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WO2003055541A1 - Intravascular pump - Google Patents

Intravascular pump Download PDF

Info

Publication number
WO2003055541A1
WO2003055541A1 PCT/GB2002/005935 GB0205935W WO03055541A1 WO 2003055541 A1 WO2003055541 A1 WO 2003055541A1 GB 0205935 W GB0205935 W GB 0205935W WO 03055541 A1 WO03055541 A1 WO 03055541A1
Authority
WO
WIPO (PCT)
Prior art keywords
pump
aorta
intravascular
directional
stent
Prior art date
Application number
PCT/GB2002/005935
Other languages
French (fr)
Inventor
Michael Henein
Ashraf Khir
Original Assignee
Michael Henein
Ashraf Khir
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 Michael Henein, Ashraf Khir filed Critical Michael Henein
Priority to EP02805845A priority Critical patent/EP1465686A1/en
Priority to US10/500,614 priority patent/US20050220636A1/en
Priority to AU2002356335A priority patent/AU2002356335A1/en
Publication of WO2003055541A1 publication Critical patent/WO2003055541A1/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
    • 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
    • A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
    • A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
    • 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
    • A61M60/139—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 inside the aorta, e.g. intra-aortic balloon 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
    • A61M60/226—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly radial components
    • A61M60/232—Centrifugal 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
    • A61M60/237—Non-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
    • 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
    • A61M60/873—Energy supply devices; Converters therefor specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8237—Charging means
    • A61M2205/8243—Charging means by induction
    • 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
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/892—Active valves, i.e. actuated by an external force

Definitions

  • Intravascular Pump This invention relates to heart pumps, and in particular, to an intravascular pump which can be used to assist the operation of a patient's heart, when it is in a weak condition.
  • intravascular heart pumps Various types are known, but these generally require major surgery, to enable them to be suitably located in an appropriate position in the heart.
  • the present invention seeks to introduce a heart pump which is capable of providing significant assistance to the heart, whilst reducing the degree of invasive surgery required to introduce it into the operative position.
  • the present invention provides an intravascular bi-directional pump which is adapted to be located in the upper aorta, whereby it can assist the left ventricle to eject in the forward direction during systole, so as to off-load the heart, and also pump an adequate amount in the reverse direction, during diastole to secure coronary flow.
  • the pump is placed either in the ascending aorta, just distal to the aortic valve leaflets, or in the upper descending aorta.
  • the pump is mounted (hung) into a stent that can be deployed by means of a balloon.
  • the latter can be withdrawn after the stent has been established in situ. Both the stent and the pump attached to it will then remain inside the aorta.
  • the pump may be inserted by either 1. Surgically slitting the aorta at the preferred position (see above) and placing the pump.
  • the pump may be powered by a direct connection, such as a wire running through the aortic wall and the skin, and connected to an outside battery, or alternatively by means of a wireless connection, for example using induction coils.
  • Figure 1 is a diagrammatic view of the heart, showing the upper aorta
  • Figure 2 is a schematic view of a positive displacement pump
  • Figure 3 is a schematic view of an axial pump
  • Figure 4 is a schematic view of a first type of centrifugal pump
  • Figure 5 is a schematic view of a second type of centrifugal pump.
  • Figure 6a is a diagrammatic cross-section through an aorta showing a first type of pump mounting
  • FIG 6b is a diagrammatic cross-section through an aorta showing a second type of pump mounting.
  • the heart is illustrated diagrammatically at 2, and the ascending aorta is indicated at 4.
  • a suitable type of heart pump (as described in more detail below) is inserted in the region 4, either by slitting the aorta at the preferred position, or by inserting the pump from the groin or lower abdomen, and advancing it along the aorta until it reaches the preferred position.
  • angioplasty type of technique. This involves mounting the pump in a stent and delivering it on a deflated balloon to the desired position, after which the balloon is withdrawn.
  • Both the stent and the pump then remain inside the aorta.
  • the pump is detachably mounted on the stent so that it can be pulled out of the body (for example via the groin) in case it should become faulty.
  • a releasable attachment mechanism may be arranged between the pump and the stent.
  • Figure 2 illustrates a first possible type of pump that may be utilised for the invention, which is a simple cylindrical positive displacement pump, having a piston 6 and flow outlets 8 and 10 at either end.
  • the pump can be arranged to move fluids in either direction.
  • Figure 3 illustrates an axial pump, having a screw type rotor 12, so that the direction of pumping can be reversed, by reversing the direction of rotation of the rotor.
  • Figure 4 illustrates an alternative type of centrifugal pump, having a rotary impeller
  • the pump can be powered either by: 1. Wireless power transmission, where the required power needed is transferred to the rotor wirelessly from outside the body by means of coils placed on the skin, or 2. Using a wire that runs through the aortic wall and the skin to be connected to an outside-the-body battery that can be charged/replaced or disconnected.
  • Figure 6a illustrates an arrangement in which a stent 32 has been inserted in the artery 34 and carries the pump 36 on a mounting 38 to which it is connected by means of a clip-on hanger arrangement.
  • the pump 36 can be carried on an electromagnetically actuated base 40 so that it is released by disconnecting the power source. In either case this allows the pump to be removed whilst leaving the stent "in-situ”.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Transplantation (AREA)
  • Pulmonology (AREA)
  • External Artificial Organs (AREA)

Abstract

An intravascular bi-directional pump is disclosed which is adapted to be located in the upper aorta, whereby it can assist the left ventricle to eject in the forward direction during systole, so as to off-load the heart, and also pump an adequate amount in the reverse direction, during diastole, to secure coronary flow.

Description

"Intravascular Pump" This invention relates to heart pumps, and in particular, to an intravascular pump which can be used to assist the operation of a patient's heart, when it is in a weak condition. Various types of intravascular heart pumps are known, but these generally require major surgery, to enable them to be suitably located in an appropriate position in the heart. The present invention seeks to introduce a heart pump which is capable of providing significant assistance to the heart, whilst reducing the degree of invasive surgery required to introduce it into the operative position. The present invention provides an intravascular bi-directional pump which is adapted to be located in the upper aorta, whereby it can assist the left ventricle to eject in the forward direction during systole, so as to off-load the heart, and also pump an adequate amount in the reverse direction, during diastole to secure coronary flow.
Preferably, the pump is placed either in the ascending aorta, just distal to the aortic valve leaflets, or in the upper descending aorta.
Preferably the pump is mounted (hung) into a stent that can be deployed by means of a balloon. The latter can be withdrawn after the stent has been established in situ. Both the stent and the pump attached to it will then remain inside the aorta. The pump may be inserted by either 1. Surgically slitting the aorta at the preferred position (see above) and placing the pump.
2. Inserting the pump subcutaneously from the groin or lower abdomen, and advancing it into the aorta until it reaches the preferred position.
Various type of pumps may be utilised to provide the functions required, such as centrifugal, positive displacement or axial. The pump may be powered by a direct connection, such as a wire running through the aortic wall and the skin, and connected to an outside battery, or alternatively by means of a wireless connection, for example using induction coils.
Some embodiments of the invention will now be described, by way of example, with reference to the accompanying drawings in which:
Figure 1 is a diagrammatic view of the heart, showing the upper aorta;
Figure 2 is a schematic view of a positive displacement pump;
Figure 3 is a schematic view of an axial pump;
Figure 4 is a schematic view of a first type of centrifugal pump, and Figure 5 is a schematic view of a second type of centrifugal pump.
Figure 6a is a diagrammatic cross-section through an aorta showing a first type of pump mounting; and
Figure 6b is a diagrammatic cross-section through an aorta showing a second type of pump mounting. Referring firstly to Figure 1 , the heart is illustrated diagrammatically at 2, and the ascending aorta is indicated at 4. A suitable type of heart pump (as described in more detail below) is inserted in the region 4, either by slitting the aorta at the preferred position, or by inserting the pump from the groin or lower abdomen, and advancing it along the aorta until it reaches the preferred position. Preferably, this is achieved using a known "angioplasty " type of technique. This involves mounting the pump in a stent and delivering it on a deflated balloon to the desired position, after which the balloon is withdrawn. Both the stent and the pump then remain inside the aorta. Preferably the pump is detachably mounted on the stent so that it can be pulled out of the body (for example via the groin) in case it should become faulty. For this purpose a releasable attachment mechanism may be arranged between the pump and the stent.
Figure 2 illustrates a first possible type of pump that may be utilised for the invention, which is a simple cylindrical positive displacement pump, having a piston 6 and flow outlets 8 and 10 at either end. By means of suitable switchable one way valves, for example in the piston, the pump can be arranged to move fluids in either direction.
Similarly, Figure 3 illustrates an axial pump, having a screw type rotor 12, so that the direction of pumping can be reversed, by reversing the direction of rotation of the rotor.
In the case of the Figure 2 or Figure 3 pumps, the direction of pumping will be reversed, so that a calculated amount is caused to flow forward towards the periphery, and backwards towards the heart in systole and diastole respectively. Figure 4 illustrates an alternative type of centrifugal pump, having a rotary impeller
14 mounted in the casing 16, so that the inlet region 18 is at the axis of the impeller, whilst the outlet 20 is at the circumference. In a pump arrangement of this kind, if a pair of impellers are arranged to rotate about the same axis 30, as illustrated diagrammatically in the view of Figure 5, the pump can be made to operate bi- directionally, depending upon which of the rotors 26 or 28 is driven at any given time. Thus if the rotor 26 is driven, whilst the rotor 28 is left stationary, fluid will be drawn into the inlet 24, past the stationary vanes of the rotor 28, and axially into the central region of the driven rotor 26 so that aperture 22 becomes an outlet. In a similar way, if the rotor 28 is driven, the aperture 22 becomes an inlet, whilst the aperture 24 becomes an outlet. Alternatively, by adding a suitably oriented additional inlet/outlet duct to the simple centrifugal pump casing of Figure 4, and closing off the axial inlet, the flow can be reversed simply by reversing the direction of rotation of the fan blades, provided that they are also suitably oriented.
The pump can be powered either by: 1. Wireless power transmission, where the required power needed is transferred to the rotor wirelessly from outside the body by means of coils placed on the skin, or 2. Using a wire that runs through the aortic wall and the skin to be connected to an outside-the-body battery that can be charged/replaced or disconnected.
In order to allow the pump to be removed from the body in case of malfunction, it may be detachably mounted on the stent as illustrated in the cross-sectional views of Figures 6a and 6b. Figure 6a illustrates an arrangement in which a stent 32 has been inserted in the artery 34 and carries the pump 36 on a mounting 38 to which it is connected by means of a clip-on hanger arrangement. Alternatively, as shown in Figure 6b, the pump 36 can be carried on an electromagnetically actuated base 40 so that it is released by disconnecting the power source. In either case this allows the pump to be removed whilst leaving the stent "in-situ".

Claims

1. An intravascular bi-directional pump which is adapted to be located in the upper aorta, whereby it can assist the left ventricle to eject in the forward direction during systole, so as to off-load the heart, and also pump an adequate amount in the reverse direction, during diastole, to secure coronary flow.
2. An intravascular bi-directional pump according to claim 1 which is adapted to be placed either in the ascending aorta, just distal to the aortic valve leaflets, or in the upper descending aorta.
3. An intravascular bi-directional pump according to claim 1 or claim 2 which is adapted to be mounted into a stent.
4. An intravascular bi-directional pump according to any preceding claim in which the pump is a centrifugal pump, a positive displacement pump or an axial flow pump.
5. A method of assisting coronary flow comprising placing a bi-directional pump in the ascending aorta, just distal to the aortic valve leaflets, or in the descending aorta.
6. A method according to claim 5 in which the pump is inserted from the groin or the lower abdomen, and advanced into the aorta until it reaches the required position.
7. A method according to claim 5 in which the pump is placed in position by slitting the aorta at a suitable position.
8. A method according to claim 3 in which the pump is mounted onto a stent by means of a releasable attachment mechanism so that the pump can be detached and pulled out of the body should it become faulty.
PCT/GB2002/005935 2001-12-28 2002-12-30 Intravascular pump WO2003055541A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP02805845A EP1465686A1 (en) 2001-12-28 2002-12-30 Intravascular pump
US10/500,614 US20050220636A1 (en) 2001-12-28 2002-12-30 Intravascular pump
AU2002356335A AU2002356335A1 (en) 2001-12-28 2002-12-30 Intravascular pump

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0131059A GB2383540B (en) 2001-12-28 2001-12-28 Intravascular pump
GB0131059.8 2001-12-28

Publications (1)

Publication Number Publication Date
WO2003055541A1 true WO2003055541A1 (en) 2003-07-10

Family

ID=9928466

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2002/005935 WO2003055541A1 (en) 2001-12-28 2002-12-30 Intravascular pump

Country Status (5)

Country Link
US (1) US20050220636A1 (en)
EP (1) EP1465686A1 (en)
AU (1) AU2002356335A1 (en)
GB (1) GB2383540B (en)
WO (1) WO2003055541A1 (en)

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AU2002356335A1 (en) 2003-07-15
GB2383540B (en) 2004-12-08
US20050220636A1 (en) 2005-10-06
GB2383540A (en) 2003-07-02
GB0131059D0 (en) 2002-02-13

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