EP4590239A2 - Ensemble poignée pour pompes à sang de cathéter - Google Patents

Ensemble poignée pour pompes à sang de cathéter

Info

Publication number
EP4590239A2
EP4590239A2 EP23869152.1A EP23869152A EP4590239A2 EP 4590239 A2 EP4590239 A2 EP 4590239A2 EP 23869152 A EP23869152 A EP 23869152A EP 4590239 A2 EP4590239 A2 EP 4590239A2
Authority
EP
European Patent Office
Prior art keywords
assembly
handle body
strain relief
motor assembly
coupling member
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23869152.1A
Other languages
German (de)
English (en)
Inventor
Daniel VARGHAI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Supira Medical Inc
Original Assignee
Shifamed Holdings LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shifamed Holdings LLC filed Critical Shifamed Holdings LLC
Publication of EP4590239A2 publication Critical patent/EP4590239A2/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/585—User interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/414—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/592—Communication of patient or blood pump data to distant operators for treatment purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/586—Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users

Definitions

  • Intra-aortic balloon pumps are used to support circulatory function, such as treating heart failure patients.
  • An IABP is typically placed within the aorta, and inflated and deflated in counter-pulsation fashion with the heart contractions, with one function being to provide additive support to the circulatory system.
  • lABPs Use of lABPs is common for treatment of heart failure patients, such as supporting a patient during high-risk percutaneous coronary intervention (HRPCI), stabilizing patient blood flow after cardiogenic shock, treating a patient associated with acute myocardial infarction (AMI) or treating decompensated heart failure.
  • HRPCI high-risk percutaneous coronary intervention
  • AMI acute myocardial infarction
  • Such circulatory support may be used alone or in with pharmacological treatment.
  • minimally invasive rotary blood pumps have been developed, which are inserted into the body in connection with the cardiovascular system to pump arterial blood from the left ventricle into the aorta to add to the native blood pumping ability of the left side of the patient’s heart.
  • Another known method is to pump venous blood from the right ventricle to the pulmonary artery to add to the native blood pumping ability of the right side of the patient’s heart.
  • An overall goal is to reduce the workload on the patient’s heart muscle to stabilize the patient, such as during a medical procedure that may put additional stress on the heart, to stabilize the patient prior to heart transplant, or for continuing support of the patient.
  • the smallest rotary blood pumps currently available may be percutaneously inserted into the vasculature of a patient through an access sheath, thereby avoiding more extensive surgical intervention, or through a vascular access graft.
  • One such device is a percutaneously inserted ventricular support device.
  • the disclosure is related to intravascular blood pump and methods of their use.
  • an intravascular blood pump system can comprise a catheter shaft extending through a lumen of a catheter.
  • the catheter shaft can have a proximal end and a distal end, where the distal end can be operably coupled to an intravascular impeller locatable within a vessel.
  • a handle can comprise a sealed housing, a motor in operable communication with the catheter shaft proximal end, and a fluid pump operably coupled to the motor.
  • the catheter shaft proximal end can be removably coupled to a rigid member extending through a sealed strain relief at a distal end of the handle.
  • the system can further comprise a cradle assembly locatable around an exterior surface of the motor within the handle, the cradle assembly can have one or more surfaces configured to retain a circuit board thereon.
  • a cradle assembly comprises one or more routing channels that can be configured to route one or more tubes within the sealed housing.
  • the catheter shaft proximal end can be configured to engage a ball seal connector at a distal end of the rigid member.
  • the system can further comprise a one or more conduits extending through a proximal strain relief configured to transition one or more electrical connections to a circuit board on the cradle assembly.
  • the system can further comprise a catheter introducer having a proximal end configured to axially engage a sheath hub.
  • the catheter can be a multi-layer catheter comprising at least one braid layer, the brain layer comprising one or more braid angles configured to conserve rotation from a proximal end of the multi-layer catheter to a distal end of the multi-layer catheter.
  • the housing can be fluid-sealed.
  • the system can further comprise one or more sensors operably connected to a circuit board locatable on the cradle assembly.
  • the system can further comprise a pressure sensor configured to determine pressure of a fluid passing through the intravascular pump system.
  • the system can further comprise a flow sensor configured to determine a flow rate of a fluid within the intravascular pump system.
  • the system can further comprise a data transmission module configured to transfer data obtained within the system to one or more peripheral devices.
  • circuit board carrier assembly can comprise a cradle having one or more mounting surfaces configured to receive one or more circuit boards, and one or more routing channels configured to route conduit therethrough, wherein the cradle is couplable to a motor assembly.
  • the cradle can be locatable within a handle of an intravascular blood pump system.
  • the routing channels comprising an attachment mechanism configured to retain the conduit.
  • the cradle can be releasably coupled to an exterior surface of the motor assembly.
  • the circuit board carrier assembly can further comprise a curved inner surface, wherein the motor assembly can be generally cylindrical.
  • the cradle frictionally positioned on an exterior surface of the motor assembly.
  • the circuit board carrier assembly can further comprise a sealed housing having a proximal strain relief and a distal tapered strain relief configured to transition conduit from an exterior of the sealed housing to the cradle within the sealed housing.
  • the circuit board carrier assembly can further comprise one or more attachment elements configured to engage the interior of the sealed housing.
  • the circuit board carrier assembly can further comprise the motor assembly, wherein the cradle is coupled to the motor assembly and both the motor assembly and cradle are removable from within the sealed housing.
  • a method of operating a self-expanding blood pump within a patient can comprise the steps of inserting a compressed self-expanding blood pump within a sheathing sleeve through a proximal opening of an introducer sheath, the introducer sheath extending from its proximal opening disposed outside the patient distally into a blood vessel of the patient. Then, advancing the sheathing sleeve within the introducer sheath until a distal opening of the sheathing sleeve can be at or beyond a distal opening of the introducer sheath.
  • the method can further comprise positioning the self-expanding blood pump within the blood vessel by rotating the handle body, wherein a drive cable catheter can be configured to rotate the self-expanding blood pump correspondingly to rotation of the handle body.
  • the drive cable extends through a multi-layer drive cable catheter coupled to a distal end of the handle body, the multi-layer drive cable catheter configured to maintain even torque from the handle body to the self-expanding blood pump.
  • the method can further comprise detecting a flow rate of a fluid from the blood pump to a motor assembly within the handle housing, wherein a one or more sensors can be configured to detect the flow rate.
  • a catheter handle device comprising a handle body; a strain relief assembly partially disposed within the handle body, the strain relief assembly providing access for an elongate member to pass from an interior of the handle body to an exterior of the handle body, the strain relief assembly comprising a coupling member that is attached to the handle body and a strain relief member attached to the coupling member and extending from the handle body, wherein the strain relief member is more flexible than the coupling member.
  • the strain relief member comprises a first polymer and the coupling member comprises a second polymer.
  • the strain relief member is molded over a distal portion of the coupling member.
  • the coupling member comprises a first coupling portion and a second coupling portion separated by a gap.
  • the gap of the coupling member is configured to receive a tab or extension of the handle body.
  • the strain relief assembly is rotatable within the handle body when the tab or extension of the handle body is inserted into the gap of the coupling member.
  • the gap includes an inner surface that is disc-shaped to facilitate rotation of the strain relief assembly.
  • the strain relief member forms a fluidic seal with an interior of the handle body.
  • the strain relief member includes one or more sealing elements.
  • the sealing elements comprise raised portions or o-rings.
  • a lumen of the coupling member is in communication with a lumen of the strain relief member.
  • the strain relief member is a flexible or compliant material and the coupling member is a substantially rigid material.
  • the elongate member comprises a drive cable of a motor assembly.
  • the handle body comprises a clamshell design with a first handle body portion coupled to a second handle body portion.
  • an o-ring is provided between the first and second handle body portions to fluidically seal the handle body portion.
  • the device includes a motor assembly disposed in the handle body and supported by the one or more mounting elements.
  • the cradle assembly is configured to at least partially conform to an outer surface of the motor assembly.
  • an electrical connection is included on the motor assembly configured to be electrically coupled to the PCB.
  • the electrical connection passes through an opening on the cradle assembly.
  • the strain relief assembly and the coupling assembly are co-molded polymers.
  • a catheter blood pump handle assembly comprising a handle body; a motor assembly disposed within the handle body; a strain relief assembly partially disposed within the handle body, the strain relief assembly providing access for a drive cable to pass from the motor assembly to a catheter blood pump external to the handle body, the strain relief assembly comprising a coupling member that is attached to the handle body and a strain relief member attached to the coupling member that extends from the handle body and forms a fluidic seal with the handle body.
  • the catheter blood pump handle assembly includes a cradle assembly removably coupled to the motor assembly, the cradle assembly comprising at least one printed circuit board (PCB) disposed on the cradle assembly.
  • PCB printed circuit board
  • the cradle assembly is configured to at least partially conform to an outer surface of the motor assembly.
  • the PCB further comprises electronics configured to control operation of the motor assembly.
  • an electrical connection on the motor assembly is configured to be electrically coupled to the PCB.
  • the electrical connection passes through an opening on the cradle assembly.
  • the strain relief member comprises a first polymer and the coupling member comprises a second polymer.
  • the strain relief assembly is molded over a distal portion of the coupling member.
  • the strain relief member and the coupling member comprise co-molded polymers.
  • the strain relief member is more compliant than the coupling member.
  • the coupling member comprises a first coupling portion and a second coupling portion separated by a gap.
  • the gap of the coupling member is configured to receive a tab or extension of the handle body.
  • the strain relief assembly is rotatable within the handle body when the tab or extension of the handle body is inserted into the gap.
  • the gap includes an inner surface that is disc-shaped to facilitate rotation of the strain relief assembly.
  • the strain relief member includes one or more sealing elements.
  • the sealing elements comprise raised portions or o-rings.
  • a lumen of the coupling member is in communication with a lumen of the strain relief member.
  • the strain relief member is a flexible or compliant material and the coupling member is a substantially rigid material.
  • a circuit board carrier assembly comprising a frame dimensioned and configured to receive a rotational motor assembly, one or more exterior mounting surfaces on the frame configured to receive one or more printed circuit boards (PCBs), and one or more openings in the frame configured to route a wire therethrough to an electrical connection of the rotational motor assembly.
  • the circuit board carrier assembly includes one or more attachment mechanisms on the frame configured to be removably coupled to a mounting bracket of the rotational motor assembly.
  • the one or more attachment mechanisms comprise openings configured to engage with tabs of the mounting bracket.
  • the interior surface of the frame comprises a curved inner surface, wherein the rotational motor assembly is generally cylindrical.
  • the circuit board carrier assembly includes one or more PCB’s coupled to the exterior mounting surface.
  • the frame is generally U-shaped. In other aspects, the frame is generally C-shaped.
  • the circuit board carrier assembly includes one or more routing channels on the one or more exterior surface configured to receive one or more conduits.
  • the frame comprises an interior surface portion configured to at least partially conform to a portion of the rotational motor assembly.
  • the frame is configured to cover at least three sides of the rotational motor assembly.
  • FIG. 1 is a side view of an exemplary blood pump that includes an expandable scaffold that supports a blood conduit with an impeller housed therein.
  • FIG. 2 is a perspective view of a blood pump system that includes the expandable blood pump distal to a handle body within a catheter therebetween, as described herein.
  • FIG. 3 A is a perspective view of handle body operably showing the distal end including a strain relief and sealed housing, as described herein.
  • FIG. 3B is a perspective view of handle body operably showing the distal end including a strain relief at a proximal end and sealed housing, as described herein.
  • FIGS. 4 A and FIG. 4B show an example of a motor assembly locatable within the handle body including a proximal and distal strain relief, as described herein.
  • FIGS. 5A-5B illustrate an example of an interior arrangement of a motor assembly within a handle body, as described herein.
  • FIGS. 6 A and FIG. 6B are detailed views of a motor assembly cradle, as described herein. DETAILED DESCRIPTION
  • the present disclosure is related to medical devices, systems, and methods of use and manufacture.
  • described herein are pumps adapted to be disposed within a physiologic vessel, wherein the distal pump portion includes one or more components that act upon fluid.
  • the pumps herein may include one or more rotating members that when rotated, can facilitate the movement of a fluid such as blood.
  • FIG. 1 shows a side view of an exemplary intravascular catheter blood pump 100.
  • the blood pump 100 includes an expandable/collapsible blood conduit 102 that is configured to transition between an expanded state, as shown in FIG. 1, and a collapsed or delivery state (not shown).
  • the conduit 102 may be in the collapsed state when confined within a delivery catheter for delivery to the heart, expanded upon release from the delivery catheter for blood pumping, and collapsed back down within the delivery catheter (or other catheter) for removal from heart.
  • the conduit 102 When in the expanded state, the conduit 102 is radially expanded so as to form an inner lumen for passing blood therethrough.
  • the inner lumen of the conduit 102 When in the expanded state, the inner lumen of the conduit 102 may be configured to accommodate blood pumped by one or more impellers therein.
  • the one or more impellers may be collapsible so that they may collapse to a smaller diameter when the conduit 102 is in the collapsed state.
  • the one or more impellers may be positioned within one or more impeller regions of the conduit 102.
  • the impeller region(s) of the conduit 102 is/are radially stiffer than other regions (e.g., adjacent regions) of the conduit 102 to prevent the impeller(s) from contacting the interior walls of the
  • the blood pump 100 includes an impeller 104 within a proximal portion of the conduit 102.
  • the blood pump 100 can include more than one impeller.
  • the blood pump 100 may include a second impeller in a distal region 122 of the fluid conduit 102.
  • blood pump 100 may include more than two impellers.
  • the conduit 102 includes a first (e.g., proximal) end having a first (e.g., proximal) opening 101, and a second (e.g., distal) end having a second (e.g., distal) opening 103.
  • the first opening 101 and second opening 103 may be configured as an inlet and outlet for blood.
  • blood may largely enter the conduit 102 via the second (e.g., distal) opening 103 and exit the conduit 102 via the first (e.g., proximal) opening 101.
  • the second opening 103 acts as a blood inlet
  • the first opening 101 acts as a blood outlet.
  • the one or more impellers e.g., impeller 104
  • the second opening 103 e.g., inlet
  • the first opening 101 e.g., outlet
  • the first opening 101 e.g., outlet
  • the conduit 102 includes a tubular expandable/collapsible scaffold 106 that provides structural support for a membrane 108 that covers at least a portion of inner surfaces and/or outer surfaces of the scaffold 106.
  • the scaffold 106 includes a material having a pattern of openings with the membrane 108 covering the openings to retain the blood within the lumen of the conduit 102.
  • the scaffold 106 may be unitary and may be made of a single piece of material.
  • the scaffold 106 may be formed by cutting (e.g., laser cutting) a tubular shaped material.
  • Exemplary materials for the scaffold 106 may include one or more of nitinol, cobalt alloys, and polymers, although other materials may be used.
  • the blood pump 100 includes proximal struts 112a that extend from the scaffold 106 near the first opening 101 (e.g., blood outlet region) and distal struts 112b that extend from the scaffold 106 near the second opening 103 (e.g., blood inlet region).
  • the proximal struts 112a are coupled to first hub 114a of a proximal shaft 110.
  • the distal struts 112b are coupled to second hub 114b of a distal portion 114.
  • the first hub 114a includes a bearing assembly through which a central drive cable 116 extends.
  • the drive cable 116 is operationally coupled to and configured to rotate the impeller 104.
  • the impeller 104 is fully positioned axially within the conduit 102. In other cases, a proximal portion of the impeller 104 is positioned at least partially outside of the conduit 102. That is, at least a portion of the impeller may be positioned in axially alignment with a distal portion of the struts 112a.
  • the conduit 102 and the scaffold 106 may characterized as having a proximal region 118, a central region 120, and a distal region 122.
  • the central region 120 may be configured to be placed across a valve (e.g., aortic valve) such that the proximal region 118 is at least partially within a first heart region (e.g., ascending aorta) and the distal region 122 is at least partially within a second heart region (e.g., left ventricle).
  • the proximal region 118 (and in some cases the distal region 122) may be configured to house an impeller therein.
  • the proximal region 118 may (and in some cases the distal region 122) has a stiffness sufficient to withstand deformation during operation of the blood pump 100 when within the beating heart and to maintain clearance (i.e., a gap) between an impeller region of the blood pump 100 and the rotating impeller 104.
  • the distal region 122 includes the second (e.g., distal) opening 103 of the conduit 102, and may serve as the blood inlet for the conduit 102.
  • the central region 120 may be less rigid relative to the proximal region 118 (and in some cases the distal region 122).
  • a distal tip 124 of the blood pump 100 is curved to form an atraumatic tip.
  • the distal tip 124 flexible (e.g., laterally bendable) to enhance the atraumatic aspects of the distal tip 124.
  • the distal tip 124 may be sufficiently flexible to bend when pressed against tissue (e.g., by a predetermined amount of force) to prevent puncture of the tissue.
  • a distal end or portion of a drive cable can be operably coupled to one or more impellers of the blood pump.
  • a motor assembly can be operationally coupled to or near a proximal end of the drive cable.
  • the motor can be configured to rotate or otherwise control operation of the one or more impellers.
  • the motor assembly can be configured to rotate one or more impellers of the blood pump during use.
  • FIG. 3 A shows a perspective view of a handle 326 that can be used in operation of an intravascular blood pump.
  • the handle can be positionable outside of a patient during use and may be configured to control or otherwise impact the function, placement, deployment, data acquisition, sensing, etc. of the blood pump and/or associated elements.
  • the handle may have a handle body 330 with one or more portions configured to be coupled to one another.
  • a first handle body portion 332a is coupled (e.g., attached, sealed, affixed, engaged, etc.) to a second handle body portion 332b.
  • the housing may have a distal strain relief 334 provided at a distal portion of the handle where the catheter shaft 310 of the blood pump enters/exits the handle. The distal strain relief can facilitate a connection and/or transition of the catheter shaft 310 to motor and fluid connections within the handle 326.
  • both the strain relief 434 and the coupling member 440 can comprise lumens or openings configured to receive a shaft or elongate member.
  • catheter shaft 410 of the catheter blood pump can be seen entering a distal end of the strain relief 434 and passing through the strain relief 434 before entering the coupling member 440.
  • a lumen of the strain relief 434 can be in communication with a lumen of the coupling member.
  • a distal end of the strain relief coupling member 440 is shown coupled to a proximal end of the strain relief 315 such that the drive cable 444 and/or the catheter shaft 410 can be configured to extend from inside of the handle body to an exterior of the handle body through the strain relief and the coupling member.
  • One or more toroidal elements 446 may be coupled to the motor assembly 428 and can be configured to provide support and/or a contact point for mounting of the motor assembly 428 to an interior of the handle.
  • a toroidal element may be an o-ring configured to dampen, reduce, prevent, or eliminate vibration of the motor assembly during operation.
  • one or more o-rings may be positioned around the motor assembly to create or support a fluidic seal between the handle body and/or the motor assembly within the handle body.
  • the motor assembly 428 may include fluid flow through one or more elements of the motor assembly.
  • FIGS. 4A-4B include fluid couplers 448 that can be configured to engage tubing and direct a flow of fluid through the tubing and the motor assembly.
  • the fluid couplers can also provide a flow of fluid to the catheter pump via the catheter shaft, such as for purging fluid during a cardiac support procedure.
  • fluid flowing through the motor assembly may be configured to flush one or more elements of a blood pump system.
  • a fluid configured to flush the blood pump may flow through the handle body (e.g., through tubing routed through the handle body) and continue distally from the motor assembly through an elongate member (e.g., catheter) to a blood pump positioned at a distal end.
  • the fluid may be configured to flush the blood pump during use.
  • a fluid configured to flush a blood pump system can be saline, water (e.g., sterile water), or other fluid configured to flush (e.g., flow) through an elongate member from the handle body to a blood pump located within a patient.
  • more than one fluid may flow through the handle body (e.g., through tubing routed within the handle body) and the motor assembly.
  • a priming fluid, flush fluid, lubricating fluid, body fluid e.g., blood
  • body fluid e.g., blood
  • tubing routed through (e.g., within) the handle body (e.g., motor assembly) can be configured to receive one or more different types of fluids.
  • tubing routed through (e.g., within) the handle body (e.g., motor assembly) can be configured to receive the same type of fluid.
  • FIG. 5 A shows a view of handle 526 that includes a handle body 530 and a motor assembly 528 mounted within the handle body. This view also shows cradle assembly 554 mounted on the motor assembly 528. Tabs 552 of the motor assembly mounting bracket can be seen extending through and engaging with openings 556 in the cradle assembly.
  • the cradle assembly 554 may be configured to optimize attachment, organization, routing, orientation, positioning, operation, etc. of components within the handle.
  • the cradle assembly 554 can be configured to receive additional elements within the handle body.
  • the cradle assembly can provide for one or more mounting surfaces configured to receive a printed circuit board (PCB) thereon.
  • PCB printed circuit board
  • FIG. 5 A shows the cradle assembly 554 mounted onto the motor assembly 528 (via the mounting platform) without a PCB mounted thereon
  • FIG. 5B shows the cradle assembly 554 with at least one PCB 556 mounted thereon.
  • the PCB can include, for example, one or more processors, electrical components, or chip components 557 disposed thereon.
  • an electrical connection 558 on the motor assembly can be electrically connected to the PCB 556.
  • the electrical connection between the PCB and e.g., a wire
  • the PCB and electrical components disposed thereon can control operation of the motor assembly and other electrical components of the catheter blood pump.
  • the handle body 530 can further include mounting posts or elements 562 configured to support the motor assembly 528.
  • the mounting posts or elements 562 can be integrated into the handle body, such as integrated within the handle body portion 532b.
  • the mounting posts or elements 562 can directly contact the motor assembly. In other embodiments, they can contact toroidal elements or o-rings 546 to reduce vibrations imparted by the motor assembly 528 on the handle 526.
  • the mounting posts or elements 562 are positioned near a proximal and distal end of the motor assembly 528, to provide support for the motor assembly within the handle.
  • FIGS. 5A-5B also show the attachment or coupling between the strain relief 534/ strain relief coupling member 540 and the handle body 530.
  • the handle body can include extensions or tabs 564 configured to reside within the gap 543 of the strain relief coupling member 540.
  • the coupling member may be retained within the handle body with extensions or tabs 564 while still allowing for rotation of the strain relief relative to the handle body (e.g., allowing for rotation of the extensions or tabs within the gap).
  • the strain relief 534 can also provide a fluidic seal between an interior and exterior of the handle body.
  • the strain relief may include one or more o-rings, raised portions, or sealing members 566 configured to engage with an interior of the handle body and assist in retaining the strain relief to the handle body.
  • Contact between the handle body and the strain relief/strain relief sealing members can be configured to maintain a fluid seal for the interior of the handle body.
  • the handle body can be fluidically sealed.
  • One or more gaskets may be locatable between contacting surfaces of the handle body portions. For example, in FIG.
  • channel 568 is shown generally around a perimeter of the second handle body portion 532b and can be configured to receive a first handle body portion in a fluid-sealed engagement.
  • the channel 568 can be configured to receive a gasket configured to seal contact between handle body portions.
  • Additional structures of the handle body, motor assembly, strain reliefs, etc. can be configured to facilitate and promote a fluid seal of the handle body.
  • strain reliefs can be configured to receive one or more handle body portions in a fluid seal engagement.
  • FIGS. 6A-6B show additional details of a cradle assembly 654 that can comprise a frame.
  • a portion of an interior surface 670 of the cradle assembly 654 is configured to conform to and engage at least a portion of the motor assembly.
  • the interior surface 670 can include a curvature configured to correspond to the shape (e.g., a curvature) of an exterior portion of the motor assembly.
  • the interior curve of the cradle assembly interior surface portion can extend between one or more sidewalls 672.
  • a motor assembly cradle can be configured to engage a motor assembly around a portion of the motor assembly exterior perimeter to allow for easy removal of the cradle from the motor assembly.
  • the cradle assembly can be shaped to facilitate easy installation and removal of the motor assembly from the cradle.
  • the cradle assembly can comprise a generally U-shaped or C-shaped design in which the frame can slide over a motor assembly for attachment to the motor assembly mounting bracket.
  • the cradle assembly can be configured to cover at least three sides of the motor assembly when the cradle assembly is mounted to the motor assembly.
  • FIG. 6A shows one or more mounting points 674 where a circuit board (e.g., PCB) may be attached, such as with screws or rivets. Also shown are openings or attachment points 654 for attachment to the motor assembly mounting platform, and opening 660 for electrical connection between the motor assembly and the PCB. Additionally, the cradle assembly can be configured to route one or more conduits, tubing, wires, etc. within the handle body. One or more channels 676 may be positioned on the cradle and configured to receive a length of conduit, tubing, wire, etc. therethrough.
  • a circuit board e.g., PCB
  • openings or attachment points 654 for attachment to the motor assembly mounting platform
  • opening 660 for electrical connection between the motor assembly and the PCB.
  • the cradle assembly can be configured to route one or more conduits, tubing, wires, etc. within the handle body.
  • One or more channels 676 may be positioned on the cradle and configured to receive a length of conduit, tubing, wire,
  • the handle assemblies described herein may include one or more sensors, which may be in electrical communication or coupling to the PCB, motor assembly, or other system components as described herein.
  • One or more sensors may be configured to acquire data associated with an intravascular blood pump.
  • one or more sensors may be in operable communication with the motor assembly. For example, a flow of fluid may be directed through the handle (e.g., through the motor assembly) and one or more sensors may be configured to sense (e.g., acquire) attributes of the fluid flowing therethrough.
  • One or more sensors may be a pressure sensor configured to sense a pressure of fluid flowing through the intravascular blood pump assembly.
  • One or more pressure sensors may be locatable on, in or near the motor assembly and configured to acquire attributes of the fluid flowing through the motor assembly.
  • one or more pressure sensors may be configured to sense a pressure of fluid flowing through the motor assembly.
  • one or more pressure sensors can be configured to detect purge pressure.
  • a catheter purge line may engage a fluid coupler and route fluid through the motor assembly while the one or more pressure sensors can be configured to detect a leak, air, flow, etc. through the catheter purge line.
  • One or more sensors may be a flow rate sensors configured to sense a flow rate of a fluid flowing through an intravascular blood pump assembly.
  • one or more flowrate sensors may be locatable on, in, or near the motor assembly and configured to acquire a flow rate of a fluid passing through the motor assembly.
  • An example of one or more flow rate sensors may be one or more sensors in operable communication with a flow of blood through the motor assembly.
  • one or more sensors can be locatable on and/or in one or more of the fluid couplers, as described herein.
  • one or more sensors may be operable connected to one or more of the fluid couplers of the motor assembly and configured to sense (e.g., detect) attributes (e.g., pressure, flow rate, temperature, etc.) of a fluid therein and/or flowing therethrough.
  • one or more sensors can be locatable on a fluid coupler (e.g., an inlet fluid coupler and/or an outlet fluid coupler) and may be configured to measure a fluid column pressure.
  • the measured fluid column pressure may be configured and/or used to estimate a pressure blood pump (e.g., at a proximal hub of the blood pump system).
  • One or more sensors may be motor assembly operation sensors configured to detect (e.g., sense) attributes of the motor assembly during operation. For example, one or more sensors may be configured to detect an operating temperature of the motor assembly. One or more sensors may be configured to detect the number of rotations made by the motor assembly. In some examples, one or more sensors may be configured to detect the number of rotations of the drive cable.
  • the handle body may enclose electrical circuitry.
  • Electrical circuity e.g., circuit boards
  • PCB printed circuit boards
  • peripheral components may be in electrical communication with the motor assembly as part of an electrical circuit.
  • data detected, acquired, and/or generated by the intravascular blood pump system may be transmitted to one or more external devices.
  • a communication means may be operably coupled to the motor assembly (e.g., to the one or more sensors) and be configured to send and receive data between the intravascular blood pump system and a remote device.
  • the communication means is a wireless communication means configured to wireless transmit and/or receive data, operation input, or otherwise control or evaluate the operation of the intravascular blood pump system (e.g., motor assembly).
  • a handle as described herein may receive one or more connections to one or more peripheral components.
  • peripheral components may be computing devices, sensors, controllers, containers, power sources, conduits, etc.
  • a peripheral component may be any component outside of the handle used with an intravascular blood pump or associated procedure.
  • Methods of advancing and operating a blood pump system can include advancing a blood pump into a blood vessel of a patient.
  • the blood pump can be a self-expanding blood pump operably coupled to a distal end of a catheter.
  • the self-expanding blood pump may be inserted into a sheath that can be passed through an introducer into a blood vessel of a patient.
  • the sheath may be configured to compress or retain the blood pump in a compressed state during navigation and advancement through the patient’s blood vessel.
  • a catheter e.g., drive cable catheter
  • the drive cable shaft may be operably coupled to a motor assembly within the handle body and extend distally to an impeller within the blood pump.
  • the blood pump is positioned at a location within the blood vessel for operation. The blood pump may be advanced from the sheath and expand to a deployed state.
  • the drive cable catheter can be configured to facilitate advancement and maneuverability of the blood pump through the blood vessel.
  • the drive cable catheter can be configured to translate rotation from a user (e.g., healthcare professional) via engagement and rotation of the handle.
  • navigating and advancing the blood pump through the patient’s vasculature may require adjustment of orientation of the distal end of the blood pump.
  • the handle may be rotated such that the distal end (e.g., the blood pump) rotates in a corresponding manner for accommodate the necessary adjustment and proceed with the placement, position, or advancement of blood pump within the patient’s vasculature.
  • the handle may be used to control operation of the blood pump during use.
  • a controller within the handle or associated with a remote device may be configured to control one or more functions of the blood pump (e.g., rate of rotation, initiation, termination, detecting with one or more sensors, etc.).
  • a blood pump system as described herein, may be introduced, advanced, and operated within the patient’s vasculature.
  • the blood pump e.g., selfexpanding blood pump
  • the blood pump may be sheathed and introduced into the patient’s vasculature.
  • an introducer may be employed to facilitate a transition of the blood pump into the patient’s blood vessel.
  • the blood pump e.g., sheathing catheter with the compressed blood pump therein
  • a user may advance or navigate advancement of the blood pump using the handle body. For example, advancing the blood pump distally into the blood vessel may require adjustment to accommodate an obstruction or junction in the blood vessel.
  • the handle may be rotated, and the drive cable catheter may translate the rotation (e.g., torque) from the handle to the distal end (e.g., the blood pump) until the advancement of the sheathing catheter can continue.
  • the rotation e.g., torque
  • positioning of the blood pump may be optimized or otherwise require rotation for proper placement. Such rotation may also be facilitated by rotating the handle.
  • any of the blood pumps described herein may include surfaces with one or more anticoagulant agents.
  • at least a portion of one or more of the hubs, conduits (e.g., scaffold and/or membrane), struts (e.g., proximal and/or distal struts), distal tips and/or impellers of the blood pumps described herein may include a coating or material having an anticoagulant agent.
  • the anticoagulant agents may include drugs such as heparin, warfarin and/or prostaglandins.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mechanical Engineering (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Human Computer Interaction (AREA)
  • External Artificial Organs (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne des pompes à sang de cathéter qui comprennent une tige de cathéter s'étendant à travers une lumière d'un cathéter. La tige de cathéter peut avoir une extrémité proximale et une extrémité distale, l'extrémité distale pouvant être couplée de manière fonctionnelle à une roue intravasculaire pouvant être placée à l'intérieur d'un vaisseau. Une poignée peut comprendre un boîtier étanche, un moteur en communication fonctionnelle avec l'extrémité proximale de la tige de cathéter, et un relief de contrainte disposé au moins partiellement dans la poignée et fournissant un accès à la tige de cathéter pour passer d'un intérieur de la poignée à un extérieur de la poignée. Un ensemble support est également prévu pour coupler le moteur à la poignée. L'invention concerne également des procédés d'utilisation.
EP23869152.1A 2022-09-20 2023-09-20 Ensemble poignée pour pompes à sang de cathéter Pending EP4590239A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263376374P 2022-09-20 2022-09-20
PCT/US2023/074709 WO2024064767A2 (fr) 2022-09-20 2023-09-20 Ensemble poignée pour pompes à sang de cathéter

Publications (1)

Publication Number Publication Date
EP4590239A2 true EP4590239A2 (fr) 2025-07-30

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Application Number Title Priority Date Filing Date
EP23869152.1A Pending EP4590239A2 (fr) 2022-09-20 2023-09-20 Ensemble poignée pour pompes à sang de cathéter

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EP (1) EP4590239A2 (fr)
WO (1) WO2024064767A2 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4034221B1 (fr) 2019-09-25 2024-11-13 Shifamed Holdings, LLC Pompes à sang de cathéter et boîtiers de pompe pliables
DE102024131393A1 (de) * 2024-10-28 2026-04-30 Witzenmann Gmbh Schlauchanordnung für medizinische Anwendungen und Verfahren zu ihrer Herstellung

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Publication number Priority date Publication date Assignee Title
US20010046380A1 (en) * 2000-02-01 2001-11-29 Cleveland Process Corporation Submersible heater
KR20030024020A (ko) * 2001-09-15 2003-03-26 지엠피바이오(주) 1회용 주사바늘 소각장치
US8323203B2 (en) * 2008-02-28 2012-12-04 Boston Scientific Scimed, Inc. Imaging catheter
US8002565B2 (en) * 2009-01-22 2011-08-23 Integro, Llc Waterproof connector kit useful for airfield lighting applications
US20120191107A1 (en) * 2010-09-17 2012-07-26 Tanner Neal A Systems and methods for positioning an elongate member inside a body
US9452069B2 (en) * 2012-04-27 2016-09-27 Medtronic Vascular, Inc. Reconfigurable stent-graft delivery system and method of use

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WO2024064767A2 (fr) 2024-03-28
WO2024064767A3 (fr) 2024-06-06

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