environment. Similar to the dilator 280, the occluder 490 may be connected to the proximal end 252 of the second arm 250 by any suitable type of connection, such as a press-fit or twist connection.

[0027] As mentioned above, the first medical device 140 and the second medical device 160 may be axially constrained by a locking mechanism. In some aspects of the present technology, the locking mechanism may be configured such that some action must be taken to lock and / or unlock it. In some aspects of the present technology, the locking mechanism may have a bias. For example, in some aspects of the present technology, the locking mechanism may be biased toward an unlocked state so as not to restrict movement of the medical device unless action is taken to lock the locking mechanism. Conversely, in some aspects of the present technology, the locking mechanism may be biased toward a locked state so as to restrict movement of the medical device unless action is taken to unlock the locking mechanism. In some aspects of the present technology, the locking mechanism may include an internal balloon located within the first lumen 235 or the second lumen 255 that is inflated by the side arms 236, 256, as described above. In some aspects of the present technology, the locking mechanism may also include a locking lever arm, as shown in FIGS. 5A and 5B. FIG. 5A shows a cross section of a hub 510 similar to hubs 220 and 120 described above. While the hub 510 is shown with a first medical device 520 passing therethrough, it will be appreciated that the hub 510 may allow for the passage of multiple medical devices. The hub 510 also includes a lever arm 530, which may be a separate component positioned within the hub body. The lever arm 530 may be configured to have a semicircular shape as shown in Figures 5A and 5B, although any shape of arm suitable for securely securing the medical device 520 and preventing its axial movement may be used.

[0028] As shown in FIG. 5A, the lever arm 530 may be pivotally connected to the hub 510 at point 532. In the unlocked position, the lever arm 530 resides within the hub body. The lever arm may include an actuation mechanism, such as a handle or tab (not shown), accessible from the exterior of the hub 510. The lever arm 530 includes a notch or catch 538 configured to fit around the circumference 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, increasing axial friction. In some aspects of the present 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 present technology, the lever arm 530 may be located at each of the hemostasis valves 238, 258. Additionally, to securely secure the lever arm in the locked position, end 534 of lever arm 530 may be configured with a recess on its distal surface that engages with a protrusion 536 located in the hub body. A side profile of end 534 and protrusion 536 is shown in FIG. 5A. Similarly, end 534 engaging with protrusion 536 is shown in FIG. 5B. In some aspects of the present technology, lever arm 530 may be overmolded with a high-friction material, such as low-durometer polyurethane or silicone.

[0029] In addition to or as an alternative to the locking mechanisms described above, the dual hubs of the present disclosure may also include a Tuohy Borst mechanism incorporated into the first or second arms of the hub body, which includes a silicone slug on the first and / or second medical device that reduces the internal diameter of the medical device passing through the respective arm, thereby securely locking the position of the medical device.

[0030] As mentioned above, in some aspects of the present technology, sheath 210 may include a dual lumen sheath. In such cases, when the dual lumen sheath is coupled to hub 220, first lumen 235 of hub 220 may be in fluid communication with one of the lumens of the dual lumen sheath, and second lumen 255 of hub 220 may be in fluid communication with the other lumen of the dual lumen sheath.

[0031] In some aspects of the present technology, the sheath 210 may include an expandable sheath. Expandable sheaths are well known to those skilled in the art and will not be described in detail herein. For example, various expandable sheaths are described in U.S. Provisional Patent Application No. 62 / 797,527, which is incorporated herein by reference.

[0032] In some aspects of the present technology, the sheath 210 may include a peel-away sheath. Peel-away sheaths are also well known to those skilled in the art and will not be 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 incorporated herein by reference. The peel-away sheath may include one or more lines of weakness formed in the sheath body and extending longitudinally along the sheath to allow it to be torn apart as needed during a patient procedure.

[0033] In some aspects of the present technology, the hub 220 may include a tab that allows it to separate from itself when it is no longer needed, such as when one or more of the medical devices are positioned within the patient.

[0034] In some aspects of the present technology, the sheath 210 may be extruded and / or laminated. In some aspects of the present technology, the introducer sheath 110, 210 may include 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.

[0035] Additionally, in some aspects of the present technology, the hub 120, 220 may be formed by overmolding. In some aspects of the present technology, the hub 120, 220 may include at least one of ethylene vinyl acetate (EVA); styrene-butadiene copolymer (SBC); styrene ethylene butylene styrene (SEBS); high density polyethylene (HDPE) material; medium density polyethylene (MDPE) material; low density polyethylene (LDPE) material; polyether ether ketone (PEEK); polyether block amide (such as PEBAX® or PebaSlix®); elastomer; synthetic rubber; polyethylene material, polyurethane material, or polycarbonate material having a modulus of elasticity of about 40 ksi; crack resistant material; or material with a low coefficient of friction.

[0036] As described above, the dual-hub introducer sheath of the present disclosure is designed to facilitate passage of catheter-type medical devices (e.g., a first medical device and a second medical device) through the lumen of the introducer sheath. In some aspects of the present technology, the first medical device is a mechanical circulatory assist device, and the second medical device is a coronary reperfusion therapy device for providing percutaneous coronary intervention (PCI) to a patient. 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 platinum chromium bare metal coronary stents Promus PREMIER™ and REBEL™, and the bioabsorbable polymer stent SYNERGY™, both from Boston Scientific, Marlborough, MA. In some aspects of the present technology, the mechanical circulatory assist device may include a rotary blood pump having a cannula, a rotor, and a rotor housing. Examples of such blood pumps include, but are not limited to, Impella® pumps, extracorporeal membrane oxygenation (ECMO) pumps, and balloon pumps. Impella® pumps may also include Impella 2.5® pumps, Impella 5.0® pumps, Impella CP® pumps, or Impella LD® pumps, all by Abiomed, Inc. of Danvers, MA.

[0037] In some aspects of the present technology, the first and second medical devices may be used with the dual-hub introducer sheath described above in a procedure in which PCI and a percutaneous ventricular assist device are used simultaneously, such as the method of unloading the left ventricle in the treatment of myocardial infarction described in U.S. patent application Ser. No. 16 / 244,998, the entire contents of which are incorporated herein by reference.

[0038] FIG. 6 illustrates an exemplary method 600 for using a dual-hub introducer sheath, such as any of the introducer sheaths described above, in accordance with aspects of the present technology. Method 600 will be described with reference to the exemplary systems depicted in FIGS. 1-5 above. Prior to using the dual-hub introducer sheath, sheath 210 is positioned within a patient's arteriotomy (not shown in FIG. 6). Prior to inserting sheath 210 into a patient, a connector port of the hub, such as connector port 270 of hub 220 described above, is coupled to a proximal end of the introducer sheath, such as end 212 of sheath 210 described above. In some aspects of the present technology, a dilator, such as dilator 280 shown in FIGS. 2 and 3, may be inserted into the sheath lumen prior to insertion into the patient. The dilator assists in positioning the sheath in areas of the patient's body that are difficult to penetrate with the sheath alone. Once inserted, the dilator is removed from the sheath lumen.

[0039] In step 610, a first medical device 140 is inserted into the first arm 230 of the dual hub 220, where the first medical device 140 is pushed through the first hemostatic valve 238 and threaded through the hub 220 toward the connector port 270. Similar to the first medical device 140, in step 620, a second medical device 160 is pushed through the second hemostatic valve 258 in the second arm 250 and then also threaded through the hub 220 toward the connector port 270. In step 630, the first and second medical devices are provided into 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 the patient's arteriotomy by pushing the first and second medical devices along the length of the sheath 210 until they exit the distal end 214 of the sheath 210.

[0040] Once in position within the patient's arteriotomy, the medical device can be used in a desired manner to treat the patient. In some aspects of the present technology, the dual-hub introducer sheath may be used to unload the patient's left ventricle, as shown in exemplary method 700 of FIG. 7. In such a case, the first medical device 140 may be a mechanical circulatory assist device, and the second medical device 160 may be a coronary reperfusion therapy device for providing percutaneous coronary intervention (PCI) to the patient. With reference to FIG. 7, in step 710, the first medical device 140 is advanced to a predetermined position within the left ventricle after exiting the distal end 214 of the sheath 210. The first medical device 140 may then be locked into position via a locking mechanism located on the first arm 230 of the hub 220. As previously discussed, such a locking mechanism may include any one of a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. In step 720, the mechanical circulatory device is operated within the left ventricle for an assist period of more than 30 minutes. In some aspects of the present technology, the mechanical circulatory device may be operated at a blood flow of 2.5 L / min. In step 730, a second medical device 160 is positioned within the patient's coronary vessel. As previously described, the second medical device 160 may then also be locked into position via a locking mechanism located on the second arm 250 of the hub 220. In step 740, after the assist period has elapsed, reperfusion therapy is applied to the coronary vessel via the PCI device as described above. Reperfusion therapy may be performed in parallel with or after the operation of the mechanical circulatory device.

[0041] In some aspects of the present technology, the various steps described above with respect to methods 600 and 700 of Figures 6 and 7 may be performed in different orders and / or concurrently with one another. Furthermore, one or more of the steps described above may be optional or combined, if desired.

[0042] The foregoing description is intended to be merely illustrative of the principles of the present technology. As such, the devices and methods described herein may be practiced other than in the described embodiments, which are presented for purposes of illustration and not limitation. It should be understood that the systems, devices, and methods disclosed herein, while described with respect to certain procedures, may be applied in any context in which it is desirable to access a patient's arteriotomy without creating multiple access sites in the patient's vasculature. In addition, features of the present disclosure may be implemented in any combination or subcombination (including multiple subsidiary combinations and subcombinations) with one or more other features described herein. The various features described or illustrated above, including components thereof, may be combined or integrated into other systems. Furthermore, certain features may be omitted or not implemented without departing from the spirit of the present technology.

Claims

1. an introducer sheath having a longitudinal axis and a lumen formed therein; and a hub coupled to a proximal end of the introducer sheath, a first arm having a first lumen and a first hemostatic valve configured for passing a first medical device, a mechanical circulatory support device, and the first hemostatic valve configured to meet a first insertion force and leakage requirement necessary for insertion of the mechanical circulatory support device into and through the first hemostatic valve; a second arm connected to the first arm and having a second lumen and a second hemostatic valve, the second lumen and the second hemostatic valve configured to pass a coronary reperfusion therapy device, the coronary reperfusion therapy device being a second medical device for providing percutaneous coronary intervention (PCI) to a patient, the second hemostatic valve configured to satisfy second insertion force and leakage requirements necessary to insert the coronary reperfusion therapy device through and pass the second hemostatic valve, the second insertion force and leakage requirements being different from the first insertion force and leakage requirements for the first hemostatic valve; 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 communicate with lumens of the introducer sheath to allow at least one of the first medical device, a mechanical circulatory assist device, and the second medical device, a coronary reperfusion therapy device, to pass through the introducer sheath for delivery to a patient; a locking mechanism comprising a locking lever arm pivotable within the hub from an unlocked position to a locked position, the locking mechanism including a notch configured to fit over and frictionally engage an outer periphery of one of the mechanical circulatory assist device and the coronary reperfusion therapy device when the locking lever arm is in the locked position; The hub comprises: An introducer system comprising:

2. The introducer system of claim 1 , wherein the first arm is disposed parallel to a longitudinal axis of the introducer sheath.

3. 3. The introducer system of claim 1, wherein the second arm is configured to branch off from the first arm at an angle of 90 degrees or less.

4. 4. The introducer system of claim 1, wherein the first arm and the second arm are arranged in a Y-configuration relative to the introducer sheath.

5. The introducer system of any one of claims 1 to 4, wherein the second arm is located proximal to the connection port.

6. An introducer system according to any one of claims 1 to 5, wherein the first arm and the second arm each have a proximal end and a distal end, and the distal end of the first arm is positioned distally of the proximal end of the second arm.

7. The introducer system of any one of claims 1 to 6, wherein the second lumen joins the first lumen within the hub.

8. 8. The introducer system of claim 7, wherein the introducer sheath comprises a single lumen for passage of the first medical device, the mechanical circulatory assist device, and the second medical device, the coronary reperfusion therapy device.

9. The introducer system of any one of claims 1 to 8, wherein the first lumen and the second lumen are maintained as separate lumens within the hub.

10. An introducer system as described in any one of claims 1 to 9, wherein the introducer sheath comprises a dual lumen sheath such that the first lumen communicates with one lumen of the dual lumen sheath and the second lumen communicates with the other lumen of the dual lumen sheath.

11. The introducer system of any one of claims 1 to 10, wherein the introducer sheath is an expandable sheath or a peel-away sheath.

12. 12. The introducer system of claim 11, wherein the introducer sheath is a peel-away sheath, and the hub further comprises a tab for enabling separation of the hub and the peel-away sheath.

13. The introducer system of any one of claims 1 to 12, wherein the first and second hemostatic valves are configured to seal the first and second lumens, respectively.

14. 14. The introducer system of claim 13, wherein the first and second hemostatic valves are each configured to be penetrable by the first medical device, a mechanical circulatory assist device, or the second medical device, a coronary reperfusion therapy device.

15. The introducer system of any one of claims 1 to 14, wherein the hub further comprises at least one sewing ring.

16. the first arm and the second arm each include at least one side port; An introducer system according to any one of claims 1 to 15.

17. 17. The introducer system of claim 16, wherein the side port comprises an irrigation port configured to receive irrigation fluid.

18. 18. The introducer system of any one of claims 1 to 17, wherein at least one of the first arm and the second arm comprises a lever arm configured to prevent one of the first medical device, a mechanical circulatory assist device, and the second medical device, a coronary reperfusion therapy device, from moving axially within the introducer sheath in a locked position after delivery to the patient.

19. 20. The introducer system of claim 18, wherein the lever arm is biased to a state configured to prevent one of the first medical device, the mechanical circulatory assist device, and the second medical device, the coronary reperfusion therapy device, from moving axially within the introducer sheath in a locked position.

20. The introducer system of any one of claims 1 to 19, wherein 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.

21. 21. The introducer system of any one of claims 1-20, wherein the hub comprises at least one of ethylene vinyl acetate (EVA); styrene-butadiene copolymer (SBC); styrene ethylene butylene styrene (SEBS); high density polyethylene (HDPE) material; medium density polyethylene (MDPE) material; low density polyethylene (LDPE) material; polyether ether ketone (PEEK); polyether block amide; elastomer; synthetic rubber; or a polyethylene material, polyurethane material, or polycarbonate material having a modulus of elasticity of about 40 ksi.

22. 22. The introducer system of any one of claims 1 to 21, wherein the coronary reperfusion therapy device is a stent optionally configured to be inserted through the second arm and the introducer sheath by a catheter.

23. 23. The introducer system of any one of claims 1 to 22, wherein the mechanical circulatory assist 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.

24. The introducer system of any one of claims 1 to 22, wherein the mechanical circulatory assist device is a rotary blood pump having a cannula, a rotor, and a rotor housing.

25. 25. The introducer system of claim 24, wherein the first arm and the introducer sheath are configured to allow passage of a cannula of a rotary blood pump.

26. 26. The introducer system of claim 25, wherein the first arm and the introducer sheath are configured to allow passage of a rotor and a rotor housing of a rotary blood pump therethrough.

27. 27. The introducer system of any one of claims 1 to 26, wherein the hub has up to five second arms, each second arm configured with a hemostatic valve and a lumen communicating with the introducer sheath to allow a second medical device to pass from the respective second arm into the introducer sheath.

28. 28. The introducer system of claim 27, wherein the second arm is disposed in a radially symmetric manner about the first arm.

29. The introducer system of any one of claims 27 to 28, wherein the hub comprises two second arms.

30. An introducer system as described in any one of claims 1 to 29, further comprising at least one third arm connected to the first arm, each third arm having a third lumen configured to allow a third medical device to pass therethrough and a third hemostatic valve.

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