NZ792017B2 - Blood pump placement and intravascular blood pump - Google Patents

Blood pump placement and intravascular blood pump

Info

Publication number
NZ792017B2
NZ792017B2 NZ792017A NZ79201721A NZ792017B2 NZ 792017 B2 NZ792017 B2 NZ 792017B2 NZ 792017 A NZ792017 A NZ 792017A NZ 79201721 A NZ79201721 A NZ 79201721A NZ 792017 B2 NZ792017 B2 NZ 792017B2
Authority
NZ
New Zealand
Prior art keywords
set according
introducer set
cannula
electric lines
introducer
Prior art date
Application number
NZ792017A
Other versions
NZ792017A (en
Inventor
Wolfgang Kerkhoffs
Ellen Keysselitz
Brimmers Cristine Rodrigues
Thorsten Siess
Original Assignee
Abiomed Europe Gmbh
Filing date
Publication date
Priority claimed from EP20155972.1A external-priority patent/EP3862034A1/en
Application filed by Abiomed Europe Gmbh filed Critical Abiomed Europe Gmbh
Publication of NZ792017A publication Critical patent/NZ792017A/en
Publication of NZ792017B2 publication Critical patent/NZ792017B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • 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
    • A61M60/221—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
    • 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
    • A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
    • 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
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • 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
    • A61M60/857—Implantable blood tubes
    • 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
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of 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
    • 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
    • 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
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/878—Electrical connections within 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
    • 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
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/88—Percutaneous cables

Abstract

introducer set comprising an intravascular blood pump for percutaneous insertion into a patient’s vasculature and a connecting catheter (25) to be connected to the intravascular blood pump, the intravascular blood pump comprising a pumping device (30) and a supply line, wherein the pumping device (30) comprises a pump section having a blood flow inlet, a blood flow outlet and an impeller rotatable about an axis of rotation for conveying blood from the blood flow inlet to the blood flow outlet, and a drive section connected to the pump section and adapted to drive the impeller, wherein the supply line is adapted to supply energy for driving the impeller, wherein an anchoring structure for anchoring the intravascular blood pump to a blood vessel wall is provided at a distal end region of the intravascular blood pump and wherein the connecting catheter (25) comprises a connector adapted to connect to the anchoring structure of the intravascular blood pump.

Claims (50)

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
1. An introducer set, comprising an intravascular blood pump for percutaneous insertion into a patient’s vasculature and a connecting catheter to be connected to the intravascular blood pump, the intravascular blood pump comprising a pumping device and a supply line, - wherein the pumping device comprises a pump section having a blood flow inlet, a blood flow outlet and an impeller rotatable about an axis of rotation for conveying blood from the blood flow inlet to the blood flow outlet, and a drive section connected to the pump section and adapted to drive the impeller, - wherein the supply line is adapted to supply energy for driving the impeller, - wherein an anchoring structure is provided at a distal end region of the intravascular blood pump and - wherein the connecting catheter comprises a connector adapted to connect to the anchoring structure of the intravascular blood pump.
2. The introducer set according to claim 1, comprising an electrically conductive connection which extends along the pump section and electrically connects the supply line with a motor of the drive section.
3. The introducer set according to claim 1 or 2, wherein the pump section comprises a cannula having a longitudinal axis and being bendable along the longitudinal axis.
4. The introducer set according to claim 3, wherein the blood flow outlet of the pump section is arranged at a distal end of the cannula.
5. The introducer set according to claim 3 or 4, wherein the electrically conductive connection comprises one or more electric lines which extend along a wall of the cannula and electrically connect the supply line with the motor of the drive section.
6. The introducer set according to claim 3 or 4, wherein the electrically conductive connection comprises one or more electric lines which extend along a wall of the cannula and electrically connect the supply line with the motor of the drive section and wherein the motor of the drive section includes a plurality of motor cables and wherein an electrical connector is provided at or in a distance distally to the distal end of the cannula, preferably proximal of the blood flow outlet, where each of the plurality of motor cables is respectively connected to one of the one or more electric lines, the electrical connector preferably being a printed circuit board, and the electrical connector preferably being covered with an insulating material, more preferably with a polymer coating, such as polyurethane.
7. The introducer set according to claim 6, wherein each one of the one or more electric lines is a stranded wire.
8. The introducer set according to claim 6, wherein each one of the one or more electric lines is a single wire.
9. The introducer set according to claim 5, wherein the motor of the drive section includes a plurality of motor cables which constitute the one or more electric lines extending along the cannula, and wherein an electrical connector is provided at or proximally of a proximal end of the cannula, preferably proximal of the blood flow inlet, where each of the plurality of motor cables is respectively connected to the supply line, the electrical connector preferably being a printed circuit board, and the electrical connector preferably being covered with an insulating material, more preferably with a polymer coating, such as polyurethane.
10. The introducer set according to any one of claims 5 to 9, wherein the one or more electric lines extend along the wall of the cannula in a longitudinal direction parallel to the longitudinal axis of the cannula, preferably along a neutral bending plane of the cannula which is predetermined by a central plane of curvature of the cannula, and are stretchable in the longitudinal direction.
11. The introducer set according to any one of claims 5 to 9, wherein the one or more electric lines extend along the wall of the cannula inside at least one bendable tube.
12. The introducer set according to claim 11, wherein the one or more electric lines are laid with slack inside the at least one bendable tube.
13. The introducer set according to claim 11 or 12, wherein one bendable tube is provided for each one of the one or more electric lines.
14. The introducer set according to any one of claims 11 to 13, wherein the at least one bendable tube is disposed along a neutral bending plane of the cannula which is predetermined by a central plane of curvature of the cannula, wherein preferably a plurality of the at least one bendable tube is arranged on opposite sides of the wall of the cannula so as to create the neutral bending plane within the cannula.
15. The introducer set according to claim 14, wherein the cannula has an even number of blood flow inlet ports, more preferably four blood flow inlet ports.
16. The introducer set according to any one of claims 11 to 15, wherein the at least one bendable tube is made of a shape memory alloy.
17. The introducer set according to claim 16, wherein the shape memory alloy is nitinol.
18. The introducer set according to any one of claims 5 to 9, wherein the one or more electric lines extend meander-like along the wall of the cannula.
19. The introducer set according to claim 18, wherein the one or more meander-like extending electric lines are arranged along a neutral bending plane of the cannula which is predetermined by a central plane of curvature of the cannula.
20. The introducer set according to any one of claims 5 to 9, wherein the one or more electric lines extend helically along the wall of the cannula.
21. The introducer set according to claim 20, wherein the cannula includes one or more reinforcing windings which extend helically along the wall of the cannula and wherein an angular orientation of the one or more helically extending electric lines relative to the longitudinal axis of the cannula is different to an angular orientation of the one or more helically extending reinforcing windings so that the one or more reinforcing windings and the one or more electric lines overlap, wherein preferably the angular orientations differ by at least 5°, preferably at least 10°.
22. The introducer set according to claim 21, wherein the angular orientation of the one or more helically extending electric lines relative to the longitudinal axis of the cannula is opposite to the angular orientation of the one or more helically extending reinforcing windings.
23. The introducer set according to claim 20, wherein the cannula includes one or more reinforcing windings which extend helically along the wall of the cannula and wherein the one or more helically extending electric lines are placed between the one or more helically extending reinforcing windings.
24. The introducer set according to claim 23, wherein the one or more helically extending reinforcing windings include a plurality of reinforcing windings arranged in parallel in an axial direction relative to the longitudinal axis of the cannula so as to be nested helically within each other, and wherein the one or more helically extending electric lines include a plurality of electric lines arranged such that exactly one of the plurality of electric lines is placed between two or more of the helically extending reinforcing windings.
25. The introducer set according to claim 24, wherein between two and nine of the reinforcing windings are present.
26. The introducer set according to any one of claims 23 to 25, wherein one or two or three of the one or more helically extending reinforcing windings are arranged between each of the one or more helically extending electric lines.
27. The introducer set according to any one of claims 23 to 26, wherein an electrically insulating layer is arranged between the helically extending reinforcing windings and the helically extending electric lines such that the reinforcing windings are arranged above the insulating layer and the electric lines are arranged below the insulating layer, or vice versa.
28. The introducer set according to claim 20, wherein the cannula includes one or more reinforcing windings, which extend helically along the wall of the cannula and wherein at least one of the electric lines is formed by a respective one of the reinforcing windings.
29. The introducer set according to claim 28, wherein an electrically insulating layer is arranged between the helically extending reinforcing windings such that neighboring reinforcing windings are arranged in alternating fashion above and below the insulating layer.
30. The introducer set according to any one of claims 20 to 29, wherein the one or more helically extending reinforcing windings are made of a flat wire.
31. The introducer set according to any one of claims 20 to 30, wherein the reinforcing windings are made of a shape memory alloy.
32. The introducer set according to any one of claims 5 to 31, wherein the one or more electric lines are arranged inside the wall of the cannula.
33. The introducer set according to any one of claims 5 to 32, wherein the wall of the cannula comprises a first foil and a second foil bonded to and covering the first foil, wherein at least one reinforcing member is arranged between the first and the second foils, preferably together with the one or more electric lines.
34. The introducer set according to claim 33, wherein the first and second foils are made of polyurethane.
35. The introducer set according to any one of claims 3 to 34, wherein the cannula is configured not to buckle when bent along its longitudinal axis by up to 180°.
36. The introducer set according to any one of claims 1 to 35, wherein the impeller is a axially-radially, diagonally or centrifugally delivering impeller.
37. The introducer set according to any one of claims 1 to 36, wherein the supply line is in the form of a supply catheter which preferably further includes at least a pressure sensor line.
38. The introducer set according to any one of claims 1 to 37, wherein the anchoring structure comprises at least one anchor adapted to anchor the intravascular blood pump in a wall of a patient’s blood vessel.
39. The introducer set according to claim 38, wherein the anchor comprises spikes that are expandable and collapsible.
40. The introducer set according to any one of claims 1 to 39, wherein the anchoring structure comprises a hook or loop at an axial end of the distal end region.
41. The introducer set according to claim 40, wherein the loop is made from a soft, elastic material and forms an atraumatic distal extension at the axial end of the distal end region.
42. The introducer set according to claim 40, wherein the loop is provided at an atraumatic distal extension of the intravascular blood pump.
43. 43 The introducer set according to any one of claims 1 to 39, wherein the anchoring structure comprises a neck-and-head structure at an axial end of the distal end region.
44. The introducer set according to claim 43, wherein a connecting surface between a head and a neck of the neck-and-head structure is inclined by 90° relative to a longitudinal axis of the intravascular blood pump, or the connecting surface is inclined by more than 90° relative to the longitudinal axis of the intravascular blood pump so as to form an undercut.
45. The introducer set according to claim 43 or 44, wherein the neck-and-head structure is formed in a recess of the distal end region.
46. The introducer set according to claim 43 or 44, wherein the neck-and-head structure is formed at an end of an atraumatic distal extension.
47. The introducer set according to any one of claims 1 to 46, wherein the connector comprises a hook adapted to hook into the anchoring structure of the intravascular blood pump.
48. The introducer set according to claim 47, the connector comprises a gripper having a first grip and a second grip adapted to close or grip around the anchoring structure of the intravascular blood pump.
49. The introducer set according to claim 48, wherein the gripper has a gripping surface, wherein the gripping surface is inclined by 90° relative to a longitudinal axis of the connecting catheter.
50. The introducer set according to claim 48, wherein the gripper has a gripping surface, wherein the gripping surface is inclined by more than 90° relative to a longitudinal axis of the connecting catheter so as to form an undercut.
NZ792017A 2021-02-02 Blood pump placement and intravascular blood pump NZ792017B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20155972.1A EP3862034A1 (en) 2020-02-06 2020-02-06 Blood pump placement and intravascular blood pump
PCT/EP2021/052436 WO2021156257A1 (en) 2020-02-06 2021-02-02 Blood pump placement and intravascular blood pump

Publications (2)

Publication Number Publication Date
NZ792017A NZ792017A (en) 2025-05-30
NZ792017B2 true NZ792017B2 (en) 2025-09-02

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