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EP-4188511-B1 - SECUREMENT DEVICES FOR INTRACARDIAC BLOOD PUMP SYSTEMS

EP4188511B1EP 4188511 B1EP4188511 B1EP 4188511B1EP-4188511-B1

Inventors

  • SHEILS, Christopher, W.
  • RODRIGUES-BRIMMERS, Cristine, Gracinda
  • SCHAEFER, ROBERT

Dates

Publication Date
20260506
Application Date
20210728

Claims (9)

  1. A device (131; 200; 300; 400) for securing an intravenous or intra-arterial medical device (122), comprising: a flexible sleeve (210) having a first lumen (212) configured to receive at least a portion of the intravenous medical device (122), a button (202; 302; 402) having a bore (220) configured to receive at least a portion of the flexible sleeve (210), a spring element (214), and a housing (201; 301; 401) comprising a second lumen (226) configured to house the flexible sleeve (210) and a cavity (219) configured to house the button (202; 302; 402) and the spring element (214), wherein the spring element (214) is configured to exert a force on the button (202; 302; 402) tending to cause the bore (220) to compress the flexible sleeve (210) unless the button (202; 302; 402) is being held in a depressed state, characterized in that the housing (201; 301; 401) comprises either a hemostasis valve (131) or at least one slot configured to accept at least one peg (131a) of a hemostasis valve (131) when the housing (201; 301; 401) is coupled with the hemostasis valve (131).
  2. The device of claim 1, wherein the housing (201; 301; 401) comprises at least one protrusion (130) with at least one eyelet (130a - 130d), the at least one protrusion (130) configured to enable the housing to be sutured to a patient's skin.
  3. The device of claim 1 or 2, wherein the at least one slot and the at least one peg (131a) comprise a bayonet connection.
  4. The device of claim 3, wherein the at least one slot further comprises at least one eyelet (204) configured to engage with the at least one peg (131a).
  5. The device of claim 3, wherein the at least one slot further comprises at least one detent configured to engage with the at least one peg (131a).
  6. The device of one of claims 1 to 5, wherein the housing (201; 301; 401) further comprises a seal configured to deform when the housing (201; 301; 401) is coupled with the hemostasis valve (131).
  7. A sheath assembly (100), comprising: a sheath body (152) configured for insertion into a patient's vasculature and for receiving at least a portion of an intravenous or intra-arterial medical device (122) a sheath hub (154) coupled to a proximal end of the sheath body (152); and a device (131; 200; 300; 400) according to any of claims 1 to 6 for securing the intravenous or intra-arterial medical device (122), said device being integral with the sheath hub or configured to couple with the sheath hub.
  8. The sheath assembly of claim 7, wherein the sheath hub (154) comprises at least one protrusion with at least one eyelet, the at least one protrusion configured to enable the sheath hub (154) to be sutured to a patient's skin.
  9. The sheath assembly of claim 7 or 8, wherein the sheath hub (154) further comprises a hemostasis valve.

Description

BACKGROUND Intracardiac heart pump assemblies can be introduced into the heart either surgically or percutaneously and used to deliver blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed in the heart, an intracardiac pump can pump blood from the left ventricle of the heart into the aorta, or pump blood from the inferior vena cava into the pulmonary artery. Intracardiac pumps can be powered by a motor located outside of the patient's body (and accompanying drive cable) or by an onboard motor located inside the patient's body. Some intracardiac blood pump systems can operate in parallel with the native heart to supplement cardiac output and partially or fully unload components of the heart. Examples of such systems include the IMPELLA® family of devices (Abiomed, Inc., Danvers Mass.). In one common approach, an intracardiac blood pump is inserted by a catheterization procedure through the femoral artery using a sheath, such as a peel away introducer sheath. The sheath can alternatively be inserted in other locations such as in the femoral vein or any path for delivery of a pump for supporting either the left or right side of the heart. The introducer sheath can be inserted into the femoral artery through an arteriotomy to create an insertion path for the pump assembly. A portion of the pump assembly is then advanced through an inner lumen of the introducer and into the artery. In some cases, once the pump assembly has been inserted, a narrower repositioning sheath may be inserted into the introducer sheath, and the introducer sheath may be peeled away. The repositioning sheath may be equipped with a structure for securing the repositioning sheath assembly to the patient. For example, the proximal hub of the repositioning sheath assembly may have a butterfly structure that may be sutured to the skin of the patient. In some cases, the introducer sheath may remain in place even after the pump assembly has been inserted. In such cases, a repositioning sheath may or may not be used in addition to the introducer sheath. Where a repositioning sheath is used, it may, for example, be inserted within the introducer sheath. In some cases, the repositioning sheath may be configured to fit within the lumen of the introducer sheath. In some cases, the lumen of the introducer sheath may be configured to expand to permit the repositioning sheath to be inserted therein. In some cases, the introducer sheath may be configured such that the repositioning sheath is not inserted into the lumen of the introducer sheath. Where the introducer sheath remains in place, it may also be equipped with a structure (e.g., a suture butterfly) for securing the introducer sheath assembly to the patient. Regardless of whether an introducer sheath, repositioning sheath, or both remain in use after the insertion of the pump assembly, a securement device may be used to hold the catheter of the pump assembly in relation to the sheath(s) through which it has been inserted. For example, a Tuohy-Borst device may be attached or incorporated into to a hub of the introducer sheath or repositioning sheath. Turning a barrel of the Tuohy-Borst device in one direction compresses a deformable internal component (e.g., a deformable ring or sleeve), which can thus be used to form a seal against the catheter of the pump assembly and resist movement of the catheter within the Tuohy-Borst device. Turning the barrel of the Tuohy-Borst device in the other direction allows the deformable internal component to relax, thus permitting movement of the catheter. However, because a Tuohy-Borst device will not restrict movement of the catheter without a deliberate action by the operator, it is possible for it to be inadvertently left in an open or semi-open position. Likewise, because a Tuohy-Borst device can provide variable amounts of resistance, an operator may accidentally under-tighten it or it may be unintentionally loosed (e.g., due to movements by the patient), allowing the catheter to move after it has been placed in its desired location. Patent document DE4213691 discloses features falling under the preamble of claim 1. BRIEF SUMMARY The present technology relates to improved securement devices for use with intracardiac blood pump assemblies. More particularly, the present technology provides securement devices that may be used with a sheath assembly (e.g., an introducer sheath assembly, repositioning sheath assembly), and which are configured to restrict movement of the catheter of the pump assembly within the sheath assembly except when a mechanism (e.g., button) of the securement device is actively being actuated (e.g., pressed, held, etc.). As will be explained in further detail below, the securement devices of the present technology may be provided as a modular unit that can be attached to a hub or a hemostasis valve of an introducer sheath or a repositioning sheath assem