阅读说明：本技术 双毂导引器护套 (Double-hub introducer sheath ) 是由 G·R·范图奇 于 2020-03-11 设计创作，主要内容包括：本申请提供一种用于向患者经皮递送第一医疗设备和第二医疗设备的导引器系统。该系统可包括导引器护套,该导引器护套具有纵向轴线和形成于其中的管腔。该系统还可包括耦接到护套的近端的毂。该毂可包括第一臂,该第一臂具有用于使第一医疗设备穿过的第一管腔和第一止血阀。该毂还可包括第二臂,该第二臂耦接到第一臂并且具有用于使第二医疗设备穿过的第二管腔和第二止血阀。此外,该毂可包括连接端口,使得第一管腔和第二管腔与导引器护套的管腔连通,以供第一医疗设备和第二医疗设备中的至少一个通过导引器护套穿过并递送至患者。(An introducer system for percutaneously delivering a first medical device and a second medical device to a patient is provided. The system may include an introducer sheath having a longitudinal axis and a lumen formed therein. The system can also include a hub coupled to the proximal end of the sheath. The hub may include a first arm having a first lumen for passing a first medical device therethrough and a first hemostasis valve. The hub may also include a second arm coupled to the first arm and having a second lumen for passing a second medical device and a second hemostasis valve. Further, the hub may include a connection port such that the first and second lumens communicate with the lumen of the introducer sheath for passage therethrough and delivery of at least one of the first and second medical devices to the patient.)

1. 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 comprising:

a first arm having a first lumen and a first hemostasis valve configured for passing a first medical device therethrough;

a second arm coupled to the first arm and having a second lumen and a second hemostasis valve configured for passing a second medical device therethrough; and

a connection port coupled to the introducer sheath and to the first and second arms such that the first and second lumens are in communication with the lumen of the introducer sheath, thereby allowing at least one of the first and second medical devices to be passed through the introducer sheath and delivered to a patient.

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

3. The introducer system of any preceding claim, wherein the second arm is configured to branch off from the first arm at an angle of no more than 90 °.

4. The introducer system of any one of claims 1 or 3, wherein the first and second arms are arranged in a Y-shaped configuration relative to the introducer sheath.

5. The introducer system of any preceding claim, wherein the second arm is located proximal to the connection port.

6. The introducer system of any preceding claim, wherein the first and second arms each have 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.

7. The introducer system of any preceding claim, wherein the second lumen merges with the first lumen within the hub.

8. The introducer system of claim 7, wherein the introducer sheath comprises a single lumen for passing the first medical device and the second medical device.

9. The introducer system of any preceding claim, wherein the first and second lumens are maintained as separate lumens within the hub.

10. The introducer system of the preceding claim, wherein 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.

11. The introducer system of any preceding claim, wherein the introducer sheath is an expandable sheath.

12. The introducer system of any preceding claim, wherein the introducer sheath is a peel-away sheath.

13. The introducer system of claim 12, wherein the hub further comprises a fin to enable separation of the hub and the peel sheath.

14. The introducer system of any of the preceding claims, wherein the first and second hemostasis valves are configured to seal the respective first and second lumens.

15. The introducer system of claim 14, wherein the first and second hemostasis valves are each configured to be penetrable by the first or second medical device.

16. The introducer system as in any preceding claim, wherein the hub further comprises at least one sewing ring.

17. The introducer system of any preceding claim, wherein the first arm and the second arm each comprise at least one side port.

18. The introducer system of claim 17, wherein the side port comprises an irrigation port configured to be supplied with an irrigation fluid.

19. The introducer system of any of the preceding claims, wherein at least one of the first and second arms 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.

20. The introducer system of claim 19, wherein the locking mechanism comprises at least one of: a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm.

21. The introducer system of any of claims 19-20, wherein the locking mechanism is biased in a state configured to prevent axial movement of one or both of the first medical device and the second medical device within the introducer sheath.

22. The introducer system of any preceding claim, wherein the introducer sheath comprises at least one of: 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.

23. The introducer system as claimed in any preceding claim, wherein the hub comprises at least one of: ethylene Vinyl Acetate (EVA); styrene-butadiene copolymers (SBC); styrene Ethylene Butylene Styrene (SEBS); a High Density Polyethylene (HDPE) material; a Medium Density Polyethylene (MDPE) material; a Low Density Polyethylene (LDPE) material; polyetheretherketone (PEEK); polyether block amide; an elastomer; synthesizing rubber; or a polyethylene, polyurethane, or polycarbonate material having an elastic modulus of about 40 ksi.

24. The introducer system as claimed in any preceding claim, 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 the patient.

25. The introducer system of claim 24, wherein the coronary reperfusion therapy device is a stent.

26. The introducer system of claim 25, wherein the stent is configured to be inserted through the second arm and introducer sheath by a catheter.

27. The introducer system of any of claims 24-26, wherein the mechanical circulatory support apparatus comprises at least one of: a blood pump; a cross-petal axial flow (TV) pump; an intra-aortic balloon pump; or an extracorporeal membrane pulmonary oxygenation (ECMO) pump.

28. The introducer system of any of claims 24-26, wherein the mechanical circulatory support apparatus is a rotary blood pump having a cannula, a rotor, and a rotor housing.

29. The introducer system of claim 28, wherein the first arm and the introducer sheath are configured to allow the cannula of the rotary blood pump to pass through.

30. The introducer system of claim 29, wherein the first arm and the introducer sheath are configured to allow the rotor and rotor housing of the rotary blood pump to pass through.

31. The introducer system as in any one of the preceding claims, wherein 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 passage of the second medical device from the respective second arm into the introducer sheath.

32. The introducer system of claim 31, wherein the second arm is arranged in a radially symmetric manner about the first arm.

33. The introducer system of any of claims 31-32, wherein the hub comprises two second arms.

34. The introducer system of any preceding claim, further comprising:

at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostasis valve configured for passing a third medical device therethrough.

35. A method, comprising:

inserting a first medical device into a first arm of an introducer hub, the first arm having a first lumen through which the first medical device passes;

inserting a second medical device into a second arm attached to the first arm, the second arm having a second lumen through which the second medical device passes;

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.

36. The method of claim 35, comprising:

inserting the first medical device and the second medical device into a lumen formed within the introducer sheath for delivery to the patient.

37. The method of claim 35, comprising:

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 being separate from the second lumen.

38. The method of any one of claims 35-37, comprising:

attaching the introducer hub to the patient via a suture ring.

39. The method of any one of claims 35-38, comprising:

providing irrigation fluid to one or both of the first and second lumens via a side port positioned on each of the first and second arms.

40. The method of any one of claims 35-39, 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.

41. The method of claim 40, wherein the locking mechanism comprises at least one of: a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm.

42. The method of claim 41, wherein 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.

43. The method of any one of claims 35-42, comprising:

inserting a third medical device into a third arm attached to the first arm, the third arm having a third lumen for passing the third medical device therethrough for delivery to the patient.

44. The method of any one of claims 35-43, comprising:

supporting the heart of the patient suffering from a sustained myocardial infarction.

45. The method of claim 44, comprising the steps of:

inserting the 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 2.5L/min for a support period of 30 minutes or more;

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.

46. The method of any one of claims 35-45, wherein the first device comprises a mechanical circulation support device.

47. The method of claim 46, wherein the mechanical circulation 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 pulmonary oxygenation (ECMO) pump.

48. The method of any of claims 35-47, wherein the second device comprises a coronary reperfusion therapy device for providing Percutaneous Coronary Intervention (PCI) to the patient.

49. The method according to any one of claims 46-48, wherein the mechanical circulatory support apparatus is operated to pump blood from the patient's left ventricle into the patient's aorta during the support period.

50. The method of any of claims 44-49, wherein the second medical device is inserted through the second arm after the first medical device is positioned on both sides of the patient's aortic valve and is unloading the patient's left ventricle.

51. The method of any of claims 45-50, wherein the second medical device is inserted through the introducer sheath at least 15 minutes after the first medical device begins to unload the patient's left ventricle.

52. The method of any of claims 44-51, wherein the 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.

53. The method of any of claims 35-52, wherein 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 passage of the second medical device from the respective second arm into the introducer sheath.

54. The method of claim 53, wherein the second arm is arranged in a radially symmetric manner about the first arm.

55. The method of any one of claims 53-54, wherein the introducer hub comprises two second arms.

56. The method of any of claims 35-54, wherein 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 configured for passage of a third medical device.

57. An introducer hub, comprising:

a first arm having a first lumen and a first hemostasis valve configured for passing a first medical device therethrough;

a second arm coupled to the first arm and having a second lumen and a second hemostasis valve configured for passing a second medical device therethrough; and

a connection port coupled to an introducer sheath and to the first and second arms such that the first and second lumens are in communication with the lumen of the introducer sheath to allow at least one of the first and second medical devices to pass through the introducer sheath for delivery to a patient.

58. The introducer hub of claim 57, wherein the first arm is disposed parallel to a longitudinal axis of the introducer sheath.

59. The introducer hub of any of claims 57-58, wherein the second arm is configured to branch off from the first arm at an angle of no more than 90 °.

60. The introducer hub of any one of claims 57 or 59, wherein the first and second arms are arranged in a Y-shaped configuration relative to the introducer sheath.

61. The introducer hub of any of claims 57-60, wherein the second arm is located proximal to the connection port.

62. The introducer hub of any of claims 57-61, wherein the first and second arms each have 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.

63. The introducer hub of any of claims 57-62, wherein the second lumen merges with the first lumen.

64. The introducer hub of any of claims 57-63, wherein the introducer sheath comprises a single lumen for passing the first medical device and the second medical device therethrough.

65. The introducer hub of any of claims 57-64, wherein the first and second lumens are maintained as separate lumens.

66. The introducer hub of any of claims 57-65, wherein 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.

67. The introducer hub of any of claims 57-66, wherein the introducer sheath is an expandable sheath.

68. The introducer hub of any of claims 57-67, wherein the introducer sheath is a peel-away sheath.

69. The introducer hub of claim 68, further comprising a fin to enable separation of the introducer hub and the dissection sheath.

70. The introducer hub of any of claims 57-69, wherein the first and second hemostasis valves are configured to seal the respective first and second lumens.

71. The introducer hub of claim 70, wherein the first and second hemostasis valves are each configured to be penetrable by the first or second medical device.

72. The introducer hub of any one of claims 57-71, further comprising at least one sewing ring.

73. The introducer hub of any one of claims 57-72, wherein the first arm and the second arm each comprise at least one side port.

74. The introducer hub of claim 73, wherein the side port comprises an irrigation port configured to be supplied with an irrigation fluid.

75. The introducer hub of any of claims 57-74, wherein at least one of the first and second arms 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.

76. The introducer hub of claim 75, wherein the locking mechanism comprises at least one of: a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm.

77. The introducer hub of any of claims 75-76, wherein the locking mechanism is biased in a state configured to prevent axial movement of one or both of the first medical device and the second medical device within the introducer sheath.

78. The introducer hub of any of claims 57-77, wherein 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 passing the second medical device from the respective second arm into the introducer sheath.

79. The introducer hub of claim 78, wherein the second arm is arranged in a radially symmetric manner about the first arm.

80. The introducer hub of any of claims 78-79, wherein the introducer hub comprises two second arms.

81. The introducer hub of any of claims 57-80, further comprising:

at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostasis valve configured for passing a third medical device therethrough.

82. The introducer hub of any of claims 57-81, wherein the introducer hub comprises at least one of: ethylene Vinyl Acetate (EVA); styrene-butadiene copolymers (SBC); styrene Ethylene Butylene Styrene (SEBS); a High Density Polyethylene (HDPE) material; a Medium Density Polyethylene (MDPE) material; a Low Density Polyethylene (LDPE) material; polyetheretherketone (PEEK); polyether block amide; an elastomer; synthesizing rubber; or a polyethylene, polyurethane, or polycarbonate material having an elastic modulus of about 40 ksi.

Background

Percutaneous mechanical support devices are currently used for a variety of clinical indications. Such support devices may include, but are not limited toPumps, extracorporeal membrane pulmonary oxygenation (ECMO) pumps, and balloon pumps.The pump may further comprise ImpellaPump, ImpellaPump, ImpellaPump and ImpellaPumps, all of which are manufactured by Abiomed corporation of dandy, massachusetts. In most cases, they are inserted percutaneously into a patient through a single access point (e.g., radial access, femoral access, axillary access), while other procedures (e.g., Percutaneous Coronary Intervention (PCI)) are performed through a second access point (e.g., contralateral femoral or radial access points). Thus, using multiple devices on a patient at the same time typically requires multiple access sites, which presents several challenges.

Disclosure of Invention

The present technology relates to systems and methods for transcutaneously delivering a first medical device and a second medical device to a patient.

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 (hub) coupled to the proximal end of the introducer sheath. The hub includes: a first arm having a first lumen and a first hemostasis valve, the first lumen and first hemostasis valve configured for passing a first medical device therethrough; 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 passing a second medical device therethrough; and a connection port coupled to the introducer sheath and to the first and second arms such that the first and second lumens are in communication with the lumen of the introducer sheath to allow at least one of the first and second medical devices to pass through the introducer sheath and be delivered to the patient. In some aspects, the first arm is disposed parallel to a longitudinal axis of the introducer sheath. In some aspects, the second arm is configured to branch from 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 relative to the introducer sheath. In some aspects, the second arm is proximal to the connection port. In some aspects, the first and second arms 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 passing the first medical device and the second medical device. 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. Further, the hub may also include fins to enable the hub and the peel-away boot to be separated. 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 sewing ring. In some aspects, the first arm and the second arm each include at least one side port. Further, the side port may include an irrigation port configured to be supplied with irrigation fluid. In some aspects, at least one of the first and second arms 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 comprises at least one of: a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. In some aspects, the locking mechanism is biased in a state 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 includes at least one of: 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 copolymers (SBC); styrene Ethylene Butylene Styrene (SEBS); a High Density Polyethylene (HDPE) material; a Medium Density Polyethylene (MDPE) material; a Low Density Polyethylene (LDPE) material; polyetheretherketone (PEEK); polyether block amide; an elastomer; synthesizing rubber; or a polyethylene, polyurethane, or polycarbonate material having 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 Percutaneous Coronary Intervention (PCI) to the 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 circulation support device comprises at least one of: a blood pump; a cross-petal axial flow (TV) pump; an intra-aortic balloon pump; or an extracorporeal membrane pulmonary oxygenation (ECMO) pump. In some aspects, the mechanical circulatory support apparatus 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 a cannula of the rotary blood pump to pass through. In some aspects, the first arm and the introducer sheath are configured to allow a rotor and a rotor housing of the rotary blood pump to pass through. In some aspects, the hub includes up to five second arms, each second arm configured with a hemostasis valve and a lumen in communication with the introducer sheath for passing a second medical device from the respective second arm into the introducer sheath. In some aspects, the second arm is arranged in a radially symmetric manner about the first arm. In some aspects, the hub includes two second arms. In some aspects, the introducer system can further include at least one third arm coupled to the first arm, each third arm having a third lumen and a third hemostasis valve configured for passing a third medical device therethrough.

In another aspect, the present 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 through which the first medical device passes; inserting a second medical device into a second arm attached to the first arm, the second arm having a second lumen through which the second medical device passes; providing a first medical device and a 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 from the distal end of the introducer sheath to the patient. In some aspects, the method further comprises inserting the first medical device and the second medical device into a lumen formed within the introducer sheath for delivery to the patient. In some aspects, the method further comprises inserting a first medical device into a first lumen formed within the introducer sheath for delivery to the patient, and inserting a second medical device into a second lumen formed within the introducer sheath for delivery to the patient, the first lumen being separate from the second lumen. In some aspects, the method further comprises attaching the introducer hub to the patient via the suture ring. In some aspects, the method further comprises providing irrigation fluid to one or both of the first and second lumens 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 adapter, 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 passing the third medical device therethrough for delivery to the patient. In some aspects, the method further comprises supporting the heart of the patient having a sustained myocardial infarction. In some aspects, the method further comprises: inserting a first medical device through the first arm and through the introducer sheath into a left ventricle of the patient; operating the first medical device at a blood flow rate of at least 2.5L/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 coronary vessel of the patient; and operating the second medical device after the support period has elapsed. In some aspects, the first apparatus comprises a mechanical circulation support apparatus. In some aspects, the mechanical circulation 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 pulmonary oxygenation (ECMO) pump. In some aspects, the second device comprises a coronary reperfusion therapy device for providing Percutaneous Coronary Intervention (PCI) to the patient. In some aspects, the mechanical circulatory support apparatus is operated to pump blood from the left ventricle of the patient into the aorta of the patient during a support session. In some aspects, after the first medical device is positioned on both sides of the patient's aortic valve and is unloading (unloading) the patient's left ventricle, a second medical device is inserted through the second arm. In some aspects, the second medical device is inserted through the introducer sheath at least 15 minutes after the first medical device begins to unload the left ventricle of the patient. In some aspects, a first medical device is positioned with a distal tip positioned within a left ventricle of a patient and pumps blood from the left ventricle of the patient into an aorta of the patient. In some aspects, the introducer hub includes up to five second arms, each second arm configured with a hemostasis valve and a lumen in communication with the introducer sheath for passage of a second medical device from the respective second arm into the introducer sheath. In some aspects, the second arm is 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 configured for passing a third medical device therethrough.

In another aspect, the present 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 passing a first medical device therethrough; 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 passing a second medical device therethrough; and a connection port coupled to the introducer sheath and to the first and second arms such that the first and second lumens are in communication with the lumen of the introducer sheath to allow at least one of the first and second medical devices to pass through the introducer sheath for delivery to a patient. In some aspects, the first arm is disposed parallel to a longitudinal axis of the introducer sheath. In some aspects, the second arm is configured to branch from 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 relative to the introducer sheath. In some aspects, the second arm is proximal to the connection port. In some aspects, the first and second arms 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. In some aspects, the introducer sheath includes a single lumen for passing the first medical device and the second medical device. 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 can further include a flap to enable separation of the introducer hub and the dissection 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 sewing ring. In some aspects, the first arm and the second arm each include at least one side port. In some aspects, the side port comprises an irrigation port configured to be supplied with irrigation fluid. In some aspects, at least one of the first and second arms 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 comprises at least one of: a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. In some aspects, the locking mechanism is biased in a state 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 includes up to five second arms, each second arm configured with a hemostasis valve and a lumen in communication with the introducer sheath for passing a second medical device from the respective second arm into the introducer sheath. In some aspects, the second arm is 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 configured for passing a third medical device therethrough. In some aspects, the introducer hub comprises at least one of: ethylene Vinyl Acetate (EVA); styrene-butadiene copolymers (SBC); styrene Ethylene Butylene Styrene (SEBS); a High Density Polyethylene (HDPE) material; a Medium Density Polyethylene (MDPE) material; a Low Density Polyethylene (LDPE) material; polyetheretherketone (PEEK); polyether block amide; an elastomer; synthesizing rubber; or a polyethylene, polyurethane, or polycarbonate material having an elastic modulus of about 40 ksi.

Drawings

The above and other objects and advantages will become apparent from the following detailed description when considered 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 for delivering a first medical device and a second medical device into a patient's arterial anatomy, in accordance with some aspects of the present disclosure;

fig. 2 illustrates a dual hub introducer sheath system having a dilator for insertion into a patient's arterial anatomy, in accordance with some aspects of the present 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 occluder sealing the lumens in the side arms;

fig. 5A shows an illustrative locking mechanism in an open state for use in a dual hub introducer sheath system, in accordance with aspects of the present disclosure;

FIG. 5B shows the locking mechanism of FIG. 5A in a locked state;

fig. 6 shows an illustrative flow diagram of a method of using a dual hub introducer sheath system in accordance with aspects of the present disclosure; and

fig. 7 shows an illustrative flow diagram of a method of unloading a left ventricle of a heart using a dual hub introducer sheath system in accordance with aspects of the present 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 a dual hub introducer sheath for use in endovascular procedures involving catheter-based ventricular assist devices, it should be understood that all of 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 described 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. First, a patient may not have two anatomically available access sites for PCI surgical devices, where, for example, two 6-7Fr sheaths may be used to facilitate surgery (e.g., balloon and stent implantation). In addition, peripheral arterial disease, vessel lumen size (too small), scar tissue from previous surgery, and other diseases may complicate access of larger devices (e.g., mechanical support devices) to the percutaneous site. The use of multiple access sites may also increase the likelihood of vascular access complications, which may be associated with increased mortality, increased hospital costs, and the like. Furthermore, because access needs to be obtained more than once, multiple access sites require more surgical time and may result in increased surgical costs due to the need for multiple vessel closure devices, additional introducers, and the like. Therefore, there is a great need to reduce the complexity of the procedure that requires the operation of multiple devices on a patient.

The systems, devices, and methods described herein relate to a dual hub introducer sheath that enables a single access site to be used with multiple devices. For purposes of illustration, but not by way of limitation, these devices are described as mechanical accessory devices (e.g., Impella devices) and devices used for PCI surgery. However, those skilled in the art will appreciate that the present disclosure is not limited to any particular type of percutaneous insertion device. Indeed, the present disclosure contemplates that, in some aspects of the present technology, the plurality of devices may be two identical devices. Until recently, such single access for multiple devices was clearly not possible because the physician was unaware that both PCI and Impella devices could be assembled from a single sheath without increasing the overall diameter of the sheath.

Successful insertion of a PCI device through the same access sheath as an immunopella device to perform both PCI and immunopella support at a single access site has recently been reported (m.l. esposisito et al, "Left vertical unloaded surface Recovery After animal mental information," Journal of the American College of medical, Elsevier, vol.72, No.5, main 2018). However, the use of current solutions can lead to hemostasis problems with introducer valves and pumps moving in and out of the ventricle when PCI devices are replaced and manipulated. These adverse effects arise because conventional introducer valves are not designed to be accessed by dual devices at all.

The apparatus 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 (hub) coupled to the proximal end of the introducer sheath. The hub includes a first arm having a first lumen and a first hemostasis valve configured for passing a first medical device therethrough. The hub also includes a second arm coupled to the first arm and having a second lumen and a second hemostasis valve configured for passage of a second medical device. Further, the hub includes a connection port coupled to the introducer sheath and to the first and second arms such that the first and second lumens communicate with the lumen of the introducer sheath to allow at least one of the first and second medical devices to pass through the introducer sheath and be delivered to the patient.

The dual hub introducer sheath of the present disclosure allows both the PCI device and the Impella device to be inserted therethrough while maintaining proper 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 of either the Impella device or the PCI device, noting that these requirements and designs are quite different. Further, the dual hub introducer sheath of the present disclosure has a locking mechanism that is isolated from the arms of the hub for the Impella device, which the physician can activate to hold the Impella in place, preventing it from advancing or retracting while performing a PCI procedure.

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. 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). Sheath 110 further includes a lumen 115, which lumen 115 extends between proximal end 112 and distal end to facilitate passage of a first medical device and a second medical device. Although fig. 1 depicts the sheath 110 having a single lumen 115, for example, in some aspects of the present technique, the sheath 110 may include two different lumens throughout the length of the sheath. In other aspects of the present technique, the sheath 110 can include any number of different lumens. The system 100 also includes a hub 120 coupled to the proximal end 112 of the sheath 110.

Hub 120 includes a first arm 130 having a proximal end 132 and a distal end 134, 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 outside environment. The first valve 138 may be penetrated by a first medical device 140. The hub 120 also includes a second arm 150 attached to the first arm 130. Like the first arm 130, the second arm 150 defines a second lumen 155 and includes 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 outside environment. The second valve 158 may be penetrated by a second medical device 160. In some aspects of the present technique, the first and second valves 138, 158 may comprise a hemostasis Valve (also referred to as a "coag" Valve), such as the Valve described in U.S. patent No. 10,576,258 entitled "Hemostatic Valve for Medical Device introducers," which is incorporated herein by reference in its entirety. Although fig. 1 shows the hub 120 including one second arm 150, it should be understood that the hub 120 may include any number of second arms arranged relative to the first arm 130.

Hub 120 also includes a connection port 170 connected to first lumen 135 and 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 and second medical devices 140, 160 can traverse the sheath 110 to be delivered to a patient when the sheath 110 is inserted into the patient. In some aspects of the present technique, such coupling may be a friction fit, for example, wherein the proximal end 112 of the sheath 110 is sized such that the 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 disengaging from the hub 120. In other aspects of the present technique, coupling may be achieved by external threads on the outer surface of the proximal end 112 of the sheath 110, for example, which interact with complementary threads on the inner surface of the connection port 170. In further aspects of the present technique, the sheath 110 can be coupled to the connection port 170 in any manner such that the first lumen 135 and the second lumen 155 can be fluidly connected to the lumen 115 of the sheath 110 via the connection port 170 of the hub 120. In some aspects of the present technique, the hub 120 may be overmolded and press-fit or compressed onto the proximal end 112 of the sheath 110.

As shown in fig. 1, in some aspects of the present technique, the hub 120 can be manufactured such that the first lumen 135 and the second lumen 155 merge within the hub 120 prior to transitioning into the connection port 170. In this case, the hub 120 can be coupled to a single lumen sheath (e.g., sheath 110 in fig. 1), wherein 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 when 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 as they traverse the sheath 110 for delivery to the patient. In other aspects of the present technique, the hub 120 can be manufactured such that the first lumen 135 and the second lumen 155 are maintained as separate lumens throughout the hub 120. In this case, the hub 120 can be coupled to a dual lumen sheath such that the first medical device 140 and the second medical device 160 are always separated when traversing the length of the sheath 110 for delivery into the arterial anatomy of a patient.

As shown in fig. 1, the second arm 150 may be arranged such that it branches 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 technique, this angle is no greater than 90 °. In this case, when the first medical device 140 is inserted into the first arm 130, it maintains a substantially straight shape within the hub 120 without having to be bent or kinked; 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 present technique, the first and second arms 130, 150 may be arranged such that they form a Y-shaped configuration relative to the longitudinal axis of the introducer sheath 110. In this case, both the first medical device 140 and the second medical device 160 can be bent 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 illustrates a configuration of a dual hub introducer sheath system 200 in accordance with aspects of the present technique. Sheath system 200 is similar to sheath system 100 in that it includes a sheath 210 having a proximal end 212 and a distal end 214 and a lumen extending between proximal end 212 and distal end 214 to facilitate passage and delivery of at least one medical device (e.g., first medical device 140 and second medical device 160 of fig. 1) to the arterial anatomy of a patient. The proximal end 212 of the sheath 210 is coupled to the connector port 270 of the hub 220. The hub 220 includes 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, the first lumen 235 being sealed from the environment by a first valve 238. Similarly, the second arm 250 forms a second lumen 255, the second lumen 255 being sealed from the environment by a second valve 258. As already described with respect to fig. 1, the first and second valves 238, 258 may include hemostasis valves and may be penetrable by the first and second medical devices. In some aspects of the present technique, as shown in fig. 2, the second lumen 255 is fluidly connected to the first lumen 235 within the hub 220. In other aspects of the present technique, the first lumen 235 and the second lumen 255 may be maintained as separate lumens within the hub 220. In some aspects of the present technique, the first and second valves 238, 258 may be inserted into position by snap caps (snap caps) to fix their positioning within the hub 220.

As shown in fig. 2 (and enlarged views 300 in fig. 3 and 4), the first arm 230 further includes a first side port 236 in fluid connection with the first lumen 235. Similarly, the second arm 250 includes a second side port 256 in fluid communication with a second lumen 255. Side port 236 and side port 256 can both serve as irrigation ports through which irrigation fluid can be injected to clear any thrombus that may form during treatment of the patient in lumens 235, 255 within hub 220. In other aspects of the present technique, the side ports 236, 256 can serve as inflation ports that are connected to an inflatable balloon within the hub 220, which can be inflated with an inflation fluid to expand the balloon to anchor or lock the positioning of the first and second medical devices 140, 160 relative to the respective arms through which the first and second medical devices 140, 160 are inserted. In such a case, the inflation balloon may compress the medical device against its corresponding arm to prevent axial movement of the medical device within the sheath once the device is deployed within the patient. Such locking mechanisms for securing the positioning of a first medical device to prevent axial movement during insertion or manipulation of a second medical device using an inner sheath balloon are known to those skilled in the art. Various locking mechanisms for securing the positioning of a first medical device against axial movement during insertion or manipulation of a second medical device using an inner sheath balloon are described, for example, in U.S. provisional patent application No. 62/797,527, which is hereby incorporated by reference in its entirety. Other locking mechanisms will be described in detail in the preceding sections. Although only one side port is shown on each arm in fig. 2 and 3, any number of side ports on each arm may be used within the scope of the present disclosure.

As described above, the second arm 250 may be disposed on the first arm 230 and configured to branch off from the first arm 230 at an angle of no more than 90 ° relative to the longitudinal axis of the sheath 210. Further, in some aspects of the present technique, 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 spaced sufficiently 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 necessarily abutting each other.

Referring to fig. 2 and 3, the hub 220 may optionally include a sewing ring 225 to assist in attaching the hub 220 to the patient after the first and second medical devices have been inserted into the patient. In certain aspects of the present technique, the sewing ring 225 may be positioned proximal to the connector port 270 because the profile of the hub 220 at this location may be less than the profile at a location proximal to the first arm 230 or the second arm 250. In other aspects of the present technique, the sewing ring 225 can be located anywhere along the body of the hub 220. Although only one sewing ring is shown in fig. 2 and 3, it should be understood that any number of sewing rings may be present to assist in securing the hub 220 to the patient.

To insert introducer sheath 210 into a patient, dilator 280 may be used in conjunction with dual hub 220. Fig. 2 and 3 also show a dilator 280 that has been inserted into the first arm 230 of the hub 220. Dilator 280 includes a proximal end 282 and a distal end 284. The length of the dilator is such that when the dilator 280 is fully inserted into the sheath 210, the distal end 284 extends beyond the distal end 214 of the sheath 210. As previously described, although first arm 230 and second arm 250 may take any configuration relative to the longitudinal axis of sheath 210 (e.g., a Y-shaped configuration), first arm 230 may be axially aligned with the longitudinal axis of sheath 210 in situations where dilator 280 is required to insert introducer sheath 210 into a patient. With this arrangement of the first arms 230, the dilator need not bend when inserted into the hub 220, which may allow for greater force to be applied when inserting the sheath 210 into a patient. Once inserted, the proximal end 282 of the dilator 280 may be connected to the proximal end 232 of the first arm 230. This may be done by any suitable type of connection, for example by a press fit or a twist connection.

As shown in figure 4, in some aspects of the present technique, an occluding device 490 may be inserted into the lumen 255 of the second arm 250. Such an occluder 490 may be inserted to prevent any backflow of fluid when the sheath 210 is inserted into a patient. This may be helpful in situations where the sheath 210 needs to be repositioned after the medical device has been removed from the first and second arms 230, 250. In such a case, due to their previous use, the respective seals 238, 258 may not be able to completely seal the lumens 235, 255 from the outside environment due to wear and tear. As with 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 by a press-fit or twist connection.

As described 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 technique, the locking mechanism may be biased. For example, in some aspects of the present technology, the locking mechanism may be biased in an unlocked state such that it does not restrict movement of the medical device unless action is taken to lock the locking mechanism. In contrast, in some aspects of the present technology, the locking mechanism may be biased in a locked state such that it restricts movement of the medical device unless action is taken to unlock the locking mechanism. In some aspects of the present technique, the locking mechanism may include an inner balloon located within the first lumen 235 or the second lumen 255, which is inflated by the sidearms 236, 256 as previously described. In some aspects of the present technique, the locking mechanism may further comprise a locking lever arm as shown in fig. 5A and 5B. Fig. 5A shows a cross-section of a hub 510 similar to the hubs 220 and 120 described previously. The hub 510 is shown with a first medical device 520 traversing therethrough, but it is understood that the hub 510 may allow multiple medical devices to pass therethrough. The hub 510 also includes a lever arm 530, and the lever arm 530 may be a separate component positioned within the hub body. Lever arm 530 may be configured to have a semi-circular shape as shown in FIGS. 5A and 5B, however any shape of arm suitable for securing medical device 520 and preventing axial movement thereof may be used.

As shown in fig. 5, lever arm 530 may be pivotally connected to 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 a 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 outer circumference of the medical device 520 when the lever arm 530 is in a locked orientation. In this orientation, as shown in fig. 5B, the notch 538 grips the medical device 520 to increase axial friction. In some aspects of the technology, the notch 538 can bend the medical device 520 when the lever arm 530 is in a locked position. In some aspects of the technique, the lever arms 530 may be located at the respective hemostasis valves 238, 258. Additionally, to secure the lever arm in a locked position, the end 534 of the lever arm 530 can be configured with a groove on its distal surface that engages a protrusion 536 located within the hub body. The side profile of end 534 and protrusion 536 is shown in fig. 5A. Similarly, fig. 5B shows end 534 engaged with tab 536. In some aspects of the technology, the lever arm 530 may be overmolded with a high friction material (e.g., low durometer polyurethane or silicone).

In addition to or in lieu of the locking mechanism described above, the dual hub of the present disclosure may also include a Tuohy Borst mechanism built into the first or second arm of the hub body. Such a mechanism includes a silicone slug (slug) whose inner diameter is reduced to the first medical device and/or the second medical device traversing the respective arm, thereby fixing the positioning of the medical devices.

As noted above, in some aspects of the present technique, sheath 210 may comprise a double lumen sheath. In this case, when the dual lumen sheath is coupled to the hub 220, the first lumen 235 of the hub 220 can be in fluid communication with one of the lumens of the dual lumen sheath and the second lumen 255 of the hub 220 can be in communication with the other lumen of the dual lumen sheath.

In some aspects of the present technique, the sheath 210 may comprise an expandable sheath. Expandable sheaths are well known to those skilled in the art and will not be described in detail herein. Various expandable sheaths are described, for example, in U.S. provisional patent application No. 62/797,527, which is incorporated herein by reference.

In some aspects of the present technique, the jacket 210 may comprise a peel-away jacket. The peel-away jackets are also well known to those skilled in the art and will not be described in detail herein. Various peel-away sheaths are described, for example, in U.S. provisional patent application No. 62/777,598, which is hereby incorporated by reference in its entirety. 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 the sheath to be pulled apart as needed during patient treatment.

In some aspects of the technique, the hub 220 may include wings that enable the hub 220 itself to be detached when it is no longer needed (e.g., when one or more of the medical devices are positioned within a patient).

In some aspects of the technique, jacket 210 may be extruded and/or laminated. In some aspects of the technique, the introducer sheath 110, 210 may include at least one of: polyether block amides (e.g. polyether block amides)Or) (ii) a 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 present technique, the hubs 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 copolymers (SBC); styrene Ethylene Butylene Styrene (SEBS); a High Density Polyethylene (HDPE) material; a Medium Density Polyethylene (MDPE) material; a Low Density Polyethylene (LDPE) material; polyetheretherketone (PEEK); polyether block amides (e.g. polyether block amides)Or) (ii) a An elastomer; synthesizing rubber; a polyethylene, polyurethane or polycarbonate material having a modulus of elasticity of about 40 ksi; a crack resistant material; or a material having a low coefficient of friction.

As mentioned in the foregoing description, the dual hub introducer sheath of the present disclosure is designed to facilitate traversal of catheter-based medical devices (e.g., a first medical device and a second medical device) within a lumen of the introducer sheath. In some aspects of the technique, 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 the patient. These PCsI surgery 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^TMAnd REBEL^TMBare metal platinum chromium coronary stents, and SYNERGY^TMBioabsorbable polymeric stents, all of which are manufactured by Boston Scientific, marburg, massachusetts. In some aspects of the technology, a mechanical circulatory support apparatus can include a rotary blood pump having a cannula, a rotor, and a rotor housing. Examples of such blood pumps include, but are not limited toPumps, extracorporeal membrane pulmonary oxygenation (ECMO) pumps, and balloon pumps.The pump may also include ImpellaPump, ImpellaPump, ImpellaPumps or ImpellaPumps, all of which are manufactured by Abiomed corporation of dandy, massachusetts.

In some aspects of the technology, the first medical device and the second medical device may be used with a dual hub introducer sheath, such as the left ventricular unloading method described in U.S. patent application No. 16/244,998, which is hereby incorporated by reference in its entirety, as described in procedures using PCI and percutaneous ventricular assist devices together, as described above.

Fig. 6 illustrates an exemplary method 600 of using a dual hub introducer sheath (e.g., any of the introducer sheaths described in the foregoing description) in accordance with aspects of the present technique. The method 600 will be described with respect to the exemplary systems depicted in fig. 1-5 above. Prior to use of the dual hub introducer sheath, the sheath 210 is positioned into the patient's arterial anatomy (not indicated in FIG. 6). Prior to insertion of the sheath 210 into the patient, a connector port of the hub (e.g., connector port 270 of hub 220 as described above) is coupled to the proximal end of the introducer sheath (e.g., end 212 of sheath 210 as described above). In some aspects of this technique, a dilator (e.g., dilator 280 shown in fig. 2 and 3) may be inserted into the lumen of the sheath prior to insertion into the patient. The dilator aids 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 lumen of the sheath.

In step 610, a first medical device 140 is inserted into the first arm 230 of the dual hub 220. Here, the first medical device 140 is pushed through the first hemostasis valve 238 and across the hub 220 toward 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 the hub 220 toward the connector port 270. In step 630, a first medical device and a second medical device are provided to the lumen of sheath 210 via connector port 270 of hub 220. In step 640, the first and second medical devices are delivered into the patient's arterial anatomy 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.

Once in place in the patient's arterial anatomy, the medical device may be used to treat the patient as desired. In some aspects of this technique, a dual hub introducer sheath may be used to unload the left ventricle of a patient, as shown in the exemplary method 700 of fig. 7. In this case, 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 Percutaneous Coronary Intervention (PCI) to the patient. Referring 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 to a location in the left ventricle of the heart. The first medical device 140 may then be locked in place via a locking mechanism located on the first arm 230 of the hub 220. As already discussed, such a locking mechanism may comprise any one of the following: a Tuohy-Borst adapter, an inflatable balloon, and a locking lever arm. In step 720, the mechanical circulation device is operated in the left ventricle for a support period of more than 30 minutes. In some aspects of the technology, the mechanical circulation device may operate at a blood flow rate of 2.5L/min. 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 place via the locking mechanism located on the second arm 250 of the hub 220 as previously described. As described above, in step 740, reperfusion therapy is applied to the coronary vessels via the PCI device after the stenting period has elapsed. The reperfusion therapy may be performed in parallel with or subsequent to operation of the mechanical circulation device.

In some aspects of the present technique, the various steps discussed above with respect to the methods 600 and 700 of fig. 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 above description is meant as an illustration only of the principles of the present technology. Thus, the apparatus and methods described herein may be practiced otherwise than as described, which are presented for purposes of illustration and not of limitation. It should be understood that while the systems, devices, and methods disclosed herein are described with reference to certain procedures, they may be applied in any environment in which it is desirable to access a patient's arterial anatomy without creating multiple access sites in the patient's vasculature. Furthermore, 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 in other systems. Finally, certain features may be omitted or not implemented without departing from the spirit of the present technology.