CA2480467A1 - Implantable heart assist system - Google Patents

Implantable heart assist system Download PDF

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Publication number
CA2480467A1
CA2480467A1 CA002480467A CA2480467A CA2480467A1 CA 2480467 A1 CA2480467 A1 CA 2480467A1 CA 002480467 A CA002480467 A CA 002480467A CA 2480467 A CA2480467 A CA 2480467A CA 2480467 A1 CA2480467 A1 CA 2480467A1
Authority
CA
Canada
Prior art keywords
pumping
extracardiac
patient
pumping system
blood
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.)
Granted
Application number
CA002480467A
Other languages
French (fr)
Other versions
CA2480467C (en
Inventor
Anthony Viole
Laksen Sirimanne
Steven F. Bolling
Shawn O'leary
Robert Pecor
Ryan Kelly
Wolfgang Werner
Masoud Beizai
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.)
Thoratec LLC
Original Assignee
Orqis Medical Corporation
Anthony Viole
Laksen Sirimanne
Steven F. Bolling
Shawn O'leary
Robert Pecor
Ryan Kelly
Wolfgang Werner
Masoud Beizai
Thoratec Corporation
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 Orqis Medical Corporation, Anthony Viole, Laksen Sirimanne, Steven F. Bolling, Shawn O'leary, Robert Pecor, Ryan Kelly, Wolfgang Werner, Masoud Beizai, Thoratec Corporation filed Critical Orqis Medical Corporation
Priority to CA2785934A priority Critical patent/CA2785934A1/en
Publication of CA2480467A1 publication Critical patent/CA2480467A1/en
Application granted granted Critical
Publication of CA2480467C publication Critical patent/CA2480467C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/104Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/117Extracorporeal pumps, i.e. the blood being pumped outside the patient's body for assisting the heart, e.g. transcutaneous or external ventricular assist devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable 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
    • A61M60/152Implantable 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 branching on and drawing blood from a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/205Non-positive displacement blood pumps
    • A61M60/216Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40Details relating to driving
    • A61M60/403Details relating to driving for non-positive displacement blood pumps
    • A61M60/422Details 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/515Regulation using real-time patient data
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/538Regulation using real-time blood pump operational parameter data, e.g. motor current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3653Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3655Arterio-venous shunts or fistulae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable 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
    • A61M60/148Implantable 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/247Positive displacement blood pumps
    • A61M60/253Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/274Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40Details relating to driving
    • A61M60/403Details relating to driving for non-positive displacement blood pumps
    • A61M60/408Details 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
    • A61M60/411Details 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
    • A61M60/414Details 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/855Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857Implantable blood tubes

Abstract

An extracardiac pumping for supplementing the circulation of blood, includin g the cardiac output, in a patient without any component thereof being connect ed to the patient's heart, and methods of using same are disclosed. One embodiment of the intravascular extracardiac system (10) comprises a pump (3 2) with inflow (50) and outflow (52) conduits that are sized and configured to be implantable intravascularly through a non-primary vessel, whereby it may positioned where desired within the patient's vasculature. The system comprises a subcardiac pump that may be driven directly or electromagnetical ly from within or without the patient. The pump is configured to be operated continuously or in a pulsatile fashion, synchronous with the patient's heart , thereby potentially reducing the afterload of the heart. In another embodiment, the system is positioned extracorporeally, with the inflow condu it and outflow conduit applied percutaneously to a non-primary vessel for circulating blood to and from the non-primary vessel or between the non- primary vessel and another blood vessel within the patient's vasculature.</S DOAB>

Claims (29)

1. An extracardiac pumping system for supplementing blood circulation through a patient without any component thereof being connected to the patient's heart, the extracardiac system comprising:
a pumping apparatus configured to pump blood through the patient at subcardiac volumetric rates, said pumping apparatus having an average flow rate that, during normal operation thereof, is substantially below that of the patient's heart when healthy;
an inflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pumping apparatus to direct blood to the pumping apparatus from a non-primary blood vessel; and an outflow conduit comprising flexible tubing having an inner diameter that is less than 25 millimeters fluidly coupled to the pumping apparatus to direct blood from the pumping apparatus to the non-primary blood vessel;
whereby connection of the first ends of the inflow and outflow conduits to the blood vessel may be made subcutaneously to permit application of the connections in an minimally-invasive procedure.
2. The extracardiac pumping system of Claim 1, wherein the pumping apparatus comprises a rotary pump.
3. The extracardiac pumping system of Claim 1, wherein the pumping apparatus is configured to operate in pulsatile fashion.
4. The extracardiac pumping system of Claim 1, wherein the pumping apparatus comprises an impeller.
5. The extracardiac pumping system of Claim 4, wherein the impeller is helically shaped.
6. The extracardiac pumping system of Claim 1, wherein the pumping apparatus comprises a rotatable cable having means for directing blood axially along the cable.
7. The extracardiac pumping system of Claim 1, wherein the pumping apparatus comprises an archemedes screw.
8. The extracardiac pumping system of Claim 4, wherein the impeller is driven mechanically by a motor through a drive wire.
9. The extracardiac pumping system of Claim 4, wherein the impeller is driven electromagnetically by a discrete electromagnetic drive.
10. The extracardiac pumping system of Claim 9, wherein the electromagnetic drive is sized and configured to be implantable.
11. The extracardiac pumping system of Claim 10, wherein the electromagnetic drive is sized and configured to be implantable within the patient's vasculature.
12. The extracardiac pumping system of Claim 1, wherein the pumping apparatus comprises a worm pump.
13. An intravascular extracardiac pumping system for supplementing blood circulation through a patient experiencing congestive heart failure without any component thereof being connected to the patient's heart, the extracardiac system comprising:
a pumping device configured to pump blood through the patient at subcardiac volumetric rates, said pumping device having an average flow rate that, during normal operation thereof, is substantially below that of the patient's heart when healthy, the pumping device configured to be positioned within the vasculature of a patient;
an inflow conduit fluidly coupled:to the pumping device to direct blood to the pumping device, the inflow conduit configured to be positioned within the vasculature of the patient; and, an outflow conduit fluidly coupled to the pumping device to direct blood away from the pumping device, the outflow conduit configured to be positioned within the vasculature of the patient;
whereby the pumping device and the inflow and outflow conduits are configured so as to,be inserted subcutaneously into the vasculature in an minimally-invasive procedure.
14. The intravascular extracardiac pumping system of Claim 13, further comprising a conduit that houses the pumping device and is configured to direct blood from a location upstream of the pumping device to a location downstream of the pumping means.
15. The intravascular extracardiac pumping system of Claim 13, wherein the pumping device comprises a rotary pump.
16. The intravascular extracardiac pumping system of Claim 13, wherein the pumping device is configured to operate in pulsatile fashion.
17. The intravascular extracardiac pumping system of Claim 13, wherein the pumping device comprises an impeller.
18. The intravascular extracardiac pumping system of Claim 17, wherein the impeller is helically shaped.
19. The intravascular extracardiac pumping system of Claim 13, wherein the pumping device comprises a rotatable cable having means for directing blood axially along the cable.
20. The intravascular extracardiac pumping system of Claim 13, wherein the pumping device comprises an archemedes screw.
21. The intravascular extracardiac pumping system of Claim 17, wherein the impeller is driven mechanically by a motor through a drive wire.
22. The intravascular extracardiac pumping system of Claim 17, wherein the impeller is driven electromagnetically by a discrete electromagnetic drive.
23. The intravascular extracardiac pumping system of Claim 22, wherein the electromagnetic drive is sized and configured to be implantable.
24. The intravascular extracardiac pumping system of Claim 23, wherein the electromagnetic drive is sized and configured to be implantable within the patient's vasculature.
25. The intravascular extracardiac pumping system of Claim 13, wherein the pumping device comprises a worm pump.
26. The intravascular extracardiac pumping system of Claim 13, further comprising an additional conduit positioned proximate the pumping device to provide an additional flow path to blood in the vasculature from a point upstream of an inflow to the pumping device to a point downstream of an outflow from the pumping device without passing through the pump.
27. The intravascular extracardiac pumping system of Claim 13 further comprising a second inlet conduit.
28. The intravascular extracardiac pumping system of Claim 13 further comprising a second outlet conduit.
29. An intravascular extracardiac blood perfusion system comprising a multilumen catheter sized and configured to be applied intrasvascularly through a non-primary vessel and a pumping device sized and configured to pump blood at subcardiac rates while residing in a first lumen of said multilumen catheter.
CA2480467A 2002-02-15 2003-02-14 Implantable heart assist system Expired - Fee Related CA2480467C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2785934A CA2785934A1 (en) 2002-02-15 2003-02-14 Implantable heart assist system

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/078,260 2002-02-15
US10/078,260 US6610004B2 (en) 1997-10-09 2002-02-15 Implantable heart assist system and method of applying same
PCT/US2003/004853 WO2003070299A1 (en) 2002-02-15 2003-02-14 Implantable heart assist system

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2785934A Division CA2785934A1 (en) 2002-02-15 2003-02-14 Implantable heart assist system

Publications (2)

Publication Number Publication Date
CA2480467A1 true CA2480467A1 (en) 2003-08-28
CA2480467C CA2480467C (en) 2012-10-02

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
CA2785934A Abandoned CA2785934A1 (en) 2002-02-15 2003-02-14 Implantable heart assist system
CA2480467A Expired - Fee Related CA2480467C (en) 2002-02-15 2003-02-14 Implantable heart assist system

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2785934A Abandoned CA2785934A1 (en) 2002-02-15 2003-02-14 Implantable heart assist system

Country Status (6)

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US (7) US6610004B2 (en)
EP (1) EP1476207A1 (en)
JP (1) JP2005517502A (en)
AU (1) AU2003215293A1 (en)
CA (2) CA2785934A1 (en)
WO (1) WO2003070299A1 (en)

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US9717833B2 (en) 2004-09-17 2017-08-01 The Penn State Research Foundation Heart assist device with expandable impeller pump
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US10117980B2 (en) 2012-05-14 2018-11-06 Tc1 Llc Distal bearing support
US10576193B2 (en) 2012-07-03 2020-03-03 Tc1 Llc Motor assembly for catheter pump
US11077294B2 (en) 2013-03-13 2021-08-03 Tc1 Llc Sheath assembly for catheter pump
US11219756B2 (en) 2012-07-03 2022-01-11 Tc1 Llc Motor assembly for catheter pump
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US10149932B2 (en) 2006-03-23 2018-12-11 The Penn State Research Foundation Heart assist device with expandable impeller pump
US10864309B2 (en) 2006-03-23 2020-12-15 The Penn State Research Foundation Heart assist device with expandable impeller pump
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US20060270894A1 (en) 2006-11-30
AU2003215293A1 (en) 2003-09-09
US7331921B2 (en) 2008-02-19
US20040019251A1 (en) 2004-01-29
US6610004B2 (en) 2003-08-26
US20030088147A1 (en) 2003-05-08
CA2480467C (en) 2012-10-02
US20040236173A1 (en) 2004-11-25
US7125376B2 (en) 2006-10-24
US20080275290A1 (en) 2008-11-06
US20020151761A1 (en) 2002-10-17
US6685621B2 (en) 2004-02-03
CA2785934A1 (en) 2003-08-28

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