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NZ768940B2 - Method of manufacturing a blood pump - Google Patents
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NZ768940B2 - Method of manufacturing a blood pump - Google Patents

Method of manufacturing a blood pump

Info

Publication number
NZ768940B2
NZ768940B2 NZ768940A NZ76894019A NZ768940B2 NZ 768940 B2 NZ768940 B2 NZ 768940B2 NZ 768940 A NZ768940 A NZ 768940A NZ 76894019 A NZ76894019 A NZ 76894019A NZ 768940 B2 NZ768940 B2 NZ 768940B2
Authority
NZ
New Zealand
Prior art keywords
outer sleeve
blood pump
molding base
casting compound
impeller
Prior art date
Application number
NZ768940A
Other versions
NZ768940A (en
Inventor
Werner Carell
Wolfgang Kerkhoffs
Frank Kirchhoff
Josef Penners
Thorsten Siess
Original Assignee
Abiomed Europe Gmbh
Filing date
Publication date
Priority claimed from EP18163761.2A external-priority patent/EP3542836A1/en
Priority claimed from EP18163758.8A external-priority patent/EP3542835A1/en
Application filed by Abiomed Europe Gmbh filed Critical Abiomed Europe Gmbh
Priority claimed from PCT/EP2019/057272 external-priority patent/WO2019180221A1/en
Publication of NZ768940A publication Critical patent/NZ768940A/en
Publication of NZ768940B2 publication Critical patent/NZ768940B2/en

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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • 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
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0211—Ceramics
    • 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
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production
    • 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
    • A61M60/10—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
    • A61M60/135—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 inside a blood vessel, e.g. using grafting
    • 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
    • A61M60/148—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 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
    • 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
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A61M60/174—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial 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
    • A61M60/10—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
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • 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
    • 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
    • A61M60/416—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 directly by the motor rotor drive shaft
    • 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
    • A61M60/804—Impellers
    • 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
    • A61M60/818—Bearings
    • 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
    • A61M60/818—Bearings
    • A61M60/825—Contact bearings, e.g. ball-and-cup or pivot bearings
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/70—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by moulding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7532—Artificial members, protheses
    • B29L2031/7534—Cardiovascular protheses

Abstract

intravascular blood pump (P) comprises a pumping device (1) including an impeller (6) and an electric motor for driving the impeller (6). A rotor (7) of the electric motor is rotatable about an axis of rotation and coupled to the impeller (6) so as to be able to cause rotation of the impeller (6). An outer sleeve (13) forms a casing of the pumping device (1), wherein stator components are fixed inside the outer sleeve (13) by means of a casting compound (18). In a method of manufacturing the blood pump (P) the stator components are placed on a molding base (30), including the outer sleeve (13) to thereby form an interspace (19) between the molding base (30) and the outer sleeve (13) in which the stator components are disposed. The casting compound (18) is then injected into the interspace (19) via the molding base to fix the stator components inside the outer sleeve (13). The outer sleeve (13) preferably comprises a magnetically conductive material to form a yoke of the electric motor.

Claims (30)

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS ;
1. A method of manufacturing an intravascular blood pump, the blood pump comprising a pumping device including an impeller and an electric motor for driving the impeller, the electric motor including a stator and a rotor, the rotor rotatable about an axis of rotation and coupled to the impeller so as to be able to cause rotation of the impeller, the method comprising the steps of: - providing a molding base sized and shaped for receiving stator components thereon; - placing the stator components on the molding base; - placing an outer sleeve on the molding base to thereby form at least a portion of an outer surface of the blood pump and an interspace between the molding base and the outer sleeve in which the stator components are disposed; and - injecting a casting compound into the interspace via the molding base to fix the stator components inside the outer sleeve.
2. The method of claim 1, wherein the outer sleeve comprises a magnetically conductive material to form a yoke of the electric motor.
3. The method according to claim 2, wherein the outer sleeve comprises a metal or metal alloy.
4. The method of any one of claims 1 to 3, wherein the step of injecting the casting compound includes feeding the casting compound through the molding base into the interspace.
5. The method of any one of claims 1 to 4, wherein the step of injecting the casting compound is carried out in a low-pressure atmosphere, in which the interspace is substantially evacuated.
6. The method of any one of claims 1 to 5, wherein the step of injecting the casting compound comprises feeding an excess amount of casting compound into and through the interspace into a riser.
7. The method of any one of claims 1 to 6, wherein the molding base is a disposable part.
8. The method of claim 7, wherein the molding base is provided as an injection molded part.
9. The method of any one of claims 1 to 8, wherein the molding base comprises a polymer.
10. The blood pump of claim 9, wherein the polymer is polyethylene, polypropylene or polytetrafluoroethylene.
11. The method of any one of claims 1 to 10, wherein the molding base comprises a pin arranged along a central longitudinal axis of the molding base and protruding from the molding base.
12. The method of claim 11, wherein the pin is provided as a metal pin.
13. The method of any one of claims 1 to 12, wherein the casting compound comprises a polymer material.
14. The method of claim 13, wherein the polymer material is an epoxy resin.
15. The method of any one of claims 1 to 14, the method further comprising the step of sealing the outer sleeve against the outside before the step of injecting the casting compound.
16. The method of any one of claims 1 to 15, further comprising the step of connecting an electric line to at least one of the stator components before the step of placing the outer sleeve on the molding base.
17. The method of any one of claims 1 to 16, wherein the step of placing the stator components on the molding base includes placing an inner sleeve on the molding base such that the interspace for injecting the casting compound is formed between the inner sleeve and the outer sleeve, and the inner sleeve forms a cavity for receiving the rotor.
18. The method of claim 17, comprising the step of providing at least one sealing ring between the outer sleeve and the inner sleeve so as to form a seal there between.
19. The method of claim 18, wherein two of the at least one sealing ring are provided axially in a row.
20. The method of claim 18 or 19, further comprising the steps of: - curing the casting compound to form a first casing section, and - mounting a second casing section against the first casing section with a further sealing ring disposed between the first and second casing sections so as to seal the at least one sealing ring against the cavity.
21. The method of claim 17, further comprising the steps of: - curing the casting compound to form a first casing section, - mounting the first casing section to a second casing section with a liquid sealing material arranged between the first casing section and the second casing section at an interface with the inner sleeve, and - curing the liquid sealing material to sealingly connect the first casing section to the second casing section at the interface with the inner sleeve.
22. An intravascular blood pump for percutaneous insertion into a patient’s blood vessel, comprising a pumping device including an impeller and an electric motor for driving the impeller, the electric motor including a stator and a rotor, the rotor rotatable about an axis of rotation and coupled to the impeller so as to be able to cause rotation of the impeller, the blood pump further comprising an outer sleeve which forms at least a portion of an outer surface of the pumping device, wherein stator components are fixed inside the outer sleeve by means of a casting compound.
23. The intravascular blood pump of claim 22, wherein the outer sleeve comprises a magnetically conductive material to form a yoke of the electric motor.
24. The intravascular blood pump of claim 23, wherein the outer sleeve comprises a metal or metal alloy.
25. The intravascular blood pump of any one of claims 22 to 24, comprising an inner sleeve to form a cavity in which the rotor is received, the inner sleeve arranged inside the outer sleeve to form an interspace between the inner sleeve and the outer sleeve in which the stator components fixed by the casting compound are disposed.
26. The intravascular blood pump of claim 25, wherein the inner sleeve is made of a ceramic material.
27. The intravascular blood pump of claim 25 or 26, comprising at least one sealing ring between the outer sleeve and the inner sleeve forming a seal there between.
28. The intravascular blood pump of claim 27, wherein two of the at least one sealing ring are provided axially in a row.
29. The intravascular blood pump of claim 27 or 28, comprising a further sealing ring disposed so as to seal the at least one sealing ring against the cavity.
30. The intravascular blood pump of claim 25 or 26, comprising a dried liquid sealing material disposed at an interface with the inner sleeve so as to seal the casting compound in the interspace against the cavity.
NZ768940A 2019-03-22 Method of manufacturing a blood pump NZ768940B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18163761.2A EP3542836A1 (en) 2018-03-23 2018-03-23 Intravascular blood pump with ceramic inner sleeve
EP18163758.8A EP3542835A1 (en) 2018-03-23 2018-03-23 Method of manufacturing a blood pump
PCT/EP2019/057272 WO2019180221A1 (en) 2018-03-23 2019-03-22 Method of manufacturing a blood pump

Publications (2)

Publication Number Publication Date
NZ768940A NZ768940A (en) 2025-05-02
NZ768940B2 true NZ768940B2 (en) 2025-08-05

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